EPA Document# EPA-740-R24-017
December 2024
United States Office of Chemical Safety and
v/crM Environmental Protection Agency Pollution Prevention
Unreasonable Risk Determination of the Risk Evaluation for
Formaldehyde
CASRN 50-00-0
December 2024
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TABLE OF CONTENTS
1 RISk"e VALUATION SCOPE 3
2 UNREASONABLE RISK DETERMINATION 4
2.1 Human Health 8
2.1.1 Populations and Exposures EPA Assessed for Human Health 9
2.1.2 Summary of Unreasonable Risks to Human Health 9
2.1.3 Basis for Unreasonable Risk to Human Health 10
2.1.4 Workers 10
2.1.5 Consumers 11
2.1.6 General Population 13
2.2 Environment 16
2.2.1 Populations and Exposures EPA Assessed for the Environment 17
2.2.2 Summary of Environmental Effects 17
2.2.3 Basis for Unreasonable Risk of Injury to the Environment 18
2.3 Additional Information Regarding the Basis for the Unreasonable Risk 18
LIST OF TABLES
Table 2-1. Supporting Basis for the Unreasonable Risk Determination for Human Health (Occupational
Conditions of Use) 19
Table 2-2. Supporting Basis for the Unreasonable Risk Determination for Human Health (Consumer
Conditions of Use) 27
LIST OF FIGURES
Figure 1-1. Risk Evaluation Document Summary Map 3
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1 RISK EVALUATION SCOPE
The TSCA risk evaluation of formaldehyde comprises a series of assessments spread across several
documents. A basic diagram showing the layout and relationships of these assessments is provided
below in Figure 1-1. In some cases, these assessments were completed jointly under TSCA and the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). These assessments are shown in dark
gray. Additionally, EPA specifically recommends reviewing the Conditions of Use of Formaldehyde
technical support document in order to provide additional clarity and context for those conditions of use
(COUs) which significantly contribute to the unreasonable risk of formaldehyde.
Systematic
Review
Conditions
of Use
Environmental
Release
Assessment
Chemistry,
Fate, and
Transport
Assessment
Environmental
Exposure
Assessment
Environmental
Hazard
Assessment
Human
Exposure
Assessments
Consumer
Indoor Air
Ambient Air
Environmental
Risk Assessment
Occupational
Human Health
Hazard
Assessment
IRIS
Assessment
Human Health
Risk Assessment
Legend
TSCAAssessment
ITI TSCA/FIFRA Shared Assessment
[ | IRIS Assessment
f": Group of Assessments
Figure 1-1. Risk Evaluation Document Summary Map
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2 UNREASONABLE RISK DETERMINATION
TSCA section 6(b)(4) requires EPA to conduct a risk evaluation to determine whether a chemical
substance presents an unreasonable risk of injury to health or the environment, without consideration of
costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible
subpopulation (PESS) identified by EPA as relevant to this risk evaluation, under the conditions of use
(COUs; also called TSCA COUs).
EPA has determined that formaldehyde presents an unreasonable risk of injury to human health under
the COUs because of acute inhalation and dermal exposures. The Agency also identified cancer and
other chronic risk due to long-term inhalation of formaldehyde. EPA did not identify risk of injury to the
environment that would contribute to the unreasonable risk determination for formaldehyde. This
unreasonable risk determination is based on the information in the Human Health Risk Assessment for
Formaldehyde, the Environmental Risk Assessment for Formaldehyde, appendices contained within
those documents, and TSDs (also called modules) that comprise this completed risk evaluation in
accordance with TSCA section 6(b). It is also based on TSCA's best available science (TSCA section
26(h)) and weight of scientific evidence standards (TSCA section 26(i)), and relevant implementing
regulations in 40 CFR part 702 including the amendments to the procedures for chemical risk evaluation
(89 FR 37028; May 3, 2024).
EPA will initiate risk management for formaldehyde by applying one or more of the requirements under
TSCA section 6(a) to the extent necessary so that formaldehyde no longer presents an unreasonable risk.
The risk management requirements will likely focus on those COUs that significantly contribute to the
unreasonable risk. However, under TSCA section 6(a), EPA is not limited to regulating the specific
COUs found to significantly contribute to unreasonable risk and may select from among a suite of risk
management options related to manufacture, processing, distribution in commerce, commercial use, and
disposal to address the unreasonable risk. For instance, the Agency may regulate upstream COUs (e.g.,
Processing, Distribution in commerce) to address downstream COUs that significantly contribute to
unreasonable risk (e.g., consumer use)—even if the upstream COUs are not significant contributors to
the unreasonable risk. The Agency would also consider whether such risk may be prevented or reduced
to a sufficient extent by action taken under another Federal law, such that referral to another agency
under TSCA section 9(a) or use of another EPA-administered authority to protect against such risk
pursuant to TSCA section 9(b) may be appropriate.
TSCA COUs represent a subset of exposures to formaldehyde. Formaldehyde is found nearly
everywhere. Living things—plants, animals, and people—produce and release formaldehyde just
through natural life (biogenic) processes. It is also formed when other chemicals breakdown in the
environment, and is released into the air when things burn, such as when automobiles emit exhaust,
when furnaces and stoves operate, and through forest fires. Formaldehyde sources in this risk evaluation
involve the manufacturing, processing, distribution in commerce, use, and disposal of formaldehyde and
formaldehyde-containing products and articles that are subject to TSCA. The highest releases of
formaldehyde from articles occur when articles are new. In addition, other articles and products
containing formaldehyde may not be subject to TSCA (i.e., comprise non-TSCA COUs), including
pesticides, food additives, drugs, cosmetics, and may be on the market. This results in a complex
exposure profile for formaldehyde.
Overall, the unreasonable risk presented by formaldehyde is based on the significant contribution from
58 out of 63 COUs (50 out of 51 occupational COUs and 8 out of 12 consumer COUs). Specifically,
EPA has determined that the unreasonable risk presented by formaldehyde is due to the following:
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• Non-cancer effects in workers from acute dermal (skin sensitization) exposure, meaning that skin
contact can result in an allergic response, for 48 out of 51 occupational COUs.
• Non-cancer effects in workers, including occupational non-users (ONUs), from acute inhalation
(sensory irritation) exposure, meaning that formaldehyde in air can result in irritation of eyes and
upper airways, for 46 out of 51 occupational COUs.
• Cancer effects in workers, including ONUs, from long-term inhalation exposure for 43 out of 51
occupational COUs.
• Non-cancer effects in consumers from acute dermal (skin sensitization) exposure for 6 out of 12
consumer COUs.
• Non-cancer effects in consumers, including bystanders, from acute inhalation (sensory irritation)
exposure for 8 out of 12 consumer COUs.
