TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-21-0189

Number: P-21-0189

TSCA Section 5(a)(3) Determination: The chemical substance is not likely to present an
unreasonable risk (5(a)(3)(C))

Chemical Name:

Specific: Fats and Glyceridic oils, algae, CASRN: 1353573-84-8.

Conditions of Use (intended, known, or reasonably foreseen)1:

Intended conditions of use (specific): Import and process for use as, and use as a feedstock in the
production of biomass based diesel, consistent with the manufacturing, processing, use,
distribution, and disposal information described in the PMN.

Known conditions of use: Applying such factors as described in footnote 1, EPA evaluated

whether there are known conditions of use and found none.

Reasonably foreseen conditions of use: Applying such factors as described in footnote 1, EPA
evaluated whether there are reasonably foreseen conditions of use and found use as a
chemical intermediate and as an additive (including in consumer products) as reasonably
foreseen based on prior TSCA submissions for analogous substances.

Summary: The chemical substance is not likely to present an unreasonable risk of injury to
health or the environment, without consideration of costs or other nonrisk factors, including an
unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by
the Administrator under the conditions of use, based on the risk assessment presented below.
EPA estimated that the new chemical substance could have limited persistence and low potential
for bioaccumulation, such that repeated exposures are not expected to cause food-chain effects
via accumulation in exposed organisms. Based on its estimated physical/chemical properties, and
test data on analogous chemical substances, EPA estimates that the chemical substance has low
environmental hazard and potential for the following human health hazards: skin irritation and
eye irritation. EPA concludes that the new chemical substance is not likely to present an
unreasonable risk under the conditions of use.

Fate: Environmental fate is the determination of which environmental compartment(s) a
chemical moves to, the expected residence time in the environmental compartment(s) and

1 Under TSCA § 3(4), the term "conditions of use" means "the circumstances, as determined by the Administrator,
under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed,
distributed in commerce, used, or disposed of." In general, EPA considers the intended conditions of use of a new
chemical substance to be those identified in the section 5(a) notification. Known conditions of use include activities
within the United States that result from manufacture that is exempt from PMN submission requirements.
Reasonably foreseen conditions of use are future circumstances, distinct from known or intended conditions of use,
under which the chemical substance may be manufactured, processed, distributed, used, or disposed of. EPA expects
that the identification of "reasonably foreseen" conditions of use will be made on a fact-specific, case-by-case basis.
EPA will apply its professional judgment and experience when considering factors such as evidence of current use
of the new chemical substance outside the United States, information about known or intended uses of chemical
substances that are structurally analogous to the new chemical substance, and conditions of use identified in an
initial PMN submission that the submitter omits in a revised PMN. The sources EPA uses to identify reasonably
foreseen conditions of use include searches of internal confidential EPA PMN databases (containing use information
on analogue chemicals), other U.S. government public sources, the National Library of Medicine's Hazardous
Substances Data Bank (HSDB), the Chemical Abstract Service STN Platform, REACH Dossiers, technical
encyclopedias (e.g., Kirk-Othmer and Ullmann), and Internet searches.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-21-0189

removal and degradation processes. Environmental fate is an important factor in determining
exposure and thus in determining whether a chemical may present an unreasonable risk. EPA
estimated physical/chemical and fate properties of the new chemical substance using data for
analogue(s) (CASRN 68002-70-0 and triglycerides). In wastewater treatment, the new chemical
substance is expected to be removed with an efficiency of 90% due to sorption and
biodegradation. Removal of the new chemical substance by biodegradation is high. Sorption of
the new chemical substance to sludge is expected to be strong to very strong and to soil and
sediment is expected to be very strong. Migration of the new chemical substance to groundwater
is expected to be negligible due to very strong sorption to soil and sediment and biodegradation.
Due to low estimated vapor pressure and Henry's law constant, the new chemical substance is
expected to undergo negligible volatilization to air. Overall, these estimates indicate that the new
chemical substance has low potential to volatilize to air or migrate to groundwater.

