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EPA Document #EPA-740-D-24-005
March 2024
Office of Chemical Safety and
Pollution Prevention
SEPA
United States
Environmental Protection Agency
Unreasonable Risk Determination of the Draft Risk Evaluation
for Formaldehyde
CASRN 50-00-0
O
A
H H
March 2024
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27 TABLE OF CONTENTS
28 1 RISK EVALUATION SCOPE 3
29 2 UNREASONABLE RISK DETERMINATION 4
30 2.1 Unreasonable Risk to Human Health 8
31 2.1.1 Populations and Exposures EPA Assessed to Determine Unreasonable Risk to Human
32 Health 9
33 2.1.2 Summary of Unreasonable Risks to Human Health 9
34 2.1,3 Basis for Unreasonable Risk to Human Health 9
35 2.1.4 Unreasonable Risk in Occupational Settings 10
36 2.1.5 Unreasonable Risk to Consumers 11
37 2.1.6 Unreasonable Risk to the General Population 13
38 2.2 Unreasonable Risk to the Environment 15
39 2.2.1 Populations and Exposures EPA Assessed to Determine Unreasonable Risk to the
40 Environment 15
41 2.2.2 Summary of Unreasonable Risks to the Environment 16
42 2.2,3 Basis for Unreasonable Risk of Injury to the Environment 16
43 2.3 Additional Information Regarding the Basis for the Unreasonable Risk 16
44
45 LIST OF TABLES
46 Table 2-1. Supporting Basis for the Draft Unreasonable Risk Determination for Human Health
47 (Occupational Conditions of Use) 17
48 Table 2-2. Supporting Basis for the Draft Unreasonable Risk Determination for Human Health
49 (Consumer Conditions of Use) 25
50
51 LIST OF FIGURES
52 Figure 1-1. Risk Evaluation Document Summary Map 3
53
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1 RISK EVALUATION SCOPE
The Toxic Substances Control Act (TSCA) draft risk evaluation of formaldehyde comprises several
human health and environmental assessment modules and two risk assessment documents—the
environmental risk assessment and the human health risk assessment. A basic diagram showing the
layout of these modular assessments and their relationships is provided in Figure 1-1. In some cases,
individual assessments were completed jointly under TSCA and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). These modules are shown in dark gray.
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 identified by EPA as relevant to the risk evaluation, under the TSCA conditions of use
(COUs).
EPA is preliminarily determining that formaldehyde presents an unreasonable risk of injury to human
health under the COUs. Risk of injury to the environment does not contribute to EPA's preliminary
determination of unreasonable risk. This draft unreasonable risk determination is based on the
information in previous sections of the modules and documents that comprise this draft risk evaluation
and the appendices and supporting documents in accordance with TSCA section 6(b), as well as (1) the
best available science (TSCA section 26(h)), (2) weight of the scientific evidence standards (TSCA
section 26(i)), and (3) relevant implementing regulations in 40 CFR part 702.
Formaldehyde is found nearly everywhere. Living things—plants, animals, and people—produce and
release formaldehyde through natural life (biogenic) processes. Formaldehyde is also produced when
other chemicals break down 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 is also used to make many things, including composite wood products, plastics, paints,
adhesives, and sealants. Over time, formaldehyde can be released from these products and articles. The
formaldehyde sources that EPA evaluates in this draft risk evaluation involve, in general, the production
and use of products that are subject to TSCA (as opposed to those products that are excluded from
TSCA, such as pesticides). The unique challenge associated with this evaluation is that the
formaldehyde released from commercial activities and products that are subject to TSCA is mixed in
with the naturally-formed formaldehyde released from all the activities and processes mentioned above.
This draft risk evaluation attempts to understand whether the risk from specific activities subject to
TSCA {i.e., the conditions of use) contribute to the unreasonable risk presented by formaldehyde. And
the risk estimates from some COUs representing workplaces clearly indicate that the direct use of
formaldehyde of those COUs contributes to the unreasonable risk of formaldehyde. However, EPA also
acknowledges that it is often difficult to understand what contribution various conditions of use are
making to the total level of formaldehyde to which a person is exposed in any given place at any given
time.
