TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0041

Number: P-20-0041

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

Chemical Name:

Specific: 1,3-Benzenedicarboxylic acid, polymer with 3-methyl-l,5-pentanediol (CASRN
76962-70-4)

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

Intended conditions of use (generic): Import for use and use as a chemical intermediate for

coatings, 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

has identified use as a polyester resin in electrophotographic toner as reasonably foreseen
based on a patent.

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 and
the terms of the proposed Significant New Use Rule (SNUR) signed by EPA.2 Although EPA

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 Administrator expects the chemical substance to be manufactured, processed, distributed, used, or
disposed of. The identification of "reasonably foreseen" conditions of use will necessarily be a case-by-case
determination and will be highly fact-specific. Reasonably foreseen conditions of use will not be based on
hypotheticals or conjecture. EPA's identification of conditions of use includes the expectation of compliance with
federal and state laws, such as worker protection standards or disposal restrictions, unless case-specific facts indicate
otherwise. Accordingly, EPA will apply its professional judgment, experience, and discretion when considering such
factors as evidence of current use of the new chemical substance outside the United States, evidence that the PMN
substance is sufficiently likely to be used for the same purposes as existing 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.

2	Reasonably foreseen conditions of use subject to a proposed SNUR are not likely to present an unreasonable risk
of injury to health or the environment. Based on EPA's experience, it is the Agency's judgment that a new use
would not commence during the pendency of a proposed SNUR because web posting of a proposed SNUR serves as
the cut-off date for a significant new use. Therefore, manufacturers and processors would not commence a
prohibited new use that would be legally required to cease upon the finalization of the SNUR. Once a SNUR is final

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0041

estimated that the new chemical substance could be very persistent, the new chemical substance
has low potential for bioaccumulation, such that repeated exposures are not expected to cause
food-chain effects via accumulation in exposed organisms. Based on submitted test data on the
new chemical substance, comparison to structurally analogous chemical substances, and other
structural information, EPA estimates that the chemical substance has high environmental hazard
and potential for the following human health hazards: eye irritation. The PMN describes
conditions of use that mitigate the human health and environmental risks. Therefore, EPA
concludes that the new chemical is not likely to present unreasonable risk to human health or the
environment under the intended conditions of use.

As set forth below, the information available to EPA is sufficient to permit the Agency to
conduct a reasoned evaluation of the health and environmental effects of the chemical substance
under the conditions of use that are not subject to the proposed SNUR, in order to determine that
the chemical substance is not likely to present an unreasonable risk under those conditions of
use. As such, EPA does not need to impose testing requirements to conduct this evaluation.
Whether testing is needed to evaluate the effects of the intended, known, or reasonably foreseen
conditions of use of a chemical substance subject to a PMN is determined on a case-by-case
basis. To the extent that testing may be necessary to conduct a reasoned evaluation of the health
or environmental effects of the reasonably foreseen conditions of use that are subject to the
proposed SNUR, EPA will make the appropriate determination if a SNUN is submitted
following finalization of the SNUR.

EPA found no known conditions of use, assessed the intended conditions of use, and addressed
reasonably foreseen conditions of use by proposing a SNUR. Therefore, EPA determines the
new chemical substance is not likely to present unreasonable risk to human health or the
environment.

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
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
analogues (polymers). In wastewater treatment, the new chemical substance is expected to be
removed with an efficiency of 90% due to sorption. Removal of the new chemical substance by
biodegradation is negligible. Sorption of the new chemical substance to sludge is expected to be
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

and effective, no manufacturer or processor - including the PMN submitter - may undertake the conditions of use
identified as a significant new use of the PMN substance in the SNUR. EPA must first evaluate the new use in
accordance with the requirements of TSCA Section 5 and (a) either conclude that the new use is not likely to present
an unreasonable risk under the conditions of use; or (b) take appropriate action under section 5(e) or 5(f). If EPA
were not to finalize the proposed SNUR, then that decision would be based on information and data provided to the
Agency during the comment period demonstrating that the reasonably foreseen conditions of use subject to the
proposed SNUR are not likely to present an unreasonable risk. Under either scenario, the reasonably foreseen
condition of use is not likely present an unreasonable risk.

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sediment. 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.

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Persistence : 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 analogues
(polymers). EPA estimated that the new chemical substance's aerobic and anaerobic
biodegradation half-lives are > 6 months. These estimates indicate that the new chemical
substance may be very persistent in aerobic environments (e.g., surface water) and anaerobic
environments (e.g., sediment).

