Poly(oxy-1,2-ethanediyl), α-(3-carboxy-1-oxosulfopropyl)-ω-hydroxy-, (C10, 5952-5957 [2015-02072]
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Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
Parts per
million
Commodity
40 CFR Part 180
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Brassica, head and stem
(subgroup 5A) .................
Brassica, leafy greens (subgroup 5B) ........................
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Cattle, liver ..........................
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[EPA–HQ–OPP–2014–0514; FRL–9920–44]
1.5
7.0
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1.0
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Cotton, gin byproducts .......
Cotton, undelinted seed .....
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6.0
0.50
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Egg .....................................
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0.01
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Goat, liver ...........................
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1.0
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Grain, aspirated fractions ...
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6.0
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Hog, meat byproducts ........
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0.05
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Horse, liver .........................
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1.0
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Lettuce, head ......................
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1.5
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Milk .....................................
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0.02
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Poultry, fat ..........................
Poultry, meat byproducts ....
Radicchio ............................
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0.01
0.01
1.5
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Sheep, liver .........................
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1.0
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Sorghum, grain, forage .......
Sorghum, grain, grain .........
Sorghum, grain, stover .......
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2.0
1.5
6.0
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Vegetable, leafy, except
Brassica, crop group 4,
except head lettuce and
radicchio ..........................
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Poly(oxy-1,2-ethanediyl), α-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10–
C16) -alkyl ethers, disodium salts;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)
alkyl ethers, disodium salts when used
as an inert ingredient (surfactant) in
pesticide formulations applied to
growing crops (seed treatment use only)
under 40 CFR 180.920 at a
concentration not to exceed 0.125% by
weight. BASF submitted a petition to
EPA under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting the
establishment of an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of poly(oxy-1,2-ethanediyl),
a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16) alkyl ethers,
disodium salts.
DATES: This regulation is effective
February 4, 2015. Objections and
requests for hearings must be received
on or before April 6, 2015, and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
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(b) Section 18 emergency exemptions.
[Reserved]
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[FR Doc. 2015–02177 Filed 2–3–15; 8:45 am]
BILLING CODE 6560–50–P
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2014–0514, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
ADDRESSES:
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(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2014–0514 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before April 6, 2015. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
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disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2014–0514, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of September
5, 2014 (79 FR 53009) (FRL–9914–98),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (PP IN–10671) by BASF, 26
Davis Dr., Research Triangle Park, NC
27709. The petition requested that 40
CFR 180.920 be amended by
establishing an exemption from the
requirement of a tolerance for residues
of poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
(C10–C12) alkyl ethers, disodium salts,
polyethoxylation content averages 4–5
moles, Chemical Abstracts Service
Registry Number (CAS Reg. No.) 68954–
91–6 and poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
(C10–C16)-alkyl ethers, disodium salts,
polyethoxylation content averages 5
moles (CAS Reg. No. 68815–56–5),
when used as an inert ingredient
(surfactant) in pesticide formulations
applied to growing crops (seed
treatment use only) at a concentration
not to exceed 0.125% by weight under
40 CFR 180.920. That document
referenced a summary of the petition
prepared by Exponent on behalf of
BASF, the petitioner, which is available
in the docket, https://
www.regulations.gov. Comments were
received on the notice of filing. EPA’s
response to these comments is
discussed in Unit V.C.
III. Inert Ingredient Definition
Inert ingredients are all ingredients
that are not active ingredients as defined
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in 40 CFR 153.125 and include, but are
not limited to, the following types of
ingredients (except when they have a
pesticidal efficacy of their own):
Solvents such as alcohols and
hydrocarbons; surfactants such as
polyoxyethylene polymers and fatty
acids; carriers such as clay and
diatomaceous earth; thickeners such as
carrageenan and modified cellulose;
wetting, spreading, and dispersing
agents; propellants in aerosol
dispensers; microencapsulating agents;
and emulsifiers. The term ‘‘inert’’ is not
intended to imply nontoxicity; the
ingredient may or may not be
chemically active. Generally, EPA has
exempted inert ingredients from the
requirement of a tolerance based on the
low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and
Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the tolerance is ‘‘safe.’’
Section 408(b)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Section
408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue . . .’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
residential settings. If EPA is able to
determine that a finite tolerance is not
necessary to ensure that there is a
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reasonable certainty that no harm will
result from aggregate exposure to the
inert ingredient, an exemption from the
requirement of a tolerance may be
established.