Taking that context into consideration, as well as the uncertainties in the overall risk estimates, EPA
examined whether the contribution of formaldehyde exposure from a COU was greater than or within
typical expected exposures from indoor air to inform EPA's preliminary determination of whether that
COU contributes to unreasonable risk. In this preliminary determination of formaldehyde unreasonable
risk:
1. EPA has a high level of certainty that 41 occupational COUs and has less certainty that 5
additional occupational COUs contribute to unreasonable risk due to non-cancer effects,
specifically sensory eye irritation associated with acute inhalation of formaldehyde;
2. EPA has a high level of certainty that 7 consumer COUs contribute to the unreasonable risk due
to non-cancer effects, specifically sensory eye irritation associated with acute inhalation of
formaldehyde;
3. EPA has a high level of certainty that 10 occupational COUs and has less certainty that 35
additional occupational COUs contribute to the unreasonable risk due to non-cancer effects,
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specifically respiratory and non-respiratory health effects in workers, including reduced
pulmonary function, increased asthma prevalence, reduced asthma control, allergy-related
conditions, male and female reproductive toxicity, and developmental effects, associated with
chronic inhalation exposures;
4. EPA is less certain about the contribution from 3 consumer COUs to the unreasonable risk due to
non-cancer effects, specifically respiratory and non-respiratory health effects, including reduced
pulmonary function, increased asthma prevalence, reduced asthma control, allergy-related
conditions, male and female reproductive toxicity, and developmental effects, associated with
chronic inhalation exposures; and
5. EPA is less certain about the contribution from 1 occupational COU to the unreasonable risk of
formaldehyde due to nasopharyngeal cancer from chronic inhalation exposures.
In this preliminary risk determination EPA has high level of certainty of the contribution to the
unreasonable risk of formaldehyde from a COU when the risk from such COU is much greater than the
risk expected from the formaldehyde based on monitored concentrations in the indoor air, and EPA is
less certain of the contribution by the COU when the risk from the COU is within the expected risk
based on monitored concentrations in the indoor air. In addition, most of the occupational and consumer
COUs (47 and 7, respectively) contribute to the unreasonable risk due to non-cancer effects, specifically
dermal sensitization associated with acute dermal exposure, meaning that skin contact can result in an
allergic response.
Taking those uncertainties into consideration, in this preliminary determination EPA is concluding that
the following COUs contribute to the unreasonable risk (see Table 2-1 and Table 2-2 for further detail
regarding the contribution from each COU):
• 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; and
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; and
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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;
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; and
o oxidizing/ reducing agent; processing aids, not otherwise listed
• Industrial use - chemical substances in industrial products - paints and coatings; adhesives and
sealants; lubricants
• 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;
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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;
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; and
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 Laundry and dishwashing products;
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; and
o Ink, toner, and colorant products; photographic supplies
• Disposal
In this preliminary determination, EPA concludes that the following COUs are not expected to
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 machinery, mechanical appliances, electrical/electronic articles; other
machinery, mechanical appliances, electronic/electronic articles; and
• Consumer use in lawn and garden products.
Whether EPA makes a determination of unreasonable risk for a particular chemical substance under
amended TSCA depends upon risk-related factors beyond exceedance of benchmarks, such as the
endpoint under consideration, the reversibility of effect, exposure-related considerations (e.g., duration,
magnitude, or frequency of exposure, or population exposed), and the confidence in the information
used to inform the hazard and exposure values. In this draft risk evaluation, the Agency describes the
strength of the scientific evidence supporting the exposure assessment as robust, moderate, slight, or
indeterminate. When the assessment is supported by robust evidence, overall confidence in the exposure
assessment is high; when supported by moderate evidence, overall confidence is medium; when
supported by slight evidence, overall confidence is low. The Agency also evaluated the weight of
scientific evidence supporting hazard assessment and dose response. This draft risk evaluation discusses
the weight of scientific evidence and overall confidence in the exposure assessment as well as the
hazard assessment in the Draft Human Health Risk Assessment for Formaldehyde. The Draft
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Environmental Risk Assessment for Formaldehyde 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 are discussed in the Draft Chemistry, Fate, and
Transport Assessment for Formaldehyde. These and other formaldehyde risk evaluation "modules" as
well as scoping, assessments, and other documents and spreadsheets can be accessed in the docket
HO-OPPT-2018-043 8.
In the formaldehyde unreasonable risk determination, EPA considered risk estimates with an overall
confidence rating of low, medium, or high. In general, the Agency makes an unreasonable risk
determination based on risk estimates that have an overall confidence rating of medium or high, since
those confidence ratings indicate the scientific evidence is adequate to characterize risk estimates despite
uncertainties. For COUs that had a low confidence rating, EPA is concluding at this time that these
COUs do not contribute to the unreasonable risk of formaldehyde.
If in the final TSCA risk evaluation for formaldehyde, EPA determines that formaldehyde presents an
unreasonable risk of injury to health or the environment under the COUs, the Agency will initiate risk
management rulemaking to mitigate identified unreasonable risk associated with formaldehyde under
the COUs by applying one or more of the requirements under TSCA section 6(a) to the extent necessary
so that formaldehyde no longer presents such risk. EPA 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.
2.1 Unreasonable Risk to Human Health
This assessment provides 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). 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 addition, the risk estimates are
based on exposure scenarios with monitoring data that likely reflects existing requirements, such as
those established by EPA {i.e., National Emission Standards for Hazardous Air Pollutants [NESHAP]
under the Clean Air Act), OSHA {i.e., formaldehyde standard), or industry or sector best practices.
