Sulfoxaflor; Pesticide Tolerances, 29041-29049 [2013-11824]
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Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Rules and Regulations
29041
SOLVENT CLEANING—Continued
End-Uses
Substitute
Decision
Precision cleaning ..........
Further information
Note that this substitute boils at room temperature. Therefore, EPA recommends using this
substitute in equipment designed to minimize
solvent losses, emissions and worker exposure. Examples of such equipment include
containers with connected hoses and valves
that allow for direct transfer of the solvent to
cleaning equipment without opening of the
storage container, and enclosed or low-emission cleaning equipment.
Observe recommendations in the manufacturer’s
MSDS and guidance for using this substitute.
ADHESIVES, COATINGS AND INKS
End-Uses
Adhesives .......................
Substitute
Decision
Trans-1-chloro-3,3,3-trifluoroprop-1-ene
sticeTM 1233zd(E)).
(Sol-
Further information
Acceptable ..
Trans-1-chloro-3,3,3-trifluoroprop-1-ene has an
ODP of approximately 0.00024 at temperate
latitudes. It has a 100-year global warming potential of 4.7 to 7. Its Chemical Abstracts Service Registry number (CAS Reg. No.) is
102687–65–0.
The manufacturer recommends an acceptable
exposure limit of 300 ppm over an 8-hour timeweighted average for trans-1-chloro-3,3,3trifluoroprop-1-ene.
Note that this substitute boils at room temperature, which may require some adjustments
when switching to this substitute. At this time, it
appears to be particularly suitable for spray adhesive applications and dip coatings.
Observe recommendations in the manufacturer’s
MSDS and guidance for using this substitute.
Coatings .........................
FIRE SUPPRESSION
End-Use
Substitute
Decision
Further information 1 2
Total flooding systems
(occupied and unoccupied areas).
K-Ace (solution of 50% potassium acetate and
50% water)..
Acceptable ..
EPA recommends that use of this system should
be in accordance with the manufacturer’s
MSDS.
1 EPA recommends that users consult Section VIII of the OSHA Technical Manual for information on selecting the appropriate types of personal protective equipment for all listed fire suppression agents. EPA has no intention of duplicating or displacing OSHA coverage related to the
use of personal protective equipment (e.g., respiratory protection), fire protection, hazard communication, worker training or any other occupational safety and health standard with respect to halon substitutes.
2 Use of all listed fire suppression agents should conform to relevant OSHA requirements, including 29 CFR Part 1910, subpart L, sections
1910.160 and 1910.162.
ENVIRONMENTAL PROTECTION
AGENCY
or on multiple commodities which are
identified and discussed later in this
document. DOW AgroSciences LLC
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
40 CFR Part 180
DATES:
[FR Doc. 2013–11871 Filed 5–16–13; 8:45 am]
BILLING CODE 6560–50–P
This regulation is effective May
17, 2013. Objections and requests for
hearings must be received on or before
July 16, 2013, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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[EPA–HQ–OPP–2010–0889; FRL–9371–4]
Sulfoxaflor; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2010–0889, is
ADDRESSES:
This regulation establishes
tolerances for residues of sulfoxaflor in
SUMMARY:
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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), EPA West
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.
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Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
Jennifer Urbanski, Registration Division,
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 347–0156; email address:
urbanski.jennifer@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 EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
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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–2010–0889 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 July 16, 2013. 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.
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Information not marked confidential
pursuant to 40 CFR part 2 may be
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–
2010–0889, 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
Confidential Business Information (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.htm.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of July 25,
2012 (77 FR 43562) (FRL–9353–6), EPA
issued a document pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 0F7777) by DOW
AgroSciences LLC, 9330 Zionsville
Road, Indianapolis, IN, 46268. The
petition requested that 40 CFR part 180
be amended by establishing tolerances
for residues of the insecticide
sulfoxaflor, or 1-(6trifluoromethylpyridin-3yl)ethyl](methyl)-oxido-l4sulfanylidenecyanamide, in or on Crop
group 1, subgroup 1A, 1B, Root
Vegetables at 0.05 ppm (from carrot,
roots at 0.05 ppm; beet, sugar, roots at
0.03 ppm; radish, roots at 0.03 ppm);
carrot, juice at 0.15 ppm; beet, sugar,
raw sugar at 0.04 ppm; beet, sugar,
molasses at 0.3 ppm; beet, sugar, thick
juice at 0.15 ppm; beet, sugar, dried
pulp at 0.07 ppm; subgroup 1C, 1D,
Tuberous and Corm Vegetables at 0.01
ppm; potato at 0.01 ppm; potato, wet
peel at 0.02 ppm; potato, chips at 0.02
ppm; potato, dried at 0.02 ppm; potato,
granules/flakes at 0.02 ppm; Crop group
2 Leaves of Root and Tuber Vegetables
at 4 ppm (from carrot, tops at 4 ppm;
beet, sugar, tops at 3 ppm; radish, tops
at 0.7 ppm); Crop group 3, subgroup 3–
07A Bulb vegetables, Onion, bulb,
subgroup at 0.01 ppm (from onion, dry
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bulb at 0.01 ppm); subgroup 3–07B Bulb
Vegetables, Onion, green, subgroup at
0.6 ppm (from onion, green at 0.6 ppm);
Crop group 4, subgroup 4A Leafy
Vegetables (except Brassica), Leafy
greens, subgroup at 5 ppm (from leafy
greens at 1.6 ppm); subgroup 4B Leafy
Vegetables (except Brassica), Leafy
petioles, subgroup at 1 ppm; (from
celery at 1 ppm); Crop group 5,
subgroup 5A Brassica Leafy Vegetables,
head and stem (except cauliflower) at 1
ppm (from cauliflower at 0.08 ppm;
broccoli at 0.45 ppm; cabbage at 1 ppm);
subgroup 5B Brassica Leafy Vegetables
(from mustard greens at 1.6 ppm); green
bean, snap, succulent at 0.7 ppm; beans,
dry at 0.25 ppm; Crop group 8 Fruiting
Vegetables (except cucurbits, plus okra)
at 1.2 ppm (from tomato at 0.45 ppm;
pepper, bell and non-bell at 1.2 ppm);
tomato, puree at 0.7 ppm; tomato, paste
at 1.6 ppm; tomato, catsup at 0.8 ppm;
Crop group 9 Cucurbit Vegetables
(except squash) at 0.3 ppm (from
cucumber at 0.3 ppm; melon at 0.3
ppm); squash at 0.03 ppm; Crop group
10 Citrus Fruits at 0.6 ppm (from orange
at 0.6 ppm; lemon at 0.45 ppm;
grapefruit at 0.25 ppm); citrus, peel at 1
ppm; citrus, dried pulp, at 0.9 ppm;
Crop group 11 Pome Fruits at 0.4 ppm
(from apple at 0.3 ppm; pear at 0.4
ppm); apple, dried pomace at 1.3 ppm;
Crop Group 12 Stone Fruits (except
cherry) at 0.6 ppm (from nectarine,
pitted fruit at 0.3 ppm; peach, pitted
fruit at 0.6 ppm; plum, pitted fruit at
0.25 ppm); cherry, pitted fruit at 2.5
ppm; cherry, dried cherry at 15 ppm;
Crop group 13, subgroup 13–07F Small
Fruit Vine Climbing subgroup (except
fuzzy kiwifruit) at 1.3 ppm (from grape
at 1.3 ppm); grape, raisins at 5 ppm;
subgroup 13–07G Low Growing Berry
subgroup at 0.6 ppm (from strawberry,
fruit at 0.6 ppm); Crop group 14 Tree
Nuts (plus pistachio) at 0.02 ppm (from
almond at 0.02 ppm; pistachio at 0.02
ppm; pecan at 0.01 ppm); almond, hulls
at 4 ppm; Crop group 20, subgroup 20–
A Rapeseed subgroup at 0.25 ppm (from
canola, seeds at 0.25 ppm); canola, meal
at 0.5 ppm; subgroup 20C Cottonseed
subgroup at 0.2 ppm (from cotton, seed
at 0.2 ppm); cotton, hulls at 0.4 ppm;
cotton, gin byproducts at 8 ppm; cotton,
aspirated grain fractions at 4.6 ppm;
wheat, grain at 0.07 ppm; wheat, forage
at 0.8 ppm; wheat, hay at 1.1 ppm;
wheat, straw at 2 ppm; barley, grain at
0.15 ppm; barley hay at 0.8 ppm; barley
straw at 1.5 ppm; barley malt sprouts at
0.2 ppm; soybean, seed at 0.2 ppm;
soybean hay at 1.8 ppm; soybean, forage
at 1.9 ppm; soybean hulls at 0.3 ppm;
soybean, meal, toasted at 0.3 ppm;
soybean, aspirated grain fractions at 18
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ppm. Tolerances of unchanged parent,
XDE–208 are also proposed for milk at
0.08 ppm; fat of cattle, goat, horse and
sheep at 0.04 ppm; kidney of cattle,
goat, horse and sheep at 0.2 ppm; meat
of cattle, goat, horse and sheep at 0.1
ppm; meat byproducts of cattle, goat,
horse and sheep at 0.25 ppm; fat and
meat of hog at 0.01 ppm; meat
byproducts of hog at 0.04 ppm; egg at
0.01 ppm; fat and meat of poultry at
0.01 ppm; meat byproduct of poultry at
0.03 ppm. That document referenced a
summary of the petition prepared by
DOW AgroSciences LLC, the registrant,
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 IV.C.
