EPA Document# EPA-740-D-20-014
April 2020
United States	Office of Chemical Safety and
Environmental Protection Agency	Pollution Prevention
Draft Scope of the Risk Evaluation for Formaldehyde
CASRN 50-00-0
O
c
H' H
April 2020

-------
TABLE OF CONTENTS
ACKNOWLEDGEMENTS	5
ABBREVIATIONS AND ACRONYMS	6
EXECUTIVE SUMMARY	10
1	INTRODUCTION	13
2	SCOPE OF THE EVALUATION	13
2.1	Reasonably Available Information	13
2.1.1	Search of Gray Literature	14
2.1.2	Search of Literature from Publicly Available Databases (Peer-reviewed Literature)	14
2.1.3	Search of TSCA Submissions	20
2.2	Conditions of Use	20
2.2.1	Conditions of Use Included in the Scope of the Risk Evaluation	21
2.2.2	Activities Excluded from the Scope of the Risk Evaluation	27
2.2.3	Production Volume	28
2.2.4	Overview of Conditions of Use and Lifecycle Diagram	28
2.3	Exposures	30
2.3.1	Physical and Chemical (P-Chem) Properties	30
2.3.2	Environmental Fate and Transport	30
2.3.3	Releases to the Environment	30
2.3.4	Environmental Exposures	32
2.3.5	Occupational Exposures	33
2.3.6	Consumer Exposures	34
2.3.7	General Population Exposures	34
2.4	Hazards (Effects)	35
2.4.1	Environmental Hazards	35
2.4.2	Human Health Hazards	35
2.5	Potentially Exposed or Susceptible Subpopulations	35
2.6	Conceptual Models	36
2.6.1	Conceptual Model for Industrial and Commercial Activities and Uses	36
2.6.2	Conceptual Model for Consumer Activities and Uses	38
2.6.3	Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards (Regulatory Overlay)	40
2.6.3.1	Ambient Air Pathway	42
2.6.3.2	Drinking W ater Pathway	42
2.6.3.3	Ambient Water Pathway	42
2.6.3.4	Disposal and Soil Pathway	43
2.6.4	Conceptual Model for Environmental Releases and Wastes	44
2.7	Analysis Plan	46
2.7.1	Physical/Chemical Properties and Environmental Fate	46
2.7.2	Exposure	47
2.7.2.1	Environmental Releases	47
2.7.2.2	Environmental Exposures	50
2.7.2.3	Occupational Exposures	52
2

-------
2.7.2.4	Consumer Exposures	53
2.7.2.5	General Population	56
2.7.3	Hazards (Effects)	58
2.7.3.1	Environmental Hazards	58
2.7.3.2	Human Health Hazards	59
2.7.4	Summary of Risk Approaches for Characterization	62
2.8 Peer Review	62
REFERENCES	63
APPENDICES	75
Appendix A GRAY LITERATURE SOURCES	75
Appendix B PHYSICAL AND CHEMICAL PROPERTIES	79
Appendix C ENVIRONMENTAL FATE AND TRANSPORT PROPERTIES	81
Appendix D REGULATORY HISTORY	83
D.l Federal Laws and Regulations																....83
D.2 State Laws and Regulations												95
D.3	International Laws and Regulations									...........................96
Appendix E PROCESS, RELEASE AND OCCUPATIONAL EXPOSURE INFORMATION 100
E.l	Process Information...							........100
E. 1.1 Manufacture (Including Import)	100
E. 1.1.1 Manufacture	100
E.l. 1.2 Import	101
E. 1.2 Processing and Distribution	101
E. 1.2.1 Processing as a Reactant or Intermediate	101
E. 1.2.2 Incorporated into an Article	103
E. 1.2.3 Incorporated into a Formulation, Mixture or Reaction Product	104
E.l.2.4 Non-Incorporative Activities	104
E.l.3 Uses	105
E.l.3.1 Chemical substances in furnishings, cleaning, and treatment/care products	105
E.l.3.2 Chemical substances in construction, paint, electrical, and metal products	105
E.l.3.3 Chemical substances in automotive and fuel products	106
E.l.3.4 Chemical substances in agriculture use products	106
E.l.3.5 Chemical substances in outdoor use products	106
E.l.3.6 Chemical substances in packaging, paper, plastic and hobby products	106
E.l.3.7 Chemical substances in products not described by other codes	106
E.l.4 Disposal	107
E.2 Preliminary Occupational Exposure Data.............									.......108
Appendix F SUPPORTING INFORMATION: CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES	115
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES	134
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES	142
3

-------
LIST OF TABLES
Table 2-1 Results of Title Screening of Submissions to EPA under Various Sections of TSCA	20
Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation	21
Table 2-3 Summary of Formaldehyde TRI Production-Related Waste Managed in 2018	31
Table 2-4 Summary of Releases of Formaldehyde to the Environment During 2018	31
Table 2-5 Potential Categories and Sources of Environmental Release Data	47
Table 2-6 Potential Sources of Occupational Exposure Data	52
LIST OF FIGURES
Figure 2-1 Gray Literature Tags by Discipline for Formaldehyde	14
Figure 2-2 Peer-Reviewed Literature - Physical-Chemical Properties Search Results for Formaldehyde
	15
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for Formaldehyde	16
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for Formaldehyde	17
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for Formaldehyde	18
Figure 2-6. Peer-reviewed Literature - Hazard Search Results for Formaldehyde	19
Figure 2-7. Formaldehyde Life Cycle Diagram	29
Figure 2-8 Formaldehyde Conceptual Model for Industrial and Commercial Activities and Uses: Worker
and Occupational Non-User Exposures and Hazards	37
Figure 2-9 Formaldehyde Conceptual Model for Consumer Activities and Uses: Consumer Exposures
and Hazards	39
Figure 2-10 Formaldehyde Conceptual Model for Environmental Releases and Wastes: Environmental
and General Population Exposures and Hazards (Regulatory Overlay)	41
Figure 2-11 Formaldehyde Conceptual Model for Environmental Releases and Wastes: Environmental
and General Population Exposures and Hazards	45
LIST OF APPENDIX TABLES
TableApx A-l. Gray Literature Sources that Yielded Results for Formaldehyde	75
TableApx B-l. Physical and Chemical Properties of Formaldehyde	79
TableApx C-l. Environmental Fate and Transport Properties of Formaldehyde	81
Table_Apx D-l. Federal Laws and Regulations	83
Table_Apx D-2. State Laws and Regulations	95
Table Apx D-3. Regulatory Actions by other Governments, Tribes, and International Agreements	96
Table Apx E-l. Summary of NIOSH HHEs with Monitoring for Formaldehyde21	108
Table Apx E-2. Summary of Industry Sectors with Formaldehyde Monitoring Samples Available from
OSHA Inspections Conducted Between 2010 and 2019	108
Table Apx F-l. Worker and Occupational Non-User Exposure Conceptual Model Supporting Table 115
Table Apx G-l. Consumer Exposure Conceptual Model Supporting Table	134
Table Apx H-l. General Population and Environmental Exposure Conceptual Model Supporting Table
	142
4

-------
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).
The OPPT Assessment Team gratefully acknowledges participation or input from Intra-agency
reviewers that included multiple offices within EPA, Inter-agency reviewers that included multiple
Federal agencies, and assistance from EPA contractors GDIT (Contract No. HHSN316201200013W),
ERG (Contract No. EP-W-12-006), Versar (Contract No. EP-W-17-006), ICF (Contract
No.68HERC19D0003), Abt Associates (Contract No. EP-W-16-009) and SRC (Contract No.
68HERH19F0213). EPA also acknowledges the contributions of technical experts from EPA's Office of
Research and Development.
Docket
Supporting information can be found in public docket: J Q-OPPT-2018-0438.
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.
5

-------
ABBREVIATIONS AND ACRONYMS
°c
Degrees Celsius
Hg
Microgram(s)
Hg/L
Micrograms per Liter
AAL
Acceptable or Allowable Ambient Levels
ACC
American Chemistry Council
ACGIH
American Conference of Governmental Industrial Hygienists
ADME
Absorption, distribution, metabolism, and excretion
AEGL
Acute Exposure Guideline Level
AERMOD
AMS (American Meteorological Society)/EPA Regulatory Model
Apx
Appendix
AQS
Air Quality System
atm
atmosphere(s)
AT SDR
Agency for Toxic Substances and Disease Registry
AWQC
Ambient Water Quality Criteria
BAF
Bioaccumulation Factor
BCF
Bioconcentration Factor
BSER
Best System of Emission Reduction
BW
Body weight
BW3 4
Body weight scaling to the 3/4 power
CAA
Clean Air Act
CASRN
Chemical Abstracts Service Registry Number
CBI
Confidential Business Information
CCL
Contaminant Candidate List
CDC
Centers for Disease Control
CDR
Chemical Data Reporting
CEHD
Chemical Exposure Health Data
CEM
Consumer Exposure Model
CEPA
Canadian Environmental Protection Act
CERCLA
Comprehensive Environmental Response, Compensation and Liability Act
CFR
Code of Federal Regulations
ChemSTEER Chemical Screening Tool for Exposure and Environmental Releases
CHIRP
Chemical Risk Information Platform
CI
Confidence interval
cm3
Cubic Centimeter(s)
coc
Concentration of Concern
CoRAP
Community Rolling Action Plan
cou
Conditions of Use
CPCat
Chemical and Product Categories
CPSC
Consumer Product Safety Commission
CSCL
Chemical Substances Control Law
CWA
Clean Water Act
DMR
Discharge Monitoring Report
DOE
Department of Energy
DOT
Department of Transportation
EC
European Commission
EC
Engineering Control

-------
ECHA
E-FAST
EHC
EPA
EPCRA
EPI Suite™
ESD
EU
FDA
FFDCA
FHSA
FIAM
FIFRA
FR
FYI
g
g/cm3
g/mol
GACT
GS
HAP
HE
HERO
HHE
HMTA
HSDB
IA
IARC
IDLH
IECCU
IPCS
IRIS
ISHA
kg
km
L
lb
LC50
LD50
LEV
LOAEL
LOEC
Log Koc
European Chemicals Agency
Exposure and Fate Assessment Screening Tool
Environmental Health Criteria
Environmental Protection Agency
Emergency Planning and Community Right-to-Know Act
Estimation Program Interface Suite™
Emission Scenario Document
European Union
Food and Drug Administration
Federal Food, Drug and Cosmetic Act
Federal Hazardous Substance Act
Formaldehyde Indoor Air Model
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Register
For Your Information
Gram(s)
Grams per cubic centimeters
Grams per Unit-Molar Mass
Generally Available Control Technology
Generic Scenario
Hazardous Air Pollutant
High-end
Health and Environmental Research Online
Health Hazard Evaluation
Hazardous Materials Transportation Act
Hazardous Substances Data Bank
Indoor air
International Agency for Research on Cancer
Immediately Dangerous to Life and Health
Indoor Environmental Concentrations in Buildings with Conditioned and Unconditioned
Zones
International Programme on Chemical Safety
Integrated Risk Information System
Industrial Safety and Health Act
Kilogram(s)
Kilometer(s)
OctanokAir Partition Coefficient
Organic Carbon:Water Partition Coefficient
Octanol:Water Partition Coefficient
Liter(s)
Pound
Lethal Concentration of 50% test organisms
Lethal Dose at which 50% of test organisms die
Local exhaust ventilation
Lowest Observed Adverse Effect Level
Lowest Observed Effect Concentration
Logarithmic Organic Carbon:Water Partition Coefficient
7

-------
Log Kow
Logarithmic Octanol:Water Partition
m
Meter(s)
m2
Square meter(s)
m3
Cubic Meter(s)MA Model-averaging
MACT
Maximum Achievable Control Technology
MCCEM
Multi-Chamber Concentration and Exposure Model
MFG
Manufacture
mg
Milligram(s)
mg/kg-bw
Milligram(s) per kilogram body weight
mg/L
Milligram(s) per Liter
mg/m3
Milligram(s) per cubic meter
mg/mL
Milligram(s) per milliliter
min
Minute(s)
MOA
Mode of Action
MP
Melting Point
MSDS
Material Safety Data Sheet
MSW
Municipal Solid Waste
MSWLF
Municipal Solid Waste Landfill(s)
MW
Molecular weight
N/A
Not Applicable
NAAQS
National Ambient Air Quality Standards
NAICS
North American Industry Classification System
ND
Non-detect (value is < analytical detection limit)
NEI
National Emissions Inventory
NESHAP
National Emission Standards for Hazardous Air Pollutants
NHANES
National Health and Nutrition Examination Survey
NICNAS
National Industrial Chemicals Notification and Assessment Scheme (Australia)
NIH
National Institute of Health
NIOSH
National Institute for Occupational Safety and Health
NIST
National Institute of Standards and Technology
NOAEL
No Observed Adverse Effect Level
NOEC
No Observed Effect Concentration
NPDES
National Pollutant Discharge Elimination System
NPL
National Priorities List
NPRI
National Pollutant Release Inventory
NSPS
New Source Performance Standards
NTP
National Toxicology Program
OCSPP
Office of Chemical Safety and Pollution Prevention
OECD
Organisation for Economic Co-operation and Development
OEHHA
Office of Environmental Health Hazard Assessment
OEL
Occupational Exposure Limit
ONU
Occupational Non-User
OPPT
Office of Pollution Prevention and Toxics
OSHA
Occupational Safety and Health Administration
ow
Office of Water
p
Persistence
PBPK
Physiologically Based Pharmacokinetic

-------
PBPK/PD
Physiologically-based pharmacokinetic / pharmacodynamic
PBT
Persistent, Bioaccumulative, Toxic
PECO
Population, Exposure, Comparator and Outcome
PEL
Permissible Exposure Limit
PESS
Potentially Exposed or Susceptible Subpopulation
PF
Phenol-formaldehyde
POD
Point of Departure
POTW
Publicly Owned Treatment Works
PPE
Personal Protective Equipment
PPm
Part(s) per million
PV
Production Volume
PWS
Public Water System
QA
Quality Assurance
QC
Quality Control
RAD
Risk Assessment Division
RCRA
Resource Conservation and Recovery Act
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals (European Union)
RegDet
Regulatory Determination
REL
Recommended Exposure Limit
SD
Standard deviation
SDS
Safety Data Sheet
SDWA
Safe Drinking Water Act
SIDS
Screening Information Dataset
STEL
Short-term Exposure Limit
STORET
STORage and RETrieval
TCCR
Transparent, Clear, Consistent and Reasonable
TCLP
Toxicity Characteristic Leaching Procedure
TIAB
Title and Abstract
TLV
Threshold Limit Value
TMF
Technical, Managerial, Financial
TRI
Toxics Release Inventory
TSCA
Toxic Substances Control Act
TURI
Toxics Use Reduction Institute (Massachusetts)
TWA
Time-weighted average
U.S.
United States
U.S.C.
United States Code
UlC
Underground Injection Control
UNEP
United Nations Environment Programme
U.S. EPA
United States Environmental Protection Agency
USGS
United States Geological Survey
VOC
Volatile Organic Compound
VP
Vapor Pressure
WHO
World Health Organization
WQP
Water Quality Portal
WQX
Water Quality Exchange

-------
EXECUTIVE SUMMARY
In December 2019, EPA designated formaldehyde (CASRN 50-00-0) as a high-priority substance for
risk evaluation following the prioritization process as required by Section 6(b) of the Toxic Substances
Control Act (TSCA) and implementing regulations (40 CFR 702) (Docket ID: EPA-HQ-OPPT-2018-
0438). The first step of the risk evaluation process is the development of the scope document and this
document fulfills the TSCA regulatory requirement to issue a draft scope document as required in 40
CFR 101 7). This draft scope for formaldehyde includes the following information: the conditions
of use, potentially exposed or susceptible subpopulations (PESS), hazards, and exposures that EPA plans
to consider in this risk evaluation, along with a description of the reasonably available information,
conceptual model, analysis plan and science approaches, and plan for peer review for this chemical
substance. EPA is providing a 45-day comment period on the draft scope. Comments received on this
draft scope document will help inform development of the final scope document and the risk evaluation.
General Information: Formaldehyde is a highly water-soluble (4.0 x 105 mg/L) gas with a vapor
pressure of 3,886 mm Hg.
Reasonably Available Information. EPA leveraged the data and information sources already described
in the document supporting the High-Priority Substance designation for formaldehyde to inform the
development of this draft scope. To further develop this draft scope, EPA conducted a comprehensive
search to identify and screen multiple evidence streams (i.e., chemistry, fate, release and engineering,
exposure, and hazard) and the search and screening results are provided in Section 2.1. Searches were
conducted for formaldehyde. Screening of literature from publicly available databases is currently in
progress; detailed information will be provided in Section 2.1.2 once screening has concluded. EPA is
seeking public comment on this draft scope document and will consider additional information
identified following publication of this draft scope document, as appropriate, in developing the final
scope document. EPA is using the systematic review process described in the Application of Systematic
Review in TSCA Risk Evaluations document (U.S. EPA, 2018a) to guide the process of searching for and
screening reasonably available information, including information already in EPA's possession, for use
and inclusion in the risk evaluation. EPA is applying these systematic review methods to collect
reasonably available information regarding hazards, exposures, PESS, and conditions of use that will
help inform the risk evaluation for formaldehyde.
Conditions of Use. EPA plans to evaluate manufacturing, including importing; processing; distribution
in commerce; industrial, commercial, and consumer uses; and disposal of formaldehyde in risk
evaluation. Formaldehyde is used in several processing activities, including use as a reactant,
incorporation into articles, and incorporation into a formulation, mixture, or reaction product-for various
industrial, commercial, and consumer applications. Formaldehyde is widely used in industrial,
commercial, and consumer applications such as textiles, foam bedding/seating, semiconductors, resins,
glues, composite wood products, paints, coatings, plastics, rubber, resins, construction materials
(including insulation and roofing), furniture, toys, and various adhesives and sealants. EPA identified
these conditions of use from information reported to EPA through CDR and TRI reporting, published
literature, and consultation with stakeholders both for uses currently in production and uses whose
production may have ceased. In addition, EPA plans to analyze distribution in commerce and disposal as
part of the risk evaluation. Section 2.2 provides details about the conditions of use within the scope of
the risk evaluation.
10

-------
Conceptual Model The conceptual model for formaldehyde is presented and discussed in Section 2.6.
Conceptual models are graphical depictions of the actual or predicted relationships of conditions of use,
exposure pathways (media), exposure routes (e.g., inhalation, dermal, oral), hazards and receptors
throughout the life cycle of the chemical substance—from manufacturing, processing, distribution in
commerce, storage, use, to release or disposal. EPA plans to focus the risk evaluation for formaldehyde
on the following exposures, hazards and receptors, however, EPA also plans to consider comments
received on this draft scope and other reasonably available information when finalizing this scope
document, and to adjust the exposure pathways, exposure routes and hazards included in the scope
document as needed.
• Exposures (Pathways and Routes), Receptors and PESS: EPA plans to analyze both human and
environmental exposures resulting from the conditions of use to formaldehyde that EPA plans to
consider in the risk evaluation. Exposures to formaldehyde are discussed in Section 2.3.
Additional information gathered through systematic review searches will also inform expected
exposures.
EPA's plan as to evaluate environmental exposure pathways in the draft scope document
considers whether and how other EPA-administered statutes and regulatory programs address the
presence of formaldehyde in media pathways falling under the jurisdiction of those authorities.
Section 2.6.3 discusses those pathways that may be addressed pursuant to other Federal laws. In
Section 2.6.4, EPA presents the conceptual model describing the identified exposures (pathways
and routes), receptors and hazards associated with the conditions of use of formaldehyde within
the scope of the risk evaluation.
Preliminarily, EPA plans to evaluate the following human and environmental exposure
pathways, routes, receptors and PESS in the scope of the risk evaluation. However, EPA plans to
consider comments received on this draft scope and other reasonably available information when
finalizing this scope document, and to adjust the exposure pathways, exposure routes and
hazards included in the scope document as needed.
-	Occupational exposures associated with industrial and commercial conditions of use:
EPA plans to evaluate exposures to workers and/or occupational non-users (ONUs) via
the inhalation route and exposures to workers via the dermal route associated with the
manufacturing, processing, use or disposal of formaldehyde (Section 2.3.5).
-	Consumer and bystander exposures associated with consumer conditions of use: EPA
plans to evaluate consumer exposure via inhalation and dermal routes (Section 2.3.6).
EPA plans to evaluate inhalation routes of exposure for the consumer user and consumer
bystander. EPA plans to evaluate dermal routes of exposure for only consumer users
(bystanders are not expected to have dermal exposure) via direct dermal contact and
vapor to skin contact. Additionally, dermal exposure will only be evaluated for select
conditions of use where there is a constant supply of product against the skin and
evaporation of product during use is inhibited due to a barrier (rag) or if there is
immersion of a body part into a pool of material.
-	General population exposures: EPA plans to evaluate general population exposure to
formaldehyde via the inhalation route for co-located and co-residing individuals due to
off-gassing from building materials used or installed in a residential setting.,(Section
2.3.7).
11

-------
-	Receptors andPESS: EPA plans to include children, women of reproductive age (e.g.,
pregnant women), workers and consumers as receptors and PESS in the risk evaluation.
-	Environmental exposures: EPA plans to evaluate exposure to formaldehyde for aquatic and
terrestrial receptors.
• Elazards: Hazards for formaldehyde are discussed in Section 2.4. EPA completed preliminary
reviews of information from peer-reviewed assessments and databases to identify potential
environmental and human health hazards for formaldehyde as part of the prioritization process.
EPA identified environmental hazard information during the prioritization process and
information collected through systematic review methods and public comments may identify
additional environmental hazards that warrant the inclusion of the environmental hazard
assessment in the risk evaluation. Environmental hazard effects were identified for aquatic and
terrestrial organisms.
EPA plans to identify and evaluate the environmental, epidemiological and toxicological
literature for formaldehyde using EPA's systematic review process. Relevant mechanistic
evidence will also be considered, if reasonably available, to inform the interpretation of findings
related to potential human health effects and the dose-response assessment. EPA plans to
evaluate all the potential human health hazards for formaldehyde identified during prioritization.
The broad health effect categories include irritation/corrosion of the skin, dermal and respiratory
sensitization, reproductive/developmental toxicity and carcinogenicity in experimental animal
studies.
Analysis Plan. The analysis plan for formaldehyde is presented in Section 2.7. The analysis plan
outlines the general science approaches that EPA plans to use for the various evidence streams (i.e.,
chemistry, fate, release and engineering, exposure, hazard) supporting the risk evaluation. The analysis
plan is based on EPA's knowledge of formaldehyde to date which includes a partial, but ongoing,
review of identified information submitted as described in Section 2.1. EPA plans to continue to
consider new information submitted by the public. EPA may update its analysis plan in the final scope
document if additional data or approaches become reasonably available.
EPA plans to seek public comments on the systematic review methods supporting the risk evaluation for
formaldehyde, including the methods for assessing the quality of data and information and the approach
for evidence synthesis and evidence integration supporting the exposure and hazard assessments. The
details will be provided in a supplemental document that EPA anticipates releasing for public comment
prior to the finalization of the scope document.
Peer Review. The draft risk evaluation for formaldehyde will be peer reviewed. Peer review will be
conducted in accordance with relevant and applicable methods for chemical risk evaluations using
EPA's Peer Review Handbook and other methods consistent with Section 26 of TSCA (See 40 CFR
702.451
12

-------
1 INTRODUCTION
This document presents for comment the scope of the risk evaluation to be conducted for formaldehyde
under the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The Frank R. Lautenberg
Chemical Safety for the 21st Century Act amended the Toxic Substances Control Act (TSCA) on June
22, 2016. The new law includes statutory requirements and deadlines for actions related to conducting
risk evaluations of existing chemicals.
TSCA § 6(b) and 40 CFR Part 702, Subpart A require the Environmental Protection Agency (EPA) to
designate chemical substances as high-priority substances for risk evaluation or low-priority substances
for which risk evaluations are not warranted at the time, and upon designating a chemical substance as a
high-priority substance, initiate a risk evaluation on the substance. TSCA § 6(b)(4) directs EPA, in
conducting risk evaluations for existing chemicals, to "determine whether a chemical substance presents
an unreasonable risk of injury to health or the environment, without consideration of costs or other non-
risk factors, including an unreasonable risk to a PESS identified as relevant to the risk evaluation by the
Administrator, under the conditions of use."
TSCA § 6(b)(4)(D) and implementing regulations require that EPA publish the scope of the risk
evaluation to be conducted, including the hazards, exposures, conditions of use and PESS that the
Administrator expects to consider, within 6 months after the initiation of a risk evaluation. In addition, a
draft scope is to be published pursuant to 40 CFR 702.41. In December 2019, EPA published a list of 20
chemical substances that have been designated high priority substances for risk evaluations (84 FR
), as required by TSCA § 6(b)(2)(B), which initiated the risk evaluation process for those chemical
substances. Formaldehyde is one of the chemicals designated as a high priority substance for risk
evaluation.
2 SCOPE OF THE EVALUATION
2.1 Reasonably Available Information
EPA conducted a comprehensive search for reasonably available information1 to support the
development of this draft scope document for formaldehyde. EPA leveraged the data and information
sources already identified in the document supporting the high-priority substance designation. In
addition, EPA searched for additional data and information on physical and chemical properties,
environmental fate, engineering, exposure, and environmental and human health hazards that could be
obtained from the following general categories of sources:
1.	Databases containing publicly available, peer-reviewed literature;
2.	Gray literature, which is defined as the broad category of data/information sources not found in
standard, peer-reviewed literature databases.
3.	Data and information submitted under TSCA Sections 4, 5, 8(e), and 8(d), as well as "for your
information" (FYI) submissions.
Following the comprehensive search, EPA performed a title and abstract screening to identify
information potentially relevant for the risk evaluation process. This step also classified the references
1 Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize
for use in risk evaluations, considering the deadlines specified in TSCA Section 6(b)(4)(G) for completing such evaluation.
Information that meets the terms of the preceding sentence is reasonably available information whether or not the
information is confidential business information, that is protected from public disclosure under TSCA Section 14 (40 CFR
702.33).
13

-------
into useful categories or tags to facilitate the sorting of information through the systematic review
process. The search and screening process were conducted based on EPA's general expectations for the
planning, execution and assessment activities outlined in the Application of Systematic Review in TSCA
Risk Evaluations document (U.S. EPA, 2018). EPA plans to publish supplemental documentation on the
systematic review methods supporting the formaldehyde risk evaluation to explain the literature and
screening process presented in this document in the form of literature inventory trees. Please note that
EPA focuses on the data collection phase (consisting of data search, data screening, and data extraction)
during the preparation of the TSCA scope document, whereas the data evaluation and integration stages
will occur during the development of the draft risk evaluation and thus are not part of the scoping
activities described in this document.
The subsequent sections summarize the data collection activities completed up to date for the general
categories of sources and topic areas (or disciplines) using systematic review methods. EPA plans to
seek public comments on the systematic review methods supporting the risk evaluation for
formaldehyde upon publication of the supplemental documentation of those methods.
2.1.1 Search of Gray Literature
EPA surveyed the gray literature2 and identified 262 search results relevant to EPA's risk assessment
needs for formaldehyde. Appendix A lists the gray literature sources that yielded 262 discrete data or
information sources relevant to formaldehyde. EPA further categorized the data and information into the
various topic areas (or disciplines) supporting the risk evaluation (e.g., physical chemistry,
environmental fate, environmental hazard, human health hazard, exposure, engineering) and the
breakdown is shown in Figure 2-1. EPA is currently identifying additional reasonably available
information (e.g., public comments), and the reported numbers in Figure 2-1 may change.
Physical.Chemical
Human.Hcalth.Hazard
Fate
Exposure
Environmental.Hazard
Engineering
Gray Literature Tags by Discipline
26/262
56/262
13/262
161/262
4/262
198/262
0	25	50	75	100
Percent Tagged (%)
Figure 2-1 Gray Literature Tags by Discipline for Formaldehyde
The percentages across disciplines do not add up to 100%, as each source may provide data or information for various topic
areas (or disciplines).
2.1.2 Search of Literature from Publicly Available Databases (Peer-reviewed Literature)
EPA is currently conducting a systematic review of the reasonably available literature. This includes
performing a comprehensive search of the reasonably available peer review literature on physical-
2 Gray literature is defined as the broad category of data/information sources not found in standard, peer reviewed literature
or databases (e.g., PubMed and Web of Science). Gray literature includes data/information sources such as white papers,
conference proceedings, technical reports, reference books, dissertations, information on various stakeholder websites, and
other databases.
14

-------
chemical (p-chem) properties, environmental fate and transport, engineering (environmental release and
occupational exposure), exposure (environmental, general population and consumer) and environmental
and human health hazards of formaldehyde. Eligibility criteria were applied in the form of PECO
(population, exposure, comparator, outcome) statements. Included references will meet the PECO
criteria, whereas excluded references will not meet the criteria (i.e., not relevant), and supplemental
material will be considered as potentially relevant. EPA plans to analyze the reasonably available
information identified for each discipline during the development of the risk evaluation. EPA is in the
process of screening the identified literature for the different disciplines; the search results are not yet
ready for review. The literature inventory trees depicting the number of references that were captured
and those that were included, excluded, or tagged as supplemental material during the screening process
for each discipline area will be shown in Figure 2-2 through Figure 2-6. "TIAB" in these figures refers
to "title and abstract screening". Note that the sum of the numbers for the various sub-categories may be
larger than the broader category because some studies may be included under multiple sub-categories. In
other cases, the sum of the various sub-categories may be smaller than the main category because some
studies may not be depicted in the sub-categories if their relevance to the risk evaluation was unclear.
r
Retrieved for Full-text
Review
<
Total for TIAB:
P-Chem
v
Exclusion
Figure 2-2 Peer-Reviewed Literature - Physical-Chemical Properties Search Results for
Formaldehyde
15

-------
Bioconcentration
Biodegradation
Hydrolysis
Photolysis
22
Retrieved for Full-text
Review
2748
Volatilization
Total for TIAB:
Fate
Wastewater Treatment
X 2726
Exclusion
Other
Figure 2-3 Peer-reviewed Literature - Fate and Transport Search Results for Formaldehyde
16

-------
Gene:?. Faulty Estimate
425
2,320
1,874
Occupational Exposure
223
Figure 2-4 Peer-reviewed Literature - Engineering Search Results for Formaldehyde

-------
aquatic species (59)
biosoiids/sludge (122)
foreign language (79)
\f consumer uses and/or products (1121)
drinking water (6)
Supplemental (1401)
dietary (115)
ambient air (1323)
epidemiological/biomonitoring study (322)
Unique HERO IDs (14002)
Excluded (8893)
PECO relevant (3436)
* ground water (56)
Included (3708)
Unclear (272)
indoor air (2057)
sediment (115)
soil (101)
surface water (370)
terrestrial species (70)
Figure 2-5 Peer-reviewed Literature - Exposure Search Results for Formaldehyde
18

-------
Human
Human Health Model
Animal
Ecotoxicological Model
3074
Plant
Retrieved for Full-text
Review
87531
3604
Total for TIAB:
Hazard
Exclusion
2858
Supplemental
Material
77995
Not yet screened
Figure 2-6. Peer-reviewed Literature - Hazard Search Results for Formaldehyde
For efficient screening, TIAB for hazard were screened in SWIFT ActiveScreener (https://www.sciome.com/swift-
actiyescrccner/). a specialized systematic review software application that uses "active" learning by which real time screening
decisions are used to prioritize unscreened studies for relevance. By leveraging this active learning tool, EPA will not need to
manually screen all of the 87,531 peer-reviewed human health and environmental hazards citations identified in its
formaldehyde literature search. To date, EPA has only identified approx. 50% of the peer-reviewed data that are likely to be
relevant to the formaldehyde risk analysis based on TIAB, therefore, the numbers presented in this diagram will change.
TIAB screening will continue until SWIFT ActiveScreener indicates that it is likely that at least 95% of the relevant studies
have been identified, a percent identification often used to evaluate the performance of machine learning applications and
considered comparable to human error rates. In addition, the supplemental tagging details are unavailable at this stage of the
draft scope document.
19

-------
2.1.3 Search of TSCA Submissions
Table 2-1 presents the results of screening the titles of data sources and reports submitted to EPA under
various sections of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century
Act. EPA screened a total of 191 submissions using inclusion/exclusion criteria specific to individual
disciplines (see Table 2-1 for the list of disciplines). The details about the criteria are not part of this
document but will be provided in a supplemental document that EPA anticipates releasing prior to the
finalization of the scope document. EPA identified 116 submissions that met the inclusion criteria in
these statements and identified 38 submissions with supplemental data. EPA excluded 37 submissions
because the reports were identified as one of the following:
•	Prepublication copy of a manuscript or letter regarding a draft manuscript that was later
published and that would be identified via other peer or gray literature searches
•	Summary of other reports
•	Study of toxicity to bacteria
•	Data not relevant to any discipline
•	Submission on a different chemical
•	Letter containing meeting notes
•	Status or progress report
•	Preliminary or interim report of a final available submitted report
•	Record of telephone communication
•	Annotated bibliography
EPA plans to conduct additional deduplication at later stages of the systematic review process (e.g., full
text screening), when more information regarding the reports is reasonably available.
Table 2-1 Results of Title Screening of Submissions to EPA under Various Sections of TSCA
Discipline
Included
Supplemental
P-Chem Properties
0
0
Environmental Fate and Transport
2
0
Environmental and General Population Exposure
25
0
Occupational Exposure/Release Information
73
1
Environmental Hazard
1
4
Human Health Hazard
56
34
2.2 Conditions of Use
As described in the Promised Designation of Formaldehyde (CASRN 50-00-0) as a High-Priority
Substance for Risk Evaluation (U.S. EPA, 2019a), EPA assembled information from the CDR and TRI
programs to determine conditions of use3 or significant changes in conditions of use of the chemical
substance. EPA also consulted a variety of other sources to identify uses of formaldehyde, including
3 Conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is
intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of (15
U.S.C. § 2602(4)).
20

-------
published literature, company websites, and government and commercial trade databases and
publications. To identify formulated products containing formaldehyde, EPA searched for safety data
sheets (SDS) using internet searches, EPA Chemical and Product Categories (CPCat) data, and other
resources in which SDSs could be found. SDSs were cross-checked with company websites to make
sure that each product SDS was current. In addition, and when applicable, EPA incorporated
communications with companies, industry groups, environmental organizations, and public comments to
supplement the use information.
After gathering the conditions of use, EPA identified those categories or subcategories of use activities
for formaldehyde that the Agency determined not to be conditions of use or will otherwise be excluded
during scoping. These categories and subcategories are described in Section 2.2.1; Table 2-2.
Also, EPA identified and described the categories and subcategories of conditions of use that will be
included in the scope of the risk evaluation (Section 2.2.1; Table 2-2). The conditions of use included in
the scope are those reflected in the life cycle diagrams and conceptual models.
2.2.1 Conditions of Use Included in the Scope of the Risk Evaluation
Table 2-2 lists the conditions of use that are included in the scope of the risk evaluation.
Table 2-2 Categories and Subcategories of Conditions of Use Included in the Scope of the Risk
Evaluation
l.ile Cycle
Stage
Category
Subcategory
Reference
Manufacturi
ng
Domestic
manufacturing
Domestic manufacturing
U.S. EPA (2019b)

