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EPA Document #EPA-740-D-24-002
March 2024
United States Office of Chemical Safety and
Environmental Protection Agency Pollution Prevention
Draft Environmental Risk Assessment for Formaldehyde
CASRN 50-00-0
o
March 2024
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27 TABLE OF CONTENTS
28 ACKNOWLEDGEMENTS 3
29 EXECUTIVE SUMMARY 4
30 1 INTRODUCTION 6
31 1.1 Background 6
32 1.2 Risk Evaluation Scope 6
33 1.2.1 Life Cycle and Production 7
34 1.2,2 Conditions of Use 10
35 1.3 Chemistry, Fate, and Transport Assessment 16
36 1.4 Environmental Release Assessment 18
37 1.5 Environmental Exposure Assessment 19
38 1.6 Transformation Products in Environmental Media 20
39 1.7 Problem Formulation for Environmental Pathways 21
40 2 RISK ASSESSMENT APPROACH 22
41 2.1 Ambient Air 22
42 2.2 Hazard Summary 23
43 2.2.1 Terrestrial Vertebrate Toxicity 24
44 2.2.2 Plant Toxicity 24
45 2.3 Summary of Environmental Risk Assessment 25
46 2.3.1 Terrestrial Vertebrate Risk Assessment 25
47 2.3.2 Plant Risk Assessment 26
48 2.3.3 Overall Confidence and Remaining Uncertainties in Environmental Risk Assessment 26
49 REFERENCES 28
50 APPENDICES 30
51 Appendix A ABBREVIATIONS AND ACRONYMS 30
52 Appendix B LIST OF DOCUMENTS AND SUPPLEMENTAL FILES 31
53
54 LIST OF TABLES
55 Table 1-1. Categories and Subcategories of Use and Corresponding Exposure Scenario in the Draft Risk
56 Evaluation for Formaldehyde 11
57 Table 1-2. Physical and Chemical Properties of Formaldehyde and Select Transformation Products .... 16
58 Table 2-1. Summary of the Most Sensitive Toxicity Endpoints for Terrestrial Organisms Exposed to
59 Formaldehyde in Air 24
60 Table 2-2. Comparison of Formaldehyde Air Concentrations and Terrestrial Organism Toxicity 25
61
62 LIST of figures
63 Figure 1-1. Risk Evaluation Document Summary Map 7
64 Figure 1-2. Formaldehyde Lifecycle Diagram 9
65 Figure 1-3. Chemical Equilibria for Formaldehyde in Aqueous Solutions 17
66 Figure 2-1. Distributions of Ambient Air Formaldehyde Concentration Based on Monitoring Data and
67 Model Data 23
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ACKNOWLEDGEMENTS
This report was jointly developed by the United States Environmental Protection Agency (U.S. EPA or
the Agency), Office of Chemical Safety and Pollution Prevention (OCSPP), Office of Pollution
Prevention and Toxics (OPPT), and the Office of Pesticide Programs (OPP).
Acknowledgements
The OPPT and OPP Assessment Teams gratefully acknowledge the participation, input, and review
comments from OPPT, OPP, and OCSPP senior managers and science advisors and assistance from
EPA contractor SRC (Contract No. 68HERH19D0022) and ERG (Contract No. 68HERD20A0002).
OPPT and OPP also gratefully acknowledge systematic review work conducted by staff in OPPT's Data
Gathering and Analysis Division.
As part of an intra-agency review, the draft Formaldehyde Risk Evaluation was provided to multiple
EPA Program Offices for review.
Docket
Supporting information can be found in public docket, Docket ID (EPA.-H.Q-OPPT-2018-043 8).
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.
Authors: Shawn Shifflett (Assessment Lead), Rochelle Bohaty (Management Lead and Branch Chief),
Melody Bernot, Whitney Hollinshead, Giorvanni Merilis, Kevin Vuilleumier
Technical Support: Mark Gibson, Hillary Hollinger.
This draft assessment was reviewed by OPPT, OPP, and OCSPP leadership.
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key Points: Kin ironincnlnl Kisk Assessment lor l-'ormsilrielmle
This assessment considers formaldehyde Toxic Substances Control Act (TSCA) conditions of use
(COl's). physical and chemical properties. en\ironmental release data, as well as en\ironmental
modeling and monitoring data of formaldehyde and concludes there is
• No risk to aquatic oruanisms as formaldehyde does not persist in water and exposure is not
expected.
• No risk to terrestrial oruanisms through soil exposure as formaldehyde does not persist in or
on land and exposure is not expected:
• No risk to terrestrial mammals throuuh inhalation as air concentrations are at least an order of
magnitude lower than the most sensiti\e toxicity \alue.
• No risk to other terrestrial taxa. e\en though no inhalation toxicity data are a\ailahle for other
terrestrial species, as there is at least an order of magnitude difference in the toxicity and
exposure for mammals; and
• No risk to plants from formaldehyde exposures in ambient air because air concentrations are 7
times lower than the most sensi ti \ e toxicity \ al Lie
EXECUTIVE SUMMARY
Formaldehyde is manufactured for a wide variety of commercial and consumer products. It is also a
naturally occurring aldehyde produced during combustion, decomposition of organic matter, and as a
byproduct of metabolism in living organisms.
EPA reviewed reasonably available information as part of the scope and development of this draft
environmental risk assessment for formaldehyde. Specifically, EPA reviewed the environmental fate and
transport of formaldehyde ( 24b). environmental releases ( )24e) and
environmental exposures ( 2024c). as well as reasonably available environmental hazard data
( ) for aquatic and terrestrial organisms. These evaluations provide the foundation for
comparing estimated formaldehyde exposures to environmental hazard data for determining potential
risk. Details on each of these topics are provided in the respective modules included as attachments to
this draft risk assessment and are summarized below.
EPA assessed formaldehyde in various media (air, water, soil). In some cases, EPA further characterized
transformation of formaldehyde to other chemical species to explain how the chemical changes in the
environment. EPA does not seek to regulate these transformation products although comparative toxicity
data indicate formaldehyde toxicity is protective of transformation product toxicity in aquatic organisms.
Environmental fate and transport data indicate formaldehyde will not persist in water due to its highly
reactive nature (U.S. EPA. 2024b. e). Specifically, formaldehyde quickly hydrates in water to methylene
glycol and can further transform to other oligomers that are structurally and chemically dissimilar to
both formaldehyde and methylene glycol; that is, transformation products do not behave similarly in
water (Bover et al.. ). Although transformation products were not evaluated for environmental risk,
comparative toxicology data for formaldehyde and transformation products are provided in the
Environmental Hazard module of this risk assessment ( 2024d) and demonstrate that
formaldehyde toxicity is protective of transformation product toxicity to aquatic organisms.
Furthermore, reported releases of formaldehyde waste to water form a smaller component of the total
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reported releases to the environment compared to other media such as air and are therefore less common
(I I024e). Surface water monitoring data indicate formaldehyde is below detection limits in 99
percent of samples ( 24c). The single recorded measurement of formaldehyde in water was
measured at 0.2 mg/L, which is below the reported detection limit (0.25 mg/L); thus, it is uncertain as a
representative measured concentration ( 024c). Water monitoring data for formaldehyde may
be informative for general context but are not associated either temporally or spatially with known
industrial releases to water. Considering these lines of evidence, EPA does not expect formaldehyde will
persist in water and therefore concludes there is no risk to aquatic organisms via surface water due to
low exposure via the water pathway.
Environmental fate and transport data also indicate formaldehyde will not persist on land (
2024b). Specifically, formaldehyde will rapidly react with proton donors on soil particle surfaces and
transform to numerous other substances that cannot be effectively characterized. Similar to surface
water, formaldehyde will rapidly hydrate in groundwater and can further transform to oligomers of
various chain length which will continue to unpredictably react with other chemical substances. These
oligomers will generally have different toxicity profiles but are expected to be less toxic than
formaldehyde. The predominant environmental release of formaldehyde to land is disposal via
underground injection ( ). Considering these lines of evidence, EPA does not expect
formaldehyde will persist in or on land and therefore concludes there is no risk to terrestrial organisms
via the land pathway because of low exposures.