Consistent with FFDCA section
408(c)(2)(A), and the factors specified in
FFDCA section 408(c)(2)(B), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts including
exposure resulting from the exemption
established by this action. EPA’s
assessment of exposures and risks
associated with poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered their
validity, completeness, and reliability as
well as the relationship of the results of
the studies to human risk. EPA has also
considered available information
concerning the variability of the
sensitivities of major identifiable
subgroups of consumers, including
infants and children. Specific
information on the studies received and
the nature of the adverse effects caused
by poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
(C10–C16)-alkyl ethers, disodium salts as
well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies are discussed in this
unit.
Poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
(C10–C16)-alkyl ethers, disodium salts
include CAS Reg. No. 68815–56–5,
which consists of a C10–C16 linear
carbon chain and average
polyethoxylation (POE) = 4.5 and CAS
Reg. No. 68954–91–6, which consists of
a C10–C12 linear alkyl carbon chain and
average polyethoxylation (POE) = 5.
Although data are not available for CAS
Reg. No. 68954–91–6, EPA relied on
available subchronic toxicity studies on
CAS Reg. No. 68815–56–5. These
studies are sufficient to assess the
subchronic toxicity of CAS Reg. No.
68954–91–6 as the only difference
between the compounds is the range of
carbon chain lengths and the testing of
the broader carbon chain length of C10–
C16 in CAS Reg. No. 68815–56–5 would
include any effects that might be seen in
tests of the narrower linear carbon chain
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length of C10–C12 (in CAS Reg. No.
68954–91–6). Reproduction and
developmental toxicity studies were not
available for review for either
compound, so reproduction data for
C12AE6 (CAS Reg. No. 9002–92–0),
which is similar to poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts in carbon
chain length and average ethoxylation,
were used as surrogate data for potential
reproductive effects of CAS Reg. Nos.
68815–56–5 and 68954–91–6. Based on
analogy to well-known metabolic
pathways for other linear alkyl ethers,
the major pathway in the primary
metabolism of both compounds is
expected to be oxidative-reductive ether
cleavage. Therefore, the metabolism of
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10–
C16)-alkyl ethers, disodium salts would
result in the formation of the
corresponding alkyl alcohol alkoxylate
such as C12AE6 (CAS Reg. No. 9002–
92–0).
The acute oral and dermal toxicity of
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10–
C16)-alkyl ethers, disodium salts is low
(toxicity category IV). The Lethal Dose
(LD)50 is >5,000 milligram/kilogram
(mg/kg) in the rat (oral) and rabbit
(dermal). They are irritating to the eyes
and non-irritating to the skin in rabbits.
They are not dermal sensitizers. Acute
inhalation toxicity studies were not
available.
Subchronic toxicity studies were
available in the rat and dog for CAS Reg
No. 68815–56–5. CAS Reg No. 68815–
56–5 was administered via the diet in
both studies. In a 90-day oral toxicity
study in rats, decreased body weight
gain was observed at 4% (equivalent to
2,000 mg/kg/day (LOAEL)) of CAS Reg
No. 68815–56–5. The NOAEL was 1%
(equivalent to 500 mg/kg/day). In a 90day toxicity study in dogs, toxicity was
not observed at 500 mg/kg/day
(NOAEL), the highest dose tested.
An acceptable developmental toxicity
study is not available; however, in a 2generation reproduction study in rats on
C12AE6, decreased body weight gain
was observed in parental animals at
0.5% (equivalent to 250 mg/kg/day).
The NOAEL was 0.1% (equivalent to 50
mg/kg/day). Offspring toxicity was
manifested as decreased weight gain in
pups, increased embryo lethality and
soft tissue anomalies at 0.5%
(equivalent to 250 mg/kg/day). The
NOAEL was 0.1% (equivalent to 50 mg/
kg/day). Although fetal qualitative
susceptibility is observed in this study,
the concern is low because effects
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occurred only in the presence of
maternal toxicity.
Chronic/carcinogenicity studies with
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, alkyl
ethers, disodium salts were not
available. However, a DEREK structural
alert analysis was conducted with
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10–
C12)-alkyl ethers, disodium salt (CAS
Reg No. 68954–91–6) and indicated no
structural alerts for carcinogenicity or
mutagenicity. Therefore, poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl
ethers, disodium salts are not expected
to be carcinogenic.
Mutagenicity studies were not
available for poly(oxy-1,2-ethanediyl),
a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16)-alkyl ethers,
disodium salts. However, an Ames test
is available on CAS Reg. No. 68439–50–
9, a surrogate alkyl alcohol alkoxylate.
The test was negative.
Neurotoxicity studies were not
available for review. Although ataxia
was observed in the dams in the
developmental toxicity study in rabbits
at 100 mg/kg/day, the onset and
persistence of ataxia were not reported
and thus could not be evaluated. Since
evidence of ataxia or other signs of
potential neurotoxicity were not
observed in the subchronic studies
conducted with rats or dogs at doses
≥500 mg/kg/day, it was concluded that
the ataxia observed in the dams was not
likely a result of neurotoxicity.