Importing
Importing
U.S. EPA (2019b)
Processing
Reactant
Adhesives and sealant chemicals in:
Plastic and resin manufacturing; Wood
product manufacturing; All other basic
organic chemical manufacturing
U.S. EPA (2019b)


Intermediate in: Pesticide, fertilizer, and
other agricultural chemical
manufacturing; Petrochemical
manufacturing; Soap, cleaning
compound, and toilet preparation
manufacturing; All other basic organic
chemical manufacturing; Plastic materials
and resin manufacturing; Adhesive
manufacturing; All other chemical
product and preparation manufacturing;
Paper manufacturing; Plastic products
manufacturing; Wood product
manufacturing; Construction;
Agriculture, forestry, fishing, and hunting
U.S. EPA (2019b)
21

-------
1 .ilc Cycle
Slsi«c
CsiU'gorv
Siihcsilojiorv
UcfomuT


Functional iluid in. Oil and gas drilling,
extraction, and support activities
U.S. EPA (2019b)
Processing aids, specific to petroleum
production in all other basic chemical
manufacturing
U.S. EPA (2019b)
Bleaching agent in wood product
manufacturing
U.S. EPA (2019b)
Agricultural chemicals in agriculture,
forestry, fishing, and hunting
U.S. EPA (2019b)
Incorporation into
an article
Finishing agents in textiles, apparel, and
leather manufacturing
U.S. EPA (2019b)
Paint additives and coating additives not
described by other categories in
transportation equipment manufacturing
(including aerospace)
U.S. EPA (2019b);
AIA (EPA-HQ-OPPT-
2018-0438-0006)
Synthetic Rubber Manufacturing in
transportation equipment manufacturing
(tires)
USTM Meeting (2019)
Adhesives and sealant chemicals in wood
product manufacturing; plastic material
and resin manufacturing (including
structural and fireworthy aerospace
interiors); construction; paper
manufacturing
U.S. EPA (2019b);
AIA (EPA-HQ-OPPT-
2018-0438-0006);
ARMA (EPA-HQ-
OPPT-2018-043 8-
0005)
Incorporation into a
formulation,
mixture, or reaction
product
Petrochemical manufacturing, petroleum,
lubricating oil and grease manufacturing;
fuel and fuel additives; lubricant and
lubricant additives; all other basic organic
chemical manufacturing
U.S. EPA (2019b);
AIA (EPA-HQ-OPPT-
2018-0438-0006);
Everlube Meeting
(2020)
Asphalt, paving, roofing, and coating
materials manufacturing
U.S. EPA (2019b);
ARMA (EPA-HQ-
OPPT-2018-043 8-
0005)
Solvents (which become part of a product
formulation or mixture) in paint and
coating manufacturing
U.S. EPA (2019b)
Processing aids, specific to petroleum
production in: oil and gas drilling,
extraction, and support activities and all
U.S. EPA (2019b);
AIA (EPA-HQ-OPPT-
2018-0438-0006); EDF
22

-------
1 .ilc Cycle
Slsi«c
CsiU'gorv
SuhrsiU'gorv
UcfomuT


other basic inorganic chemical
manufacturing
(EP A-HQ-OPPT-2018-
0438-0017)


Paint additives and coating additives not
described by other categories in: paint
and coating manufacturing and plastic
material and resin manufacturing
U.S. EPA (2019b)


Intermediate in: all other basic chemical
manufacturing; all other chemical product
and preparation manufacturing; plastic
material and resin manufacturing; oil and
gas drilling, extraction, and support
activities; wholesale and retail trade
U.S. EPA (2019b)


Other: Preservative in all other chemical
product and preparation manufacturing
U.S. EPA (2019b)


Solid separation agents in miscellaneous
manufacturing
U.S. EPA (2019b)


Agricultural chemicals (non-pesticidal)
in: agriculture, forestry, fishing, and
hunting; pesticide, fertilizer, and other
agricultural chemical manufacturing
U.S. EPA (2019b)


Surface active agents in plastic material
and resin manufacturing
U.S. EPA (2019b)


Ion exchange agents in adhesive
manufacturing and paint and coating
manufacturing
U.S. EPA (2019b)


Lubricant and lubricant additive in
adhesive manufacturing
U.S. EPA (2019b)


Plating agents and surface treating agents
in all other chemical product and
preparation manufacturing
U.S. EPA (2019b)


Functional fluids (closed system) in soap,
cleaning compound, and toilet
preparation manufacturing
U.S. EPA (2019b)


Other: Laboratory chemicals
U.S. EPA (2019b)


Adhesive and sealant chemical in
adhesive manufacturing
U.S. EPA (2019b)


Bleaching agents in textile, apparel, and
leather manufacturing
U.S. EPA (2019b)
23

-------
1 .ilc Cycle
Slsi«c
CsiU'gorv
Siihcsilojiorv
UcfomuT

Repackaging
Sales lo distributors for laboratory
chemicals
U.S. LP A p.uyb)

Recycling
Recycling
U.S. EPA (2019b)
Industrial
Use
Non-incorporative
activities
Process aid in: Oil and gas drilling,
extraction, and support activities (e.g.,
hydraulic fracking fluid)
U.S. EPA (2019b);
EDF (EPA-HQ-OPPT-
2018-0438-0017)


Used in: construction and agriculture,
forestry, fishing, and hunting
U.S. EPA (2019b)
Disposal
Disposal
Disposal
U.S. EPA (2019b)
Commercial
Uses
Chemical
substances in
furnishing,
treatment/care
products
Floor coverings; Foam seating and
bedding products; Furniture and
furnishings not covered elsewhere;
Cleaning and furniture care products;
Fabric, textile, and leather products not
covered elsewhere
U.S. EPA (2016); U.S.
EPA (2019b); Certified
Labs (1995); CPSC
email (2019);

Chemical
substances in
treatment products
Water treatment products
U.S. EPA (2019b);
Mansfield Sanitary
(1985); Chemetrics
(1989); Calgon (1990)

Chemical
substances in
treatment/care
products
Laundry and dishwashing products;
Personal care products
U.S. EPA (2019b)

Chemical
substances in
construction, paint,
electrical, and metal
products
Adhesives and Sealants; Paint and
coatings
U.S. EPA (2019b) E.I.
Dupont de Nemours &
Co. (1989; 1995)

Chemical
substances in
construction, paint,
electrical, and metal
products
Building/construction materials - wood
and engineered wood products;
Building/construction materials not
covered elsewhere
U.S. EPA (2019b);
U.S. EPA (2016)

Chemical
substances in
electrical products
Electrical and electronic products
(including semiconductors)
U.S. EPA (2019b); IPC
Meeting (2019);
Enthone-OMI, Inc.
(1990)
24

-------
1 .ilc Cycle
Slsi«c
CsiU'gorv
Siihcsilojiorv
UcfomuT

Chemical
substances in metal
products
\lelal products nol co\ ered elsewhere
U.S. LP A p.uyb),
Formica brand products
(1988)

Chemical
substances in
automotive and fuel
products
Automotive care products; Lubricants
and greases; Fuels and related products
U.S. EPA (2019b);
USTM Meeting (2019);
Northern Labs, Inc
(1990); Everlube
Meeting (2020)

Chemical
substances in
agriculture use
products
Lawn and garden products
U.S. EPA (2019b)

Chemical
substances in
outdoor use
products
Explosive materials
U.S. EPA (2019b)

Chemical
substances in
packaging, paper,
plastic, and hobby
products
Food packaging; Paper products; Plastic
and rubber products; Toys, playground,
and sporting equipment
U.S. EPA (2019b);
AC A Meeting (2019);
ACC 2019 (EPA-HQ-
OPPT-2018-043 8-
0018); Franklin
International (1992);
Enthone-OMI, Inc
(1992)

Chemical
substances in hobby
products
Arts, crafts, and hobby materials
U.S. EPA (2019b);
Day-Glo Corporation
(1993); Elmers (2012)

Chemical
substances in
packaging, paper,
plastic, hobby
products
Ink, toner, and colorant products;
Photographic supplies
U.S. EPA (2019b);
Graphic Controls
Industrial Products
(1985); Eastman-
Kodak (1996)

Chemical
substances in
products not
described by other
codes
Laboratory Chemicals (e.g., specimen
preservation, medical samples, mortuary
science)
U.S. EPA (2019b);
Dodge Chemical Co
(1988); Pierce
Chemicals (1988)
Consumer
Uses
Chemical
substances in
Floor coverings; Foam seating and
bedding products; Cleaning and furniture
U.S. EPA (2019b);
U.S. EPA (2016);
25

-------
1 .ilc Cycle
Slsi«c
CsiU'gorv
Siihcsilojiorv
UcfomuT

furnishing
treatment/care
care products, Furniture and furnishings
not covered elsewhere
Keller-Reck ill
Colman Inc (1991)

products
Fabric, textile, and leather products not
covered elsewhere (clothing)
CPSC Email (2019)

Chemical
substances in
treatment products
Water treatment products
U.S. EPA (2019b);
Mansfield Sanitary
(1985); Chemetrics
(1989); Calgon (1990)

Chemical
substances in
treatment/care
products
Laundry and dishwashing products;
Personal care products
U.S. EPA (2019b);
Phoenix Brands (2007),
Suavitel (2016);
Colgate-Palmolive
Company (2015);
Softsoap (2016);
Keller-Reckitt &
Colman Inc (1991)

Chemical
substances in
construction, paint,
Adhesives and Sealants; Paint and
coatings
U.S. EPA (2019b);
Dexter Crown Metro
Aerospace Inc (1992)

electrical, and metal
products
Building/construction materials - wood
and engineered wood products;
Building/construction materials not
covered elsewhere
U.S. EPA (2019b);
U.S. EPA (2016)

Chemical
substances in
electrical products
Electrical and electronic products
(including semiconductors)
U.S. EPA (2019b); IPC
Meeting (2019);
Enthone-OMI, Inc.
(1990)

Chemical
substances in
automotive and fuel
products
Automotive care products; Lubricants
and greases; Fuels and related products
U.S. EPA (2019b);
USTM Meeting (2019);
Northern Labs, Inc
(1990); Everlube
Meeting (2020)

Chemical
substances in
agriculture use
products
Lawn and garden products
U.S. EPA (2019b);

Chemical
substances in
packaging, paper,
Paper products; Plastic and rubber
products; Toys, playground, and sporting
equipment
U.S. EPA (2019b);
AC A Meeting (2019);
ACC (EPA-HQ-OPPT-
2018-0438-0018);
26

-------
l.ile Cycle
Sla«e
Csilegorv
Subcategory
Reference

plastic, hobby
products

Enthone-OMI, Inc.
(1992)

Chemical
substances in hobby
products
Arts, crafts, and hobby materials
U.S. EPA (2019b);
Day-Glo Color
Corporation (1993);
Elmers (2012)

Chemical
substances in
packaging, paper,
and plastic
Ink, toner, and colorant products;
Photographic supplies
U.S. EPA (2019b);
Graphic Controls
Industrial Products
(1985); Franklin
International (1992);
Eastman Kodak
Company (1996)
• Life Cycle Stage Use Definitions
-	"Industrial use" means use at a site at which one or more chemicals or mixtures are
manufactured (including imported) or processed.
-	"Commercial use" means the use of a chemical or a mixture containing a chemical (including
as part of an article) in a commercial enterprise providing saleable goods or services.
-	"Consumer use" means the use of a chemical or a mixture containing a chemical (including as
part of an article, such as furniture or clothing) when sold to or made available to consumers
for their use.
2.2.2 Activities Excluded from the Scope of the Risk Evaluation
As explained in the final rule for Procedures for Chemical Risk Evaluation Under the Amended Toxic
Substances Control Act, TSCA Section 6(b)(4)(D) requires EPA to identify "the hazards, exposures,
conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to
consider" in a risk evaluation, suggesting that EPA may exclude certain activities that it determines to be
conditions of use on a case-by-case basis (82 FR 33736, 33729; July 20, 2017). As a result, EPA plans
to not include in this scope or in the risk evaluation the activities described below that the Agency has
concluded do not constitute conditions of use.
EPA has determined that formaldehyde has several uses outside the scope of TSCA. Specifically,
formaldehyde has several pesticidal uses in agriculture and as an antimicrobial pesticide. Formaldehyde
is also used in personal care products, cosmetics, hair treatments, mouthwash, nail treatment, shaving
cream, soap, shampoo, and deodorants. Miscellaneous non-TSCA uses include use of formaldehyde in
food packaging adhesives and sugar refineries (Earthjustice (EPA-HQ-OPPT-2018-0438-0019)). These
uses are excluded from the definition of "chemical substance" in TSCA § 3(2)(B)(vi). Activities and
releases associated with these uses of formaldehyde are therefore not "conditions of use" (defined as
circumstances associated with "a chemical substance4," TSCA § 3(4)) and will not be evaluated during
4Chemical substance means any organic or inorganic substance of a particular molecular identity, including any combination
of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature, and any element or
uncombined radical. Chemical substance does not include (1) any mixture; (2) any pesticide (as defined in the Federal
27

-------
risk evaluation]. However, manufacturing, processing, and industrial uses of these products are covered
by TSCA and will be considered a condition of use. Additionally, EPA has determined that three types
of composite wood products in panel form only (hardwood plywood, particleboard, and medium density
fiberboard [including thin-medium density fiberboard]) currently regulated under the Formaldehyde
Emission Standards for Composite Wood Products final rule (i.e., 40 CFR 770) will not be included in
the scope of this evaluation because these products are manufactured domestically and/or imported only
after meeting the Congressionally mandated emission standards, which are verified through an actively
managed EPA third-party certification program. EPA has determined that other non-TSCA Title VI
regulated "composite," "engineered," or "pressed" wood products will be included in the scope of this
evaluation.
2,2.3 Production Volume
As reported to EPA during the 2016 CDR reporting period and described here as a range to protect
production volumes that were claimed as confidential business information (CBI), production volume of
formaldehyde in 2015 was between 1 billion and 5 billion pounds (U.S EPA, 2017; Figure 2-1). EPA
also reviews pre-2015 CDR production volume information, as detailed in the Proposed Designation o f
Formaldehyde fCASRN50-00-0) as a High-Priority Substance for Risk Evaluation (U.S. EPA, 2019a)
and will include future production volume information as it becomes available to support the exposure
assessment.
2.2.4 Overview of Conditions of Use and Lifecycle Diagram
The life cycle diagram provided in Figure 2-7 depicts the conditions of use that are considered within
the scope of the risk evaluation for the various life cycle stages including manufacturing, processing, use
(industrial, commercial, and consumer), distribution and disposal of formaldehyde. Section 2.2.1
summarizes the descriptions of the industrial, commercial and consumer use categories included in the
life cycle diagram. The descriptions provide a brief overview of the use category. The activities that
EPA determined are out of scope are not included in the life cycle diagram. Appendix E contains more
detailed descriptions (e.g., process descriptions, worker activities) for each manufacture, processing, use
and disposal category. The information in the life cycle diagram is grouped according to the 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)5.
Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a
pesticide; (3) tobacco or any tobacco product; (4) any source material, special nuclear material, or byproduct material (as
such terms are defined in the Atomic Energy Act of 1954 and regulations issued under such Act); (5) any article the sale of
which is subject to the tax imposed by Section 4181 of the Internal Revenue Code of 1954 (determined without regard to any
exemptions from such tax provided by Section 4182 or 4221 or any other provision of such Code), and; (6) any food, food
additive, drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and Cosmetic Act)
when manufactured, processed, or distributed in commerce for use as a food, food additive, drug, cosmetic, or device
5 The descriptions are primarily based on the corresponding industrial function category and/or commercial and consumer
product category descriptions and can be found in EPA's Instructions for Reporting 20.1.6 TSCA Chemical Data Reporting.
28

-------
MFG/IMPORT
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES RELEASES and DISPOSAL
Manufacture
(Including
Import)
(1-5 billion
lbs)
I
Processing as Reactant
Adkesives and sealant chemicals (plastics and resin manufacturing;
wood product manufacturing; all other basic inorganic chemical
manufacturing); Intermediate (pesticide, fertilizer, and other
agricultural chemical manufacturing; petrochemical manufacturing;
soap, cleaning compound, and toilet preparation manufacturing).. .See
Table 2-2
Incorporated into Formulation
Petrochemical manufacturing, petroleum, lubricating oil and grease
manufacturing (fuel and fuel additives, lubricant and lubricant
additives; all other basic organic chemical manufacturing); Asphalt,
paving, roofing, and coating materials manufacturing; Solvents which
become part of a product formulation or mixture (paint and coating
manufacturing); Processing aids, specific to petroleum production (oil
and gas drilling, extraction, and support activities),.. See Table 2-2
Incorporated into Article
Finishing agents (textiles, apparel, and leather manufacturing); Paint
additives and coating additives not described by other categories
(transportation equipment manufacturing including aerospace) .... See
Table 2-2
Repackaging (Laboratory chemicals)
Recycling
Non-incorporative activities1
(e.g., process aid)
Furnishings, Cleaning, and
Treatment/Care Products1,2
(e.g., laundry and dishwashing
products,...)
Construction, Paint, Electrical,
and Metal Products1,2
Automotive and Fuel
Products1,2
(e.g. lubricants, ...)
Outdoor Use Products1
(e.g. explosive materials)
Packaging, Paper, Plastic,
Hobby Products1,2
(e.g., food packaging, toys,
sporting equipment, photographic
supplies, ...)
Other Use1
(e.g., laboratory use in medical
labs, embalming)
Disposal
See Conceptual Model for
Environmental Releases and
Wastes
I I Manufacture
'	' (Including Import)
~
Processing
	] Uses.
1.	Industrial and/or
commercial.
2.	Consumer
Figure 2-7. Formaldehyde Life Cycle Diagram
Please refer to Table 2-2 for the comprehensive list of processing activities and the relevant sub-categories for industrial, commercial, and consumers uses. Volume is not
depicted in the life cycle diagram for processing and industrial and commercial uses as specific production volume is claimed as CBI or withheld pursuant to TSC A
Section § 14.
29

-------
2.3 Exposures
For TSCA exposure assessments, EPA plans to analyze exposures and releases to the environment
resulting from the conditions of use within the scope of the risk evaluation for formaldehyde. Release
pathways and routes will be described to characterize the relationship or connection between the
conditions of use of the chemical and the exposure to human receptors, including PESS, and
environmental receptors. EPA plans to consider, where relevant, the duration, intensity (concentration),
frequency, and number of exposures in characterizing exposures to formaldehyde.
2.3.1	Physical and Chemical (P-Chem) Properties
Consideration of p-chem properties is essential for a thorough understanding or prediction of
environmental fate (i.e., transport and transformation) and the eventual environmental concentrations.
They can also inform other components of the risk evaluation, i.e., the hazard and exposure assessments.
EPA plans to use the physical and chemical properties described in the Proposed Designation of
Formaldehyde fCASRN"50-00-0) as a High-Priority Substance for Risk Evaluation (U.S. EPA, 2019a) to
support the development of the risk evaluation for formaldehyde. The values for the physical and
chemical properties (Appendix B) may be updated as EPA collects additional information through
systematic review methods.
2.3.2	Environmental Fate and Transport
Understanding of environmental fate and transport processes assists in the determination of the specific
exposure pathways and potential human and environmental receptors that need to be assessed in the risk
evaluation for formaldehyde. EPA plans to use the environmental fate characteristics described in the
Proposed Designation	naldehyde fCASRN 50-00-0) as a High-Priority Substance for Risk
Evaluation (U.S. EPA, 2019a) to support the development of the risk evaluation for formaldehyde. The
values for the environmental fate properties (Appendix C) may be updated as EPA collects additional
information through systematic review methods.
2.3.3	Releases to the Environment
Releases to the environment from conditions of use (e.g., manufacturing, industrial and commercial
processes, commercial or consumer uses) are a 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 that EPA plans to evaluate are data reported to the Toxics Release Inventory
(TRI) program. EPA's TRI database contains information on chemical waste management activities that
are reported by industrial and federal facilities, including quantities released into the environment (i.e.,
to air, water, and disposed of to land), treated, burned for energy, recycled, or transferred off-site to
other facilities for these purposes.
Under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA)
formaldehyde is a TRI-reportable substance effective January 1, 1987 (40 CFR 372.65). For TRI
reporting6, facilities in covered sectors in the United States are required to disclose releases and other
waste management activity quantities of formaldehyde under the CASRN 50-00-0 if they manufacture
(including import) or process more than 25,000 pounds or otherwise use more than 10,000 pounds of the
chemical in a given year by July 1 of the following year.
6 For TRI reporting criteria see https://www.epa.gOY/toxics-release-iiiventorv-tri-program/basics-tri-reporling
30

-------
Table 2-3 provides production-related waste management data for formaldehyde reported by facilities to
the TRI program for reporting year 2018.7 As shown in the table, 715 facilities reported a total of over
132 million pounds of formaldehyde production-related waste managed in 2018. Of this total,
approximately 70 million pounds were treated, nearly 35 million pounds were recycled, over 20 million
pounds were released or otherwise disposed of, and over 7 million pounds were burned for energy
recovery. Of the 70 million pounds of formaldehyde that were treated, about 65 million pounds were
treated on site and 5 million pounds were treated off site. Similarly, 99% of the formaldehyde waste that
was recycled was recycled on site, and 93% of the formaldehyde waste that was used for energy
recovery was combusted on site.
Table 2-3 Summary of Formaldehyde TRI Production-Related Waste Managed in 2018
Year
Number of
Kacilities
Recycled (lbs)
Recovered
for
r.nergy
(lbs)'
Treated
(lbs)
Released111"
(lbs)
Tolal
Prod ucl ion
Related Wasle
(lbs)
2018
715
34,831,401
7,135,922
70,021,737
20,196,004
132,185,063
Data source: 2018 TRI Data (Updated November 2019)
3 Terminology used in these columns may not match the more detailed data element names used in the TRI public data and analysis access points.
b Does not include releases due to one-time event not associated with production such as remedial actions or earthquakes.
c Counts all releases including release quantities transferred and release quantities disposed of by a receiving facility reporting to TRI.
Table 2-4 provides a summary of the quantities of formaldehyde released to the environment during
2018 as reported to TRI.21 Of the more than 20 million pounds of formaldehyde that were disposed of or
otherwise released to the environment during 2018, 19 million pounds were released or disposed of on
site, and one million pounds were disposed of or released off site. Nearly 3/4 of all the formaldehyde that
was disposed of or released occurred to land, the majority of which (14.2 million pounds) was disposed
of on-site to Class I underground injection wells and about 240,000 pounds was disposed of off-site to
Class I underground injection wells. Over 4.6 million pounds of formaldehyde were released to air; 93%
of which was in the form of point source air (stack) emissions. Releases to water and other releases not
mentioned above accounted for small amounts of the total releases at just 1% and 2%, respectively.
Table 2-4 Summary of Releases of Formaldehyde to the Environment During 2018
Ycsir
Number
ol'
l-'sicililics
Air Rt
Si sick Air
Rclcsiscs
(II)N)
¦Icsiscs
l"iiiiili\e
Air
Rclcsiscs
(II)N)
\\ silcr
Rclcsiscs
(Ills)
( Isiss 1
I mlcr-
liround
Injection
I ll)S)
.sinri l)ispo>
RCRA
Suhiiilc (
Isindlills
(Ills)
Sll
All oilier
1 -SHI (1
Dispossil;l
(Ills)
Oilier
Rclcsiscs •'
(ll)S)
lolsil
Rclcsiscs 1,1
(Ihs)
Totals
2018
715
4,277,398
333,355
214,861
14,478,154
178,228
308,328
371,471
20,161,796
4,610,754
14,964,710
Data source: 2018 TRI Data (Updated November 2019)
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 These release quantities do include releases due to one-time events not associated with production such as remedial actions or earthquakes.
c Counts release quantities once at final disposition, accounting for transfers to other TRI reporting facilities that ultimately dispose of the chemical waste.
7 Reporting year 2018 is the most recent TRI data available. Data presented in Table 2-3 were queried using TRI Explorer
and uses the 2018 National Analysis data set (released to the public in November 2019). This dataset includes revisions for
the years 1988 to 2018 processed by EPA.
31

-------
The total production-related waste managed quantity shown in Table 2-3 does not include any quantities
reported as catastrophic or one-time releases. It does include quantities transferred off site to receiving
facilities for release or disposal and, if the receiving facilities are subject to the TRI reporting
requirements, they would report these quantities as on-site releases and these same quantities would be
included in the total release. This is referred to as "double counting", because the quantities are counted
twice. That is, when a facility transfers a quantity of a chemical off site for disposal to another facility,
the facility reports the quantity as transferred off site for disposal and the receiving facility reports the
same quantity of the chemical as disposed of on site. This is done because total production-related waste
values in the TRI database considers all instances of where and how the waste is managed (first as a
quantity sent off site for disposal and next as a quantity disposed of on-site), and reflects both the off-
site transfer and the on-site disposal quantities, as represented in Table 2-3. However, the TRI program
recognizes that this is the same quantity of the chemical and therefore included it only once in the total
release aggregation in Table 2-4. As a result, the total release quantities shown in the two tables differ
slightly.
EPA plans to review these data in conducting the exposure assessment component of the risk evaluation
for formaldehyde.
2,3.4 Environmental Exposures
The manufacturing, processing, distribution, use and disposal of formaldehyde can result in releases to
the environment. Environmental exposures are informed by releases into the environment, overall
persistence, degradation, and bioaccumulation within the environment, and partitioning across different
media. EPA plans to identify and evaluate reasonably available environmental exposure data utilizing
EPA's systematic review process for the risk evaluation.
EPA expects environmental exposure can occur as a result of releases of formaldehyde to the
environment (via direct releases, indirect releases, or deposition from other media) and will review
environmental exposure in the risk evaluation. EPA plans to identify and evaluate monitoring studies in
peer reviewed literature as well as relevant and reliable monitoring data sources (e.g., discharge
monitoring report (DMR) and water quality portal (WQP)) utilizing EPA's systematic review process to
inform environmental exposure. Monitoring studies that measure environmental concentrations or
concentrations of chemical substances in biota will also be identified and evaluated utilizing EPA's
systematic review process since such studies can provide evidence of exposure. Environmental exposure
of terrestrial species to formaldehyde is a possible pathway and receptor. However, such exposure is
limited to activities like plant ingestion. Formaldehyde is not expected to bioaccumulate in fish (U.S.
EPA, 2019) and therefore environmental exposure of terrestrial species via fish ingestion is not
expected.
Formaldehyde is expected to be present in the outdoor environment as a result of releases from multiple
industrial and commercial conditions of use identified in Section 2.2. Chemical manufacturing,
manufacturing of products containing formaldehyde) and use of formaldehyde in other chemical
manufacturing processes could all cause releases to different media to the outdoor environment.
Disposal and waste treatment activities associated with formaldehyde and formaldehyde containing
products are also expected to result in releases to the outdoor environment. EPA expects formaldehyde
to be present in ambient air as a result of these releases. While data reported to TRI indicate releases of
formaldehyde to surface water, ongoing presence of formaldehyde in surface water is expected to be
limited due to the rapid and nearly complete hydration of formaldehyde to a gem-diol, methylene glycol,
in water (WHO, 2002; Environment Canada, 2001).
32

-------
2.3.5 Occupational Exposures
EPA plans to analyze worker activities where there is a potential for exposure under the various
conditions of use (manufacturing, processing, industrial/commercial uses, and disposal) described in
Section 2.2.1. In addition, EPA may analyze exposure to ONUs, workers who do not directly handle the
chemical but perform work in an area where the chemical is present. EPA also expects to consider the
effect(s) that engineering controls (EC) and/or personal protective equipment (PPE) have on
occupational exposure levels as part of the draft risk evaluation.
Worker Activities
Worker activities associated with the conditions of use within the scope of the risk evaluation for
formaldehyde that EPA plans to analyze, include, but are not limited to:
•	Unloading and transferring formaldehyde or formaldehyde solutions to and from storage
containers and process vessels;
•	Sampling chemicals, formulations, or products for quality control;
•	Repackaging chemicals, formulations, or products containing formaldehyde;
•	Applying formulations and products containing formaldehyde onto substrates (e.g., applying
paints and coatings, thinners, and paint removers containing formaldehyde);
•	Handling, transporting, and disposing waste containing formaldehyde; and
•	Performing other work activities in or near areas where formaldehyde is used.
Additional key data that will inform occupational exposure assessment include: 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, presented in
Appendix E.2.
Inhalation
EPA plans to analyze inhalation exposure for workers and ONUs for all conditions of use specified in
Section 2.2. Formaldehyde has an OSHA standard OSHA 1910.1048 (OSHA, 2019). The Permissible
Exposure Limit (PEL) is 0.75 parts per million (ppm) over an 8-hour workday, time weighted average
(TWA) and a Short-Term Exposure Limit (STEL) of 2 ppm. The OSHA standard also includes, but not
limited to requirements for exposure monitoring, recordkeeping, PPE if other ECs are not feasible, and
hazard communication. This chemical also has a NIOSH Recommended Exposure Limit (REL) of 0.016
ppm TWA and 15 minute Ceiling limit of 0.1 ppm. NIOSH considers formaldehyde to be a potential
occupational carcinogen with an Immediately Dangerous to Life or Health (IDLH) value of 20 ppm
(NIOSH 2018). The American Conference of Governmental Industrial Hygienists (ACGIH) set the
Threshold Limit Value (TLV) at 0.1 ppm TWA and 0.3 ppm STEL.
Oral
EPA generally does not evaluate occupational exposures through the oral route. Workers may
inadvertently transfer chemicals from their hands to their mouths or ingest inhaled particles that deposit
in the upper respiratory tract. The frequency and significance of this exposure route are dependent on
several factors including the p-chem properties of the substance during expected worker activities,
workers' awareness of the chemical hazards, the visibility of the chemicals on the hands while working,
workplace practices, and personal hygiene that is difficult to predict (Cherrie et al., 2006). However,
EPA will consider the oral exposure on a case by case basis.
33

-------
Dermal
EPA plans to analyze dermal exposure to workers through liquid contact with formulations that contain
formaldehyde. ONUs do not directly handle these formulations; therefore, liquid contact is not expected
for ONUs. OSHA standard (	18) requires that skin contact with 1 % or more of formaldehyde be
prevented by chemical protective clothing and equipment.
2.3.6	Consumer Exposures
Consumer exposure to formaldehyde can occur via inhalation and dermal routes during and after using
consumer products containing formaldehyde within a residence. Consumer exposure to formaldehyde
can also occur via inhalation due to off-gassing from various products used or installed within a
residence. Consumer exposure to formaldehyde via the oral (ingestion) route is not expected, since
formaldehyde is highly volatile and not expected to absorb to dust or other particles within a residence
which could then be ingested.
Consumer exposure to formaldehyde via the inhalation route is expected for both the consumer user and
consumer bystander during and after use of a consumer product containing formaldehyde within a
residence. The consumer user is the individual utilizing a consumer product containing formaldehyde
within a residence within a specified room of use. The consumer bystander is one or more individuals
located within a residence where a consumer product containing formaldehyde is used but is not within
the room of use during product use.
Consumer exposure to formaldehyde via the dermal route is only expected for the consumer user during
and immediately after use of a consumer product containing formaldehyde. A consumer bystander is not
expected to come into direct dermal contact with a consumer product containing formaldehyde during or
immediately after use.
Oral consumer exposure to formaldehyde will not be evaluated since it is highly volatile and not
expected to sorb onto material within a residence which a consumer could ingest.
2.3.7	General Population Exposures
Environmental releases of formaldehyde from certain conditions of use identified in Section 2.2,
such as manufacturing, processing, distribution, use and disposal, as well as off-gassing from
installation and use of various building products (pressed wood products, carpets, etc.) (NICNAS
2006) in a residential setting, may lead to general population exposure.
Based on these environmental releases reported in Section 2.3.3, as well as P-Chem and fate
properties of formaldehyde discussed in Section 2.3.2, Appendix B and Appendix C, EPA
anticipates formaldehyde may be present in ambient air. While data reported to TRI indicate releases
of formaldehyde to surface water, ongoing presence of formaldehyde in surface water is expected to
be limited due to the rapid and nearly complete hydration of formaldehyde to a gem-diol, methylene
glycol, in water (WHO, 2002; Environment Canada, 2001). Formaldehyde is not expected to
bioaccumulate in fish (U.S. EPA, 2019a) and, given its low octanol/water partition coefficient,
adsorption to soil is likely low (ATSDR 1999).
34

-------
2.4 Hazards (Effects)
2.4.1	Environmental Hazards
As described in the Proposed Designation of Formaldehyde (CASRN 50-00-0) as a High-Priority
Substance for Risk Evaluation (U.S. EPA, 2019a), EPA considered reasonably available information
from peer-reviewed assessments and databases to identify potential environmental hazards
for formaldehyde. EPA considers all the potential environmental hazards for formaldehyde identified
during prioritization to be relevant for the risk evaluation and thus they remain within the scope of the
evaluation. EPA is in the process of identifying additional reasonably available information through
systematic review methods and public comments, which may update the list of potential environmental
hazards associated with formaldehyde exposure. If necessary, EPA plans to update the list of potential
hazards in the final scope document of the formaldehyde. Based on information identified during
prioritization, environmental hazard effects were identified for aquatic and terrestrial organisms.
EPA plans to conduct an environmental risk characterization of formaldehyde to determine whether
there are risks to the aquatic and/or terrestrial environments from the measured and/or predicted
concentrations of formaldehyde in environmental media (i.e., water, sediment, soil, and tissue). The data
for environmental monitoring and toxicity will be used in this risk characterization to determine whether
exposure to formaldehyde poses risk for adverse effects in aquatic and/or terrestrial organisms.
2.4.2	Human Health Hazards
As described in the Proposed Designation of Formaldehyde (CASRN 50-00-0) as a High-Priority
Substance for Risk Evaluation (U.S. EPA, 2019a), EPA considered reasonably available information
from peer-reviewed assessments and databases to identify potential human health hazards for
formaldehyde. EPA considers all of the potential human health hazards for formaldehyde identified
during prioritization to be relevant for the risk evaluation and thus they remain within the scope of the
evaluation. The preliminary literature survey identified studies reporting acute toxicity, repeated dose
toxicity, genetic toxicity, reproductive and developmental toxicity, carcinogenicity, epidemiological or
biomonitoring studies and absorption, distribution, metabolism, and excretion (ADME) of
formaldehyde.
EPA has identified adverse effects for a number of the screened outcome domains during prioritization
including inhalation toxicity and carcinogenicity. EPA is in the process of identifying additional
reasonably available information through systematic review methods and public input, which may
update the list of potential human health hazards under the scope of the risk evaluation. If necessary,
EPA plans to update the list of potential hazards in the final scope document of the formaldehyde risk
evaluation.
2.5 Potentially Exposed or Susceptible Subpopulations
TSCA § 6(b)(4) requires EPA to determine whether a chemical substance presents an unreasonable risk
to "a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation."
TSCA §3(12) states that "the term 'potentially exposed or susceptible subpopulation' means a group of
individuals within the general population identified by the Administrator who, due to either greater
susceptibility or greater exposure, may be at greater risk than the general population 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 (	01 la).
35

