TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0364

Number: P-18-0364

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

Chemical Name:

Generic: Alkali humates, polymers with substituted acrylamides
Conditions of Use (intended, known, or reasonably foreseen)1:

Intended conditions of use (generic): Manufacture and process for use, and use as an industrial
quality control additive, 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 none.

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.

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 fromPMN 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 STNPlatform, 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-18-0364

Although EPA estimated that the new chemical substance could be very persistent, the new
chemical substance has a low potential for bioaccumulation, such that repeated exposures are not
expected to cause food-chain effects via accumulation in exposed organisms. Based onEPA's
TSCA New Chemicals Program Chemical Category for Polyanionic Polymers (& Momomers)2,
physical/chemical properties, and test data on analogues, EPA estimates that the chemical
substance has low environmental hazard and potential for the following human health hazards:
skin 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
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
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.

Persistence3: 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

2	TSCA New Chemicals Program (NCP) Chemical Categories, https://www.ep a. gov/reviewin g-new -che mica Is -
under-toxic-substances-control-act-tsca/chemical -categories -used-review-new.

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)

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0364

substance maybe 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 a 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
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 and by comparing it to a functionally analogous chemical

4	Bioaccumulation: A chemical substance is considered to have a lowpotential for bio accumulation if there are
bioconcentration factois (BCF) or bio accumulation factors (BAF) of less than 1,000 orthere 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 orthere 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 frombenchmark 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.

(Iittp://www.oecd.org/officialdocuments/publicdisplavdocumentpdf/?cote=env/im/monof2014')4&doclanguage=eny).
structure-activity relationships, and/or structural alerts to support characterizing human health hazards.

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0364

substance for which there is information on human health hazard. Absorption is expected to be
nil via all routes based on physical/chemical properties. EPA identified hazards for skin, eye, and
respiratory tract irritation based on the submitted Safety Data Sheet (SDS). EPA identified
potential hazards for blood and developmental toxicity by chelation of nutrient metals by the
poly-anionic groups in the new chemical substance. However, EPA identified a no-observed-
adverse-effect-level (NO AEL) of400 mg/kg-bw/day based on developmental toxicity for an
analogue, which indicates low hazard for this endpoint. EPA used the NOAEL for deriving
exposure route- and population-specific points of departure for quantifying risks as a worst case.
EPA qualitatively evaluated hazards for irritation.

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 polyanionic polymers (special class within ECOSAR v.2.0). This substance falls
within the TSCA New Chemicals Category of Polyanionic Polymers (& Monomers). Acute
toxicity values estimated for fish, aquatic invertebrates, and algae are all >100 mg/L. Chronic
toxicity values estimated for fish, aquatic invertebrates, and algae are all >10 mg/L. These
toxicity values indicate that the new chemical substance is expected to have low environmental
hazard. Application of assessment factors of 5 and 10 to acute and chronic toxicity values,
respectively, results in acute and chronic concentrations of concern of 20 mg/L (20,000 ppb) and
1 mg/L (1000 ppb), respectively.

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.

6 A chemical substance is considered to have low ecotoxicity hazard if the F ish, Daphnid and Algae LC50 values are
greater than 100 mg/L, or if the Fish and Daphnid chronic values (Ch Vs) 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 QSARcut-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 Ch Vs 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
Ch Vs is less than 0.1 mg/L (Sustainable Futures httos ://www.epa.gov/sustainable-futures/sustainable-futures-p 2-
frame work-manual).

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0364

EPA estimates occupational exposure and environmental release of the new chemical substance
under the intended conditions of use described in the PMN using Che mSTEER (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 dermal and inhalation exposures.
Releases to air, water, and landfill were estimated. Exposure to the general population was
assessed via drinking water ingestion and fugitive air exposure. Exposures were not assessed for
the general population via stack air inhalation and landfill because predicted environmental
releases are expected to be negligible (below modeling thresholds). Exposures were not assessed
for the general population via fish ingestion because bioaccumulation potential was evaluated to
be low. Consumer exposures were not assessed because consumer uses were not identified as
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 is derived
by applying uncertainty factors 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 experimental animals to
humans) and 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 whenNOAELs and LOAELs, respectively, are used to identify hazard.
When allometric scaling or pharmacokinetic modeling is used to derive an effect level, the UF h
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

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TSCA Section 5(a)(3) Determination for Premanufacture Notice (PMN) P-18-0364

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
developmental toxicity via inhalation based on quantitative hazard data for an analogue (MOE =
32,000,000; Benchmark MOE = 100). Risks were not identified for workers for developmental
toxicity via dermal exposure based on quantitative hazard data for an analogue (MOE = 10,323;
Benchmark MOE = 100). Irritation hazards to workers via inhalation and dermal contact were
identified based on information provided in the SDS prepared by the submitter. 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 personal protective equipment (PPE),
including impervious gloves, eye protection, and respiratory 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.

Risks were not identified for the general population for developmental toxicity via drinking
water or fugitive air inhalation based on quantitative hazard data for an analogue (MOEs >
4,300,000; Benchmark MOE = 100). Risks were not evaluated for the general population via
landfill leachate or stack air inhalation because predicted environmental releases are expected to
be negligible (below modeling thresholds). Irritation hazards to the general population are not
expected via fugitive or stack air releases due to dilution of the new chemical substance in the
media. Risks to consumers were not evaluated because consumer uses were not identified as
conditions of use.

Risks to the environment were not identified based on low hazard.

Because worker exposures can be controlled by PPE, no unreasonable risks to the general
population or environment were identified, and there are no expected consumer uses, 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.

3-19-2020		[s[	

Date:	Tala R. Henry, Ph D.

Deputy Director for Programs

Office of Pollution Prevention and Toxics

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