Based upon review of the data
supporting the petition, EPA has
increased the proposed tolerances of
almond, hulls to 6.0 ppm; barley, grain
to 0.4 ppm; barley, hay to 1.0 ppm;
barley, straw to 2.0 ppm; beet, sugar,
molasses to 0.25 ppm; berry, low
growing, subgroup 13–07G to 0.7 ppm;
citrus, dried pulp to 3.60 ppm; fruit,
citrus, group 10–10 to 0.7 ppm; fruit,
pome, group 11–10 to 0.5 ppm; fruit,
small, vine climbing, subgroup 13–07F,
except fuzzy kiwi fruit to 2.0 ppm; fruit,
stone, group 12 to 3.0 ppm; grape, raisin
to 6.0 ppm; leafy greens, subgroup 4A
to 6.0 ppm; leafy petiole, subgroup 4B
to 2.0 ppm; onion, green, subgroup 3–
07B to 0.7 ppm; tomato, paste 2.6 ppm;
tomato, puree to 1.2 ppm; vegetable,
brassica, leafy, group 5, except
cauliflower to 2.0 ppm; vegetable,
cucurbit, group 9 to 0.4 ppm; vegetable,
root and tuber, group 1 to 0.05 ppm;
wheat, grain to 0.08 ppm; wheat, forage
to 1.0 ppm; wheat, hay to 1.5 ppm;
cattle, meat to 0.15 ppm; cattle, fat to 0.1
ppm; cattle, meat byproducts to 0.4
ppm; milk to 0.15 ppm; goat, meat to
0.15 ppm; goat, fat to 0.1 ppm; goat,
meat byproducts to 0.4 ppm; horse,
meat to 0.15 ppm; horse, fat to 0.1 ppm;
horse, meat byproducts to 0.4 ppm;
sheep, meat to 0.15 ppm; sheep, fat to
0.1 ppm; and sheep, meat byproducts to
0.4 ppm. EPA has decreased the
proposed tolerances of bean, dry seed to
0.2 ppm; bean, succulent to 4.0 ppm;
cotton, hulls to 0.35 ppm; cotton, gin
byproducts to 6.0 ppm; nuts, tree, group
14 to 0.015 ppm; pistachio to 0.015
ppm; vegetable, fruiting, group 10 to 0.7
ppm; vegetable, leaves of root and tuber,
group 2 to 3.0 ppm; hog, meat
byproducts to 0.1 ppm; and poultry,
meat byproducts to 0.1 ppm. EPA has
added the following tolerances: beet,
sugar, dried pulp at 0.07 ppm; grain,
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aspirated fractions at 20.0 ppm;
vegetable, legume, foliage, group 7 at 3.0
ppm; and watercress at 6.0 ppm. EPA
has not established a tolerance for an
individual commodity if that
commodity is included in a crop group
tolerance. The reasons for these changes
are explained in Unit IV.D.
III. Aggregate Risk Assessment and
Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish 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. . . .’’
Consistent with FFDCA section
408(b)(2)(D), and the factors specified in
FFDCA section 408(b)(2)(D), 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 sulfoxaflor
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with sulfoxaflor follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its 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.
Sulfoxaflor is the first member of a
new class of insecticides, the
sulfoximines, and is a highly efficacious
activator of the nicotinic acetylcholine
receptor (nAChR) in insects. Toxicity
and mechanistic studies in rats, rabbits,
dogs and mice indicate that sulfoxaflor
is an activator of the mammalian nAChR
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29043
as well, but to a much lesser degree and
in a species-specific manner. The
database of guideline toxicity studies
indicates that the nervous system and
liver are the target organ systems,
resulting in developmental toxicity,
hepatotoxicity, and other apical effects.
Developmental/offspring toxicity,
manifested as skeletal abnormalities and
neonatal deaths, was observed in rats
only. The skeletal abnormalities,
including forelimb flexure, bent
clavicles, and hindlimb rotation, likely
resulted from skeletal muscle
contraction due to activation of the
skeletal muscle nAChR in utero.
Contraction of the diaphragm, also
related to skeletal muscle nAChR
activation, prevented normal breathing
in neonates and resulted in increased
mortality in the reproduction studies.
Furthermore, targeted studies indicate
that offspring effects are dependent
upon in utero exposure to sulfoxaflor.
The skeletal abnormalities were
observed at high doses in the
developmental and reproduction studies
while decreased neonatal survival was
observed at slightly lower levels (e.g.,
mid- and high-dose animals).
Exposure to sulfoxaflor and its major
metabolites resulted in hepatotoxicity in
several guideline studies. For example,
sulfoxaflor caused liver weight and
enzyme changes, hypertrophy,
proliferation, and tumors in subchronic
and chronic studies. Short-term studies
with metabolites resulted in similar
liver effects. For sulfoxaflor,
hepatoxicity occurred at lower doses in
long-term studies compared to shortterm studies.
In addition to the developmental and
hepatic effects, treatment with
sulfoxaflor resulted in decreased food
consumption and body weight as well
as changes in the male reproductive
system. Decreased body weight, body
weight changes, and food consumption
were observed during the first few days
of several oral studies at the mid- and
high-dose levels. As a result of
decreased feeding early in the studies,
body weights were typically lower in
the mid- and high-dose groups
compared to the controls, although the
differences were not generally
statistically significant. Decreased
palatability is a likely contributor to this
effect as body weight decreases were
often observed at study initiation but
were comparable to control animals
within several weeks.
Effects in the male reproductive
organs were observed in the chronic/
carcinogenicity study in rats that
included increased testicular and
epididymal weights, atrophy of
seminiferous tubules, and decreased
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secretory material in the coagulating
glands, prostate, and seminal vesicles.
Additionally, there was an increased
incidence of interstitial cell (Leydig cell)
tumors. The Leydig cell tumors
observed after exposure to sulfoxaflor
are not considered treatment related due
to the lack of dose response, the lack of
statistical significance for the combined
tumors (unilateral and bilateral), and the
high background rates for this tumor
type in F344 rats. The primary effects on
male reproductive organs are considered
secondary to the loss of normal
testicular function due to the size of the
interstitial cell (Leydig Cell) adenomas.
Consequently, the secondary effects to
the male reproductive organs are also
not considered treatment related.
Clinical indications of neurotoxicity
were only observed at high doses in the
acute neurotoxicity study in rats. At the
highest dose tested, muscle tremors and
twitches, convulsions, hindlimb
splaying, increased lacrimation and
salivation, decreased pupil size and
response to touch, gait abnormalities
and decreased rectal temperature were
observed. Decreased motor activity was
also observed in the mid- and high-dose
groups. Since the neurotoxicity was
observed only at a very high dose and
many of the effects are not consistent
with the perturbation of the nicotinic
receptor system (e.g., salivation,
lacrimation, and pupil response), it is
unlikely that these effects are due to
activation of the nAChR.
Finally, tumors were observed in
chronic rat and mouse studies. In rats,
significant increases in the incidence of
hepatocellular adenomas and combined
adenomas and/or carcinomas in the
high-dose males were observed when
compared to controls. In mice, there
were significant increases in
hepatocellular adenomas, carcinomas,
and combined adenomas and/or
carcinomas in high dose males when
compared to controls. In female mice,
there was an increase in the incidences
of carcinomas at the high dose.
Although this increase did not reach
statistical significance, the incidences
exceeded the historical control range for
this tumor type was corroborated with
the presence of non-neoplastic lesions at
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this dose. EPA determined that the liver
tumors in mice were treatment-related.
Using data from several mechanistic
studies, EPA also determined that the
liver effects in mice and rats are nonlinear (threshold) in their mode of
action (MoA) and the MoA for the liver
tumors is consistent with a constitutive
androstane receptor (CAR) mediated,
mitogenic mode-of-action. Leydig cell
tumors were also observed in the highdose group of male rates, but it was
determined that the tumors were not
related to treatment. There was also a
significant increase in the incidence of
preputial gland tumors in male rats in
the high-dose group. Marginal increases
were also observed in the low- and middose groups; however, the incident
values for these groups were within the
range of historical control values. Given
that the liver tumors are produced by a
non-linear mechanism, the Leydig cell
tumors were not treatment-related, and
the preputial gland tumors only
occurred at the high dose in one sex of
one species, EPA concluded that the
evidence of potential carcinogenicity
was weak and that that quantification of
risk using a non-linear approach (i.e.,
reference dose (RfD) will adequately
account for all chronic toxicity,
including any potential carcinogenic
effects, that could result from exposure
to sulfoxaflor. The current NOAEL of
5.13 mg/kg/day used for chronic dietary
risk assessment is significantly (4x)
lower than the dose where tumors were
observed ≥ 21.3 mg/kg/day.
In addition, EPA determined there
was sufficient evidence to support a
developmental mode-of-action (i.e.,
activation of the nAChR) accounting for
the skeletal abnormalities and increased
mortality observed in the rat.
Furthermore, there was sufficient
evidence to support that rats are
uniquely sensitive to these
developmental effects, informing
interspecies uncertainty. Although the
database indicates that the
developmental effects are unlikely to be
relevant to humans, the effects will be
considered as relevant to humans unless
additional information to the contrary is
provided. Data are sufficient to support
reducing the interspecies uncertainty
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factor to 3X for the developmental
effects.
Specific information on the studies
received and the nature of the adverse
effects caused by sulfoxaflor as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Sulfoxaflor—New Active Ingredient
Human Health Risk Assessment of Uses
on Numerous Crops’’ at pages 14–31 in
docket ID number EPA–HQ–OPP–2010–
0889.
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 no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). 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. A summary of the
toxicological endpoints for sulfoxaflor
used for human risk assessment is
shown in Table 1 of this unit.