-------
During the Prioritization process, EPA identified the following PESS based on CDR information and
studies reporting developmental and reproductive effects: children, women of reproductive age (e.g.,
pregnant women), consumers and workers (U.S. EPA, 2019a). EPA plans to evaluate these PESS in the
risk evaluation.
In developing exposure scenarios, EPA plans to analyze reasonably available information to ascertain
whether some human receptor groups may be exposed via exposure pathways that may be distinct to a
particular subpopulation or life stage (e.g., children's crawling, mouthing or hand-to-mouth behaviors)
and whether some human receptor groups may have higher exposure via identified pathways of
exposure due to unique characteristics (e.g., activities, duration or location of exposure) when compared
with the general population (	1106a). Likewise, EPA plans to evaluate reasonably available
human health hazard information to ascertain whether some human receptor groups may have greater
susceptibility than the general population to the chemical's hazard(s).
2.6 Conceptual Models
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of formaldehyde. Pathways and
routes of exposure associated with workers and ONUs are described in Section 2.6.1, and pathways and
routes of exposure associated with consumers are described in Section 2.6.2. Pathways and routes of
exposure associated with environmental releases and wastes, including those pathways that may be
addressed pursuant to other Federal laws are discussed and depicted in the conceptual model shown in
Section 2.6.3. Pathways and routes of exposure associated with environmental releases and wastes,
excluding those pathways that may be addressed pursuant to other Federal laws, are presented in the
conceptual model shown in Section 2.6.4.
2.6.1 Conceptual Model for Industrial and Commercial Activities and Uses
Figure 2-8 illustrates the conceptual model for the pathways of exposure from industrial and commercial
activities and uses that EPA plans to include in the risk evaluation. There is potential for exposures to
workers and ONU via inhalation routes and exposures to workers via dermal routes. For industrial and
commercial activities and uses, it is expected that potential routes of exposure are through vapor and/or
mists and through liquid contact with formaldehyde containing solutions. Due to formaldehyde's high
volatility, EPA expects the inhalation pathway to be most likely source of exposure to workers and
ONUs.
Workers at waste management facilities may be exposed to formaldehyde via inhalation or dermal
routes during waste handling, treatment or disposal. EPA plans to evaluate activities resulting in
exposures associated with distribution in commerce (e.g., loading, unloading) throughout the various
lifecycle stages and conditions of use (e.g., manufacturing, processing, industrial use, commercial use,
and disposal) rather than a single distribution scenario. For each condition of use identified in Table 2-2,
an initial determination was made as to whether or not each combination of exposure pathway, route,
and receptor will be analyzed in the risk evaluation. The results of that analysis along with the
supporting rationale are presented in Appendix F.
36

-------
INDUSTRIAL AND COMMERCIAL	EXPOSURE PATHWAY	EXPOSURE ROUTE	RECEPTORS	HAZARDS
ACTIVITIES /USES
Manufacturing
Dermal
Workers
Liquid Contact
Processing
-As a reactant intermediate
-Incorporation into an article
-Incorporation into formulation, mixture, or reaction
product
Hazards potentially
associated with acute
and or chronic
exposures
Non-Incorporath e Activities
Occupational Non-
Users
Inhalation
Adhesives and Sealants
Furniture and
Furnishings not covered
elsewhere
Arts. Craft and Hobby
Materials
Ink. toner, and colorant
	products	
Fugitive
Emissions
Automotive Care
Products
Laundry and
dishwashing products
Building/Construction
Materials- wood and
engineered wood
products and other
	products	
Lawn Products
Lubricants and greases
Cleaning and Furniture
Care Products
Metal Products
Packaging (e.g. food
	packaging)	
Paints and Coatings
Electrical Products
Explosive Products
Paper Products
Fabric. Textile, and
leather products not
elsewhere
Personal Care Products
Photographic Supplies
Floor Coverings
Foam Setting and
Bedding Products
Toys, playground and
sporting equipment
Fuel and related
products
Water Treatment
Products
Recycling
Waste Handling, Treatment, and
Disposal
Wastewater, L iquid wastes, and Solid Wasters
fSee Environmental Release Conceptual Model)
Figure 2-8 Formaldehyde Conceptual Model for Industrial and Commercial Activities and Uses: Worker and Occupational Non-User
Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from industrial and commercial activities and uses of
formaldehyde.
37

-------
2.6.2 Conceptual Model for Consumer Activities and Uses
The conceptual model in Figure 2-9 presents the exposure pathways, exposure routes and hazards to
human receptors from consumer activities and uses of formaldehyde that EPA plans to include in the
risk evaluation.
EPA plans to evaluate consumer exposure via inhalation and dermal routes resulting from use of
formaldehyde containing consumer products within a residence. Consumer products may be in liquid or
aerosol form. Formaldehyde is highly volatile and therefore not expected to be present in solid form
during consumer use. Additionally, formaldehyde is not expected to adsorb to dust, particulate, or other
materials which a consumer could ingest. Therefore, EPA does not plan to evaluate consumer exposure
via any oral route. The results and supporting rationale are included in Appendix G.
Inhalation
Consumer exposure via the inhalation route is expected for both the consumer user and consumer
bystander. Exposure via inhalation can occur through the inhalation of vapor or mist directly or
indirectly from overspray of a consumer product. Both liquid and aerosol product forms can have an
overspray fraction readily available for uptake by a consumer via inhalation. Exposure via inhalation can
also occur as a result of offgassing from certain building products or components installed or utilized
within a residence.
Consumer exposure via the inhalation route will be evaluated for both the consumer user and consumer
bystander. EPA plans to evaluate inhalation exposure based on an overspray fraction of product during
use and from offgassing from building products or components installed or utilized within a residence.
Dermal
Consumer exposure via the dermal route is expected for the consumer user. Consumer bystanders are
not expected to experience direct or indirect dermal contact during product use since they are not within
the room of use during product use. Therefore, EPA plans to only evaluate dermal exposure for the
consumer user.
Exposure via the dermal route can occur through the deposition of liquid, vapor, or mist directly or
indirectly onto the skin. Since vapor or mist in this context refers to overspray material which may
redeposit onto the skin during use, it is included in the liquid contact pathway within the conceptual
model presented in Figure 2-9.
EPA plans to evaluate dermal exposure based on the permeation of formaldehyde through the skin as
well as vapor to skin. The evaluation of dermal exposure will be limited to select scenarios where
evaporation of material from the skin is prohibited or limited due to a physical barrier (wet rag soaked
with product) or where full immersion of a body part is expected during product use.
38

-------
CONSUMER ACTIVITIES	EXPOSURE	EXPOSURE	RFfFPTDRs	HAZARDS
AND USES	PATHWAYS	ROUTES	HAZARDS
Agricultural Products
(N on-Pest jcidal)
Adhesives & Sealants
Building Construction
Materials - Wood &
Engineered Wood
w Products
Building Construction
Materials Not Covered
Elsewhere
Fabric. Textile, & Leather
Products Not Covered
Elsewhere
Arts. Crafts, and Hobby
Materials
Liquid Contact
Dermal
Consumer L'sers
Electrical & Electronic
Products
Foam Seatrns & Bedding
Products
Hazards Potentially
Associated with Acute
and or Chronic
Exposures
Floor Coverings
Furniture & Furnishings
Not Covered Elsewhere
Fuels and Related
Products
Paints and Coatings
Indoor Air
Personal Care Products
Products
Water Treatment
Products
Plastic & Rubber
Products Not Covered
Elsewhere
Cleaning and Furniture
Care Products
Toys.. Playground, and
Sporting Equipment
Lubricants and Greases
Photographic Supplies
Laundry and Dish
Washing Products
Ink Toner and Colorant
Product
Consumer Handling of
Disposal and Waste
nasieviaier, L.iquia naszes ana oona nasiez
(See Enxsronmemal Release Conceptual Models)
Figure 2-9 Formaldehyde Conceptual Model for Consumer Activities and Uses: Consumer Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human receptors from consumer activities and uses of formaldehyde.
a Receptors include PESS (see Section 2.5).
39

-------
2,6.3 Conceptual Model for Environmental Releases and Wastes: Potential Exposures and
Hazards (Regulatory Overlay)
In this section, EPA presents the conceptual models describing the identified exposures (pathways and
routes), receptors and hazards associated with the conditions of use of formaldehyde within the scope of
the risk evaluation. It also discusses those pathways that may be addressed pursuant to other Federal
laws.
In complying with TSCA, EPA plans to efficiently use Agency resources, avoid duplicating efforts
taken pursuant to other Agency programs, maximize scientific and analytical efforts, and meet the
statutory deadline for completing risk evaluations. OPPT is working closely with the offices within EPA
that administer and implement the Clean Air Act (CAA), the Safe Drinking Water Act (SDWA), the
Clean Water Act (CWA) and the Resource Conservation and Recovery Act (RCRA), to identify how
those statutes and any associated regulatory programs address the presence of formaldehyde in exposure
pathways falling under the jurisdiction of these EPA statutes.
The conceptual model in Figure 2-10 presents the potential exposure pathways, exposure routes and
hazards to human and environmental receptors from releases and waste streams associated with
industrial, commercial, and consumer uses of formaldehyde. This figure includes overlays, labeled and
shaded to depict the regulatory programs (e.g., CAA, SDWA, CWA, RCRA) and associated pathways
that EPA considered in developing this conceptual model for the draft scope document. The pathways
are further described in Section 2.6.3.1 through Section 2.6.3.4.
40

-------
RELEASES AND W ASTES FROM
INDUSTRIAL / COMMERCIAL /
CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE
ROUTES
RECEPTORS
SDWA
Indirect discharge
Oral
RCRA- Haz List
Underground ___
Injection
Land
Disposal
Ground
Water
Soil
CAA-HAP
Inhalation
Fugitive Emissions

Air
Terrestrial
Species
Emissions to Air
Off-site Waste
Transfer
Recycling. Other
Treatment
Water. Sediment
I lazardous and
Municipal Waste
Landfill
r>
Industrial Pre-
T reatment or
Industrial WWT
Wastewater or
Liquid Wastes
Liquid Wastes
Solid Wastes
I la/ardous and
Municipal Waste
Incinerators
Hazards Potentially
Associated with
Acute and/or Chronic
Exposures
Figure 2-10 Formaldehyde Conceptual Model for Environmental Releases and Wastes: Environmental and General Population
Exposures and Hazards (Regulatory Overlay)
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from releases and wastes from industrial,
commercial, and consumer uses of Formaldehyde including the environmental statutes covering those pathways.
a)	Industrial wastewater or liquid wastes may be treated on-site and then released to surface water (direct discharge), or pre-treated and released to Publicly Owned
Treatment Works (POTW) (indirect discharge). For consumer uses, such wastes may be released directly to POTW. Drinking water will undergo further treatment
drinking water treatment plant. Ground water may also be a source of drinking water. Inhalation from drinking water may occur via showering.
b)	Receptors include PESS (see Section 2.5).
c)	For regulation of hazardous and municipal waste incinerators and municipal waste landfills CAA and RCRA may have shared regulatory authority.

-------
2.6.3.1	Ambient Air Pathway
The Clean Air Act (CAA) contains a list of hazardous air pollutants (HAP) and provides EPA with the
authority to add to that list pollutants that present, or may present, a threat of adverse human health
effects or adverse environmental effects. For stationary source categories emitting HAP, the CAA
requires issuance of technology-based standards and, if necessary, additions or revisions to address
developments in practices, processes, and control technologies, and to ensure the standards adequately
protect public health and the environment. The CAA thereby provides EPA with comprehensive
authority to regulate emissions to ambient air of any hazardous air pollutant. Formaldehyde is a HAP.
EPA has issued a number of technology-based standards for source categories that emit formaldehyde to
ambient air and, as appropriate, has reviewed, or is in the process of reviewing remaining risks.
Emission pathways to ambient air from commercial and industrial stationary sources and associated
inhalation exposure of the general population or terrestrial species in this TSCA evaluation from
stationary source releases of formaldehyde to ambient air are covered under the jurisdiction of the CAA.
EPA's Office of Air and Radiation and Office of Pollution Prevention and Toxics will continue to work
together to provide an understanding and analysis of the CAA regulatory analytical processes and to
exchange information related to toxicity and occurrence data on chemicals undergoing risk evaluation
under TSCA.
2.6.3.2	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). Under SDWA
EPA must also review and revise "as appropriate" existing drinking water regulations every 6 years.
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
every 5 years and make Regulatory Determinations (RegDet) to regulate (or not) 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.
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.
Formaldehyde is currently listed on EPA's Fourth Contaminant Candidate List (CCL 4). In accordance
with EPA-OW's process, formaldehyde was evaluated under the fourth Regulatory Determination
process under SDWA and did not make a regulatory determination at this time.
2.6.3.3	Ambient Water Pathway
EPA develops recommended water quality criteria under Section 304(a) of the CWA for pollutants in
surface water that are protective of aquatic life or human health designated uses. EPA has not developed
CWA Section 304(a) recommended water quality criteria for the protection of human or aquatic life for
formaldehyde, so there are no national recommended criteria for this use available for adoption into state
water quality standards and available for use in NPDES permits. EPA may publish CWA Section 304(a)
42

-------
ambient water quality criteria and/or aquatic life criteria for formaldehyde in the future if it is identified
as a priority under the CWA.
2.6.3.4 Disposal and Soil Pathway
Formaldehyde is included on the list of hazardous wastes pursuant to RCRA 3001 (40 CFR §§ 261.33)
as a listed waste on the U122, K009, K010, K038, K040, K156, K157 lists. The general standard in
Section RCRA 3004(a) for the technical criteria that govern the management (treatment, storage, and
disposal) of hazardous waste are those "necessary to protect human health and the environment," RCRA
3004(a). The regulatory criteria for identifying "characteristic" hazardous wastes and for "listing" a
waste as hazardous also relate solely to the potential risks to human health or the environment (40 CFR
§§ 261.11, 261.21-261.24). RCRA statutory criteria for identifying hazardous wastes require EPA to
"tak[e] into account toxicity, persistence, and degradability in nature, potential for accumulation in
tissue, and other related factors such as flammability, corrosiveness, and other hazardous
characteristics." Subtitle C controls cover not only hazardous wastes that are landfilled, but also
hazardous wastes that are incinerated (subject to joint control under RCRA Subtitle C and the Clean Air
Act (CAA) hazardous waste combustion Maximum Achievable Control Technology (MACT)) or
injected into Underground Injection Control (UIC) Class I hazardous waste wells (subject to joint
control under Subtitle C and the Safe Drinking Water Act (SDWA)).
Emissions to ambient air from municipal and industrial waste incineration and energy recovery units that
form combustion by-products from incineration treatment of formaldehyde wastes may be subject to
regulations, as would formaldehyde that is burned for energy recovery.
On-site releases to land that go to underground injection in the risk evaluation. TRI reporting in 2018
indicated 14,478,154 pounds released to underground injection to a Class I well. Environmental disposal
of formaldehyde injected into Class I hazardous waste well types are presumed to be managed and
prevented from further environmental release by RCRA and SDWA regulations. Therefore, disposal of
formaldehyde via underground injection is not likely to result in environmental and general population
exposures.
EPA has identified releases to land that go to RCRA Subtitle C hazardous waste landfills. Based on
2018 reporting, TRI land disposal includes Subtitle C landfills (178,228 pounds) and reported as
transferred to "other landfills" both on-site and off-site (308,328 pounds reported in 2018). Design
standards for Subtitle C landfills require double liner, double leachate collection and removal systems,
leak detection system, run on, runoff, and wind dispersal controls, and a construction quality assurance
program. They are also subject to closure and post-closure care requirements including installing and
maintaining a final cover, continuing operation of the leachate collection and removal system until
leachate is no longer detected, maintaining and monitoring the leak detection and groundwater
monitoring system. Bulk liquids may not be disposed in Subtitle C landfills. Subtitle C landfill operators
are required to implement an analysis and testing program to ensure adequate knowledge of waste being
managed, and to train personnel on routine and emergency operations at the facility. Hazardous waste
being disposed in Subtitle C landfills must also meet RCRA waste treatment standards before disposal.
Given these controls, general population exposure in groundwater from Subtitle C landfill leachate is not
expected to be a significant pathway.
Formaldehyde is present in commercial and consumer products that may be disposed of in landfills, such
as Municipal Solid Waste (MSW) landfills. On-site releases RCRA Subtitle D municipal solid waste
landfills leading to exposures of the general population (including susceptible populations) or terrestrial
species from such releases may occur based on current TRI releases (i.e., 308,328 lb in 2018) for
43

-------
formaldehyde. While permitted and managed by the individual states, municipal solid waste landfills are
required by federal regulations to implement some of the same requirements as Subtitle C landfills.
MSW landfills generally must have a liner system with leachate collection and conduct groundwater
monitoring and corrective action when releases are detected. MSW landfills are also subject to closure
and post-closure care requirements and must have financial assurance for funding of any needed
corrective actions. MSW landfills have also been designed to allow for the small amounts of hazardous
waste generated by households and very small quantity waste generators (less than 220 lbs per month).
Bulk liquids, such as free solvent, may not be disposed of at MSW landfills.
On-site releases to land from industrial non-hazardous and construction/demolition waste landfills may
occur for formaldehyde. Industrial non-hazardous and construction/demolition waste landfills are
primarily regulated under authorized state regulatory programs, but states must implement federal
regulatory requirements for siting, groundwater monitoring, and corrective action, and a prohibition on
open dumping and disposal of bulk liquids. States may also establish additional requirements such as for
liners, post-closure and financial assurance, but are not required to do so.
2,6.4 Conceptual Model for Environmental Releases and Wastes
As described in Section 2.6.3, some pathways in the conceptual models are covered under the
jurisdiction of other environmental statutes administered by EPA. The conceptual model depicted in
Figure 2-11 presents the exposure pathways, exposure routes and hazards to human and environmental
receptors from releases and wastes from industrial, commercial, and consumer uses of formaldehyde
that EPA plans to consider in the risk evaluation. The exposure pathways, exposure routes and hazards
presented in this conceptual model are subject to change in the final scope, in light of comments
received on this draft scope and other reasonably available information. EPA continues to consider
whether and how other EPA-administered statutes and any associated regulatory programs address the
presence of formaldehyde in exposure pathways falling under the jurisdiction of these EPA statutes.
The diagram shown in Figure 2-11 includes releases from industrial, commercial and/or consumers uses
and direct or indirect releases to ambient air resulting from consumer use or installation of building
materials and products containing formaldehyde as well as land application of biosolids and soil from
POTWs or Industrial WWTs that may lead to exposure to aquatic and terrestrial receptors and the
general population.
Releases to water/sediment via direct and indirect discharges to water that may lead to exposure to
aquatic and terrestrial receptors and general population from exposure to ambient water via recreational
activities such as swimming or boating are not included due to the rapid and nearly complete hydration
of formaldehyde to a gem-diol, methylene glycol in water. The supporting basis for general population
and environmental pathways considered for formaldehyde are included in Appendix H.
44

-------
RELEASES AMD WASTES FROM
INDUSTRIAL / COMMERCIAL /
CONSUMER USES
EXPOSURE PATHWAYS
EXPOSURE
ROUTES
RECEPTORS HAZARDS
Wastewater or
Liquid Wastes
Industrial Pre-
Treatmentor
Industrial WWT


1
Indirect discharge
*
POTW



¦ Water. Sediment)
Biosolids
CAA
RCRA
SDWA
CWA
Land
Disposal
Soil
'lids J
General
Population
I lazards Potentially
Associated with
Acute and/or Chronic
Exposures
Ground
Water
Co-Location
Or
Co-Residence
Air
Inhalation
Terrestrial
Species
Emissions to Air
Consumer Activities
- (Off-Gassing from -
Building Materials)
Figure 2-11 Formaldehyde Conceptual Model for Environmental Releases and Wastes: Environmental and General Population
Exposures and Hazards
The conceptual model presents the exposure pathways, exposure routes and hazards to human and environmental receptors from releases and wastes from industrial,
commercial, and consumer uses of Formaldehyde that EPA plans to consider in the risk evaluation.
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.
b)	Receptors include PESS (see Section 2.5).
45

-------
2.7 Analysis Plan
The analysis plan is based on EPA's knowledge of formaldehyde to date which includes a partial, but
not complete review of identified information as described in Section 2.1. EPA encourages
submission of additional existing data, such as full study reports or workplace monitoring from
industry sources, that may be relevant for further evaluating conditions of use, exposures, hazards and
PESS during risk evaluation. Further, EPA may consider any relevant CBI in the risk evaluation in a
manner that protects the confidentiality of the information from public disclosure. EPA plans to
consider new information submitted by the public. EPA may update its analysis plan in the final scope
document if additional data or approaches become reasonably available.
2.7.1 Physical/Chemical Properties and Environmental Fate
EPA plans to analyze the physical and chemical (p-chem) properties and environmental fate and
transport of formaldehyde as follows:
1)	Review reasonably available measured or estimated p-chem and environmental fate
endpoint data collected using systematic review procedures and, where reasonably
available, environmental assessments conducted by other regulatory agencies.
EPA plans to review data and information collected through the systematic review methods
and public comments about the p-chem properties (Appendix B) and fate endpoints (Appendix
C), some of which appeared in the Proposed Designation of Formaldehyde (CASRN 50-00-0)
as a High-Priority Substance for Risk Evaluation (U.S. EPA, 2019a) and in Appendices B and
C. All sources cited in EPA's analysis will be evaluated according to the procedures described
in the systematic review documentation that EPA plans to publish prior to finalizing the scope
document. Where the systematic review process fails to identify experimentally measured
chemical property values of sufficiently high quality, these values will likely be estimated
using chemical parameter estimation models as appropriate. Model-estimated fate properties
will be reviewed for applicability and quality.
2)	Using measured data and/or modeling, determine the influence of environmental fate
endpoints (e.g., persistence, bioaccumulation, partitioning, transport) on exposure
pathways and routes of exposure to human and environmental receptors.
Measured data and, where necessary, model predictions of physical/chemical properties and
environmental fate endpoints will be used to characterize the persistence and movement of
formaldehyde within and across environmental media. The fate endpoints of interest include
volatilization, sorption to organic matter in soil and sediments, water solubility, aqueous and
atmospheric photolysis rates, aerobic and anaerobic biodegradation rates, and potential
bioconcentration and bioaccumulation. These endpoints will be used in exposure calculations.
3)	Conduct a weight of the scientific evidence evaluation of environmental fate data,
including qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the physical/chemical and
environmental fate evidence identified in the literature inventory using the methods described
in the systematic review documentation that EPA plans to publish prior to finalizing the scope
document.
46

-------
2,7.2 Exposure
EPA plans to analyze exposure levels for indoor air, ambient air (consumer activities affecting co-
located/co-residence populations), sediment, soil, and terrestrial biota associated to exposure to
formaldehyde. EPA has not yet determined the exposure levels in these media or how they may be
used in the risk evaluation. EPA plans to analyze scenario-specific exposures. Based on their p-chem
properties, expected sources, and transport and transformation within the outdoor and indoor
environment, chemical substances can be more prevalent in some media and less prevalent in other
media. Exposure level(s) of formaldehyde can be characterized through a combination of reasonably
available monitoring data and modeling approaches.
2.7.2.1 Environmental Releases
1)	Review reasonably available published literature and other reasonably available
information on processes and activities associated with the conditions of use to analyze
the types of releases and wastes generated.
EPA has reviewed some key data sources containing information on processes and activities
resulting in releases, and the information found is presented in Appendix A. EPA plans to
continue to review data sources identified during risk evaluation using the evaluation strategy
in the systematic review documentation that EPA plans to publish prior to finalizing the scope
document. Potential sources of environmental release data are summarized in Table 2-5.
Table 2-5 Potential Categories and Sources of Environmental Release Data	
U.S. EPA TRI Data	
U.S. EPA Generic Scenarios	
OECD Emission Scenario Documents	
Discharge Monitoring Report (DMR) surface water discharge data for formaldehyde from
NPDES-permitted facilities	
2)	Review reasonably available chemical-specific release data, including measured or
estimated release data (e.g., data from risk assessments by other environmental
agencies).
EPA has reviewed key release data sources including the Toxics Release Inventory (TRI), and
the data from this source is summarized in Section 2.3.3. EPA plans to continue to review
relevant data sources as identified during risk evaluation. EPA plans to match identified data to
applicable conditions of use and identify data gaps where no data are found for particular
conditions of use. EPA plans to attempt to address data gaps identified as described in steps 3
and 4 below by considering potential surrogate data and models.
Additionally, for conditions of use where no measured data on releases are reasonably
available, EPA may use a variety of methods including release estimation approaches and
assumptions in the Chemical Screening Tool for Occupational Exposures and Releases
CheroSTEER (U.S. EPA, 2016).
3)	Review reasonably available measured or estimated release data for surrogate chemicals
that have similar uses and physical properties.
EPA plans to review literature sources identified and if surrogate data are found, EPA plans to
match these data to applicable conditions of use for potentially filling data gaps.
47

-------
4)	Review reasonably available data that may be used in developing, adapting or applying
exposure models to the particular risk evaluation.
This item will be performed after completion of #2 and #3 above. EPA plans to evaluate
relevant data to determine whether the data can be used to develop, adapt or apply models for
specific conditions of use (and corresponding release scenarios). EPA has identified
information from various EPA statutes (including, for example, regulatory limits, reporting
thresholds or disposal requirements) that may be relevant to release estimation. EPA plans to
further consider relevant regulatory requirements in estimating releases during risk evaluation.
5)	Review and determine applicability of OECD Emission Scenario Documents (ESDs) and
EPA Generic Scenarios to estimation of environmental releases.
EPA has identified potentially relevant OECD Emission Scenario Documents (ESDs) and EPA
Generic Scenarios (GS) that correspond to some conditions of use; for example, the 2009 ESD
on Plastics Additives and the 2011 ESD on Chemical Industry may be useful. EPA plans to
need to critically review these generic scenarios and ESDs to determine their applicability to
the conditions of use assessed.
EPA Generic Scenarios are all available at the following: https://www.epa.gov/tsca-screening-
tools/chernsteer-chemical-screening-tool-exposures-and-environmental-
releases#genericscenarios
The following Generic Scenarios contain information related to the potential uses of
formaldehyde:
o EPA's Formulation of Waterborne Coatings Revised Draft Generic Scenario for
Estimating Occupational Exposures and Environmental Releases (June 2014);
o EPA's Additives in Plastics Processing (Compounding) - Draft Generic Scenario for
Estimating Occupational Exposures and Environmental Releases (May 2004);
o EPA's Additives in Plastics Processing (Converting) - Draft Generic Scenario for
Estimating Occupational Exposures and Environmental Releases (May 2004);
o EPA's Leather Tanning - Revised Draft Generic Scenario for Estimating
Occupational Exposures and Environmental Releases (June 2001);
o EPA's Leather Dyeing - Revised Draft Generic Scenario for Estimating Occupational
Exposures and Environmental Releases (September 2000);
o EPA's Fabric Finishing - Final Generic Scenario for Estimating Occupational
Exposures and Environmental Releases (September 1994);
o EPA's Generic Scenario - Final Application of Chemicals in Enhanced Oil Recovery
Steam Stimulation, Steam Flooding, and Polymer/Surfactant Flooding (1994);
o EPA's Generic Scenario - Final Application of Waterborne Wood Preservatives
Using Pressure Treatment (1994);
o EPA's Generic Scenario - Final Water Treatment Disinfectants - Application (1994);
and
o EPA's Generic Scenario - Material Fabrication Processes for Manufacture of Printed
Circuit Boards (1994).
OECD Emission Scenario Documents are available at the following:
http://www.oecd.org/chemicalsafetv/risk-assessment/emissionscenariodocuments.htm
The following ESD contain information related to the potential uses of formaldehyde:
48

-------
http://www.oecd.org/chemicalsafety/emissionscenariodocuments.htm
o OECD's Complementing Document to the ESI) On Plastic Additives: Plastic Additives
Dunns' the Use of End Products (May 2019);
o OECD's ESP on the Use of Textile Dyes (February 2017);
o OECD's C ,omvlementim Document for ESP) on Coating Industry: Application of
Paint Solvents for Industrial Coatins (December 2015);
o OECD's ESP on the Industrial Use of Adhesive it 2015);
o OECD's ESP on Chemicals Used in Oil We luction (June 2013);
° OECD's ESP on the Use ofMeiatworkimFlui ober 2011);
o OECD's ESP on the Chemical Industry (September 2011);
o OECD's ESI) on Coating Application via Spray Pointing in the Automotive
Re finishing Industry (July 2011);
o OECD's ESP on the Blending of Fragrance Oils into Commercial and Consumer
Products (September I
o OECD's ESP i	nutation of Radiation Curable Coatings, Inks and Adhesive s
(January 2010);
° OECD's ESP on Plastic Additives (July 2009);
o OECD's. ESP on Coating Industry (Paint, Lacquers, and Varnishes) (July 2009);
o OECD's ESP on Adhesive Formulation (April 2009); and
o OECD's ESP on Lubricants and Lubricant Additives (November 2004).
EPA was not able to identify ESDs or GSs corresponding to several conditions of use
including recycling of formaldehyde. EPA plans to 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 certain conditions of use. If ESDs and GSs are not
reasonably available, other methods may be considered.
6)	Map or group each condition of use to a release assessment scenario(s).
EPA has identified release scenarios and mapped (i.e., grouped) them to relevant conditions of
use as shown in Appendix F. EPA was not able to identify release scenarios corresponding to
some conditions of use (e.g., recycling). EPA plans to perform targeted research to understand
those uses, which may inform identification of release scenarios. EPA may further refine the
mapping of release scenarios based on factors (e.g., process equipment and handling,
magnitude of production volume used, and release sources and usage rates of formaldehyde
and formulations containing formaldehyde, or professional judgment) corresponding to
conditions of use as additional information is identified during risk evaluation.
7)	Evaluate the weight of the scientific evidence of environmental release data.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation
that EPA plans to publish prior to finalizing the scope document. The data integration strategy
will be designed to be fit-for-purpose in which EPA plans to use systematic review methods to
assemble the relevant data, evaluate the data for quality and relevance, including strengths and
limitations, followed by synthesis and integration of the evidence.
49

-------
2.7.2.2 Environmental Exposures
EPA plans to conduct the following to develop its environmental exposure assessment of
formaldehyde:
1)	Review reasonably available environmental and biological monitoring data for all media
relevant to environmental exposure.
EPA plans to evaluate environmental exposure for the following environmental media
sediment and to a limited extent soil. Nutrient uptake and air intake of formaldehyde by
terrestrial plant species from sediment and soil can lead to environmental exposure to
terrestrial species through ingestion of the terrestrial plant species. Depending on the
information identified and evaluated through EPA's systematic review process related to these
pathways, routes, species, and biota, EPA plans to develop and build out relevant exposure
scenarios to evaluate environmental exposure.
Formaldehyde is not expected to bioaccumulate in fish (U.S. EPA, 2019a) and therefore EPA
does not plan to evaluate environmental exposure through oral routes via fish ingestion. Given
formaldehyde's low octanol/water partition coefficient, adsorption to soil is likely low
(ATSDR, 1999) and therefore EPA does not plan to evaluate environmental exposure through
oral routes via soil and dust ingestion for larger terrestrial species. Depending on information
identified and evaluated through EPA's systematic review process, exposure through oral and
dermal routes via soil may be considered for smaller soil dwelling terrestrial species such as
earthworms.
2)	Review reasonably available information on releases to determine how modeled
estimates of concentrations near industrial point sources compare with reasonably
available monitoring data.
Reasonably available environmental exposure models that meet the TSCA Section 26(h) and
(i) Science Standards and that estimate environmental concentrations will be considered for
use in this evaluation alongside reasonably available environmental monitoring data identified
and evaluated through EPA's systematic review process to characterize environmental
exposures. Modeling approaches to estimate environmental concentrations of the chemical
substance of interest generally consider the following inputs: direct environmental releases
indirect environmental releases (i.e., air deposition), fate and transport (partitioning within
media) and characteristics of the environment (e.g., river flow, volume of lake, meteorological
data). Release data can be obtained from various databases and is being developed as part of
the environmental release assessment discussed in 2.7.2.1. Some models which may be
considered for this evaluation include the Exposure and Fate Assessment Screening Tool (E-
FAST) and PWC.
3)	Determine applicability of existing additional contextualizing information for any
monitored data or modeled estimates during risk evaluation.
Information identified and evaluated through EPA's systematic review process that is relevant
to the exposure levels to be evaluated will be reviewed to determine how representative they
are of current conditions, behaviors, uses, and use patterns. Sampling and analysis
methodologies will also be reviewed to determine representativeness. These reviews add an
additional layer of review and effort, but are necessary because of changes to knowledge,
50

-------
understanding, methodologies, technology, sensitivity, levels of detection, uses, and use
patterns.
Information and data identified and evaluated through EPA's systematic review process will
be integrated throughout the risk evaluation process. The specific means by which information
and data gets integrated depends on the context under which it is found and the relevancy to
the exposure levels to be evaluated, monitoring data may be utilized to develop a trend
analysis which can help inform the risk evaluation. Monitoring data may also be utilized to
inform representativeness of modeled estimates, sensitivity of models used, or to provide
further comparisons between monitored and modeled data. Information and data may also be
integrated to inform inclusion or exclusion of certain environmental media, pathways, or
exposure routes. It may also be used to inform model inputs or how EPA builds out various
exposure scenarios.
4)	Group each condition(s) of use to environmental assessment scenario(s).
Refine and finalize exposure scenarios for environmental receptors by considering
combinations of sources (use descriptors), exposure pathways including routes, and
populations exposed. For formaldehyde, the following are noteworthy considerations in
constructing exposure scenarios for environmental receptors:
Estimates of environmental concentrations near industrial point sources based on
reasonably available monitoring data.
Modeling inputs for release into the media of interest, fate and transport and
characteristics of the environment.
Reasonably available biomonitoring data. Monitoring data could be used to
compare with species or taxa-specific toxicological benchmarks.
Applicability of existing additional contextualizing information for any monitored
data or modeled estimates during risk evaluation. Review and characterize the
spatial and temporal variability, to the extent that data are reasonably available, and
characterize exposed aquatic and terrestrial populations.
Weight of the scientific evidence of environmental occurrence data and modeled
estimates.
5)	Evaluate the weight of the scientific evidence of environmental occurrence data and
modeled estimates.
Information and data identified and evaluated through EPA's systematic review process will
receive a data quality rating (score) representing high, medium, low, or unacceptable quality
based on a series of metrics developed and incorporated into the review process. The metrics
will provide a base from which EPA plans to begin to apply a weight of the scientific evidence
to each piece of information or data. The weight of the scientific evidence will, in turn, inform
if and how the various pieces of information or data can or will be integrated into the risk
evaluation process. The data quality rating and weight of the scientific evidence will be
utilized to develop scientifically supported conclusions regarding exposure levels, as well as
confidence and uncertainty surrounding the exposure levels found.
51