Environmental fate and transport data indicate formaldehyde does not bioaccumulate (
2024b). Considering the lines of evidence described above regarding the lack of persistence of
formaldehyde in water and on land, and because formaldehyde does not bioaccumulate, EPA concludes
there is no risk to terrestrial organisms via the dietary pathway.
Environmental fate and transport data indicate formaldehyde can persist in air—although formaldehyde
is subject to photolysis or chemical reactions in the presence of free-radicals or other components in the
ambient air (including moisture) ( 2024b). In direct sunlight, the formaldehyde half-life is
estimated to be between 1.4 and 4 hours. This persistence can be longer if direct sunlight is not present
or if releases are at night. A large portion of reported environmental releases in multiple databases were
also identified to the ambient air ( 2024e). EPA similarly identified ambient monitoring data
supporting the persistence of formaldehyde in ambient air, even though the source of monitored
formaldehyde may be due to several sources, including industrial releases from TSCA COUs, biogenic1
sources, or secondary formation from other chemical substances that cannot be determined (
2024c). Considering these lines of evidence, EPA expects formaldehyde will be present in ambient air
and could result in short, transient exposures to terrestrial organisms. However, attributing these
terrestrial exposures to a TSCA-specific COU is difficult due to multiple sources of formaldehyde in
ambient air (industrial, biogenic, secondary formation, etc.). EPA evaluated potential environmental
exposures of terrestrial organisms to formaldehyde from the ambient air. The Agency's analysis
considers the toxicity of formaldehyde exposure to both plants (via air exposure) and terrestrial
vertebrates (via inhalation) and compares those to modeled and measured ambient air concentrations.
The most sensitive reported toxicity values reported were approximately an order of magnitude higher
than the highest measured or modeled formaldehyde concentration in air indicating no risk to both plants
and terrestrial vertebrates relative to the most sensitive toxicity endpoints.
1 Produced by living organisms
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1 INTRODUCTION
1.1 Background
Formaldehyde is a gas that is distributed in solution as formalin or in a solid as paraformaldehyde. It is
produced industrially and may be used in a wide variety of commercial and consumer products,
including textiles, foam bedding/seating, semiconductors, resins, glues, composite wood products,
paints, coatings, plastics, rubber, construction materials (including insulation and roofing), furniture,
toys, and in various adhesives and sealants. Formaldehyde is also a naturally occurring aldehyde
produced during combustion, the decomposition of organic matter, and is produced in living things
through metabolism. Thus, formaldehyde is ubiquitous in indoor and ambient air environments.
Formaldehyde is a high priority chemical undergoing the TSCA risk evaluation process. There are many
COUs for formaldehyde ranging from use in agricultural products to rubber matting. Not all are relevant
for this draft risk assessment as it is a TSCA-specific document that serves to support risk management
needs by OPPT and is one of many documents comprising the Draft Formaldehyde Risk Evaluation (see
Figure 1-1) (Docket ID: EPA-HQ-QPPT-2018-0438).
1.2 Risk Evaluation Scope
The TSCA risk evaluation of formaldehyde comprises several human health and environmental
assessment modules and two risk assessment documents—the ecological risk assessment and the human
health risk assessment. A basic diagram showing the layout of these assessments and the relationships is
provided in Figure 1-1. This OPPT environmental risk assessment is shaded blue. In some cases,
modular assessments were completed jointly under TSCA (OPPT) and FIFRA (OPP). These modules
are shown in dark gray. This draft assessment relies on the jointly (OPP/OPPT) completed
Environmental Hazard Assessment ( !024d); the Chemistry, Fate, and Transport Assessment
(I ); and OPPT's Environmental Release Assessment and Environmental Exposure
Assessment (U.S. EPA. 2024e) modules.
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Systematic
Review
Conditions of
Use
Chemistry,
Fate, and
Transport
Assessment
Environmental
Release
Assessment
Environmental
Exposure
Assessment
Environmental
Hazard
Assessment
Human
Exposure
Assessments
Occupational
Consumer
Indoor Air
AmbientAir
Human Health
Hazard
Assessment
IRIS
Assessment
Legend
| | This Module
| | TSCAAssessment
| | TSCA/FIFRAShared Assessment
| IRISAssessment
Group of Assessments
Figure 1-1. Risk Evaluation Document Summary Map
EPA published the Final Scope for the Risk Evaluation for Formaldehyde 50-0-0 (U.S. EPA. 2020) in
August 2020. The published final scope document describes the hazards, exposures, COUs, and other
factors EPA expected to consider in its formaldehyde risk evaluation in accordance with the
requirements of TSCA section 6(b)(4)(D). Following publication of the final scope document, EPA
considered and reviewed reasonably available information2 in a fit-for-purpose approach to develop
this risk evaluation, leveraging existing EPA assessment work, collaborating across offices, relying on
best available science, and basing the analyses on the weight of scientific evidence as required by
EPA's Risk Evaluation Rule under TSCA (see 82 FR 33726, July 20, 2017). Reasonably available
information was reviewed, and the quality evaluated, in accordance with EPA's Draft Systematic
Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances (U.S. EPA. 2021).
which underwent review by EPA's Science Advisory Committee on Chemicals (SACC) in April 2022.
A full description of the systematic review protocol for formaldehyde, including chemical-specific
protocols, is available in the Systematic Review Supplemental File (U.S. EPA. 2023a).
These modules leveraged the data and information sources already identified in the Final Scope of the
Risk Evaluation for Formaldehyde (U.S. EPA. 2020). OPPT conducted a comprehensive search for
reasonably available information to identify relevant formaldehyde data for use in the risk evaluation. In
some modules, data were also located in collaboration with other EPA offices.
1.2.1 Life Cycle and Production
The Life Cycle Diagram (LCD)—which depicts the COUs of use that are within the scope of the risk
evaluation during various life cycle stages, including manufacturing, processing, use (industrial,
2 "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 these terms is reasonably available information whether or not the information is
confidential business information (CBI), that is protected from public disclosure under TSCA section 14 (40 CFR 702.33).
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commercial, consumer), distribution, and disposal—is shown below in Figure 1-2. The LCD has been
updated since it was included in the Final Scope for the Risk Evaluation for Formaldehyde 50-00-0
(I J020). Agricultural use products (non-pesticidal) have been included; it was inadvertently
omitted under the industrial, commercial, and consumer uses lifecycle stage in the diagram in the final
scope document.
The current domestic formaldehyde production volume is 453 million to 2.3 billion kg/year. This is
based on the Chemical Data Reporting (CDR) Rule under TSCA, which requires U.S. manufacturers
(including importers) to provide EPA with information on the chemicals they manufacture or import into
the United States every 4 years. For the 2020 CDR cycle, data collected for formaldehyde is further
detailed in the Use Report for Formaldehyde (CAS RN 50-00-0) ( ket: EP A-HQ-OPPT-2018-043 8).
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MFG/IMPORI
PROCESSING
INDUSTRIAL, COMMERCIAL, CONSUMER USES RELEASES and DISPOSAL
Manufacture
(Including
Import)
(453M-2.27B
kg/yr)
233
234
I
Processing as Reactant
Adhesives 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 1-2
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
aud gas drilling, extraction, and support activities)... See Table 1-2
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 1-2
Repackaging (Laboratory chemicals)
Recycling
Figure 1-2. Formaldehyde Lifecycle Diagram
Non-incorporative activities'
Furnishings, Cleaning, and
Treatment/Care Products1-2
Construction, Paint, Electrical,
and Metal Products1-2
Automotive and Fuel
Products1-2
Agricultural Use Products1,2
Outdoor Use Products'
Packaging, Paper, Plastic,
Hobbv Products'-2
Other Use1
See Conceptual Model for
Environmental Releases ami
Hastes
| | Manufacture
'—' (Including Import)
~ Processing
] Uses.
1. Industrial and/or
commercial.
