UNITED STATES ENVIRONMENTAL PROT ECT ION AGENCY WASIDNGTON, D. C. 20460

MEM ORANDUM

Dat e : 5 March 2014 OFFICE OF CHEMICA L SA FETY AND
POLL UT ION PREV E NTION

SUB JECT: S ulfoxaflo r- Human Health Risk Assessment of the FIFRA Section 18

Eme rgency Exemp tion Use on Sorghum.

FR OM: P C Cod e: 0052 1 0

Decision No .: 487020

P etition No.: l4TX02
Risk Assessment Type: Sing l e Chemi cal

, Aggregate

TXR No

. : None
MRlD No.: None

Michael A. Doherty, Ph.D.

, Senior Chem i s t
Za ida Fi g u e r oa, Indu s trial H yg ieni st 

# ijf ..,£t

Risk Assessmen t Branch II 

## 7 DP Barcode: 041 7536 Regi strati on No.: 62719 -6 25

R egu l atory Action: Sec tion 18 Registration Ca se No.: None
CAS No.: 946578-00- 3
40 CFR 180.668

Health Effects Division (7509 P ) 

## U

# ~ THROUGH: C hristina Swartz, Branch C hief

Risk Assessmen t Branch II

H ealt h Effect s Div i s i o n (7509 P)

TO: Keri Grin stea d /Ta wanda Maignan (Team 09)

Risk Integration, Minor Use & Em e r gency Re spo n se Branch Reg i stration Division (7505P)

J ennifer U rb anskiNenus Eag le (Team 01)

In se · cticide-Rodent icid e Branch

R egistrat ion Division (7505P)

CONCLUSIONS

HED has evaluated the hum an health risks associated w ith the r equeste d emer ge nc y exemption

use of the insecticide sulfoxaflor on sorghum. Ther e are no proposed o r existing r esidential uses f or sulfoxaflor; therefore

, t hi s risk assessmen t addresse s the potential dietary (foo d + drinking water) and occupational exposures as sociated with the proposed u se. HED conclu des tha t th e re is a reasonable certainty that no harm will re s ult from aggregate expos ure to

· s ulfoxaflo r

assoc iated with the requested Section 18 use; further

, the re are no concerns for occu pat ional

Page 1 of 18exposure and risk estimates associated with the proposed use pattern. The supported tolerances

and the tolerance definition are s ummarized below.

INTRODUCTION

The state ofTexas 1 is r equesting an emergency exemption under FIFRA Section 18 for the use of

sulfoxaflor on sorghum to control sugarcane aphid (Melanaphis sacchari). This is the first
Section 18 request for this use. The Agency has been petitioned by Dow AgroSciences (the registrant for sulfoxaflor) to register additional uses of sulfoxaflor and establish tole rance s for

residues of sulfoxaflor in multiple crops, including sorghum ( PP #4F8237).

In 2012, HED completed a human health risk assessment for sulfoxaflor, addressing uses on

numerous commodi t ies (M. Doherty et al., D 382604, 26 Sep t 2012; subsequent citations of this

assessment are listed as "D382 604. ")

.

ASSESSMENT SUMMARY

Sulfoxaflor { 

### N -[ methyloxido[l-[ 6-(trifluoromethyl)-3

- pyridinyl]ethyl]-1.. 4 -sulfany li dene] cyanamide} is the first member of a new class of in secticides, the sulfox imines

. The

sulfoxi rnine s act through a unique interaction with the nicotinic acetylcholine receptor in insects.
Sulfoxaflor is a highly efficacious agonist of the nicotinic receptor. The s tructural novelty of

s ulfoxaflor makes it sta ble in the presence of monooxygenase enzymes t hat degrade
neonicotinoid s and cause virtually all known cases of resistance in the field ofthis class of

insectic ides.

The Section 18 r equest is for application of Transform n.• WG, a wettable granule containing 50% (w / w) sulfoxaflor. U nd er this exemption, sulfoxaflor may be applied to approximately 3 million

acres of sorghum in Texas (however, see Footnote 1). Applications would be made from spring through late summer of the 2014 growing season using either ground-based, aerial, or chemigation equipment. The proposed use directions are summarized in Table 1.

Table 1. Summary of Proposed Use Directions a Specific Exemptio n Use of Sulfoxaflor on Sorghum.

Use Timing; Product Single Use Maximum Maximum PHI Use Directions and

Type; and [File Rate Uses per Seasonal (Days) Limitations Equipment Symbol] Season Use Rate

Foliar use. Transform·· 0.023-0.047 2 0

. 09lb 7 Do not make a pp lications less Application by WG lb a. i./ acre a.i ./ acre / yr (grain) than 14 days apart. ground, aerial, (62719-625] Do not make more than two or chemigation 14 applications per year. equipment. (forage, stover) Do not apply more than 0.09
lb a. i./acre per year.

1 The exemption request notes that Lousianna

, Oklahom a, and Mississippi have indicated that they will pursue a specific exemption for use of sulfoxaflor on sorghum. This risk assessment assumes that the entire U.S. sorghum

crop is treated with sulfoxaflor. Provided the use rates and timing are the same as those described for the use in Texas, t his risk assessment implicitly includes other states seeking this emergency exemption.

Pa ge 2 of 18

### Page 3 of 18

The nomenclature of sulfoxaflor is summarized in Table 2, below. The physical/chemical properties of sulfoxaflor (Appendix B) indicate that the compound is not particularly volatile (vapor pressure ≤ 1.4 x 10 - 6 

### Pa) and based on the K OW 

### (~6.35) it is not expected to partition into fatty tissue or bioaccumulate.

Table 2. Test Compound Nomenclature

. Compound

Common name Sulfoxaflor Company experimental name XDE

- 208

IUPAC name [methyl(oxo){1

- [6

- (trifluoromethyl)

- 3

- pyridyl]ethyl}

- λ 6

- sulfanylidene]cyanamide

CAS name [N

- methyloxido[1

- [6

- (trifluoromethyl)

- 3

- pyridinyl]ethyl] λ 4

- sulfanylidene] cyanamide

CAS # 946578

- 00

- 3



### Toxicology

The toxicology database for sulfoxaflor is adequate for FQPA consideration, including the assessment of potential increased susceptibility of infants and children. The database includes a developmental toxicity study in rats and rabbits, a 2