-------
2.7.2.3 Occupational Exposures
EPA plans to analyze both worker and occupational non-user exposures as follows:
1)	Review reasonably available exposure monitoring data for specific condition(s) of use.
EPA plans to review exposure data including workplace monitoring data collected by
government agencies such as the OSHA and the NIOSH, and monitoring data found in
published literature. These workplace monitoring data include personal exposure monitoring
data (direct exposures) and area monitoring data (indirect exposures).
EPA has preliminarily reviewed reasonably available monitoring data collected by OSHA and
NIOSH and will match these data to applicable conditions of use. EPA has also identified
additional data sources that may contain relevant monitoring data for the various conditions of
use. EPA plans to review these sources and extract relevant data for consideration and analysis
during risk evaluation. The following are some data sources identified thus far:
Table 2-6 Potential Sources of Occupational Exposure Data	
1999 ATSDR Toxicological Profile for Formaldehyde	
OSHA Chemical Exposure Health Data (CEHD) program data	
NIOSH Health Hazard Evaluation (HHE) Program reports	
2)	Review reasonably available exposure data for surrogate chemicals that have uses,
volatility and chemical and physical properties similar to formaldehyde.
EPA plans to review literature sources identified and if surrogate data are found, these data
will be matched to applicable conditions of use for potentially filling data gaps.
3)	For conditions of use where data are limited or not reasonably available, review existing
exposure models that may be applicable in estimating exposure levels.
EPA has identified potentially relevant OECD ESDs and EPA GS corresponding to some
conditions of use. Section 2.7.2.1 provides details on the relevant OECD ESDs and EPA GS
that corresponding to some formaldehyde conditions of use. EPA plans to critically review
these generic scenarios and ESDs to determine their applicability to the conditions of use
assessed. EPA was not able to identify ESDs or GS's corresponding to some conditions of use,
including recycling of formaldehyde. EPA plans to 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 certain conditions of use.
4)	Review reasonably available data that may be used in developing, adapting or applying
exposure models to a particular risk evaluation scenario.
This step will be performed after Steps #2 and #3 are completed. Based on information
developed from Steps #2 and #3, EPA plans to evaluate relevant data to determine whether the
data can be used to develop, adapt, or apply models for specific conditions of use (and
corresponding exposure scenarios). EPA may utilize existing, peer-reviewed exposure models
developed by EPA/OPPT, other government agencies, or reasonably available in the scientific
literature, or EPA may elect to develop additional models to assess specific condition(s) of
use. Inhalation exposure models may be simple box models or two-zone (near-field/far-field)
52

-------
models. In two-zone models, the near-field exposure represents potential inhalation exposures
to workers, and the far-field exposure represents potential inhalation exposures to ONUs.
5)	Consider and incorporate applicable EC and/or PPE into exposure scenarios.
EPA plans to review potentially relevant data sources on ECs and PPE to determine their
applicability and incorporation into exposure scenarios during risk evaluation. EPA plans to
assess worker exposure pre- and post-implementation of ECs, using reasonably available
information on control technologies and control effectiveness. For example, EPA may assess
worker exposure in industrial use scenarios before and after implementation of local exhaust
ventilation.
6)	Map or group each condition of use to occupational exposure assessment scenario(s).
EPA has identified occupational exposure scenarios and mapped them to relevant conditions
of use as shown in Appendix F. As presented in the fourth column of TableApx F-l, EPA has
grouped the conditions of use into release/exposure scenarios which EPA plans to analyze.
EPA may further refine the mapping of occupational exposure scenarios based on factors (e.g.,
process equipment and handling, magnitude of production volume used, and exposure/release
sources) corresponding to conditions of use as additional information is identified during risk
evaluation.
7)	Evaluate the weight of the scientific evidence of occupational exposure data, which may
include qualitative and quantitative sources of information.
During risk evaluation, EPA plans to evaluate and integrate the exposure evidence identified in
the literature inventory using the methods described in the systematic review documentation
that EPA plans to publish prior to finalizing the scope document. EPA plans to rely on the
weight of the scientific evidence when evaluating and integrating occupational data. The data
integration strategy will be designed to be fit-for-purpose in which EPA plans to use
systematic review methods to assemble the relevant data, evaluate the data for quality and
relevance, including strengths and limitations, followed by synthesis and integration of the
evidence.
2.7.2.4 Consumer Exposures
EPA plans to analyze consumer exposure to formaldehyde resulting from use of products containing
formaldehyde within a residence. Consumer exposure will be evaluated for both the consumer user
and consumer bystander as described below.
1) Group each condition of use to consumer exposure assessment scenario(s).
Consumer exposure scenarios will be built out based on the conditions of use and on products
containing formaldehyde available for consumer use identified in Section 2.2.1. Consumer
exposure will be evaluated for inhalation and dermal routes.
Consumer exposure via the inhalation route will be evaluated for both the consumer user and
consumer bystander. Consumer inhalation exposure will be evaluated for liquid and aerosol
product use as well as exposure resulting from offgassing from consumer products installed or
used within a residence.
53

-------
Consumer exposure via the dermal route will only be evaluated for the consumer user as a
consumer bystander, as defined in this evaluation, is not expected to receive a dermal
exposure. Additionally, due to the high volatility of formaldehyde, dermal exposure will only
be evaluated for select conditions of use where there is a constant supply of product against the
skin and evaporation of product during use is inhibited due to a barrier (rag) or full immersion
of a body part into a pool of material occurs.
When evaluating consumer exposure, EPA plans to evaluate the methodologies to be used
based on information identified and evaluated as part of EPA's systematic review process.
Information EPA plans to utilize consumer use pattern information (amount of a product used
and duration of product use) and product specific information (amount of chemical in products
(weight fraction)). Other information like room of use will depend on the intended use of
products and where it is most likely to be used. Such information may be found in published
literature and consumer use surveys. Building parameters like size of building, volume of
room where use occurs, air exchange rates, ventilation rates, and similar parameters are
expected to be relatively consistent across residences and will rely on default values within
models or data from EPA's exposure factors handbook. EPA plans to consider a range of
values when evaluating exposure and will vary specific parameters to which the selected
model(s) is(are) sensitive.
2)	Evaluate the relative potential of indoor exposure pathways based on reasonably
available data.
Exposure pathways associated with inhalation and dermal routes are expected to be the
predominant exposure pathways to be evaluated for consumer exposure to formaldehyde. This
is based on p-chem properties, fate properties, expected chemical behaviors associated with
the conditions of use identified in Section 2.2.1, and product use patterns. The high volatility
of formaldehyde indicates inhalation exposure can result from evaporation of products used on
a surface (furniture, counter tops, floors, etc.), aerosolization of product during application,
and offgassing from products containing formaldehyde. The high volatility of formaldehyde
also indicates that formaldehyde in liquid products applied to a surface may rapidly volatize
leading to an inhalation exposure rather than a dermal exposure. Dermal exposure may occur
during use of a liquid product (or possibly an aerosol product applied to a surface), however,
the high volatility of formaldehyde indicates dermal exposure may be limited to certain
scenarios where evaporation is prohibited, or full immersion into a product occurs. Once in the
vapor phase, formaldehyde is expected to remain in the vapor phase and is not expected to
adsorb to particles or dust, therefore EPA does not plan to evaluate exposure via an oral
pathway (ingestion of dust, mouthing, etc.).
3)	Review existing indoor exposure models that may be applicable in estimating indoor air,
indoor dust concentrations, or indoor dust surface loadings.
Consumer inhalation exposure can be evaluated utilizing several different models including
Consumer Exposure Model (CEM), Multi-Chamber Concentration and Exposure Model
(MCCEM), and for off-gassing IECCU or FIAM. Selection of the appropriate EPA model
depends on a fit-for-purpose analysis of the conditions of use, products available, and relevant,
pre-defined scenarios within the various models.
54

-------
Consumer dermal exposure will be evaluated utilizing CEM, since MCCEM, IECCU, and
FIAM do not have dermal components. Other consumer models, like CONSEXPO, may have
a dermal component, but are not EPA models. While we are not excluding the use of non-EPA
models, use of such models require a more thorough review of the model, model components,
peer review background, and other aspects prior to use. Dermal exposure can vary depending
on the methodology used within a given model. EPA plans to utilize a permeability approach
with respect to dermal exposure due to the scenarios to be evaluated (prohibited evaporation
due to a barrier or full immersion into a product during use). Within CEM, the permeability
approach is more representative of these consumer scenarios because it does not consider
evaporation. The fraction absorbed approach within CEM considers evaporation and therefore
may not be representative of the scenarios EPA plans to evaluate.
4)	Review reasonably available empirical data that may be used in developing, adapting or
applying exposure models to a particular risk evaluation scenario. For example, existing
models developed for a chemical assessment may be applicable to another chemical
assessment if model parameter data are reasonably available.
The information and data identified and evaluated under EPA's systematic review process may
include certain empirical data which may be used to develop, adapt, or apply certain exposure
models. Empirical data can also be used for comparison purposes to identify trends,
similarities, or differences between approaches or models. Where differences are identified,
EPA may consider the underlying parameters and assumptions to identify why differences
may exist.
Empirical information and data can also help inform inputs for certain exposure models used
for this evaluation. EPA plans to evaluate the reasonably available information involving
permeability coefficients associated with formaldehyde in multiple product mixtures (aqueous,
solvent, or mixture). The absence of empirical information and data can inform revisions to
approaches or methodologies currently included for this evaluation.
5)	Review reasonably available consumer product-specific sources to determine how those
exposure estimates compare with each other and with indoor monitoring data reporting
formaldehyde in specific media (e.g., dust or indoor air).
The information and data identified and evaluated under EPA's systematic review process may
include consumer exposure information for specific consumer products, consumer uses, or
consumer use locations. This information can be used to identify trends as well as compare or
contrast results in different locations. It can also be used to inform modeling methodologies
and approaches utilized by EPA for this evaluation. Some challenges arise with product
specific consumer exposure information since it may not align adequately with a specific
condition of use analyzed in this evaluation.
6)	Review reasonably available population- or subpopulation-specific exposure factors and
activity patterns to determine if PESS need to be further refined.
The information and data identified and evaluated under EPA's systematic review process may
include exposure information for PESS. This information can include exposure factors or
activity patterns not captured in other information and data source categories. Use of PESS
specific information can be used to inform approaches and methodologies necessary to
adequately consider PESS in this evaluation. The expected methodologies and approaches
55

-------
described for consumer exposure in this evaluation indirectly capture PESS in the evaluation.
Consumer users are defined for this evaluation, and EPA plans to evaluate representative age
groups which are expected to be intended users of formaldehyde containing consumer
products. Considering PESS, consumer users for this evaluation may be men and women of
reproductive age, individuals with pre-existing health conditions which could impact their
ability to manage an exposure, or elderly individuals. However, an infant is not expected to be
an intended consumer user for anticipated products identified for this evaluation and therefore
would not be considered PESS as a user. At the same time, infants may fall into the category
of consumer bystander as defined in this evaluation. Consumer bystanders can fall into any age
group (infant to elderly) and therefore are considered as part of the consumer bystander
exposure evaluation. Depending on the units associated with various health endpoints
identified for this evaluation determines if PESS evaluations need to be expanded or refined. If
a health endpoint is based on a concentration, then PESS is addressed alongside all other age
groups since concentration at a given receptor point is independent of an individual's surface
area, body weight, inhalation rates, etc. If a health endpoint is based on a dose, then to
adequately consider PESS, some additional analysis or refinement may be necessary.
7) Evaluate the weight of the scientific evidence of consumer exposure estimates based on
different approaches.
Information and data identified and evaluated through EPA's systematic review process will
receive a data quality rating (score) representing high, medium, low, or unacceptable quality
based on a series of metrics developed and incorporated into the review process. The metrics
will provide a base from which EPA plans to begin to apply a weight of the scientific evidence
to each piece of information or data. The weight of the scientific evidence will, in turn, inform
if and how the various pieces of information or data can or will be integrated into the risk
evaluation process. The data quality rating and weight of the scientific evidence will be
utilized to develop scientifically supported conclusions regarding exposure levels, as well as
confidence and uncertainty surrounding the exposure levels found.
2.7.2.5 General Population
EPA plans to analyze general population exposures via the inhalation route as a result of off-
gassing for co-location and co-residence populations. Co-location, for purposes of this evaluation,
refers to an individual living very near a separate residence where one or more consumer products
from which formaldehyde is expected to off-gas for an extended period of time are utilized and
installed. Co-residence, for purposes of this evaluation, refers to an individual living adjacent to
(immediately above or next to) a separate residence where one or more consumer products from
which formaldehyde is expected to off-gas for an extended period of time are utilized and
installed.
1) Refine and finalize exposure scenarios for general population by considering
combinations of sources and uses, exposure pathways including routes, and exposed
populations.
General population exposure scenarios will be built out based on the information and data
identified and evaluated as part of EPA's systematic review process. General population
exposure for co-located and co-residence scenarios may consist of one or more distances very
near a residence (co-location) or one or more building configurations (co-residence).
56

-------
2)	Review reasonably available environmental and biological monitoring data for exposure
pathways and media to which general population exposures are expected.
Information and data identified and evaluated as part of EPA's systematic review process will
be utilized to inform decisions about exposure pathways and media to which general
population exposures may occur.
3)	For exposure pathways where empirical data is not reasonably available, review existing
exposure models that may be applicable in estimating exposure levels.
General population exposure levels can be estimated utilizing a variety of EPA models. Co-
location scenarios can be modeled using AERMOD since it allows a user to model
concentrations at very small distances from an emission source. Co-residence scenarios can be
modeled using IECCU since it is an indoor air pollutant transport model capable of modeling
multiple zones and multiple building configurations based on user defined inputs.
4)	Consider and incorporate applicable media-specific regulations into exposure scenarios
or modeling approaches.
General population exposure for co-located and co-residence scenarios resulting from off-
gassing may need to consider variable emission rates due to the promulgation of regulations
under TSCA which limits formaldehyde content in certain composite wood products (as
defined by the regulation). The regulation was promulgated in 2016, so consideration of off-
gassing products before and after this date may need to be evaluated separately since off-
gassing can be ongoing for more than 4 years. Screening level analysis may be applicable in
this situation to identify if off-gassing after 4 years can lead to acute or chronic exposure levels
or concerns. Further consideration of this approach will be reviewed throughout the risk
evaluation process.
5)	Review reasonably available exposure modeled estimates. For example, existing models
developed for a previous formaldehyde chemical assessment may be applicable to EPA's
assessment.
The information and data identified and evaluated as part of EPA's systematic review process
may include modeled estimates of formaldehyde concentrations associated with general
population exposure. This information can be used to inform approaches and methodologies
utilized by EPA for this evaluation. The degree to which this information is used depends on a
variety of factors including comparability of different models used, model parameters utilized
to derive modeled estimates, and comparability of such modeled scenarios and results.
6)	Review reasonably available information about population- or subpopulation-specific
exposure factors and activity patterns to determine if PESS need to be further defined
(e.g., early life and/or puberty as a potential critical window of exposure).
The information and data identified and evaluated under EPA's systematic review process may
include exposure information for PESS. This information can include exposure factors or
activity patterns not captured in other information and data source categories. Use of PESS
specific information can be used to inform approaches and methodologies necessary to
adequately consider PESS in this evaluation. The expected methodologies and approaches
described for general population in this evaluation indirectly capture PESS in the evaluation.
Individuals within the general population can fall into any age group (infant to elderly) and
therefore are considered part of the general population evaluated for exposure in this
57

-------
evaluation. Depending on the units associated with various health endpoints identified for this
evaluation determines if PES S evaluations need to be expanded or refined. If a health endpoint
is based on a concentration, then PESS is addressed alongside all other age groups since
concentration at a given receptor point is independent of an individual's surface area, body
weight, inhalation rates, etc. If a health endpoint is based on a dose, then to adequately
consider PESS, some additional analysis or refinement may be necessary.
7) Evaluate the weight of the scientific evidence of general population exposure estimates
based on different approaches.
Information and data identified and evaluated through EPA's systematic review process will
receive a data quality rating (score) representing high, medium, low, or unacceptable quality
based on a series of metrics developed and incorporated into the review process. The metrics
will provide a base from which EPA plans to begin to apply a weight of the scientific evidence
to each piece of information or data. The weight of the scientific evidence will, in turn, inform
if and how the various pieces of information or data can or will be integrated into the risk
evaluation process. The data quality rating and weight of the scientific evidence will be
utilized to develop scientifically supported conclusions regarding exposure levels, as well as
confidence and uncertainty surrounding the exposure levels found
2.7.3 Hazards (Effects)
2.7.3.1 Environmental Hazards
EPA plans to conduct an environmental hazard assessment of formaldehyde as follows:
1) Review reasonably available environmental hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput
screening methods; data on categories and read-across; in vitro studies).
EPA plans to analyze the hazards of formaldehyde to aquatic and/or terrestrial organisms,
including plants, invertebrates (e.g., insects, arachnids, mollusks, and crustaceans), and
vertebrates (e.g., mammals, birds, amphibians, fish, and reptiles) across exposure durations
and conditions if potential environmental hazards are identified through public comments and
the results of the systematic search and screening of the literature. Additional types of
environmental hazard information will also be considered (i.e., analogue and read-across data)
when characterizing the potential hazards of formaldehyde to aquatic and/or terrestrial
organisms.
EPA plans to evaluate environmental hazard data using the environmental toxicity data quality
criteria outlined in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document. The study evaluation results will be documented in the risk
evaluation phase and data from suitable studies will be extracted and integrated in the risk
evaluation process.
Hazard endpoints (e.g., mortality, growth, immobility, and reproduction) will be evaluated,
while considering data availability, relevance and quality.
58

-------
2)	Derive hazard thresholds for aquatic and/or terrestrial organisms.
Depending on the robustness of the evaluated data for a particular organism or taxa (e.g.,
aquatic invertebrates), environmental hazard values (e.g., ECx, LCx, NOEC, LOEC) may be
derived and used to further understand the hazard characteristics of formaldehyde to aquatic
and/or terrestrial species. Identified environmental hazard thresholds may be used to derive
concentrations of concern (COC), based on endpoints that may affect populations of organisms
or taxa analyzed
3)	Evaluate the weight of the scientific evidence of environmental hazard data.
During risk evaluation, EPA plans to evaluate and integrate the environmental hazard evidence
identified in the literature inventory using the methods described in the systematic review
documentation that EPA plans to publish prior to finalizing the scope document.
4)	Consider the route(s) of exposure, based on reasonably available monitoring and
modeling data, and other reasonably available approaches to integrate exposure and
hazard assessments.
EPA plans to consider aquatic (e.g., water and sediment exposures) and terrestrial pathways in
the formaldehyde conceptual model. These organisms may be exposed to formaldehyde via a
number of environmental pathways (i.e., surface water, sediment, soil, and diet).
5)	Conduct an environmental risk characterization of Formaldehyde.
EPA plans to conduct a risk characterization of formaldehyde to identify if there are risks to
the aquatic and/or terrestrial environments from the measured and/or predicted concentrations
of formaldehyde in environmental media (i.e., water, sediment, and soil). Risk quotients (RQs)
may be derived by the application of hazard and exposure benchmarks to characterize
environmental risk.
6)	Consider a Persistent, Bioaccumulative, and Toxic (PBT) Assessment of Formaldehyde.
EPA may consider assessing the persistence, bioaccumulation, and toxic (PBT) potential of
formaldehyde after reviewing relevant p-chem properties and exposure pathways. EPA plans
to assess the reasonably available studies collected from the systematic review process relating
to bioaccumulation and bioconcentration (BAF/BCF) of formaldehyde. In addition, EPA plans
to integrate traditional environmental hazard endpoint values (e.g., LCso and LOEC) and
exposure concentrations (e.g., surface water concentrations, tissue concentrations) for
formaldehyde with the fate parameters (e.g., BAF, BCF, BMF, and TMF).
2.7.3.2 Human Health Hazards
EPA plans to analyze human health hazards as follows:
1) Review reasonably available human health hazard data, including data from alternative
test methods (e.g., computational toxicology and bioinformatics; high-throughput
screening methods; data on categories and read-across; in vitro studies; systems biology).
EPA plans to use systematic review methods to evaluate the epidemiological and toxicological
literature for formaldehyde. EPA plans to publish the systematic review documentation prior
to finalizing the scope document.
59

-------
Mechanistic data may include analyses of alternative test data such as novel in vitro test
methods, in silico and high throughput screening. The association between acute and chronic
exposure scenarios to formaldehyde and each health outcome will also be integrated. Study
results will be extracted and presented in evidence tables or another appropriate format by
organ/system.
2)	Conduct hazard identification (the qualitative process of identifying non-cancer and
cancer endpoints) and dose-response assessment (the quantitative relationship between
hazard and exposure) for identified human health hazard endpoints.
EPA plans to identify human health hazards from acute and chronic exposures by evaluating
the human and animal data that meet the systematic review data quality criteria described in
the systematic review documentation that EPA plans to publish prior to finalizing the scope
document. Hazards identified by studies meeting data quality criteria will be grouped by routes
of exposure relevant to humans (oral, dermal, inhalation) and by cancer and noncancer
endpoints.
Dose-response assessment will be performed in accordance with EPA guidance (U.S. EPA.
2012a. 20 j j_h, |). Dose-response analyses may be used if the data meet data quality criteria
and if additional information on the identified hazard endpoints are not reasonably available or
would not alter the analysis.
The cancer mode of action (MOA) determines how cancer risks can be quantitatively
evaluated. Carcinogenic hazards have been identified for formaldehyde as noted in the
Proposed Designation _ naldehyde fCASRN"50-00-0) as a High-Priority Substance for
Risk Evaluation (U.S. EPA, 2019a). EPA plans to evaluate information on genotoxicity and
the mode of action for all cancer endpoints to determine the appropriate approach for
quantitative cancer assessment in accordance with the U.S. EPA Guidelines for Carcinogen
Risk Assessment (I .S TP \ 2005).
3)	In evaluating reasonably available data, determine whether particular human receptor
groups may have greater susceptibility to the chemical's hazard(s) than the general
population.
Reasonably available human health hazard data will be evaluated to ascertain whether some
human receptor groups may have greater susceptibility than the general population to
formaldehyde hazard(s). Susceptibility of particular human receptor groups to formaldehyde
will be determined by evaluating information on factors that influence susceptibility.
EPA has reviewed some sources containing hazard information associated with susceptible
populations and lifestages such as pregnant women and infants. Pregnancy (i.e., gestation) and
childhood are potential susceptible lifestages for formaldehyde exposure. The European
Chemicals Agency 2017 document Investigation Report: Formaldehyde and Formaldehyde
Releasers (ECHA, 2017) contains a list of studies that will be evaluated to ascertain whether
some human receptor groups may have greater susceptibility than the general population to
formaldehyde's hazard(s). EPA plans to review the current state of the literature in order to
potentially quantify these differences for risk evaluation purposes.
60

-------
4)	Derive points of departure (PODs) where appropriate for the routes and durations of
exposure; conduct benchmark dose modeling depending on the reasonably available
data. Adjust the PODs as appropriate to conform (e.g., adjust for duration of exposure)
to the specific exposure scenarios evaluated.
Hazard data will be evaluated to determine the type of dose-response modeling that is
applicable. Where modeling is feasible, a set of dose-response models that are consistent with
a variety of potentially underlying biological processes will be applied to empirically model
the dose-response relationships in the range of the observed data consistent with the EPA's
Benchmark Dose Technical Guidance Document. Where dose-response modeling is not
feasible, NOAELs or LOAELs will be identified. Non-quantitative data will also be evaluated
for contribution to weight of the scientific evidence or for evaluation of qualitative endpoints
that are not appropriate for dose-response assessment.
EPA plans to evaluate whether the reasonably available PBPK and empirical kinetic models
are adequate for route-to-route and interspecies extrapolation of the POD, or for extrapolation
of the POD to standard exposure durations (e.g., lifetime continuous exposure). If application
of the PBPK model is not possible, oral PODs may be adjusted by BW3/4 scaling in accordance
with U.S. EPA. (2011). and inhalation PODs may be adjusted by exposure duration and
chemical properties in accordance with
5)	Evaluate the weight of the scientific evidence of human health hazard data.
During risk evaluation, EPA plans to evaluate and integrate the human health hazard evidence
identified in the literature inventory under acute and chronic exposure conditions using the
methods described in the systematic review documentation that EPA plans to publish prior to
finalizing the scope document.
6)	Consider the route(s) of exposure (e.g., oral, inhalation, dermal), reasonably available
route-to-route extrapolation approaches; biomonitoring data; and approaches to
correlate internal and external exposures to integrate exposure and hazard assessment.
At this stage of review, EPA believes there will be sufficient data to conduct dose-response
analysis and/or benchmark dose modeling for the oral route of exposure for formaldehyde.
EPA plans to also evaluate any potential human health hazards following dermal and
inhalation exposure to formaldehyde, which could be important for worker, consumer, and
general population risk analysis. Reasonably available data will be assessed to determine
whether or not a point of departure can be identified for the dermal and inhalation routes. This
may include using route-to-route extrapolation methods where appropriate depending on the
nature of the reasonably available data.
If sufficient toxicity studies are not identified in the literature search to assess risks from
dermal and inhalation exposures, then a route-to-route extrapolation from oral toxicity studies
would be needed to assess systemic risks from dermal or inhalation exposures. Without an
adequate PBPK model, the approaches described in the EPA guidance document Risk
Assessment Guidance for Superfund Volume I: Human Health Evaluation Manual (Part E,
Supplemental Guidance for Dermal Risk Assessment) (U.S. EPA. 2004a) could be applied to
extrapolate from oral to dermal exposure. These approaches may be able to further inform the
relative importance of dermal exposures compared with other routes of exposure. Similar
methodology may also be used for assessing inhalation exposures
61

-------
2.7.4 Summary of Risk Approaches for Characterization
Risk characterization is an integral component of the risk assessment process for both environmental
and human health risks. EPA plans to derive the risk characterization in accordance with the EPA's
Risk Characterization Handbook (U.S. EPA... 2000). As defined in the EPA's Risk Characterization
Policy, "the risk characterization integrates information from the preceding components of the risk
evaluation and synthesizes an overall conclusion about risk that is complete, informative and useful
for decision makers." Risk characterization is considered to be a conscious and deliberate process to
bring all important considerations about risk, not only the likelihood of the risk but also the strengths
and limitations of the assessment, and a description of how others have assessed the risk into an
integrated picture.
Risk characterization at EPA assumes different levels of complexity depending on the nature of the
risk assessment being characterized. The level of information contained in each risk characterization
varies according to the type of assessment for which the characterization is written. Regardless of the
level of complexity or information, the risk characterization for TSCA risk evaluations will be
prepared in a manner that is transparent, clear, consistent, and reasonable (TCCR) (U.S. EPA. 2000).
EPA plans to also present information in this section consistent with approaches described in the
Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82FR
33726). For instance, in the risk characterization summary, EPA plans to further carry out the
obligations under TSCA Section 26; for example, by identifying and assessing uncertainty and
variability in each step of the risk evaluation, discussing considerations of data quality such as the
reliability, relevance and whether the methods utilized were reasonable and consistent, explaining any
assumptions used, and discussing information generated from independent peer review. EPA plans to
also be guided by the EPA's Information Quality Guidelines (U.S. 2002) as it provides guidance for
presenting risk information. Consistent with those guidelines, in the risk characterization, EPA plans
to also identify: (1) Each population addressed by an estimate of applicable risk effects; (2) the
expected risk or central estimate of risk for the PESS affected; (3) each appropriate upper-bound or
lower bound estimate of risk; (4) each significant uncertainty identified in the process of the
assessment of risk effects and the studies that would assist in resolving the uncertainty; and (5) peer
reviewed studies known to the Agency that support, are directly relevant to, or fail to support any
estimate of risk effects and the methodology used to reconcile inconsistencies in the scientific
information.
2.8 Peer Review
Peer review will be conducted in accordance with EPA's regulatory procedures for chemical risk
evaluations, including using EPA's Peer Review Handbook and other methods consistent with Section
26 of TSCA (See 40 CFR 702.45). As explained in the Risk Evaluation Rule, the purpose of peer
review is for the independent review of the science underlying the risk assessment. Peer review will
therefore address aspects of the underlying science as outlined in the charge to the peer review panel
such as hazard assessment, assessment of dose-response, exposure assessment, and risk
characterization. The draft risk evaluation for formaldehyde will be peer reviewed.
62

-------
REFERENCES
ACC (American Chemistry Council). (2019). Public Comment on the Proposed Designation of
Formaldehyde as a High Priority Chemical Substance submitted by Kimberly Wise White of the
(ACC) under TSCA, Docket no. EPA-HQ-OPPT-2018-0438-0018
AIA (Aerospace Industries Association). (2019). Public Comment on the Proposed Designation of
Formaldehyde as a High Priority Chemical Substance submitted by David Hyde, Director,
Environmental Policy, Aerospace Industries Association. Docket no. EPA-HQ-OPPT-2018-043 8-
0006
Aldrich Chemical Corporation. (1999). Hexamethylenetetramine, 99+% A.C.S. Reagent. Retrieved
January 7, 2020. https://hazard.com/msds/f2/bxr/bxrps.html
ARMA (Asphalf Roofing Manufacturers Association). (2019). Public Comment on the Proposed
Designation of Formaldehyde as a High Priority Chemical Substance submitted by Reed Hitchcock,
Executive Vice President, Asphalf Roofing Manufacturers Association. Docket no. EPA-HQ-OPPT-
2018-0438-0005
Atkinson, R. (1992). Gas-phase tropospheric chemistry of organic compounds. J Phys Chem Ref Data
Monograph no. 2. HERO ID: 5348427
ATSDR (Agency for Toxic Substances and Disease Registry). (1999). Toxicological profile for
formaldehyde [ATSDR Tox Profile], Atlanta, GA: U.S. Department of Health and Human Services,
Public Health Service, http://www.atsdr.cdc.gov/toxprofiles/tplll.pdf. HERO ID: 93087
ATSDR (Agency for Toxic Substances and Disease Registry). (2010). Addendum to the toxicological
profile for formaldehyde. Atlanta, GA: U.S. Department of Health and Human Services, Agency for
Toxic Substances and Disease Registry, Division of Toxicology and Environmental Medicine.
https://www.atsdr.cdc.gov/toxprofiles/formaldehyde_addendum.pdf?id=l 167&tid=39. HERO ID:
5160116
ATSDR (Agency for Toxic Substances and Disease Registry). (2016). Possible health
implications from exposure to formaldehyde emitted from laminate flooring samples tested by
the Consumer Product Safety Commission. Atlanta, GA: Center for Disease Control and
Prevention, National Center for Environmental Health, Agency for Toxic Substances and
Disease Registry, https://www.cdc.gov/nceh/laminateflooring/docs/laminate-flooring-report-3-
22-2016 508.pdf
Beecham Home Improvement Products, Inc. (1986). Weldwood Waterproof Resorcinol Glue.
Retrieved January 7, 2020. https://hazard.com/msds/f2/bsh/bshhh.html
Betterton, EA. (1992). Henry's Law constants of soluble and moderately soluble organic gases:
Effects on aqueous phase chemistry. In JO Nriagu (Ed.), Gaseous Pollutants: Characterization and
Cycling. New York, NY: John Wiley. http://www.wiley.com/WileyCDA/WileyTitle/productCd-
0471548987.html. HERO ID: 77998
Binder, W.H.; Dunky, M; Jahromi, S. (2005). Melamine Resins. In Kirk-Othmer
Encyclopedia of Chemical Technology: John Wiley & Sons.
https://doi.org/10.1002/Q471238961.melabind.a01
63

-------
Calgon Corporation. (1990). Coagulant Aid 289. Retrieved January 7, 2020.
https://hazard.com/msds/f2/btl/btlmj.html
Campbell, C. (2016). Adhesives. In Kirk-Othmer Encyclopedia of Chemical Technology:
John Wiley & Sons. https://doi.org/10.1002/Q4 ' 1 tvv I 0104080 :1 I '0309.a01.pub4
CDC (Centers for Disease Control and Prevention). (2013). National Health and Nutrition
Examination Survey Data (NHANES) [Database], Atlanta, GA: CDC National Center for Health
Statistics. Retrieved from https://www.cdc.gov/nchs/nhanes/index.htm. HERO ID: 6127682
Certified Labs (Division of NCH Corporation). (1995). Cut-thru aerosol 5049. Retrieved January 7,
2020. https://hazard.com/msds/f2/cbc/cbciv.html
Chemetrics. (1989). Chlorine Chemets, ULR Chemets, Vacuettes. Retrieved January 7, 2020.
https://hazard.com/msds/f2/blb/blbrc.html
Cherrie, JW., Semple, S. Christopher, Y., Saleem, A., Hughson, G.W., Phillips, A. (2006). How
important is inadvertent ingestion of hazardous substances at work? Ann Occup Hyg. 50(7):693-704.
HERO ID: 460308
Colgate-Palmolive Company. (2015). Irish Spring Body Wash Deep Action Scrub. Retrieved January
7, 2020. https://www.whatsinproducts.eom//brands/show msds/1/16934
Colgate-Palmolive Company. (2016). Suavitel Fabric Softener Liquid Morning Sun. Retrieved
January 7, 2020. https://www.whatsinproducts.eom//brands/show msds/1/16979
Colgate-Palmolive Company. (2016). Softsoap Liquid Hand Soap Aloe Vera. Retrieved January 7,
2020. https://www.whatsinproducts.eom//brands/show msds/1/16971
CPCat. (2015). Exploring consumer exposure pathways and patterns of use for chemicals in
the environment. Toxicology Reports, 2, 228-237. doi:
http://dx.doi. ore/ S 0.10 "i 6/i. toxrep .2014.12.009
DAP. (2008). Alex latex caulk plus silicone. Retrieved January 7, 2020.
https://www.whatsinproducts.eom//brands/show msds/1/10345
Day-Glo Color Corporation. (1993). Tempera Paint. Retrieved January 7, 2020.
https://hazard.eom//msds/files/bzr/bzrfs.html.
Dexter Crown Metro Aerospace Inc. (1992). Epoxy Primer. Retrieved January 7, 2020.
https://hazard.eom/msds/f2./bxn./bxnYe.html
Dodge Chemical Co. (1988). Permaglo. Retrieved January 7, 2020.
https://hazard.eom/msds/f2./bm.k/bmkxk.htm.l
Eastman Kodak Company. (1996). Flexicolor Stabilizer III and Replenisher Working Solution.
Retrieved January 7, 2020. https://hazard.eom//m.sds/f2./cdz/cdzfs.html
Earthjustice. (2019). Public Comment on the Proposed Designation of Formaldehyde as a High
Priority Chemical Substance submitted by Eve C. Gartner, Staff Attorney, Earthjustice. Docket no
EPA-HQ-OPPT-2018-043 8-0019.
64