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29045
TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFOXAFLOR FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Exposure/scenario
Acute dietary (Females 13–50
years of age).
Acute dietary (General population including infants and
children).
Chronic dietary (All populations)
Dermal short-term (1 to 30
days) and intermediate-term
(1 to 6 months).
Inhalation short-term (1 to 30
days) and intermediate-term
(1 to 6 months).
Cancer (Oral, dermal, inhalation).
Point of departure
and
uncertainty/safety
factors
RfD, PAD, LOC for
Risk
assessment
NOAEL = 1.8 mg/kg/
day.
UFA = 3x
UFH = 10x
FQPA SF = 1x
NOAEL = 25 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
NOAEL= 5.13 mg/
kg/day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Dermal (or oral)
study NOAEL =
1.8 mg/kg/day
(dermal absorption
rate = 2.4%.
UFA = 3x
UFH = 10x
Inhalation (or oral)
study NOAEL= 1.8
mg/kg/day (inhalation absorption
rate = 100%).
UFA = 3x
UFH = 10x
Acute RfD = 0.06
mg/kg/day.
aPAD = 0.06 mg/kg/
day
Developmental Neurotoxicity Study LOAEL = 7.1 mg/kg/day
based on decreased neonatal survival (PND 0–4).
Acute RfD = 0.25
mg/kg/day.
aPAD = 0.25 mg/kg/
day
Acute Neurotoxicity Study LOAEL = 75 mg/kg/day based on
decreased motor activity.
Chronic RfD = 0.05
mg/kg/day.
cPAD = 0.05 mg/kg/
day
Chronic/Carcinogenicity Study- Rat LOAEL = 21.3 mg/kg/day
based on liver effects including increase blood cholesterol,
liver weight, hypertrophy, fatty change, single cell necrosis
and macrophages.
LOC for MOE = 30 ..
Developmental Neurotoxicity Study LOAEL = 7.1 mg/kg/day
based on decreased neonatal survival (PND 0–4).
LOC for MOE = 30 ..
Developmental Neurotoxicity Study LOAEL = 7.1 mg/kg/day
based on decreased neonatal survival (PND 0–4).
Study and toxicological effects
Quantification of risk using a non-linear approach (i.e. reference dose (RfD) will adequately account for all
chronic toxicity, including carcinogenicity, that could result from exposure to sulfoxaflor.
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to sulfoxaflor, EPA considered
exposure under the petitioned-for
tolerances. EPA assessed dietary
exposures from sulfoxaflor in food as
follows:
i. Acute exposure. Quantitative acute
dietary exposure and risk assessments
are performed for a food-use pesticide,
if a toxicological study has indicated the
possibility of an effect of concern
occurring as a result of a 1-day or single
exposure. Such effects were identified
for sulfoxaflor. In estimating acute
dietary exposure, EPA used food
consumption information from the
United States Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII). As to
residue levels in food, EPA used
maximum residue values from field
trials rather than tolerance-level residue
estimates. For crop groups, the residue
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values were translated from
representative crops to the other crops
in the group. For processed
commodities, empirical processing
factors were used for all commodities
unless an empirical factor was not
available, in which case the DEEM
default estimate was used. Residue
estimates for livestock were derived
using maximum observed residues in
the cattle and hen feeding studies. EPA
has assumed 100% of crops covered by
the registration request are treated with
sulfoxaflor.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the USDA 1994–1996 and 1998
CSFII. As to residue levels in food, EPA
has made the same refinements as those
described for the acute exposure
assessment, with two exceptions: (1)
Average residue levels from crop field
trials were used rather than maximum
values and (2) average residues from
feeding studies, rather than maximum
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values, were used to derive residue
estimates for livestock commodities.
EPA has assumed 100% of crops
covered by the registration request are
treated with sulfoxaflor.
iii. Cancer. EPA determines whether
quantitative cancer exposure and risk
assessments are appropriate for a fooduse pesticide based on the weight of the
evidence from cancer studies and other
relevant data. Cancer risk is quantified
using a linear or nonlinear approach. If
sufficient information on the
carcinogenic mode of action is available,
a threshold or nonlinear approach is
used and a cancer RfD is calculated
based on an earlier noncancer key event.
If carcinogenic mode of action data is
not available, or if the mode of action
data determines a mutagenic mode of
action, a default linear cancer slope
factor approach is utilized. Based on the
data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD
approach is appropriate for assessing
cancer risk to sulfoxaflor. Cancer risk
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was assessed using the same exposure
estimates as discussed in Unit III.C.1.ii.,
chronic exposure.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use PCT information in the dietary
assessment for sulfoxaflor. One hundred
percent CT was assumed for all food
commodities. Maximum residue levels
from field trials were used for the acute
exposure assessment while average
residue levels from field trials were
used for the chronic exposure
assessment. Section 408(b)(2)(E) of
FFDCA authorizes EPA to use available
data and information on the anticipated
residue levels of pesticide residues in
food and the actual levels of pesticide
residues that have been measured in
food. If EPA relies on such information,
EPA must require pursuant to FFDCA
section 408(f)(1) that data be provided 5
years after the tolerance is established,
modified, or left in effect, demonstrating
that the levels in food are not above the
levels anticipated. For the present
action, EPA will issue such data call-ins
as are required by FFDCA section
408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be
required to be submitted no later than
5 years from the date of issuance of
these tolerances.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for sulfoxaflor in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of sulfoxaflor.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
Two scenarios were modeled, use of
sulfoxaflor on non-aquatic row and
orchard crops and use of sulfoxaflor on
watercress. For the non-aquatic crop
scenario, based on the Pesticide Root
Zone Model/Exposure Analysis
Modeling System (PRZM/EXAMS) and
Screening Concentration in Ground
Water (SCI–GROW) models, the
estimated drinking water concentrations
(EDWCs) of sulfoxaflor for acute
exposures are estimated to be 26.4 parts
per billion (ppb) for surface water and
69.2 ppb for ground water. For chronic
exposures for non-cancer assessments,
EDWCs are estimated to be 13.5 ppb for
surface water and 69.2 ppb for ground
water. For chronic exposures for cancer
assessments, EDWCs are estimated to be
9.3 ppb for surface water and 69.2 ppb
for ground water.
For the watercress scenario, based on
the Tier I Rice Model, the estimated
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drinking water concentrations (EDWCs)
of sulfoxaflor for surface water are
estimated to be 91.3 parts per billion
(ppb) after one application, 182.5 parts
per billion (ppb) after two applications,
and 273.8 parts per billion (ppb) after
three applications. The 2007 census of
agriculture estimates that approximately
680 acres of the U.S. are used for
watercress production; thus, this use
represents a very small fraction of the
potential crop acreage that may be
treated with sulfoxaflor. Moreover, the
inputs to the Tier 1 rice model are quite
conservative, especially with regard to
application efficiency (the model
assumes that there is no interception of
the applied material by the watercress
plants) and the 10-cm water column at
the time of application (information
from watercress growers indicates that
watercress fields are drained prior to
pesticide applications). Finally, the rice
model predicts pesticide concentrations
in water in the field and not drinking
water per se where concentrations are
expected to be lower due to dissipation
processes such as degradation, stream
flow, and dilution. While the use on
watercress may theoretically impact
drinking water for a few individuals,
EPA does not believe that the EDWCs
and residue profiles associated with the
watercress use give a representative
depiction of the potential exposure
profile for any major identifiable
subgroup of consumers within the U.S.
EPA has assessed dietary exposure
using the EDWCs from both the nonaquatic uses and the watercress use.
Dietary risk estimates using both sets of
EDWCs are below the Agency’s level of
concern. For risk characterization
purposes, EPA is focusing on the nonaquatic-crop EDWCs because they are
more representative of the expected
exposure profile for the majority of the
population. Furthermore, EPA adjusted
the water concentration values to take
into account the source of the water
(surface water vs. groundwater); the
relative amounts of parent sulfoxaflor,
X11719474, and X11519540; and the
relative liver toxicity of the metabolites
as compared to the parent compound
(0.3X and 10X for X11719474 and
X11519540, respectively). A full
discussion of the approach used by EPA
is available in Volume 77, No. 189 of the
Federal Register (77 FR 59561,
September 28, 2012). In summary, the
three adjusted EDWCs are as follows:
For acute dietary risk assessment of
the general population, the groundwater
EDWC is greater than the surface water
EDWC and was used in the assessment.
The residue profile in groundwater is
60.9 ppb X11719474 and 8.3 ppb
X11519540 (totaling 69.2 ppb). Parent
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Sfmt 4700
sulfoxaflor is not expected to occur in
groundwater. For this assessment, the
regulatory toxicological endpoint is
based on neurotoxicity. There is no
information to relate the neurotoxicity
of the metabolites to that of sulfoxaflor;
therefore, no toxicity adjustment was
made to the EDWC.
For acute dietary risk assessment of
females 13–49, the regulatory endpoint
is attributable only to the parent
compound (as previously discussed);
therefore, the surface water EDWC is the
most appropriate EDWC for this
assessment even though it is of a lower
value than the groundwater EDWC,
which reflects metabolites only. The
EDWC of 9.4 ppb was used and no
toxicological adjustment was made.
For chronic dietary risk assessment,
the toxicological endpoint is liver
effects, for which it is possible to
account for the relative toxicities of
X11719474 and X11519540 as compared
to sulfoxaflor. The groundwater EDWC
is greater than the surface water EDWC.