- generation reproduction study in rats, and acute, subchro nic, and developmental neurotoxicity studies in rats. The Agency has not received
a 28

- day inhalation study in the rat; however , that study has been waived for sulfoxaflor (TXR# 0056310)

. EPA waived the requirement for a subchronic inhalation data based on, among other things, its conclusion that even if an additional 10X safety factor were applied, inhalation exposure would not raise a risk of concern. The lack of a subchronic inhalation study is not considered a data gap and a database uncertainty fact or is not required

. Toxicity and mechanistic studies in rats, rabbits, dogs and mice indicate that the liver and the nervous systems are target organ systems. Liver effects in subchronic and chronic studies include organ weight and enzyme changes, hypert rophy, proliferation, and tumors ; long

- term studies result ed in hepatic effects at
doses lower than in short

- term studies

. Based on the weight of evidence, the Cancer Assessment Review Committee ( CARC ) determined that there is a “Suggestive Evidence of Carcinogenic Potential” for sulfoxaflor and that quantification of ri sk using a non

- linear approach [ i.e., oral reference dose (RfD) ] will adequately account for all chronic toxicity, including carcinogen icity, that could result from exposure to sulfoxaflor ( TXR # 0056301 , 26 April 2012 ).

Sulfoxaflor also affects the neurological system by interacting with the fetal isoform of the intermuscular nicotinic acetylcholine receptor (nAChR). This interaction re sults in the contraction of skeletal muscles causing limb flexure and bent clavicle in fetuses and decreased neonatal survival due to the constriction of the diaphragm muscles. HED determined this mode of action ( MOA ) was plausible and supported by the av ailable mechanistic data ( D382604 ).

HED has recommended that the required 10X FQPA Safety Factor be reduced to 1X based on the following considerations: 1) the toxicology database for sulfoxaflor is complete with regard to FQPA consideration, including th e required developmental and reproductive toxicity studies;

### Page 4 of 18

2) the required neurotoxicity studies, including the developmental neurotoxicity study (DNT) have been submitted, are considered adequate; 3) although there is evidence of quantitative susceptibil ity 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, HED’s degree of concern for human susceptibility is reduced based on the s pecial studies submitted in support of the mode of action; and 4) although some refinements are used in the exposure assessment, the dietary and drinking water assessments still result in upper

- bound estimates of exposure.

In addition

, HED has reduced the 10X interspecies factor (UF A 

### ) to 3X for assessments based on nicotinic receptor

- mediated effects (i.e., acute dietary risk assessment for women of reproductive age and for dermal and inhalation risk assessments). There is extensive mechanistic data
i ndicating that rats may be uniquely sensitive to the developmental effects of sulfoxaflor: 1) there were no developmental effects observed in the rabbit and 2) when the different adult rat, adult human, or fetal human nAChR isoforms are expressed in Xenopu s oocytes, t here was no indication of activation in the receptors in the presence of sulfoxaflor. Therefore, only the rat fetal isoform of the nAChR appears to be responsive to perturbation by sulfoxaflor. Quantitatively, the human fetal nAChR is at leas t 500

- fold less sensitive than the rat fetal nAChR based on the highest concentration tested in the human receptor studies compared to the effective dose in the rat fetal receptor study. The absence of nAChR activation in the human receptors precludes the manifestation of skeletal abnormalities and neonatal deaths. The Agency is reducing the UF A 

### to 3X based on the evidence that the human nAChR is not more sensitive than
the rat. For a full discussion of the receptor data, see D382604. Summaries of the su lfoxaflor endpoints used for risk assessment are shown in the tables below.

Table 3a

. Sulfoxaflor Toxicological Doses and Endpoints for Use in Dietary Human Health Risk Assessments

. Exposure/ Scenario Point of Departure Uncertainty/

FQPA Safety

Factors RfD / PAD Study and Toxicological Effects

Acute Dietary (General Population, including Infants and Children) NOAEL= 25 mg/kg/day UF A = 10x

UF H =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.

Acute Dietary (Females 13

- 49 years of age) NOAEL = 1.8 mg/kg/day UF A = 3x

UF H =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
nicotinic

- receptor

- mediated
decreased neonatal survival on postnatal day (PND ) 0 through 4 Chronic Dietary (All Populations) NOAEL=
5.13 mg/kg/day UF A = 10x

UF H =10x FQPA SF= 1x Chronic RfD =

0.0 5 mg/kg/day

cPAD =
0.0 5 mg/kg/day Chronic/Carcinogenicity Study in

the Rat LOAEL = 21.3 mg/kg/day based on liver effects including increased blood cholesterol, liver weight, hypertrophy, fatty change, single cell necrosis and macrophages
observed in the males and females

. Cancer (oral, dermal, inhalation) Sulfoxaflor is classified as “Suggestive Evidence of Carcinogenic Potential

. ” Q uantification of risk using a non

- linear approach ( i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity.

### Page 5 of 18

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no ob served adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose.

Table 3b

. Sulfoxaflor Toxicological Doses and Endpoints for Use in Occupational Human Health Risk

Assessments

. Exposure/
Scenario Point of Departure Uncertainty

Factors Level of Concern for

Risk Assessment Study and Toxicological Effects

Dermal
Short

- and
Intermediate

Term NOAEL= 1.8 mg/kg/day

DAF = 2. 4 % UF A =3x

UF H =10x Occupational LOC

for MOE = 30 Developmental Neurotoxicity Study

LOAEL = 7.1 mg/kg/day based on
nicotinic

- receptor

- mediated
decreased neonatal survival on postnatal day (PND ) 0 through 4

Inhalation
Short

- and
Intermediate

Term NOAEL= 1.8 mg/kg/day

I nhalation and oral absorption are assumed to
be equivalent UF A =3x

UF H =10x Occupational LOC

for MOE = 30 Developmental Neurotoxicity Study

LOAEL = 7.1 mg/kg/day based on
nicotinic

- receptor

- mediated
decreased neonatal survival (PND 0

- 4) Cancer (oral, dermal, inhalation) Sulfoxaflor is classified as “Suggestive Evidence of Carcinogenic Potential.” Quantification of risk

using a non

- linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity. Point of Departure (POD) = A data point or an estimated point that is derived from observ ed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF =

uncerta inty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). MOE = margin of expos ure. LOC = level of

concern.