The COUs evaluated for formaldehyde are listed in Table 2-1 and Table 2-2. The Conditions of Use of
the Risk Evaluation for Formaldehyde technical support document provides additional context regarding
the COUs evaluated. The following COUs are determined to significantly contribute to the unreasonable
risk:
• Manufacturing (domestic manufacture)
• Manufacturing (import)
• Processing - as a reactant in:
o adhesives and sealant chemicals in plastic and resin manufacturing; wood product
manufacturing; paint and coating manufacturing; and basic organic chemical
manufacturing
o an intermediate in pesticide, fertilizer, and other agricultural chemical manufacturing;
petrochemical manufacturing; soap, cleaning compound, and toilet preparation
manufacturing; 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; and agriculture, forestry, fishing, and hunting
o a functional fluid in oil and gas drilling, extraction, and support activities
o processing aids specific to petroleum production in all other basic chemical
manufacturing
o bleaching agent in wood product manufacturing
o agricultural chemicals in agriculture, forestry, fishing, and hunting
• Processing - incorporation into an article, in:
o finishing agents in textiles, apparel, and leather manufacturing
o paint additives and coating additives not described by other categories in transportation
equipment manufacturing (including aerospace)
o additive in rubber product manufacturing
o adhesives and sealant chemicals in wood product manufacturing; plastic material and
resin manufacturing (including structural and fireworthy aerospace interiors);
construction (including roofing materials); and paper manufacturing
• Processing - incorporation into a formulation, mixture, or reaction product, in:
o petrochemical manufacturing; petroleum, lubricating oil and grease manufacturing; fuel
and fuel additives; lubricant and lubricant additives; petroleum and coal products
manufacturing; and basic organic chemical manufacturing
o asphalt, paving, roofing, and coating materials manufacturing
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o solvents (which become part of a product formulation or mixture) in paint and coating
manufacturing
o processing aids, specific to petroleum production oil and gas drilling, extraction, and
support activities; chemical product and preparation manufacturing; and basic inorganic
chemical manufacturing
o paint additives and coating additives not described by other categories in paint and
coating manufacturing and plastic material and resin manufacturing
o an intermediate in basic chemical manufacturing; chemical product and preparation
manufacturing; plastic material and resin manufacturing; oil and gas drilling, extraction,
and support activities; and wholesale and retail trade
o solid separation agents in miscellaneous manufacturing
o agricultural chemicals (nonpesticidal) in agriculture, forestry, fishing, and hunting;
pesticide, fertilizer, and agricultural chemical manufacturing
o surface active agents in plastic material and resin manufacturing
o ion exchange agents in adhesive manufacturing and paint and coating manufacturing
o lubricant and lubricant additive in adhesive manufacturing
o plating agents and surface treating agents in chemical product and preparation
manufacturing
o soap, cleaning compound, and toilet preparation manufacturing
o laboratory chemicals
o adhesive and sealant chemical in adhesive manufacturing
o bleaching agents in textile, apparel, and leather manufacturing
Processing - repackaging - sales to distributors for laboratory chemicals
Processing - recycling
Distribution - distribution in commerce
Industrial use (non-incorporative activities)
o as a process aid in oil and gas drilling, extraction, and support activities; process aid
specific to petroleum production, hydraulic fracturing
o used in: construction
o oxidizing/ reducing agent; processing aids, not otherwise listed
Industrial use - chemical substances in industrial products
o paints and coatings; adhesives and sealants; lubricants
o aerospace use in: paints and coatings; adhesives and sealants; lubricant; and foam
insulation
Commercial use in:
o 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
o water treatment products
o laundry and dishwashing products
o adhesives and sealants; paint and coatings
o 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
o machinery, mechanical appliances, electrical/electronic articles; other machinery,
mechanical appliances, electronic/electronic articles
o construction and building materials covering large surface areas, including metal articles;
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o automotive care products; lubricants and greases; fuels and related products
o lawn and garden products
o explosive materials
o arts, crafts, and hobby materials
o ink, toner, and colorant products; photographic supplies
o laboratory chemicals
• Consumer use in:
o 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
o fabric, textile, and leather products (clothing)
o adhesives and sealant; paint and coatings
o 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
o automotive care products; lubricants and greases; fuels and related products
o paper products; plastic and rubber products; toys, playground, and sporting equipment
o arts, crafts, and hobby materials
o ink, toner, and colorant products; photographic supplies
• Disposal.
The following COUs do not significantly contribute to the unreasonable risk:
• Commercial use in paper products; plastic and rubber products; toys, playground, and sporting
equipment
• Consumer use in water treatment products
• Consumer use in laundry and dishwashing products
• Consumer use in machinery, mechanical appliances, electrical/electronic articles; other
machinery, mechanical appliances, electronic/electronic articles
• Consumer use in lawn and garden products.
Whether EPA makes a determination of unreasonable risk for a particular chemical substance under
TSCA depends upon risk-related factors beyond exceedance of benchmarks, such as the endpoint under
consideration, the reversibility of the effect, exposure-related considerations (e.g., duration, magnitude,
frequency of exposure, population exposed), and the confidence in the information used to inform the
hazard and exposure values. EPA also considered, where relevant, the Agency's analyses on aggregate
exposures. This unreasonable risk determination explains how the Agency considered these risk related
factors in the determination.
In the risk evaluation, the Agency describes the strength of the scientific evidence supporting the human
health and environmental assessments as robust, moderate, or slight. Robust confidence suggests
thorough understanding of the scientific evidence and uncertainties, and the supporting weight of
scientific evidence outweighs the uncertainties to the point where it is unlikely that the uncertainties
could have a significant effect on the risk estimates. Moderate confidence suggests some understanding
of the scientific evidence and uncertainties, and the supporting scientific evidence weighed against the
uncertainties is reasonably adequate to characterize risk. Slight confidence is assigned when the weight
of scientific evidence may not be adequate to characterize the risk, and when the Agency is making the
best scientific assessment possible in the absence of complete information.
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This risk evaluation discusses important assumptions and key sources of uncertainty in the risk
characterization, and these are described in more detail in the weight of the scientific evidence and
overall confidence in exposure assessment (Section 2.5), as well as the weight of scientific evidence and
overall confidence in hazard assessment (Section 3.2) in the Human Health Risk Assessment for
Formaldehyde. In the Environmental Risk Assessment for Formaldehyde (Section 2.3.3), the Agency
describes weighing the scientific evidence to determine confidence in the environmental risk
assessment. The strengths, limitations, assumptions, and key sources of uncertainty in the fate and
transport of formaldehyde are discussed in Section 3.8 of the Chemistry, Fate, and Transport
Assessment for Formaldehyde.
In the formaldehyde unreasonable risk determination, EPA reviewed risk estimates with an overall
confidence rating of slight, moderate, or robust and the Agency considered COUs with indeterminate
exposures and COUs with limited reasonably available information. In general, EPA makes an
unreasonable risk determination based on risk estimates that have an overall confidence rating of
moderate or robust—because those confidence ratings indicate the scientific evidence is adequate to
characterize risk estimates despite uncertainties or is such that it is unlikely the uncertainties could have
a significant effect on the risk estimates.