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. For example, before determining
whether a COU contributed to the unreasonable risk of formaldehyde to the general population, the
Agency compared the exposures and risk estimates for people living and working near formaldehyde
release sources (fenceline populations) with risk estimates from "background" air concentrations of
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formaldehyde {i.e., ambient or outdoor air that includes formaldehyde typically released from
"biogenic" or other non-TSCA sources).
2.1.1 Populations and Exposures EPA Assessed to Determine Unreasonable Risk to
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. With respect to health endpoints upon which EPA is
basing this preliminary unreasonable risk determination, the Agency has medium or high confidence in
the following point of departures (PODs): (1) nasopharyngeal cancer due to chronic inhalation; (2) non-
cancer effects (sensory irritation) due to acute inhalation; (3) non-cancer respiratory effects (reduced
pulmonary function, allergy-related conditions, asthma, and sensory irritation) due to chronic inhalation;
and (4) non-cancer effects (sensitization) due to acute dermal exposure. EPA evaluated risk from
inhalation and dermal exposure of formaldehyde to workers as well as inhalation exposures to ONUs.
The Agency evaluated risk from inhalation and dermal exposure to consumer users and risk from
inhalation exposure to bystanders. Finally, EPA also evaluated risk from inhalation exposure to the
general population.
Oral exposures were not assessed quantitatively as there is no supporting evidence that the oral route is a
reasonably foreseen route of exposure for occupational and general populations ((see Draft Human
Health Risk Assessment for Formaldehyde). 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 (see Draft Consumer Exposure
Assessment for Formaldehyde). Descriptions of the data used for human health exposure and human
health hazards are provided in the Draft Human Health Risk Assessment for Formaldehyde.
Uncertainties for overall exposures and hazards are presented in the Draft Human Health Risk
Assessment for Formaldehye and summarized separately in the Occupational, Consumer, Indoor Air,
and Ambient Air Exposure Assessments Modules, and are considered in this preliminary unreasonable
risk determination.
2.1.2 Summary of Unreasonable Risks to Human Health
EPA is preliminarily determining that the unreasonable risks presented by formaldehyde are due to
• non-cancer effects in workers from inhalation and acute dermal exposures;
• cancer effects for some workers from inhalation exposures under one condition of use;
• non-cancer effects in occupational non-users (ONUs) from inhalation exposures; and
• non-cancer effects in consumers and bystanders from inhalation and acute dermal exposures.
Table 2-1 and Table 2-2 provide further detail regarding which COUs contribute to the above health
effects.
EPA's exposure and overall risk characterization confidence levels are summarized in the Draft Human
Health Risk Assessment for Formaldehyde as are health risk estimates for workers, including ONUs, the
general population, consumers, and bystanders
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
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susceptibility than the general population to the hazard posed by formaldehyde. The Agency identified
as potentially exposed or susceptible subpopulation(s) (PESS) people who are expected to have greater
exposure to formaldehyde, such as workers exposed to formaldehyde, 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 Draft Human Health Risk Assessment for Formaldehyde).
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, nasal damage. A full
PESS analysis is in Appendices C. 1 and C.2 of the Draft 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 levels whereas risk estimates at the central tendency exposure are
generally estimates of average or typical exposure. EPA aggregated exposures across certain routes and
exposure scenarios for consumers and bystanders for COUs with quantitative risk estimates. The
uncertainty factors of 10 (acute inhalation due to sensory irritation and acute dermal due to sensitization)
and 3 (chronic inhalation due to respiratory effects) for human variability that EPA applied to MOEs
accounts for increased susceptibility of populations such as children and elderly populations. EPA also
generally relies on high-end exposure levels to make an unreasonable risk determination to capture
vulnerable populations that are expected to have higher exposures. For cancer, although there is likely to
be variability in susceptibility across the human population, EPA did not identify specific human groups
that are expected to be more susceptible to cancer following formaldehyde exposure. Therefore, for
cancer risk, EPA is using central tendency risk estimates as staring point to inform the risk
determination. More information on how EPA characterized sentinel and aggregate risks is provided in
the Human Health Risk Assessment, Section 4.3.
2.1.4 Unreasonable Risk in Occupational Settings
Based on the occupational risk estimates and related risk factors, EPA is preliminarily determining that
the non-cancer risks from worker acute inhalation and dermal exposure to formaldehyde in occupational
settings contribute to the unreasonable risk presented by formaldehyde. EPA is also preliminarily
determining that chronic inhalation exposures to formaldehyde workers and in occupational settings
contribute to the unreasonable risk presented by formaldehyde. Cancer risks in excess of the benchmark
(lxlO"4) were identified for one COU for worker chronic inhalation exposure: automotive care products;
lubricants and greases; fuels and related products. Products under this commercial COU include
polishes, waxes, and other detailing products such as a vinyl coatings, greases and other lubricants used
in the maintenance of automobiles, machinery, and other equipment. EPA did not make a preliminary
risk determination for one COU that presents slight evidence and therefore was of low confidence.