Bioaccumulation4: 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 analogues (polymers). EPA estimated that the new chemical substance has low
bioaccumulation potential based on large predicted molecular volume, which limits
bioavailability. Although EPA estimated that the new chemical substance could be very
persistent, the substance has low potential for bioaccumulation, such that repeated exposures are
not expected to cause food-chain effects via accumulation in exposed organisms.

Human Health Hazard5: Human health hazard is relevant to whether a new chemical substance

3	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 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 there are equivalent or analogous data. (64 FR 60194;
November 4, 1999)

4	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 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 there are equivalent or analogous data.
(64 FR 60194; November 4 1999)

5	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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0041

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 is information on human health hazard, and other structural
information. Absorption of the new chemical substance is expected to be nil through the skin,
lungs, and gastrointestinal (GI) tract based on physical/chemical properties. Absorption of the
low molecular weight (LMW) fraction ([claimed CBI] < 500 Daltons, [claimed CBI] < 1000
Daltons) is expected to be moderate through the skin and GI tract, and poor through the lungs
based on physical/chemical properties. For the new chemical substance, EPA identified hazards
for eye irritation, systemic effects, and developmental effects based on analogue data for a
potential metabolite. However, systemic and developmental effects were evaluated to be low
hazard based on analogue data. Submitted test data on the new chemical substance indicated low
acute oral toxicity in rats (OECD 401). For the new chemical substance, EPA did not identify
hazards for subacute dermal exposures since the systemic and developmental effects are
expected to require subchronic or chronic exposure. Therefore, EPA qualitatively evaluated
systemic, developmental, and irritation effects.

Environmental Hazard6: 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 determined environmental hazard for this new chemical substance based on SAR
predictions for nonionic polymers (special class within ECOSAR v.2.0). Acute toxicity values
estimated for fish, aquatic invertebrates, and algae are 3.8 mg/L, 6.4 mg/L and 2.0 mg/L,
respectively. Chronic toxicity values estimated for fish, aquatic invertebrates, and algae are
0.0022 mg/L, 0.02 mg/L and 0.03 mg/L, respectively. These toxicity values indicate that the new
chemical substance is expected to have high environmental hazard. Application of assessment
factors of 4 and 10 to acute and chronic toxicity values, respectively, results in acute and chronic
concentrations of concern of 0.5 mg/L (500 ppb) and 0.0.001 mg/L (1 ppb), respectively.

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.

6 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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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 assessment, EPA assessed worker exposure via the dermal route; inhalation exposures to
workers are not expected. No releases to air or water are expected. Exposure to the general
population via drinking water and fish ingestion were not expected due to no predicted releases
to water. Fugitive air inhalation is expected to be negligible. Exposure is not expected via
groundwater impacted by landfill leaching and stack air inhalation because migration from
landfill and releases to stack air are expected to be negligible (below modeling thresholds).
Consumer exposures were not assessed because consumer uses were not identified as conditions
of use.

Risk Characterization: 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 were not evaluated for workers via dermal exposure since exposures are only expected to
occur over 10 days/year, and the identified hazards require subchronic or chronic exposure
durations. Risks were not evaluated for workers via inhalation exposure because exposures are
expected to be negligible. Eye irritation hazards to workers were identified based on analogue data
for a metabolite. Risks for these endpoints were not quantified due to a lack of dose-response for
these hazards. However, exposures can be mitigated by the use of appropriate PPE, including eye
protection. EPA expects that employers will require and that workers will use appropriate PPE
consistent with the SDS prepared by the new chemical submitter, in a manner adequate to protect
them.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-20-0041

Risks to the general population were not evaluated because general population exposures are not
expected. Risks to consumers were not evaluated because consumer uses were not identified as
conditions of use.

Risks to the environment were not identified due to no releases to water.

It is reasonably foreseen, based on a patent, that the new chemical substance could be used as
polyester resin in electrophotographic toner. The SNUR that has been proposed for this chemical
substance defines certain conditions of use as significant new uses. The proposed significant new
uses include use other than as intended in the PMN. Conditions of use that fall under the
restrictions of the proposed SNUR are not likely to present unreasonable risk of injury to health
or the environment because (1) those conditions of use are not likely to be commenced during
the pendency of the proposed SNUR, and (2) upon finalization of the SNUR, those conditions of
use would be prohibited unless and until EPA makes an affirmative determination that the
significant new use is not likely to present an unreasonable risk or takes appropriate action under
section 5(e) or 5(f).

4/29/2020			ls[	

Date:	Tala R. Henry, Ph.D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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