### Residue Profile and Dietary Risk

Residue data for sulfoxaflor in/on sorghum commodities were not provided with the Section 18
submission ; however, the Agency has recently received a tolerance petition for sulfoxaflor that
includes a registration request and residue data for sorghum

. Thos e residue data were used to
derive the recommended tolerance levels. Sorghum commodities are significant livestock feedstuffs; therefore, HED has examined the impact of this specific exemption on livestock dietary burdens. The maximum reasonable dietary burden estimates increased relative to the previous assessment for all four livestock categories; however, the degree of the increase was small enough that revis ions to tolerances for livestock commodities are not necessary.

The requested use may result i n human exposure to sulfoxaflor and/or its metabolites in food and drinking water. Toxicology, residue chemistry, and environmental fate data submitted to the Agency show that there are a unique set of exposure profiles that need to be considered when

ass essing this insecticide. In short, given the toxicological endpoints being used for risk assessment, information on which chemical species can result in those effects, and differences in the residue profiles for foods, surface water, and groundwater, this assessment focuses on the following three combinations for evaluating dietary exposure:

 Acute dietary exposure, general population: sulfoxaflor in food and the metabolites designated X11719474 and X11519540 in groundwater;

### Page 6 of 18

 Acute dietary exposure, women o f child

- bearing age: sulfoxaflor in food and surface

water;

 Chronic dietary exposure, all populations: sulfoxaflor in food and the metabolites designated X11719474 and X11519540 in groundwater, factoring in information on the relative potency of the meta bolites to elicit the liver effects being used as the endpoint in the assessment. Relative to sulfoxaflor, these factors are 0. 3 X for X11719474 and 10X
for X11519540.

Further information regarding these assessments

, the rationale for selecting the exposure profiles

, and the derivation of the toxicity factors is available in the Section 3 Human Health Risk Assessment (D382604)

.

In evaluating dietary exposure, HED has noted that estimated drinking water concentration s (EDWCs) provided by the Environmental Fate and Effects Division (EFED; D418282, M. Ruhman, 28 February 2014) based on the sulfoxaflor use on sorghum resulted in lower estimates than those used in the previous risk assessment. Furthermore, the food consu mption database used to support HED’s dietary exposure assessments (NHANES/WWEIA) does not report any consumption of sorghum, either as grain or as syrup. Therefore, new dietary exposure and risk estimates were not developed for this Section 18 assessment . Previous dietary risk estimates are
below HED’s level of concern (typically 100% of the population

- adjusted dose) for both acute and chronic dietary exposure and for all population subgroups. For acute exposures, the dietary
risk estimate is ≤ 1 % of the acute population adjusted dose (aPAD) for all population groups, except for all infants, which is 4 % of the aPAD

. Chronic risk estimates are 3 % of the chronic population adjusted dose (cPAD) for the U.S. population and 9 % of the cPAD for all infants, the highest exposed population subgroup.

Occupational Exposure and Risk

The submitted Section 18 label lists 2 applications per season with a minimum 14

- day

retreatment interval ; therefore, short

- (1 to 30 days) and intermediate

- term (1 to 6 months)

exposur es are expected for handlers. In the previous risk assessment (D382604), occupational margins of exposure (MOEs) were estimated for the “high

- acreage field crops” scenario, which would include sorghum. Occupational activities addressed in the previous ri sk assessment include application

- related tasks (mixing, loading, applying, etc.) as well as post

- application tasks (scouting, weeding, irrigating, etc.). The application rates used in the previous assessment were greater than the rates currently proposed for the Section 18 use on sorghum; therefore, t he occupational exposure and risk estimates for the proposed use are expected to be less than those assessed in the previous sulfoxaflor assessment ( D382604 ). The current level of concern (LOC) for assessing short

- and intermediate

- term occupational exposure to sulfoxaflor is a margin of exposure (MOE) that is less than 30. At a baseline level of personal protective equipment (PPE), the previously estimated occupational MOEs range from 80 to 7 ,0 00,000, and t he vast majority of the estimates are greater than 300. All estimated occupational MOEs indicate that risks are
below HED’s level of concern , including those associated with the proposed use of sulfoxaflor on sorghum

.

### Page 7 of 18

Sulfoxaflor does not appear to hav e a mode of action in common with other pesticide active ingredients or their metabolites

, nor does sulfoxaflor have metabolites common to other active ingredients. Therefore, HED has not conducted a cumulative risk assessment involving
sulfoxaflor and ot her active ingredients

.

HED concludes that there is a reasonable certainty of no harm from aggregate exposure to sulfoxaflor associated with the requested Section 18 use. In addition, there are no identified risks
of concern for occupational exposures associated with the use on sorghum and the most recent risk assessment is protective of the proposed use

.

HED is recommending th e establishment of time

- limited tolerances for residues of the
insecticide sulfoxaflor, incl uding its metabolites and degradates, in or on the commodities in the
table below. Compliance with the tolerance levels specified below is to be determined by measuring only sulfoxaflor in or on the commodity. An acceptable analytical method is
available for enforcing these tolerances.

Table 4 . Time

- Limited Tolerances to Support the Emergency Exemption Use of Sulfoxaflor on Sorghum

. Commodity Recommended Tolerance, ppm Sorghum, forage 0.40 Sorghum, grain 0.30 Sorghum, stover 0.90



### The recommended tolerances were derived using the OECD tolerance/MRL calculation procedures

. HED notes that there is already a permanent tolerance for sulfoxaflor residues in/on aspirated grain fractions at 20 ppm. That tolerance is sufficient to address residues in/on aspirated grain fractions that may come from sorghum.

Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical. These data, which include studies from the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1); the Agricultural Handler Exposure Task Force (AHETF) database; and the Agricultural Re

- entry Task Force (ARTF) database; are subject to ethics review pursuant to 40 CFR 26, have received that review, and are compliant with applicable ethics requirements. For certain studies that review may have included review by the Human Studies Review Board. Descriptions of data sources as well as guidance on their use can be found at: http:/ /www.epa.gov/pesticides/science/handler

- exposure

data.html and http://www.epa.gov/pesticides/science/post

- app

- exposure

- data.html

.

DETAILED TOXICOLOGICAL CONSIDERATIONS

Based on the use pattern and the toxicological profile of sulfoxaflor, HED selected endpoints and doses for acute and chronic dietary risk assessment and for evaluating short

- and intermediate

term exposure via dermal and inhalation pathways

. As there are no re sidential uses at this time, endpoints for assessing incidental oral exposure were not selected, and exposure via the dermal and inhalation pathways is relevant for assessing occupational exposure only.

### Page 8 of 18

In support of the Section 3 registration request, Dow AgroSciences has submitted a large number of mechanistic studies designed to elucidate the mode of action of sulfoxaflor for the developmental effects observed in rats and its relevance for human health effects. These data indicate that rats may be un iquely sensitive to the developmental effects resulting from agonism of the nicotinic receptor by sulfoxaflor. In fact, humans may not be susceptible to these effects based on the lack of responsiveness of the human nicotinic receptor to sulfoxaflor in th e agonism study. Furthermore, the observation that no neonatal deaths or neuromuscular/skeletal effects were noted in the rabbit developmental toxicity study supports the conclusion that rats are uniquely sensitive to developmental toxicity due to sulfoxa flor exposure. In addition, there is support for the pharmacodynamic differences in how sulfoxaflor interacts with rat fetal receptors versus adult rat, fetal human, and adult human receptors. These differences suggest that to the
extent that neonatal de ath in rats occurs as a result of sulfoxaflor binding to the fetal receptor, these effects would not be observed in humans. Overall, these data suggest as a conservative assumption that rats and humans are at most pharmacodynamically comparable. Consequen tly,

HED has reduced the interspecies UF to 3x.

A comprehensive analysis of the mode

- of

- action studies was completed in conjunction with the Section 3 evaluation and is not presented herein; rather, this assessment focuses on the dose

response portion of the toxicological database. However, since the developmental and reproductive MOA described in the Assessment Summary is critical to endpoint selection, a brief review is given here. The developmental and reproductive MOA for sulfoxaflor describes the
ab ility of sulfoxaflor to act as an agonist rat fetal intermuscular nicotinic acetylcholine receptor (nAChR). That is, sulfoxaflor interacts with the nAChR, causing an increase in skeletal muscle
contraction . This leads to skeletal abnormalities (i.e., for elimb flexure and bent clavicles) and increased neonatal deaths from constriction of the diaphragm muscles. The s e receptors, although present, are slightly different in fetal and adult lifestages. The differences are such that sulfoxaflor only interacts with the fetal form. Therefore the developmental endpoints are only applicable to life stages with the fetal receptor isoform and , therefore, only appropriate for assessing risks to women of reprodu ctive age.

HED has recommended that the required 10X FQPA Safety Factor be reduced to 1X based on the following considerations , which are further discussed below : 1) the toxicology database for sulfoxaflor is complete with regard to FQPA consideration, in cluding the required developmental and reproductive toxicity studies; 2) the required neurotoxicity studies, including the developmental neurotoxicity study (DNT) have been submitted, are considered adequate; 3) although there is evidence of quantitative s usceptibility 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, HED’s degree of concern for human susceptibility is
reduced base d on the special studies submitted in support of the mode of action; and 4) although some refinements are used in the exposure assessment, the dietary and drinking water

assessments still result in upper

- bound estimates of exposure.

### Page 9 of 18

Completeness of the T oxicology Database : The toxicology database for sulfoxaflor is adequate for FQPA consideration including a developmental toxicity study in rats and rabbits, a 2

- generation reproduction study in rats, and acute, subchronic, and developmental neurotoxicity
studies in rats

.

An acceptable guideline inhalation study is required for all food

- use registrations ; however in the case of sulfoxaflor, t he use of an oral study is considered protective for inhalation exposure for the following reasons: 1) The acute inhalation toxicity (Category IV) is lower than the acute oral LD 50 

### (Category III); 2) T he vapor pressure is low (≤1.4×10
- 6 

### Pa = 1.05×10 - 8 

### mm Hg at 20°C); 3) T here is adequate characterization of toxicity; 4) O ral absorption is >90%

– substantially higher ab s orption via the inhalation route is not expected; 5) Oral absorption is rapid; 6) Sulfoxaflor is not subject to enterohepatic circulation, making the absorbed oral dose available systemically; and

7 ) S ulfoxaflor is not subject to in vivo me tabolism and therefore potential first

- pass effects are not relevant.

Therefore, the subchronic inhalation study is waived for sulfoxaflor. The lack of a subchronic inhalation study is not considered a data gap and a database uncertainty factor is not required (TXR# 0056310).

Evidence of Neurotoxicity : 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

.

Evide nce of Sensitivity/Susceptibility in the Developing or Young Animal : Although there was quantitative susceptibility observed in the DNT, there is no residual uncertainty because the effects are well characterized, a clear NOAEL was identified, and the end points 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 app arent 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 wer e 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 suscept ibility in the developmental studies in the rat or rabbit.

Residual Uncertainty in the Exposure Database : There are no residual uncertainties with regard to dietary and occupational exposure. T he dietary exposure assessments are based on high

- end
health protective residue levels (that account for parent and metabolites of concern), processing factors, and percent crop treated assumptions (100%). Actual exposure to sulfoxaflor will likely
be lower than the estimated exposure . Furthermore, conservative, u pper

- bound assumptions

### Page 10 of 18

were used to determine exposure through drinking water sources, such that these exposures have
not been underestimated.