For COUs assessed, worker risks were evaluated using the central tendency and high-end estimates to
account for susceptible populations that may be exposed while working. In a majority of the COUs, non-
cancer risks were found for both central tendency and high-end exposures, while cancer risks were
mainly found for high-end exposures. There were no COUs assessed qualitatively for the occupational
analysis.
EPA analyzed the occupational scenarios using a time weighted average for a typical 8-hour shift as well
as a 12-hour shift. The risk determination is only based on a time weighted average for 8-hours as this is
the most common scenario and also represents a more conservative estimate of risk to account for
susceptible populations. For many COUs assessed, ONUs were evaluated using the central tendency
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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. For three COUs, (i) manufacturing; (ii)
processing as a reactant; and (iii) processing, incorporation into an article: additive in rubber product
manufacturing, EPA had specific ONU data, and these COUs were evaluated using the ONU high-end
exposures. Additionally, EPA evaluated dermal exposures only for workers since ONUs are not
expected to directly handle formaldehyde.
Non-cancer risk estimates were calculated from acute and chronic exposures. These terms are in
reference to the duration of exposure to formaldehyde. Acute refers to an exposure time frame of 24
hours or less (15 minutes for inhalation) and chronic refers to an exposure time frame of greater than
three months. Chronic cancer risk estimates include 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.
EPA considered other sources of formaldehyde in the outdoor and indoor environments to provide a
rational context for interpreting the inhalation risk estimates of the occupational uses. For example,
biogenic sources of formaldehyde result in outdoor air concentrations of about 0.28 |ig/m3; the
maximum monitored ambient air concentration of formaldehyde was 60.1 |ig/m3 and the maximum
modeled formaldehyde concentration was 50.5 |ig/m3 The monitored indoor air concentrations of
formaldehyde (collected from March 2018 to June 2019) range from 0.27 to 124.2 |ig/m3 for all homes,
with 95% of homes having concentrations below -40 |ig/m3, and other reports suggest candles, incense,
cooking and wood combustion activities can emit formaldehyde with concentrations up to 44.2 |ig/m3.
Across all conditions of use, full work shift (8 to 12 hours) inhalation exposure concentrations of
formaldehyde were between 7.5 to 17,353.3 |ig/m3 for workers and ONUs. Therefore, some inhalation
exposure concentrations for workers and ONUs are within the outdoor and indoor air concentrations,
and some, are greater than what would be expected from total indoor and outdoor exposures. In this
preliminary risk determination EPA has high level of certainty of the contribution of an occupational
COU when the risk from such occupational COUs is much greater than the risk expected from the
formaldehyde based on monitored concentrations in the indoor air, and EPA is less certain of the
contribution by the occupational COU when the risk from the COU is within the expected risk based on
monitored concentrations in the indoor air. Most of the occupational COUs contribute to the
unreasonable risk presented by formaldehyde due to acute dermal exposures at the workplace.
More information on EPA's confidence in these risk estimates and the uncertainties associated with
them can be found in the Draft Human Health Risk Assessment for Formaldehyde.
2.1.5 Unreasonable Risk to Consumers
Based on the consumer risk estimates and related risk factors, EPA is preliminarily determining that
non-cancer risks from acute inhalation exposure to formaldehyde for consumer users and bystanders and
chronic inhalation for consumers contribute to the unreasonable risk of formaldehyde. 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. Several of the consumer COUs assessed indicated
that the consumer dermal exposures contribute to the unreasonable risk of formaldehyde. In addition,
chronic risk was not assessed for some COUs because EPA does not expect consumers to use the
products or articles containing formaldehyde for a length of time that would result in chronic exposure
to formaldehyde. EPA is not finding that cancer risk due to chronic inhalation exposures to consumers
and bystanders contribute to the unreasonable risk of formaldehyde.
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Consumers and bystander risks were evaluated for consumer COUs that represent specific age groups.
Typically, consumers are adults since most 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 appropriate 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 it is unclear how a consumer exposure would occur during a normal use of an electronic
product, such as a circuit board component located within an electronic product. 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 (see Human
Health Risk Assessment Module).
For all of the consumer COUs, EPA evaluated the risk to consumers and bystanders using the high-end
exposures to account for vulnerable populations that are expected to have higher exposures to certain
uses, such as children with asthma.