2. Consumer
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235 1,2,2 Conditions of Use
236 As part of the TSCA risk evaluation, OPPT is assessing formaldehyde COUs that were included in the
237 final scope document—including industrial, commercial, and consumer applications such as textiles,
238 foam bedding/seating, semiconductors, resins, glues, composite wood products, paints, coatings,
239 plastics, rubber, resins, construction materials (including insulation and roofing), furniture, toys, and
240 various adhesives and sealants (see Table 1-1). The COUs were evaluated using the corresponding
241 environmental exposure scenarios for aquatic and terrestrial organisms. A comprehensive description of
242 COUs is available in the Draft Conditions of Use for the Formaldehyde Risk Evaluation document
243 (EPA. 2024aY
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244 Table 1-1. Categories and Subcategories of Use and Corresponding Exposure Scenario in the Draft Risk Evaluation for
245 Formaldehyde
Cone
ition(s) of Use
Life Cycle Stage
Category
Subcategory
Manufacturing
Domestic manufacturing
Domestic manufacturing
Importing
Importing
Processing
Reactant
Adhesives and sealant chemicals in: Plastic and resin manufacturing;
Wood product manufacturing; Paint and coating manufacturing; basic
organic chemical manufacturing
Processing
Reactant
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; chemical product and preparation manufacturing; Paper
manufacturing; Paint and coating manufacturing; Plastic products
manufacturing; Synthetic rubber manufacturing; Wood product
manufacturing; Construction; Agriculture, forestry, fishing, and hunting
Processing
Reactant
Functional fluid in: Oil and gas drilling, extraction, and support activities
Processing
Reactant
Processing aids, specific to petroleum production in all other basic
chemical manufacturing
Processing
Reactant
Bleaching agent in wood product manufacturing
Processing
Reactant
Agricultural chemicals in agriculture, forestry, fishing, and hunting
Processing
Incorporation into an article
Finishing agents in textiles, apparel, and leather manufacturing
Processing
Incorporation into an article
Paint additives and coating additives not described by other categories in
transportation equipment manufacturing (including aerospace)
Processing
Incorporation into an article
Additive in rubber product manufacturing
Processing
Incorporation into an article
Adhesives and sealant chemicals in wood product manufacturing; plastic
material and resin manufacturing (including structural and fireworthy
aerospace interiors); construction (including roofing materials); paper
manufacturing
Processing
Incorporation into a formulation,
mixture, or reaction product
Petrochemical manufacturing, petroleum, lubricating oil and grease
manufacturing; fuel and fuel additives; lubricant and lubricant additives;
basic organic chemical manufacturing; all other petroleum and coal
products manufacturing
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Cone
ition(s) of Use
Life Cycle Stage
Category
Subcategory
Processing
Incorporation into a formulation,
mixture, or reaction product
Asphalt, paving, roofing, and coating materials manufacturing
Incorporation into a formulation,
mixture, or reaction product
Solvents (which become part of a product formulation or mixture) in
paint and coating manufacturing
Incorporation into a formulation,
mixture, or reaction product
Processing aids, specific to petroleum production in: oil and gas drilling,
extraction, and support activities; chemical product and preparation
manufacturing; and basic inorganic chemical manufacturing
Incorporation into a formulation,
mixture, or reaction product
Paint additives and coating additives not described by other categories in:
Paint and coating manufacturing; Plastic material and resin
manufacturing
Incorporation into a formulation,
mixture, or reaction product
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
Incorporation into a formulation,
mixture, or reaction product
Solid separation agents in miscellaneous manufacturing
Incorporation into a formulation,
mixture, or reaction product
Agricultural chemicals (nonpesticidal) in: Agriculture, forestry, fishing,
and hunting; pesticide, fertilizer, and other agricultural chemical
manufacturing
Incorporation into a formulation,
mixture, or reaction product
Surface active agents in plastic material and resin manufacturing
Incorporation into a formulation,
mixture, or reaction product
Ion exchange agents in adhesive manufacturing and paint and coating
manufacturing
Incorporation into a formulation,
mixture, or reaction product
Lubricant and lubricant additive in adhesive manufacturing
Incorporation into a formulation,
mixture, or reaction product
Plating agents and surface treating agents in all other chemical product
and preparation manufacturing
Incorporation into a formulation,
mixture, or reaction product
Soap, cleaning compound, and toilet preparation manufacturing
Incorporation into a formulation,
mixture, or reaction product
Laboratory chemicals
Incorporation into a formulation,
mixture, or reaction product
Adhesive and sealant chemical in adhesive manufacturing
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Cone
ition(s) of Use
Life Cycle Stage
Category
Subcategory
Incorporation into a formulation,
mixture, or reaction product
Bleaching agents in textile, apparel, and leather manufacturing
Repackaging
Sales to distributors for laboratory chemicals
Recycling
Recycling
Distribution
Distribution
Distribution in Commerce
Industrial Use
Non-incorporative activities
Process aid in: Oil and gas drilling, extraction, and support activities;
process aid specific to petroleum production, hydraulic fracturing
Industrial Use
Non-incorporative activities
Used in: construction
Industrial Use
Non-incorporative activities
Oxidizing/reducing agent; processing aids, not otherwise listed
Industrial Use
Chemical substances in industrial
products
Paints and coatings; adhesives and sealants; lubricants
Commercial Uses
Chemical substances in furnishing
treatment/care products
Floor coverings; Foam seating and bedding products; Furniture &
furnishings including stone, plaster, cement, glass and ceramic articles;
metal articles; or rubber articles; Cleaning and furniture care products;
Leather conditioner; Leather tanning, dye, finishing impregnation and
care products; Textile (fabric) dyes; Textile finishing and impregnating/
surface treatment products.
Chemical substances in treatment
products
Water treatment products
Chemical substances in treatment/care
products
Laundry and dishwashing products
Chemical substances in construction,
paint, electrical, and metal products
Adhesives and Sealants; Paint and coatings
Chemical substances in furnishing
treatment/care products
Construction and building materials covering large surface areas,
including wood articles; Construction and building materials covering
large surface areas, including paper articles; metal articles; stone, plaster,
cement, glass and ceramic articles
Chemical substances in electrical
products
Machinery, mechanical appliances, electrical/electronic articles; Other
machinery, mechanical appliances, electronic/electronic articles
Chemical substances in metal products
Construction and building materials covering large surface areas,
including metal articles
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Cone
ition(s) of Use
Life Cycle Stage
Category
Subcategory
Commerical Uses
Chemical substances in automotive and
fuel products
Automotive care products; Lubricants and greases; Fuels and related
products
Chemical substances in agriculture use
products
Lawn and garden products
Chemical substances in outdoor use
products
Explosive materials
Chemical substances in packaging,
paper, plastic, hobby products
Paper products; Plastic and rubber products; Toys, playground, and
sporting equipment
Chemical substances in packaging,
paper, plastic, hobby products
Arts, crafts, and hobby materials
Chemical substances in packaging,
paper, plastic, hobby products
Ink, toner, and colorant products; Photographic supplies
Chemical substances in products not
described by other codes
Laboratory Chemicals
Consumer Uses
Chemical substances in furnishing
treatment/care products
Floor coverings; Foam seating and bedding products; Cleaning and
furniture care products; Furniture & furnishings including stone, plaster,
cement, glass and ceramic articles; metal articles; or rubber articles
Consumer Uses
Chemical substances in furnishing
treatment/care products
Fabric, textile, and leather products not covered elsewhere (clothing)
Consumer Uses
Chemical substances in treatment
products
Water treatment products
Consumer Uses
Chemical substances in treatment/care
products
Laundry and dishwashing products
Consumer Uses
Chemical substances in construction,
paint, electrical, and metal products
Adhesives and Sealants; Paint and coatings
Consumer Uses
Chemical substances in construction,
paint, electrical, and metal products
Construction and building materials covering large surface areas,
including wood articles; Construction and building materials covering
large surface areas, including paper articles; metal articles; stone, plaster,
cement, glass and ceramic articles
Consumer Uses
Chemical substances in electrical
products
Machinery, mechanical appliances, electrical/electronic articles; Other
machinery, mechanical appliances, electronic/electronic articles
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Cone
ition(s) of Use
Life Cycle Stage
Category
Subcategory
Consumer Uses
Chemical substances in automotive and
fuel products
Automotive care products; Lubricants and greases; Fuels and related
products
Consumer Uses
Chemical substances in agriculture use
products
Lawn and garden products
Consumer Uses
Chemical substances in packaging,
paper, plastic, hobby products
Paper products; Plastic and rubber products; Toys, playground, and
sporting equipment
Consumer Uses
Chemical substances in hobby products
Arts, crafts, and hobby materials
Consumer Uses
Chemical substances in packaging,
paper, and plastic
Ink, toner, and colorant products; Photographic supplies
Disposal
Disposal
Disposal
246
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1.3 Chemistry, Fate, and Transport Assessment
EPA considered all reasonably available information identified by the Agency through its systematic
review process under TSCA and submissions under FIFRA to characterize the physical and chemical
properties as well as the environmental fate and transport of formaldehyde. Physical and chemical
properties of formaldehyde, and some known environmental transformation products (methylene glycol,
paraformaldehyde) are provided in Table 1-2. Formaldehyde is expected to be a gas under most
environmental conditions. Due to the reactivity of formaldehyde, it is not expected to persist in most
environmental media but may be abundant due to continual release and formation from secondary
sources like combustion or degradation of other organic chemicals.