Acute Dietary Endpoint for the General Population: The endpoint used for establishing the
aPAD for the general population was selected from the acute neurotoxicity study in rats. An aPAD of 0.25 mg/kg/day was derived from a NOAEL of 25 mg/kg/day and a 100

- fold uncertainty factor that included 10x for inter

- species extrapolations, 10x for intra

- spec ies variations, and a 1x FQPA safety factor . The LOAEL of 75 mg/kg is based on decreased motor activity on D ay 1 of dosing . More severe effects were observed at the high dose (750 mg/kg) including increased muscle tremors and twitches, convulsions, hindl imb splaying, increased lacrimation and salivation, decreased pupil size and response to touch, gait abnormalities and decreased rectal temperature. None of these effects were observed either 8 or 15 days after dosing. This endpoint is appropriate for th e acute dietary exposure assessment because it is the result of a single dose, is an appropriate route of exposure (oral) and is protective of the general population.

Acute Dietary Endpoint for Females 13

- 49 years of age: The endpoint used for establishing the
aPAD for females 13

- 49 years of age was selected from the DNT study in rats. An aPAD of 0.06 mg/kg/day was derived from a developmental NOAEL of 1.8 mg/kg/day and a 30

- fold uncertainty factor that included 3x for i nter

- species extrapolation, 10x for intra

- species variation, and 1x FQPA safety factor . The endpoint of concern is decreased neonatal survival in postnatal day ( PND ) 0

- 4 offspring at the LOAEL of 7.1 mg/kg/day. This endpoint is appropriate because
it is a single dose effect, is of a relevant route of exposure (oral), and is protective for fetuses in

utero

.

Non

- guideline critical window studies support the use of this endpoint for an acute exposure
assessment. A series of non

- guideline studies were condu cted to accurately define the critical window of exposure for developmental effects. These studies indicate that a maternal oral dose
of sulfoxaflor between G estation D ay 20 and parturition will result in decreased neonatal
survival in rats. Due to the b revity of this critical window, it’s assumed that a single dose within this period can result in decreased offspring survival and skeletal abnormalities.

Chronic Dietary Endpoint for the General Population : The endpoint used for establishing the
cPAD was selected from the chronic/carcinogenicity combined study in the rat. The cPAD of
0.0 5 mg/kg/day was derived from a NOAEL of 5.13 mg/kg/day and a 100

- fold uncertainty factor
that included 10x for inter

- species extrapolation, 10x for intra

- species variability, and a 1x FQPA
SF. The LOAEL of 21.3 mg/kg /day is based on liver effects including increased blood cholesterol, liver weight, hypertrophy, fatty change, single cell necrosis and macrop hages in
males and females. The selected study is appropriate for selecting the dose and endpoint based on duration and route of exposure.

Dermal Absorption Factor: HED has compared data depicting in vivo and in vitro dermal absorption of sulfoxaflor in rats with in vitro dermal absorption in human skin to derive a
human

- equivalent in vivo dermal absorption factor of 2. 5 %.

### Page 11 of 18

Dermal and Inhalation (short

- and intermediate

- term): The endpoint used for short

- and
intermediate

- term dermal exposure was select ed from the DNT study in rats. The endpoint of
concern is decreased neonatal survival in PND 0

- 4 offspring with a NOAEL of 1.8 mg/kg/day and a LOAEL of 7.1 mg/kg/day. The level of concern (LOC) for these assessments is 30, which
is derived from a 3X fact or for inter

- species extrapolation and a 10x factor for intra

- species variability. Although a route

- specific dermal study i s available, the selected endpoint was chosen from the DNT because it is protective of developmental parameters not measured in the dermal study. As previously noted, the endpoint is appropriate for assessing risk to women of
child

- bearing age; nevertheless, this endpoint is protective of other effects and will be used to assess risk from dermal and/or inhalation exposure for other po pulation groups as well.

The use of an oral study is considered protective for inhalation exposure for the following reasons: 1) The acute inhalation toxicity (Category IV) is lower than the acute oral LD 50 

### (Category III); 2) the vapor pressure is low [ ≤1.4×10 - 6 

### Pa (1.05×10 - 8 

### mm Hg) at 20°C ] ; 3) there is adequate characterization of toxicity; 4) oral absorption is >90%

– substantially higher
ab s orption via the inhalation route is not expected; 5) oral absorption is rapid; 6) sulfoxaflor is not subject to enterohepatic circulation, making the absorbed oral dose available systemically; and 7) sulfoxaflor is not subject to in vivo metabolism and therefore potential first

- pass effects
are not relevant. EPA waived the requirement for a subchronic inhalation s tudy (TXR# 0056310) based on, among other things, its conclusion that even if an additional 10X safety factor were applied, inhalation exposure would not raise a risk of concern. The lack of a subchronic inhalation study is not considered a data gap and a database uncertainty factor is not required.

Cancer Classification:

The CARC, in accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March, 2005), determined that there is a “Suggestive Evidence of Carcinogenic Potential” for
sulfoxaflor based on the preputial gland tumor response in seen in rats. When there is suggestive evidence, the Agency does not attempt a dose

- response assessment as the nature of the data generally would not support one. Rather , the Agency has determine d that 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. The CARC considered the following factors i n their weight

- of

- evidence deliberation on assessing the carcinogenic potential of sulfoxaflor.

i. The liver tumors observed in male rats and male and female mice were considered to be

treatment

- related;

ii. The hypothesized mode of action (CAR mediated, mitoge nic) for liver tumors was adequately supported by studies that clearly identified the sequence of key events, dose

response concordance and temporal relationship to the tumor type. There is convincing evidence that the hepatocarcinogenic effects are not li kely to occur below a defined dose range. The mode of action data met the criteria established by the Agency;

iii. The Leydig cell tumors were not considered to be treatment

- related in male rats because there is a high background rate for this tumor type in th e particular strain of rats (F344) tested;

### Page 12 of 18

iv. There was evidence of a response for carcinomas of the preputial glands in male rats. Preputial gland tumors are not commonly diagnosed in bioassay studies. The available data were inadequate to draw confident con clusions regarding this response due to the small sample size and lack of histopathology data on all animals. Thus, it was not possible to determine whether the preputial gland tumors are due to treatment. If the response is positive, this would be an unu sual finding. Because the tumors could not be discounted, they were used in the suggestive classification; and

v. There is no mutagenicity concern from the in vivo or in vitro genetic toxicity assays.

