UNITED STATES ENVI RO NMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460

MEMORANDUM

Date: 1 4 October 20 14 O FF I CE OF C HEMICAL SAF ETY AND
POLLUTION PREVENTION

SUB JECT: Sulfoxaflor

- Addendum to t h e Human Health Risk Assessment of t h e FIFRA
Section 18 Emerge ncy Exemption Use on Sorghum.

PC Code: 0052 10
Decision No.: 487020
Petition No.: 14TX02
Ri sk Assessment Type: Single Ch emical

, Aggregate
TXR No.: None

MRID No.: None

FROM: Mi c h ael A. Doherty, Ph

. D., Sen i or Ch emist
Risk Assessmen t Branch II
Heal t h Effects Di vision (7509P) DP B arcode: 042334 8
Re gistration No.: 62719-625 Regulatory Action: Section 18
Re g i strat i on Case No.: None

CAS No.: 946578-00

- 3
40 CFR 180.668

THROUG H : Christina Swartz, Branch Chief

# ~ A

# ~ Ri sk Assessment Branch II 

# U**~** Heal th Effects Division (7509 P)

TO : Keri Grinstead/Tawan da Maignan (Team 09)
Ri sk Int egration, Minor U se & Emergency Response Branch Regi s trati o n Divi sio n (7505P)

Jenni fer Urbanski/V enu s Eagle (Team 01)

In sect i c id e -Rodenticide Br anch

R egistration D i vision (7505 P )

This addendum to the sub ject r isk asses s m e nt i s bein g issued to corre ct the dietary exposure / ri sk

s ummary pre sented on Page 6 of the original assessment (D417536

, 5 March 2014). Aside from
that paragraph, there are n o other chan ges to the or i gina l memo. The enti re assess men t is presented below for comp l eteness

.

Pag e 1 of 18CONCLUSIONS

HED has evaluated the human health risks associated with the requested emergency exemption

use of the insecticide su l foxaflor on sorghum. There are no proposed or existing residential uses for sulfoxaflor; therefore, this risk assessment addresses the potential dietary (food+ drinking water) and occupationa l exposures associated with the proposed use. HED concludes that there

i s a reasonable certainty that no harm will result from aggrega t e exposure to sulfoxaflor
associated with the requested Sect i on 18 use; further, there are no concerns for occupational

exposure and risk estimates associated with the p r oposed use pattern. The supported tolerances
and the tolerance definition are summarized below.

INTRODUCTION

The state ofTexas 1 is requesting 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

reg i strant for sulfoxaflor) to register additional uses of su l foxaflor and establish tolerances 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 commodities (M. Doherty 

### eta!., 0382604, 26 Sept 2012; subsequent citations ofthis

assessment are listed as "0382604

. ' ').

ASSESSMENT SUMMARY

Sulfoxaflor { 

### N

- [ methyloxido [ 1

- [ 6-(trifluoromethy l ) -3-p yridinyl ] ethy l] -A. 4 -sulfanylidene] cyanamide} is the firs t member of a new class of insecticides, the su l foximi n es. The

su l foximines act through a unique interaction with the nicotinic acetylcholine receptor in insects.
Sulfoxaflor is a highly efficacio u s agonist of the nicotinic receptor. The structural novelty of
sulfoxaflor makes it stab l e in the presence of monooxygenase enzymes that degrade
neonicotinoids and cause virtually all known cases of resistance in the field of this class of
insecticides.

The Section 18 request i s for application ofTransform T M

WG, a wettable granule containing 50% (w / w) sulfoxaflor. Under this exemption, sulfoxaflor may be applied to approximately 3 million

acres of sorghum in Texas (however, see Footnote 1). Applications wou ld be made from spring through late summe r of the 2014 growing season using either ground -b ased

, aerial, or chemigation equipment. The proposed use directions are summarized in Table 1

.

1 The exemption request notes that Lousianna

, Ok l ahoma

, and Mississippi have indicated that they will pursue a specific exemption for use of sulfoxaftor 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, th i s r i sk assessment implicitly includes other states seeking this emergency exemption.

Page 2 of 18

### Page 3 of 18

Table 1. Summary of Proposed Use Directions a Specific Exemption Use of Sulfoxaflor on Sorghum. Use Timing; Type; and Equipment Product

[File Symbol] Single Use

Rate Maximu

m Uses

per Season Maximum

Seasonal
Use Rate PHI

(Days) Use Directions and

Limitations

Foliar use. Application by ground, aerial, or chemigation equipment. Transform TM

WG [62719

- 625] 0.023

– 0.047

lb a.i./acre 2 0.09 lb a.i./acre/yr 7

(grain)

14 (forage, stover) Do not make applications less than 14 days apart.

Do not make more than two applications per year.

Do not apply more than 0.09 lb a.i./acre per year.