-------
EDF (Environmental Defence Fund) (2019). Public Comment on the Proposed Designation of
Formaldehyde as a High Priority Chemical Substance submitted by Robert Stockman of the
Environmental Defense Fund. Docket no. EPA-HQ-OPPT-2018-043 8-0017
EC (European Commission). (2018). Information Platform for Chemical Monitoring Data [Database],
Retrieved from https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html. HERO ID:
4571684
ECHA (European Chemicals Agency). (2017). Investigation Report: Formaldehyde and
Formaldehyde Releasers. Helsinki, Finland: European Union, European Chemicals Agency.
ECHA (European Chemicals Agency). (2019). Annex XV restriction report, proposal for a restriction:
Formaldehyde and formaldehyde releasers. Helsinki, Finland: European Union, European Chemicals
Agency, https://echa.europa.eu/documents/10162/13641/rest_formaldehyde_axvreport_en.pdf/2c798
a08-591c-eed9-8180-a3c5a0362e37. HERO ID: 5155562
E.I. Dupont de Nemours & Co. (1989). Teflon-S LT Green, Non-Stick LM FEP 964-101. Retrieved
January 7, 2020. https://hazard.com/msds/f2/bqd/bqdce.html
E.I. Dupont de Nemours & Co. (1995). Lacquer Thinner and Cleaning Solvent. Retrieved January 7,
2020. https://hazard.com/msds/f2/bzv/bzvrv.html
Elmers. (2012). CraftBond Acid-Free Multi-Purpose Spray Adhesive. Retrieved January 7, 2020.
Elsevier. (2019). Reaxys: p-chem property data for formaldehyde. CAS Registry Number: 50-00-0.
Available online
E/M Corporation. (1992). Everlube. Retrieved January 7, 2020.
https://hazard.eom/msds/f2./bqv/bqvis. html
Enthone-OMI, Inc. (1990). Enplate CU-406 A, 3317. Retrieved January 7, 2020.
https://hazard.eom/msds/f2./bch/bchft).html
Enthone-OMI, Inc. (1992):SEL-REX-XR-235B Addition Agent DCAS. Retrieved January 7, 2020.
https://hazard.eom/msds/f2./bzs/bzslz.htm.l
Environment Canada. (2000). Priority substances list assessment report: Formaldehyde. Ottawa,
Ontario: Government of Canada, Environment Canada, Health Canada.
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/ewh-semt/alt_formats/hecs-
sesc/pdf/pubs/contaminants/psl2-lsp2/formaldehyde/formaldehyde-eng.pdf. HERO ID: 1256545
FDA (U.S. Food and Drug Administration). (1991). FDA Total Diet Study [Database], Retrieved from
http://www.fda.gov/Food/FoodScienceResearch/TotalDietStudy/ucml84293.htm. HERO ID: 4571554
FDA (U.S. Food and Drug Administration). (2020). Code of federal regulations. Title 21 - Food and
drugs. Chapter 1: Parts 170-189. Available online at https://www.govinfo.gov/content/pkg/CFR-2019-
title21-vol3/pdf/CFR-2019-title21-vol3-chapI.pdf HERO ID: 6308849
Finnegan, J.A.; Gersh, B.P.; Lang, J.B.; Levy, R. (2000). Building Materials, Plastic. In Kirk-
Othmer Encyclopedia of Chemical Technology: John Wiley & Sons.
https://dot.org/10.1002/04712389t-U; I :01 I'\">< * < ij i t vdl
65

-------
Formica brand products. (1988). Formica brand metal laminate. Retrieved January 7, 2020.
http s://h azard. eom/ro sds/Ł2/btw/btwzd. htm 1
Franklin International. (1992). Titebond II Wood Glue. Retrieved January 7, 2020.
https://hazard.com/msds/f2/bwc/bwcrd.html
Gerberich, RH; Seaman, GC. (2013). Formaldehyde. In Kirk-Othmer Encyclopedia of
Chemical Technology: John Wiley & Sons.
https://doi.org/10.1002/Q4712389i	7051802.a01.pub3
Gerike, P; Gode, P. (1990). The biodegradability and inhibitory concentration of some disinfectant.
Chemosphere 21: 799-812. http://dx.doi.org/10.1016/0045-6535(90)90267-W. HERO ID: 5348404
Graphic Controls/Industrial Product Division. (1985). Code 30 Ink Red. Retrieved January 7, 2020.
https://hazard.eom//msds/f2/biw/biwmf.html
Hose, JE; Lightner, DV. (1980). Absence of formaldehyde residues in Penaeid shrimp exposed to
formalin. Aquaculture 21: 197-201. http://dx.doi.org/10.1016/0044-8486(80)90028-9. HERO ID:
5348406
Howard, PH. (1991). Formaldehyde. In Handbook of Environmental Degradation Rates. Boca Raton,
FL: Lewis Publishers/CRC Press. HERO ID: 5348432
HSDB (Hazardous Substances Data Bank). (2015). Formaldehyde, CASRN: 50-00-0. U.S.
Department of Health and Human Services, National Institutes of Health, National Library of
Medicine. https://toxnet.nlm.nih.gov/cgi-bin/sis/search/a?dbs+hsdb:@term+@DOCNO+164. HERO
ID:5348400
Hunter, W.N. (2000). Alcohols, Polyhydric. In Kirk-Othmer Encyclopedia of Chemical
Technology: John Wiley & Sons.
https://doi.org/10.1002/04712389( I 01 12031 SOSi I 1 L'O.aOl
Keller-Reckitt & Colman Inc. (1991). Toilet Soap Type 1. Retrieved January 7, 2020.
https://hazard.com/msds/f2/bmw/bmwdr.html
Keller-Reckitt & Colman, Inc. (1991). Dishwashing compound, hand. Retrieved January 7, 2020.
https://hazard.com/msds/f2/bmw/bmwds.html
Kleen Brite Laboratories, Inc. (1989). Liquid Dishwashing Detergent, 13300. Retrieved January 7,
2020. https://hazard.com/msds/f2/bls/blsqm.html
Kopf, P.W. (2003). Phenolic Resins. In Kirk-Othmer Encyclopedia of Chemical
Technology: John Wiley & Sons.
https://dot.org/10.1002/04712389t-U080:14 1 I I lb 06.a01.pub2
Lewis, RJ. (1993). Formaldehyde. In Hawley's Condensed Chemical Dictionary (12th ed.). New
York, NY: Van Nostrand Reinhold. HERO ID: 5348434
Maine Legislature. (2019). 38 MRSA Chapter 16-D: Toxic chemicals in children's products. (Maine
Revised Statuses Title 38 Chapter 16-D). Maine Legislature.
https://legislature.maine.gov/statutes/38/title38chl6-Dsec0.html. HERO ID: 6305877
66

-------
Mansfield Sanitary, Inc. (1985). TDX Treatment Chemical. Retrieved January 7, 2020.
https://hazard.eom/msds/E2./bfz/bfznv.html
Massachusetts Executive Office of Energy and Environmental Affairs. (2018). 301 CMR 41.00: Toxic
or hazardous substances list. (Code of Massachusetts Regulations Title 301 Part 41.00). Massachusetts
Executive Office of Energy and Environmental Affairs. https://www.mass.gov/regulations/301-CMR-
4100-toxic-or-hazardous-substances-list. HERO ID: 6305845
MDH (Minnesota Department of Health). (2019). Toxic Free Kids Act Minnesota Stat. 116.9401 to
116.9407. Available online at https://www.revisor.mn.gOv/statutes/cite/116.9401#stat.116.9401
HERO ID: 6307819
MDI. (2002). Comparitive Toxicogenomics Database [Database], Retrieved from http://ctdbase.org.
HERO ID: 4571354
Meeting. (November 18, 2019). Meeting with EPA and American Coating Association (ACA).
Meeting. (August 14, 2019). Meeting with EPA and U.S. Tire Manufacturers Association (USTM).
Meeting. (December 12, 2019). Meeting with EPA and IPC.
Meeting. (February 6, 2020). Meeting with EPA and Everlube.
Michigan Department of Environment Great Lake and Energy. (2018). Mich. Admin. Code R. 299.44:
Generic groundwater cleanup criteria (Table 1). (Michigan Administrative Code R. 299.44). Michigan
Department of Environment, Great Lake, and Energy, https://www.mi chigan.gov/egle/0,9429,7-13 5-
3311_4109_9846-251790—,00.html. HERO ID: 6305858
Michigan Department of Environment Great Lake and Energy. (2018). Mich. Admin. Code R.299.49:
Footnotes for generic cleanup criteria tables. (Michigan Administrative Code R.299.49). Michigan
Department of Environment, Great Lakes, and Energy. https://www.michigan.gov/egleA),9429,7-135-
3311_4109_9846-251790—,00.html. HERO ID: 6305859
New Jersey Department of Health and Senior Services. (2018). 8:59 N.J. Admin. Code § 9.1: Right to
know hazardous substance list-General provisions. New Jersey Department of Health and Senior
Services. HERO ID: 6309953
NICNAS (National Industrial Chemicals Notification and Assessment Scheme). (2006). Priority
existing chemical assessment report no. 28 formaldehyde. Sydney, Australia: Australian Government
Department of Health, National Industrial Chemicals Notification and Assessment Scheme.
https://search.nicnas.gov.au/s/redirect?collection=nicnas-assessments&url=https%3A%2F%2F
www.nicnas.gov.au%2F	data%2Fassets%2Fword_doc%2F0003%2F34833%2FPEC28-formalde
hyde.docx&auth=%2FvwWAFkciLGpojWMy%2F9E9w&profile=_ default&rank=l&query=50-00-
0+%2B%5BQ%3A50-00-0%5D+%7C3%3AAssessments. HERO ID: 192040
NIOSH (National Institute for Occupational Safety and Health). (2018). NIOSH pocket guide to
chemical hazards: Formaldehyde. Atlanta, GA: United States Department of Health and Human
Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and
Health, https://www.cdc.gov/niosh/npg/npgd0293.html. HERO ID: 646691
67

-------
NIST (National Institute of Standards and Technology). (2013). NIST Chemistry WebBook.
Formaldehyde (50-00-0). Standard Reference Database No. 69. Washington, DC: US Sec Commerce.
https://webbook.nist.gov/cgi/cbook.cgi?ID=50-00-0&Units=SI. HERO ID: 5348398
NLM (National Institutes of Health, National Library of Medicine). (2019). PubChem: Hazardous
Substance Data Bank: Formaldehyde, 50-00-0. Available online at
https://pubchem.ncbi.nlm.nih.gov/compound/712#source=HSDB
Northern Labs, Inc. (1990). Kit Paste Car Wax. Retrieved January 7, 2020.
https://hazard.com/msds/f2/bmd/bmdgf.html
NTP (National Toxicology Program). (2010). Final report on carcinogens: Background document for
formaldehyde [NTP] (pp. i-512). U.S. Department of Health and Human Services, National Institutes
of Health, National Toxicology Program.
https://web.archive.Org/web/20151017072550/https://ntp.niehs.nih.gov/ntp/roc/twelfth/2009/novembe
r/formaldehyde_bd_final_508.pdf. HERO ID: 1041161
NTP (National Toxicology Program). (2016). Report on carcinogens, fourteenth edition:
Formaldehyde. Research Triangle Park, NC: U.S. Department of Health and Human Services,
National Institutes of Health, National Toxicology Program.
https://ntp.niehs.nih.gov/ntp/roc/content/profiles/formaldehyde.pdf. HERO ID: 5160139
OECD (Organisation for Economic Co-operation and Development). (2002). SIDS initial assessment
report for SIAM 14. Formaldehyde (CAS no: 50-00-0) [OECD SIDS], Paris, France: UNEP
Publications. https://hpvchemicals.oecd.org/ui/handler.axd?id=5525377e-1442-43d0-8c76-
f8cacfadf8bb. HERO ID: 5348397
OECD (Organisation for Economic Co-operation and Development). (2004a, revised in
2009). Emission Scenario Document on Plastic Additives. (Number 3). Paris, France.
http://www.oecd. org/officialdocuments/displavdocument/?cote=env/im/mono(2004Wrevl&d
oclamguage=em
OECD (Organisation for Economic Co-operation and Development). (2004b). Emission
Scenario Document on Lubricants and Lubricant Additives. (Number 10). Paris, France.
http://www.oecd.org/officialdocuments/publicdisplavdocumentpdf/?cote=env/im/mono(2004)
ioctamguage=em
OECD (Organisation for Economic Co-operation and Development). (2009). Emission
Scenario Document on Coating Industry (Paints, Lacquers and Varnishes). (Number 22).
Paris, France, http://www.oecd.org/officialdocuments/publicdisplavdocumentpdf/?cote=env
/im/mono(T "
OECD (Organisation for Economic Co-operation and Development). (2013). Emission
Scenario Document on the Industrial Use of Adhesives for Substrate Bonding. Paris, France.
http://www.oecd.org/officialdocuments/publicdisplavdocumentpdf/?cote=ENV/JM/MONO(2
015)4&doclanguage=en
OECD (Organisation for Economic Co-operation and Development). (2018). OECD Monitoring
Database [Database], HERO ID: 4571754
68

-------
OECD (Organisation for Economic Co-operation and Development). (2019). Complementing
Document to the Emission Scenario Document on Plastic Additives: Plastic Additives during
the Use of End Products. (Number 38). Paris, France, http://www.oecd.ore/officialdocuments
/publicdisplavdocumentpdf/?cote=ENV/JM/MONO	:doclanguage=en
OEHHA (California Office of Environmental Health Hazard Assessment). (2020). Cal Code Regs.
Title 27, § 27001: Chemicals known to the state to cause cancer or reproductive toxicity. (California
Code of Regulations Title 27 Section 27001). https://govt.westlaw.com/calregs/Document/I54B9D2B
0D4501 lDEA95CA4428EC25FA0?contextData=%28sc.Default%29&transitionType=Default.
HERO ID: 6305878
O'Neil, MJ. (2013). Formaldehyde. In The Merck Index (15th ed.). Cambridge, UK: The Royal
Society of Chemistry.
OR Health Authority (Oregon Health Authority). (2015). Toxic-free kids act.
https://public.health.oregon.gov/HealthyEnvironments/HealthyNeighborhoods/ToxicSubstances/Pages
/Toxic-Free-Kids.aspx. HERO ID: 3827485
OSHA. (1992). Occupational exposure to formaldehyde—OSHA. Response to Court remand; final
rule. Fed Reg 57: 22290-22328. HERO ID: 1314358
OSHA (Occupational Safety & Health Administration). (2019). Permissible exposure limits: OSHA
annotated table Z-l. United States Department of Labor, Occupational Safety & Health
Administration, https://www.osha.gov/dsg/annotated-pels/tablez-l.html. HERO ID: 5353123
Phoenix Brands. (2007). Fab/Dynamo/ABC/Ajax 2x Heavy Duty Liquid Detergent. Retrieved January
7, 2020. https://www.whatsinproducts.eom//brands/show msds/1/9592
Pierce Chemicals. (1988). 496 Arterial Embaling Fluid Safety Data Sheet. Retrieved January 7, 2020.
https://hazard.eom/msds/f2./bm.n./bmnqb.htm.l
Pipeline and Hazardous Materials Safety Administration. (2019). 49 CFR § 172.101: Purpose and use
of hazardous materials table. (Code of Federal Regulations Title 49 Section 172.101). Pipeline and
Hazardous Materials Safety Administration. https://www.govinfo.gov/app/details/CFR-2019-title49-
vol2/CFR-2019-title49-vol2-sec 172-101. HERO ID: 6308742
Rumble, JR. (2018). Formaldehyde. In CRC Handbook of Chemistry and Physics (99th ed.). Boca
Raton, FL: CRC Press. Taylor & Francis Group. HERO ID: 5348412
Sifco Selective Plating (1989). #3 Etching and Desmutting Solution. Retrieved January 7, 2020.
https://hazard.com/msds/f2/bgk/bgkdk.html
Sigma-Aldrich. (2019). Formalin Solution, neutral buffered, 10%. Retrieved January 7, 2020.
https://www.siemaaldrich.com/catalog/prodiict/siema/ht501128?lane=en®ion=US
Sills, JB; Allen, JL. (1979). Residues of formaldehyde undetected in fish exposed to formalin. Prog
Fish Cult 41: 67-68. HERO ID: 5348379
Sprayway. (2015). Foaming Rug and Upholstry Cleaner. Retrieved January 7, 2020.
https://www.whatsin.prodiicts.eom//brands/show msds/1/18753
Starr, J.B. (2000). Acetal Resins. In Kirk-Othmer Encyclopedia of Chemical Technology:
69

-------
John Wiley & Sons. https://doi.Org/10.1002/0471238961.0103052019200118.a01
State of Pennsylvania. (1984). P.L. 734, No. 159: Worker and Community Right-To-Know Act.
(Phamphlet Law 734 No 159). State of Pennsylvania, https://www.legis.state.pa.us/cfdocs/legis/li/
uconsCheck.cfm?yr=1984&sessInd=0&act=159. HERO ID: 6305875
State of Pennsylvania. (1986). 34 Pa. Code § 323: Hazardous substance list. (Pennsylvania Code Title
34 Chapter 323). State of Pennsylvania. HERO ID: 6305876
State of Washington Department of Ecology. (2019). WAC 173-334-130: The reporting list of
chemicals of high concern to children (CHCC list). (Washington Administrative Code Title 173
Chapter 173-334 Section 173-334-130). State of Washington Department of Ecology.
https://apps.leg.wa.gov/WAC/default.aspx?cite=173-334-130. HERO ID: 6311348
Su, F; Calvert, JG; Shaw, JH. (1979). Mechanism of the photooxidation of gaseous formaldehyde. J
Phys Chem 83: 3185-3191. http://dx.doi.Org/https://doi.org/10.1021/jl00488a001. HERO ID:
5348376
SYKE (Finnish Environment Institute). (2018). Data bank of environmental properties of chemicals :
Formaldehyde (CASRN: 50-00-0).
http://wwwp.ymparisto.fi/scripts/Kemrek/Kemrek_uk.asp?Method=MAKECHEMdetailsform&txtCh
emld=188. HERO ID: 5348375
Tomer, A; Kane, J. (2015). The great port mismatch. U.S. goods trade and international
transportation. Brookings/JPMorgan Chase (Washington D.C.).URL: https://www.brookings.edu/wp-
content/uploads/2015/06/brgkssrvygcifreightnetworks.pdf HERO ID: 5018559
Tsai, KP; Chen, CY. (2007). An algal toxicity database of organic toxicants derived by a closed-
system technique. Environ Toxicol Chem 26: 1931-1939. http://dx.doi.Org/10.1897/06-612R.l. HERO
ID:3617867
TURI (Massachusetts Toxics Use Reduction Institute). (2006). Five chemicals alternatives assessment
study. Lowel, MA. http://infohouse.p2ric.org/ref/09/08261.pdf. HERO ID: 3981053
U.S. Consumer Product Safety Commission. (2019). Interagency comments on the proposed scoping
document for formaldehyde (CAS RN 50-00-0).
U.S. EPA (U.S. Environmental Protection Agency). (1976). Investigation of Selected Potential
Environmental Contaminants: Formaldehyde - Final Report. (560276009, PB256839).
http://nepis.epa.gov/exe/ZyPURL.cgi?Dockey=910127JR.txt. HERO ID: 1256833
U.S. EPA (U.S. Environmental Protection Agency). (1991). Locating and Estimating Air Emissions
from sources of formaldehyde (Revised), https://www3.epa.eov/ttn/chief/le/formal.pdf
U.S. EPA (U.S. Environmental Protection Agency). (1994). Methods for derivation of inhalation
reference concentrations and application of inhalation dosimetry. Report No. EPA/600/8-
90/066F. https://cfpub.epa.gov/ncea/risk/recordisplav.cfm?deid=71993&	129&CFTOKE
N=2500(
U.S. EPA (U.S. Environmental Protection Agency). (1994). Fabric Finishing - Final Generic Scenario
for Estimating Occupational Exposures and Environmental Releases, https://www.epa.gov/tsca-
70

-------
screening-tools/chemsteer-chemical-screening-tool-exposures-and-environmental-
releases#genericscenarios
U.S. EPA (U.S. Environmental Protection Agency). (2000). Science Policy Council Handbook-Risk
Characterization Handbook. U.S. EPA Science Policy Council. Report No. EPA/100/B-00/002.
https://www.epa.gov/risk/risk-characterization-handbook
U.S. EPA (U.S. Environmental Protection Agency). (2004a). Risk Assessment Guidance for
Superfund Volume I: Human Health Evaluation Manual (Part E, Supplemental Guidance for Dermal
Risk Assessment). (EPA/540/R/99/005). Washington, DC: U.S. Environmental Protection Agency,
Risk Assessment Forum, http://www.epa.gov/oswer/riskassessmeiit/ragse/index.htm HERO ID:
664634.
U.S. EPA (U.S. Environmental Protection Agency). (2004b). Generic Scenario; Additives in
Plastics Processing (Compounding) - Draft Generic Scenario for Estimating Occupational
Exposures and Environmental Releases.
U.S. EPA (U.S. Environmental Protection Agency). (2004c). Generic Scenario; Additives in
Plastics Processing (Converting) - Draft Generic Scenario for Estimating Occupational
Exposures and Environmental Releases.
U.S. EPA (U.S. Environmental Protection Agency). (2005). Guidelines for carcinogen risk assessment
[EPA Report], (EPA/630/P-03/001F). Washington, DC: U.S. Environmental Protection Agency, Risk
Assessment Forum, https://www.epa.gov/sites/production/files/2013-
09/documents/cancer_guidelines_final_3-25-05.pdf. HERO ID: 86237
U.S. EPA (U.S. Environmental Protection Agency). (2006). Targeted National Sewage Sludge Survey
[Database], https://www.epa.gov/biosolids/sewage-sludge-surveys. HERO ID: 4571702
U.S. EPA (U.S. Environmental Protection Agency). (2007). EPA Discharge Monitoring Report Data
[Database], https://cfpub.epa.gov/dmr/. HERO ID: 4571528
U.S. EPA (U.S. Environmental Protection Agency). (2008). Interim acute exposure guideline levels
(AEGLs) for formaldehyde (CAS reg. no. 50-00-0). Washington, DC: U.S. Environmental Protection
Agency, National Advisory Committee for Acute Exposure Guideline Levels for Hazardous
Substances, https://www.epa.gov/sites/production/files/2014-
07/documents/formaldehyde_tsd_interim_07_2008.vl_0.pdf. HERO ID: 5113354
U.S EPA. (U.S. Environmental Protection Agency). (201 la). Exposure Factors Handbook: 2011
edition [EPA Report], (EPA/600/R-090/052F). Washington, DC.
http://cfpub.epa.gov/ncea/cfm/recordisplav.cfm?deid=236252. HERO ID: 786546
U.S. EPA. (U.S. Environmental Protection Agency). (201 lb). Recommended Use of Body Weight %
as the Default Method in Derivation of the Oral Reference Dose. (EPA/100/R-11/0001). Washington,
DC: U.S. Environmental Protection Agency, Risk Assessment Forum. February.
https://www.epa.gov/sites/prodiiction/files/2013-09/dociiments/recommended-use-of-bw34.pdf
HERO ID: 752972
71

-------
U.S. EPA (U.S. Environmental Protection Agency). (2012a). Benchmark Dose Technical Guidance.
Risk Assessment Forum. Document No. EPA/100/R-12/001. https://www.epa.gov/risk/benchmark-
dose-technical-guidance
U.S. EPA (U.S. Environmental Protection Agency). (2012b). PhysProp database. Estimation
Programs Interface Suite for Microsoft Windows, v 4.11: Formaldehyde (CASRN: 50-00-0) [Fact
Sheet], Washington, DC. https://www.epa.gov/tsca-screening-tools/epi-suitetm-estimation- program-
interface
U.S. EPA (U.S. Environmental Protection Agency). (2013). 1986-2002 inventory update reporting
rule data (non-confidential production volume in pounds). Washington, DC: Washington, DC. U.S.
Environmental Protection Agency, Office of Pollution Prevention and Toxics. HERO ID: 6114854
U.S. EPA (U.S. Environmental Protection Agency). (2014). Formulation of Waterborne
Coatings Revised Draft Generic Scenario for Estimating Occupational Exposures and
Environmental Releases.
U.S. EPA (U.S. Environmental Protection Agency). (2015). Consolidated list of lists under
EPCRA/CERCLA/CAA §112(r) (March 2015 Version). Washington, DC.
https://www.epa.gov/epcra/consolidated-list-lists-under-epcracerclacaa-ssll2r-march-2015-version.
HERO ID: 5181101
U.S. Environmental Protection Agency (EPA). (2016). Formaldehyde Emission Standards for
Composite Wood Products. Retrieved from https://www.ecfr.gov/cgi-
bin/retrieveECFR?gp=&SID=d679100be7cffabbefD56d61862c3fa9&mc=true&n=pt40.34.770&r=PA
RT&tv=HTML#se40.34.7'
U.S. EPA. (U.S. Environmental Protection Agency). (2016a). Chemical Screening Tool for
Occupational Exposures and Releases (ChemSTEER). HERO ID: 6305895
U.S. EPA (U.S. Environmental Protection Agency). (2016b). Instructions for reporting 2016
TSCA chemical data reporting. Washington, DC: Office of Pollution Prevention and Toxics.
https://www.epa.gov/chemical-data-reportine/instmctions-reportine-20164sca-chemical-data-
reporting
U.S. EPA (U.S. Environmental Protection Agency). (2017). Chemical data reporting (2012 and 2016
Public CDR database) [Database], Washington, DC: U.S. Environmental Protection Agency, Office of
Pollution Prevention and Toxics, http://www.epa.gov/cdr/. HERO ID: 6275311
U.S. EPA (U.S. Environmental Protection Agency). (2018). Application of systematic review in
TSCA risk evaluations. (740-P1-8001). Washington, DC: U.S. Environmental Protection Agency,
Office of Chemical Safety and Pollution Prevention, https://www.epa.gov/sites/production/files/2018-
06/documents/final_application_of_sr_in_tsca_05-3l-18.pdf. HERO ID: 4532281
U.S. EPA (U.S. Environmental Protection Agency). (2019a). Proposed Designation of Formaldehyde
(CASRN 50-00-0) as a High Priority Substance for Risk Evaluation.
https://www.epa.eov/sites/prodiiction/files/2019-08/dociiments/formaldehyde 50-00-0 high-
priorityproposeddesignation 08z	'
72

-------
U.S. EPA (U.S. Environmental Protection Agency). (2019b). Chemical data reporting (2012 and 2016
CBI CDR database). Washington, DC.: Office of Pollution Prevention and Toxics. HERO ID:
6296234
U.S. EPA (U.S. Environmental Protection Agency). (2019c). TRI Explorer (2018 dataset released
November 2019). Washington, DC: U.S. Environmental Protection Agency.
https://enviro.epa.gov/triexplorer/. (accessed January 17, 2020). HERO ID: 6323208
U.S. EPA (U.S. Environmental Protection Agency). (2019d). 40 CFR 60 Subpart VV: Standards of
performance for equipment leaks of VOC in the synthetic organic chemicals manufacturing industry
for which construction, reconstruction, or modification commenced after January 5, 1981, and on or
Before November 7, 2006. (Code of Federal Regulations Title 40 Part 60 Subpart VV).
https://www.govinfo.gov/content/pkg/CFR-2019-title40-vol7/xml/CFR-2019-title40-vol7-part60.xml.
HERO ID: 6305255
U.S. EPA (U.S. Environmental Protection Agency). (2019e). 40 CFR 261.24: Toxicity characteristic.
(Code of Federal Regulations Title 40 Part 261.24). Washington, D.C. https://www.ecfr.gov/cgi-
bin/text-
idx?SID=abl3936bdc4faeba7b691105e22f4564&mc=true&node=se40.28.26 l_124&rgn=div8.
HERO ID: 5176427
U.S. EPA (U.S. Environmental Protection Agency). (2019f). 40 CFR 261.33: Discarded commercial
chemical products, off-specification species, container residues, and spill residues thereof. (Code of
Federal Regulations Title 40 Part 261.33). Washington, D.C. https://www.ecfr.gov/cgi-
bin/retrieveECFR?gp=&SID=abl3936bdc4faeba7b691105e22f4564&mc=true&n=pt40.28.261&r=P
ART&ty=HTML#se40.28.261_133. HERO ID: 5176428
U.S. EPA (U.S. Environmental Protection Agency). (2019g). 40 CFR § 302.4: Designation of
hazardous substances. (Code of Federal Regulations Title 40 Section 302.4).
https://www.govinfo.gov/app/details/CFR-2019-title40-vol30/CFR-2019-title40-vol30-sec302-4.
HERO ID: 6305426
U.S. EPA (U.S. Environmental Protection Agency). (2019h). 40 CFR § 372.65: Chemicals and
chemical categories to which this part applies. (Code of Federal Regulations Title 40 Section 372.65).
Washington, DC. https://www.govinfo.gov/app/details/CFR-2019-title40-vol30/CFR-2019-title40-
vol30-sec372-65. HERO ID: 3808937
van Heerden, E; van Vuren, JHJ; Steyn, GJ. (1995). LC50 determination for malachite green and
formalin on rainbow trout (Oncorhynchus mykiss) juveniles. Water SA 22: 87-94. HERO ID:
5349725
Wang, SP; He, GL; Chen, RR; Li, F; Li, GQ. (2012). The involvement of cytochrome p450
monooxygenases in methanol elimination in Drosophila melanogaster larvae. Arch Insect Biochem
Physiol 79: 264-275. http://dx.doi.org/10.1002/arch.21021. HERO ID: 1105455
Warne M, SJ; Schifko, AD. (1999). Toxicity of laundry detergent components to a freshwater
cladoceran and their contribution to detergent toxicity. Ecotoxicol Environ Saf 44: 196-206. HERO
ID:4119158
Waterstrat, PR; Marking, LL. (1995). Clinical evaluation of formalin, hydrogen peroxide, and sodium
chloride for the treatment of Saprolegnia parasitica on fall chinook salmon eggs. Prog Fish Cult 57:
73

-------
287-291. http://dx.doi.org/10.1577/1548-8640(1995)057<0287:CCEOFH>2.3.C0;2. HERO ID:
1974244
Wellborn, TL, Jr. (1969). The toxicity of nine therapeutic and herbicidal compounds to striped bass.
The Progressive Fish-Culturist 31: 27-32. https://www.tandfonline.com/doi/abs/10.1577/1548-
8640(1969)31%5B27%3ATTONTA%5D2.0.CO%3B2. HERO ID: 5349719
WHO (World Health Organization). (2002). Concise international chemical assessment document 40.
Geneva, Switzerland: World Health Organization, International Programme on Chemical Safety.
https://www.who.int/ipcs/publications/cicad/en/cicad40.pdf. HERO ID: 626167
Wilkins, R. M. (2004). Controlled Release Technology, Agricultural. In Kirk-Othmer
Encyclopedia of Chemical Technology: John Wiley & Sons.
https://doi.org/10.1002/Q4712389i	3907150518.a01.pub2
Willard, FL; Kodras, R. (1967). Survey of chemical compounds tested in vitro against rumen protozoa
for possible control of bloat. Applied Microbiology 15: 1014-1019. HERO ID: 1252036
Willford, WA. (1966). Toxicity of 22 therapeutic compounds to six fishes [Report], In Investigations
in Fish Control (- ed.). (18). Washington, D.C.: U.S. Fish and Wildlife Service, The Bureau of Sport
Fisheries and Wildlife, http://pubs.er.usgs.gov/publication/ifcl8. HERO ID: 5349722
Williams, L.L. (2002). Amino Resins and Plastics. In Kirk-Othmer Encyclopedia of
Chemical Technology: John Wiley & Sons.
https://doi.org/10.1002/Q4712389.	3091212.a01.Dub2
74

-------
APPENDICES
Appendix A GRAY LITERATURE SOURCES
Table Apx A-l
. Gray Literature Sources that Yielded Results for Formaldehyde
Source/
Agency
Source Name
Source Type
Source
(afesjorv
AT SDR
ATSDR Tox Profile Updates and Addendums
Other US
Agency
Resources
Assessment or
Related
Document
AT SDR
ATSDR Toxicological Profiles (original
publication)
Other US
Agency
Resources
Assessment or
Related
Document
Australian
Government
Department
of Health
NICNAS Assessments (human health. Tier I,
11 or 111)
International
Resources
Assessment or
Related
Document
CAL EPA
Technical Support Documents for regulations:
Cancer Potency Information
Other US
Agency
Resources
Assessment or
Related
Document
CAL EPA
Technical Support Documents for regulations:
Reference Exposure Levels (RELs)
Other US
Agency
Resources
Assessment or
Related
Document
CAL EPA
Technical Support Documents for regulations:
Proposition 65, Cancer
Other US
Agency
Resources
Assessment or
Related
Document
ECHA
ECHA Documents
International
Resources
Assessment or
Related
Document
ECHA
Annex XV Restriction Report
International
Resources
Assessment or
Related
Document
Env Canada
Priority Substances List Assessment Report;
State of Science Report, Environment Canada
Assessment
International
Resources
Assessment or
Related
Document
Env Canada
Chemicals at a Glance (fact sheets)
International
Resources
Assessment or
Related
Document
75

-------
Source/
Agency
Source Name
Source Type
Source
Category
|ji\ (
Guidelines, Risk Management, Regulations
International
Resources
Assessment or
Related
Document
EPA
Office of Water: STORET and Water Quality
Exchange (WQX)
U.S. EPA
Resources
Database
EPA
Office of Air: Air Emission Factors
U.S. EPA
Resources
Regulatory
Document or
List
EPA
Office of Air: TRI
U.S. EPA
Resources
Database
EPA
Office of Air: AQS, Annual
U.S. EPA
Resources
Database
EPA
TSCA. Hazard Characterizations
U.S. EPA
Resources
Assessment or
Related
Document
EPA
IRIS Summary
U.S. EPA
Resources
Assessment or
Related
Document
EPA
Support document for AEGLS
U.S. EPA
Resources
Assessment or
Related
Document
EPA
Office of Air: National Emissions Inventory
(NEI) - National Emissions Inventory (NE1)
Data (2014, 201 1, 2008)
U.S. EPA
Resources
Database
EPA
Office of Air: National Emissions Inventory
(NEI) - Additional Documents
U.S. EPA
Resources
Assessment or
Related
Document
EPA
EPA Pesticide Chemical Search (assessment)
U.S. EPA
Resources
Assessment or
Related
Document
EPA
Other EPA: Misc sources
U.S. EPA
Resources
General Search
EPA
EPA: AP-42
U.S. EPA
Resources
Regulatory
Document or
List
EPA
TRI: Envirofacts Toxics Release Inventory
2017 Updated Data set
U.S. EPA
Resources
Database
76

-------
Source/
Agency
Source Name
Source Type
Source
Category
LPA
EPA. Generic Scenario
U.S. EPA
Resources
Assessment or
Related
Document
EPA
EPA Discharge Monitoring Report Data
U.S. EPA
Resources
Database
EPA
EPA Ambient Monitoring Technology
Information Center - Air Toxics Data
U.S. EPA
Resources
Database
EPA
Office of Water: CFRs
U.S. EPA
Resources
Regulatory
Document or
List
EPA
Office of Air: CFRs and Dockets
U.S. EPA
Resources
Regulatory
Document or
List
I ARC
I ARC Monograph
International
Resources
Assessment or
Related
Document
Japan
Japanese Ministry of the Environment
Assessments - Environmental Risk
Assessments (Class I Designated Chemical
Substances Summary Table)
International
Resources
Regulatory
Document or
List
KOECT
Kirk-Othmer Encyclopedia of Chemical
Technology Journal Article
Other
Resource
Encyclopedia
NIOSH
CDC NIOSH - Occupational Health Guideline
Documents
Other US
Agency
Resources
Assessment or
Related
Document
NIOSH
CDC NIOSH - Pocket Guides
Other US
Agency
Resources
Database
NIOSH
CDC NIOSH - Health Hazard Evaluations
(HHEs)
Other US
Agency
Resources
Assessment or
Related
Document
NIOSH
CDC NIOSH - Publications and Products
Other US
Agency
Resources
Assessment or
Related
Document
NLM
National Library of Medicine's HazMap
Other US
Agency
Resources
Database
77