DETAILED RESIDUE CHEMISTRY CONSIDERATIONS

Pesticide Metabolism and Environmental Degradation

HED has reviewed extensive metabolism data submitted by the registrant to support the Section 3 registrations and has concluded that the nature of the residue is adequately understood in plants, livestock and rotational crops. HED has determined that for plants and livestock the
residue of concern for tolerance setting and risk assessment is the parent, sulfoxaflor. In drinking water , residues of concern for risk assessment are sulfoxaflor and its two metabolites designated X11719474 and X11519540 (E. Holman, D398294, 6 April 2012 )

.

Table 5

. Summary of Sulfoxaflor Metabolites and Degradates to be included in the Risk Assessment and Tolerance Expression

. Matrix Risk Assessment Tolerance Expression

Plants Primary Crops Sulfoxaflor Sulfoxaflor

Rotational Crop Sulfoxaflor 1 Sulfoxaflor

Livestock Ruminant Sulfoxaflor Sulfoxaflor

Poultry Sulfoxaflor Sulfoxaflor Drinking Water Sulfoxaflor + X11719474 + X11519540 NA

1 Based on the proposed later season foliar application use pattern; decision may need to be revisited for future early s eason soil application uses.



### Analytical Method s

HED has concluded that adequate analytical methods have been submitted for both data collection and for enforcement purposes. In the submitted field trial s , r esidues of sulfo x aflor and its metabolites in crops were determined using the Dow analytical method designated as 091031

. The proposed method for tolerance enforcement in plant commodities is method 091116 : Enforcement Method for the Determination of Sulfoxaflor (XDE

- 208) and its Main Metabolites in Agricultural Commodities using Offline Solid

- Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection. Method 091116 extracts residues with
acetonitrile/water and includes use of a deuterated internal standard, hydrolysis with NaOH to release base

- labile conjugates , and clean up via solid

- phase extrac tion. This method is applicable for the quantitative determination of residues of sulfoxaflor , [1

- (6

- trifluoromethylpyridin

- 3

- yl)ethyl](methyl)

- oxido

- λ 6



### - sulfanylidenecyanamide and its metabolites, X11719474, N

- ((methyl)oxido){1

- [6

- (trifluoromethyl)pyridin e

- 3

- yl]ethyl}

- λ 6



### - sulfanylidene)urea and X11721061, 1

- [6

- (trifluoromethyl)pyridin

- 3

- yl]ethanol, in agricultural commodities and

### Page 13 of 18

processed products. The method was adequately validated

, with a limit of quantitation (LOQ) of
0.010 mg/kg for all matrices , inc luding sorghum

. The FDA MRM was reported by the registrant to be not suitable for analysis of sulfoxaflor and/or its metabolites; the German multiresidue method S

- 19 may be suitable.

Drinking Water Residue Profile

References: D418282. Ruhman, M. 28 February 2014. “ Estimated Drinking Water Concentrations of the Proposed

section 18 Use of Sulfoxaflor on Sorghum. ”

D382617. Ruhman, M. 1 August 2012. “Estimated Drinking Water Concentrations of the New Chemical Sulfoxaflor from Proposed use on Beans, Berries, Canola, Citrus, Fruits (Pome & Stone), Ornamentals, Soybeans, Tree nuts, Turf grass, Vegetables (Brassica, Bulb, Cucurbits, Fruiting, Okra, Leafy, Root and Tuber) and Watercress for the Use in Human Health Risk Assessment.”



### Monitoring data depicting residues of sulfoxaflor in drinking water are not available

. In support of the 2012 Section 3 risk assessment for sulfoxaflor uses on multiple crops, the EFED used modeling to estimate upper

- bound conce ntrations of sulfoxaflor in surface and ground water. The use on citrus resulted in the highest estimated drinking water concentrations (EDWCs) for sulfoxaflor (Table 6 ). The summed numbers in Table 6 reflect the combinations of residues and
their toxici ty profiles. A complete discussion of the rationale for the combinations is provided in the 2012 risk assessment (D382604).

Table 6 . Estimated Drinking Water Concentrations (EDWCs) for Total Toxic Residues of Sulfoxaflor in Surface
and Ground Waters from Use on Citrus

.

Water Source * Total Concentration, ppb [Sulfoxaflor + X11719474 + X11519540]

Acute Peak 1 Non

- cancer/Chronic 2 Cancer 3

Surface (PRZM/EXAMS) 26.4 [9.4 + 15.0 + 2.0] 13.5 [1.9 + 10.2 + 1.4] 9.3 [1.5 + 6.9 + 0.9]

Ground (SCI

- GROW) 69.2 [0.0 + 60.9 + 8.3]

* Surface water EDWCs include sulfoxaflor + X11719474 + X11519540. Due to rapid degradation of sulfoxaflor
in aerobic soil systems (half

- life = 0.4 days), the EDWC for groundwater includes X11719474 + X11519540.

1 Peak value , from Florida citrus ; 2 1

- in

- 10

- year annual mean values , California citrus ; 3 1

- in

- 10

- year overall annual
mean values , California citrus

.



### F or this Section 18, EFED has modeled the use of sulfoxaflor on sorghum (D418282) and determined that the EDWCs are expected to be less than those used in the 2012 assessment.

Food Residue Profile

No residue data were submitted with this Section 18 request for the use of sulfoxaflor on sorghum . However, HED is currently evaluating a Section 3 request for the use of sulfoxaflor on sorghum and other crops. In support of that request , Dow AgroScience s, LLC submitted field
trial data for sulfoxaflor in/on soghum commodities ( forage, grain, and stover) from 9 field trials conducted during 201 2 in major sorghum

- growing regions of the Unites States

.

Each trial included three plots: an untreated control plot and two treated plots. Treated plots received two foliar applications of GF

- 2372, each at a target formulated product rate of 0.09

### Page 14 of 18

lb/A, equivalent to 0.045 lb a.i./A based on the certified test substance concentration of 49.1%. Test substance was ap plied to one treated plot at approximately 21 and 7 days before typical commercial timing for forage collection, and to another treated plot at approximately 28 and 14 days before typical commercial harvest. A locally available adjuvant that might typical ly be used with an insecticide on sorghum was included within the tank mixture at each application. Application spray volumes ranged from 19.9 to 30.0 gal/A. Applications were performed with pressurized ground spray equipment, using a tractor mounted boom or a backpack sprayer with a
hand

- held boom. All of the field trials are supported by adequate analytical methods and storage stability data. The results of the field trials are summarized in Table 7

.