The residue profile in groundwater
consists of 60.9 ppb X11719474 and 8.3
ppb X11519540. Adjusting for the
relative toxicity results in 18.3 ppb
equivalents of X11719474 and 83 ppb
X11519540 (totaling 101.3 ppb). The
adjusted groundwater EDCW is greater
than the surface water EDWC (9.3 ppb)
and was, therefore, used to assess the
chronic dietary exposure scenario.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Sulfoxaflor is not registered for any
specific use patterns that would result
in residential exposure.
4. 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 sulfoxaflor to share a common
mechanism of toxicity with any other
substances, and sulfoxaflor does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
sulfoxaflor 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
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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 tenfold (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 Safety Factor (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.
Although there was quantitative
susceptibility observed in the
developmental neurotoxicity (DNT)
study, there is no residual uncertainty
because the effects are well
characterized, a clear NOAEL was
identified, and the endpoints chosen for
risk assessment are protective of
potential in utero and developmental
effects. Quantitative susceptibility in the
DNT was based on an increased rate of
neonatal deaths at a dose where no
maternal toxicity was observed.
However, the apparent enhanced
sensitivity may be due to the limited
number of evaluations conducted in
dams in the study rather than a true
sensitivity of the young. Qualitative
susceptibility was observed in the 2generation reproduction study since
neonatal deaths were observed at the
same dose that resulted in
hepatotoxicity in parental animals.
However, these effects occurred at a
higher dose compared to the offspring
effects observed in the DNT. Finally,
there was no evidence of quantitative or
qualitative susceptibility in the
developmental studies in the rat or
rabbit.
As described in Section A.
Toxicological Profile, the Agency
considers the rat to be uniquely
sensitive to these developmental effects.
There is sufficient evidence indicating
that neonatal death in rats occurs as a
result of sulfoxaflor binding to the fetal
receptor. Sulfoxaflor does not bind the
human fetal receptor in similar manner,
precluding developmental effects in
humans by this mechanism of toxicity.
3. Conclusion. EPA has determined
that reliable data show the safety of
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infants and children would be
adequately protected if the FQPA SF
were reduced to 1X. That decision is
based on the following findings:
i. The toxicity database for sulfoxaflor
is complete.
ii. The level of concern for
neurotoxicity is low because the effects
are well characterized, the doseresponse curve for these effects is well
characterized, and clear NOAELs have
been identified.
iii. Although there is evidence of
quantitative susceptibility in the DNT
study, based on decreased survival of
offspring up to postnatal day 4, the
endpoints and doses selected for risk
assessment are protective for these
effects; further, EPA’s degree of concern
for human susceptibility is reduced
based on the special studies submitted
in support of the mode of action.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
either maximum or average residue
levels from field trials. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to sulfoxaflor in
drinking water. Although some
refinements were used in the exposure
assessment, the dietary and drinking
water assessments will still result in the
upper-bound estimates of exposure (see
Unit III.C.2).
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. Using the exposure
assumptions discussed in this unit for
acute exposure, the acute dietary
exposure from food and water to
sulfoxaflor will occupy 16% of the
aPAD for children 1–2 years old and
females 13–49 years old, the population
groups receiving the greatest exposure.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that chronic exposure to sulfoxaflor
from food and water will utilize 18% of
the cPAD for infants, the population
group receiving the greatest exposure.
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29047
There are no residential uses for
sulfoxaflor.
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). A short-term adverse
effect was identified; however,
sulfoxaflor is not registered for any use
patterns that would result in short-term
residential exposure. Short-term risk is
assessed based on short-term residential
exposure plus chronic dietary exposure.
Because there is no short-term
residential exposure and chronic dietary
exposure has already been assessed
under the appropriately protective
cPAD (which is at least as protective as
the POD used to assess short-term risk),
no further assessment of short-term risk
is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating short-term risk for
sulfoxaflor.
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). An
intermediate-term adverse effect was
identified; however, sulfoxaflor is not
registered for any use patterns that
would result in intermediate-term
residential exposure. Intermediate-term
risk is assessed based on intermediateterm residential exposure plus chronic
dietary exposure. Because there is no
intermediate-term residential exposure
and chronic dietary exposure has
already been assessed under the
appropriately protective cPAD (which is
at least as protective as the POD used to
assess intermediate-term risk), no
further assessment of intermediate-term
risk is necessary, and EPA relies on the
chronic dietary risk assessment for
evaluating intermediate-term risk for
sulfoxaflor.
5. Aggregate cancer risk for U.S.
population. As described in Unit III.A,
EPA has concluded that assessments
using a non-linear approach (e.g., a
chronic RfD-based assessment) will
adequately account for all chronic
toxicity, including carcinogenicity that
could result from exposure to
sulfoxaflor. Chronic dietary risk
estimates are below EPA’s level of
concern; therefore, cancer risk is also
below EPA’s level of concern.
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 sulfoxaflor
residues.
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IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
is available to enforce the tolerance
expression. High performance liquid
chromatographic (HPLC) methods with
positive-ion electro spray (ESI) tandem
mass spectrometry (LC/MS/MS) were
developed for data collection and
enforcement of sulfoxaflor residues and
the two metabolites X11719474 and
X11721061. Method 091116 was
developed for plant commodities, and
Method 091188 was developed for
livestock commodities. FDA
multiresidue methods are not suitable
for analysis of sulfoxaflor; however, data
were provided which indicate that the
DFG S–19 multiresidue method may
provide satisfactory results. The
analytical enforcement methodology
may be requested from: Chief,
Analytical Chemistry Branch,
Environmental Science Center, 701
Mapes Rd., Ft. Meade, MD 20755–5350;
telephone number: (410) 305–2905;
email address:
residuemethods@epa.gov.
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B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level. The Codex has not
established any MRLs for sulfoxaflor.
C. Response to Comments
Two comments were received by
email on the notice of filing. One
commenter asked for clarification on the
proposed tolerance for Subgroup 5B
Brassica Leafy Vegetables. EPA
contacted the registrant and confirmed
that the proposed tolerance for this
subgroup is 1.6 ppm. The second
commenter asked for clarification on the
proposed tolerances for Crop Group 1,
specifically questioning the discrepancy
in proposed tolerances between radish
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roots and carrot and beets, sugar roots.
EPA responded that the tolerances listed
in the company’s notice of filing are
only proposed and not necessarily what
the Agency will grant. To cover these
commodities, EPA is granting a single
tolerance of 0.05 ppm for vegetable, root
and tuber, group 1. The comments and
EPA responses can be found in the
docket.
D. Revisions to Petitioned-For
Tolerances
Many of the tolerance levels proposed
by the registrant are different from those
being established by the EPA. The
reason for these differences is that the
registrant determined the proposed
tolerances using the North American
Free-Trade Agreement tolerance
calculator rather than using the
Organization for Economic Co-operation
and Development (OECD) calculation
procedures. In order to maximize global
regulatory harmonization, it became
EPA policy in April 2011, which was
after receipt of the sulfoxaflor
submission, to use the OECD calculation
procedures to derive tolerance levels. In
addition, the registrant proposed
tolerances for some crops as both an
individual crop and as members of a
crop group. EPA has not established a
tolerance for an individual commodity
if that commodity is included in a crop
group tolerance. EPA is not establishing
tolerances for cattle, sheep, goat, and
horse kidney as proposed, as kidneys
are covered under the requested meat
byproducts tolerances. Nor is EPA
establishing a tolerance for residues in
plum, prune, dried as residue levels is
adequately addressed by the tolerance
listing for the stone fruit crop group raw
agricultural commodity. EPA is
establishing four tolerances which were
not proposed by the petitioner:
Beet, sugar, dried pulp at 0.07 ppm
due to the potential for concentration of
residues upon production of the dried
pulp commodity. The petitioner’s
evaluation indicates that it did not think
a separate tolerance would be necessary
but EPA’s analysis of the data shows
otherwise;
Grain, aspirated fractions at 20 ppm to
cover residues in this feed item. The
tolerance is necessary to support uses
on barley and wheat but a tolerance was
not requested, apparently an oversight
by the petitioner;
Watercress at 6.0 ppm. The petitioner
requested this use but did not provide
a requested tolerance level; and
Crop Group 7 (Vegetables, legume,
foliage) at 7.0 ppm. The tolerance is
necessary to support uses on Crop
Group 6 (legume vegetables) but the
petitioner only requested tolerances for
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several individual commodities in Crop
Group 7, apparently as an oversight. See
Unit II. for specific revisions.
V. Conclusion
Therefore, tolerances are established
for residues of sulfoxaflor, 1-(6trifluoromethylpyridin-3yl)ethyl](methyl)-oxido-l6sulfanylidenecyanamide, as indicated in
Unit II.
VI. Statutory and Executive Order
Reviews
This final rule establishes tolerances
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 final rule
has been exempted from review under
Executive Order 12866, this final rule 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 final rule 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 tolerance 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 final rule 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
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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 final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(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 of 1995
(NTTAA) (15 U.S.C. 272 note).
VII. 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: May 6, 2012.
Steven Bradbury,
Director, 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. Section 180.670 is added to subpart
C to read as follows:
■
wreier-aviles on DSK5TPTVN1PROD with RULES
§ 180.670 Sulfoxaflor; tolerances for
residues.
(a) General. Tolerances are
established for residues of the
insecticide sulfoxaflor, including its
metabolites and degradate, in or on the
commodities in the table below.
Compliance with the tolerance levels
specified below is to be determined by
measuring only sulfoxaflor (N[methyloxido[1-[6-(trifluoromethyl)-3pyridinyl]ethyl]-g4sulfanylidene]cyanamide).
