## Section 18 Emergency Specific Exemption

2016

Transform® WG Insecticide Sulfoxaflor EPA Reg. No 62719

- 625 For the control of the sugarcane aphid, Melanaphis sacchari

in sorghum in Texas

Dow AgroSciences

## 2016 FIFRA SECTION 18

General information requirements of §40 CFR 166.20(a) in an application for a specific exemption.

 SPECIFIC

QUARANTINE

PUBLIC HEALTH

i. This application to the Administrator of the Environmental Protection Agency (EPA) for a specific exemption to authorize the use of Sulfoxaflor (Transform® WG Insecticide EPA Reg. No. 62719

- 625) to control the sugarcane aphid, Melanaphis s acchari in sorghum by the Texas Department of Agriculture. Any questions related to this request should be addressed to:

Dale R. Scott Coordinator for Pesticide Product Evaluation and Registration Texas Department of Agriculture

P.O. Box 12847 Austin, TX 78711 Phone: (512) 936

- 2535

Fax: (888) 216

- 9860 dale.scott@TexasAgriculture.gov

ii. The following qualified experts are also available to answer questions:

University Representatives: Dr. M.O. (Mo) Way

Profes sor of Entomology

Texas A&M AgriLife Research and Extension Center 1509 Aggie Drive Beaumont, TX 77713 409.752.2741 x 2231 (office) moway@aesrg.tamu.edu TYPE OF EXEMPTION BEING REQUESTED

SECTION 166.20(a)(1): IDENTITY OF CONTACT PERSONSRaul T. Villanueva

- Ph. D. Texas A&M AgriLife Extension Assistant Professor and Entomologist 2401 East Highway 83, Weslaco, TX 78596 rtvillanueva@ag.tamu.edu Tel: (956) 968

- 5581 Tel: (956) 969

- 5604 Fax: (956) 969

- 5639

Registrant Representative:

Tami Jones

- Jeff

erson U.S. Regulatory Leader U.S. Regulatory & Government Affairs

- Crop Protection Dow AgroSciences

9330 Zionsv ille Road Indianapolis IN 46268 phone: 31 7.337.3574

email: tjjonesjefferson@dow.com

i. Common Chemical Name (Active Ingredient): Sulfoxaflor

Trade Name and EPA Reg. No.: Transform® WG Insecticide

, EPA Reg. No.

62719

- 625

Formulation: Active Ingredient 50%

i. Sites to be treated: Sorghum fields (grain and forage) with the sugarcane aphid, Melanaphis s acchari

statewide.

ii. Method of Application : Applications wil l be made by foliar application.

iii. Rate of Application:

0.75

– 1.5 oz of Transform® WG/acre (0.023

– 0.047 lb ai/acre)

iv. Maximum Number of Applications: 2 applications per year (maximum of 3 oz/acre (0.094 lb ai/acre) SECTION 166.20(a)(2): DESCRIPTION OF THE PESTICIDE REQUESTED

SECTION 166.20(a)(3): DESCRIPTION OF THE PROPOSED USEv. Total Ac reage to be Treated: According to the National Agricultural Statistics Service (NASS), 3 million acres of sorghum was planted in Texas in 2013. During the 2015 use season, 1,021,657 acres were treated with Transform® WG, according to estimates provided by Dow AgroScience s

.

vi. Total Amount of Pesticide to be used: According to the previously mentioned statistics, if all 3 million acres of sorghum were treated with the maximum rate (1.5 oz /acre or 0.047 lb ai/acre) and the maximum numbers of applications are made (2 applications or 3.0 oz/acre or 0.094 lb ai/acre) then 70,313.5 gallons of Tra nsform® WG would be used in 2016

.

vii. Restrictions and Requirements:

 Preharvest Interval: Do not apply within 7 days of harvest for grain or 14 days of harvest for forage , hay or stover.

 Re

- Entry Interval (REI): 24 hrs

 Minimum Treatment Interval: Do not make applications less than 14 days

apart.

 Do not make more than two applications per acre per year.