Table 7 . Summary of residue data from sorghum field trials with S ulfoxaflor. a

Commodity EP b Total appl. rate
lb a.i./A PHI

(day) n Sulfoxaflor Residue (ppm)

Min Max HAFT c Median (STMdR) Mean

(STMR) Std.

Dev. Sorghum Forage WDG 0.0878

- 0.0907 7 9 0.017 0.202 0.198 0.082 0.094 0.059 Sorghum Grain WDG 0.0878

- 0.0907 14 9 0.016 0.152 0.150 0.039 0.063 0.049 Sorghum Stover WDG 0.0878

- 0.0907 14 9 0.034 0.733 0.601 0.199 0.221 0.172

a The LOQ (0.010 ppm) was used for all residue values reported as < LOQ in all calculations (mean, median, etc.). Minima and maxima are on a per

- sample basis; all other summary values reflect per

- trial averages.

b EP = End

- use Product; Test item was GF

- 3272, a 49.1% a.i. water

- dispersible granule formulation.

c HAFT = H ighest Average Field Trial.



### Sorghum grain is a commodity that may form aspirated grain fractions (AGF). Studies showing the degree to which sulfoxaflor concentrates in/on sorghum AGF were not provided. Previously
submitted studies resulted in concentra tion factors of 21X and 95X for wheat and soybean AGF, respectively, and the establishment of a tolerance for residues of sulfoxaflor in/on AGF at 20 ppm. For purposes of this Section 18 assessment, HED is using the soybean factor (95X) to
estimate residu es of sulfoxaflor in/on sorghum AGF. Multiplying the median grain residue (0.039 ppm) by 95 results in an anticipated residue of 3.7 ppm, which is well below the
established tolerance.

In addition to aspirated grain fractions, sorghum grain, fodder, and stover may be used as livestock feedstuffs; therefore, HED has estimated reasonably balanced livestock dietary burdens for cattle, poultry and swine (Table 8 ). The resulting dietary burd ens are greater than those estimated previously; however, they do not result in a need for revised tolerances for residues of sulfoxaflor in livestock commodities (Table 9 ).

Table 8 . Estimated Reasonably Balanced Livestock Dietary Burdens

. *

Crop Commodity Classification Highest Residue
or Median Residue %

DM % of
Diet Contribution,

ppm Beef Cattle

Grain Aspirated fractions Carbohydrate Median 4.56 85 5 0.268 Beet, sugar Molasses Carbohydrate Median 0.23 75 10 0.031 Sorghum, grain Grain Carbohydrate Median 0.049 86 40 0.023 Barley Grain Carbohydrate Median 0.048 88 25 0.014 Soybean Meal Protein Median 0.135 92 5 0.007 Barley Straw Roughage Highest Residue 2.2 89 10 0.247

Wheat Straw Roughage Highest Residue 1.641 88 5 0.093

Total 100 0.683

### Page 15 of 18

Table 8 . Estimated Reasonably Balanced Livestock Dietary Burdens

. *

Crop Commodity Classification Highest Residue
or Median Residue %

DM % of
Diet Contribution,

ppm Dairy Cattle Beet, sugar Molasses Carbohydrate Median 0.23 75 10 0.031 Sorghum, grain Grain Carbohydrate Median 0.049 86 35 0.020 Soybean Meal Protein Median 0.135 92 10 0.015

Wheat Forage Roughage Highest Residue 1.4 25 20 1.120 Rape Forage Roughage Highest Residue 1.5 30 10 0.500

Triticale Forage Roughage Highest Residue 1.4 30 15 0.700

Total 100 2.386 Poultry Sorghum, grain Grain Carbohydrate Median 0.049 75 0.037 Soybean Meal Protein Median 0.135 25 0.034

Total 100 0.071

Swine Sorghum, grain Grain Carbohydrate Median 0.049 80 0.039 Barley Grain Carbohydrate Median 0.048 5 0.002 Soybean Meal Protein Median 0.135 15 0.020

Total 100 0.061

* For cattle, contribution = residue ÷ (% Dry Matter/100) × % of Diet/100. For poultry and swine, contribution =
residue × % of Diet/100.

Table 9 . Summary of Anticipated Sulfoxaflor Residues in Livestock Commodities

. Livestock Commodity Matrix

- to

- Feed
Ratio * Anticipated Residue, ppm Current Tolerance, ppm

Cattle (Dietary Burden = 2.27 ppm)

Milk 0.0 476 0.1081 0.15

Muscle 0.0 481 0.1092 0.15

Fat 0.0 258 0.0586 0.10

Liver 0. 1146 0.2601 0.40 (meat byproducts) Kidney 0.0 700 0.1589 Poultry (Dietary Burden = 0.054 ppm) Egg 0.0553 0.0030 0.01

Muscle 0.0612 0.0033 0.01

Fat 0.1119 0.0060 0.01

Liver 0.0174 0.0009 0.01

Swine (Dietary Burden = 0.03 ppm)

Muscle 0.0 481 0.0014 0.01

Fat 0.0 258 0.0008 0.01

Liver 0. 1146 0.0034 0.01 (meat byproducts) Kidney 0.0 700 0.0021

* From livestock feeding studies. See D398756 ( D. McNeilly, 21 November 2012 )



### DETAILED EXPOSURE AND RISK ANALYSES

Dietary Exposure and Risk

HED has not generated new dietary exposure and risk estimates for this Section 18 risk assessment. HED currently uses the Dietary Exposure Evaluation Model DEEM

- FCID, Version
3.16 . This model uses 2003

- 2008 food consumption data from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, What We Eat in America,

### Page 16 of 18

(NHANES/WWEIA). The two sorghum entries in the food forms databas e are sorghum grain and sorghum syrup, both of which are reported as having no consumption. As previously noted, the sulfoxaflor residues in drinking water from the use on sorghum are expected to be lower than those previously assessed. Therefore, the di etary exposure estimates from the 2012 assessment (Table 10) are not changed by th e proposed Section 18 use. Dietary risk estimates from exposure to sulfoxaflor through food and water are below HED’s level of concern.