Immunotoxicity studies were not
available for review. However, evidence
of immunotoxicity was not observed in
the submitted studies.
Metabolism studies on poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts were not
available for review. However, based on
analogy to known metabolic pathways
for linear alkyl ethers, the major
pathway in the primary metabolism is
expected to be oxidative-reductive ether
cleavage. Therefore, the primary
metabolism of poly(oxy-1,2-ethanediyl),
a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, alkyl ethers, disodium salts
occurs via oxidative-reductive ether
hydrolysis resulting in the formation of
linear alkyl alcohols and polyethylene
glycol metabolites. The alcohols would
undergo oxidation by alcohol
dehydrogenase and aldehyde
dehydrogenase to generate a fatty acid
metabolite that is degraded by boxidation to carbon dioxide (CO2) and
water (H2O). The polyethylene glycol
metabolites would be degraded via
oxidation by alcohol dehydrogenase and
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aldehyde dehydrogenase to generate a
dienoic polyethylene ether acid that
may be conjugated and excreted. Also,
the alcohol function may be sulfated by
sulfotransferases and excreted.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which the NOAEL and the
LOAEL are identified. Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). For non-threshold
risks, the Agency assumes that any
amount of exposure will lead to some
degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/pesticides/factsheets/
riskassess.htm.
An acute effect was not found in the
database therefore an acute dietary
assessment is not necessary. The 2generation reproduction study in the rat
was selected for the chronic exposure
for this risk assessment. The NOAEL in
this study was 50 mg/kg/day. The
LOAEL was 250 mg/kg/day based on
decreased weight gain. This study
represents the lowest NOAEL in the
database in the most sensitive species.
The dermal and inhalation absorption
rates were assumed to be 100%. The
standard inter- and intra-species
uncertainty factors were applied. The
Food Quality Protection Act Safety
Factor (FQPA SF) of tenfold (10X) was
retained for the lack of a developmental
toxicity study.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to poly(oxy-1,2-ethanediyl), a(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16)-alkyl ethers,
disodium salts, EPA considered
exposure under the proposed exemption
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from the requirement of a tolerance.
EPA assessed dietary exposures from
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10–
C16)-alkyl ethers, disodium salts in food
as follows:
Dietary exposure (food and drinking
water) to poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
(C10–C16)-alkyl ethers, disodium salts
can occur following ingestion of foods
with residues from seed-treated crops.
Because no adverse effects attributable
to a single exposure of poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts were seen in
the toxicity databases, an acute dietary
risk assessment is not necessary. For the
chronic dietary risk assessment, EPA
used the Dietary Exposure Evaluation
Model software with the Food
Commodity Intake Database (DEEM–
FCIDTM), Version 3.16, and food
consumption information from the U.S.
Department of Agriculture’s (USDA’s)
2003–2008 National Health and
Nutrition Examination Survey, What We
Eat in America (NHANES/WWEIA). One
hundred percent crop treated was
assumed, default processing factors, and
tolerance-level residues for all foods and
use limitations of not more than 0.125%
by weight in pesticide formulations.
2. Cancer. A DEREK structural alert
analysis indicated no structural alerts
for carcinogenicity or mutagenicity.
Therefore, poly(oxy-1,2-ethanediyl), a(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16)-alkyl ethers,
disodium salts are not expected to be
carcinogenic and a cancer risk
assessment is unnecessary.
3. Dietary exposure from drinking
water. For the purpose of the screening
level dietary risk assessment to support
this request for an exemption from the
requirement of a tolerance for poly(oxy1,2-ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts, a
conservative drinking water
concentration value of 100 parts per
billion (ppb) based on screening level
modeling was used to assess the
contribution to drinking water for the
chronic dietary risk assessments for
parent compound. These values were
directly entered into the dietary
exposure model.
4. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors, and
tables).
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Poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
(C10–C16)-alkyl ethers, disodium salts
are not expected to result in residential
exposure based on its use pattern as a
seed treatment for agricultural crops.
5. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl
ethers, disodium salts to share a
common mechanism of toxicity with
any other substances, and poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl
ethers, disodium salts does not appear
to produce a toxic metabolite produced
by other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that poly(oxy-1,2-ethanediyl),
a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, alkyl ethers, disodium salts
does not have a common mechanism of
toxicity with other substances. For
information regarding EPA’s efforts to
determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and
Children
1. In general. Section 408(b)(2)(C) of
FFDCA provides that EPA shall apply
an additional 10X margin of safety for
infants and children in the case of
threshold effects to account for prenatal
and postnatal toxicity and the
completeness of the database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. This additional margin of
safety is commonly referred to as the
FQPA SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional safety
factor when reliable data available to
EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity.