VerDate Mar<15>2010
15:13 May 16, 2013
Jkt 229001
Parts per
million
Commodity
29049
(d) Indirect or inadvertent
registrations. [Reserved]
[FR Doc. 2013–11824 Filed 5–16–13; 8:45 am]
Almond, hulls ............................
Barley, grain .............................
Barley, hay ................................
Barley, straw .............................
Bean, dry seed .........................
Bean, succulent ........................
Beet, sugar, dried pulp .............
Beet, sugar, molasses ..............
Berry, low growing, subgroup
13–07G .................................
Cattle, fat ..................................
Cattle, meat ..............................
Cattle, meat byproducts ...........
Cauliflower ................................
Citrus, dried pulp ......................
Cotton, gin byproducts .............
Cotton, hulls ..............................
Cottonseed subgroup 20C .......
Fruit, citrus, group 10–10 .........
Fruit, pome, group 11–10 .........
Fruit, small, vine climbing, subgroup 13–07F, except fuzzy
kiwi fruit .................................
Fruit, stone, group 12 ...............
Goat, fat ....................................
Goat, meat ................................
Goat, meat byproducts .............
Grain, aspirated fractions .........
Grape, raisin .............................
Hog, fat .....................................
Hog, meat .................................
Hog, meat byproducts ..............
Horse, fat ..................................
Horse, meat ..............................
Horse, meat byproducts ...........
Leafy greens, subgroup 4A ......
Leafy petiole, subgroup 4B ......
Milk ...........................................
Nuts, tree, group 14 .................
Onion, bulb, subgroup 3–07A ..
Onion, green, subgroup 3–07B
Pistachio ...................................
Poultry, eggs .............................
Poultry, fat ................................
Poultry, meat ............................
Poultry, meat byproducts ..........
Rapeseed, meal .......................
Rapeseed subgroup 20A ..........
Sheep, fat .................................
Sheep, meat .............................
Sheep, meat byproducts ..........
Soybean, seed ..........................
Tomato, paste ...........................
Tomato, puree ..........................
Vegetable, brassica, leafy,
group 5, except cauliflower ...
Vegetable, cucurbit, group 9 ....
Vegetable, fruiting, group 8–10
Vegetable, leaves of root and
tuber, group 2 .......................
Vegetable, legume, group 7 .....
Vegetable, root and tuber,
group 1 ..................................
Watercress ................................
Wheat, forage ...........................
Wheat, grain .............................
Wheat, hay ...............................
Wheat, straw .............................
6.0
0.40
1.0
2.0
0.20
4.0
0.07
0.25
0.70
0.10
0.15
0.40
0.08
3.6
6.0
0.35
0.20
0.70
0.50
2.0
3.0
0.10
0.15
0.40
20.0
6.0
0.01
0.01
0.01
0.10
0.15
0.40
6.0
2.0
0.15
0.015
0.01
0.70
0.015
0.01
0.01
0.01
0.01
0.50
0.40
0.10
0.15
0.40
0.20
2.60
1.20
2.0
0.40
0.70
3.0
3.0
0.05
6.0
1.0
0.08
1.5
2.0
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
PO 00000
Frm 00031
Fmt 4700
Sfmt 4700
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0852; FRL–9385–3]
Streptomycin; Pesticide Tolerances for
Emergency Exemptions
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
time-limited tolerances for residues of
streptomycin in or on grapefruit and
grapefruit, dried pulp. This action is in
response to EPA’s granting of an
emergency exemption under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizing use of the
pesticide on grapefruit. This regulation
establishes maximum permissible levels
for residues of streptomycin in or on
these commodities. The time-limited
tolerances expire on December 31, 2015.
DATES: This regulation is effective May
17, 2013. Objections and requests for
hearings must be received on or before
July 16, 2013 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:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2011–0852, 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), EPA West
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:
Andrea Conrath, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9356; email address:
conrath.andrea@epa.gov.
ADDRESSES:
E:\FR\FM\17MYR1.SGM
17MYR1
Agencies
[Federal Register Volume 78, Number 96 (Friday, May 17, 2013)]
[Rules and Regulations]
[Pages 29041-29049]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11824]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0889; FRL-9371-4]
Sulfoxaflor; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
sulfoxaflor in or on multiple commodities which are identified and
discussed later in this document. DOW AgroSciences LLC requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 17, 2013. Objections and
requests for hearings must be received on or before July 16, 2013, 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-2010-0889, 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), EPA West 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.
[[Page 29042]]
FOR FURTHER INFORMATION CONTACT: Jennifer Urbanski, Registration
Division, Office of Pesticide Programs, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001;
telephone number: (703) 347-0156; email address:
urbanski.jennifer@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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://ecfr.gpoaccess.gov/cgi/t/text/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-2010-0889 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
July 16, 2013. 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 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-2010-0889, 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 Confidential Business
Information (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.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
0F7777) by DOW AgroSciences LLC, 9330 Zionsville Road, Indianapolis,
IN, 46268. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the insecticide sulfoxaflor, or
1-(6-trifluoromethylpyridin-3-yl)ethyl](methyl)-oxido-[lambda]4-
sulfanylidenecyanamide, in or on Crop group 1, subgroup 1A, 1B, Root
Vegetables at 0.05 ppm (from carrot, roots at 0.05 ppm; beet, sugar,
roots at 0.03 ppm; radish, roots at 0.03 ppm); carrot, juice at 0.15
ppm; beet, sugar, raw sugar at 0.04 ppm; beet, sugar, molasses at 0.3
ppm; beet, sugar, thick juice at 0.15 ppm; beet, sugar, dried pulp at
0.07 ppm; subgroup 1C, 1D, Tuberous and Corm Vegetables at 0.01 ppm;
potato at 0.01 ppm; potato, wet peel at 0.02 ppm; potato, chips at 0.02
ppm; potato, dried at 0.02 ppm; potato, granules/flakes at 0.02 ppm;
Crop group 2 Leaves of Root and Tuber Vegetables at 4 ppm (from carrot,
tops at 4 ppm; beet, sugar, tops at 3 ppm; radish, tops at 0.7 ppm);
Crop group 3, subgroup 3-07A Bulb vegetables, Onion, bulb, subgroup at
0.01 ppm (from onion, dry bulb at 0.01 ppm); subgroup 3-07B Bulb
Vegetables, Onion, green, subgroup at 0.6 ppm (from onion, green at 0.6
ppm); Crop group 4, subgroup 4A Leafy Vegetables (except Brassica),
Leafy greens, subgroup at 5 ppm (from leafy greens at 1.6 ppm);
subgroup 4B Leafy Vegetables (except Brassica), Leafy petioles,
subgroup at 1 ppm; (from celery at 1 ppm); Crop group 5, subgroup 5A
Brassica Leafy Vegetables, head and stem (except cauliflower) at 1 ppm
(from cauliflower at 0.08 ppm; broccoli at 0.45 ppm; cabbage at 1 ppm);
subgroup 5B Brassica Leafy Vegetables (from mustard greens at 1.6 ppm);
green bean, snap, succulent at 0.7 ppm; beans, dry at 0.25 ppm; Crop
group 8 Fruiting Vegetables (except cucurbits, plus okra) at 1.2 ppm
(from tomato at 0.45 ppm; pepper, bell and non-bell at 1.2 ppm);
tomato, puree at 0.7 ppm; tomato, paste at 1.6 ppm; tomato, catsup at
0.8 ppm; Crop group 9 Cucurbit Vegetables (except squash) at 0.3 ppm
(from cucumber at 0.3 ppm; melon at 0.3 ppm); squash at 0.03 ppm; Crop
group 10 Citrus Fruits at 0.6 ppm (from orange at 0.6 ppm; lemon at
0.45 ppm; grapefruit at 0.25 ppm); citrus, peel at 1 ppm; citrus, dried
pulp, at 0.9 ppm; Crop group 11 Pome Fruits at 0.4 ppm (from apple at
0.3 ppm; pear at 0.4 ppm); apple, dried pomace at 1.3 ppm; Crop Group
12 Stone Fruits (except cherry) at 0.6 ppm (from nectarine, pitted
fruit at 0.3 ppm; peach, pitted fruit at 0.6 ppm; plum, pitted fruit at
0.25 ppm); cherry, pitted fruit at 2.5 ppm; cherry, dried cherry at 15
ppm; Crop group 13, subgroup 13-07F Small Fruit Vine Climbing subgroup
(except fuzzy kiwifruit) at 1.3 ppm (from grape at 1.3 ppm); grape,
raisins at 5 ppm; subgroup 13-07G Low Growing Berry subgroup at 0.6 ppm
(from strawberry, fruit at 0.6 ppm); Crop group 14 Tree Nuts (plus
pistachio) at 0.02 ppm (from almond at 0.02 ppm; pistachio at 0.02 ppm;
pecan at 0.01 ppm); almond, hulls at 4 ppm; Crop group 20, subgroup 20-
A Rapeseed subgroup at 0.25 ppm (from canola, seeds at 0.25 ppm);
canola, meal at 0.5 ppm; subgroup 20C Cottonseed subgroup at 0.2 ppm
(from cotton, seed at 0.2 ppm); cotton, hulls at 0.4 ppm; cotton, gin
byproducts at 8 ppm; cotton, aspirated grain fractions at 4.6 ppm;
wheat, grain at 0.07 ppm; wheat, forage at 0.8 ppm; wheat, hay at 1.1
ppm; wheat, straw at 2 ppm; barley, grain at 0.15 ppm; barley hay at
0.8 ppm; barley straw at 1.5 ppm; barley malt sprouts at 0.2 ppm;
soybean, seed at 0.2 ppm; soybean hay at 1.8 ppm; soybean, forage at
1.9 ppm; soybean hulls at 0.3 ppm; soybean, meal, toasted at 0.3 ppm;
soybean, aspirated grain fractions at 18
[[Page 29043]]
ppm. Tolerances of unchanged parent, XDE-208 are also proposed for milk
at 0.08 ppm; fat of cattle, goat, horse and sheep at 0.04 ppm; kidney
of cattle, goat, horse and sheep at 0.2 ppm; meat of cattle, goat,
horse and sheep at 0.1 ppm; meat byproducts of cattle, goat, horse and
sheep at 0.25 ppm; fat and meat of hog at 0.01 ppm; meat byproducts of
hog at 0.04 ppm; egg at 0.01 ppm; fat and meat of poultry at 0.01 ppm;
meat byproduct of poultry at 0.03 ppm. That document referenced a
summary of the petition prepared by DOW AgroSciences LLC, the
registrant, 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 IV.C.