-------
Source/
Agency
Source Name
Source Type
Source
Category
MP
RoC Monographs
Other I S
Agency
Resources
Assessment or
Related
Document
NTP
Additional NTP Reports
Other US
Agency
Resources
Assessment or
Related
Document
OECD
OECD Substitution and Alternatives
Assessment
International
Resources
Assessment or
Related
Document
OECD
OECD S1DS
International
Resources
Assessment or
Related
Document
OECD
OECD Emission Scenario Documents
International
Resources
Assessment or
Related
Document
OECD
OECD: General Site
International
Resources
General Search
OSHA
OSHA Chemical Exposure Health Data
Other US
Agency
Resources
Database
OSHA
U.S. OSHA Chemical Exposure Health Data
(CEHD) program data [ERG]
Other US
Agency
Resources
Database
RIVM
RIVM Reports: Risk Assessments
International
Resources
Assessment or
Related
Document
RIVM
Probit Function Technical Support Document
International
Resources
Assessment or
Related
Document
TERA
Toxicology Excellence for Risk Assessment
Other
Resources
Assessment or
Related
Document
78

-------
Appendix B PHYSICAL AND CHEMICAL PROPERTIES
This appendix provides p-chem information and data found in preliminary data gathering for
formaldehyde. Table Apx B-l summarizes the p-chem property values preliminarily selected for use in
the risk evaluation from among the range of reported values collected as of March 2020. This table
differs from that presented in the Proposed Designation of Formaldehyde (CASRN"50-0 a High-
Priority Substance for Risk Evaluation (U.S. EPA 2019) and may be updated as EPA collects additional
information through systematic review methods. All p-chem property values that were extracted and
evaluated as of March 2020 are presented in the supplemental file Data Extraction and Data Evaluation
Tables for Physical Chemical Property Studies (EP A-HQ-OPPT-2018-043 8).
Table Apx B-l. Physical and Chemical Properties of Formaldehyde
Properly or Kndpoinl
Value51
Reference
Data Qualify
Kill in»
Molecular formula
CH20
NA
NA
Molecular weight
30.026 g/mol
NA
NA
Physical state
Colorless gas
Rumble, 2018
High
Physical properties
Clear, water-white, very
slightly acid, gas or
liquid; pungent,
suffocating odor
NLM, 2019
High
Melting point
-118.3 to -92°C
Elsevier, 2019
High
Boiling point
-19.5 °C at 760 mm Hg
O'Neil, 2013
High
Density
0.815 g/cm3 at -20°C
Rumble, 2018
High
Vapor pressure
3890 mm Hg at 25°C
NLM, 2019
High
Vapor density
1.067 (air = 1)
NLM, 2019
High
Water solubility
4xl05 mg/L at 20°C
NLM, 2019
High
Log Octanol/water partition
coefficient (Log Kow)
0.35
NLM, 2019
High
Henry's Law constant
3.37><10"7 atm-m3/mol at
25°C
NLM, 2019
High
79

-------
Propcrlv or Kmlpoinl
YsiIik"1
Uc IV mice
Qiiiililv
Killing
Flash point
NAb


Auto flammability
ca. 300 °C
O'Neil, 2013
High
Viscosity
Not available


Refractive index
1.3746
NLM, 2019
High
Dielectric constant
Not available


aMeasured unless otherwise noted; bSelected value for gas state; NA = not applicable
80

-------
Appendix C ENVIRONMENTAL FATE AND TRANSPORT
PROPERTIES
Table Apx C-l. Environmental Fate and Transport Properties of Formaldehyde
Properly or
Knilpoinl

Reference
Direct
Photodegradation
t% = 6 hours in simulated sunlight
A'TSDR. (1999): Su (1979)
t% = 1.6-19 hours in sunlight; degradation products Fh,
CO, H+, HCO
ATSDR {' 1999)
citing Lewis (1993)
Indirect
Photodegradation
45 hours (based on "OH reaction rate constant
8.5	x 10"12 cm3/molecule-second at 25 °C)
57 days (based on nitrate radicals reaction rate constant
5.6	x 10"16 cm3/molecule-second at 25 °C)
HSDB (2015):
Atkinson (1992): NIST (2013)
Hydrolysis
Not expected; however, in an aqueous environment,
formaldehyde will be fully hydrated to the gem-diol,
methylene glycol
OECD (2002) citina Betterton
(1992): HSDB C . DR.
C1999)
Biodegradation
(Aerobic)
Water: 100%/30 hours (die-away test) in stagnant
lake water
HSDB Ł201: . )9)
citing
Sediment: 90%/28 days (OECD 30ID) with non-
acclimated inoculum
OECD (2002) citina Gerike
(1990): HSDB C
Biodegradation
(Anaerobic)
Water: 100%/48 hours (die-away test) in stagnant
lake water
HSDB (2015);
ATSDR i'1999)
Wastewater
Treatment
Removal/secondary treatment: 57-99%, removal
percentages based upon data from a semi- continuous
sewage and continuous activated sludge biological
treatment simulator
Howard (1991)
94% total removal (93% by biodegradation, 0.28% by
sludge, 0% by volatilization to air; estimated)13
U.S. EPA (2012b)
Bioconcentration
Factor
Not expected; based on a lack of evidence of
bioaccumulation in a variety of fish and shrimp and a
log Kow of 0.35; studies suggest that formaldehyde is
rapidly metabolized
OECD (2002): Hose and
Lightner (1980); Sills and Allen
(1979)
3.2 (estimated)13
U.S. EPA (2012b)
Bioaccumulation
Factor
1.1 (estimated)13
U.S. EPA (2012b)
81

-------
Properly or
Knilpoinl
V:ilue:l
Reference
Shi 1 organic
Carbon:Water
Partition
Coefficient (Log
Koc)
Absorbs in cki\ minerals. used as a soil In 111 l
citing De and Chandra (1978)
0 (Koc = 1; MCI method);
0.89 (Koc = 7.8; Kow method) (estimated)b
U.S. EPA (2012b)
"Measured unless otherwise noted; bEPI Suite™physical property inputs: Log K0w = 0.35, BP = -19.5 °C, MP =
-92 °C, VP = 3,890 mm Hg, WS = 4 x 105 mg/L, HLC = 3.37 x 10-7(atm-m3/mole), BIOP = 4, BioA = 1 and
BioS = 1 SMILES: 0=C; OH = hydroxyl radical; K0c = organic carbon-water partitioning coefficient; K0w =
octanol-water partition coefficient
82

-------
Appendix D REGULATORY HISTORY
The chemical substance, formaldehyde, is subject to federal and state laws and regulations in the United
States (TableApx D-l and TableApx D-2). Regulatory actions by other governments, tribes and
international agreements applicable to formaldehyde are listed in Table Apx D-3.
EPA conducted a search of existing domestic and international laws, regulations and assessments
pertaining to Formaldehyde. Appendix D contains the compiled information from available federal,
state, international and other government sources. EPA evaluated and considered the impact of these
existing laws and regulations (e.g., regulations on landfill disposal, design and operations) during
scoping to determine what, if any, further analysis might be necessary as part of the risk evaluation.
Consideration of the nexus between these existing regulations and TSCA uses may additionally be made
as detailed/specific conditions of use and exposure scenarios are developed in conducting the analysis
phase of the risk evaluation.
D.l Federal Laws and Regulations
Table Apx D-l. Federal Laws and Regulations
Malulcs/Uegiilalions
Description of Aiilhorilv/Uegulalion
Description of Regulation
EPA Regulations
Toxic Substances
Control Act (TSCA)
- Section 6(b)
EPA is directed to identify high-priority
chemical substances for risk evaluation; and
conduct risk evaluations on at least 20 high
priority substances no later than three and
one-half years after the date of enactment of
the Frank R. Lautenberg Chemical Safety for
the 21st Century Act.
Formaldehyde is one of the 20
chemicals EPA designated as a
High-Priority Substance for
risk evaluation under TSCA
(84 FR 71924, December 30,
2019). Designation of
formaldehyde as high-priority
substance constitutes the
initiation of the risk evaluation
on the chemical.
Toxic Substances
Control Act (TSCA)
- Section 8(b)
EPA must compile, keep current and publish
a list (the TSCA Inventory) of each chemical
substance manufactured (including imported)
or processed in the United States.
Formaldehyde is on the initial
TSCA Inventory and therefore
was not subject to EPA's new
chemicals review process
under TSCA Section 5 (60 FR
16309. March 29. 19951
Toxic Substances
Control Act (TSCA)
- Section 8(e)
Manufacturers (including importers),
processors, and distributors must
immediately notify EPA if they obtain
information that supports the conclusion that
a chemical substance or mixture presents a
substantial risk of injury to health or the
environment.
23 risk reports received for
formaldehyde, or containing
information related to
formaldehyde were received
between 1989 and 2011. (U.S.
EPA, ChemView. Accessed
April 3, 2019). Link to the
8(e) submission crosswalk
HERE:
83

-------
MsiliiU's/Ucgiihilions
Description of Aiilhorhy/Ucgiihilion
Description of Ucgiihilion
Toxic Substances
Control Act (TSCA)
- Subchapter 6
TSCA Title VI sets formaldehyde emission
standards for composite wood products (i.e.,
hardwood plywood, medium density
fiberboard, and thin-medium density
fiberboard) and requires that any component
parts or finished goods fabricated with
composite wood products use compliant
panels that have met the emission standards
and been tested/certified by an EPA
recognized TSCA Title VI third party
certifier. The TSCA Title VI program also
has provisions for labeling, recordkeeping,
import certification, and accreditation/third
party certification oversight and annual
reporting on the regulated composite wood
products manufactured by mills.
TSCA Title VI sets
formaldehyde emission
standards for composite wood
products (i.e., hardwood
plywood, medium density
fiberboard, and thin-medium
density fiberboard) and
requires third party
certification, oversight, and
annual reports to be submitted
to EPA annually on all panel
manufacturing under the
TSCA Title VI program both
domestically and
internationally (81 FR 89674).
Emergency Planning
and Community
Right-To-Know Act
(EPCRA) - Section
313
Requires annual reporting from facilities in
specific industry sectors that employ 10 or
more full-time equivalent employees and that
manufacture, process or otherwise use a TRI-
listed chemical in quantities above threshold
levels. A facility that meets reporting
requirements must submit a reporting form
for each chemical for which it triggered
reporting, providing data across a variety of
categories, including activities and uses of
the chemical, releases and other waste
management (e.g., quantities recycled,
treated, combusted) and pollution prevention
activities (under Section 6607 of the
Pollution Prevention Act). These data
include on- and off-site data as well as
multimedia data (i.e., air, land and water).
Formaldehyde is a listed
substance subject to reporting
requirements under 40 CFR
372.65 effective as of January
1, 1987.
Federal Insecticide,
Fungicide, and
Rodenticide Act
(FIFRA) - Sections 3
and 6
FIFRA governs the sale, distribution and use
of pesticides. Section 3 of FIFRA generally
requires that pesticide products be registered
by EPA prior to distribution or sale.
Pesticides may only be registered if, among
other things, they do not cause "unreasonable
adverse effects on the environment." Section
6 of FIFRA provides EPA with the authority
to cancel pesticide registrations if either (1)
the pesticide, labeling, or other material does
not comply with FIFRA; or (2) when used in
Formaldehyde was registered
as an antimicrobial,
conventional chemical on
January 25, 1967.
In June 2008 EPA published a
reregi strati on eligibility
decision for formaldehyde and
paraformaldehyde (Case 0556;
EPA Document 739-R-08-
004). Formaldehyde is
currently under registration
84

-------
MsiliiU's/Ucgiihilions
Description of \uthonlv/Kc»ul;i(ion
Description of Ucgiihilion

accordance with widespread and commonly
recognized practice, the pesticide generally
causes unreasonable adverse effects on the
environment.
review, and the final work
plan has been published (EPA-
HQ-OPP-2015-0739).
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
pesticide residues (including inert
ingredients) on food. Prior to issuing a
tolerance or exemption from tolerance, EPA
must determine that the pesticide residues
permitted under the action are "safe."
Section 408(b) of the FFDCA defines "safe"
to mean a reasonable certainty that no harm
will result from aggregate, nonoccupational
exposures to the pesticide. Pesticide
tolerances or exemptions from tolerance that
do not meet the FFDCA safety standard are
subject to revocation under FFDCA Section
408(d) or (e). 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.
Formaldehyde is no longer
exempt from the requirement
of a tolerance (the maximum
residue level that can remain
on food or feed commodities
under 40 CFR Part 180,
Subpart D).
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 (BSER) which (taking into account
the cost of achieving reductions and
environmental impacts and energy
requirements) EPA determines has been
adequately demonstrated.
Formaldehyde is subject to the
NSPS for equipment leaks of
volatile organic compounds
(VOCs) in the synthetic
organic chemicals
manufacturing industry for
which construction,
reconstruction or modification
began after January 5, 1981
and on or before November 7,
2006 (40 CFR Part 60, Subpart
VV).
Clean Air Act (CAA)
- Section 112(b)
Defines the original list of 189 hazardous air
pollutants (HAPs). Under 112(c) of the
Formaldehyde is listed as a
HAP (42 U.S.C 7412).
85

-------
MsiliiU's/Ucgiihilions
Description of \uthonlv/Kc»ul;i(ion
Description of Ucgiihilion

CAA, EPA must identify and list source
categories that emit HAP and then set
emission standards for those listed source
categories under CAA Section 112(d). CAA
Section 112(b)(3)(A) specifies that any
person may petition the Administrator to
modify the list of HAP by adding or deleting
a substance. Since 1990, EPA has removed
two pollutants from the original list leaving
187 at present.

Clean Air Act (CAA)
- Section 112(d)
Directs EPA to establish, by rule, NESHAPs
for each category or subcategory of listed
major sources and area sources of HAPs
(listed pursuant to Section 112(c)). For major
sources the standards must require the
maximum degree of emission reduction that
EPA determines is achievable by each
particular source category. This is generally
referred to as maximum achievable control
technology (MACT). For area sources, the
standards must require generally achievable
control technology (GACT) though may
require MACT.
EPA has established
NESHAPs for a number of
source categories that emit
formaldehyde to air. See
httos ://www.eoa. gov/stationar
v-sources-air-
Dolluti on/nati onal -emi s si on-
standards-hazardous-air-
Dollutants-neshaD-9.
Formaldehyde is also listed
within the definition of Total
hazardous air pollutant
emissions which sums the
emissions of six compounds:
(acetaldehyde, acrolein,
formaldehyde, methanol,
phenol, and propionaldehyde).
40 CFR Subpart DDDD
Clean Air Act (CAA)
- Section 183(e)
Section 183(e) requires EPA to list the
categories of consumer and commercial
products that account for at least 80 percent
of all VOC emissions in areas that violate the
National Ambient Air Quality Standards
(NAAQS) for ozone and to issue standards
for these categories that require "best
available controls." In lieu of regulations,
EPA may issue control techniques guidelines
if the guidelines are determined to be
substantially as effective as regulations.
Formaldehyde is listed under
the National Volatile Organic
Compound Emission
Standards for Aerosol
Coatings (40 CFR part 59,
subpart E). Formaldehyde has
a reactivity factor of 8.97 g
03/g VOC.
86

-------
MsiliiU's/Ucgiihilions
Description of \uthonlv/Kc»ul;i(ion
Description of Ucgiihilion
Safe Drinking Water
Act (SDWA) -
Section 1412(b)
Every 5 years, EPA must publish a list of
contaminants that: (1) are currently
unregulated, (2) are known or anticipated to
occur in public water systems (PWSs) and
(3) may require regulations under SDWA.
EPA must also determine whether to regulate
at least five contaminants from the list every
5 years.
Formaldehyde was identified
on both the Third (2009) and
Fourth (2016) Contaminant
Candidate Lists (CCL) (74 FR
51850, October 8, 2009) and
(81 FR 81099, November 17,
2016).
Resource
Conservation and
Recovery Act
(RCRA) - Section
3001
Directs EPA to develop and promulgate
criteria for identifying the characteristics of
hazardous waste, and for listing hazardous
waste, taking into account toxicity,
persistence, and degradability in nature,
potential for accumulation in tissue and other
related factors such as flammability,
corrosiveness, and other hazardous
characteristics.
Formaldehyde is included on
the list of hazardous wastes
pursuant to RCRA 3001.
RCRA Hazardous Waste
Code: U122 (40 CFR 261.33).
Formaldehyde is also listed as
part of various groups of
chemicals in Appendix VII to
Part 261 - Basis for Listing
Hazardous Waste as K009,
K010, K038, K040, K156, and
K157 (40 CFR Appendix VII
to Part 261).
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the AutoAlliance International,
Inc. of Flat Rock Michigan
and DamlierChrysler
Corporation, Jefferson North
Assembly Plant, Detroit
Michigan entries which permit
a TCLP extraction sample not-
to-exceed limit of 84.2 mg/L
of formaldehyde in their
leachate extract, and a total
concentration of formaldehyde
not to exceed 689 mg/kg, and
a maximum allowable
groundwater concentration
(|ig/L) of 1,380.
87

-------
MsiliiU's/Ucgiihilions
Description of Aiilhorhy/Ucgiihilion
Description of Ucgiihilion


Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the Eastman Chemical
Company - Texas Operations
which permits a bottom ash
leachable concentration at 347
mg/L.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the Ford Motor Company
Dearborn Assembly Plant
which permits a TCLP
extraction sample not to
exceed 80 mg/L of
formaldehyde in their leachate
extract, a total concentration of
formaldehyde not to exceed
700 mg/kg, and a total
concentration of formaldehyde
not to exceed 689 mg/kg, and
a maximum allowable
groundwater concentration
(|ig/L) of 1,400.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the Ford Motor Company,
Kansas City Assembly Plant
which permits a TCLP
extraction sample not to
exceed 343 mg/L of
formaldehyde in their leachate
extract and a total
concentration of formaldehyde
not to exceed 6880 mg/kg.
88

-------
MsiliiU's/Ucgiihilions
Description of Aiilhorhy/Ucgiihilion
Description of Ucgiihilion


Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the Ford Motor Company,
Michigan Truck Plant and
Wayne Integrated Stamping
and Assembly Plant which
permits a TCLP extraction
sample not to exceed 84.2
mg/L of formaldehyde in their
leachate extract, a total
concentration of formaldehyde
not to exceed 689 mg/kg, and
a maximum allowable
groundwater concentration
(|ig/L) of 1,380.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the Ford Motor Company,
Wixom Assembly Plant which
permits a TCLP extraction
sample not to exceed 84.2
mg/L of formaldehyde in their
leachate extract and a total
concentration of formaldehyde
not to exceed 689 mg/kg.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the General Motors
Corporation Assembly Plant
which permits a TCLP
extraction sample not to
exceed 84 mg/L of
formaldehyde in their leachate
extract, a total concentration of
formaldehyde not to exceed
700 mg/kg, and a maximum
89

-------
MsiliiU's/Ucgiihilions
Description of Aiilhorhy/Ucgiihilion
Description of Ucgiihilion
allowable groundwater
concentration (|ig/L) of 1,390.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the General Motors
Corporation, Flint Truck and
Hamtramck facilities which
permit TCLP extraction
samples not to exceed 63 mg/L
of formaldehyde in their
leachate extract and total
concentrations of
formaldehyde not to exceed
535 mg/kg.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the General Motors
Corporation, Hamtramck
which permits a TCLP
extraction sample not to
exceed 63 mg/L of
formaldehyde in their leachate
extract, a total concentration of
formaldehyde not to exceed
535 mg/kg.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the General Motors
Corporation Janesville Truck
Assembly Plant which permits
a TCLP extraction sample not
to exceed 43 mg/L of
formaldehyde in their leachate
extract, a total concentration of
formaldehyde not to exceed
540 mg/kg, and a maximum
90

-------
MsiliiU's/Ucgiihilions
Description of Aiilhorhy/Ucgiihilion
Description of Ucgiihilion


allowable groundwater
concentration (mg/L) of 0.950.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the General Motors
Corporation Lansing Car
Assembly - Body Plant which
permits a TCLP extraction
sample not to exceed 672
mg/L of formaldehyde in their
leachate extract and a total
concentration of formaldehyde
not to exceed 2100 mg/kg.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the General Motors
Corporation Pontiac East -
Body Plant which permits a
TCLP extraction sample not to
exceed 63 mg/L of
formaldehyde in their leachate
extract and a total
concentration of formaldehyde
not to exceed 535 mg/kg.
Formaldehyde is also listed as
part of Appendix IX to Part
261 - Wastes Excluded from
Non-Specific Sources under
the Trigen/Cinergy-USFOS of
Lansing LLC at General
Motors Corporation, Lansing
Grand River which permits a
TCLP extraction sample not to
exceed 84.2 mg/L of
formaldehyde in their leachate
extract and a total
concentration of formaldehyde
not to exceed 689 mg/kg.
91

-------
MsiliiU's/Ucgiihilions
Description of Aiilhorhy/Ucgiihilion
Description of Ucgiihilion
Comprehensive
Environmental
Response,
Compensation and
Liability Act
(CERCLA) -
Sections 102(a) and
103
Authorizes EPA to promulgate regulations
designating as hazardous substances those
substances which, when released into the
environment, may present substantial danger
to the public health or welfare or the
environment.
EPA must also promulgate regulations
establishing the quantity of any hazardous
substance the release of which must be
reported under Section 103.
Section 103 requires persons in charge of
vessels or facilities to report to the National
Response Center if they have knowledge of a
release of a hazardous substance above the
reportable quantity threshold.
Formaldehyde is a hazardous
substance under CERCLA.
Releases of formaldehyde in
excess of 100 pounds must be
reported (40 CFR 302.4).
Superfund
Amendments and
Reauthorization Act
(SARA) -
Requires the Agency to revise the hazardous
ranking system and update the National
Priorities List of hazardous waste sites,
increases state and citizen involvement in the
superfund program and provides new
enforcement authorities and settlement tools.
Formaldehyde is listed 224
scoring 605 points on SARA,
an amendment to CERCLA
and the CERCLA Priority List
of Hazardous Substances. This
list includes substances most
commonly found at facilities
on the CERCLA National
Priorities List (NPL) that have
been deemed to pose the
greatest threat to public health.
Other Federal Regulations
Federal Food, Drug,
and Cosmetic Act
(FFDCA)
Provides the FDA with authority to oversee
the safety of food, drugs and cosmetics.
The FDA regulates
formaldehyde as a fumigant
under its food additive and
GRAS regulations (21 CFR
174.340, 175.105, 175.210,
175.300, 176.170, 176.180,
176.200, 177.1200,
177.2410, and 178.3120).
Formaldehyde is also listed
as an adhesive used in food
packaging at 21 CFR
175.105.
Formaldehyde is also listed
as an "Inactive Ingredient
for approved Drug
92

-------
MsiliiU's/Ucgiihilions
Description of \uthonlv/Kc»ul;i(ion
Description of Ucgiihilion


Products" by FDA with an
established limit of 0.2%
W/W on the amount of
formaldehyde that can be
present a solution, and
0.27% WAV on the amount
of formaldehyde that can be
present in an emulsion or
cream (FDA Inactive
Ingredient Database.
Accessed April 10, 2019.
Federal Hazardous
Substance Act
(FHSA)
Requires precautionary labeling on the
immediate container of hazardous household
products and allows the Consumer Product
Safety Commission (CPSC) to ban certain
products that are so dangerous or the nature
of the hazard is such that labeling is not
adequate to protect consumers.
Under the Federal Hazardous
Substance Act, Section
1500.83(a)(31), formaldehyde
and products containing 1% or
more formaldehyde are listed
as "strong sensitizer"
substances by CPSC (16 CFR
1500.13).
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 (29
U.S.C Section 651 et seq.).
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.
In 2013, OSHA issued
occupational safety and health
standards for formaldehyde
that included a PEL of 0.75
ppm TWA, exposure
monitoring, control measures
and respiratory protection (29
CFR 1910.1048(c)(1)). OSHA
has separate sections of the
CFR for formaldehyde PELs
for shipyard and construction
employment; however, those
sections reference the generic
formaldehyde PEL at
1910.1048(c)(1),
Atomic Energy Act
The Atomic Energy Act authorizes the
Department of Energy (DOE) to regulate the
health and safety of its contractor employees.
10 CFR 851.23, Worker
Safety and Health Program,
requires the use of the 2005
ACGIH TLVs if they are more
protective than the OSHA
PEL. The 2005 TLV for
formaldehyde is [value of the
TLV] ppm (8hr Time
Weighted Average) and
93

-------
MsiliiU's/Ucgiihilions
Description of \ulhonlv/Kc»ul;i
-------
D.2 State Laws and Regulations
Table Apx D-2. State Laws and Regulations
Stale Actions
Description of Action
State Air
Regulations
Allowable Ambient Levels (AAL) of Formaldehyde in New Hampshire
(Env-A 1400: Regulated Toxic Air Pollutants) is 1.3 (|ig/m3) for a 24-hour
AAL, 0.88 (|ig/m3) for an annual AAL, 0.015 lbs/day for a 24-hour de-
minimis, and 5.6 lbs/year for an annual de-minimis.
Acceptable Ambient Levels (AAL) of Formaldehyde in Rhode Island is 50
(|ig/m3) for a 1-hour AAL, 40 (|ig/m3) for a 24-hour AAL, and 0.08 lbs/year
for an annual (Air Pollution Regulation No. 22). As well, the requirement for
registration has a threshold of 9 lbs/year as a minimum quantity for air
emissions of formaldehyde; any exceedance of this minimum would trigger a
reporting requirement the following year (Air Pollution Regulation No.
22.4.2(c)).
State Drinking
Water Standards
and Guidelines
Formaldehyde is listed in the groundwater: residential and nonresidential
part 201 generic cleanup criteria and screening levels in Michigan with the
following levels: residential drinking water criteria of 1,300 ppm,
nonresidential drinking water criteria of 3,800 ppm, groundwater surface
water interface criteria of 120 ppm, residential groundwater volatilization to
indoor air inhalation criteria of 63,000 ppm, nonresidential groundwater
volatilization to indoor air inhalation criteria of 360,000 ppm, and a water
solubility of 550,000,000 ppm (Mich. Admin. Code r.299.44 and r.299.49,
2017),
State PELs
California (PEL of 0.75 ppm and a STEL of 2 (Cal Code Regs. Title 8, §
5155 and Cal Code Regs. Title 8, § 5217)
Hawaii PEL: 0.75 ppm and a STEL of 2 for 15 minutes (Hawaii
Administrative Rules Section 12-60-50 which refer to 29 CFR § 1910.1048
as a proxy for formaldehyde).
State Right-to-
Know Acts
Formaldehyde is found in the following State Right to-Know Acts:
Massachusetts (105 Code Mass. Regs. § 670.000 Appendix A), New Jersey
(8:59 N.J. Admin. Code § 9.1) and Pennsylvania (P.L. 734, No. 159 and 34
Pa. Code § 323).]
Chemicals of High
Concern to Children
Several states have adopted reporting laws for chemicals in children's
products containing Formaldehyde, including Maine (38 MRS A Chapter 16-
D), Minnesota (Toxic Free Kids Act Minn. Stat. 116.9401 to 116.9407),
Oregon (Toxic-Free Kids Act, Senate Bill 478, 2015), Vermont (18 V.S.A §
1776) and Washington State (Wash. Admin. Code 173-334-130).
95

-------
Stale Actions
Description of Action
Volatile Organic
Compound (VOC)
Regulations for
Consumer Products
Many states regulate Formaldehyde as a VOC. These regulations may set
VOC limits for consumer products and/or ban the sale of certain consumer
products as an ingredient and/or impurity. Regulated products vary from
state to state, and could include composite wood products, aerosol coating
products, as well as antiperspirant and deodorant (among other products).
Composite Wood Products and Aerosol Coating Product in California (Title
17, California Code of Regulations, Division 3, Chapter 1, Subchapter 8.5,
Article 3 and 17 CCR 93120), Antiperspirant and Deodorant in Delaware
(Adm. Code Title 7, 1141), Antiperspirant and Deodorant in Illinois (35
Adm Code 223), Antiperspirant and Deodorant in New Hampshire (Env-A
4100) all have VOC regulations or limits for consumer products. Some of
these states also require emissions reporting.
Other
California listed formaldehyde on Proposition 65 in 1988 due to cancer. (Cal
Code Regs. Title 27, § 27001).
Formaldehyde is listed as a Candidate Chemical under California's Safer
Consumer Products Program (Health and Safety Code § 25252 and 25253).
California issued a Health Hazard Alert for formaldehyde (Hazard
Evaluation System and Information Service, 2016).
Massachusetts designated formaldehyde as a Higher Hazard Substance
requiring reporting starting in 2012 (301 CMR 41.00).
D.3 International Laws and Regulations
Table Apx D-3. Regulatory Actions by other Governments, Tribes, and International Agreements
C'ou ill rv/
Organization
Requirements and Restrictions
Canada
Formaldehyde is on the Canadian List of Toxic Substances (CEPA, 1999
Schedule 1). A Priority Substances List (PSL) Assessment determined that
formaldehyde is primarily used in the production of resins and fertilizers
and enters the Canadian environment from direct human sources such as
automotive and other fuel combustion and industrial on-site uses.
Secondary formation occurs by the oxidation of natural and anthropogenic
organic compounds present in air. The PSL Assessment report for
formaldehyde determined that formaldehyde contributes to photochemical
formation of ground-level ozone; and therefore, continued and improving
monitoring at sites likely to release formaldehyde is desirable; especially
those sites with industrial uses for resins and for fertilizers as well as
releases from pulp and paper mills. The PSL assessment also
96

-------
C'ou ill rv/
Org;iniz;ilion
Ucqiiircmcnls sind Ucslriclions

recommended continued investigation into options to reduce indoor air
exposure to formaldehyde (EC ISBN 0-0662-29447-5, 1999).
Other regulations include:
•	Canada's National Pollutant Release Inventory (NPRI).
•	Off Road Compression-Ignition Engine Emission Regulations
(SOR/2005-32).
•	CCPA and Governments of Canada, Ontario, and Alberta Memorandum
of Understanding for Environmental Protection Through Action Under
CCPA Responsible Care (MOU, August 14, 2013).
•	Environmental Emergency Regulations (SOR/2003-307).
•	On-Road Vehicle and Engine Emission Regulations (SOR/2003-2).
•	Off-Road Small Spark-Ignition Engine Emission Regulations
(SOR/2003-355).
European Union
Formaldehyde is listed on the ECHA Inventory (EC Number 200-001-8)
and the EU: CLP Harmonized Classification (index number 605-001-00-
5).
Formaldehyde was evaluated under the 2013 Community rolling action
plan (CoRAP) under regulation (EC) No 1907/2006 - REACH
(Registration, Evaluation, Authorisation and Restriction of Chemicals)
ECHA database. Accessed April 19, 2019).
Australia
Formaldehyde was assessed under a Priority Existing Chemical
designation (designated March 5, 2002) in response to occupational and
public health concerns. The main industrial use of formaldehyde is for the
manufacture of formaldehyde-based resins, which are widely used in a
variety of industries, predominantly the wood industry. Formaldehyde is
also used directly or in formulations in a number of industries including
medicine-related industries (such as forensic/hospital mortuaries and
pathology laboratories), embalming in funeral homes, film processing,
textile treatments, leather tanning, and a wide range of personal care
and consumer products. The concentrations of formaldehyde in these
products range from 40%, such as in embalming and film processing
solutions, to < 0.2%, such as in the majority of cosmetics and consumer
products (NICNAS, 2006, Priority Existing Chemical Assessment Report
No. 28 for Formaldehyde-. Accessed April 18, 2019/
Japan
Formaldehyde 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)
97

-------
C'ou ill rv/
Org;iniz;ilioii
Ucqiiircmcnls sind Restrictions

•	Act on Confirmation, etc. of Release Amounts of Specific Chemical
Substances in the Environment and Promotion of Improvements to the
Management Thereof
•	Industrial Safety and Health Act (ISHA)
•	Air Pollution Control Law
•	Water Pollution Control Law
•	Act on the Control of Household Products Containing Harmful
Substances
•	Poisonous and Deleterious Substances Control Act
(National Institute of Technology and Evaluation [NITE] Chemical Risk
Information Platform [CHIRP], (Accessed April 18, 2019).
Basel Convention
B3010 (urea, phenol, and melamine formaldehyde resins) are listed as a
category of waste under the Basel Convention. Although the United States
is not currently a party to the Basel Convention, this treaty still affects U.S.
importers and exporters.
OECD Control of
Transboundary
Movements of Wastes
Destined for Recovery
Operations
B3010 (urea, phenol, and melamine formaldehyde resins) are listed as a
category of waste subject to The Amber Control Procedure under Council
Decision C (2001) 107/Final.
World Health
Organization (WHO)
WHO has not established a tolerable daily intake for formaldehyde;
however, did note that the average daily intake of formaldehyde is 0.02
mg/day for outdoor air; 0.05-2 mg/day for indoor conventional buildings,
<1-10 mg/day for buildings without sources of formaldehyde, 0.2-0.8
mg/day for workplaces without occupational use of formaldehyde, 4
mg/day for work places using formaldehyde, and 0-1 mg/day for
environmental tobacco smoke (smoking 20 cigarettes a day corresponds
with an intake of 1 mg/day of formaldehyde). The average daily intake of
formaldehyde in drinking water is generally 0.2 mg/day and the quantity of
formaldehyde generally ingested in food (contingent on the meal
composition) may range from 1.5 to 14 mg/day. (Environmental Health
Criteria (EHC) Monograph 89, 1989).
Australia, Austria,
Belgium, Canada,
Denmark, Finland,
France, Germany,
Hungary, Ireland,
Israel, Japan, Latvia
Occupational exposure limits for formaldehyde (GESTIS International
limit values for chemical agents (Occupational exposure limits, OELs)
database. (Accessed April 18, 2019).
98

-------
C'ou ill rv/
Org;iniz;ilioii
Ucqiiircmcnls sind Restrictions
New Zealand,
People's Republic of
China, Poland,
Romania, Singapore,
South Korea, Spain,
Sweden, Switzerland,
the Netherlands,
U.S.A, and the United
Kingdom