 Do not apply more than a total of 3.0 oz of Transform WG (0.09 lb ai of sulfoxaflor) per acre per year.

Duration of the Proposed use: Early Spring through Late Fall

viii. Earliest Possible Harvest Date: Late May in South Texas

Registered Alternative Pesticides: Of the registered alternative pesticides, only Dimethoate 4 EC (dimethoate, EPA Reg

. No.

19713

- 231) has provided adequate control. Dimethoate is an organophosphate which is labeled for use on sorghum at 1 pint per acre. Dimethoate, which is highly toxic to bees, has a use

restriction that does not allow its use during pollen shed in sorghum. Insects have historically

shown resistance to organophosphates . Three other pesticides registered for use in sorghum did not provide adequate control of the aphid. Those pesticides are:

Karate ® with Zeon TM Technology (Lambda Cyholothrin 22.8%, EPA Reg

. No. 100

- 1097)

Lor sban® Advanced , others (Chlorpyrifos 40.2%, EPA Reg. No. 62719

- 591) Asana® XL (Esfenvalerate 8.4%, EPA Reg. No. 352

- 515)

Of the above mentioned insecticides, Karate ® and Asana® are pyrethroids and Lorsban® is an organophosphate. Both pyrethroids and organophosphates have shown resistance potential. In field tests conducted in 2013 by Texas A&M Agri L ife professionals, Karate® and Asana® both

SECTION 166.20(a)(4): ALTERNATIVE METHODS OF CONTROLprovided some initial po pulation reduction when used at labeled rates. However, population

spikes were observed soon after treatments in some instances. Chlorpyrifos did not provide satisfactory control at labeled rates.

Sivanto ® was approved for use in 2015 and is available to producers for SCA control

. Even though Sivanto ® is available , Transform® is still needed to prevent resistance build up, which is common in aphids. Transform® is also needed due to the fact that it has a 7 day pre harvest interval, whereas Sivanto® has a 14 day restriction. The 7 day window is needed to treat late season aphid infestations prior to harvest

. Without the late season control prior to harve s t , aphid populations can create large amounts of honeydew with creates major problems with the harvest equipment and lodging of the sorghum, preventing harvest all together

.

A few varieties of resistant sorghum have been identified by researchers, but sufficient qua n tities of agronomically acceptable cultivars wi ll not be available for the 20 16 planting season.

Table to Address Issues with Registered Alternatives:

Chemical (active ingredient) Application

Type (soil, seed, foliar, etc.) Number of

Applications/ growing

season Comments

- reason insecticide

unsuitable

Imidacloprid Seed 1 Due to the nature of the app lication as a seed treatment, it is doubtful that it can provide season

- long

control. Further test s will be

evaluated this season.

Clothianidin Seed 1 Due to the nature of the application as a seed treatment, it is doubtful that it can provide season

- long

control. Further test s will be

evaluated this season.

Thiamethoxam Seed 1 Due to the nature of the application as a seed treatment, it is doubtful that it can provide season

- long

control. Further test s will be

evaluated this season.

Dimethoate Foliar 3 Provided inconsistent control. Has restriction of no applications during pollen shed due to the toxicity to bees. 28 day PHI Chlorpyrifos Foliar 3 Results of less than satisfactory control. PHI prevents late season application. (30 days PHI of 1 pint /acre, 60 days PHI of 1+ pints/acre) Lambda Cyhalothrin Foliar 3 (can only Good initial control, but flaredapply twice after crop has emerged and

once after is in soft dough

stage. populations in test. 30 day PHI.

Esfenvalerate Foliar 1 Good initial control, but residual was short, actually flaring populations. 21 day PHI

Turbufos Soil

- Band @

planting 1

- 5cm wide

band Will not provide season long

control.

Two replicated field trials were conducted on the aphid in 2013. The first was conducted by Dr. Mo Way in August in China, T exas . The second replicated test was conducted in Weslaco,

T exas, by Dr. Raul Villanueva and D. Sekula. In both trials, data showed that Transf orm® WG at 0.75/acre provided good control of Melanaphis s acchari

.