2.1 Human Health
Calculated risk estimates (margin of exposures [MOEs] or cancer risk estimates) can provide a risk
profile of formaldehyde by presenting a range of estimates for different health effects for different
COUs. When characterizing the risk to human health from occupational exposures during risk
evaluation under TSCA, EPA conducts baseline assessments of risk and makes its determination of
unreasonable risk from a baseline scenario that does not assume use of respiratory protection or other
personal protective equipment (PPE)1. Making unreasonable risk determinations based on the baseline
scenario should not be viewed as an indication that EPA believes there are no occupational safety
protections in place at any location, or that there is widespread noncompliance with existing regulations
that may be applicable to formaldehyde. Rather, it reflects the Agency's recognition that unreasonable
risk may exist for subpopulations of workers that may be highly exposed because they are not covered
by Occupational Safety and Health Administration (OSHA) standards, such as self-employed
individuals and public sector workers who are not covered by a state plan, or because their employer is
out of compliance with OSHA standards, or because EPA finds unreasonable risk for purposes of TSCA
notwithstanding existing OSHA requirements. Jn general, the risk estimates are based on exposure
scenarios with monitoring data that reflect existing requirements, such as those established by EPA (e.g.,
National Emission Standards for Hazardous Air Pollutants [NESHAP] under the Clean Air Act), OSHA
(i.e., formaldehyde standard), or industry or sector best practices. However, in the case of formaldehyde,
the monitoring data might not fully reflect some recent regulatory actions under TSCA Title VI, as
described below.
A calculated MOE that is less than the benchmark MOE is a starting point for informing a determination
of unreasonable risk of injury to health, based on non-cancer effects. Similarly, a calculated cancer risk
estimate that is greater than the cancer benchmark is a starting point for informing a determination of
unreasonable risk of injury to health from cancer. It is important to emphasize that these calculated risk
estimates alone are not "bright-line" indicators of unreasonable risk.
1 It should be noted that, in some cases, baseline conditions may reflect certain mitigation measures, such as engineering
controls, in instances where exposure estimates are based on monitoring data at facilities that have engineering controls in
place.
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2.1.1 Populations and Exposures EPA Assessed for Human Health
EPA evaluated risk to workers, including occupational non-users (ONUs), consumer users and
bystanders, and the general population using reasonably available monitoring and modeling data for
inhalation and dermal exposures, as applicable.
EPA evaluated risk from two exposure routes—inhalation and dermal—and to different population
groups:
• Workers: evaluated risk from inhalation and dermal exposures;
• ONUs: evaluated risk from inhalation exposures;
• Consumers: evaluated risk from inhalation and dermal exposures;
• Bystanders (consumer): evaluated risk from inhalation exposures; and
• General population: evaluated risk from inhalation exposures.
Oral exposures were not assessed quantitatively for occupational, consumer, and the general population
as there is no supporting evidence indicating that the oral route is a route of exposure {Human Health
Risk Assessment for Formaldehyde, Section 3.2.5). EPA qualitatively assessed some oral exposures for
relevant consumer COUs, but EPA is determining that this route is not likely to contribute to risk to
consumers or bystanders due to the high volatility of formaldehyde, rapid evaporation rate, and due to a
lack of supporting evidence via the oral pathway from products and articles (iConsumer Exposure
Assessment for Formaldehyde, Section 1.1.1.1.2.; Appendix C). Descriptions of the data used for human
health exposure and human health hazards are provided in the Human Health Risk Assessment for
Formaldehyde, Section 2.1, 2.2, 2.3, 2.4, and Section 3.1. Uncertainties for overall exposures and
hazards are presented in the Human Health Risk Assessment for Formaldehyde Section 2.5 and Section
3.2, are described in the Occupational Exposure Assessment for Formaldehyde, Consumer Exposure
Assessment for Formaldehyde, Indoor Air Exposure Assessment for Formaldehyde, and Ambient Air
Exposure Assessment for Formaldehyde, and are considered in the unreasonable risk determination.
2.1.2 Summary of Unreasonable Risks to Human Health
EPA has determined that the unreasonable risk presented by formaldehyde is due to
• non-cancer effects in workers from acute inhalation (sensory irritation) and acute dermal (skin
sensitization) exposures;
• non-cancer effects in ONUs from acute inhalation (sensory irritation) exposures;
• cancer effects in workers and ONUs from long-term inhalation exposures; and
• non-cancer effects in consumers and bystanders from acute inhalation (sensory irritation) and
acute dermal (skin sensitization) exposures.
Table 2-1 and Table 2-2 provide further detail regarding the conditions of use that EPA has determined
significantly contribute to the unreasonable risk of formaldehyde.
Sensory irritation consists of irritation of eyes and upper airways and is commonly used as a parameter
for setting occupational exposure limits. Although sensory irritation may be reversible and less serious
than cancer, sensory irritation is still a serious effect that can lead to other undesirable outcomes such as
reduced visibility or falls in the workplace. As such, risk estimates based on sensory irritation in
workers, including ONUs, are a starting point for informing a determination of unreasonable risk. In
addition, sensory irritation may have similar effects in consumers and bystanders, so EPA considers the
effect from these acute exposures to inform a determination of unreasonable risk.
Similarly, skin sensitization or irritation of the skin, including allergic reaction, is a known occupational
illness. Due to its prevalence, persistence, and impact on quality of life, skin sensitization is recognized
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as an important occupational and general health issue. The risk estimates based on skin sensitization are
a starting point for informing a determination of unreasonable risk.
EPA's exposure and overall risk characterization confidence levels are summarized in the Human
Health Risk Assessment for Formaldehyde, Sections 2.5 and 3.2. The health risk estimates for workers,
including ONUs—as well as the general population, consumers, and bystanders—are presented in
Section 4.2 of the Human Health Risk Assessment for Formaldehyde.
2.1.3 Basis for Unreasonable Risk to Human Health
In developing the exposure and hazard assessments for formaldehyde, EPA analyzed reasonably
available information to ascertain whether some human populations may have greater exposure and/or
susceptibility than the general population to the hazard posed by formaldehyde. The Agency identified
as Potentially Exposed or Susceptible Subpopulations (PESS) people who are expected to have greater
exposure to formaldehyde, such as people exposed to formaldehyde at work, those who frequently use
consumer products containing high concentrations of formaldehyde, people living or working near
facilities that emit formaldehyde, and people living in mobile homes and other indoor environments with
high formaldehyde concentrations (see Human Health Risk Assessment for Formaldehyde, Section 4.2.6
and Table 4-4). Additionally, EPA identified as PESS people who may have greater susceptibility to the
health effects of formaldehyde, including, infants and children, developing embryos and fetuses, people
of reproductive age, and people who have pre-existing health conditions, such as asthma, allergies, or
nasal damage. A full PESS analysis is in Appendix C. 1. and Appendix C.2 of the Human Health Risk
Assessment for Formaldehyde.
Risk estimates based on high-end exposure levels (e.g., 95th percentile) are generally intended to cover
individuals with sentinel exposure, whereas risk estimates for the central tendency exposure are intended
to cover average or typical exposure. In terms of aggregate exposures, cancer risk is only quantified for
inhalation exposures and therefore cannot be quantitatively aggregated across multiple routes. Similarly,
the non-cancer risks are highly route-specific with the effect occurring near the portal of entry. EPA
concluded that the non-cancer risks are not additive across routes (i.e., inhalation and dermal). EPA
considered the combined exposures that may result from multiple sources releasing formaldehyde to air
in a particular indoor or outdoor environment. More information on how EPA characterized sentinel and
aggregate risks is provided in Section 4.3 of the Human Health Risk Assessment for Formaldehyde.