Table 1-2. Physical and Chemical Properties of Formaldehyde and Select Transformation
Products"
Chemical Properties
Formaldehyde
Methylene Glycol
Paraformaldehyde
Molecular formula
CH20
CH2(OH)2
HO(CH20)„H
(n = 8-100)
CASRN for Chemical
Identity
50-00-0
463-57-0
30525-89-4
Molecular weight
30.026 g/mol
48.02 g/mol
(30.03)n g/mol (varies)
Physical form
Colorless gas
Colorless liquid
White crystalline solid
Melting point
-92.0 to-118.3 °C
-43.8 °C
120 to 170 °C
Boiling point
-19.5 °C
131.6 °C
None identified
Density
0.815 g/cm3 at 20 °C
1.20 g/cm3
1.46 g/cm3 at 15 °C
Vapor pressure
3,890 mmHg at 25 °C
3.11 mmHg at 25°C
1.45 mmHg @25 °C
Vapor density
1.067 (air = 1)
None identified
1.03 (air = 1)
Water solubility
<55% 400 to 550 g/L
Miscible
Insoluble
Octanol/water partition
coefficient (log Kow)
0.35
-0.79
N/A
Henry's Law constant
3.37E-7 atm/m3mol
at 25 °C
1.65E-7 atm/m3mol
at 25 °C
N/A
a Physical and chemical properties for formaldehyde, methylene glycol, and paraformaldehyde are considered
best estimates. Because the chemical substance often exists in a mixture at varying concentrations, these
properties can vary based on the equilibration with other chemical substances present. Quality ratings for
formaldehyde and select transformation products can be found in the Chemistry, Fate, and Transport Module
fU.S. EPA. 2024b).
In water, formaldehyde quickly hydrates in seconds to form methylene glycol which can polymerize to
form oligomers of various chain lengths, and paraformaldehyde ( 024b) which are all
structurally different compounds when compared to formaldehyde (Figure 1-3). Formaldehyde is not
expected to be found in aquatic systems for this reason ( 24c).
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0 n HC\ OH llf,
JL H'°*H ~ X "°
II^M + --MM
fo}«
1 Jn=2-7
Formaldehyde watef methylene glycol mulliP!e methylene glycols
t
ho'Ko}h
1 ¦* n=8-l00
paraformaldehyde
Figure 1-3. Chemical Equilibria for Formaldehyde in Aqueous Solutions
Adapted from (Bover et al.. 2013).
In soil, formaldehyde is also expected to quickly transform to products that are structurally dissimilar to
the parent formaldehyde; thus, formaldehyde is not expected to be found in soil (U.S. EPA. 2024b). The
transformation products are generally expected to have negligible toxicity; however, not all
transformations can be accounted for due to the highly reactive nature of formaldehyde. Formaldehyde
can be formed in the early stages of plant residue decomposition in soil and is degraded by bacteria in
the soil. Formaldehyde is expected to undergo abiotic (hydration and nucleophilic addition) chemical
reactions in soils to form other compounds.
In air, formaldehyde is susceptible to direct and indirect photolysis; however, it may persist in air
environments with low or no sunlight (e.g., nighttime). As such, the primary exposure route for
formaldehyde is expected to be the air pathway (U.S. EPA. 2024c). More specifically, the half4ife of
formaldehyde in air depends on the intensity and duration of sunlight and ambient conditions such as
temperature and humidity. Under direct sunlight, formaldehyde will undergo photolysis with a half4ife
up to 4 hours yielding mainly hydroperoxyl radical (HO2), carbon monoxide (CO), and hydrogen (Fh).
In the absence of sunlight, formaldehyde can persist with a half4ife up to 114 days.
Bioconcentration and/or bioaccumulation is not expected for formaldehyde due to the physical and
chemical properties of the substance (U.S. EPA. 2024b). Furthermore, formaldehyde has a log Kow of
0.35 that similarly confers low potential for bioaccumulation (BAF <1) in both aquatic and terrestrial
organisms (U.S. EPA. 2024b). Given the log Kow and associated low BAF, in conjunction with the
reactivity of formaldehyde, it is not expected to accumulate in the environment. Therefore, no evaluation
of the potential trophic transfer of formaldehyde was conducted.
EPA has high confidence in the overall fate and transport profile of formaldehyde and
paraformaldehyde; however, the Agency is less confident in the overall fate and transport of the
transformation products methylene glycol and poly(oxy)methylene glycol. Key sources of uncertainty
for this assessment are related to formaldehyde equilibrium in various media and subsequent
transformation. In cases where there are little fate and transport data, EPA relied on physical and
chemical properties to describe the expected fate and transport of the respective chemical. As such,
while EPA has some uncertainty in the precision of a specific parameter value, it has confidence in the
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overall fate and transport profile of formaldehyde. Additional details can be found in the Draft
Chemistry, Fate, and Transport Assessment for Formaldehyde (U.S. EPA. 2024b) document.
1.4 Environmental Release Assessment
Formaldehyde is directly released to all three environmental media (air, land, and water) from TSCA
COUs (I. c. < ^ \ 20 J I'1). It is also released to the environment during regulated non-TSCA uses (e.g.,
as a pesticide), as a transformation product of different parent chemicals, and from combustion sources.
EPA reviewed release data from the Toxics Release Inventory (TRI; data from 2016 to 2021), Discharge
Monitoring Report (DMR; data from 2016 to 2021), and the 2017 National Emissions Inventory (NEI)
to identify releases to the environment that are relevant to the formaldehyde COUs, as provided in Table
1-1. From review of these databases, waste streams containing formaldehyde are being directly
discharged to surface water, indirectly discharged to publicly owned treatment works
(POTW)/wastewater treatment (WWT) plants, disposed of via different land disposal methods (e.g.,
landfills, underground injection), sent to incineration, and emitted via fugitive and stack releases.
Based on TRI and DMR reporting from 2016 to 2021, less than 150,000 kg each year of formaldehyde
are directly discharged to surface water for TSCA-related activities based on reporting from 168
facilities. Approximately 2 million kg each year are indirectly discharged to POTWs or other wastewater
WWT plants according to reporting from 168 facilities (U.S. EPA. 2024e). Based on a review of these
databases, waste streams containing formaldehyde are transferred to POTW or WWT plants, biological
wastewater treatment systems have shown a mean removal efficiency of 99.9 percent for formaldehyde
based on literature and 92 percent removal of methylene glycol through biodegredation based on
EPISuite™ estimates (U.S. EPA. 2024b). These disposal routes provide additional time for
formaldehyde and methylene glycol to further transform to chemically dissimilar products in the
presence of water prior to being discharged to surface water.