### 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, sub chronic, 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 ba sed 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. Toxicity and mechanistic studies in rats, rabbits, dogs and mice indicate that the liver and the nervous systems are target

organ sys tems. Liver effects in subchronic and chronic studies include organ weight and enzyme changes, hypertrophy, proliferation, and tumors; long

- term studies resulted in hepatic effects at
doses lower than in short

- term studies. Based on the weight of evidenc e, the Cancer Assessment Review Committee (CARC) determined that there is a “Suggestive Evidence of Carcinogenic Potential” for sulfoxaflor and that quantification of risk using a non

- linear approach [i.e., oral

### Page 4 of 18

reference dose (RfD)] will adequately accoun t for all chronic toxicity, including carcinogenicity, 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 acet ylcholine receptor (nAChR). This interaction results 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 ac tion (MOA) was plausible and supported by the available 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 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) althou gh 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, HED’s degree of concern fo r human susceptibility is reduced based 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
estimate s 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 assessme nts). There is extensive mechanistic data indicating 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 Xenopus 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. Quan titatively, the human fetal nAChR is at least 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 act ivation 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 rece ptor data, see D382604. Summaries of the sulfoxaflor 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.

### Page 5 of 18

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 (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 =

0.05 mg/kg/day

cPAD = 0.05 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.” Quantification of risk using a non

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

Po int 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 obse rved 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 E ndpoints 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

Inhalation 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 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). MOE = margin of exposure. LOC = level of

concern.

### Page 6 of 18

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 f or sulfoxaflor that includes a registration request and residue data for sorghum. Those 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 revisions to tolerances for livestock commodities are not necessary.

The requested use may result in human exposure to sulfoxaflor and/or its metabolites in food and drinking water. Toxicology, residue chemistry, and environmental fate data submitted to the Agency sh ow that there are a unique set of exposure profiles that need to be considered when assessing 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 metabol ites designated X11719474 and X11519540 in groundwater;

 Acute dietary exposure, women of 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 metabolites to elicit the liver effects being used as the endpoint in the assessment. Relative to sulfoxaflor, these factors are 0.3X 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 concentrations (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 consumption 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
estim ates 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 ac ute exposures, the highest
risk estimate is 16% aPAD for the “ children 1

- 2 years old ” and “ females 13

- 49 years old ” population subgroups

. For c hronic exposures, the highest risk estimate is 18% cPAD for the all infants population subgroup

.

### Page 7 of 18

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) exposures 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 risk assessment include application

- related tasks (mix ing, 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

o ccupational 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 the 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

.

Sulfoxaflor does not appear to have 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
sulfo xaflor and other 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 occupationa l exposures associated with the use on sorghum and the most recent risk assessment is protective of the proposed use

.

HED is recommending the establishment of time

- limited tolerances for residues of the insecticide sulfoxaflor, including its metabolites a nd 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 to lerances.

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.

### Page 8 of 18

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 residential 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.

In support of the Section 3 registration request, Dow AgroSciences has submitted a large number
of mechanistic stu dies 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 uniquely sensitive to the developmental effects resulting from ago nism 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 the 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 sulfoxaflor exposure. In addition, there is support for the pharmacody namic 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 death in rats occurs as a result of sulfoxaflor binding to the fet al 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. Consequently, 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 an d 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 ability of sulfoxaflor to act as an agonist rat fetal intermuscula r 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., forelimb flexure and bent clavicles) and
increased neonatal deaths from constriction of the diaphragm muscles. These receptors, although

### Page 9 of 18

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 reproductive age.

HED has recommended that the required 10X FQPA Safety Factor be reduced to 1X based on the following consider ations , which are further discussed below : 1) the toxicology database for sulfoxaflor is complete with regard to FQPA consideration, including the required developmental and reproductive toxicity studies; 2) the required neurotoxicity studies, including th e developmental neurotoxicity study (DNT) have been submitted, are considered adequate; 3) 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 s elected for risk assessment are protective for these effects; further, HED’s degree of concern for human susceptibility is reduced based on the special studies submitted in support of the mode of action; and 4) although some refinements are used in the exp osure assessment, the dietary and drinking water

assessments still result in upper

- bound estimates of exposure.

Completeness of the Toxicology 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

ca se 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 metabolism 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 conce rn 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

.
Evidence of Sensitivity/Susceptibility in the Developing or Young Animal : Alt hough there was quantitative susceptibility observed in the DNT, there is no residual uncertainty because the

### Page 10 of 18

effects are well characterized, a clear NOAEL was identified, and the endpoints chosen for risk assessment are protective of potential in utero an d 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 evaluation s 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

a nimals. 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.