Persistence2: Persistence is relevant to whether a new chemical substance is likely to present an
unreasonable risk because chemicals that are not degraded in the environment at rates that
prevent substantial buildup in the environment, and thus increase potential for exposure, may
present a risk if the substance presents a hazard to human health or the environment. EPA
estimated degradation half-lives of the new chemical substance using data for analogue(s)
(CASRN 68002-70-0). EPA estimated that the new chemical substance's aerobic and anaerobic
biodegradation half-lives are < 2 months. These estimates indicate that the new chemical
substance may have limited persistence in aerobic environments (e.g., surface water) and
anaerobic environments (e.g., sediment).

Bioaccumulation3: Bioaccumulation is relevant to whether a new chemical substance is likely to
present an unreasonable risk because substances that bioaccumulate in aquatic and/or terrestrial
species pose the potential for elevated exposures to humans and other organisms via food chains.
EPA estimated the potential for the new chemical substance to bioaccumulate using data for
analogue(s) (triglycerides). EPA estimated that the new chemical substance has low
bioaccumulation potential based on expected metabolism. EPA estimated that the new chemical
substance could have limited persistence and low potential for bioaccumulation, such that
repeated exposures are not expected to cause food-chain effects via accumulation in exposed
organisms.

2	Persistence: A chemical substance is considered to have limited persistence if it has a half-life in water, soil or
sediment of less than 2 months or if there are equivalent or analogous data. A chemical substance is considered to be
persistent if it has a half-life in water, soil or sediments of greater than 2 months but less than or equal to 6 months
or if there are equivalent or analogous data. A chemical substance is considered to be very persistent if it has a half-
life in water, soil or sediments of greater than 6 months or if there are equivalent or analogous data. (64 FR 60194;
November 4, 1999)

3	Bioaccumulation: A chemical substance is considered to have a low potential for bioaccumulation if there are
bioconcentration factors (BCF) or bioaccumulation factors (BAF) of less than 1,000 or if there are equivalent or
analogous data. A chemical substance is considered to be bioaccumulative if there are BCFs or BAFs of 1,000 or
greater and less than or equal to 5,000 or there are equivalent or analogous data. A chemical substance is considered
to be very bioaccumulative if there are BCFs or BAFs of 5,000 or greater or if there are equivalent or analogous
data. (64 FR 60194; November 4 1999)

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Human Health Hazard4: Human health hazard is relevant to whether a new chemical substance
is likely to present an unreasonable risk because the significance of the risk is dependent upon
both the hazard (or toxicity) of the chemical substance and the extent of exposure to the
substance. EPA estimated the human health hazard of this chemical substance based on its
estimated physical/chemical properties, by comparing it to structurally analogous chemical
substances for which there are information on absorption and human health hazard, and other
structural information. Absorption for the new chemical substance is expected to be moderate
through the skin and nil through the lungs based on physical/chemical properties. Absorption
through the gastrointestinal (GI) tract is expected to be good based on analogue data (OECD
SIDS for Glycerides, 2014). For the new chemical substance, EPA identified skin and eye
irritation as hazards based on test data for an analogue, and the OECD SIDS glycerides category.
No systemic effects were identified for the new chemical substance. This is supported by the
OECD SIDS Initial Assessment Profile for Glycerides (2014), which identified repeated dose
oral toxicity data for three triglycerides (CASRNs 538-23-8, 85409-09-2, and 73398-61-5). One
of these (CASRN 538-23-8) showed evidence of reproductive and developmental effects and
systemic effects. EPA identified a NOAEL of 2,390 mg/kg-bw/day. EPA qualitatively evaluated
irritation effects.

Environmental Hazard5: Environmental hazard is relevant to whether a new chemical
substance is likely to present unreasonable risk because the significance of the risk is dependent
upon both the hazard (or toxicity) of the chemical substance and the extent of exposure to the
substance. EPA estimated environmental hazard based on the negligible water solubility of the