Based upon review of the data supporting the petition, EPA has
increased the proposed tolerances of almond, hulls to 6.0 ppm; barley,
grain to 0.4 ppm; barley, hay to 1.0 ppm; barley, straw to 2.0 ppm;
beet, sugar, molasses to 0.25 ppm; berry, low growing, subgroup 13-07G
to 0.7 ppm; citrus, dried pulp to 3.60 ppm; fruit, citrus, group 10-10
to 0.7 ppm; fruit, pome, group 11-10 to 0.5 ppm; fruit, small, vine
climbing, subgroup 13-07F, except fuzzy kiwi fruit to 2.0 ppm; fruit,
stone, group 12 to 3.0 ppm; grape, raisin to 6.0 ppm; leafy greens,
subgroup 4A to 6.0 ppm; leafy petiole, subgroup 4B to 2.0 ppm; onion,
green, subgroup 3-07B to 0.7 ppm; tomato, paste 2.6 ppm; tomato, puree
to 1.2 ppm; vegetable, brassica, leafy, group 5, except cauliflower to
2.0 ppm; vegetable, cucurbit, group 9 to 0.4 ppm; vegetable, root and
tuber, group 1 to 0.05 ppm; wheat, grain to 0.08 ppm; wheat, forage to
1.0 ppm; wheat, hay to 1.5 ppm; cattle, meat to 0.15 ppm; cattle, fat
to 0.1 ppm; cattle, meat byproducts to 0.4 ppm; milk to 0.15 ppm; goat,
meat to 0.15 ppm; goat, fat to 0.1 ppm; goat, meat byproducts to 0.4
ppm; horse, meat to 0.15 ppm; horse, fat to 0.1 ppm; horse, meat
byproducts to 0.4 ppm; sheep, meat to 0.15 ppm; sheep, fat to 0.1 ppm;
and sheep, meat byproducts to 0.4 ppm. EPA has decreased the proposed
tolerances of bean, dry seed to 0.2 ppm; bean, succulent to 4.0 ppm;
cotton, hulls to 0.35 ppm; cotton, gin byproducts to 6.0 ppm; nuts,
tree, group 14 to 0.015 ppm; pistachio to 0.015 ppm; vegetable,
fruiting, group 10 to 0.7 ppm; vegetable, leaves of root and tuber,
group 2 to 3.0 ppm; hog, meat byproducts to 0.1 ppm; and poultry, meat
byproducts to 0.1 ppm. EPA has added the following tolerances: beet,
sugar, dried pulp at 0.07 ppm; grain, aspirated fractions at 20.0 ppm;
vegetable, legume, foliage, group 7 at 3.0 ppm; and watercress at 6.0
ppm. EPA has not established a tolerance for an individual commodity if
that commodity is included in a crop group tolerance. The reasons for
these changes are explained in Unit IV.D.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . .
.''
Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 sulfoxaflor including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with sulfoxaflor follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
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.
Sulfoxaflor is the first member of a new class of insecticides, the
sulfoximines, and is a highly efficacious activator of the nicotinic
acetylcholine receptor (nAChR) in insects. Toxicity and mechanistic
studies in rats, rabbits, dogs and mice indicate that sulfoxaflor is an
activator of the mammalian nAChR as well, but to a much lesser degree
and in a species-specific manner. The database of guideline toxicity
studies indicates that the nervous system and liver are the target
organ systems, resulting in developmental toxicity, hepatotoxicity, and
other apical effects.
Developmental/offspring toxicity, manifested as skeletal
abnormalities and neonatal deaths, was observed in rats only. The
skeletal abnormalities, including forelimb flexure, bent clavicles, and
hindlimb rotation, likely resulted from skeletal muscle contraction due
to activation of the skeletal muscle nAChR in utero. Contraction of the
diaphragm, also related to skeletal muscle nAChR activation, prevented
normal breathing in neonates and resulted in increased mortality in the
reproduction studies. Furthermore, targeted studies indicate that
offspring effects are dependent upon in utero exposure to sulfoxaflor.
The skeletal abnormalities were observed at high doses in the
developmental and reproduction studies while decreased neonatal
survival was observed at slightly lower levels (e.g., mid- and high-
dose animals).
Exposure to sulfoxaflor and its major metabolites resulted in
hepatotoxicity in several guideline studies. For example, sulfoxaflor
caused liver weight and enzyme changes, hypertrophy, proliferation, and
tumors in subchronic and chronic studies. Short-term studies with
metabolites resulted in similar liver effects. For sulfoxaflor,
hepatoxicity occurred at lower doses in long-term studies compared to
short-term studies.
In addition to the developmental and hepatic effects, treatment
with sulfoxaflor resulted in decreased food consumption and body weight
as well as changes in the male reproductive system. Decreased body
weight, body weight changes, and food consumption were observed during
the first few days of several oral studies at the mid- and high-dose
levels. As a result of decreased feeding early in the studies, body
weights were typically lower in the mid- and high-dose groups compared
to the controls, although the differences were not generally
statistically significant. Decreased palatability is a likely
contributor to this effect as body weight decreases were often observed
at study initiation but were comparable to control animals within
several weeks.
Effects in the male reproductive organs were observed in the
chronic/carcinogenicity study in rats that included increased
testicular and epididymal weights, atrophy of seminiferous tubules, and
decreased
[[Page 29044]]
secretory material in the coagulating glands, prostate, and seminal
vesicles. Additionally, there was an increased incidence of
interstitial cell (Leydig cell) tumors. The Leydig cell tumors observed
after exposure to sulfoxaflor are not considered treatment related due
to the lack of dose response, the lack of statistical significance for
the combined tumors (unilateral and bilateral), and the high background
rates for this tumor type in F344 rats. The primary effects on male
reproductive organs are considered secondary to the loss of normal
testicular function due to the size of the interstitial cell (Leydig
Cell) adenomas. Consequently, the secondary effects to the male
reproductive organs are also not considered treatment related.
Clinical indications of neurotoxicity were only observed at high
doses in the acute neurotoxicity study in rats. At the highest dose
tested, muscle tremors and twitches, convulsions, hindlimb splaying,
increased lacrimation and salivation, decreased pupil size and response
to touch, gait abnormalities and decreased rectal temperature were
observed. Decreased motor activity was also observed in the mid- and
high-dose groups. Since the neurotoxicity was observed only at a very
high dose and many of the effects are not consistent with the
perturbation of the nicotinic receptor system (e.g., salivation,
lacrimation, and pupil response), it is unlikely that these effects are
due to activation of the nAChR.
Finally, tumors were observed in chronic rat and mouse studies. In
rats, significant increases in the incidence of hepatocellular adenomas
and combined adenomas and/or carcinomas in the high-dose males were
observed when compared to controls. In mice, there were significant
increases in hepatocellular adenomas, carcinomas, and combined adenomas
and/or carcinomas in high dose males when compared to controls. In
female mice, there was an increase in the incidences of carcinomas at
the high dose. Although this increase did not reach statistical
significance, the incidences exceeded the historical control range for
this tumor type was corroborated with the presence of non-neoplastic
lesions at this dose. EPA determined that the liver tumors in mice were
treatment-related. Using data from several mechanistic studies, EPA
also determined that the liver effects in mice and rats are non-linear
(threshold) in their mode of action (MoA) and the MoA for the liver
tumors is consistent with a constitutive androstane receptor (CAR)
mediated, mitogenic mode-of-action. Leydig cell tumors were also
observed in the high-dose group of male rates, but it was determined
that the tumors were not related to treatment. There was also a
significant increase in the incidence of preputial gland tumors in male
rats in the high-dose group. Marginal increases were also observed in
the low- and mid-dose groups; however, the incident values for these
groups were within the range of historical control values. Given that
the liver tumors are produced by a non-linear mechanism, the Leydig
cell tumors were not treatment-related, and the preputial gland tumors
only occurred at the high dose in one sex of one species, EPA concluded
that the evidence of potential carcinogenicity was weak and that that
quantification of risk using a non-linear approach (i.e., reference
dose (RfD) will adequately account for all chronic toxicity, including
any potential carcinogenic effects, that could result from exposure to
sulfoxaflor. The current NOAEL of 5.13 mg/kg/day used for chronic
dietary risk assessment is significantly (4x) lower than the dose where
tumors were observed >= 21.3 mg/kg/day.
In addition, EPA determined there was sufficient evidence to
support a developmental mode-of-action (i.e., activation of the nAChR)
accounting for the skeletal abnormalities and increased mortality
observed in the rat. Furthermore, there was sufficient evidence to
support that rats are uniquely sensitive to these developmental
effects, informing interspecies uncertainty. Although the database
indicates that the developmental effects are unlikely to be relevant to
humans, the effects will be considered as relevant to humans unless
additional information to the contrary is provided. Data are sufficient
to support reducing the interspecies uncertainty factor to 3X for the
developmental effects.