2.1.4 Workers
Based on the occupational risk estimates and related risk factors, EPA has determined that formaldehyde
presents unreasonable risk due to:
• non-cancer risks from acute inhalation exposure to workers, including ONUs;
• non-cancer risks from acute dermal exposure to workers; and
• cancer risk from long term inhalation exposure to workers, including ONUs.
With respect to the non-cancer chronic effects, the point of departure (POD) used is based on pulmonary
function response in children, however, several SACC Committee members had concerns with
determining risk to workers based on health effects observed in children. See page 56 of the Meeting
Minutes and Final Report for the Science Advisory Committee on Chemicals Public Virtual Meeting
"Peer Review of the 2024 Draft Risk Evaluation for Formaldehyde. "
For each occupational COU, EPA provided a high-end and a central tendency risk estimate. The high-
end risk estimates are based on the 95th percentile of the exposure data and the central tendency risk
estimates are based on the 50th percentile of the exposure data. The distributions may show large
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variability for each exposure scenario due to variations in work tasks, different processes, and
engineering controls across the different sites represented in the data. The 95th percentile represents
those worker exposure groups that may have high exposure or sentinel exposure at the workplace.
For acute effects, the use of the high-end risk estimate was used to make a risk determination as the
hazard effect can occur after experiencing the exposure only once and no additional assumptions on
frequency are needed. For long-term exposures leading to cancer risks, in general, EPA considered the
high-end risk estimates for workers and central tendency for ONUs, since EPA generally used
monitoring data (i.e., workplace measured concentrations) that represents a range of exposure scenarios
across workers and, in most cases, cannot be tied to specific worker tasks.
For acute exposures, EPA calculated risk estimates based on samples that were measured for 15 minutes
and up to 60 minutes. In addition, EPA considered exposure samples that fell between 15 minutes and
330 minutes, the cut-off EPA used for full-shift estimates. In addition, EPA analyzed and considered
risk estimates for the occupational scenarios using a time-weighted average (TWA) for a typical 8-hour
shift as well as a 12-hourr shift. EPA assumes that the worker is exposed for 250 days (8 hrs/day, 5 days
per week for 50 weeks) unless additional information suggests otherwise. Cancer risk estimates were
calculated and included an exposure time frame over a 40-year work tenure for the high-end exposure
and a 31-year work tenure for the central tendency exposure. Worker cancer risk estimates across
occupational TSCA COUs for inhalation exposure range from 6,7/10 9 to 1.3/10 2 for both high-end
and central tendency exposures. More detail regarding the assumptions is described in Section 4.2.1.1.2.
of the Human Health Risk Assessment for Formaldehyde.
For many COUs assessed, ONUs were evaluated using the central tendency estimates for workers since
the risk to ONUs are assumed to be equal to or less than risk to workers who handle materials containing
formaldehyde as a part of their job. Additionally, EPA evaluated dermal exposures only for workers
since ONUs are not expected to directly handle formaldehyde.
For two commercial COUs that contain wood articles and composite wood products regulated under
TSCA Title VI—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; and
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—the exposure scenario is based on monitoring data of
installation and demolition of building and construction materials, and EPA does not expect that the
monitoring data reflects exposures from articles covered under TSCA Title VI. Although EPA found
risks to workers from these COUs, the Agency has determined that composite wood products regulated
under Title VI do not significantly contribute to the unreasonable risk of formaldehyde included in this
two commercial COUs.
More information on EPA's confidence in these risk estimates and the uncertainties associated with
them can be found in Section 2.5.1 of the Human Health Risk Assessment for Formaldehyde.
2.1.5 Consumers
Based on the consumer risk estimates and related risk factors, EPA has determined that formaldehyde
presents unreasonable risk due to
• non-cancer risks from acute inhalation and dermal exposure to consumers; and
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• non-cancer risk from acute inhalation exposure to bystanders.
Dermal exposures were assessed for acute non-cancer risks for consumers only since bystanders would
not be expected to physically interact with any of the consumer COUs. EPA does not expect most
consumer exposures to be chronic in nature because product use patterns generally tend to be infrequent
with relatively short durations of use, such as glue, craft paint, lawn fertilizers, and automotive polishes.
Therefore, EPA did not consider risks for consumers due to long-term exposures, but EPA considered
chronic exposures to the general population from many sources of formaldehyde within homes and
vehicles.
Consumers and bystander risks were evaluated for consumer COUs that represent applicable age groups.
Typically, consumers are adults since most COUs/products purchased are for adult use or application,
while bystanders would include other adults in the home as well as children.
For some consumer COUs, EPA determined that certain exposure routes were not likely and, therefore,
were not assessed for the relevant COU. For example, for one consumer COU—Machinery, mechanical
appliances, electrical/ electronic articles; other machinery, mechanical appliances, electronic/ electronic
articles—no assessment was made for any exposure route as EPA determined there were no viable
exposure pathways via inhalation or dermal routes for products within this COU. This is because normal
consumer use of an electronic product, such as a circuit board component located within an electronic
product, will not entail handling them in a way that would result in exposure to the consumer. Circuit
boards may include formaldehyde-based adhesives in small amounts to glue the intricate parts, such as
wiring separate components together before encasing them in a larger body. Many of these products
might include appliances, electric controls, telephones, electrical switches, and circuit breakers (Section
2.2. of the Human Health Risk Assessment for Formaldehyde).
For the remaining consumer COUs, EPA evaluated the risk to consumers and bystanders using the 15-
minute peak and 1-year average daily concentrations for inhalation exposures and the dermal loading
during relevant product and article use with the Consumer Exposure Model (CEM). For the
unreasonable risk determination, EPA considered the high-end exposures, because it is reasonable that a
consumer may experiences high-end exposure from use of a single product (e.g., one that contains a
high amount of formaldehyde) and that exposure can result in a hazard effect.
For two consumer COUs that contain wood 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 and 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,
EPA found acute inhalation risks. Both COUs contain wood articles and composite wood products
regulated under TSCA Title VI. However, consistent with EPA's findings as part of the Indoor Air
Exposure Assessment for Formaldehyde and as explained in Section 2.1.6. of this Unreasonable Risk
Determination, the Agency has determined that composite wood products regulated under Title VI do
not significantly contribute to the unreasonable risk of formaldehyde due to acute inhalation effects for
consumers.
EPA has medium confidence in the inhalation exposure assessment for consumers and medium
confidence in the dermal exposure assessment for consumers. More information on EPA's confidence in
these risk estimates and the uncertainties associated with them can be found in the Human Health Risk
Assessment for Formaldehyde, Section 2.5.2.
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EPA did not quantify exposures for some COUs in which EPA had a slight confidence in the exposure
assessment. For this reason, the Agency has determined that the following consumer COUs do not
significantly contribute to the unreasonable risk: (1) Water treatment products, (2) Laundry and
dishwashing products, and (3) Lawn and garden products.