4	A chemical substance is considered to have low human health hazard if effects are observed in animal studies with
a No Observed Adverse Effect Level (NOAEL) equal to or greater than 1,000 mg/kg/day or if there are equivalent
data on analogous chemical substances; a chemical substance is considered to have moderate human health hazard if
effects are observed in animal studies with a NOAEL less than 1,000 mg/kg/day or if there are equivalent data on
analogous chemical substances; a chemical substance is considered to have high human health hazard if there is
evidence of adverse effects in humans or conclusive evidence of severe effects in animal studies with a NOAEL of
less than or equal to 10 mg/kg/day or if there are equivalent data on analogous chemical substances. EPA may also
use Benchmark Dose Levels (BMDL) derived from benchmark dose (BMD) modeling as points of departure for
toxic effects. See https://www.epa.gov/bmds/what-benchmark-dose-software-bmds. Using this approach, a BMDL
is associated with a benchmark response, for example a 5 or 10 % incidence of effect. The aforementioned
characterizations of hazard (low, medium, high) would also apply to BMDLs. In the absence of animal data on a
chemical or analogous chemical substance, EPA may use other data or information such as from in vitro assays,
chemical categories (e.g., Organization for Economic Co-operation and Development, 2014 Guidance on Grouping
of Chemicals, Second Edition. ENV/JM/MONO(2014)4. Series on Testing & Assessment No. 194. Environment
Directorate, Organization for Economic Co-operation and Development, Paris, France.

(http://www.oecd.org/officialdocuments/publicdisplavdocumentpdf/?cote=env/im/mono(2014)4&doclanguage=en)).
structure-activity relationships, and/or structural alerts to support characterizing human health hazards.

5	A chemical substance is considered to have low ecotoxicity hazard if the Fish, Daphnid and Algae LC50 values are
greater than 100 mg/L, or if the Fish and Daphnid chronic values (ChVs) are greater than 10.0 mg/L, or there are not
effects at saturation (occurs when water solubility of a chemical substance is lower than an effect concentration), or
the log Kow value exceeds QSAR cut-offs. A chemical substance is considered to have moderate ecotoxicity hazard
if the lowest of the Fish, Daphnid or Algae LC50s is greater than 1 mg/L and less than 100 mg/L, or where the Fish
or Daphnid ChVs are greater than 0.1 mg/L and less than 10.0 mg/L. A chemical substance is considered to have
high ecotoxicity hazard, or if either the Fish, Daphnid or Algae LC50s are less than 1 mg/L, or any Fish or Daphnid
ChVs is less than 0.1 mg/L (Sustainable Futures https://www.epa.gov/sustainable-futures/sustainable-futures-p2-
framework-manual).

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-21-0189

new chemical substance. This substance falls within the TSCA New Chemicals Category of
Esters.6 Acute and chronic toxicity values for fish, aquatic invertebrates, and algae are all no
effects at saturation. The new chemical substance is expected to have low environmental hazard.
Because hazards are not expected up to the water solubility limit, acute and chronic
concentrations of concern are not identified.

Exposure: The exposure to a new chemical substance is potentially relevant to whether a new
chemical substance is likely to present unreasonable risks because the significance of the risk is
dependent upon both the hazard (or toxicity) of the chemical substance and the extent of
exposure to the substance.

EPA estimates occupational exposure and environmental release of the new chemical substance
under the intended conditions of use described in the PMN using ChemSTEER (Chemical
Screening Tool for Exposures and Environmental Releases; https://www.epa.gov/tsca-screening-
tools/chemsteer-chemical-screening-tool-exposures-and-environmental-releases). EPA uses
EFAST (the Exposure and Fate Assessment Screening Tool; https://www.epa.gov/tsca-
screening-tools/e-fast-exposure-and-fate-assessment-screening-tool-version-2014) to estimate
general population, consumer, and environmental exposures.

EPA considers workers to be a potentially exposed or susceptible subpopulation (PESS) on the
basis of greater exposure potential compared to the general population. EPA also considers PESS
in conducting general population drinking water exposures by evaluating risks associated with
water intake rates for multiple age groups, ranging from infants to adults. EPA considers
consumers of specific products to be a potentially exposed or susceptible subpopulation on the
basis of greater exposure potential compared to the general population who do not use specific
products.

For this new chemical assessment, EPA assessed worker exposure via dermal exposure, and
inhalation exposures to workers are not expected. Releases to water, air, and landfill were
estimated. Exposure to the general population was assessed via drinking water. Exposure to the
general population was not assessed via fish ingestion because bioaccumulation potential was
evaluated to be low. Exposure to the general population was not assessed via groundwater
impacted by landfill leachate because exposures are expected to be negligible (below modeling
thresholds) under the intended conditions of use. Exposure to the general population was not
assessed via inhalation of stack air because no relevant hazards were identified for the new
chemical substance via inhalation. Exposure to the general population was not assessed via
inhalation of fugitive air because releases to fugitive air are not expected. Consumer exposures
were not assessed because consumer uses were not identified as intended conditions of use.