Specific information on the studies received and the nature of the
adverse effects caused by sulfoxaflor as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Sulfoxaflor--New Active Ingredient
Human Health Risk Assessment of Uses on Numerous Crops'' at pages 14-31
in docket ID number EPA-HQ-OPP-2010-0889.
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 no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). 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. A summary of the toxicological
endpoints for sulfoxaflor used for human risk assessment is shown in
Table 1 of this unit.
[[Page 29045]]
Table 1--Summary of Toxicological Doses and Endpoints for Sulfoxaflor for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors Risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 NOAEL = 1.8 mg/kg/ Acute RfD = 0.06 mg/ Developmental Neurotoxicity Study
years of age). day. kg/day. LOAEL = 7.1 mg/kg/day based on
UFA = 3x............ aPAD = 0.06 mg/kg/ decreased neonatal survival (PND
UFH = 10x........... day. 0-4).
FQPA SF = 1x........
Acute dietary (General population NOAEL = 25 mg/kg/day Acute RfD = 0.25 mg/ Acute Neurotoxicity Study LOAEL =
including infants and children). UFA = 10x........... kg/day. 75 mg/kg/day based on decreased
UFH = 10x........... aPAD = 0.25 mg/kg/ motor activity.
FQPA SF = 1x........ day.
Chronic dietary (All populations) NOAEL= 5.13 mg/kg/ Chronic RfD = 0.05 Chronic/Carcinogenicity Study- Rat
day. mg/kg/day. LOAEL = 21.3 mg/kg/day based on
UFA = 10x........... cPAD = 0.05 mg/kg/ liver effects including increase
UFH = 10x........... day. blood cholesterol, liver weight,
FQPA SF = 1x........ hypertrophy, fatty change, single
cell necrosis and macrophages.
Dermal short-term (1 to 30 days) Dermal (or oral) LOC for MOE = 30... Developmental Neurotoxicity Study
and intermediate-term (1 to 6 study NOAEL = 1.8 LOAEL = 7.1 mg/kg/day based on
months). mg/kg/day (dermal decreased neonatal survival (PND
absorption rate = 0-4).
2.4%.
UFA = 3x............
UFH = 10x...........
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 30... Developmental Neurotoxicity Study
days) and intermediate-term (1 study NOAEL= 1.8 mg/ LOAEL = 7.1 mg/kg/day based on
to 6 months). kg/day (inhalation decreased neonatal survival (PND
absorption rate = 0-4).
100%).
UFA = 3x............
UFH = 10x...........
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Quantification of risk using a non-linear approach (i.e. reference dose (RfD)
will adequately account for all chronic toxicity, including carcinogenicity,
that could result from exposure to sulfoxaflor.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sulfoxaflor, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from sulfoxaflor in food
as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. Such effects were identified
for sulfoxaflor. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of
Food Intake by Individuals (CSFII). As to residue levels in food, EPA
used maximum residue values from field trials rather than tolerance-
level residue estimates. For crop groups, the residue values were
translated from representative crops to the other crops in the group.
For processed commodities, empirical processing factors were used for
all commodities unless an empirical factor was not available, in which
case the DEEM default estimate was used. Residue estimates for
livestock were derived using maximum observed residues in the cattle
and hen feeding studies. EPA has assumed 100% of crops covered by the
registration request are treated with sulfoxaflor.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA has made the same
refinements as those described for the acute exposure assessment, with
two exceptions: (1) Average residue levels from crop field trials were
used rather than maximum values and (2) average residues from feeding
studies, rather than maximum values, were used to derive residue
estimates for livestock commodities. EPA has assumed 100% of crops
covered by the registration request are treated with sulfoxaflor.
iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or nonlinear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data is not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that a nonlinear RfD approach is appropriate
for assessing cancer risk to sulfoxaflor. Cancer risk
[[Page 29046]]
was assessed using the same exposure estimates as discussed in Unit
III.C.1.ii., chronic exposure.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use PCT information in the dietary assessment for
sulfoxaflor. One hundred percent CT was assumed for all food
commodities. Maximum residue levels from field trials were used for the
acute exposure assessment while average residue levels from field
trials were used for the chronic exposure assessment. Section
408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for sulfoxaflor in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of sulfoxaflor. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www.epa.gov/oppefed1/models/water/index.htm.
Two scenarios were modeled, use of sulfoxaflor on non-aquatic row
and orchard crops and use of sulfoxaflor on watercress. For the non-
aquatic crop scenario, based on the Pesticide Root Zone Model/Exposure
Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in
Ground Water (SCI-GROW) models, the estimated drinking water
concentrations (EDWCs) of sulfoxaflor for acute exposures are estimated
to be 26.4 parts per billion (ppb) for surface water and 69.2 ppb for
ground water. For chronic exposures for non-cancer assessments, EDWCs
are estimated to be 13.5 ppb for surface water and 69.2 ppb for ground
water. For chronic exposures for cancer assessments, EDWCs are
estimated to be 9.3 ppb for surface water and 69.2 ppb for ground
water.
For the watercress scenario, based on the Tier I Rice Model, the
estimated drinking water concentrations (EDWCs) of sulfoxaflor for
surface water are estimated to be 91.3 parts per billion (ppb) after
one application, 182.5 parts per billion (ppb) after two applications,
and 273.8 parts per billion (ppb) after three applications. The 2007
census of agriculture estimates that approximately 680 acres of the
U.S. are used for watercress production; thus, this use represents a
very small fraction of the potential crop acreage that may be treated
with sulfoxaflor. Moreover, the inputs to the Tier 1 rice model are
quite conservative, especially with regard to application efficiency
(the model assumes that there is no interception of the applied
material by the watercress plants) and the 10-cm water column at the
time of application (information from watercress growers indicates that
watercress fields are drained prior to pesticide applications).
Finally, the rice model predicts pesticide concentrations in water in
the field and not drinking water per se where concentrations are
expected to be lower due to dissipation processes such as degradation,
stream flow, and dilution. While the use on watercress may
theoretically impact drinking water for a few individuals, EPA does not
believe that the EDWCs and residue profiles associated with the
watercress use give a representative depiction of the potential
exposure profile for any major identifiable subgroup of consumers
within the U.S.
EPA has assessed dietary exposure using the EDWCs from both the
non-aquatic uses and the watercress use. Dietary risk estimates using
both sets of EDWCs are below the Agency's level of concern. For risk
characterization purposes, EPA is focusing on the non-aquatic-crop
EDWCs because they are more representative of the expected exposure
profile for the majority of the population. Furthermore, EPA adjusted
the water concentration values to take into account the source of the
water (surface water vs. groundwater); the relative amounts of parent
sulfoxaflor, X11719474, and X11519540; and the relative liver toxicity
of the metabolites as compared to the parent compound (0.3X and 10X for
X11719474 and X11519540, respectively). A full discussion of the
approach used by EPA is available in Volume 77, No. 189 of the Federal
Register (77 FR 59561, September 28, 2012). In summary, the three
adjusted EDWCs are as follows:
For acute dietary risk assessment of the general population, the
groundwater EDWC is greater than the surface water EDWC and was used in
the assessment. The residue profile in groundwater is 60.9 ppb
X11719474 and 8.3 ppb X11519540 (totaling 69.2 ppb). Parent sulfoxaflor
is not expected to occur in groundwater. For this assessment, the
regulatory toxicological endpoint is based on neurotoxicity. There is
no information to relate the neurotoxicity of the metabolites to that
of sulfoxaflor; therefore, no toxicity adjustment was made to the EDWC.
For acute dietary risk assessment of females 13-49, the regulatory
endpoint is attributable only to the parent compound (as previously
discussed); therefore, the surface water EDWC is the most appropriate
EDWC for this assessment even though it is of a lower value than the
groundwater EDWC, which reflects metabolites only. The EDWC of 9.4 ppb
was used and no toxicological adjustment was made.
For chronic dietary risk assessment, the toxicological endpoint is
liver effects, for which it is possible to account for the relative
toxicities of X11719474 and X11519540 as compared to sulfoxaflor. The
groundwater EDWC is greater than the surface water EDWC. The residue
profile in groundwater consists of 60.9 ppb X11719474 and 8.3 ppb
X11519540. Adjusting for the relative toxicity results in 18.3 ppb
equivalents of X11719474 and 83 ppb X11519540 (totaling 101.3 ppb). The
adjusted groundwater EDCW is greater than the surface water EDWC (9.3
ppb) and was, therefore, used to assess the chronic dietary exposure
scenario.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Sulfoxaflor is not
registered for any specific use patterns that would result in
residential exposure.
4. 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
sulfoxaflor to share a common mechanism of toxicity with any other
substances, and sulfoxaflor does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that sulfoxaflor 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
[[Page 29047]]
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 tenfold (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 Safety
Factor (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. Although there was
quantitative susceptibility observed in the developmental neurotoxicity
(DNT) study, there is no residual uncertainty because the effects are
well characterized, a clear NOAEL was identified, and the endpoints
chosen for risk assessment are protective of potential in utero and
developmental effects. Quantitative susceptibility in the DNT was based
on an increased rate of neonatal deaths at a dose where no maternal
toxicity was observed. However, the apparent enhanced sensitivity may
be due to the limited number of evaluations conducted in dams in the
study rather than a true sensitivity of the young. Qualitative
susceptibility was observed in the 2-generation reproduction study
since neonatal deaths were observed at the same dose that resulted in
hepatotoxicity in parental animals. However, these effects occurred at
a higher dose compared to the offspring effects observed in the DNT.