The toxicity database for poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl
ethers, disodium salts contains two
subchronic studies, a reproductive
toxicity study, a developmental toxicity
study and mutagenicity studies.
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5955
Qualitative fetal susceptibility was
observed in the 2-generation toxicity
study in rats. However, concern for fetal
effects are low since they only occurred
in the presence of maternal toxicity and
protecting against maternal toxicity will
subsequently prevent fetal toxicity. In
addition, the chronic reference dose
(cRfD) was based on this study and will
be protective of fetal effects. However,
since the developmental study in rabbits
was unacceptable, the FQPA SF of 10X
was retained to account for an
incomplete database.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. An acute aggregate risk
assessment takes into account acute
exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
a single oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts is not
expected to pose an acute risk.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, alkyl
ethers, disodium salts from food and
water will utilize 16.2% of the cPAD for
non-nursing infants, the population
group receiving the greatest exposure.
There are no residential uses for
poly(oxy-1,2-ethanediyl), a-(3-carboxy1-oxosulfopropyl)-w-hydroxy-, (C10–
C16)-alkyl ethers, disodium salts.
3. Short-term risk. Short-term
aggregate exposure takes into account
short-term residential exposure plus
chronic exposure to food and water
(considered to be a background
exposure level). Since poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts have no
uses that would result in short-term
residential exposure, the Agency has
determined that it is appropriate to
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aggregate chronic exposure through food
and water only.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Since poly(oxy-1,2-ethanediyl), a-(3carboxy-1-oxosulfopropyl)-w-hydroxy-,
(C10–C16)-alkyl ethers, disodium salts
have no uses that would result in
intermediate-term residential exposure,
the Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water only.
5. Aggregate cancer risk for U.S.
population. Based on a DEREK
structural alert analysis and the lack of
mutagenicity, poly(oxy-1,2-ethanediyl),
a-(3-carboxy-1-oxosulfopropyl)-whydroxy-, (C10–C16)-alkyl ethers,
disodium salts are considered not likely
to be carcinogenic.
6. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
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B. Response to Comments
A comment was received from a
private citizen who was concerned
about the reaction of fatty acid esters to
any future chemicals added to the
environment. The Agency understands
the commenter’s concerns and
recognizes that some individuals believe
that no residue of pesticides should be
allowed because of potential
interactions with other chemicals.
However, under the existing legal
framework provided by FFDCA section
408, EPA is authorized to establish
pesticide tolerances or exemptions
where persons seeking such tolerances
or exemptions have demonstrated that
the pesticide meets the safety standard
imposed by the statute, which EPA has
determined here.
VI. Conclusions
Therefore, an exemption from the
requirement of a tolerance is established
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under 40 CFR 180.920 for poly(oxy-1,2ethanediyl), a-(3-carboxy-1oxosulfopropyl)-w-hydroxy-, (C10–C16)alkyl ethers, disodium salts (CAS Reg.
Nos. 68954–91–6 and 68815–56–5)
when used as inert ingredients
(surfactant) in pesticide products used
for seed treatment only at a
concentration not to exceed 0.125% in
the end-use formulation.
VII. Statutory and Executive Order
Reviews
This action establishes exemptions to
the requirement for a tolerance under
FFDCA section 408(d) in response to a
petition submitted to the Agency. The
Office of Management and Budget
(OMB) has exempted these types of
actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (62 FR 19885,
April 23, 1997). This action does not
contain any information collections
subject to OMB approval under the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), nor does it require
any special considerations under
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the exemptions in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers,
food processors, food handlers, and food
retailers, not States or tribes, nor does
this action alter the relationships or
distribution of power and
responsibilities established by Congress
in the preemption provisions of FFDCA
section 408(n)(4). As such, the Agency
has determined that this action will not
have a substantial direct effect on States
or tribal governments, on the
relationship between the national
government and the States or tribal
governments, or on the distribution of
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power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: January 15, 2015.
Susan Lewis,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, add alphabetically to
the table after ‘‘Poly(oxy-1,2ethanediyl),a-isotridecyl-w-methoxy
(CAS Reg. No. 345642–79–7)’’ the two
inert ingredients listed below to read as
follows:
■
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
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Federal Register / Vol. 80, No. 23 / Wednesday, February 4, 2015 / Rules and Regulations
Inert ingredients
Limits
*
*
*
*
Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, Not to exceed
(C10–C12)-alkyl ethers, disodium salts, polyoxylene content avertreatment use
ages 4–5 moles (CAS Reg. No. 68815–56–5).