Based on TRI reporting from 2016 to 2021, most waste of formaldehyde is disposed of via land disposal
methods. The most significant method of land disposal of formaldehyde is via underground injection
with 22 sites disposing of more than 5 million kg of formaldehyde annually. The amount of waste
reported to be disposed of in RCRA Subtitle C landfills and other landfills varies across the reporting
years from 200 facilities reporting a total of 423,517 kg per year in 2016 to the most recent year
(RY2021) of 127,348 kg per year. Other land disposal methods (e.g., surface impoundments,
solidification/stabilization) are also reported at lower levels. Formaldehyde is not expected to persist in
water or soils, thus EPA determined that additional analyses of releases to water or land were not needed
and targeted its review of release information to fugitive and stack emissions of formaldehyde from
TSCA COUs.
EPA identified more than 150,000 point source emission data records (including unit-level estimates) for
formaldehyde across the two EPA databases (TRI data from 2016 to 2021 and 2017 NEI). To
characterize this amount of data, EPA utilized the self-reported North American Industry Classification
System (NAICS) codes to assign sites into CDR industrial sectors. These industrial sectors can be
directly correlated with the TSCA COUs, as further discussed in the Draft Environmental Release
Assessment for Formaldehyde (U. 2024e). Most TSCA COUs indicate one or more industrial
sectors, and in some cases an industrial sector can appear in more than one TSCA COU. Therefore, an
industrial sector may be associated with multiple formaldehyde TSCA COUs.
For this fit-for-purpose TSCA risk assessment, EPA targeted its review of environmental releases to
point sources, and did not review the road, nonroad, and other automotive exhaust information
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identified, as formaldehyde produced from combustion sources is not assessed as an independent COU
subcategory in this draft risk evaluation. EPA focused its environmental release assessment on total
facility emissions which can include emission from both uses of formaldehyde and combustion sources
at the same facility or, potentially, only combustion sources from that facility.
EPA categorizes the facilities and corresponding release information by industrial sectors that can be
directly correlated to the TSCA industrial COUs. For commercial COUs, EPA used professional
judgement to assign the industrial sector to commercial COUs, where applicable. For a few COUs
(Commercial use - chemical substances in treatment/care products - laundry and dishwashing products;
Commercial use - chemical substances in treatment products - water treatment products; Commercial
use - chemical substances in outdoor use products - explosive materials; and Commercial use -
chemical substances in products not described by other codes - other: laboratory chemicals), releases
were only qualitatively assessed due to limited use information. For the COU Distribution in commerce,
formaldehyde released accidently during transit has occurred based on available information, but it was
not quantified due to uncertainties in the frequency or volume that may occur in the future. Additional
details are provided in the Draft Environmental Releases for Formaldehyde ( ).
In the Draft Environmental Release Assessment for Formaldehyde ( )24e). EPA identified
approximately 800 TRI facilities between 2016 and 2021 and approximately 50,000 NEI facilities in
2017 with reported air releases of formaldehyde ( |24e). From these facilities, EPA
identified the maximum release reported through TRI was 10,161 kg/year-site (IS: Paper
Manufacturing) for a fugitive release reported in 2019 and 158,757 kg/year-site (IS: Wood Product
Manufacturing) for a stack release reported in 2017. The NEI program identified sites reporting as high
as 138,205 kg/year-site (IS: Wholesale and Retail Trade) for fugitive releases and 1,412,023 kg/year-site
(IS: Oil and Gas Drilling, Extraction and Support Activities) for stack releases reporting in 2017, in
which the higher releases are associated with sectors not required to report to TRI. The high release sites
in NEI were associated with natural gas compressor stations and airport operations, which EPA expects
is from combustion sources. EPA analyzed the release information by the industrial sector, providing the
minimum, median, 95th percentile, and maximum releases across the entire distribution of reported
releases within each industrial sector, as further discussed in the Draft Environmental Release
Assessment for Formaldehyde (U.S. EPA. 2024e)
In general, EPA has medium to high confidence in environmental releases for industrial COUs3 and low
to medium confidence in commercial COUs4. EPA has high data quality ratings for TRI and NEI, which
are supported by numerous facility-reported estimates. Some sites that emit formaldehyde may not be
included in these databases if the release amount does not meet the reporting threshold for the respective
program. EPA used total emissions per site that may combine formaldehyde emissions from multiple
COUs if the site's formaldehyde-generating processes are applicable to more than one COU. For
example, a facility may manufacture formaldehyde as well as process formaldehyde as a reactant. In
some cases, the formaldehyde generating process may also fall outside of scope of the risk evaluation.
1.5 Environmental Exposure Assessment
Although formaldehyde is directly released to water, land, and air, formaldehyde concentrations were
not modeled for the water and land pathways because formaldehyde and the corresponding
environmental transformation products are not expected to persist in soil and water based on physical-
3 COUs that are included under the life cycle stage of manufacturing, processing, and industrial use.
4 COUs that are included under the life cycle stage of commercial uses.
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chemical and fate and transport characteristics (see Section 1.3). Formaldehyde air concentrations are
estimated and summarized in Section 2.1.
Available environmental formaldehyde monitoring data {i.e., water and ambient air) were reviewed.
While the surface water monitoring data for formaldehyde are limited and have many uncertainties, the
data are consistent with the conclusion that formaldehyde is not likely to be present in surface water.
Formaldehyde concentrations were usually below detection limits. According to the Water Quality
Portal (WQP), of 866 formaldehyde monitoring sampling events between 1969 and 2022 (
2022b). only 11 percent of samples reported formaldehyde concentrations. However, most
formaldehyde concentrations were reported from sampling events before 1975 and the quality of the
data could not be verified (U.S. EPA. 2024c). For sampling after 1975, 11 formaldehyde concentrations
were detected but were also low quality due to percent recoveries in lab results. Approximately 90
percent of samples had no characterization of the sampling media {e.g., surface vs. groundwater,
analytical methodology {e.g., [GC/MS]). Also, for approximately 85 percent of samples, there was no
description of the specific forms of formaldehyde measured {e.g., degradants) in water. In addition,
replicate sampling was conducted for only 21 samples. Despite formaldehyde's rapid transformation in
water, repeat sampling was not conducted over time. The low quality of all detected samples diminished
EPA's confidence that the data reasonably represented formaldehyde concentrations in surface water.
Agency staff contacted state representatives responsible for those data sets but did not receive a
response. Furthermore, monitoring events could not be connected either temporally or spatially with
known formaldehyde releases to water resulting from TSCA COUs. Considering these lines of evidence,
environmental exposures to formaldehyde are not expected via the water pathway.
Extensive ambient air monitoring data are available for formaldehyde. These data show that
formaldehyde is prevalent in ambient air and confirms that air is a major formaldehyde exposure
pathway. Although these data represent real formaldehyde concentrations in ambient air, the source is
unknown and likely a combination of TSCA and non-TSCA sources {e.g., biogenic, secondary
formation of formaldehyde in the environment, etc.). EPA summarizes available formaldehyde ambient
air monitoring data in Section 2.1 of this draft assessment. Considering these lines of evidence, EPA
expects formaldehyde will be present in air and could result in exposures to terrestrial organisms.
1.6 Transformation Products in Environmental Media
Based on the conclusion of the environmental chemistry, fate, and exposure assessments (U.S. EPA.
2024b. c, e), formaldehyde does not persist in water. It rapidly transforms to methylene glycol and
oligomers of various chain length which are similarly reactive and have limited persistence. Data are not
reasonably available for assessment of these transformation products and characterizing their
downstream effects would result in a highly uncertain risk assessment. Therefore, these transformation
products were not further assessed for risk to aquatic or terrestrial organisms, and EPA does not consider
formaldehyde or these transformation products a concern in aquatic environments. Likewise, these are
out of scope for the Formaldehyde Risk Evaluation. Although transformation products were not
evaluated for environmental risk, comparative toxicology data for formaldehyde and transformation
products are provided in the Environmental Hazard Module of this risk assessment ( 2024d)
and demonstrate that formaldehyde toxicity is protective of transformation product toxicity to aquatic
organisms.
Similarly, rapid transformation of formaldehyde is expected in soil. Data are also not reasonably
available for these transformation products and EPA does not consider formaldehyde or these
transformation products a concern in soil.
