Federal Register / Vol. 78, No. 96 / Friday, May 17, 2013 / Rules and Regulations 29041 

SOLVENT CLEANING—Continued 

End-Uses Substitute Decision Further information 

Precision cleaning .......... 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 Substitute Decision Further information 

Adhesives ....................... Trans-1-chloro-3,3,3-trifluoroprop-1-ene (SolsticeTM 1233zd(E)).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. 

Coatings ......................... The manufacturer recommends an acceptable 

exposure limit of 300 ppm over an 8-hour timeweighted average for trans-1-chloro-3,3,3- 

trifluoroprop-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. 

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. 

1EPA 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. 

[FR Doc. 2013–11871 Filed 5–16–13; 8:45 am] 

BILLING CODE 6560–50–P 

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 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. 


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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-l4- 

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 


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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, 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 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 

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 

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 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

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

Risk 

assessment 

Study and toxicological effects 

Acute dietary (Females 13–50 

years of age).

NOAEL = 1.8 mg/kg/ 

day.

UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

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 dietary (General population including infants and 

children).

NOAEL = 25 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

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 dietary (All populations) NOAEL= 5.13 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

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. 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Dermal (or oral) 

study NOAEL = 

1.8 mg/kg/day 

(dermal absorption 

rate = 2.4%.

UFA = 3x 

UFH = 10x 

LOC for MOE = 30 .. Developmental Neurotoxicity Study LOAEL = 7.1 mg/kg/day 

based on decreased neonatal survival (PND 0–4). 

Inhalation short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Inhalation (or oral) 

study NOAEL= 1.8 

mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 3x 

UFH = 10x 

LOC for MOE = 30 .. Developmental Neurotoxicity Study LOAEL = 7.1 mg/kg/day 

based on decreased neonatal survival (PND 0–4). 

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 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 

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 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 

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 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 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. 

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. 

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-l6- 

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 


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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: 

§ 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]-g4- 

sulfanylidene]cyanamide). 

Commodity Parts per 

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 

kiwi fruit ................................. 2.0 

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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0852; FRL–9385–3] 

Streptomycin; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: 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). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0852, 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. 

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. 


wreier-aviles on DSK5TPTVN1PROD with RULES