Residual Uncer tainty 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 con cern), processing factors, and percent crop treated assumptions (100%). Actual exposure to sulfoxaflor will likely
be lower than the estimated exposure . Furthermore, conservative, upper

- bound assumptions were used to determine exposure through drinking w ater 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

a PAD 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

- species variations, and a 1x FQPA safety factor. The LOAEL of 75 mg/kg is based on decreased motor activity on Day 1 of dosing. More severe effects were observed at the high dose (750 mg/kg) including increased muscle tremors and twitches, convulsions, hindlimb 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 the acute dietary exposure assessment because it is the result of a single dose, is an appr opriate 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 a PAD 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 inter

- species extrapolation, 10x for intra

- species variation, and 1x FQPA safety factor. The endpoint of concern is decreas ed 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 cri tical window studies support the use of this endpoint for an acute exposure
assessment. A series of non

- guideline studies were conducted to accurately define the critical window of exposure for developmental effects. These studies indicate that a materna l oral dose of sulfoxaflor between Gestation Day 20 and parturition will result in decreased neonatal

### Page 11 of 18

survival in rats. Due to the brevity of this critical window, it’s assumed that a single dose within this period can result in decreased offspring surviv al 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 0.05 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 macrophages 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%.

Dermal and Inhalation (short

- and intermediate

- term): The endpoin t used for short

- and
intermediate

- term dermal exposure was selected 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 factor for inter

- species extrapolation and a 10x factor for intra

- species variability. Although a route

- specific dermal study is 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 population 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 th e 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 expecte d; 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 rel evant. EPA waived the requirement for a subchronic inhalation study (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. W hen there is suggestive evidence, the Agency does not attempt a dose

- response assessment as the nature of the data

### Page 12 of 18

generally would not support one. Rather, the Agency has determined 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 in their weight

- of

- evidence deliberation on assessing the carcinogenic poten tial 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, mitogenic) 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

ev idence that the hepatocarcinogenic effects are not likely 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
ther e is a high background rate for this tumor type in the particular strain of rats (F344) tested;

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 conclusions 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 treatmen t. If the response is positive, this would be an unusual 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.

DETA ILED RESIDUE CHEMISTRY CONSIDERATIONS

Pesticide Metabolism and Environmental Degradation

HED has reviewed extensive metabolism data submitted by the registrant to support the Section
3 r egistrations 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 pare nt, 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 season soil application uses.

### Page 13 of 18

Analytical Methods

HED has concluded that adequate analytical methods have been submitted for both data

c ollection and for enforcement purposes. In the submitted field trial s , residues of sulfoxaflor and its metabolites in crops were determined using the Dow analytical method designated as 091031. The proposed method for tolerance enforcement in plant commo dities 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 extraction. This method is applicable for the quantitative determina tion 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)pyridine

- 3

- yl]ethyl}

- λ 6



### - sulfanylidene)urea and X11721061, 1

- [6

- (triflu oromethyl)pyridin

- 3

- yl]ethanol, in agricultural commodities and processed products. The method was adequately validated, with a limit of quantitation (LOQ) of
0.010 mg/kg for all matrices , including sorghum

. The FDA MRM was reported by the registrant to b e 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 concentrations 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 toxicity profiles. A complete discussion of the rationale for the comb inations 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 [Sulfoxa flor + 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.

### Page 14 of 18 1 Peak value , from Florida citrus ; 2 1

- in

- 10

- year annual mean values , California cit rus ; 3 1

- in

- 10

- year overall annual
mean values , California citrus

.



### For 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 Residu e 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 cr ops. In support of that request, Dow AgroSciences, LLC submitted field trial data for sulfoxaflor in/on soghum commodities (forage, grain, and stover) from 9 field trials conducted during 2012 in major sorghum

- growing regions of the Unites States.

Each t rial 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 lb/A, equivalent to 0.045 lb a.i./A based on the certified test substa nce concentration of 49.1%. Test substance was applied 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 typically 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 gro und 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 concentration 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 residues 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 b elow the
established tolerance.

### Page 15 of 18

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 (Tabl e 8 ). The resulting dietary burdens 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 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)

### Page 16 of 18

Table 9 . Summary of Anticipated Sulfoxaflor Residues in Livestock Commodities

. Livestock Commodity Matrix

- to

- Feed
Ratio * Anticipated Residue, ppm Current Tolerance, 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, (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 the 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, there 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
chemical

- by

- chemical basis, the Agency is now requiring interim mitigation measures for aerial

### Page 17 of 18

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 membership 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 policy 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

es timates of hazard (e.g., a NOAEL or PAD), or the risks themselves can be aggregated. When 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 gr anting the Section 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 pro duce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that sulfoxaflor has a common mechanism of toxicity with other
substances. For information regarding EPA’s efforts to determin e which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulatin g effects from substances found to have
a common mechanism on EPA’s website at : http://www.epa.gov/pesticides/cumulative/.

DETAILED OCCUPATIONAL EXPOSURE CONSIDERATIONS

The proposed use is on sorghum; therefore, there is the potential for occupational ha ndler 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 18 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

.

### Page 18 of 18

Restricted Entry Interval (REI)

The 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

D382604. 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 & 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.

D417536. 5 March 2014. Doherty, M. and Figueroa, Z. Sulfoxaflor

– Human Health Risk Assessment of the FIFRA Section 18 Emergency Exemption Use on Sorghum.

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