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This environmental risk assessment focuses on exposure to formaldehyde (only) in air based on
reasonably available data.
1.7 Problem Formulation for Environmental Pathways
Following publication of the final scope document in 2020, EPA considered and reviewed reasonably
available information in a fit-for-purpose approach to determine which pathways were relevant for
assessments. EPA leveraged existing assessment work, collaborating across offices, relying on best
available science, and based on the weight of scientific evidence as required by EPA's Risk Evaluation
Rule under TSCA for these risk assessments.
Based on the Draft Chemistry, Fate, and Transport Assessment for Formaldehyde ( '024b).
formaldehyde COUs are not expected to result in formaldehyde exposure to aquatic or soil organisms.
Therefore, EPA did not pursue assessments of these exposure pathways. In contrast, the Chemistry,
Fate, and Transport Assessment Module, as well as ambient monitoring data, indicate that formaldehyde
will be present in ambient air and may result in exposure to terrestrial organisms (inhalation, ambient air
exposure) based on the continuous release of formaldehyde from various formaldehyde COUs. As such,
in this draft environmental risk assessment, EPA focuses on releases to the ambient air and potential
exposures resulting from such releases under TSCA COUs to plants and terrestrial organisms. EPA
conducted an analysis to evaluate potential environmental exposures of terrestrial organisms to
formaldehyde from the ambient air. EPA's analysis compares the toxicity of formaldehyde to plants (via
air exposure) and terrestrial vertebrates (via inhalation) to modeled and measured ambient air
concentrations.
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2 RISK ASSESSMENT APPROACH
EPA used information from all reasonably available sources to characterize exposure, hazard, and risk
posed from formaldehyde in air to terrestrial organisms. Modeled or measured environmental
concentrations for ambient air reported in the Draft Environmental Exposure Assessment for
Formaldehyde ( ) were compared to hazard values for terrestrial organisms reported in
the Environmental Hazard Assessment (I v < < \ 2024d).
2.1 Ambient Air
The highest measured concentration of formaldehyde in ambient air was 60.1 |j,g/m3. The highest
modeled concentration of formaldehyde in ambient air for a TSCA COU was 50.5 |j,g/m3 (
2024c). EPA sought to contextualize these data by modeling all potential sources of formaldehye,
including biogenic sources, using AirToxScreen. The sources of these data are summarized below but
are described in full in the Ambient Air Exposure Module ( ).
EPA used the Ambient Monitoring Technology Information Center (AMTIC) ( 022a) to
determine measured concentrations of formaldehyde in ambient air. It encompasses anthropogenic
sources, biogenic sources, secondary formation, mobile sources, combustion sources, and other sources;
however, the dataset does not differentiate among the various sources. Samples are submitted to the
AMTIC database on a state-by-state basis. Data is provided at the discretion of the submitting program
pending approval by AMTIC. Data submitted must meet be collected and quantified using one of the
AMTIC pre-approved methodologies (EPA. 2021). Approved sample collection methods included the
automated Fluxsense system, pressure vessel collection, or silica cartridge collection followed by
quantification by UV absorption, HPLC (high-performance liquid chromatography) photo-diode array,
or FTIR (Fourier-transform infrared spectroscopy). Collection durations for Fluxsense systems were set
at 5 minutes while pressure vessel and silica cartridge collection durations ranged from 3 hours to 24
hours. All sampling methods were composite samples and concentrations were averaged over the sample
collection duration. Monitoring locations and annual summary statistics are provided in the Ambient Air
Exposure Module ( 2024a).
EPA extracted all monitored ambient air concentrations of formaldehyde from the AMTIC ambient air
monitoring dataset across 6 years of data (2015 to 2020, n = 233,961 samples, 214 locations). These
years were selected to best inform the assessment according to data extracted from TRI for the release
assessment. From this dataset, the highest measured formaldehyde air concentration was 60.1 [j,g/m3
( 1022a). These data are shown in Figure 2-1. These monitoring data are based on multiple
monitoring sites (n = 195) from 2015 to 2020. It is worth noting that these data represent different
sampling techniques and durations (ranging from 5 minutes to 24 hours sampling periods), but all values
shown are above the detection limit. Method detection limits were provided with the concentration data
by the submitting agency on a sample-by-sample basis and vary significantly between sampling and
quantification methodologies (lxl0~5 |ig/m3 to 55,900 |ig/m3; median = 4.9 |ig/m3).
EPA used the peer-reviewed Integrated Indoor-Outdoor Air Calculator (IIOAC) to model formaldehyde
concentrations in ambient air. The concentrations for all TSCA COUs ranged from 1.1 x ] o 4 |ig/m3 to
5.7 |ig/m3 when modeled for distances between 100 and 1,000 m of release facilities and represent
annual-averaged modeled concentrations. This range was selected to understand localized impacts from
site-ambiguous releasers since formaldehyde will likely undergo complete degradation via photolysis
within hours. However, the continuous release of formaldehyde from industrial sources either via
fugitive or stack emissions mean that these communities could be continuously exposed to the estimated
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concentration. These values are illustrated in Figure 2-1. The highest modeled formaldehyde ambient air
concentration was 50.5 |ag/m3 when estimated at 100 m from the release source (not shown).
EPA used AirToxScreen to understand the relative contributions of non-TSCA sources to put risks from
TSCA sources in context. AirToxScreen uses the chemical transport model (CMAQ) and the dispersion
model (AERMOD) to estimate ambient air concentrations across the United States. EPA used data from
the 2019 AirToxScreen to understand the relative relationship of formaldehyde concentrations in
ambient air resulting from various sources. The tool uses data from the NEI, which is a comprehensive
and detailed estimate of air emissions of criteria pollutants, criteria precursors, and hazardous air
pollutants from air emissions sources. These data allow EPA to differentiate among modeled emissions
from various source categories such as point, nonpoint and mobile sources, biogenic emissions, and
fires. In this draft assessment, EPA used data from AirToxScreen to estimate a 95th percentile
concentration of formaldehyde from all modeled biogenic sources. This estimate captures concentrations
that are reasonably expected to occur without human contributions. The Agency used this estimate for
comparison to concentrations from other formaldehyde sources including those that are expected from
formaldehyde TSCA COUs. Figure 2-1 shows where TSCA COUs fall in the distribution of all sources
of formaldehyde according to AirToxScreen.
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2.3 Summary of Environmental Risk Assessment
The Agency did not assess risk to aquatic and soil organisms in this risk assessment because exposure is
not expected; thus, risk is not expected. The highest measured concentration of formaldehyde in ambient
air was 60.1 |j,g/m3 and the highest modeled concentration of formaldehyde in ambient air from a TSCA
COU was 50.5 |.ig/ms (U.S. EPA. 2024c). Terrestrial organism hazard values are approximately an order
of magnitude above the highest measured and modeled concentration of formaldehyde in ambient air
(Table 2-2). Thus, no risk to terrestrial organisms is expected relative to the toxicity endpoints.
Table 2-2. Comparison of Formaldehyde Air Concentrations and Terrestrial Organism Toxicity
Receptor
Most Sensitive Toxicity Endpoint
(Hg/m3)
Highest Measured Concentration in
Ambient Air
(|ig/m3)
Terrestrial vertebrates
(inhalation)
3,680 LOAEC; 1,230 NOAEC
60.1
Terrestrial plants
438 NOAEC
60.1
LOAEC = lowest-observed-adverse-effect-concentration; NOAEC = no-observed-adverse-effect-concentration
Hazard data suggest terrestrial plants are the most sensitive terrestrial receptor group to formaldehyde air
exposure using apical endpoints. Toxicity endpoints for plants ranged from 438 to 34,188 |ag/m3; thus,
the most sensitive endpoint identified is likely protective across taxa. Furthermore, the most sensitive
toxicity endpoint identified for mammal inhalation of formaldehyde was only toxic to rats but not toxic
to hamsters or monkeys suggesting the most sensitive value is more broadly protective across taxa. The
highest concentration of formaldehyde in ambient air (60.1 |ag/m3) is greater than 60 times lower than
the lowest concentration that elicited effects on mammal growth (3,680 |ag/m3) with inhalation exposure
and greater than 20 times lower than the lowest concentration that did not yield any toxic effect (1,230
Hg/m3). Similarly, the highest concentration is greater than 7 times higher than the lowest concentration
that elicited any effect on plant growth (438 |j,g/m3).