Similar to occupational COUs, EPA considered other sources of formaldehyde in the outdoor and indoor
environment to provide a rational context for interpreting the inhalation risk estimates of the consumer
uses. For example, biogenic sources of formaldehyde result in outdoor air concentrations of about 0.28
|ig/m3; the maximum monitored ambient air concentration of formaldehyde was 60.1 |ig/m3 and the
maximum modeled formaldehyde concentration is 50.5 |ig/m3; and the monitored indoor air
concentrations of formaldehyde (collected from March 2018 to June 2019) range from 0.27 to 124.2
|ig/m3 for all homes, with 95 percent of homes having concentrations below -40 |ig/m3, and other
reports suggest candles, incense, cooking and wood combustion alone can emit formaldehyde with
concentrations up to 44.2 |ig/m3. In this preliminary determination, EPA has high level of certainty to
the contribution of a consumer COU when the risk from such consumer COU is much greater than the
risk expected from the formaldehyde in the indoor air, and EPA is less certain of the contribution by the
consumer COU when the risk from the COU is within the expected risk from indoor air. Most of the
consumer COUs contribute to the unreasonable risk presented by formaldehyde due to acute dermal
exposures.
EPA has high 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 Draft Human Health Risk
Assessment for Formaldehyde.
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2.1,6 Unreasonable Risk to the General Population
Based on the risk estimates calculated using releases from manufacturing, processing, and industrial
uses of formaldehyde, and related risk factors, EPA is preliminarily determining that there are no cancer
risk effects that contribute to the unreasonable risk of formaldehyde to the general population, including
people living or working near facilities (fenceline populations) from the ambient air. In addition, EPA is
preliminarily determining that there are non-cancer risk effects to the general population due to chronic
inhalation exposure from consumer products in residences and automobiles for four of the consumer
COUs assessed which contribute to the unreasonable risk of formaldehyde in indoor air.
For members of the general population exposed due to releases from the COUs, EPA considers a cancer
risk benchmark range of 1x 10~4 to 1 x 10 6; however, the benchmark is not considered a "bright-line" and
other risk related factors were considered. EPA considered other sources of formaldehyde in the outdoor
and indoor environment to provide a rational context for interpreting the risk estimates to the general
population. For example, EPA also considered the biogenic sources which result in outdoor air
concentrations of about 0.28 |ig/m3, and the estimated annual ambient (outdoor) air concentration near
releasing facilities, which ranged from 0.0001 to 5.75 |ig/m3 for formaldehyde COUs. EPA also
considered concentrations of formaldehyde monitored in ambient air, which ranged from below the
method detection limit to 60.1 |ig/m3 and a median value of 1.6 |ig/m3.
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.
Inhalation — Ambient Air
EPA is using the results from IIOAC modeling in the formaldehyde ambient air assessment to determine
whether there is unreasonable risk under the COUs to individuals living 100 to 1,000 m from industrial
facilities that report air releases of formaldehyde attributable to its domestic manufacturing, import,
processing, and industrial COUs. 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 general
population exposed to formaldehyde. EPA did not include other commercial COUs of formaldehyde in
its ambient air assessment because those commercial releases associated with commercial COUs are
generally lower than industrial releases (for example commercial uses related to adhesives and sealants,
construction and building materials, automotive care products).
The maximum outdoor air concentration near releasing facilities from the COUs is up to 5.7 |ig/m3,
which is below the maximum monitored ambient air concentration of 60.1 |ig/m3. These data suggest
that formaldehyde contributions from the COUs are not substantially higher than formaldehyde
concentrations that are expected to occur due to background levels. As a result, EPA has preliminarily
determined that no formaldehyde COUs contribute to the unreasonable risk of formaldehyde for cancer
to the general population. Cancer inhalation risk estimates from IIOAC modeling and from
AirToxScreen modeling of biogenic and secondary formation sources are presented in the Draft Human
Health Risk Assessment for Formaldehyde. EPA's confidence in inhalation risk estimates for cancer risk
is moderate at both 100 and 1,000 m.
For one COU, distribution in commerce, EPA did not find any information to evaluate releases via
ambient air. EPA also did not expect this COU to be similar to other COUs evaluated and therefore
could not use similar data.
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EPA has high confidence in the overall characterization of exposures for this ambient air exposure
assessment due to the use of environmental release data from multiple sources. The greatest uncertainty
is associated with the contribution to the total formaldehyde in ambient monitoring data from the COUs
due to the contributions from biogenic sources and other background sources. More information on
EPA's confidence in these risk estimates and the uncertainties associated with them can be found in the
Draft Human Health Risk Assessment Module.
Inhalation — Indoor Air
EPA estimated cancer and non-cancer risks in indoor air for four consumer COUs via the inhalation
pathway in two common indoor environments: automobile and residential. These COUs were chosen
because they represent the most common products found in these two indoor environments. 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 (residential);
• Fabric, textile, and leather products not covered elsewhere (clothing) (residential and
automobile);
• 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 (residential);
• Paper products; Plastic and rubber products; Toys, playground, and sporting equipment
(residential).
EPA considered available indoor air monitoring data as well as air concentrations modeled based on
emissions associated with the four COUs assessed, as described in thz Draft Indoor Air Exposure
Assessment for Formaldehyde. The cancer risk estimates are based on indoor monitoring data based on
the assumptions that those concentrations represent an average exposure over a 78-year lifetime. The
basis for chronic non-cancer and cancer risk estimates for indoor air were designed to estimate
concentrations at the central tendency because this represents the most common scenario in an indoor
environment.