Risk Characterization: EPA applies a margin of exposure approach to calculate potential
human health risks of new chemicals. A benchmark (acceptable) margin of exposure (MOE) is
derived by applying uncertainty factors (UF) for the following types of extrapolations: intra-
species extrapolation (UFh = 10 to account for variation in sensitivity among the human
population), inter-species extrapolation (UFa = 10 to account for extrapolating from

6 TSCA New Chemicals Program (NCP) Chemical Categories, https://www.epa.gov/reviewing-new-chemicals-
under-toxic-substances-control-act-tsca/chemical-categories-used-review-new.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-21-0189

experimental animals to humans) and Lowest Observed Adverse Effect Level (LOAEL)-to-
NOAEL extrapolation (UFl = 10 to account for using a LOAEL when a NOAEL is not
available). Hence, in the New Chemicals Program, a benchmark MOE is typically 100 and 1,000
when NOAELs and LOAELs, respectively, are used to identify hazard. When allometric scaling
or pharmacokinetic modeling is used to derive an effect level, the UFh may be reduced to 3, for a
benchmark MOE of 30. The benchmark MOE is used to compare to the MOE calculated by
comparing the toxicity NOAEL or LOAEL to the estimated exposure concentrations. When the
calculated MOE is equal to or exceeds the benchmark MOE, the new chemical substance is not
likely to present an unreasonable risk. EPA assesses risks to workers considering engineering
controls described in the PMN but in the absence of personal protective equipment (PPE) such as
gloves and respirators. If risks are preliminarily identified, EPA then considers whether the risks
would be mitigated by the use of PPE (e.g., impervious gloves, respirator).

Risks to human health for the new chemical substance were evaluated using the route-specific
effect level (i.e., NOAEL) described above. Risks were not identified for workers for systemic
effects via dermal contact based on quantitative hazard data for an analogue (MOE =145;
Benchmark MOE = 100). Skin and eye irritation hazards to workers via dermal contact were
identified based on test data for an analogue and the OECD SIDS glycerides category. Risks for
these endpoints were not quantified due to a lack of dose-response for these hazards.

Risks were not identified for the general population for systemic effects via exposure to drinking
water based on quantitative hazard data for an analogue (MOEs > 1,000; Benchmark MOE =
100). Irritation hazards to the general population are not expected via drinking water ingestion
due to dilution of the chemical substance in the media. Risks were not evaluated for the general
population via fish ingestion because bioaccumulation potential was evaluated to be low. Risks
were not evaluated for the general population via groundwater impacted by landfill leachate
because exposures were below modeling thresholds (expected to be negligible). Risks were not
evaluated for the general population via stack air inhalation because inhalation hazards were not
identified. Risks were not evaluated for the general population via fugitive air inhalation because
releases to fugitive air are not expected. Risks to consumers were not evaluated because
consumer uses were not identified as intended conditions of use. Risks to the general population
from other reasonably foreseen uses are not expected because the calculated Drinking Water
Exposure Limit (DWEL) is very high (158,000 ppb), and for the risk calculation for the intended
conditions of use, the quantified MOE is significantly greater than the Benchmark MOE.

Because unreasonable risk was not identified for workers exposed to the neat substance,
unreasonable risk to consumers from other reasonably foreseen uses is not expected.

Risks from acute and chronic exposures to the environment are not expected at any concentration
due to the water solubility limit of the new chemical substance (i.e., no effects at saturation).

Because no unreasonable risks to workers, the general population, or environment were
identified, and unreasonable risks to consumers from reasonably foreseen exposures were not
identified, EPA has determined that the new chemical substance is not likely to present
unreasonable risk to human health or the environment under the conditions of use.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-21-0189

03/02/2022

Date:

	/s/	

Madison H. Le, Director

New Chemicals Division

Office of Pollution Prevention and Toxics

U.S. Environmental Protection Agency

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