Poly(oxy-1,2-ethanediyl), a-(3-carboxy-1-oxosulfopropyl)-w-hydroxy-, Not to exceed
(C10–C16)-alkyl ethers, disodium salts, polyoxyethylene content avertreatment use
ages 5 moles (CAS Reg. No. 68954–91–6).
*
*
*
[FR Doc. 2015–02072 Filed 2–3–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–SFUND–1983–0002; FRL–9922–
37–Region–2]
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List: Partial
Deletion of the Fulton Terminals
Superfund Site
United States Environmental
Protection Agency.
ACTION: Direct final rule.
AGENCY:
The Fulton Terminals
Superfund site (Site), located in the City
of Fulton, Oswego County, New York,
consists of an ‘‘On-Property’’ portion, an
approximately 1.5-acre parcel of land
bounded on the west by First Street, on
the south by Shaw Street, on the east by
New York State Route 481, and on the
north by a warehouse, and an ‘‘OffProperty’’ portion, defined by the area
between the On-Property portion’s
western property boundary to the
Oswego River (approximately 50 feet).
The Environmental Protection Agency
(EPA) Region 2, is publishing this direct
final Notice of Partial Deletion (NOPD)
of the On-Property portion of the Site
from the National Priorities List (NPL).
The NPL, promulgated pursuant to
Section 105 of the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an
appendix of the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP). This direct
final partial deletion is being published
by EPA with the concurrence of the
State of New York, through the New
York State Department of
Environmental Conservation (NYSDEC),
because EPA has determined that all
appropriate response actions under
CERCLA have been completed at the
On-Property portion of the Site and that
tkelley on DSK3SPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
20:27 Feb 03, 2015
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*
*
0.125% for seed
only.
*
Surfactant.
0.125% for seed
only.
Surfactant
*
the soil on the On-Property portion of
the Site and the groundwater beneath
the On-Property portion of the Site no
longer pose a threat to public health or
the environment. The NOPD pertains to
the On-Property portion of the Site. The
Off-Property portion of the Site will
remain on the NPL. Because residual
groundwater contamination remains in
the Off-Property portion of the Site,
groundwater monitoring and five-year
reviews will still be required for this
area. The partial deletion does not
preclude future actions under
Superfund.
DATES: This direct final partial deletion
will be effective April 6, 2015 unless
EPA receives adverse comments by
March 6, 2015. If adverse comments are
received, EPA will publish a timely
withdrawal of this direct final NOPD in
the Federal Register, informing the
public that the partial deletion will not
take effect.
ADDRESSES: Submit your comments,
identified by Docket ID no. EPA–HQ–
SFUND–1983–0002, by one of the
following methods:
Web site: https://www.regulations.gov.
Follow the on-line instructions for
submitting comments.
Email: tsiamis.christos@epa.gov.
Fax: To the attention of Christos
Tsiamis at 212–637–3966.
Mail: To the attention of Christos
Tsiamis, Remedial Project Manager,
Emergency and Remedial Response
Division, U.S. Environmental Protection
Agency, Region 2, 290 Broadway, 20th
Floor, New York, NY 10007–1866.
Hand Delivery: Superfund Records
Center, 290 Broadway, 18th Floor, New
York, NY 10007–1866 (telephone: 212–
637–4308). Such deliveries are only
accepted during the Record Center’s
normal hours of operation (Monday to
Friday from 9:00 a.m. to 5:00 p.m.).
Special arrangements should be made
for deliveries of boxed information.
Instructions: Direct your comments to
Docket ID no. EPA–HQ–SFUND–1983–
0002. EPA’s policy is that all comments
received will be included in the Docket
without change and may be made
available online at https://
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*
*
*
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or via email. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your
comments. If you send comments to
EPA via email, your email address will
be included as part of the comment that
is placed in the Docket and made
available on the Web site. If you submit
electronic comments, EPA recommends
that you include your name and other
contact information in the body of your
comments and with any disks or CD–
ROMs that you submit. If EPA cannot
read your comments because of
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comments fully.
Electronic files should avoid the use of
special characters and any form of
encryption and should be free of any
defects or viruses.
Docket: All documents in the Docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly-available Docket
materials can be obtained either
electronically at https://
www.regulations.gov or in hard copy at:
U.S. Environmental Protection
Agency, Region 2, Superfund Records
Center, 290 Broadway, 18th Floor, New
York, NY 10007–1866, Phone: 212–637–
4308, Hours: Monday to Friday from
9:00 a.m. to 5:00 p.m. and Fulton Public
Library, 160 South First Street, Fulton,
NY 13069, Phone: 315–592–5159,
Hours: Tue–Thu: 9:00 a.m.–7:00 p.m.,
E:\FR\FM\04FER1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 23 (Wednesday, February 4, 2015)]
[Rules and Regulations]
[Pages 5952-5957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02072]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2014-0514; FRL-9920-44]
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16) -alkyl ethers, disodium salts; Exemption
From the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16) alkyl ethers, disodium salts when used as an inert
ingredient (surfactant) in pesticide formulations applied to growing
crops (seed treatment use only) under 40 CFR 180.920 at a concentration
not to exceed 0.125% by weight. BASF submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the
establishment of an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16) alkyl
ethers, disodium salts.