Several tests were conducted during the 2014 and 2015 growing season. These trials confirmed

that sulfoxaflor gave outstanding control when compared to other registered products in controlling Melanaphis s acchari in sorghum production. The applications allowed under the section 18 exemption also showed overwhelming success of the insecticide in Texas.

The following documents provide data to support the efficacy of sulfoxaflor for control of Melanaphis s acchari in sorghum:

2014 Grain Sorghum Insecticide Efficacy Trials (Attachment A) 2015 Sugarcane Aphid Insecticide Efficacy Trial (Attachment B) Sorghum Insecti cide Screening for 2014 Annual Report (Attachment C ) Dr. Way ALL DATA for Sorghum Insecticide Screening (Attachment D ) Brewer Data (Attachment E ) An Integrated Regional Response to an Invasive Aphid Pest of Sorghum (Attachmen t F ) 2015 Occurrence Maps (Attachment G)

Based on the 2013 Weslaco data it seemed that dimethoate worked as well as Transform, (see graph bellow for precounting

, 7dd and 14daa) however Dr. Kerns and Mexican colleagues did not have good results. In addition the PHI of Dimethoate is 38 days. In the Lorsban and Asana plots you can see increase of populations at 14 daa. The time was flowering to grain filling. By the way grains did not fill and they looked wrinkled and dehydrated. SECTION 166.20(a)( 5 ): EFFICACY OF USE PROPOSED UNDER SECTION 18Pre

- Count 7dd 14dd

Acute Assessment

Food consumption information from the USDA 1994

- 1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and maximum residues from field trials rather

than tolerance

- level residue estimates were used. It was assumed that 100% of crops c overed by the registration request are treated and maximum residue levels from field trials were used.

Drinking water. Two scenarios were modeled, use of sulfoxaflor on non

- aquatic row and orchard crops and use of sulfoxaflor on watercress. For the non

- aquatic crop scenario, based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and

Screenin g Concentration in Ground Water (SCI

- GROW) models, the estimated drinking water concentrations (EDWCs) of sulfoxaflor for acute exposures are 26.4 ppb for surface water and 69.2 ppb for ground water. For chronic exposures, EDWCs are 13.5 ppb for surface wa ter and 69.2 ppb for ground water. For chronic exposures for cancer assessments, EDWCs are 9.3 ppb for surface water and 69.2 ppb for ground water. For the watercress scenario, the EDWCs for

SECTION 166.20(a)( 6 ): EXPECTED RESIDUES FOR FOOD USES

Michael Hare, Ph.D.surface water are 91.3 ppb after one application, 182.5 ppb after two applications and 273.8 ppb

after three applications.

Dietary risk estimates using both sets of EDWCs are below levels of concern. The non

- aquatic

crop EDWCs are more representative of the expected exposure profile for the majority of the population. Also, water concentration values are adjusted to take into account the source of the water; the relative amounts of parent sulfoxaflor, X11719474, and X11519540; and the relative liver toxicity of the metabolites as compared to the parent compound.

For acute dietary risk assessment of the general population, the groundwater EDWC is greater than the surface water EDWC and was used in the assessment. The residue profile in groundwater is 60.9 ppb X11719474 and 8.3 ppb X11519540 (totaling 69.2 ppb). Parent sulfoxaflor does not occur in groundwater. The regulatory toxicological endpoint is based on neurotoxicity.

For acute dietary risk assessment of females 13

- 49, the regulatory endpoint is attributable only to the parent compound; therefore, the surface wa ter EDWC of 9.4 ppb was used for this

assessment.

A tolerance of 0.3 ppm for sulfoxaflor on grain sorghum has been established. There is no expectation of residues of sulfoxaflor and its metabolites in animal commodities as a result of the proposed use on sorghum. Thus, animal feeding studies are not needed, and tolerances need not be established for meat, milk, poultry, and eggs.

Drinking water exposures are the driver in the dietary assessment accounting for 100% of the exposures. Exposures through fo od (sorghum grain and syrup) are zero.