2.1.6 General Population
The risk estimates calculated using releases from manufacturing, processing, and industrial uses of
formaldehyde indicates risk for general population due to formaldehyde concentration in ambient air.
In addition, EPA considered residential and nonresidential exposures for its evaluation of formaldehyde
indoor air concentrations. Although the risk evaluation indicates risk, EPA did not identify risk from the
following exposure routes that would contribute to the unreasonable risk of formaldehyde:
• non-cancer risk from acute inhalation exposure to ambient and indoor air to the general
population;
• non-cancer risk from long-term inhalation exposure to ambient and indoor air to the general
population; and
• cancer risk from long-term inhalation exposure to ambient and indoor air to the general
population.
For members of the general population exposed due to releases from the manufacturing, processing, and
industrial COUs, EPA considers a cancer risk benchmark of 1 x 1CT6; however, the benchmark is not
considered a bright-line and other risk related factors were considered such as the endpoint under
consideration, the reversibility of the effect, exposure-related considerations (e.g., duration, magnitude,
frequency of exposure, population exposed), and the confidence in the information used to inform the
hazard and exposure values.
Formaldehyde is not expected to persist in water or land based on the chemical, fate, and transport
properties of formaldehyde. As such, EPA does not expect general population exposure to formaldehyde
to occur via either the water or land pathway and therefore did not quantitatively assess exposures via
these routes.
Section 4.2.4 of the Human Health Risk Assessment for Formaldehyde provides detailed information
regarding the risk estimates for ambient air, and Section 4.2.3 of the Human Health Risk Assessment for
Formaldehyde provides detailed information regarding the risk estimates for indoor air.
Inhalation — Ambient Air
EPA's assessment relied on a combination of monitoring data for formaldehyde from the Ambient
Monitoring Technology Information Center (AMTIC) Ambient Monitoring Archive from 2015 through
2020, and modeled data using tools like the AirTox Screening Tool and the Integrated-Outdoor Air
Calculator (IIOAC). The AMTIC data reflects aggregate exposures from all sources of formaldehyde
(including TSCA and other sources of formaldehyde). The IIOAC modeled concentrations are specific
to TSCA sources, based on industry sector release data from 2016 to 2021 under the Toxics Release
Inventory (TRI) program, and are linked to relevant TSCA COUs for the formaldehyde risk evaluation.
EPA also used the Human Exposure Model (HEM) to help understand how modeled air concentrations
(and associated risks) at the national level intersected with populated areas. The HEM results also
represent an aggregation of exposures from multiple nearby facilities (e.g., facilities in proximity to
others releasing formaldehyde to the ambient air).
Short-term risk estimates for ambient air in this assessment are based on the maximum release scenario
and the 95th percentile modeled daily average exposure concentrations at 100 meters (m) from a
Page 13 of 28
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releasing facility as described in Section 2.4.2.1.1 of the Ambient Air Exposure Assessment for
Formaldehyde.
Acute Risk: None of the risk estimates were below the acute benchmark MOE of 3 for exposures
primarily attributable to the manufacturing, processing, and industrial COUs, indicating that acute risk to
the general population is not expected.
Chronic Risk: Long-term risk estimates for ambient air are based on the 95th percentile release scenario
and the 95th percentile modeled annual average exposure concentrations within the area distance of 100
to 1,000 meters from a releasing facility as described in Section 2.4.2.1.2 and thq Ambient Air Exposure
Assessment for Formaldehyde. The population living or working within 100 to 1,000 m of the facilities
(or fenceline population) are considered PESS and would represent the highest exposure group of the
general population exposed to formaldehyde.
Non-Cancer Chronic Risk: None of the non-cancer risk estimates were below the benchmark MOE of 3
for exposures primarily attributable to the TSCA COUs, indicating that non-cancer chronic risk to the
general population is not expected.
Cancer Risk: The risk evaluation calculated cancer risk to the general population for 23 of the 44 COUs
assessed due to formaldehyde concentrations in ambient air; however, formaldehyde concentrations are
highly variable based on location, releases, weather conditions, and other sources of formaldehyde, and
there is uncertainty in the geographic and temporal nature of the cancer risk estimates. EPA has medium
confidence in the ambient air risk assessment, due to uncertainties related to input parameters, and
spatial and temporal differences across the multiple lines of evidence considered.
The highest risk is above the 1 x 10~6 cancer benchmark for some communities—particularly those near
releasing facilities and especially some facilities with releases attributed to combustion. There remain
uncertainties with regard to cancer hazard assessment as described in the Human Health Risk
Assessment for Formaldehyde. Additional conversative assumptions that reduce EPA's confidence in the
realism of its risk calculations include:
• that individuals within 100 to 1000 m are exposed to high-end modeled formaldehyde
concentrations in ambient air for the entire duration of their life {i.e., 78 years); and
• that no atmospheric degradation of formaldehyde occurs, which may reduce ambient air
concentrations.
Furthermore, additional regulatory measures already promulgated but not yet implemented under the
Clean Air Act (e.g., regulations expected to reduce emissions from combustion sources such as vehicles,
oil and gas and other facilities), as well as regulatory steps EPA expects to promulgate under TSCA to
address the unreasonable risk to workers and consumers would be expected to also reduce ambient
exposures to the general population. As such, all of these considerations lead the Agency to find that
general population exposures from ambient air emissions under the conditions of use of formaldehyde
do not significantly contribute to the unreasonable risk of formaldehyde. More information on EPA's
confidence in exposures, risk estimates, and risk characterization for ambient air can be found in Section
4.2.4.7 of the Human Health Risk Assessment for Formaldehyde.
Inhalation — Indoor Air
There are many sources of formaldehyde within homes and vehicles. These include sources from articles
such as building materials, wood flooring, paint, and fabrics as well as combustion sources like candles,
fireplaces, or stoves. Additionally, consumer products containing formaldehyde may also add to indoor
Page 14 of 28
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concentrations of formaldehyde. EPA considered monitoring data as an indication of aggregate exposure
and risks from all sources contributing to formaldehyde in indoor air, but the monitoring data do not
provide information about the relative contributions of each source. EPA also used models to estimate
formaldehyde concentrations from TSCA conditions of use that cannot otherwise be distinguished from
other sources of formaldehyde reflected in measured indoor concentration data. EPA used the Consumer
Exposure Model (CEM) to estimate long-term indoor air exposures and refined the results with IECCU
modeling to estimate acute and long-term risks for exposure to formaldehyde in residential indoor air
associated with specific TSCA COUs.
Using the AHHS II, EPA estimated a median aggregate cancer risk of 2/10 4 and a maximum risk value
of 1.3x10 3. However, this risk estimate is expected to represent long-term aggregate exposures that
include TSCA COUs as well as other sources. Furthermore, the survey was conducted from March 2018
through June 2019, and therefore does not fully reflect implementation of the Formaldehyde Standards
for Composite Wood Products (40 CFR Part 770), which required (1) compliance with emissions
standards for certain composite wood panels by June 2018, and (2) compliance for laminated products
by March 2024. It is expected that this aggregate cancer risk will decrease considerably as a result of
implementation of the composite wood products rule. EPA further refined the indoor air assessment by
using two different models.