DATES: This regulation is effective February 4, 2015. Objections and
requests for hearings must be received on or before April 6, 2015, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0514, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0514 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
April 6, 2015. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be
[[Page 5953]]
disclosed publicly by EPA without prior notice. Submit the non-CBI copy
of your objection or hearing request, identified by docket ID number
EPA-HQ-OPP-2014-0514, by one of the following methods:
Federal eRulemaking Portal:
http:[sol][sol]www.regulations.gov. Follow the online instructions for
submitting comments. Do not submit electronically any information you
consider to be CBI or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http:[sol][sol]www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at
http:[sol][sol]www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), EPA issued a document pursuant to FFDCA section 408, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10671) by BASF, 26 Davis Dr., Research Triangle Park, NC 27709. The
petition requested that 40 CFR 180.920 be amended by establishing an
exemption from the requirement of a tolerance for residues of poly(oxy-
1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C12) alkyl ethers, disodium salts,
polyethoxylation content averages 4-5 moles, Chemical Abstracts Service
Registry Number (CAS Reg. No.) 68954-91-6 and poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts, polyethoxylation content
averages 5 moles (CAS Reg. No. 68815-56-5), when used as an inert
ingredient (surfactant) in pesticide formulations applied to growing
crops (seed treatment use only) at a concentration not to exceed 0.125%
by weight under 40 CFR 180.920. That document referenced a summary of
the petition prepared by Exponent on behalf of BASF, the petitioner,
which is available in the docket, http:[sol][sol]www.regulations.gov.
Comments were received on the notice of filing. EPA's response to these
comments is discussed in Unit V.C.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers,
disodium salts include CAS Reg. No. 68815-56-5, which consists of a
C10-C16 linear carbon chain and average
polyethoxylation (POE) = 4.5 and CAS Reg. No. 68954-91-6, which
consists of a C10-C12 linear alkyl carbon chain
and average polyethoxylation (POE) = 5. Although data are not available
for CAS Reg. No. 68954-91-6, EPA relied on available subchronic
toxicity studies on CAS Reg. No. 68815-56-5. These studies are
sufficient to assess the subchronic toxicity of CAS Reg. No. 68954-91-6
as the only difference between the compounds is the range of carbon
chain lengths and the testing of the broader carbon chain length of
C10-C16 in CAS Reg. No. 68815-56-5 would include
any effects that might be seen in tests of the narrower linear carbon
chain
[[Page 5954]]
length of C10-C12 (in CAS Reg. No. 68954-91-6).
Reproduction and developmental toxicity studies were not available for
review for either compound, so reproduction data for C12AE6 (CAS Reg.
No. 9002-92-0), which is similar to poly(oxy-1,2-ethanediyl), [alpha]-
(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts in carbon chain length and
average ethoxylation, were used as surrogate data for potential
reproductive effects of CAS Reg. Nos. 68815-56-5 and 68954-91-6. Based
on analogy to well-known metabolic pathways for other linear alkyl
ethers, the major pathway in the primary metabolism of both compounds
is expected to be oxidative-reductive ether cleavage. Therefore, the
metabolism of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl
ethers, disodium salts would result in the formation of the
corresponding alkyl alcohol alkoxylate such as C12AE6 (CAS Reg. No.
9002-92-0).
The acute oral and dermal toxicity of poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts is low (toxicity category
IV). The Lethal Dose (LD)50 is >5,000 milligram/kilogram
(mg/kg) in the rat (oral) and rabbit (dermal). They are irritating to
the eyes and non-irritating to the skin in rabbits. They are not dermal
sensitizers. Acute inhalation toxicity studies were not available.
Subchronic toxicity studies were available in the rat and dog for
CAS Reg No. 68815-56-5. CAS Reg No. 68815-56-5 was administered via the
diet in both studies. In a 90-day oral toxicity study in rats,
decreased body weight gain was observed at 4% (equivalent to 2,000 mg/
kg/day (LOAEL)) of CAS Reg No. 68815-56-5. The NOAEL was 1% (equivalent
to 500 mg/kg/day). In a 90-day toxicity study in dogs, toxicity was not
observed at 500 mg/kg/day (NOAEL), the highest dose tested.