99

-------
Appendix E PROCESS, RELEASE AND OCCUPATIONAL
EXPOSURE INFORMATION
This appendix provides information and data found in preliminary data gathering for formaldehyde.
E.l Process Information
Process-related information potentially relevant to the risk evaluation may include process diagrams,
descriptions and equipment. Such information may inform potential release sources and worker
exposure activities.
E.l.l Manufacture (Including Import)
The 2016 CDR reported that, in 2015, 30 facilities domestically manufactured formaldehyde, four
facilities imported formaldehyde, one facility both domestically manufactured and imported
formaldehyde, and the manufacture/import activity for six facilities was claimed as CBI or withheld
(U.S. EPA, 2019b).
E.l.1.1 Manufacture
Currently, most formaldehyde is manufactured using one of two methods using methanol and air as
feedstocks: a silver-catalyst-based process and a metal-oxide-catalyst-based process. Both processes mix
preheated air with vaporized methanol, feed the gaseous mixture into a reactor, cool the reactor
products, and then separate the products to recover an aqueous formaldehyde solution. The silver-
catalyst-based process uses a feed that is rich in methanol and completely converts the oxygen while the
metal-oxide-based process uses a feed that is lean in methanol and completely converts the methanol.
Both processes must keep the mixture of methanol and oxygen outside of the flammable range.
Approximately 70% of newly installed formaldehyde production capacity uses the metal oxide process
(Gerberich et al., 2013).
The silver-catalyst-based process operates the reactor at approximately atmospheric pressure and a
temperature of 600 to 650 °C. The separation process uses absorption, distillation, and anion exchange
to produce a product of aqueous formaldehyde solution that is up to 55 wt% formaldehyde and less than
1.5% methanol. This process can achieve an overall yield of 86 to 90% on a methanol basis (Gerberich
et al., 2013).
The metal-oxide-based process uses metal oxide catalysts such as vanadium oxide and iron oxide-
molybdenum oxide. The reactor operates at approximately atmospheric pressure and a temperature of
300 to 400 °C. The separation process uses absorption and ion exchange to produce a product of
aqueous formaldehyde solution that is up to 55 wt% formaldehyde and less than 1% methanol. This
process can achieve an overall yield of 88 to 92% on a methanol basis (Gerberich et al., 2013).
New production processes are in development, including the partial oxidation of methane and the
dehydrogenation of methanol, but no units are commercial (Gerberich et al., 2013).
Manufacturers sell the commercial product as formaldehyde as an aqueous solution with concentrations
from 25 to 56 wt%. Common formaldehyde grades include formulations of 37, 44, 50, and 56 wt%
(Gerberich et al., 2013). In the 2016 CDR, all 31 facilities that reported domestically manufacturing
formaldehyde in 2015 reported manufacturing formaldehyde in liquid form. Formaldehyde was reported
100

-------
to be manufactured at concentrations of 30 to 60 wt% by 30 facilities and at a concentration of 90 wt%
or greater by one facility (U.S. EPA, 2019b).
Liquid solutions of formaldehyde are unstable. Methanol can be added as an inhibitor to minimize
polymerization. Both low-methanol and methanol-added grades of formaldehyde solution are available
for sale. Formaldehyde solutions are shipped in stainless steel or lined carbon steel storage vessels. The
shipping and storage of formaldehyde must consider the shelf life of the solution, which is a function of
temperature and the composition of the solution. Manufacturers recommend minimum temperatures for
storing the formaldehyde solution, which is a function of the weight percent of both formaldehyde and
methanol inhibitor (Gerberich et al., 2013).
E.l.1.2 Import
Commodity chemicals such as formaldehyde may be imported into the United States in bulk via water,
air, land, and intermodal shipments (Tomer, 2015). These shipments take the form of oceangoing
chemical tankers, railcars, tank trucks, and intermodal tank containers. Chemicals shipped in bulk
containers may be repackaged into smaller containers for resale, such as drums or bottles. Domestically
manufactured commodity chemicals may be shipped within the United States in liquid cargo barges,
railcars, tank trucks, tank containers, intermediate bulk containers (IBCs)/totes, and drums. Both
imported and domestically manufactured commodity chemicals may be repackaged by wholesalers for
resale; for example, repackaging bulk packaging into drums or bottles. The type and size of container
will vary depending on customer requirements. In some cases, QC samples may be taken at import and
repackaging sites for analyses. Some import facilities may only serve as storage and distribution
locations, and repackaging/sampling may not occur at all import facilities.
In the 2016 CDR, of the four facilities that reported importing formaldehyde in 2015, one reported
importing formaldehyde as a liquid at a concentration of 30 to 60 wt%, one reported the form as a liquid
at a concentration of 1 to 30 wt%, one reported the form as a liquid at a concentration of less than 1
wt%, and one reported the form as a solid or liquid at a concentration of 1 to 30 wt% (U.S. EPA, 2019b).
E.1.2 Processing and Distribution
E.l.2.1 Processing as a Reactant or Intermediate
Processing as a reactant or intermediate is the use of formaldehyde as a feedstock in the production of
another chemical via a chemical reaction in which formaldehyde is consumed to form the product.
According to the 2016 CDR, formaldehyde is used as a reactant or intermediate in the production of the
following products (U.S. EPA, 2016):
•	Adhesive and sealant chemicals;
•	Plastic materials and resins;
•	Pesticide, fertilizer, and other agricultural chemicals;
•	Petrochemicals;
•	Soap, cleaning compound, and toilet preparation chemicals;
•	Functional fluids; and
•	Other organic chemicals.
Exact operations for all of the uses of formaldehyde as a reactant to produce other chemicals are not
known at this time. For using a chemical as a reactant, operations would typically involve unloading the
chemical from transport containers and feeding the chemical into a reaction vessel(s), where the
101

-------
chemical would react either fully or to a lesser extent. Following completion of the reaction, the
produced substance may be purified further, thus removing unreacted formaldehyde (if any exists).
Some formaldehyde-derived chemicals, such as formaldehyde-based resins, may decompose to re-form
formaldehyde during the chemical's use or over the lifespan of articles produced using these chemicals.
Therefore, EPA plans to consider the exposure potential to formaldehyde of formaldehyde-derived
chemicals that may generate formaldehyde during the chemical's use even if the formaldehyde is reacted
to completion during the production of the chemical.
A significant use of formaldehyde as a reactant is in the production of formaldehyde-based resins. The
following formaldehyde-based resins are the most common (Gerberich et al., 2013).
Amino resins are thermosetting resins synthesized by reacting an aldehyde, such as formaldehyde, with
an amino-functionalized chemical. Common amino compounds used are urea and melamine. The amino
resins may be copolymerized with comonomers, such as using both urea and melamine or
copolymerizing with phenol. The largest use of amino resins is as adhesives used to manufacture
composite wood products. Other uses of amino resins include laminates for wood products, such as
laminated wood beams, countertops, and parquet flooring; textile fabric finishes; tire adhesives; pre-
impregnated papers; molding compounds; coatings; and curing agents for other resins (Williams, 2002;
Binder et al., 2005).
Urea-formaldehyde (UF) and melamine-formaldehyde (MF) resins are manufactured by pumping
aqueous formaldehyde and a strong base (caustic) into a heated reactor. Urea and/or melamine, which
are solids, are fed into the reactor through hoppers. The reaction of formaldehyde with an amine
proceeds via a two-step process. The first step is the methylolation or hydroxymethylation of the amine
with formaldehyde. The second step is the polycondensation of monomer units to form polymer and
release water. The reaction can be controlled to control the extent of reaction. The process may produce
a stable syrup of methylols without proceeding through polycondensation to form the polymer. This
methylol syrup may be packaged and shipped for use as an intermediate as an adhesive or molding
compound. This intermediate may then subsequently be combined with an acid and heated to
polymerize and cure the resin after its application. Instead of using the syrup as an intermediate, the
process may alternatively blend the syrup with filler to form a molding compound. Fillers, such as
cellulose or pulp may be conveyed through hoppers and into a mixer to blend with the syrup, and the
syrup-filler blend may then be extruded, blended with other additives, milled into a powder and then
packaged for sale. Another option is to spray dry the syrup, pulverize into a powder, and blend and
package the spray-dried resin for sale (Williams, 2002; Binder et al., 2005).
Phenol-formaldehyde (PF) resins are synthesized by reacting phenol or a substituted phenol with
formaldehyde. PF resins may be produced as thermoplastic or thermosetting polymers and may be
liquids or solids. Liquid formulations include both dispersions and suspensions. PF resins are typically
manufactured by adding formaldehyde and phenol or substituted phenol into a reactor, temperature is
controlled using cooling water with the degree of polymerization monitored using samples (Kopf, 2003;
EPA, 1991).
Polvacetal resin is the common term for the family of formaldehyde-based homopolymer and copolymer
thermoplastics. Generally, the process includes generation of anhydrous formaldehyde from
formaldehyde solution, polymerization, the final solid polymer product can be processed easily by
102

-------
extrusion or injection molding. They can be reinforced with glass or fluorocarbon fibers and can be
pigmented (Finnegan et al, 2000; Starr, 2000, EPA, 1991).
Formaldehyde is commonly reacted to form polyols. Several polyols made from formaldehyde include:
pentaerythritol, made from acetaldehyde and formaldehyde; trimethylolpropane, made from n-
butyraldehyde and formaldehyde; and neopentyl glycol, made from isobutyraldehyde and formaldehyde.
These polyols have uses in synthetic lubricants industries. Pentaerythritol is used in a wide variety of
paints, coatings, and varnishes and can be used to produce explosives (pentaerythritol tetranitrate).
Trimethylolpropane is also used in urethane coatings, polyurethane foams, and multifunctional
monomers. Neopentyl glycol is used in plastics and coatings (Gerberich et al., 2013; Hunter, 2000).
EPA plans to investigate processing uses of formaldehyde during risk evaluation.
E. 1.2.2 Incorporated into an Article
Incorporation into an article typically refers to a process in which a chemical becomes an integral
component of an article (as defined at 40 CFR 704.3) for distribution in commerce. In the 2016 CDR,
some submitters reported formaldehyde incorporated into an article. EPA has identified some uses of
formaldehyde-based polymers that are used in an adhesive, coating, or textile finish that are then used in
the manufacture of an article. Some example applications of formaldehyde-based polymers that may be
incorporated into an article include:
•	Formaldehyde-based resins used as wood product adhesives;
•	Formaldehyde-based polymers used in coatings that are applied to articles;
•	Formaldehyde-based resins used in fiberglass mats;
•	Formaldehyde-based resins used in paper treating and coating;
•	Formaldehyde-based resins used in pre-impregnated fiber composites;
•	Formaldehyde-based resins used in textile finishing; and
•	As paint additives and coating additives in transportation equipment manufacturing,
•	and in plastic and resin manufacturing (U.S. EPA, 2019; USTMA Meeting Notes; AIA, 2019
(EPA-HQ-OPPT-2018-043 8-0006); ARMA, 2019 (EPA-HQ-OPPT-2018-0438-0005))
According to the North American Insulation Manufacturers Association, formaldehyde-based resins are
used in fiberglass, and rock and slag wool products. An example of the typical process involves spraying
the fibers with aqueous solutions containing formaldehyde-based resins then curing to thermally set the
binder. NAIMA reported typical weight concentrations of the binder at 3-6% (NAIMA, 2019). The
aerospace industry uses epoxy and phenolic resins in pre-impregnated fiber composites (AIA, 2019).
Tire manufacturing uses formaldehyde-based resins and textiles pretreated with resorcinol-formaldehyde
latex dip (USTMA Meeting, 2019).
For use of adhesives reported under this code used in wood product and other articles, EPA expects
processes to include applications by spray, brush, or roll coating of adhesive (OECD, 2013). For leather
manufacturing, formalin has been reported to be used as a tanning agent in leather tanning (CPCat,
2015; NICNAS, 2006). For textile and apparel manufacturing, the general process for formaldehyde-
based resins as finishing agents include three steps, pad/dry/cure, process that includes submerging the
textile in a finishing solution containing formaldehyde-based resins, then drying and curing the textile
(U.S. EPA, 1994; NICNAS, 2006).
103

-------
In general, for plastic manufacturing, the final plastic article is produced in a conversion process that
forms the compounded plastic into the finished products (U.S. EPA, 2004b; OECD, 2004a). The
converting process is different depending on whether the plastic is a thermoplastic or a thermosetting
material (U.S. EPA, 2004c). Thermoplastics converting involves the melting of the plastic material,
forming it into a new shape and then cooling it (U.S. EPA, 2004c; OECD, 2004b). The converting of
thermoplastics may involve extrusion, injection molding, blow molding, rotational molding or
thermoforming (U.S. EPA, 2004c; OECD, 2004b).
Conversion of thermosetting materials involves using heat and pressure to promote curing, typically
through cross-linking (OECD, 2004b). The primary conversion process for thermosetting materials is
compression molding; however, fiber reinforced thermosetting plastics are converted using hand layup,
spray molding and filament winding (OECD, 2004b). After the forming process, finishing operations
such as filing, grinding, sanding, polishing, painting, bonding, coating and engraving are performed to
complete the process (U.S. EPA, 2004c).
EPA plans to investigate processing uses where formaldehyde incorporated into an article during risk
evaluation.
E.l.2.3 Incorporated into a Formulation, Mixture or Reaction Product
Incorporation into a formulation, mixture or reaction product refers to the process of mixing or blending
of several raw materials to obtain a single product or preparation. In the 2016 CDR and in various public
comments from industry and other companies, uses of formaldehyde that require incorporation into
formulation, mixture, or reaction products were reported. In addition, EPA has identified formulated
products that contained formaldehyde. Examples include coagulant aid (Calgon Corporation, 1990),
lacquer thinner (E.I. Dupont de Nemours & Co.,1995), craft paint (Day-Glo Color Corporation, 1993),
and wood glue (Franklin International, 1992).
Formaldehyde-specific formulation processes were not identified from preliminary literature; however,
several Emission Scenario Documents (ESDs) published by the OECD have been identified that provide
general process descriptions for these types of processes. The formulation of coatings typically involves
dispersion, milling, finishing and filling into final packages (OECD, 2009; U.S. EPA, 2014a). Adhesive
formulations involve mixing together volatile and non-volatile chemical components in sealed, unsealed
or heated processes (OECD, 2009). Sealed processes are most common for adhesive formulation
because many adhesives are designed to set or react when exposed to ambient conditions (OECD, 2009).
Lubricant formulation typically involves the blending of two or more components, including liquid and
solid additives, together in a blending vessel (OECD, 2004b). The formulation step can involve
compounding with additives and other raw materials to form a masterbatch in either open or closed
blending processes (U.S. EPA, 2004b; OECD, 2009).
EPA plans to further investigate processing uses where formaldehyde incorporated into a formulation,
mixture, or reaction product during risk evaluation.
E.l.2.4 Non-Incorporative Activities
Non-incorporative uses are those that use formaldehyde other uses such as a chemical processing aid or
manufacturing aid. A processing aid is a chemical added to a chemical mixture that is used to improve
the processing of the chemical mixture but does not become part of the reaction product and not
intended to affect the function of a substance or article created. Examples include buffers, dehydrating
agents, and sequestering agents (U.S. EPA, 2016).
104

-------
The 2016 CDR reports a processing aid use of formaldehyde in oil and gas drilling, extraction, and
support activities (U.S. EPA, 2019). Preliminary literature reported the use of formaldehyde as a
corrosion inhibitor and hydrogen sulfide scavenger in oil production operations (Gerberich et al., 2013).
The 2016 CDR also reports additional non-incorporative uses of formaldehyde for the agriculture,
forestry, fishing and hunting industry, and construction industry (U.S. EPA, 2019).
E.1.3 Uses
E.l.3.1 Chemical substances in furnishings, cleaning, and treatment/care products
As stated in Section 2.2.1, formaldehyde is used to manufacture floor coverings, foam seating and
bedding products, furniture and furnishings, cleaning and furniture care products, and fabric, textile, and
leather products. The use of these products may require specialty installation, cutting, or other
manipulation of the material for its use. The use of cleaning and treatment care products may include
spray application.
Safety data sheets reported use of formaldehyde in water treatment products, the percent of
formaldehyde in these formulations is unknown (Mansfield Sanitary, Inc., 1985; Chemetrics, 1989;
Calgon, 1990). Formaldehyde has also been reported in laundry and dishwashing products and personal
care products. EPA plans to evaluate these conditions of use during risk evaluation.
E.l.3.2 Chemical substances in construction, paint, electrical, and metal products
Adhesives and Sealants
As discussed during processing activities, formaldehyde-based resins (e.g., urea-formaldehyde resins,
melamine-formaldehyde resin, etc.) are used as adhesives incorporated into wood and engineered wood
products. Formaldehyde is incorporated as a hardener or an ion exchange agent in the production of
acrylics, which are a class of structural adhesives (CPCat, 2015). EPA plans to evaluate this condition of
use during risk evaluation.
Paint and Coatings
According to American Coating Association (ACA), formaldehyde is present in trace amounts in most
raw materials used in paints and coatings such as latex resins and fluorescent pigments (ACA, 2019).
EPA has identified formaldehyde used in lacquer thinner and cleaning solvent at 0.1% concentration
(E.I. Dupont de Nemours & Co., 1995) and non-stick coating for metals at 1% concentration (E.I.
Dupont de Nemours & Co., 1989). EPA plans to evaluate this condition of use during risk evaluation.
Building/construction materials- wood, engineered wood products and other materials not covered
elsewhere
As stated in Appendix E.l.2.2, formaldehyde is heavily used for the production of binders used in the
production of wood and engineered wood products. In addition, the formaldehyde resins (e.g., urea-
formaldehyde resin) have been reported to be used in the manufacturing of fiber glass mats (discussed in
Appendix E.l.2.2), these mats are then used to make different roofing products. Formaldehyde exposure
can occur during this manufacturing as off-gassing of formaldehyde can occur when hot asphalt contacts
the fiberglass mat that use formaldehyde-based resins as binders (ARMA, 2019). Formaldehyde is also
reported in other construction material such as cement, laminates and other products (ECHA, 2019).
105

-------
Electrical/electronic and Metal products not covered elsewhere
Molding compounds based on amino resins are used for parts of electrical devices (Williams, 2002). As
stated for paints and coatings, formaldehyde is used in the surface coating of metal products. EPA has
not identified specific process information for the use but EPA plans to evaluate this condition of use
during risk evaluation.
E.l.3.3 Chemical substances in automotive and fuel products
AIA reports use of formaldehyde in the manufacture, operations, and maintenance of aerospace products
in lubricants, including dry film lubricants, graphite paste, and lubricating oil (AIA, 2019). EPA has not
identified specific process information for the use of these automotive and fuel products but EPA plans
to evaluate this condition of use during risk evaluation.
E.l.3.4 Chemical substances in agriculture use products
Urea-formaldehyde is used in the manufacture of controlled-release fertilizers, which release nutrients at
a constant rate. End users of controlled-release fertilizers include agricultural, horticultural, landscaping,
and consumer markets (ECHA, 2019). EPA plans to evaluate this condition of use during risk
evaluation.
E.l.3.5 Chemical substances in outdoor use products
EPA has not identified specific process information for the use of formaldehyde in explosive materials
in the preliminary literature review but EPA plans to evaluate this condition of use during risk
evaluation.
K. 1.3.6 Chemical substances in packaging, paper, plastic and hobby products
Formaldehyde and formaldehyde resins are used in the manufacturing of pulp and paper manufacturing.
Packaging products may contain formaldehyde from its use in adhesive, paper, and plastic
manufacturing. The use of these products may involve cutting or other manipulation to suit the purpose
of the products. EPA assumes that formaldehyde is in toys, playground, and sporting equipment through
its use in adhesives and plastic materials. The installation and use of these toys and equipment would be
reviewed for potential exposure to formaldehyde. Safety data sheets identified formaldehyde in craft
paint and glue at less than 0.1% (Day-Glo Color Corporation, 1993; Elmers, 2012). EPA has not
identified specific process information for the use of formaldehyde in these conditions of use in the
preliminary literature review but EPA plans to evaluate this condition of use during risk evaluation.
Photographic Supplies
Preliminary literature identified the use of formaldehyde in products used for the processing of film.
These products are mixed with other components, typically diluted with water in a bath, the film is
placed into the bath for final processing, rinsed then dried. The concentration of formaldehyde in these
products can be as high as 35% (NICNAS, 2006). EPA plans to evaluate this condition of use during
risk evaluation.
E.l.3.7 Chemical substances in products not described by other codes
Embalming
Formaldehyde is a common chemical used in embalming at mortuary labs and funeral homes. Expected
worker activities could include: handling concentrated formaldehyde solutions, preparing diluted
solutions, arterial and cavity embalming, spray applications, and equipment cleaning (ECHA, 2019).
The concentration of formaldehyde in these products can be as high as 40% (NICNAS, 2006). EPA
plans to evaluate this condition of use during risk evaluation.
106

-------
Other Laboratory Uses
Formaldehyde is also used for tissue preservation at other laboratories including medical labs to preserve
samples (Sigma-Aldrich, 2019). EPA plans to evaluate this condition of use during risk evaluation.
E.1.4 Disposal
Each of the conditions of use of formaldehyde may generate waste streams of the chemical that are
collected and transported to third-party sites for disposal, treatment, or recycling. Industrial sites that
treat or dispose onsite wastes that they themselves generate are assessed in each condition of use
assessment. Similarly, point source discharges of formaldehyde to surface water are assessed in each
condition of use assessment (point source discharges are exempt as solid wastes under RCRA). Wastes
of formaldehyde that are generated during a condition of use and sent to a third-party site for treatment,
disposal, or recycling may include the following:
•	Wastewater: Formaldehyde may be contained in wastewater discharged to POTW or other, non-
public treatment works for treatment. Industrial wastewater containing formaldehyde discharged
to a POTW may be subject to EPA or authorized NPDES state pretreatment programs..
•	Solid Wastes: Solid wastes are defined under RCRA as any material that is discarded by being:
abandoned; inherently waste-like; a discarded military munition; or recycled in certain ways
(certain instances of the generation and legitimate reclamation of secondary materials are
exempted as solid wastes under RCRA). Solid wastes may subsequently meet RCRA's definition
of hazardous waste by either being listed as a waste at 40 CFR §§ 261.30 to 261.35 or by
meeting waste-like characteristics as defined at 40 CFR §§ 261.20 to 261.24. Solid wastes that
are hazardous wastes are regulated under the more stringent requirements of Subtitle C of
RCRA, whereas non-hazardous solid wastes are regulated under the less stringent requirements
of Subtitle D of RCRA.
Formaldehyde is a U-listed hazardous waste under code U122 under RCRA; therefore,
discarded, unused pure and commercial grades of formaldehyde are regulated as a hazardous
waste under RCRA (40 CFR § 261.33(f)).
•	Wastes Exempted as Solid Wastes under RCRA: Certain conditions of use of formaldehyde may
generate wastes of formaldehyde that are exempted as solid wastes under 40 CFR § 261.4(a). For
example, the generation and legitimate reclamation of hazardous secondary materials of
formaldehyde may be exempt as a solid waste.
2018 TRI reports 715 facilities managed, in total, over 132 million pounds of formaldehyde as waste. Of
this total, approximately 70 million pounds were treated, nearly 35 million pounds were recycled, over
20 million pounds were released or otherwise disposed of, and over 7 million pounds were burned for
energy recovery. Of the 70 million pounds of formaldehyde that were treated, about 65 million pounds
were treated on site and 5 million pounds were treated off site. Similarly, 99% of the formaldehyde
waste that was recycled was recycled on site, and 93% of the formaldehyde waste that was used for
energy recovery was combusted on site.
Nearly three-quarters of the formaldehyde that was disposed of or released occurred to land, the majority
of which (14.2 million pounds) was disposed of on-site to Class I underground injection wells and about
107

-------
240,000 pounds was disposed of off-site to Class I underground injection wells. Over 4.6 million pounds
of formaldehyde were released to air; 93% of which was in the form of point source air (stack)
emissions. Releases to water and other releases not mentioned above accounted for small amounts of the
total releases at just 1% and 2%, respectively {U.S. EPA, 2017, 5041148}.
E.2 Preliminary Occupational Exposure Data
EPA presents below an example of occupational exposure-related information obtained from
preliminary data gathering. EPA plans to consider this information and data in combination with other
data and methods for use in the risk evaluation.
TableApx E-l summarizes NIOSH Health Hazard Evaluations identified during EPA's preliminary
data gathering.
Table Apx E-l. Summary of NIOSH HHEs with
Monitoring for Formaldehyde3
Year of Publication
Report Number
Facility Description
2016
HHE-2016-0145-3292
Plastic bag manufacturer
2015
HHE-2015-0011-3253
Outpatient medical clinic (shared-use building)
2013
HHE-2013 -0075-3264
Automotive parts manufacturer
2012
HHE-2012-0025-3207
Electrical cable accessory manufacturer
2012
HHE-2012-0135-3184
Medical examiner office
2010
HHE-2010-0001-3295
Insect rearing facility
2001
HETA-2001 -0030-3020
Medical center - Charlotte, North Carolina
1999
HETA-99-0185-2787
Plastic injection molding e.g., corner guards for
mattresses, pallet legs, diaper pales.
1999
HETA-99-0173-2856
Recreation - National wildlife refuge
1998
HETA-98-0279-2722
Furniture manufacturer
1998
HETA-98-0194-2721
Recreation - US fish and wildlife service
1997
HETA-97-0084-2669
Electrical product assembly - Printed circuit board
1997
HETA-97-0062-2662
Medical center - Anchorage, Alaska
1997
HETA-97-0049-2650
Medical center - Philadelphia, Pennsylvania
1997
HETA-97-0154-2693
Power generation services - Siemens
1983
HHE-83-156-1622
Automotive parts manufacturer - plastic
1982
NIOSH-108-17a
Wood product manufacturer - Medford, Oregon
1982
NIOSH-108-18a
Wood product manufacturer - Medford, Oregon
1981
NIOSH-108-19a
Wood product manufacturer - Springfield, Oregon
a Table includes HHEs identified to date.
Table Apx E-2 summarizes the OSHA inspection monitoring data identified in the CEHD from 2010 to
2019 by North American Industry Classification System (NAICS) code.
Table Apx E-2. Summary of Industry Sectors with Formaldehyde Monitoring Samples Available
from OSHA Inspections Conducted Between 2010 and 2019.		
NAICS
NAICS Description
Number of
Data Points
No NAICS code reported
197
108

-------
NAICS
NAICS Description
Number of
Data Points
111411
Mushroom Production
2
112120
Dairy Cattle and Milk Production
13
112130
Dual-Purpose Cattle Ranching and Farming
5
112340
Poultry Hatcheries
17
112511
Finfish Farming and Fish Hatcheries
3
213112
Support Activities for Oil and Gas Operations
5
236118
Residential Remodelers
2
236220
Commercial and Institutional Building Construction
1
238160
Roofing Contractors
3
238310
Drywall and Insulation Contractors
18
238330
Flooring Contractors
2
238390
Other Building Finishing Contractors
4
311119
Other Animal Food Manufacturing
6
311412
Frozen Specialty Food Manufacturing
2
311812
Commercial Bakeries
10
311822
Flour Mixes and Dough Manufacturing from Purchased Flour
5
311830
Tortilla Manufacturing
8
313210
Broadwoven Fabric Mills
1
313310
Textile and Fabric Finishing Mills
3
313311
Broadwoven Fabric Finishing Mills
6
313312
Textile and Fabric Finishing (except Broadwoven Fabric) Mills
4
313320
Fabric Coating Mills
39
314911
Textile Bag Mills
4
314999
All Other Miscellaneous Textile Product Mills
5
315299
All Other Cut and Sew Apparel Manufacturing
4
316210
Footwear Manufacturing
7
316211
Rubber and Plastics Footwear Manufacturing
4
321113
Sawmills
6
321211
Hardwood Veneer and Plywood Manufacturing
2
321212
Softwood Veneer and Plywood Manufacturing
4
321213
Engineered Wood Member (except Truss) Manufacturing
9
321219
Reconstituted Wood Product Manufacturing
3
321911
Wood Window and Door Manufacturing
15
321912
Cut Stock, Resawing Lumber, and Planing
4
321918
Other Millwork (including Flooring)
40
321920
Wood Container and Pallet Manufacturing
3
321992
Prefabricated Wood Building Manufacturing
2
321999
All Other Miscellaneous Wood Product Manufacturing
16
322121
Paper (except Newsprint) Mills
4
322222
Coated and Laminated Paper Manufacturing
6
322299
All Other Converted Paper Product Manufacturing
2
109

-------
NAICS
NAICS Description
Number of
Data Points
323110
Commercial Lithographic Printing
4
323111
Commercial Printing (except Screen and Books)
7
323113
Commercial Screen Printing
4
323119
Other Commercial Printing
4
324121
Asphalt Paving Mixture and Block Manufacturing
2
324122
Asphalt Shingle and Coating Materials Manufacturing
1
325180
Other Basic Inorganic Chemical Manufacturing
5
325188
All Other Basic Inorganic Chemical Manufacturing
4
325193
Ethyl Alcohol Manufacturing
2
325199
All Other Basic Organic Chemical Manufacturing
6
325211
Plastics Material and Resin Manufacturing
19
325212
Synthetic Rubber Manufacturing
4
325314
Fertilizer (Mixing Only) Manufacturing
4
325412
Pharmaceutical Preparation Manufacturing
10
325510
Paint and Coating Manufacturing
9
325520
Adhesive Manufacturing
1
325611
Soap and Other Detergent Manufacturing
15
325620
Toilet Preparation Manufacturing
63
325991
Custom Compounding of Purchased Resins
3
325998
All Other Miscellaneous Chemical Product and Preparation Manufacturing
38
326111
Plastics Bag and Pouch Manufacturing
32
326112
Plastics Packaging Film and Sheet (including Laminated) Manufacturing
17
326113
Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing
7
326121
Unlaminated Plastics Profile Shape Manufacturing
3
326122
Plastics Pipe and Pipe Fitting Manufacturing
12
326130
Laminated Plastics Plate, Sheet (except Packaging), and Shape Manufacturing
14
326150
Urethane and Other Foam Product (except Polystyrene) Manufacturing
1
326199
All Other Plastics Product Manufacturing
127
326220
Rubber and Plastics Hoses and Belting Manufacturing
4
326299
All Other Rubber Product Manufacturing
56
327110
Pottery, Ceramics, and Plumbing Fixture Manufacturing
1
327120
Clay Building Material and Refractories Manufacturing
19
327122
Ceramic Wall and Floor Tile Manufacturing
1
327125
Nonclay Refractory Manufacturing
15
327212
Other Pressed and Blown Glass and Glassware Manufacturing
8
327390
Other Concrete Product Manufacturing
3
327910
Abrasive Product Manufacturing
28
327993
Mineral Wool Manufacturing
37
327999
All Other Miscellaneous Nonmetallic Mineral Product Manufacturing
13
331111
Iron and Steel Mills
4
331210
Iron and Steel Pipe and Tube Manufacturing from Purchased Steel
3
110

-------
NAICS
NAICS Description
Number of
Data Points
331316
Aluminum Extruded Product Manufacturing
4
331419
Primary Smelting and Refining of Nonferrous Metal (except Copper and Aluminum)
6
331511
Iron Foundries
141
331513
Steel Foundries (except Investment)
88
331521
Aluminum Die-Casting Foundries
11
331522
Nonferrous (except Aluminum) Die-Casting Foundries
13
331524
Aluminum Foundries (except Die-Casting)
33
331525
Copper Foundries (except Die-Casting)
16
331528
Other Nonferrous Foundries (except Die-Casting)
16
332212
Hand and Edge Tool Manufacturing
3
332312
Fabricated Structural Metal Manufacturing
8
332313
Plate Work Manufacturing
5
332321
Metal Window and Door Manufacturing
8
332322
Sheet Metal Work Manufacturing
1
332410
Power Boiler and Heat Exchanger Manufacturing
5
332431
Metal Can Manufacturing
12
332439
Other Metal Container Manufacturing
25
332618
Other Fabricated Wire Product Manufacturing
2
332722
Bolt, Nut, Screw, Rivet, and Washer Manufacturing
4
332812
Metal Coating, Engraving (except Jewelry and Silverware), and Allied Services to
Manufacturers
29
332813
Electroplating, Plating, Polishing, Anodizing, and Coloring
6
332994
Small Arms, Ordnance, and Ordnance Accessories Manufacturing
6
332996
Fabricated Pipe and Pipe Fitting Manufacturing
3
332997
Industrial Pattern Manufacturing
20
332998
Enameled Iron and Metal Sanitary Ware Manufacturing
4
332999
All Other Miscellaneous Fabricated Metal Product Manufacturing
26
333220
Plastics and Rubber Industry Machinery Manufacturing
4
333244
Printing Machinery and Equipment Manufacturing
3
333314
Optical Instrument and Lens Manufacturing
4
333411
Air Purification Equipment Manufacturing
6
333415
Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial
Refrigeration Equipment Manufacturing
2
333511
Industrial Mold Manufacturing
21
333992
Welding and Soldering Equipment Manufacturing
2
333994
Industrial Process Furnace and Oven Manufacturing
7
334220
Radio and Television Broadcasting and Wireless Communications Equipment
Manufacturing
2
334310
Audio and Video Equipment Manufacturing
1
334412
Bare Printed Circuit Board Manufacturing
21
334419
Other Electronic Component Manufacturing
7
334511
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and
Instrument Manufacturing
4
Ill

-------
NAICS
NAICS Description
Number of
Data Points
334512
Automatic Environmental Control Manufacturing for Residential, Commercial, and
Appliance Use
4
334515
Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals
2
334519
Other Measuring and Controlling Device Manufacturing
10
335122
Commercial, Industrial, and Institutional Electric Lighting Fixture Manufacturing
2
335311
Power, Distribution, and Specialty Transformer Manufacturing
2
335931
Current-Carrying Wiring Device Manufacturing
2
336111
Automobile Manufacturing
4
336112
Light Truck and Utility Vehicle Manufacturing
10
336211
Motor Vehicle Body Manufacturing
6
336212
Truck Trailer Manufacturing
1
336311
Carburetor, Piston, Piston Ring, and Valve Manufacturing
4
336322
Other Motor Vehicle Electrical and Electronic Equipment Manufacturing
5
336340
Motor Vehicle Brake System Manufacturing
11
336370
Motor Vehicle Metal Stamping
3
336399
All Other Motor Vehicle Parts Manufacturing
38
336411
Aircraft Manufacturing
2
336412
Aircraft Engine and Engine Parts Manufacturing
1
336413
Other Aircraft Parts and Auxiliary Equipment Manufacturing
3
336510
Railroad Rolling Stock Manufacturing
17
336612
Boat Building
8
337110
Wood Kitchen Cabinet and Countertop Manufacturing
62
337121
Upholstered Household Furniture Manufacturing
2
337122
Nonupholstered Wood Household Furniture Manufacturing
1
337127
Institutional Furniture Manufacturing
23
337211
Wood Office Furniture Manufacturing
16
337215
Showcase, Partition, Shelving, and Locker Manufacturing
7
339112
Surgical and Medical Instrument Manufacturing
30
339113
Surgical Appliance and Supplies Manufacturing
5
339920
Sporting and Athletic Goods Manufacturing
7
339932
Game, Toy, and Childrens Vehicle Manufacturing
5
339991
Gasket, Packing, and Sealing Device Manufacturing
25
339999
All Other Miscellaneous Manufacturing
24
423210
Furniture Merchant Wholesalers
3
423220
Home Furnishing Merchant Wholesalers
4
423310
Lumber, Plywood, Millwork, and Wood Panel Merchant Wholesalers
9
423730
Warm Air Heating and Air-Conditioning Equipment and Supplies Merchant Wholesalers
4
423830
Industrial Machinery and Equipment Merchant Wholesalers
2
423930
Recyclable Material Merchant Wholesalers
8
423990
Other Miscellaneous Durable Goods Merchant Wholesalers
5
424120
Stationery and Office Supplies Merchant Wholesalers
4
112

-------
NAICS
NAICS Description
Number of
Data Points
424210
Drags and Druggists' Sundries Merchant Wholesalers
3
424320
Men's and Boys' Clothing and Furnishings Merchant Wholesalers
8
424330
Women's, Children's, and Infants' Clothing and Accessories Merchant Wholesalers
7
424410
General Line Grocery Merchant Wholesalers
5
424470
Meat and Meat Product Merchant Wholesalers
2
424690
Other Chemical and Allied Products Merchant Wholesalers
20
442110
Furniture Stores
2
444130
Hardware Stores
3
444190
Other Building Material Dealers
2
445110
Supermarkets and Other Grocery (except Convenience) Stores
5
445210
Meat Markets
1
446120
Cosmetics, Beauty Supplies, and Perfume Stores
38
446199
All Other Health and Personal Care Stores
9
447110
Gasoline Stations with Convenience Stores
1
448110
Men's Clothing Stores
3
448120
Women's Clothing Stores
5
448140
Family Clothing Stores
4
448190
Other Clothing Stores
2
452112
Discount Department Stores
9
453998
All Other Miscellaneous Store Retailers (except Tobacco Stores)
3
482111
Line-Haul Railroads
4
482112
Short Line Railroads
2
484121
General Freight Tracking, Long-Distance, Trackload
4
488210
Support Activities for Rail Transportation
1
493110
General Warehousing and Storage
5
493120
Refrigerated Warehousing and Storage
4
511120
Periodical Publishers
4
522110
Commercial Banking
2
524113
Direct Life Insurance Carriers
7
541330
Engineering Services
1
541410
Interior Design Services
2
541940
Veterinary Services
31
561210
Facilities Support Services
1
561422
Telemarketing Bureaus and Other Contact Centers
4
561720
Janitorial Services
7
562211
Hazardous Waste Treatment and Disposal
10
562219
Other Nonhazardous Waste Treatment and Disposal
2
562910
Remediation Services
3
611110
Elementary and Secondary Schools
4
611310
Colleges, Universities, and Professional Schools
40
611511
Cosmetology and Barber Schools
9
113

-------
NAICS
NAICS Description
Number of
Data Points
611519
Other Technical and Trade Schools
3
621111
Offices of Physicians (except Mental Health Specialists)
3
621112
Offices of Physicians, Mental Health Specialists
2
621210
Offices of Dentists
5
621320
Offices of Optometrists
12
621399
Offices of All Other Miscellaneous Health Practitioners
3
621491
HMO Medical Centers
5
621511
Medical Laboratories
170
621910
Ambulance Services
6
621999
All Other Miscellaneous Ambulatory Health Care Services
4
622110
General Medical and Surgical Hospitals
146
622310
Specialty (except Psychiatric and Substance Abuse) Hospitals
2
711310
Promoters of Performing Arts, Sports, and Similar Events with Facilities
6
713290
Other Gambling Industries
15
713990
All Other Amusement and Recreation Industries
1
721120
Casino Hotels
7
811111
General Automotive Repair
2
811121
Automotive Body, Paint, and Interior Repair and Maintenance
2
811310
Commercial and Industrial Machinery and Equipment (except Automotive and Electronic)
Repair and Maintenance
3
811420
Reupholstery and Furniture Repair
4
811490
Other Personal and Household Goods Repair and Maintenance
1
812111
Barber Shops
15
812112
Beauty Salons
515
812113
Nail Salons
7
812199
Other Personal Care Services
3
812210
Funeral Homes and Funeral Services
179
812220
Cemeteries and Crematories
2
812921
Photofinishing Laboratories (except One-Hour)
4
813990
Other Similar Organizations (except Business, Professional, Labor, and Political
Organizations)
1
921130
Public Finance Activities
5
921190
Other General Government Support
5
922130
Legal Counsel and Prosecution
2
922190
Other Justice, Public Order, and Safety Activities
2
923140
Administration of Veterans' Affairs
10
926120
Regulation and Administration of Transportation Programs
3
926150
Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors
235
928110
National Security
4
114

-------
Appendix F SUPPORTING INFORMATION: CONCEPTUAL MODEL FOR INDUSTRIAL
AND COMMERCIAL ACTIVITIES AND USES
TableApx F-l. Worker and Occupational Non-User Exposure Conceptual Model Supporting Table
l.ili- < \ik-
Shim-
C;iU-»iir\
Sul>i;iU-»iir\
Ri'k'iisi- /
l!\|)iisuiv
Siiiiiirio
I!\|)iisiiiv
P;ilh\\;i\
I!\|)iisiiiv
Riiuk-
Ri'i'i'plur /
Piipuhiliiiii
I'kilis In
K;iliiin;ik-




Liquid
Contact
Dermal
Workers
Yes
Formaldehyde is expected to be
manufactured and sold in aqueous
formaldehyde solution. Therefore,
dermal exposures to liquid is
expected for workers.