The monitored indoor air concentrations of formaldehyde (collected from March 2018 to June 2019)
range from 0.27 to 124.2 |ig/m3 for all homes, with 95 percent of homes having concentrations below
-40 |ig/m3, and other reports suggest candles, incense, cooking and wood combustion can emit
formaldehyde with concentrations up to 44.2 |ig/m3. The risk estimates in the indoor 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.
The data used for cancer risk estimates was based on monitoring conducted before the Formaldehyde
Emissions Standards for Composite Wood Products final rule pursuant to Title VI of TSCA that was
enacted in 2018. TSCA Title VI reduces exposure to formaldehyde emissions from certain composite
wood products such as hardwood plywood, medium density fiberboard, and particleboard. By including
certain requirements for these composite wood products such as product-testing requirements, labeling,
recordkeeping, and import certification, TSCA Title VI ensures that hardwood plywood, medium-
density fiberboard, and particleboard products sold, supplied, offered for sale, imported to, or
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manufactured in the United States comply with EPA's emission standards. In addition, by March 2024,
laminated products—a type of product in which a wood veneer is applied to a composite wood core—
will be considered hardwood plywood, significantly expanding the scope of TSCA Title VI to further
reduce formaldehyde emissions from composite wood products. Similarly, the chronic non-cancer risk
estimates for indoor air are based on studies with medium level of confidence regarding the use of the
COU-specific emission rates, and the transformation of formaldehyde once it is released from the
articles. Therefore, in this preliminary determination, EPA is finding that the COUs related to exposure
in residences from wood articles does not contribute to the unreasonable risk of formaldehyde. In
addition, in this preliminary determination, EPA finds that based on the risk estimates of the other COUs
evaluated, those COUs do not contribute to the unreasonable risk of formaldehyde based on chronic
inhalation exposures to the general population.
EPA's overall confidence in the indoor air consumer analysis was medium. More information on EPA's
confidence in these risk estimates and the uncertainties associated with them can be found in the Draft
Human Health Risk Assessment for Formaldehyde of the draft risk evaluation.
2.2 Unreasonable Risk to the 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
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 to Determine Unreasonable Risk to the
Environment
For terrestrial organisms, EPA evaluated exposures via air. EPA 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 high confidence in environmental releases for industrial COUs1 and low
to medium confidence in commercial COUs. Environmental fate and transport data indicate
formaldehyde does not bioaccumulate. EPA concluded that risk to terrestrial organisms via the dietary
pathway is not indicated. EPA has high confidence in this assessment conclusion.
1 COUs that are included under the life cycle stage of manufacturing, processing, and industrial use.
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2.2.2 Summary of Unreasonable Risks to the Environment
EPA quantitatively assessed risk via the ambient air pathway for the COUs evaluated and is
preliminarily identifying:
• no indication of risk to terrestrial mammals through air exposure because air concentrations are
much lower than the most sensitive toxicity value;
• no indication of risk to other terrestrial taxa, because even though no inhalation toxicity data are
available for other terrestrial species, there are orders of magnitude difference in the toxicity and
exposure for mammals; and
• no indication of risk to plants from formaldehyde exposures in ambient air because air
concentrations are an order of magnitude less than the most sensitive toxicity value.
EPA qualitatively assessed risk via the surface water, dietary, and land pathways and concluded that
these were not relevant pathways of exposure and is preliminarily identifying:
• 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. EPA has high confidence in its environmental
assessment conclusion.
2.2.3 Basis for Unreasonable Risk of Injury to the Environment
Based on the draft risk evaluation for formaldehyde—including the risk estimates, the environmental
effects of formaldehyde, the exposures, physical-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 EPA 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 the Draft 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 draft unreasonable risk determination of injury to
human health and the environment presented in this draft formaldehyde risk evaluation. In these tables, a
checkmark (V) indicates how the COU 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 1, for this draft 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 Draft 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.