The acute dietary exposure from food and water to sulfoxaflor is 16% of the aPAD for children

1

- 2 years old and females 13

- 49 years old, the population groups receiving the greatest exposure.

Chronic Assessment

The same refinements as those used for the acute exposure assessment were used, with two exceptions: (1) average residue levels from crop field trials were used rather than maximum values and (2) average residues from feeding studies, rather than maximum valu es, were used to derive residue estimates for livestock commodities. It was assumed that 100% of crops are treated and average residue levels from field trials were used.

For chronic dietary risk assessment, the toxicological endpoint is liver effects, fo r which it is possible to account for the relative toxicities of X11719474 and X11519540 as compared to sulfoxaflor. The groundwater EDWC is greater than the surface water EDWC. The residue profile in groundwater is 60.9 ppb X11719474 and 8.3 ppb X11519540 . Adjusting for the relative toxicity results in 18.3 ppb equivalents of X11719474 and 83 ppb X11519540 (totaling 101.3 ppb). The adjusted groundwater EDWC is greater than the surface water EDWC (9.3 ppb) and was used to assess the chronic dietary exposure scenario.The maximum dietary residue intake via consumption of sorghum commodities would be only a

small portion of the RfD (<0.001%) and therefore, should not cause any additional risk to humans via chronic dietary exposure. Consumption of sorghum by sensitive sub

- populations

such as children and non

- nursing infants is essentially zero. Thus, the risk of these subpopulations to chronic dietary exposure to sulfoxaflor used on grain sorghum would be insignificant.

The major contributor to the risk was water (100%). There was no contribution from grain sorghum to the dietary exposure. All other populations under the chronic assessment show risk

estimates that are below levels of concern.

Chronic exposure to sulfoxaflor from food and water is 18% of the cPAD for infants, the population group receiving the greatest exposure. There are no residential uses for sulfoxaflor.

Short

- term risk. Because there is no short

- term residential exposure and chronic dietary exposure has already been assessed, no further assessment of short

- term risk is necessary, the chronic dietary risk assessment for evaluating short

- term risk for sulfoxaflor is suffic ient.

Intermediate

- term risk. Intermediate

- term risk is assessed based on intermediate

- term residential exposure plus chronic dietary exposure. Because there is no residential exposure and chronic dietary exposure has already been assessed, no further ass essment of intermediate

- term risk is

necessary.

Cumulative effects. Sulfoxaflor does not share a common mechanism of toxicity with any other substances, and does not produce a toxic metabolite produced by other substances. Thus,

sulfoxaflor does not have a common mechanism of toxicity with other substances.

Cancer. A nonlinear RfD approach is appropriate for assessing cancer risk to sulfoxaflor. This approach will account for all chronic toxicity, including carcinogenicity that could result from

exposure to sulfoxaflor. Chronic dietary risk estimates are below levels of concern; therefore,

cancer risk is also below levels of concern.

There is a reasonable certainty that no harm will result to the general population, or to infants and children from aggreg ate exposure to sulfoxaflor as used in this emergency exemption

request.

Human Health

Toxicological Profile

SECTION 166.20(a)( 7 ): DISCUSSION OF RISK INFORMATION

Human Health Effects

– Michael Hare, Ph.D.
Ecological Effects

– David Villarreal, Ph.D.

Environmental Fate

– David Villarreal, Ph.D.Sulfoxaflor is a member of a new class of insecticides, the sulfoximines. It is an activator of the

nicotinic acetylcholine receptor (nAChR) in insects and, to a lesser degree, mammals. The

nervous system and liver are the target organs, resulting in developmental toxicity and hepatotoxicity.

Developmental toxicity was observed in rats only. Sulfoxaflor produced skeletal abnormalities likely resulting from skeletal muscle contraction due to activation of t he skeletal muscle nAChR in utero. Contraction of the diaphragm, also related to skeletal muscle nAChR activation, prevented normal breathing in neonates and increased mortality. The skeletal abnormalities occurred at high doses while decreased neonatal su rvival occurred at slightly lower levels.