An acceptable developmental toxicity study is not available;
however, in a 2-generation reproduction study in rats on C12AE6,
decreased body weight gain was observed in parental animals at 0.5%
(equivalent to 250 mg/kg/day). The NOAEL was 0.1% (equivalent to 50 mg/
kg/day). Offspring toxicity was manifested as decreased weight gain in
pups, increased embryo lethality and soft tissue anomalies at 0.5%
(equivalent to 250 mg/kg/day). The NOAEL was 0.1% (equivalent to 50 mg/
kg/day). Although fetal qualitative susceptibility is observed in this
study, the concern is low because effects occurred only in the presence
of maternal toxicity.
Chronic/carcinogenicity studies with poly(oxy-1,2-ethanediyl),
[alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers,
disodium salts were not available. However, a DEREK structural alert
analysis was conducted with poly(oxy-1,2-ethanediyl), [alpha]-(3-
carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C12)-alkyl ethers, disodium salt (CAS Reg No. 68954-91-6)
and indicated no structural alerts for carcinogenicity or mutagenicity.
Therefore, poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers, disodium salts are not
expected to be carcinogenic.
Mutagenicity studies were not available for poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts. However,
an Ames test is available on CAS Reg. No. 68439-50-9, a surrogate alkyl
alcohol alkoxylate. The test was negative.
Neurotoxicity studies were not available for review. Although
ataxia was observed in the dams in the developmental toxicity study in
rabbits at 100 mg/kg/day, the onset and persistence of ataxia were not
reported and thus could not be evaluated. Since evidence of ataxia or
other signs of potential neurotoxicity were not observed in the
subchronic studies conducted with rats or dogs at doses >=500 mg/kg/
day, it was concluded that the ataxia observed in the dams was not
likely a result of neurotoxicity.
Immunotoxicity studies were not available for review. However,
evidence of immunotoxicity was not observed in the submitted studies.
Metabolism studies on poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-
1-oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-
alkyl ethers, disodium salts were not available for review. However,
based on analogy to known metabolic pathways for linear alkyl ethers,
the major pathway in the primary metabolism is expected to be
oxidative-reductive ether cleavage. Therefore, the primary metabolism
of poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, alkyl ethers, disodium salts occurs via oxidative-
reductive ether hydrolysis resulting in the formation of linear alkyl
alcohols and polyethylene glycol metabolites. The alcohols would
undergo oxidation by alcohol dehydrogenase and aldehyde dehydrogenase
to generate a fatty acid metabolite that is degraded by [beta]-
oxidation to carbon dioxide (CO2) and water
(H2O). The polyethylene glycol metabolites would be degraded
via oxidation by alcohol dehydrogenase and aldehyde dehydrogenase to
generate a dienoic polyethylene ether acid that may be conjugated and
excreted. Also, the alcohol function may be sulfated by
sulfotransferases and excreted.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm.
An acute effect was not found in the database therefore an acute
dietary assessment is not necessary. The 2-generation reproduction
study in the rat was selected for the chronic exposure for this risk
assessment. The NOAEL in this study was 50 mg/kg/day. The LOAEL was 250
mg/kg/day based on decreased weight gain. This study represents the
lowest NOAEL in the database in the most sensitive species. The dermal
and inhalation absorption rates were assumed to be 100%. The standard
inter- and intra-species uncertainty factors were applied. The Food
Quality Protection Act Safety Factor (FQPA SF) of tenfold (10X) was
retained for the lack of a developmental toxicity study.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl
ethers, disodium salts, EPA considered exposure under the proposed
exemption
[[Page 5955]]
from the requirement of a tolerance. EPA assessed dietary exposures
from poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers,
disodium salts in food as follows:
Dietary exposure (food and drinking water) to poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts can occur
following ingestion of foods with residues from seed-treated crops.
Because no adverse effects attributable to a single exposure of
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts
were seen in the toxicity databases, an acute dietary risk assessment
is not necessary. For the chronic dietary risk assessment, EPA used the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCIDTM), Version 3.16, and food
consumption information from the U.S. Department of Agriculture's
(USDA's) 2003-2008 National Health and Nutrition Examination Survey,
What We Eat in America (NHANES/WWEIA). One hundred percent crop treated
was assumed, default processing factors, and tolerance-level residues
for all foods and use limitations of not more than 0.125% by weight in
pesticide formulations.
2. Cancer. A DEREK structural alert analysis indicated no
structural alerts for carcinogenicity or mutagenicity. Therefore,
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts
are not expected to be carcinogenic and a cancer risk assessment is
unnecessary.
3. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts, a
conservative drinking water concentration value of 100 parts per
billion (ppb) based on screening level modeling was used to assess the
contribution to drinking water for the chronic dietary risk assessments
for parent compound. These values were directly entered into the
dietary exposure model.
4. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, and tables).
Poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-
[omega]-hydroxy-, (C10-C16)-alkyl ethers,
disodium salts are not expected to result in residential exposure based
on its use pattern as a seed treatment for agricultural crops.
5. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
EPA has not found poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, alkyl ethers, disodium salts to share
a common mechanism of toxicity with any other substances, and poly(oxy-
1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
alkyl ethers, disodium salts does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
alkyl ethers, disodium salts does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at https://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional 10X margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA SF. In applying this
provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. The toxicity database for
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, alkyl ethers, disodium salts contains two subchronic studies,
a reproductive toxicity study, a developmental toxicity study and
mutagenicity studies. Qualitative fetal susceptibility was observed in
the 2-generation toxicity study in rats. However, concern for fetal
effects are low since they only occurred in the presence of maternal
toxicity and protecting against maternal toxicity will subsequently
prevent fetal toxicity. In addition, the chronic reference dose (cRfD)
was based on this study and will be protective of fetal effects.
However, since the developmental study in rabbits was unacceptable, the
FQPA SF of 10X was retained to account for an incomplete database.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts
is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, alkyl ethers, disodium salts from food and water will utilize
16.2% of the cPAD for non-nursing infants, the population group
receiving the greatest exposure. There are no residential uses for
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Since
poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-
hydroxy-, (C10-C16)-alkyl ethers, disodium salts
have no uses that would result in short-term residential exposure, the
Agency has determined that it is appropriate to
[[Page 5956]]
aggregate chronic exposure through food and water only.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Since poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl
ethers, disodium salts have no uses that would result in intermediate-
term residential exposure, the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water only.
5. Aggregate cancer risk for U.S. population. Based on a DEREK
structural alert analysis and the lack of mutagenicity, poly(oxy-1,2-
ethanediyl), [alpha]-(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-,
(C10-C16)-alkyl ethers, disodium salts are
considered not likely to be carcinogenic.
6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to poly(oxy-1,2-ethanediyl), [alpha]-(3-carboxy-1-
oxosulfopropyl)-[omega]-hydroxy-, (C10-C16)-alkyl
ethers, disodium salts residues.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Response to Comments
A comment was received from a private citizen who was concerned
about the reaction of fatty acid esters to any future chemicals added
to the environment. The Agency understands the commenter's concerns and
recognizes that some individuals believe that no residue of pesticides
should be allowed because of potential interactions with other
chemicals. However, under the existing legal framework provided by
FFDCA section 408, EPA is authorized to establish pesticide tolerances
or exemptions where persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
the statute, which EPA has determined here.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for poly(oxy-1,2-ethanediyl), [alpha]-
(3-carboxy-1-oxosulfopropyl)-[omega]-hydroxy-, (C10-
C16)-alkyl ethers, disodium salts (CAS Reg. Nos. 68954-91-6
and 68815-56-5) when used as inert ingredients (surfactant) in
pesticide products used for seed treatment only at a concentration not
to exceed 0.125% in the end-use formulation.
VII. Statutory and Executive Order Reviews
This action establishes exemptions to the requirement for a
tolerance under FFDCA section 408(d) in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735,
October 4, 1993). Because this action has been exempted from review
under Executive Order 12866, this action is not subject to Executive
Order 13211, entitled ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This action does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special
considerations under Executive Order 12898, entitled ``Federal Actions
to Address Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the exemptions in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 15, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.920, add alphabetically to the table after ``Poly(oxy-
1,2-ethanediyl),[alpha]-isotridecyl-[omega]-methoxy (CAS Reg. No.
345642-79-7)'' the two inert ingredients listed below to read as
follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
[[Page 5957]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Poly(oxy-1,2-ethanediyl), Not to exceed Surfactant.
[alpha]-(3-carboxy-1- 0.125% for seed
oxosulfopropyl)-[omega]-hydroxy- treatment use
, (C10-C12)-alkyl ethers, only.
disodium salts, polyoxylene
content averages 4-5 moles (CAS
Reg. No. 68815-56-5).
Poly(oxy-1,2-ethanediyl), Not to exceed Surfactant
[alpha]-(3-carboxy-1- 0.125% for seed
oxosulfopropyl)-[omega]-hydroxy- treatment use
, (C10-C16)-alkyl ethers, only.
disodium salts, polyoxyethylene
content averages 5 moles (CAS
Reg. No. 68954-91-6).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2015-02072 Filed 2-3-15; 8:45 am]
BILLING CODE 6560-50-P