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Table 2-1. Supporting Basis for the Draft Unreasonable Risk Determination for Human Health (Occupational Conditions of Use)
¦S EPA has high level of certainty of the contribution to the unreasonable risk
~ EPA has less certainty of the contribution to the unreasonable risk
Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Human Health Effects''
Acute
Non-cancer
Chronic
Non-cancer
Cancer
Manufacturing
Domestic
Manufacturing
Domestic Manufacturing
Worker
Dermal
V
Inhalation
S
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Import
Import
Worker
Dermal
S
Inhalation
V
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Processing
Processing -
reactant
Use in adhesives and sealant chemicals
Worker
Dermal
V
Inhalation
S
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Use as an intermediate
Worker
Dermal
V
Inhalation
S
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Use as a functional fluid
Worker
Dermal
S
Inhalation
V
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Worker
Dermal
S
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Life Cycle
Stage
Human Health Effects''
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Chronic
Non-cancer
Cancer
Processing aids, specific to petroleum
production in all other basic chemical
manufacturing
Inhalation
•/
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Worker
Dermal
Processing -
reactant
Bleaching agent in wood product
manufacturing
Inhalation
•/
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Worker
Dermal
S
Agricultural chemicals in agriculture,
forestry, fishing, and hunting
Inhalation
V
~
ONU
Inhalation
Processing
General
Population
Inhalation -
Ambient Air
Worker
Dermal
S
Finishing agents in textiles, apparel, and
leather manufacturing
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
S
Inhalation
V
V
Processing -
incorporation
into an article
ONU
Inhalation
V
General
Population
Inhalation -
Ambient Air
Worker
Dermal
Inhalation
S
Additive in rubber product manufacturing
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Adhesives and sealant chemicals in wood
Worker
Dermal
S
product manufacturing
Inhalation
V
V
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Life Cycle
Stage
Human Health Effects''
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Chronic
Non-cancer
Cancer
ONU
Inhalation
•/
V
General
Inhalation -
Population
Ambient Air
Worker
Dermal
•/
Inhalation
~
Petrochemical manufacturing
ONU
Inhalation
•/
General
Inhalation -
Population
Ambient Air
Worker
Dermal
V
Asphalt, paving, roofing, and coating
materials manufacturing
Inhalation
S
~
ONU
Inhalation
V
General
Population
Inhalation -
Ambient Air
Worker
Dermal
V
Processing -
incorporation
into
Solvents (which become part of a product
Inhalation
S
~
formulation or mixture) in paint and coating
ONU
Inhalation
V
manufacturing
General
Inhalation -
Processing
formulation,
Population
Ambient Air
mixture, or
reaction
product
Worker
Dermal
S
Processing aids, specific to petroleum
production
Inhalation
S
~
ONU
Inhalation
V
General
Population
Inhalation -
Ambient Air
Worker
Dermal
S
Paint additives and coating additives not
described by other categories
Inhalation
V
~
ONU
Inhalation
S
General
Population
Inhalation -
Ambient Air
Worker
Dermal
S
Processing for use as an intermediate
Inhalation
V
~
ONU
Inhalation
S
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Life Cycle
Stage
Human Health Effects''
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Chronic
Non-cancer
Cancer
Inhalation -
Ambient Air
General
Population
Worker
Dermal
~
Solid separation agents in miscellaneous
manufacturing
Inhalation
V
~
Processing -
ONU
Inhalation
S
Processing
incorporation
into
General
Population
Inhalation -
Ambient Air
formulation,
mixture, or
reaction
Worker
Dermal
V
Inhalation
S
~
product
Agricultural chemicals (nonpesticidal)
ONU
Inhalation
V
General
Population
Inhalation -
Ambient Air
Worker
Dermal
V
Surface active agents in plastic material and
resin manufacturing
Inhalation
S
~
ONU
Inhalation
V
General
Population
Inhalation -
Ambient Air
Worker
Dermal
V
Ion exchange agents in adhesive
Inhalation
S
~
manufacturing and paint and coating
ONU
Inhalation
V
manufacturing
General
Population
Inhalation -
Ambient Air
Lubricant and lubricant additive in adhesive
Worker
Dermal
S
manufacturing
Inhalation
V
~
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Life Cycle
Stage
Human Health Effects''
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Chronic
Non-cancer
Cancer
ONU
Inhalation
•/
General
Inhalation -
Population
Ambient Air
Worker
Dermal
•/
Plating agents and surface treating agents in
Inhalation
~
all other chemical product and preparation
ONU
Inhalation
•/
manufacturing
General
Population
Inhalation -
Ambient Air
Worker
Dermal
V
Soap, cleaning compound, and toilet
preparation manufacturing
Inhalation
S
~
Processing -
incorporation
into
formulation,
mixture, or
ONU
Inhalation
V
General
Inhalation -
Processing
Population
Ambient Air
Worker
Dermal
V
reaction
Inhalation
S
~
product
Laboratory chemicals
ONU
Inhalation
V
General
Inhalation -
Population
Ambient Air
Worker
Dermal
S
Adhesive and sealant chemical in adhesive
manufacturing
Inhalation
S
~
ONU
Inhalation
V
General
Population
Inhalation -
Ambient Air
Worker
Dermal
S
Bleaching agents in textile, apparel, and
leather manufacturing
Inhalation
V
~
ONU
Inhalation
S
General
Population
Inhalation -
Ambient Air
Repackaging
Sales to distributors for laboratory
chemicals
Worker
Dermal
S
Inhalation
V
~
ONU
Inhalation
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Life Cycle
Stage
Category
Subcategory
Population
Exposure Route"
Human Health Effects''
Acute
Non-cancer
Chronic
Non-cancer
Cancer
General
Population
Inhalation -
Ambient Air
Recyling
Recycling
Worker
Dermal
~
Inhalation
•/
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Distribution in
Commerce
Distribution in
Commerce
Distribution in commerce
Worker
Dermal
Inhalation
V
V
ONU
Inhalation
V
General
Population
Inhalation -
Ambient 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
S
Inhalation
V
ONU
Inhalation
V
General
Population
Inhalation -
Ambient Air
Use in construction
Worker
Dermal
V
Inhalation
S
V
ONU
Inhalation
V
General
Population
Inhalation -
Ambient Air
Oxidizing/reducing agent; processing aids,
not otherwise listed
Worker
Dermal
V
Inhalation
S
~
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Industrial
products
Paints and coatings; adhesives and sealants;
lubricants
Worker
Dermal
V
Inhalation
S
V
ONU
Inhalation
V
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Life Cycle
Stage
Human Health Effects''
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Chronic
Non-cancer
Cancer
General
Population
Inhalation -
Ambient Air
Floor coverings; foam seating and bedding
Worker
Dermal
~
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.