Sulfoxaflor and its major metabolites produced liver weight and enzyme changes, and tumors in subchronic, chronic and short

- term studies. Hepatotoxicity occurred at lower doses in long

- term studies compared to sho rt

- term studies.

Reproductive effects included an increase in Leydig cell tumors which were not treatment related due to the lack of dose response, the lack of statistical significance for the combined tumors, and the high background rates for this tumor type in F344 rats. The primary effects on male reproductive organs are secondary to the loss of normal testicular function due to the size of the Leydig Cell adenomas. The secondary effects to the male reproductive organs are also not

treatment related. It appears that rats are uniquely sensitive to these developmental effects and are unlikely to be relevant to humans.

Clinical indications of neurotoxicity were observed at the highest dose tested in the acute neurotoxicity study in rats. Decreased motor ac tivity was also observed in the mid

- and high

dose groups. Since the neurotoxicity was observed only at a very high dose and many of the effects are not consistent with the perturbation of the nicotinic receptor system, it is unlikely that

these effects ar e due to activation of the nAChR.

Tumors have been observed in rat and mouse studies. In rats, there were significant increases in hepatocellular adenomas in the high

- dose males. In mice, there were significant increases in hepatocellular adenomas and car cinomas in high dose males. In female mice, there was an increase in carcinomas at the high dose. Liver tumors in mice were treatment

- related. Leydig cell tumors were also observed in the high

- dose group of male rats, but were not related to treatment.

The re was also a significant increase in preputial gland tumors in male rats in the high

- dose group. Given that the liver tumors are produced by a non

- linear mechanism, the Leydig cell

tumors were not treatment

- related, and the preputial gland tumors only occ urred at the high dose in one sex of one species, the evidence of carcinogenicity was weak.

Ecological Toxicity Sulfoxaflor (N

- [methyloxido[ 1

- [6

- (trifluoromethyl)

- 3

- pyridinyl]ethyl]

- lambda 4

- sulfanylidene]) is a new variety of insecticide as a member of the sulfoxamine subclass of neonicotinoid insecticides. It is considered an agonist of the nicotinic acetylcholine receptor and exhibits

excit atory responses including tremors, followed by paralysis and mortality in target insects. Sulfoxaflor consists of two diastereomers in a ratio of approximately 50:50 with each diastereomer consisting of two enantiomers. Sulfoxaflor is systemically distrib uted in plantswhen applied. The chemical acts through both contact action and ingestion and provides both

rapid knockdown (symptoms are typically observed within 1

- 2 hours of application) and residual control (generally provides from 7 to 21 days of resid ual control). Incident reports submitted to EPA since approximately 1994 have been tracked via the Incident Data System. Over the 2012 growing season, a Section 18 emergency use was granted for application of sulfoxaflor to cotton in four states (MS, LA, A R, TN). No incident reports have been received in association with the

use of sulfoxaflor in this situation.

Sulfoxaflor is classified as practically non

- toxic on an acute exposure basis, with 96

- h LC 50 values of >400 mg a.i./L for all three freshwater f ish species tested (bluegill, rainbow trout, and common carp). Mortality was 5% or less at the highest test treatments in each of these studies.

Treatment

- related sublethal effects included discoloration at the highest treatment concentration (100% of fish at 400 mg a.i./L for bluegill) and fish swimming on the bottom (1 fish at 400 mg a.i./L for rainbow trout). No other treatment

- related sublethal effects were reported. For an estuarine/marine sheepshead minnow, sulfoxaflor was also practically non

- toxic w ith an LC 50 of 288 mg a.i./L. Sublethal effects included loss of equilibrium or lying on the bottom of aquaria at 200 and 400 mg a.i./L. The primary degradate of sulfoxaflor is also classified as practically non

toxic to rainbow trout on an acute exposure basis (96

- h LC 50 >500 mg a.i./L).