Table 10 . Summary of Acute and Chro nic Dietary Exposure and Risk Estimates for Sulfoxaflor.

Population Subgroup Acute (95 th Percentile) Chronic Cancer

Estimated Exposure (mg/kg/day) Estimated

Risk, %

aPAD Estimated

Exposure (mg/kg/day) Estimated

Risk, %

cPAD Exposure

(mg/kg/day) Estimated

Risk U.S. Population 0.0 15832 6 0.00 3343 7

See Chronic All infants 0.0 31158 12 0.009110 18

Children 1

- 2 yrs 0.04 4887 1 6 0.007867 16

Children 3

- 5 yrs 0.0 32523 1 3 0.00 6210 12

Children 6

- 12 yrs 0.0 18338 7 0.00 3892 8

Youth 13

- 19 yrs 0.0 10829 4 0.00 2456 5

Adults 20

- 49 yrs 0.0 11137 4 0.00 2812 6 Adults 50+ yrs 0.01 1446 5 0.00 2992 6
Females 13

- 49 yrs 0.009495 16 0.00 2809 6 

### Entries with the highest acute and chronic risk estimates are bolded

.

Residential Exposure and Risk

At this time, t here are no uses of sulfoxaflor that will result in residential exposures.

Spray drift is always a potential source of exposure to residents nearby spraying operations. This is particularly the case with aerial application, but, to a lesser extent could also be a potential source of exposure from ground applications of sulfoxaflor. The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State Lead Agencies for pesticide regulation and other parties to develop the best spray drift management practices. On a
chemi cal

- by

- chemical basis, the Agency is now requiring interim mitigation measures for aerial applications that must be placed on product labels/labeling. The Agency has completed its evaluation of the new database submitted by the Spray Drift Task Force, a m embership of U.S. pesticide registrants, and is developing a policy on how to appropriately apply the data and the AgDRIFT computer model to its risk assessments for pesticides applied by air, orchard airblast and ground hydraulic methods. After the polic y is in place, the Agency may impose further refinements in spray drift management practices to reduce off

- target drift with specific products with significant risks associated with drift.

Aggregate Exposure and Risk

In accordance with the FQPA, HED must consider and aggregate (add) pesticide exposures and risks from three major sources: food, drinking water, and residential exposures. In an aggregate assessment, exposures from relevant sources are added together and compared to quantitative
estimates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated. When

### Page 17 of 18

aggregating exposures and risks from various sources, HED considers both the route and duration of exposure.

In the case of sulfoxaflor, there are no residential uses at this time. Consequently, aggregate exposure and risk estimates are equivalent to the dietary (food + drinking water) exposure and
risk estimates discussed above and summarized in Table 1 0

. There are no aggregate risk issues that would preclude granting the S ection 18 registration for use on sorghum or establishing time

limited tolerances for residues of sulfoxaflor in/on sorghum commodities.

Cumulative Exposure and Risk

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as

to sulfoxaflor and any other substances and sulfoxaflor does not appear to produce a toxic metabolite produced by other substances. For the purposes of this toleranc e action, therefore,
EPA has not assumed that sulfoxaflor has a common mechanism of toxicity with other
substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative eff ects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have
a common mechanism on EPA’s website at : http://w ww.epa.gov/pesticides/cumulative/.

DETAILED OCCUPATIONAL EXPOSURE CONSIDERATIONS

The proposed use is on sorghum ; therefore, there is the potential for occupational handler and
post

- application exposure. As noted previously, HED completed occupational handler and post

application risk assessments in 2012 and the scenarios and application rates considered in that assessment are sufficient to cover occupational exposures/risks associated with the Section 1 8 use on sorghum. Margins of exposure (MOEs) for combined (dermal + inhalation) exposures for
handler scenarios in the 2012 assessment range from 80 to 25,000. For post

- application exposures, the MOEs range from 950 to 7,000,000. The occupational level of concern for sulfoxaflor is 30; therefore, these MOEs indicate that occupational risks are not of concern

.

Restricted Entry Interval (REI)

T he REI on the Transform TM 

### WG label is 24 hours. HED recommends that RD ensure that the proper REI is listed on both labels according to the acute toxicity profile and the formulation for each product.

REFERENCES FOR AGENCY MEMORANDA

D3 82604. 26 September 2012. M. Doherty, D. McNeilly, E. Scollon, Z. Figueroa. Sulfoxaflor

– New Active Ingredient Human Health Risk Assessment of Uses on Numerous Crops.

D382617. 1 August 2012. Ruhman, M. Estimated Drinking Water Concentrations of the New Chemical Sulfoxaflor from Proposed use on Beans, Berries, Canola, Citrus, Fruits (Pome &

### Page 18 of 18

Stone), Ornamentals, Soybeans, Tree nuts, Turf grass, Vegetables (Brassica, Bulb, Cucurbits, Fruiting, Okra, Leafy, Root and Tuber) and Watercress for the Use i n Human Health Risk
Assessment.

D398756. 12 September 2012. D. McNeilly. Sulfoxaflor. Petition for the Section 3 Registration and Establishment of T olerances for the New Insecticide Sulfoxaflor on:

B arley, Brassica Leafy Vegetables, Bulb Vegetables, Canola (Rapeseed), Citrus, Cotton, Cucurbit Vegetables, Fruiting Vegetables, Leafy Vegetables (Except Brassica ), Leaves of Root and Tuber Vegetables, Low Growing Berries, Okra, Ornamentals (Herbaceous and Woody), Pistachio, Pome Fruit, Root and Tuber Vegetables, Small Fruit Vine Climbing (Except Fuzzy Kiwifruit ), Soybean, Stone Fruit, Beans (Succulent, Edible Podded, and Dry), Tree Nuts, Triticale, Turf Grass, Watercress, Wheat. Summary of Analytical Chemistry and
Residue Chemistry Data.

D418282. 28 February 2014. Ruhman, M. Estimated Drinking Water Concentrations of the Proposed section 18 Use of Sulfoxaflor on Sorghum.