EPA estimated risks for four COUs expected to be significant and persistent emitters of formaldehyde in
the indoor air environment. These types of products can include furniture, cabinetry, drywall, plaster,
tile, wallpaper, flooring, foam seating, mattresses, clothing, household cleaning supplies, cardboard
boxes, plastic home articles, toys, and sporting equipment. The four consumer COUs assessed included
• 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;
• Fabric, textile, and leather products not covered elsewhere (clothing);
• 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; and
• Paper products; plastic and rubber products; toys, playground, and sporting equipment.
The risk estimates in the indoor air scenario for the residential COUs included two COUs with wood
products: (1) 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; and (2) 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. These COUs contain composite wood
products, many of which are regulated as finished goods under TSCA Title VI. Finished goods include
furniture and cabinetry while other regulated composite wood products include flooring. TSCA Title VI
reduces exposure to formaldehyde emissions from certain composite wood products such as hardwood
plywood, medium density fiberboard, and particleboard.
The CEM is commonly used by EPA to estimate exposure to chemicals in consumer products and
articles for TSCA conditions of use; however, the model tends to over-estimate formaldehyde indoor air
concentrations since it has a constant rate of formaldehyde emissions. Previous studies have
demonstrated that articles generally exhibit an initial period of high emissions, followed by a rapid, non-
linear decline in the emission rate. To address the uncertainties for the CEM, EPA modeled indoor air
concentrations using the IECCU Model. However, based on studies conducted in residential homes, it is
Page 15 of 28
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possible that air concentrations resulting from formaldehyde emissions from articles may remain
elevated longer than the IECCU models indicate. In general, articles with large surface areas may
contribute significantly to formaldehyde concentrations measured in homes. The extent of this
contribution is variable, depending on the article, consumer preferences, room of use, home size and
configuration, ventilation rates, and relevant meteorological parameters {i.e., temperature and humidity).
Peak exposures to formaldehyde from these articles are expected to occur within 1 year of manufacture
or use and formaldehyde concentrations substantially diminish within the first few months and years of
the article life. Using both models provides the potential range of formaldehyde concentrations in indoor
air given the uncertainties of both models. The lowest long-term, non-cancer risk estimate calculated
with CEM is 0.59 (for construction materials) and with IECCU all the risk estimates are greater than the
benchmark MOE of 3. The highest cancer risk estimates calculated with CEM was 3.6x 1CT4 (for
construction materials), and with IECCU was 7.03 xlCT5 (for construction materials). Beyond the scope
of the models were other variables involved during the production of composite wood products subject
to TSCA Title VI, such as resin chemistry, core type, and curing process. Based on emissions associated
with the four COUs assessed, as described in the Human Health Risk Assessment for Formaldehyde,
Section 4.2.3, EPA did not identify risk from the general population long-term inhalation exposure to
indoor air from wood articles that would contribute to the unreasonable risk of formaldehyde. This
includes wood articles and composite wood products that are regulated pursuant to TSCA Title VI.
The largest contributors to the average daily concentration of formaldehyde in a typical home are the
wood articles, and the lowest contributions are from the Fabrics and paper, included in the paper
products; plastic and rubber products; toys, playground, and sporting equipment and fabric, textile, and
leather products not covered elsewhere (clothing) COUs. Therefore, EPA did not identify risk based on
acute inhalation exposures to the general population in indoor air that would significantly contribute to
the unreasonable risk determination for formaldehyde.
Finally, EPA assessed the risk to the general population in automobiles using CEM only, because
IECCU modeling {i.e., Simulation Program for Estimating Chemical Emissions from Sources and
Related Changes to Indoor Environmental Concentrations in Buildings with Conditions and
Unconditioned Zones) cannot account for the indoor environment in automobiles. Polyoxymethylene or
POM, is a specialized, engineered polymer in which formaldehyde is used as an upstream ingredient and
can be found in a wide range of automobile products—including interiors such as seatbelts, buckles,
door trims, and dashboards. Formaldehyde emissions are expected to be very low since most of the
formaldehyde in POM materials are expected to be mostly reacted by the time of installation in a
vehicle. Therefore, based on the CEM results, EPA did not identify risk from exposures to the general
population in automobiles indoor air that would contribute to the unreasonable risk of formaldehyde.
In summary, EPA did not identify risk from general population exposure to the indoor air in homes and
automobiles for common household products and automobile interiors that would contribute to the
unreasonable risk of formaldehyde. This includes composite wood products manufactured under TSCA
Title VI and automobile products made from POM. EPA's overall confidence in the indoor air consumer
analysis was medium. More information on the Agency's confidence in these risk estimates and the
uncertainties associated with them can be found in the Human Health Risk Assessment for
Formaldehyde, Section 2.5.3. and in the model discussions in Section 3.2.2. and Section 3.3.2 of the
Indoor Air Exposure Assessment for Formaldehyde.
2.2 Environment
In general, the Agency determines a risk profile by comparing a range of environmental toxicity
endpoints with ambient concentrations associated with the COUs of formaldehyde. When the ambient
Page 16 of 28
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concentrations are less than the concentrations associated with the toxicity endpoint, this generally
means that risk of injury to the environment that would support a determination of unreasonable risk for
the chemical substance is not indicated. When the ambient concentration is greater than the
concentration associated with the toxicity endpoint, this generally means that risk of injury to the
environment that would support a determination of unreasonable risk for the chemical substance is
indicated.
2.2.1 Populations and Exposures EPA Assessed for the Environment
For terrestrial organisms, EPA evaluated exposures via air. The Agency expects the air pathway
(inhalation, ambient air exposure) is the dominant pathway and route of exposure to formaldehyde for
terrestrial organisms based on the continuous release of formaldehyde from various sources.
EPA did not quantitatively evaluate exposures to aquatic organisms via water or land pathways.
Although formaldehyde is directly released to water, land, and air, formaldehyde concentrations were
not modeled for the water and land pathways because formaldehyde is not expected to persist in soil and
water based on physical-chemical, fate, and transport characteristics. Formaldehyde does not absorb or
bind to soil or sediment and does not persist on land (due to volatility and reactivity of formaldehyde).
Because formaldehyde is not expected to persist in water or soils, EPA determined that an in-depth
analysis of releases to water or land was not justified and targeted its review of releases to air.
In general, EPA has medium to robust confidence in environmental releases for industrial COUs2 and
slight to medium confidence in commercial COUs. Environmental fate and transport data indicate
formaldehyde does not bioaccumulate. The Agency concluded that risk to terrestrial organisms via the
dietary pathway is not indicated. EPA has high confidence in this assessment conclusion.
2.2.2 Summary of Environmental Effects
EPA quantitatively assessed risk via the ambient air pathway for the COUs evaluated and has
determined that
• no indication of risk to terrestrial mammals through air exposure because air concentrations are
much lower than the concentration needed to produce an adverse effect; and
• no indication of risk to plants from formaldehyde exposures in ambient air because air
concentrations are approximately 7 times below concentrations that would result in adverse
effects to plants.