Inhalation
•/
V
Furnishing
treatment/ care
products
ONU
Inhalation
V
Treatment
products
Worker
Dermal
V
Water treatment products
Inhalation
S
~
ONU
Inhalation
Treatment/ care
products
Worker
Dermal
S
Laundry and dishwashing products
Inhalation
Commercial
ONU
Inhalation
Use
Construction,
Worker
Dermal
V
paint,
electrical, and
metal products
Adhesives and sealants; Paint and coatings
Inhalation
S
V
ONU
Inhalation
V
Construction and building materials
Worker
Dermal
S
Furnishing
treatment/care
products
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
Inhalation
V
V
ONU
Inhalation
V
Machinery, mechanical appliances,
Worker
Dermal
S
Electrical
products
electrical/electronic articles; other
machinery, mechanical appliances,
electronic/electronic articles
Inhalation
V
~
ONU
Inhalation
Metal products
Worker
Dermal
V
Inhalation
S
~
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Life Cycle
Stage
Human Health Effects''
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Chronic
Non-cancer
Cancer
Construction and building materials
covering large surface areas, including
metal articles
ONU
Inhalation
Automotive
Automotive care products; lubricants and
greases; fuels and related products
Worker
Dermal
•/
and fuel
Inhalation
S
V
~
products
ONU
Inhalation
V
~
Agriculture use
products
Worker
Dermal
S
Lawn and garden products
Inhalation
S
~
ONU
Inhalation
Outdoor use
products
Worker
Dermal
S
Commercial
Use
Explosive materials
Inhalation
V
~
ONU
Inhalation
Packaging,
paper, plastic,
Paper products; plastic and rubber products;
toys, playground, and sporting equipment
Worker
Dermal
Inhalation
hobby products
ONU
Inhalation
Packaging,
paper, plastic,
Worker
Dermal
V
Arts, crafts, and hobby materials
Inhalation
S
~
hobby products
ONU
Inhalation
~
Packaging,
paper, plastic,
Ink, toner, and colorant products;
photographic supplies
Worker
Dermal
S
Inhalation
V
~
hobby products
ONU
Inhalation
Products not
Worker
Dermal
V
described by
Laboratory chemicals
Inhalation
S
V
other codes
ONU
Inhalation
V
Worker
Dermal
S
Inhalation
V
~
Disposal
Disposal
Disposal
ONU
Inhalation
General
Population
Inhalation -
Ambient Air
Page 24 of 28
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Life Cycle
Stage
Human Health Effects''
Category
Subcategory
Population
Exposure Route"
Acute
Non-cancer
Chronic
Non-cancer
Cancer
" 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.
h Grayed-out boxes indicate certain exposure routes that were not assessed because it was determined that there was no viable exposure pathway.
Table 2-2. Supporting Basis for the Draft Unreasonable Risk Determination for Human Health (Consumer Conditions of Use)
¦S EPA has high level of certainty of the contribution to the unreasonable risk
~ EPA has less certainty of the contribution to the unreasonable risk
Life
Cycle
Stage
Category
Subcategory
Population"''
Exposure Route
Human Health Effects'
Acute Non-cancer
Chronic Non-
cancer
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
Y
Inhalation
V
Bystander
Inhalation
Y
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,
Adhesives and sealants; paint and coatings
Consumer
Dermal
Inhalation
¦/
~
Bystander
Inhalation
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Life
Cycle
Stage
Consumer
Use
Category
and metal
products
Subcategory
Population"''
Exposure Route
Human Health Effects'
Acute Non-cancer
Chronic Non-
cancer
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
V
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 care products; lubricants and
greases; fuels and related products
Consumer
Dermal
V
Inhalation
V
Bystander
Inhalation
Y
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
V
Inhalation
~
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.
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Life
Human Health Effects'
Cycle
Stage
Category
Subcategory
Population"''
Exposure Route
Acute Non-cancer
Chronic Non-
cancer
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.
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