Although terrestrial organisms may be exposed to formaldehyde in air, EPA did not identify risk to any
environmental taxa due to formaldehyde under its conditions of use. The Agency has high confidence in
this assessment conclusion.
2,3.1 Terrestrial Vertebrate Risk Assessment
The most sensitive toxicity endpoint for terrestrial vertebrate exposure to formaldehyde via inhalation is
at least an order of magnitude higher than the highest measured ambient air concentrations and TSCA
COU-modeled formaldehyde concentrations in air; thus, risk to terrestrial vertebrates via formaldehyde
inhalation is not expected relative to toxicity endpoints (Table 2-2).
There is uncertainty in potential inhalation exposure durations that are relevant for terrestrial organisms
based on formaldehyde use patterns. It is anticipated that most exposures would be short and transient in
nature, in the order of minutes to hours, or be intermittent due to the reactive nature of formaldehyde.
While formaldehyde exposure duration is longer in the toxicity study than the shorter-duration
intermittent exposures expected in terrestrial environments from TSCA uses, the longer duration
exposure toxicity endpoints are expected to be protective of those shorter duration exposures because
longer term durations are expected to be more toxic.
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An additional factor which can impact EPA's ability to attribute exposure for a specific terrestrial
organism to a specific TSCA COU is the transient nature of most terrestrial organisms and the absence
of specific activity pattern data of such organisms in or around a particular industrial process which
could be attributed to a TSCA COU.
2,3,2 Plant Risk Assessment
Modeled and measured concentration data are approximately 7 times below concentrations that would
result in adverse effects based on available plant toxicity data. As for terrestrial inhalation exposures,
there is uncertainty in the air exposures for plants. The most sensitive reported endpoint for plant air
exposure was associated with a 4-week study in the common bean. Given the expected intermittent and
short duration exposures expected in the environmental due to TSCA COUs, the study duration is longer
than the expected exposure and is assumed to be protective of shorter-term exposures.
2.3,3 Overall Confidence and Remaining Uncertainties in Environmental Risk
Assessment
OPPT uses several considerations when weighing the scientific evidence to determine confidence in the
draft environmental risk assessment. These considerations include the quality of the database,
consistency, strength, and precision, biological gradient/dose response, and relevance. This approach is
consistent with the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical
Substances flJ.S. EPA. 2021/ EPA has high confidence in this environmental risk assessment.
The Agency has high confidence in the conclusion that there is no risk to aquatic organisms relative to
toxicity endpoints. Multiple lines of supporting evidence support this conclusion. Environmental fate
and transport data indicate formaldehyde rapidly transforms to other forms (chemically dissimilar to
formaldehyde) in water and is expected to have negligible persistence in water (as either formaldehyde
or its hydrated form methylene glycol). In addition, there are limited releases of formaldehyde directly
to surface water. Furthermore, available monitoring data demonstrate formaldehyde has not been
detected in water. These qualities support a high confidence conclusion.
EPA has high confidence in the conclusion that there is no risk to terrestrial organisms relative to
toxicity endpoints via the land pathway. Multiple lines of evidence support this conclusion.
Environmental fate and transport data indicate formaldehyde does not absorb or bind to soil or sediment
and has negligible persistence on land (due to volatility and reactivity of formaldehyde) (U.S. EPA.
2024b). Furthermore, formaldehyde is reactive and will volatilize from soils. The predominant
environmental release of formaldehyde to land is disposal via underground injection ( >24e).
These qualities support a high confidence conclusion.
EPA also has high confidence that there is no risk to terrestrial organisms via the dietary pathway.
Environmental fate and transport data indicate formaldehyde does not bioaccumulate (
2024b). As formaldehyde is also not expected to persist in the water and land pathways, the potential for
dietary exposure is limited. These qualities support a high confidence conclusion.
EPA also has high confidence in the conclusion that there is no risk to terrestrial organism via the air
pathway as ambient air concentrations are approximately an order of magnitude lower than toxicity
values. Both modeled and measured ambient air concentrations support this conclusion and multiple
taxa had representative hazard values for evaluation. There is uncertainty in the exposure estimates as
formaldehyde exposure is expected to be transient due to its reactive nature. Toxicity endpoints
associated with longer exposure durations are expected to be protective of shorter exposures.
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649 Additional details on overall confidence and remaining uncertainties are described in the following
650 modules: Environmental Fate and Transport ( (24b), Environmental Hazard (
651 2024d). Environmental Exposure (U.S. EPA. 2024c). and Environmental Release (I * < P \ 2024e)
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REFERENCES
Rm ci U.Ueldtetli R, Rciv/cbi W l\ Rcisio 1 >\ , Uill R KLusseri t 1 >, 1 ichici ,K i,
Shank. RC: Slaea. TJ; Snyder. PW; Anderse: (2013). Amended safety assessment of
formaldehyde and methylene glycol as used in cosmetics. Int J Toxicol 32: 5S-32S.
http://dx.doi.orE
EPA, US. (2021). Best practices for review and validation of ambient air monitoring data. (EPA-454/B-
21-007). Washington, DC: U.S. Environmental Protection Agency.
(2024a). Draft Conditions of Use for the Formaldehyde Risk Evaluation. Washington, DC:
U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.
(2024b). Draft Consumer Exposure Assessment for Formaldehyde. Washington, DC: U.S.
Environmental Protection Agency, Office of Pollution Prevention and Toxics.
(2024c). Draft Environmental Risk Assessment Characterization of Formaldehyde.
Washington, DC: U.S. Environmental Protection Agency, Office of Pollution Prevention and
Toxics.
(2024d). Draft Human Health Hazard Assessment for Fromaldehyde. Washington, DC: U.S.
Environmental Protection Agency, Office of Pollution Prevention and Toxics.
(2024e). Draft Human Health Risk Assessment Characterization of Formaldehyde.
Washington, DC: U.S. Environmental Protection Agency, Office of Pollution Prevention and
Toxics.
(2024f). Draft Indoor Air Exposure Assessment for Formaldehyde. Washington, DC: U.S.
Environmental Protection Agency, Office of Pollution Prevention and Toxics.
(2024g). Draft Occupational Exposure Assessment for Formaldehyde. Washington, DC: U.S.
Environmental Protection Agency, Office of Pollution Prevention and Toxics.
Mutters. RG: Madore. I lerowicz. A. (1993). Formaldehyde exposure affects growth and
metabolism of common bean. J Air Waste Manag Assoc 43: 113-116.
http://dx.doi.ore 10 1080/1 I t\t ; it.
U.S. EPA. (2020). Final scope of the risk evaluation for formaldehyde; CASRN 50-00-0. Washington,
DC: Office of Chemical Safety and Pollution Prevention.
(2021). Draft systematic review protocol supporting TSCA risk evaluations for chemical
substances, Version 1.0: A generic TSCA systematic review protocol with chemical-specific
methodologies. (EPA Document #EPA-D-20-031). Washington, DC: Office of Chemical Safety
and Pollution Prevention. https://www.reeiilations.eov/dociiment/EPA-HQ-OPPT-2'
0005
U.S. EPA. (2022b). Formaldehyde (FDH) (CAS RN: 50-00-0): WQP Output (NWIS, STEWARDS &
STORET), Site data & sample results (physical/chemical metadata).
(2023a). Draft Risk Evaluation for Formaldehyde - Systematic Review Protocol. Washington,
DC: Office of Chemical Safety and Pollution Prevention.
(2023b). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File:
Data Extraction Information for Environmental Hazard and Human Health Hazard Animal
Toxicology and Epidemiology. Washington, DC: Office of Chemical Safety and Pollution
Prevention.
U.S. EPA. (2023c). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File:
Data Extraction Information for General Population, Consumer, and Environmental Exposure.