EPA qualitatively assessed risk via the surface water, dietary, and land pathways and concluded that
these were not relevant pathways of exposure and has determined that
• no indication of risk to terrestrial organisms through soil exposure because exposure is not
expected since formaldehyde does not absorb or bind to soil and does not persist on land;
• no indication of risk to aquatic organisms because exposure is not expected since formaldehyde
rapidly transforms in water and is not expected to persist; and
• no indication of risk to terrestrial organisms through a dietary pathway because formaldehyde
does not bioaccumulate.
Although terrestrial organisms may be exposed to formaldehyde in air, EPA did not identify risk to any
environmental taxa due to formaldehyde under its COUs. The Agency has high confidence in its
environmental assessment conclusion.
2 COUs that are included under the life cycle stage of manufacturing, processing, and industrial use.
Page 17 of 28
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2,2,3 Basis for Unreasonable Risk of Injury to the Environment
Based on the risk evaluation for formaldehyde, including the risk estimates, the environmental effects of
formaldehyde, the exposures, physical and chemical properties of formaldehyde, and consideration of
uncertainties, EPA did not identify risk of injury to the environment that would contribute to the
unreasonable risk determination for formaldehyde. Ambient air was determined to be the driver of
exposure, but the Agency does not expect this pathway to contribute to unreasonable risk to the
environment. EPA does not expect exposure to formaldehyde via water, land, or dietary pathways to
contribute to unreasonable risk to the environment. The Agency's overall environmental risk
characterization confidence levels were varied and are summarized in Section 2.4 of the Environmental
Exposure Assessment for Formaldehyde.
2.3 Additional Information Regarding the Basis for the Unreasonable Risk
Table 2-1 and Table 2-2 summarize the basis for this unreasonable risk determination of injury to human
health and the environment presented in this formaldehyde risk evaluation. In these tables, a checkmark
(•/) indicates how the COU significantly contributes to the unreasonable risk by identifying the type of
effect (e.g., non-cancer and cancer for human health) and the exposure route to the population or
receptor that results in such contribution. As explained in Section 2, for this unreasonable risk
determination, EPA considered the effects of formaldehyde to human health at the central tendency and
high-end—as well as effects of formaldehyde to human health from the exposures associated from the
condition of use, risk estimates, and uncertainties in the analysis. See Section 4.2 of the Human Health
Risk Assessment for Formaldehyde for a summary of risk estimates. In addition, certain exposure routes
for some COUs were not assessed because it was determined that there was no viable exposure pathway.
These COUs and their respective exposure routes are grayed-out in Table 2-1 and Table 2-2.
Page 18 of 28
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Table 2-1. Su
pporting Basis for the Unreasonable Risk Determination for Human Health*
Occupational Conditions of Use)
Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Cancer
Manufacturing
Domestic
Manufacturing
Domestic Manufacturing
Worker
Dermal
V
Inhalation
•/
V
ONU
Inhalation
•/
V
General
Population
Inhalation - Ambient
Air
Import
Import
Worker
Dermal
•/
Inhalation
•/
-------
Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Cancer
Processing
Processing -
reactant
General
Population
Inhalation - Ambient
Air
Bleaching agent in wood product manufacturing
Worker
Dermal
V
Inhalation
V
~
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Agricultural chemicals in agriculture, forestry, fishing, and
hunting
Worker
Dermal
V
Inhalation
•/
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Processing -
incorporation
into an article
Finishing agents in textiles, apparel, and leather
manufacturing
Worker
Dermal
•/
Inhalation
•/
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Paint additives and coating additives not described by other
categories in transportation equipment manufacturing
(including aerospace)
Worker
Dermal
•/
Inhalation
V
ONU
Inhalation
V
General
Population
Inhalation - Ambient
Air
Additive in rubber product manufacturing
Worker
Dermal
Inhalation
•/
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Adhesives and sealant chemicals in wood product
manufacturing; plastic material (including structural and
fireworthy aerospace interiors); construction (including
roofing materials); paper manufacturing
Worker
Dermal
S
Inhalation
V
V
ONU
Inhalation
V
V
General
Population
Inhalation - Ambient
Air
Worker
Dermal
V
Page 20 of 28
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Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Cancer
Petrochemical manufacturing, petroleum, lubricating oil and
Inhalation
•/
V
grease manufacturing; fuel and fuel additives; lubricant and
ONU
Inhalation
lubricant additives; basic organic chemical manufacturing;
and petroleum and coal products manufacturing
General
Population
Inhalation - Ambient
Air
Worker
Dermal
•/
Asphalt, paving, roofing, and coating materials
manufacturing
Inhalation
•/
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Worker
Dermal
•/
Solvents (which become part of a product formulation or
mixture) in paint and coating manufacturing
Inhalation
V
V
ONU
Inhalation
General
Inhalation - Ambient
Processing -
incorporation
into
Population
Air
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
Worker
Dermal
V
Inhalation
V
V
Processing
formulation,
ONU
Inhalation
mixture, or
reaction
General
Population
Inhalation - Ambient
Air
product
Worker
Dermal
V
Paint additives and coating additives not described by other
Inhalation
V
-------
Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Cancer
Worker
Dermal
V
Agricultural chemicals (nonpesticidal) in: Agriculture,
Inhalation
•/
V
forestry, fishing, and hunting; pesticide, fertilizer, and
ONU
Inhalation
agricultural chemical manufacturing
General
Population
Inhalation - Ambient
Air
Worker
Dermal
•/
Surface active agents in plastic material and resin
manufacturing
Inhalation
V
~
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Processing -
incorporation
into
formulation,
mixture, or
reaction
Worker
Dermal
V
Ion exchange agents in adhesive manufacturing and paint
and coating manufacturing
Inhalation
V
~
ONU
Inhalation
Processing
General
Population
Inhalation - Ambient
Air
Worker
Dermal
V
product
Inhalation
•/
~
Lubricant and lubricant additive in adhesive manufacturing
ONU
Inhalation
General
Inhalation - Ambient
Population
Air
Worker
Dermal
Plating agents and surface treating agents in all other
chemical product and preparation manufacturing
Inhalation
•/
~
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Worker
Dermal
•/
Soap, cleaning compound, and toilet preparation
manufacturing
Inhalation
•/
~
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Worker
Dermal
S
Laboratory chemicals
Inhalation
V
V
ONU
Inhalation
Page 22 of 28
-------
Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Cancer
Processing
Processing -
incorporation
into
formulation,
mixture, or
reaction
product
General
Population
Inhalation - Ambient
Air
Adhesive and sealant chemical in adhesive manufacturing
Worker
Dermal
V
Inhalation
V
~
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Bleaching agents in textile, apparel, and leather
manufacturing
Worker
Dermal
V
Inhalation
•/
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Repackaging
Sales to distributors for laboratory chemicals
Worker
Dermal
•/
Inhalation
•/
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Recyling
Recycling
Worker
Dermal
•/
Inhalation
V
V
ONU
Inhalation
V
V
General
Population
Inhalation - Ambient
Air
Distribution in
Commerce
Distribution in
Commerce
Distribution in commerce
Worker
Dermal
Inhalation
V
V
ONU
Inhalation
General
Population
Inhalation - Ambicnl
Air
Industrial Use
Non-
incorporative
activities
Process aid in: Oil and gas drilling, extraction, and support
activities; process aid specific to petroleum production,
hydraulic fracturing
Worker
Dermal
V
Inhalation
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Use in construction
Worker
Dermal
V
Inhalation
V
V
Page 23 of 28
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Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Cancer
Industrial Use
Non-
incorporative
activities
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Oxidizing/reducing agent; processing aids, not otherwise
listed
Worker
Dermal
V
Inhalation
•/
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Industrial
products
Paints and coatings; adhesives and sealants; lubricants
Worker
Dermal
•/
Inhalation
•/
V
ONU
Inhalation
V
General
Population
Inhalation - Ambient
Air
Aerospace use in: paints and coating; adhesives and sealants;
lubricants; and foam insulation
Worker
Dermal
•/
Inhalation
V
V
ONU
Inhalation
V
General
Population
Inhalation - Ambient
Air
Commercial
Use
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.