Domestic
Manufacture

Manufacturing of
Formaldehyde
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature). EPA
plans to analyze inhalation
exposures.

Domestic Manufacture





Manufacture



Misl
Inhalation
Workers.
ONU
No
Mist generation is not expected
during manufacturing.




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

Import
Import
Repackaging of
formaldehyde
Liquid
Contact
Dermal
Workers
Yes
Formaldehyde may be imported in
an aqueous solution; therefore,
dermal exposure is expected for
workers. However, exposure will
only occur in the event the
imported material is repackaged.
115

-------
l.il'i- ( \ik-
Shim-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
P;ilh\\;i\
I!\|)iisiiiv
Knuk-
Ri'ivpliir /
Piipiihilioii
Pkilis In
K;iliiui;ik-




Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature). EPA
plans to analyze inhalation
exposures. However, exposure will
only occur in the event the
imported material is repackaged.




Mist
Inhalation
Workers,
ONU
No
Mist generation is not expected
during repackaging of import
containers.




Liquid
Contact
I )ermal
ONU
No
I )ermal exposure by ()Nl J is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Processing
Reactant
Adhesives and sealant
chemicals in:
-	Plastic and resin
manufacturing
-	Wood product
manufacturing
-	All other basic organic
chemical manufacturing
Intermediate in:
-	Pesticide, fertilizer, and
other agricultural
chemical manufacturing
Formaldehyde as a
chemical
intermediate for
resin and other
chemical
production
Liquid
Contact
Dermal
Workers
Yes
Workers are expected to handle
aqueous solution containing
formaldehyde; therefore, dermal
exposure is expected to be a
pathway.
116

-------
l.il'i- ( \ik-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
P;ilh\\;i\
I!\|)iisiiiv
Knuk-
Ri'ivpliir /
Piipiihilioii
Pkilis In
K;iliiui;ik-


-	Petrochemical
manufacturing
-	Soap, cleaning
compound, and toilet
preparation manufacturing
-	All other basic organic
chemical manufacturing
-	Plastic materials and
resin manufacturing
-	Adhesive manufacturing
-	All other chemical
product and preparation
manufacturing
-	Paper manufacturing
-	Plastic products
manufacturing
-	Wood product
manufacturing
-	Construction
-	Agriculture, forestry,
fishing, and hunting
Functional fluid in:
-	Oil and gas drilling,
extraction, and support
activities
Processing aids, specific
to petroleum production
in:
-	All other basic chemical
manufacturing
Bleaching agent in wood
product manufacturing
Agricultural chemicals in:
agriculture, forestry,
fishing, and hunting

Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature). EPA
plans to evaluate inhalation
exposures.
Mist
Inhalation
Workers,
ONU
No
Mist generation is not expected
during processing.
Liquid
Contact
I )ermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
117

-------
l.il'i- ( \ik-
Shim-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
P;ilh\\;i\
I!\|)iisiiiv
Knuk-
Ri'ivpliir /
Piipiihilioii
Pkilis In
K;iliiui;ik-




Liquid
Contact
Dermal
Workers
Yes
Workers are expected to handle
aqueous solution containing
formaldehyde; therefore, dermal
exposure is expected to be a
pathway.
Processing
Incorporatio
n into an
article
Finishing agent in:
-Textiles, apparel, and
leather manufacturing
Textile Finishing
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature). EPA
plans to analyze inhalation
exposures.
Leather Tanning
Misl
Inhalation
Workers,
ONU
No
Mist generation is not expected
during processing.




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


Paint additives and
coating additives not
described by other
categories in:
-Transportation
equipment manufacturing
(including aerospace)

Liquid
Contact
Dermal
Workers
Yes
Workers are expected to handle
aqueous solution containing
formaldehyde; therefore, dermal
exposure is expected to be a
pathway.
Processing
Incorporatio
n into an
article
Application of
paint and coatings
in transportation
equipment
(including spray or
roll coating)
Vapor
Inhalation
Workers,
ONU
Yes
Inhalation exposure from off
gassing from the resin or vapor
generated from use of
formaldehyde containing solution
may be possible. EPA plans to
evaluate inhalation exposure.



Mist
Inhalation
Workers,
ONU
Yes
Mist generation may occur from
spray coating application and will
be analyzed.
118

-------
Life ( \ik-
Slum-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
l>;ilh\\;i\
I!\|)iisiiiv
kiiuk-
Ri'ivpliir /
Piipiihilioii
Phi lis In
l;.\;illl:iU'
K;iliiui;ik-




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




Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde may be
possible, EPA plans to evaluate
dermal exposure.
Processing
Incorporatio
n into an
article
Synthetic Rubber
Manufacturing in:
-Transportation
Equipment Manufacturing
(Tires)
Tire
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from off
gassing of the resin and from the
final article will be evaluated.
Manufacturing
Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected
during processing.




Liquid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Processing
Incorporatio
n into an
article
Adhesives and sealant
chemicals in:
-Wood product
manufacturing
-Plastic material and resin
manufacturing (including
structural and fireworthy
aerospace interiors)
-Construction
Use of adhesive
for wood product,
plastic material,
and general
construction
material
manufacturing
Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from off
gassing of the resin and from the
final article will be evaluated.
119

-------
l.il'i- ( \ik-
Shim-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
P;ilh\\;i\
I!\|)iisiiiv
Knuk-
Ri'ivpliir /
Piipiihilioii
Pkilis In
K;iliiui;ik-



( spray, brush, or
roll application of
adhesive to, but
not limited, to
floors, plastic and
wood furniture)
Mist
Inhalation
Workers,
ONU
Yes
Mist generation can occur if
adhesive is spray-applied.



Liquid
Contact
I )ermal
ONI J
No
Dermal exposure by ONU is not
expected lor this condition of use
as they are not expected to directly
handle the chemical.


Petrochemical
manufacturing, petroleum,
lubricating oil and grease
manufacturing.
-	Fuel and fuel additives
-	Lubricant and lubricant
additives
-	all other basic organic
chemical manufacturing

Liquid
Contact
Dermal
Workers
Yes
Formaldehyde may be handled in
an aqueous solution form;
therefore, EPA plans to evaluate
for potential dermal exposure.








Processing
Incorporatio
n into a
formulation,
mixture, or
reaction
product
Asphalt, Paving, Roofing,
and Coating Materials
Manufacturing.
Solvents (which become
part of a product
formulation or mixture)
in:
-Paint and coating
manufacturing
Processing of
formaldehyde into
formulations,
mixtures, or
reaction products
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature). EPA
plans to evaluate inhalation
exposures










Processing aids, specific
to petroleum production
in:
- Oil and gas drilling,
extraction, and support
activities

Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected
during processing.
120

-------
Life ( \ik-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
l';illi\\;i\
I!\|)iisiiiv
kiiuk-
Ri'ivpliir /
Piipuliilioii
Phi lis In
l;.\;illl;iU'
K;iliiui;ik'


-	All other basic organic
chemical manufacturing
Paint additives and
coating additives not
described by other
categories in:
-	Paint and coating
manufacturing
-	Plastic material and resin
manufacturing
Intermediate in
-	All other basic chemical
manufacturing
-	Plastic material and resin
manufacturing
-	Oil and gas drilling,
extraction, and support
activities
-	Wholesale and retail
trade
Other: Preservative in all
other chemical product
and preparation
manufacturing:
Solid separation agents in
miscellaneous
manufacturing
Agricultural chemicals
(non-pesticidal)i
-Agriculture, forestry,
fishing, and hunting
-	Pesticide, fertilizer, and
other agricultural
chemical manufacturing
Surface active agents in
plastic material and resin
manulacturiim

Liquid
Contact
1 )ermal
ONIJ
No
Dermal exposure by ONIJ is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
121

-------
Life ( \ik-
Slum-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
P;ilh\\;i\
I!\|)iisiiiv
kiiuk-
Ri'ivpliir /
Piipiihilioii
Phi lis In
l;.\;illl:iU'
K;iliiui;ik-


Ion exchange agents in:
-	Adhesive manufacturing
-	Paint and coating
manufacturing








Lubricant and lubricant
additive in adhesive
manufacturing








Plating agents and surface
treating agents in all other
chemical product and
preparation manufacturing








functional fluids (closed
system) in soap, cleaning
compound, and toilet
preparation manufacturing








1 .aboratory chemicals:
other








Adhesive and sealant
chemical in adhesive
manufacturing








Bleaching agents in
textile, apparel, and
leather manulacturiim






Processing
Repackaging
Laboratory chemical in
Repackaging
Liquid
Contact
Dermal
Workers
Yes
Formaldehyde may be received in
an aqueous solution; therefore,
dermal exposure is expected for
workers. However, exposure will
only occur in the event the
imported material is repackaged.
other: sales to distributors
Vapor
Inhalation
Workers,
ONU
Yes
Due to its high volatility,
inhalation exposures will be
analyzed. However, exposure will
only occur in the event the
imported material is repackaged.
122

-------
Life ( \ik-
Slum-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
l>;ilh\\;i\
I!\|)iisiiiv
kiiuk-
Ri'ivpliir /
Piipiihilioii
Phi lis In
l;.\;illl:iU'
K;iliiui;ik-




Mist
Inhalation
Workers.
ONI J
No
Mist generation is not expected
during repackaging of received
containers.




Liquid
Contact
Dermal
ONI J
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Distribution in
commerce
Distribution
in commerce
Distribution in commerce
Distribution of
formaldehyde,
formaldehyde
solutions, or
products
containing
formaldehyde in
commerce
Liquid
Contact,
Vapor
Dermal,
Inhalation
Worker,
ONU
Yes
EPA plans to analyze activities
resulting in exposures associated
with distribution in commerce (e.g.
loading, unloading) throughout the
various lifecycle stages and
conditions of use (e.g.
manufacturing, processing,
industrial use, commercial use,
disposal) rather than as a single
distribution scenario.




Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
Industrial Use
Non-
incorporativ
e activities
Processing aid in oil and
gas drilling, extraction,
and support activities
(e.g., hydraulic tracking
fluid)
Use of
formaldehyde for
oilfield well
production
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.




Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected
during use.
123

-------
Life ( \ik-
Slum-
C;iU-»iir\
Sul>i:ik-»nr\
Ri'k'.isi- /
l!\|)osuiv
Siiii.iriii
I!\|)iisiiiv
l>;ilh\\;i\
I!\|)iisiiiv
kiiuk-
Ri'ivpliir /
Piipiihilioii
Phi lis In
l;.\;illl:iU'
K;iliiui;ik-




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




Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
Industrial Use
Non-
incorporativ
e activities
Construction;
Industrial use of
formaldehyde for
construction and
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Agriculture, forestry,
fishing and hunting
agriculture
activities (e.g.
processing aid)
Mist
Inhalation
Workers.
ONU
Yes
Mist generation is not expected
during use.




Liquid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Commercial
Chemical
substances
in furnishing
-Floor coverings
-Foam seating and
bedding products
-Furniture and furnishings
not covered elsewhere
Installation and
demolition of
formaldehyde-
based furnishings
and
building/constructi
on materials in
residential, public
and commercial
buildings, and
other structures
Liquid
Contact
I )ermal
Workers
No
Depending on products covered for
this exposure scenario, dermal
contact with liquid for workers is
not expected for these finished
articles.
Use
treatment/ca
re products
-Building/ construction
materials (wood and
engineered wood
products)
Vapor
Inhalation
Workers,
ONU
Yes
Off-gassing of formaldehyde from
these products is expected. EPA
plans to evaluate inhalation
exposure.
124

-------
l.il'i- C\ik-
Si un-
C;ili-»iir\
Sul>i:ili-»nr\
Ki-li-;isi- /
l!\|)osun-
Sii-ii.iriii
l!\|)iisun-
l>;ilh\\;i\
l!\|)iisun-
knuii-
Ki-ii-plur /
Piipiihilioii
Phi lis In
l;.\;illl:ili-
K;iliiui;ili-

Chemical
substances
in
construction.
paint.
electrical.
-I Suilding/ construction
materials not covered
elsewhere

Mist
Inhalation
Workers.
ONI J
No
Mist generation is not expected
during use.

and metal
products


Liquid
Contact
Dermal
ONI J
No
Dermal exposure by ()Nl J is not
expected for this condition of use
as they are not expected to directly
handle the chemical.




Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
commercial
Chemical
substances
in furnishing
-Cleaning and Furniture
Workers handling
cleaning and
furniture care
products (spray
application)
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Use
treatment/ca
re products
Care Products
Mist
Inhalation
Workers,
ONU
Yes
Depending on products, mist
generation may occur from spray
application and will be analyzed.




Liquid
Contact
I )ermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Commercial
Use

Fabric, textile, and leather
products not covered
elsewhere
Workers handling
fabric, textile, and
leather products
Liquid
Contact
I )ermal
Workers
No
Dermal contact with liquid for
workers is not expected for these
finished articles.
125

-------
Life ( >ik-
Si un-
C;ili-»iir\
Siil>i:ili-»nr\
Ki-li-;isi- /
l!\|)osun-
Sii-ii.iriii
l!\|)iisun-
P;ilh\\;i\
l!\|)iisun-
kinili-
Ki-ii-plur /
I'lipuliilion
Philis In
r.\;illl;ili-
K;iliiui;ili-

Chemical


Vapor
Inhalation
Workers,
ONU
Yes
Depending on the product, vapor
generation and/or off-gassing of
formaldehyde is expected. EPA
plans to evaluate inhalation
exposure.

substances
in
Furnishing,
cleaning,
and
treatment/ca










Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected
during use.

re products


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




Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
commercial
Chemical
substances
Water treatment products
Use of
formulations
containing
formaldehyde for
water treatment
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Use
treatment/ca
re products
Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected
during use.




I.iquid
Contact
1 )ermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
126

-------
Life ( >ik-
Si un-
C;ili-»iir\
Siil>i:ili-»nr\
Ki-li-;isi- /
l!\|)osun-
Sii-ii.iriii
l!\|)iisun-
P;ilh\\;i\
l!\|)iisun-
kinili-
Ki-ii-plur /
I'lipuliilion
Philis In
r.\;illl;ili-
K;iliiui;ili-
commercial
Use
Chemical
substances
in
treatment/ca
re products
Personal care products;
Workers handling
formulations
containing
formaldehyde in
personal care
products
Liquid
Contact
Dermal
Workers
Yes
Based off currently identified
products, dermal exposures to
formulations containing
formaldehyde are expected for
workers.
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Mist
Inhalation
Workers.
ONU
Yes
Based off currently identified
products, mist generation is not
expected, but this may change as
products are identified.
Liquid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Commercial
Use
Chemical
substances
in
construction,
paint,
electrical,
and metal
products
Adhesives and Sealants
Paint and coatings
Use of
formulations
containing
formaldehyde for
spray applications
(e.g., spray or roll)
Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Mist
Inhalation
Workers,
ONU
Yes
Mist generation may occur from
spray coating application and will
be analyzed.
127

-------
l.il'i- C\ik-
Si un-
C;ili-»iir\
Sul>i:ili-»nr\
Ki-li-;isi- /
l!\|)osun-
Sii-ii.iriii
I!\|)iisun-
l>;ilh\\;i\
l!\|)iisun-
knuii-
Ki-ii-plur /
Piipiihilioii
Phi lis In
l;.\;illl:ili-
K;iliiui;ili-




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




Liquid
Contact
I )ermal
Workers
No
Depending 011 identified products,
products may be finished articles
with 110 expected liquid contact
w ith 1'ormuldehyde.
commercial
Chemical
substances
in electrical
products
Electrical and electronic
products (including
semiconductors)
Use of electronic
Vapor
Inhalation
Workers,
ONU
Yes
Depending on identified products,
inhalation exposure from off-
gassing or vapor generation will be
evaluated.
Use
Chemical
substances
in metal
products
Metal products not
covered elsewhere
and metal products
Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected
during use.




Liquid
Contact
Dermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Commercial
Chemical
substances
in products
-Automotive care products
-Lubricants and greases
Use of
formulations
containing
formaldehyde in
fuels, lubricants,
and automotive
care products.
Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
Use
-Fuels and related
products
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
128

-------
l.il'i- C\ik-
Si un-
C;ili-»iir\
Sul>i:ili-»nr\
Ki-li-;isi- /
l!\|)osun-
Sii-ii.iriii
l!\|)iisun-
l>;ilh\\;i\
l!\|)iisun-
knuii-
Ki-ii-plur /
Piipiihilioii
Phi lis In
l;.\;illl:ili-
K;iliiui;ili-




Mist
Inhalation
Workers.
ONI J
No
Mist generation is not expected
during use.




I.iquid
Contact
Dermal
ONI J
No
Dermal exposure by ()Nl J is not
expected for this condition of use
as they are not expected to directly
handle the chemical.




Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
commercial
Chemical
substances
-Lawn and related
products
Use of fertilizer
containing
formaldehyde in
outdoors including
lawns
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Use
agriculture
use products
Mist
Inhalation
Workers,
ONU
Yes
Mist generation may occur from
spray application and will be
analyzed.




I.iquid
Contact
I )ermal
ONU
No
Dermal exposure by ONU is not
expected lor this condition of use
as they are not expected to directly
handle the chemical.
Commercial
Use
Chemical
substances
in outdoor
products
-Explosive Materials
Use of explosive
materials
Liquid
Contact
Dermal
Workers
Yes
Depending on the material,
EPA plans to evaluate dermal
exposure to formaldehyde if
applicable.
129

-------
Life ( >ik-
Si un-
C;ili-»iir\
Siil>i:ili-»nr\
Ki-li-;isi- /
l!\|)osun-
Sii-ii.iriii
l!\|)iisun-
P;ilh\\;i\
l!\|)iisun-
kinili-
Ki-ii-plur /
I'lipuliilion
Philis In
l"\:illl:ili-
K;iliiui;ili-




Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Mist
Inhalation
Workers.
ONU
No
Mist generation not expected for
use.
Liquid
Contact
Dermal
ONU
No
1 )ermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
commercial
Use
Chemical
substances
in
packaging,
paper,
plastic,
hobby
products
-	Food packaging
-	Paper products
-	Plastic and rubber
products
-	Toys, playground, and
sporting equipment
Use of packaging,
paper, and hobby
products
Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
Vapor
Inhalation
Workers,
ONU
Yes
Inhalation exposure from vapor
generation and off-gassing from
articles will be evaluated.
Mist
Inhalation
Workers.
ONU
No
Mist generation not expected for
use.
Liquid
Contact
Dermal
ONU
No
1 )ermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
130

-------
Life ( >ik-
Si un-
C;ili-»iir\
Siil>i:ili-»nr\
Ki-li-;isi- /
l!\|)osun-
Sii-ii.iriii
l!\|)iisun-
P;ilh\\;i\
l!\|)iisun-
kinili-
Ki-ii-plur /
I'lipuliilion
Philis In
r.\;illl;ili-
K;iliiui;ili-




Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.



Use of
formulations
containing
formaldehyde in
craft materials
Use of printing
ink, toner and
colorant products
containing
formaldehyde





commercial
Chemical
substances
in
packaging,
- Arts, crafts, and hobby
materials
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Use
paper,
plastic,
hobby
products
- Ink, toner, and colorant
products
Mist
Inhalation
Workers,
ONU
No
Mist generation is not expected
during use.




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

Chemical


Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
Commercial
Use
substances
in
packaging,
paper,
plastic,
hobby
Photographic supplies
Photo processing
using formulations
containing
formaldehyde
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.

products











Mist
Inhalation
Workers.
ONU
No
Mist generation is not expected
during use.
131

-------
l.il'i- C\ik-
Si un-
C;ili-»iir\
Sul>i:ili-»nr\
Ki-li-;isi- /
l!\|)osun-
Sii-ii.iriii
l!\|)iisun-
l>;ilh\\;i\
l!\|)iisun-
knuii-
Ki-ii-plur /
Piipiihilioii
Phi lis In
l;.\;illl:ili-
K;iliiui;ili-




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




Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
commercial
Other
Laboratory Use
Embalming
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
Use
General laboratory
use
Mist
Inhalation
Workers,
ONU
Yes
Mist generation may occur from
spray application and will be
analyzed.




I.iquid
Contact
I )ermal
ONU
No
Dermal exposure by ONU is not
expected for this condition of use
as they are not expected to directly
handle the chemical.
Disposal
Waste
Handling,
Disposal of formaldehyde
Worker handling
Liquid
Contact
Dermal
Workers
Yes
Dermal exposures to formulations
containing formaldehyde are
expected for workers.
Treatment
and Disposal
wastes
of wastes
Vapor
Inhalation
Workers,
ONU
Yes
Formaldehyde is volatile (3890
mm Hg at room temperature),
inhalation exposure from vapor
will be evaluated.
132

-------
Life ( \ik-
C;iU-»iir\
Sul>i:ik-»nr\
Kck'iisc /
l!\|)osuiv
Sii-ii.iriii
I!\|)iisiiiv
P;! 1 hw ;i\
I!\|)iisiiiv
kniik-
Ki-ii-plur /
Piipiihilioii
Phi lis In
l;.\;illl;iU'
K;iliiui;ik-




Mist
Inhalation
Workers.
ONI J
No
Mist generation is not expected
during use.
Liquid
Contact
Dermal
ONI J
No
Dermal exposure by ()Nl J is not
expected for this condition of use
as tliev are not expected to directly
handle the chemical.
133

-------
Appendix G SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR CONSUMER
ACTIVITIES AND USES
Table Apx G-l. Consumer Exposure Conceptual Model Supporting Table
life
( \cle
S(;i»e
( iileiion
SulK'iili'gon
Koloiisc from Source
r.\|)osuri'
PillllWin
Koulc
Km'plor
I'lilllS (o
Kiilioiiiilo
Consumer
Use
Air Care
Products
Air Care
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Long-term
emission/mass-transfer
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.
Floor
Coverings
Floor
Coverings
Direct contact through
application or use of
products using
formaldehyde-based
products
Long-term
emission/mass-transfer
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via
inhalation will be evaluated.
Cleaning
and
Furniture
Care
Products
Cleaning and
Furniture
Care Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.
Long-term
emission/mass-transfer
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.
134

-------
life
( >clo
Si;i»e
( iileiion
SulK'iili'gon
Koloiisc from Source
l'l\|)OMIIV
Koulc
Km'plor
I'lilllS (o
Kiilioiiiilo

Lubricants
and Greases
Lubricants
and Greases
Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.
Long-term
emission/mass-transfer
Arts, Crafts,
and Hobby
Materials
Arts, Crafts,
and Hobby
Materials
Direct contact through
application or use of
products using
formaldehyde -based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.
Long-term
emission/mass-transfer
Toys,
Playground,
and Sporting
Equipment
Toys,
Playground,
and Sporting
Equipment
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via
inhalation will be evaluated.
135

-------
life
( >clo
Si;i»e
( iileiion
SulK'iili'gon
Koloiisc from Source
l'l\|)OMIIV
Koulc
Km'plor
I'lilllS (o
Kiilioiiiilo



Long-term
emission/mass-transfer






Plastic &
Rubber
Products Not
Plastic &
Rubber
Products Not
Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.

Covered
Elsewhere
Covered
Elsewhere
Long-term
emission/mass-transfer
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via
inhalation will be evaluated.



Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.

Paints and
Coatings
Paints and
Coatings
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.



Long-term
emission/mass-transfer


Bystanders


Ink, Toner,
and Colorant
Products
Ink, Toner,
and Colorant
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.

Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via
inhalation will be evaluated.
136

-------
life
( >clo
Si;i»e
( iileiion
SulK'iili'gon
Koloiisc from Source
l'l\|)OMIIV
Koulc
Km'plor
I'lilllS (o
Kiilioiiiilo



Long-term
emission/mass-transfer








Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.

Photographi
c Supplies
Photographic
Supplies
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.



Long-term
emission/mass-transfer


Bystanders


Foam
Seating &
Bedding
Products
Foam Seating
& Bedding
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via

Products
Long-term
emission/mass-transfer


Bystanders

inhalation will be evaluated.

Fabric,
Textile, &
Leather
Products Not
Covered
Elsewhere
Fabric,
Textile, &
Leather
Products Not
Covered
Elsewhere
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Depending on the product, vapor
generation and/or off-gassing of
formaldehyde is expected. Exposure via
inhalation will be evaluated.
137

-------
life
( >clo
Si;i»e
( iileiion
SulK'iili'gon
Koloiisc from Source
r.xposuiT
Koulc
Km'plor
I'lilllS (o
Kiilioiiiilo



Long-term
emission/mass-transfer






Furniture &
Furnishings
Not Covered
Furniture &
Furnishings
Not Covered
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via
inhalation will be evaluated.

Elsewhere
Elsewhere
Long-term
emission/mass-transfer





Building/Co
nstruction
Materials -
Wood &
Engineered
Wood
Products
Building/Con
struction
Materials -
Wood &
Engineered
Wood
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via
inhalation will be evaluated.

Long-term
emission/mass-transfer





Building/Co
nstruction
Materials
Building/Con
struction
Materials Not
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via

Not Covered
Elsewhere
Covered
Elsewhere
Long-term
emission/mass-transfer


Bystanders

inhalation will be evaluated.
138

-------
life
( >clo
Si;i»e
( iileiion
SulK'iili'gon
Koloiisc from Source
l'l\|)OMIIV
Koulc
Km'plor
I'lilllS (o
Kiilioiiiilo

Electrical &
Electronic
Products
Electrical &
Electronic
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via
inhalation will be evaluated.

Long-term
emission/mass-transfer







Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.

Fuels and
Related
Products
Fuels and
Related
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.



Long-term
emission/mass-transfer




Paper
Products
Paper
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Off-gassing of formaldehyde from these
products is expected. Exposure via
inhalation will be evaluated.

Long-term
emission/mass-transfer




Agricultural
Products
(Non-
Pesticidal)
Agricultural
Products
(Non-
Pesticidal)
Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.
139

-------
life
( >clo
Si;i»e
( iileiion
SulK'iili'gon
Koloiisc from Source
r.xposuiT
Koulc
Km'plor
I'lilllS (o
Kiilioiiiilo



Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.



Long-term
emission/mass-transfer






Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.

Water
Treatment
Products
Water
Treatment
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Yes
Vapor generation is expected during
application. Exposure via inhalation will



Long-term
emission/mass-transfer


Bystanders

be evaluated.

Laundry and
Dishwashing
Products
Laundry and
Dishwashing
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.

Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Bystanders
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.



Long-term
emission/mass-transfer




140

-------
life
( >clo
Si;i»e
( iileiion
SulK'iili'gon
Koloiisc from Source
l'l\|)OMIIV
Roulc
Km'plor
I'lilllS lo
Kiilioiiiilo



Direct contact through
application or use of
products using
formaldehyde-based
products
Liquid
Dermal
Consumers
Yes
Evaporation of product from the skin may
be limited or prohibited during use of
liquid products. Exposure via dermal route
will be evaluated.

Personal
Care
Products
Personal Care
Products
Direct contact through
application or use of
products using
formaldehyde-based
products
Indoor Air
Inhalation
Consumers
and
Yes
Vapor generation is expected during
application. Exposure via inhalation will
be evaluated.



Long-term
emission/mass-transfer


Bystanders

141

-------
Appendix H SUPPORTING INFORMATION - CONCEPTUAL MODEL FOR
ENVIRONMENTAL RELEASES AND WASTES
Table Apx H-l. General Population ant
Environmental Exposure Conceptual Model Supporting Table
Life
Cu-le
S(;i»c
C.ili'Korics
Kck'sisi*
I'lxposuiv PiidiNin /
Mi'din
Mxposuiv
Routes
Km'plor /
Population
I'lilllS lo
Kiilionnk-
All
1 Emissions lo
\ll
1 Emissions lo \ 11"
(liidusiiial or
('limine ivial i
Near facilil> anihieui
air aiiiceiiiraliiins
Inhalation
(leneral
l\ipiilaliiin
\n
l'iii'iiiakleli\de is a II \l'. liecanse
slaliiiiiai> siimve releases of
fnrniaklelisde In anihieni an are
under llie jurisdiction ol I lie ( \\
Indirect deposition In
nearln bodies of ualer
and mhI catchments
()i;il. Dermal
(leneral
l\ipnlaliiiii
\n
ii:d
\quatic and
1 erresiiial
Receptors
\n
Emissions to
Air
Emissions to Air
(Consumer
Activities)
Near residence
ambient air
concentrations
Inhalation
General
Population
Yes
Consumer use or installation of
various building materials within a
residence can lead to long-term off-
gassing of formaldehyde from such
materials. EPA plans to evaluate
exposure to co-located and co-
residence populations associated
with off-gassing from consumer
products used or installed in a
residence.
Wastewater or
Liquid Wastes
Industrial pre-
treatment and
wastewater
treatment, or
POTW
Direct release into
surface water and
indirect partitioning to
sediment
TBD
Aquatic and
Terrestrial
Receptors
No
Ongoing presence of formaldehyde
in surface water is expected to be
limited due to the rapid and nearly
complete hydration of
formaldehyde to a gem-diol,
methylene glycol, in water.
8 The exposure pathways, exposure routes and hazards EPA plans to evaluate are subject to change in the final scope, in light of comments received on this draft scope
and other reasonably available information. EPA continues to consider whether and how other EPA-administered statutes and any associated regulatory programs address
the presence of formaldehyde in exposure pathways falling under the jurisdiction of these EPA statutes.
142

-------
life
( \cle
S(;i»o
('.ilcgorics
Koloiiso
I'lxposuiv Pa(h\\a\ /
Modin
Mxposuiv
Routes
Km'plor/
Population
PlilllS 1(1
i:\:iiiiiiics
Rationale



Direct release mud
surface waler and
pariiiioiiiiiu lo
sedimeiil
()ral
Dermal and
(leueral
I'opiilaliou
\o




1 )riiiknm Waler \ la
Surface or (irouiid
Waler
()ral
Dermal and
liihalalion (e u .
slkiwcriiim
(leueral
Kipiilaliou
\o
The drink in1.: waler exposure
palhwas for formaIdchule is
curreuiK addressed in ihe SDW \
rei!iilalor\ auaKlical process fur
public waler svsienis



Biosolids: application
to soil and/or
migration to surface
water
Oral (e.g.,
ingestion/
drinking surface
water)
Dermal (direct
contact with
surface water)
General
Population
Yes
Although formaldehyde is a volatile
chemical and not expected to sorb
onto soil, EPA plans to analyze this
pathway




TBD
Aquatic and
Terrestrial
Receptors
Yes



Underground
injection
\1mraliou lo
()ral
Dermal
(leueral
I'opulaliou
\o
l ormaldehsde is released lo ( lass 1


urouudwaler. poieuiial
surface driiiknm waler
ii:d
\qualic and
Terrestrial
kecepiors
\o
I uderurouud Injection \\ells w Inch
are co\ ered h\ SDW \ and k('k \

Solid and
Hazardous,
Municipal landfill
l.eachale lo sml.
mound waler and or
()ral (en.
iimesiioin
Dermal
(leueral
I'opulaliou
\o
I'ormaldehsde is included on I he
lisi nf hazardous wasies pursuaui lo
k("k \ '(ml (4(i ( I k jfjf -('1 ">

Liquid Wastes
and other land
disposal
nuimaliou lo surlace
waler
ii:d
\qualic and
1 erresirial
kecepiors
\|
143

-------