Washington, DC: Office of Chemical Safety and Pollution Prevention.
U.S. EPA. (2023d). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File:
Data Quality Evaluation and Data Extraction Information for Environmental Fate and Transport.
Washington, DC: Office of Chemical Safety and Pollution Prevention.
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U.S. EPA. (2023e). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File:
Data Quality Evaluation and Extraction Information for Environmental Release and
Occupational Exposure. Washington, DC: Office of Chemical Safety and Pollution Prevention.
U.S. EPA. (2023f). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File:
Data Quality Evaluation for General Population, Consumer, and Environmental Exposure.
Washington, DC: Office of Chemical Safety and Pollution Prevention.
U.S. EPA. (2023g). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File:
Data Quality Evaluation Information for Environmental Hazard. Washington, DC: Office of
Chemical Safety and Pollution Prevention.
U.S. EPA. (2023h). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File:
Data Quality Evaluation Information for Human Health Hazard Animal Toxicology.
Washington, DC: Office of Chemical Safety and Pollution Prevention.
U.S. EPA. (2023i). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File:
Data Quality Evaluation Information for Human Health Hazard Epidemiology. Washington, DC:
Office of Chemical Safety and Pollution Prevention.
U.S. EPA. (2023j). Draft Risk Evaluation for Formaldehyde - Systematic Review Supplmental Fuile:
Data Quality Evaluation and Data Extraction Information for Physical and Chemical Properties.
Washington, DC: Office of Chemical Safety and Pollution Prevention.
U.S. EPA. (2024a). Draft Ambient Air Exposure Assessment for the Formaldehyde Risk Evaluation.
Washington, DC: Office of Chemical Safety and Pollution Prevention.
(2024b). Draft Chemistry, Fate and Transport Assessment for Formaldehyde. Washington,
DC: Office of Chemical Safety and Pollution Prevention.
(2024c). Draft Environmental Exposure Assessment for Formaldehyde. Washington, DC:
Office of Chemical Safety and Pollution Prevention.
(2024d). Draft Environmental Hazard Assessment of Formaldehyde. Washington, DC: Office
of Chemical Safety and Pollution Prevention.
(2024e). Draft Environmental Release Assessment for Formaldehyde. Washington, DC:
Office of Chemical Safety and Pollution Prevention.
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APPENDICES
Appendix A ABBREVIATIONS AND ACRONYMS
AMTIC Ambient Monitoring Technology Information Center
CASRN Chemical Abstracts Service Registry Number
CBI Confidential business information
CDR Chemical Data Reporting (Rule)
CFR Code of Federal Regulations
COU Condition of use (TSCA)
DMR Discharge Monitoring Report
EPA Environmental Protection Agency
HOC Integrated Indoor-Outdoor Air Calculator (model)
IRIS Integrated Risk Information System
Koc Soil organic carbon: water partitioning coefficient
Kow Octanol: water partition coefficient
LCD Lifecycle diagram
LOAEC Lowest-observable-adverse-effect-concentration
LOQ Limit of quantification
Log Koc Logarithmic organic carbon: water partition coefficient
Log Kow Logarithmic octanol: water partition coefficient
MRID Master Record Identification (number)
NAICS North American Industry Classification System
NEI National Emissions Inventory
NOAEC No-observed-adverse-effect-concentration
OCSPP Office of Chemical Safety and Pollution Prevention
OPP Offi ce of Pe sti ci de Program s
OPPT Office of Pollution Prevention and Toxics
POTW Publicly owned treatment works
STORET STOrage and RETrieval and Water Quality exchange
SVOC Semi-volatile compound
TRI Toxics Release Inventory
TSCA Toxic Substances Control Act
U.S. United States
UV Ultraviolet (light)
VP Vapor pressure
WQP Water Quality Portal
WWT Wastewater treatment (plant)
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Appendix B LIST OF DOCUMENTS AND SUPPLEMENTAL FILES
List of Documents and Corresponding Supplemental Files
1. Draft Executive Summary for the Formaldehyde Risk Evaluation
2. Draft Conditions of Use for the Formaldehyde Risk Evaluation, (EPA. 2024a)
3. Draft Risk Evaluation for Formaldehyde - Systematic Review Protocol ( 2023a)
3.1. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data Quality
Evaluation and Data Extraction Information for Physical and Chemical Properties (
2023i)
3.2. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data Quality
Evaluation and Data Extraction Information for Environmental Fate and Transport (U.S.
EPA. 2023d)
3.3. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data Quality
Evaluation and Data Extraction Information for Environmental Release and Occupational
Exposure ( 23e)
3.4. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data Quality
Evaluation Information for General Population, Consumer, and Environmental Exposure.
( >23 f)
3.5. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data
Extraction Information for General Population, Consumer, and Environmental Exposure (U.S.
EPA. 2023c)
3.6. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data Quality
Evaluation Information for Human Health Hazard Epidemiology ( 023i)
3.7. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data Quality
Evaluation Information for Human Health Hazard Animal Toxicology ( 2023h)
3.8. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data Quality
Evaluation Information for Environmental Hazard ( 023 e)
3.9. Draft Risk Evaluation for Formaldehyde - Systematic Review Supplemental File: Data
Extraction Information for Environmental Hazard and Human Health Hazard Animal
Toxicology and Epidemiology ( 2023b)
4. Draft Environmental Risk Assessment for Formaldehyde, (EPA. 2024c)
5. Draft Chemistry, Fate, and Transport Assessment for Formaldehyde, (U.S. EPA. 2024b)
6. Draft Environmental Release Assessment for Formaldehyde, ( 2024e)
6.1. Supplemental Air Release Summary and Statistics for NEI and TRIfor Formaldehyde.xlsx
6.2. Supplemental Land Release Summary for TRIfor Formaldehyde.xlsx
6.3. Supplemental Water Release Summary for DMR and TRIfor Formaldehyde.xlsx
7. Draft of Environmental Exposure Assessment for Formaldehyde, ( )
7.1. Supplemental Water Quality Portal Results for Formaldehyde.xlsx
8. Draft Environmental Hazard Assessment for Formaldehyde, (I c< \V \ 2024d)
9. Draft Human Health Risk Assessment for Formaldehyde ( >24e)
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10. Draft Occupational Exposure Assessment for Formaldehyde, ( )24g)
10.1. Draft Formaldehyde Occupational Exposure Modeling Parameter Summary.xlsx
10.2. Formaldehyde Draft RE - Occupational Exposure Modeling Parameter Summary - public
release - March 2024
10.3. Formaldehyde Draft RE - Occupational Monitoring Data Summary - public release - March
2024
1 1. Draft Consumer Exposure Assessment for Formaldehyde, (EPA. 2024b)
11.1. Formaldehyde Draft RE - Consumer Modeling, Supplement A - public release - March
2024.xlsx
11.2. Formaldehyde Draft RE - Consumer - Indoor Air Acute and Chronic Inhalation Risk
Calculator, Supplement B - public release - March 2024.xlsx
11.3. Formaldehyde Draft RE - Consumer Acute Dermal Risk Calculator, Supplement B - public
release - March 2024.xlsx
12. Draft Indoor Air Exposure Assessment for Formaldehyde, (EPA. 2024f)
12.1. Formaldehyde Draft RE - Consumer Modeling, Supplement A - public release - March
2024.xlsx
12.2. Formaldehyde Draft RE - Consumer - Indoor Air Acute and Chronic Inhalation Risk
Calculator, Supplement B - public release - March 2024.xlsx
13. Draft Ambient Air Exposure Assessment for Formaldehyde, ( 024a)
13.1. Formaldehyde Draft RE - IIOAC Assessment Results and Risk Calcs Supplement A for Ambient
Air - public release - March 2024.xlsx
13.2. Formaldehyde Draft RE- IIOAC Assessment Results and Risk Calcs Supplement B- public
release - March 2024
14. Draft Human Health Hazard Assessment for Formaldehyde, ( 24d).
15. Unreasonable Risk Determination of the Draft Risk Determination for Formaldehyde
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