
[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]


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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.

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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 http://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 http://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 http://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: http://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 http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://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, http://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 http://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 http://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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  Table 1--Summary of Toxicological Doses and Endpoints for Sulfoxaflor for Use in Human Health Risk Assessment
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                                    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 http://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 http://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
------------------------------------------------------------------------

    (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