Finally, there was no evidence of quantitative or qualitative
susceptibility in the developmental studies in the rat or rabbit.
As described in Section A. Toxicological Profile, the Agency
considers the rat to be uniquely sensitive to these developmental
effects. There is sufficient evidence indicating that neonatal death in
rats occurs as a result of sulfoxaflor binding to the fetal receptor.
Sulfoxaflor does not bind the human fetal receptor in similar manner,
precluding developmental effects in humans by this mechanism of
toxicity.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for sulfoxaflor is complete.
ii. The level of concern for neurotoxicity is low because the
effects are well characterized, the dose-response curve for these
effects is well characterized, and clear NOAELs have been identified.
iii. Although there is evidence of quantitative susceptibility in
the DNT study, based on decreased survival of offspring up to postnatal
day 4, the endpoints and doses selected for risk assessment are
protective for these effects; further, EPA's degree of concern for
human susceptibility is reduced based on the special studies submitted
in support of the mode of action.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and either maximum or average residue levels from field
trials. EPA made conservative (protective) assumptions in the ground
and surface water modeling used to assess exposure to sulfoxaflor in
drinking water. Although some refinements were used in the exposure
assessment, the dietary and drinking water assessments will still
result in the upper-bound estimates of exposure (see Unit III.C.2).
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to sulfoxaflor will occupy 16% of the aPAD for children 1-2 years old
and females 13-49 years old, the population groups receiving the
greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sulfoxaflor from food and water will utilize 18% of the cPAD for
infants, the population group receiving the greatest exposure. There
are no residential uses for sulfoxaflor.
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). A short-term
adverse effect was identified; however, sulfoxaflor is not registered
for any use patterns that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. Because there is no short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
sulfoxaflor.
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). An intermediate-term adverse effect was identified; however,
sulfoxaflor is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
sulfoxaflor.
5. Aggregate cancer risk for U.S. population. As described in Unit
III.A, EPA has concluded that assessments using a non-linear approach
(e.g., a chronic RfD-based assessment) will adequately account for all
chronic toxicity, including carcinogenicity that could result from
exposure to sulfoxaflor. Chronic dietary risk estimates are below EPA's
level of concern; therefore, cancer risk is also below EPA's level of
concern.
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 sulfoxaflor residues.
[[Page 29048]]
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. High performance liquid chromatographic (HPLC)
methods with positive-ion electro spray (ESI) tandem mass spectrometry
(LC/MS/MS) were developed for data collection and enforcement of
sulfoxaflor residues and the two metabolites X11719474 and X11721061.
Method 091116 was developed for plant commodities, and Method 091188
was developed for livestock commodities. FDA multiresidue methods are
not suitable for analysis of sulfoxaflor; however, data were provided
which indicate that the DFG S-19 multiresidue method may provide
satisfactory results. The analytical enforcement methodology may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone
number: (410) 305-2905; email address: residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established any MRLs for sulfoxaflor.
C. Response to Comments
Two comments were received by email on the notice of filing. One
commenter asked for clarification on the proposed tolerance for
Subgroup 5B Brassica Leafy Vegetables. EPA contacted the registrant and
confirmed that the proposed tolerance for this subgroup is 1.6 ppm. The
second commenter asked for clarification on the proposed tolerances for
Crop Group 1, specifically questioning the discrepancy in proposed
tolerances between radish roots and carrot and beets, sugar roots. EPA
responded that the tolerances listed in the company's notice of filing
are only proposed and not necessarily what the Agency will grant. To
cover these commodities, EPA is granting a single tolerance of 0.05 ppm
for vegetable, root and tuber, group 1. The comments and EPA responses
can be found in the docket.
D. Revisions to Petitioned-For Tolerances
Many of the tolerance levels proposed by the registrant are
different from those being established by the EPA. The reason for these
differences is that the registrant determined the proposed tolerances
using the North American Free-Trade Agreement tolerance calculator
rather than using the Organization for Economic Co-operation and
Development (OECD) calculation procedures. In order to maximize global
regulatory harmonization, it became EPA policy in April 2011, which was
after receipt of the sulfoxaflor submission, to use the OECD
calculation procedures to derive tolerance levels. In addition, the
registrant proposed tolerances for some crops as both an individual
crop and as members of a crop group. EPA has not established a
tolerance for an individual commodity if that commodity is included in
a crop group tolerance. EPA is not establishing tolerances for cattle,
sheep, goat, and horse kidney as proposed, as kidneys are covered under
the requested meat byproducts tolerances. Nor is EPA establishing a
tolerance for residues in plum, prune, dried as residue levels is
adequately addressed by the tolerance listing for the stone fruit crop
group raw agricultural commodity. EPA is establishing four tolerances
which were not proposed by the petitioner:
Beet, sugar, dried pulp at 0.07 ppm due to the potential for
concentration of residues upon production of the dried pulp commodity.
The petitioner's evaluation indicates that it did not think a separate
tolerance would be necessary but EPA's analysis of the data shows
otherwise;
Grain, aspirated fractions at 20 ppm to cover residues in this feed
item. The tolerance is necessary to support uses on barley and wheat
but a tolerance was not requested, apparently an oversight by the
petitioner;
Watercress at 6.0 ppm. The petitioner requested this use but did
not provide a requested tolerance level; and
Crop Group 7 (Vegetables, legume, foliage) at 7.0 ppm. The
tolerance is necessary to support uses on Crop Group 6 (legume
vegetables) but the petitioner only requested tolerances for several
individual commodities in Crop Group 7, apparently as an oversight. See
Unit II. for specific revisions.
V. Conclusion
Therefore, tolerances are established for residues of sulfoxaflor,
1-(6-trifluoromethylpyridin-3-yl)ethyl](methyl)-oxido-[lambda]\6\-
sulfanylidenecyanamide, as indicated in Unit II.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 final rule 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 tolerance 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 final rule 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
[[Page 29049]]
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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).
VII. 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: May 6, 2012.
Steven Bradbury,
Director, 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. Section 180.670 is added to subpart C to read as follows:
Sec. 180.670 Sulfoxaflor; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide sulfoxaflor, including its metabolites and degradate, in or
on the commodities in the table below. Compliance with the tolerance
levels specified below is to be determined by measuring only
sulfoxaflor (N-[methyloxido[1-[6-(trifluoromethyl)-3-pyridinyl]ethyl]-
[gamma]\4\-sulfanylidene]cyanamide).
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls.............................................. 6.0
Barley, grain.............................................. 0.40
Barley, hay................................................ 1.0
Barley, straw.............................................. 2.0
Bean, dry seed............................................. 0.20
Bean, succulent............................................ 4.0
Beet, sugar, dried pulp.................................... 0.07
Beet, sugar, molasses...................................... 0.25
Berry, low growing, subgroup 13-07G........................ 0.70
Cattle, fat................................................ 0.10
Cattle, meat............................................... 0.15
Cattle, meat byproducts.................................... 0.40
Cauliflower................................................ 0.08
Citrus, dried pulp......................................... 3.6
Cotton, gin byproducts..................................... 6.0
Cotton, hulls.............................................. 0.35
Cottonseed subgroup 20C.................................... 0.20
Fruit, citrus, group 10-10................................. 0.70
Fruit, pome, group 11-10................................... 0.50
Fruit, small, vine climbing, subgroup 13-07F, except fuzzy 2.0
kiwi fruit................................................
Fruit, stone, group 12..................................... 3.0
Goat, fat.................................................. 0.10
Goat, meat................................................. 0.15
Goat, meat byproducts...................................... 0.40
Grain, aspirated fractions................................. 20.0
Grape, raisin.............................................. 6.0
Hog, fat................................................... 0.01
Hog, meat.................................................. 0.01
Hog, meat byproducts....................................... 0.01
Horse, fat................................................. 0.10
Horse, meat................................................ 0.15
Horse, meat byproducts..................................... 0.40
Leafy greens, subgroup 4A.................................. 6.0
Leafy petiole, subgroup 4B................................. 2.0
Milk....................................................... 0.15
Nuts, tree, group 14....................................... 0.015
Onion, bulb, subgroup 3-07A................................ 0.01
Onion, green, subgroup 3-07B............................... 0.70
Pistachio.................................................. 0.015
Poultry, eggs.............................................. 0.01
Poultry, fat............................................... 0.01
Poultry, meat.............................................. 0.01
Poultry, meat byproducts................................... 0.01
Rapeseed, meal............................................. 0.50
Rapeseed subgroup 20A...................................... 0.40
Sheep, fat................................................. 0.10
Sheep, meat................................................ 0.15
Sheep, meat byproducts..................................... 0.40
Soybean, seed.............................................. 0.20
Tomato, paste.............................................. 2.60
Tomato, puree.............................................. 1.20
Vegetable, brassica, leafy, group 5, except cauliflower.... 2.0
Vegetable, cucurbit, group 9............................... 0.40
Vegetable, fruiting, group 8-10............................ 0.70
Vegetable, leaves of root and tuber, group 2............... 3.0
Vegetable, legume, group 7................................. 3.0
Vegetable, root and tuber, group 1......................... 0.05
Watercress................................................. 6.0
Wheat, forage.............................................. 1.0
Wheat, grain............................................... 0.08
Wheat, hay................................................. 1.5
Wheat, straw............................................... 2.0
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(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent registrations. [Reserved]
[FR Doc. 2013-11824 Filed 5-16-13; 8:45 am]
BILLING CODE 6560-50-P