Worker
Dermal
V
Inhalation
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Treatment
products
Water treatment products
Worker
Dermal
V
Inhalation
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Treatment/
care products
Laundry and dishwashing products
Worker
Dermal
V
Inhalation
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Page 24 of 28
-------
Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Cancer
Construction,
paint,
electrical, and
metal products
Worker
Dermal
V
Inhalation
V
V
Adhesives and sealants; Paint and coatings
ONU
Inhalation
V
General
Population
Inhalation - Ambient
Air
Construction and building materials covering large surface
areas, including wood articles; construction and building
Worker
Dermal
V
Furnishing
Inhalation
V
V
treatment/care
materials covering large surface areas, including paper
ONU
Inhalation
products
articles; metal articles; stone, plaster, cement, glass and
ceramic articles
General
Population
Inhalation - Ambient
Air
Worker
Dermal
V
Electrical
products
Machinery, mechanical appliances, electrical/electronic
Inhalation
V
~
articles; other machinery, mechanical appliances,
ONU
Inhalation
•/
electronic/electronic articles
General
Population
Inhalation - Ambient
Air
Commercial
Worker
Dermal
V
Use
Metal
products
Construction and building materials covering large surface
areas, including metal articles
Inhalation
•/
~
ONU
Inhalation
•/
General
Population
Inhalation - Ambient
Air
Worker
Dermal
•/
Automotive
Automotive articles and automotive care products; lubricants
and greases; fuels and related products
Inhalation
•/
~
and fuel
ONU
Inhalation
products
General
Population
Inhalation - Ambient
Air
Worker
Dermal
•/
Agriculture
use products
Inhalation
V
Lawn and garden products
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Outdoor use
products
Worker
Dermal
V
Explosive materials
Inhalation
ONU
Inhalation
Page 25 of 28
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Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Cancer
Commercial
Use
General
Population
Inhalation - Ambient
Air
Packaging,
paper, plastic,
hobby
products
Paper products; plastic and rubber products; toys,
playground, and sporting equipment
Worker
Dermal
Inhalation
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Packaging,
paper, plastic,
hobby
products
Arts, crafts, and hobby materials
Worker
Dermal
V
Inhalation
•/
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Packaging,
paper, plastic,
hobby
products
Ink, toner, and colorant products; photographic supplies
Worker
Dermal
•/
Inhalation
•/
V
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
Products not
described by
other codes
Laboratory chemicals
Worker
Dermal
•/
Inhalation
V
ONU
Inhalation
V
General
Population
Inhalation - Ambient
Air
Disposal
Disposal
Disposal
Worker
Dermal
V
Inhalation
ONU
Inhalation
General
Population
Inhalation - Ambient
Air
" Only Inhalation exposure routes were assessed for ONUs and General Population. Additionally, General Population inhalation exposure routes were assessed using
the ambient air pathway and are labeled to reflect the specific route.
b Grayed-out boxes indicate certain exposure routes that were not assessed because it was determined that there was no viable exposure pathway.
Blank boxes indicate that the particular exposure pathway and human health effect do not significantly contribute to the unreasonable risk.
Page 26 of 28
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Table 2-2. Supporting Basis for the Unreasonable Risk Determination for Human Health (Consumer Conditions of Use)
Life
Cycle
Stage
Category
Subcategory
Population"''
Exposure Route
Human Health
Effects: Acute
Non-cancer1
Consumer
Use
Furnishings
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
Dermal
V
Inhalation
•/
Bystander
Inhalation
V
General Population
Inhalation - Indoor Air
Furnishing
treatment/ care
products
Fabric, textile, and leather products not covered elsewhere
(clothing)
Consumer
Dermal
Inhalation
•/
Bystander
Inhalation
General Population
Inhalation - Indoor Air
Treatment products
Water treatment products
Consumer
Dermal
Inhalation
Bystander
Inhalation
Treatment/ care
products
Laundry and dishwashing products
Consumer
Dermal
Inhalation
Bystander
Inhalation
Construction, paint,
electrical, and metal
products
Adhesives and sealants; paint and coatings
Consumer
Dermal
•/
Inhalation
Bystander
Inhalation
•/
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
Dermal
Inhalation
•/
Bystander
Inhalation
V
General Population
Inhalation - Indoor Air
Electrical products
Machinery, mechanical appliances, electrical/ electronic
articles; other machinery, mechanical appliances,
electronic/ electronic articles
Consumer
Dermal
Inhalation
Bystander
Inhalation
Automotive and fuel
products
Automotive articles and automotive care products;
lubricants and greases; fuels and related products
Consumer
Dermal
V
Inhalation
V
Bystander
Inhalation
V
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Life
Cycle
Stage
Category
Subcategory
Population"''
Exposure Route
Human Health
Effects: Acute
Non-cancer1
Consumer
Use
Agriculture use
products
Lawn and garden products
Consumer
Dermal
Inhalation
Bystander
Inhalation
Packaging, paper,
plastic, hobby
products
Paper products; plastic and rubber products; toys,
playground, and sporting equipment
Consumer
Dermal
Inhalation
V
Bystander
Inhalation
•/
General Population
Inhalation - Indoor Air
Hobby products
Arts, crafts, and hobby materials
Consumer
Dermal
•/
Inhalation
V
Bystander
Inhalation
•/
Packaging, paper,
and plastic
Ink, toner, and colorant products; photographic supplies
Consumer
Dermal
V
Inhalation
•/
Bystander
Inhalation
•/
" Only inhalation exposure routes were assessed for Bystander.
h Typically, "Consumer" represents "Adult" or "Youth" age groups; "Bystander" typically represents "Child" and "Infant" age groups. "Infant" represents ages 0-2;
"Child" represents ages 3-10; "Youth" represents ages 11-20; and "Adult" represents ages 21+.
c Grayed-out boxes indicate certain exposure routes that were not assessed because it was determined that there was no viable exposure pathway.
Blank boxes indicate that the particular exposure pathway and human health effect do not significantly contribute to the unreasonable risk.
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