Adverse effects from chronic exposure to sulfoxaflor were examined with two fish species (fathead minnow and sheepshead minnow) during early life stage toxicity tests. For fathead minnow, the 30

- d NOAEC is 5 mg a.i./L bas ed on a 30% reduction in mean fish weight relative to controls at the next highest concentration (LOAEC=10 mg a.i./L). No statistically significant

and/or treatment

- related effects were reported for hatching success, fry survival and length. For sheepshead minnow, the 30

- d NOAEC is 1.3 mg a.i./L based on a statistically significant reduction in mean length (3% relative to controls) at 2.5 mg a.i./L. No statistically significant

and/or treatment

- related effects were reported for hatching success, fry surviva l and mean weight.

The acute toxicity of sulfoxaflor was evaluated for one freshwater invertebrate species, the water flea and two saltwater species (mysid shrimp and Eastern oyster). For the water flea, the 48

- h

EC 50 is >400 mg a.i./L, the highest concentration tested. For Eastern oyster, new shell growth was significantly reduced at 120 mg a.i./L (75% reduction relative to control). The 96

- h EC 50 for shell growth is 93 mg a.i./L. No mortality occurred at any test concentration. Mysid shrimp are

the most acutely sensitive invertebrate species tested with sulfoxaflor based on water column only exposures, with a 96

- h LC 50 of 0.67 mg a.i./L. The primary degradate of sulfoxaflor is also classified as practically non

- toxic to the water flea (EC 50 >240 mg a.i./L).

The chronic effects of sulfoxaflor to the water flea were determined in a semi

- static system over a period of 21 days to nominal concentrations of 6.25, 12.5, 25, 50 and 100 mg a.i./L. Adult mortality, reproduction rate (number of young), length of the surviving adults, and days to first brood were used to determine the toxicity endpoints. No treatment

- related effects on adult mortality or adult length were observed. The reproduction rate and days to first brood were significantly (p<0.05) differe nt in the 100 mg a.i./L test group (40% reduction in mean number of offspring; 35% increase in time to first brood). No significant effects were observed onsurvival, growth or reproduction at the lower test concentrations. The 21

- day NOAEC and

LOAEC were determined to be 50 and 100 mg a.i./L, respectively.

The chronic effects of sulfoxaflor to mysid shrimp were determined in a flow

- through system over a period of 28 days to nominal concentrations of 0.063, 0.13, 0.25, 0.50 and 1.0 mg a.i./L. Mortality of parent (F 0 ) and first generation (F 1 ), reproduction rate of F 0 (number of young), length of the surviving F 0 and F 1 , and days to first brood by F 0 were used to determine the toxicity endpoints. Complete F 0 mortality (100%) was observed at the highest test concentration of 1.0 mg a.i./L within 7 days; no treatment

- related effects on F 0 /F 1 mortality, F 0 reproduction
rate, or F 0 /F 1 length were observed at the lower test concentrations. The 28

- day NOAEC and LOAEC were determined to be 0.11 mg and 0.25 mg a.i./L , respectively.

Sulfoxaflor exhibited relatively low toxicity to aquatic non

- vascular plants. The most sensitive aquatic nonvascular plant is the freshwater diatom with a 96

- h EC 50 of 81.2 mg a.i./L. Similarly,

sulfoxaflor was not toxic to the freshwater vascular aquatic plant, Lemna gibba , up to the limit amount, as indicated by a 7

- d EC 50 for frond count, dry weight and growth rate of >100 mg a.i./L with no significant adverse effects on these endpoints observed at any treatment concentration.

Based on an acute oral LD 50 of 676 mg a.i./kg bw for bobwhite quail, sulfoxaflor is considered slightly toxic to birds on an acute oral exposure basis. On a subacute, dietary exposure basis, sulfoxaflor is classified as practically nontoxic to birds, with 5

- d LC 50 values of >5620 mg/kg

diet for mallard ducks and bobwhite quail. The NOAEL from these studies is 5620 mg/kg

- diet as no treatment related mortality of sublethal effects were observed at any treatment. Similarly, the primary degradate is classified as pract ically nontoxic to birds on an acute oral exposure basis

with a LD 50 of >2250 mg a.i./kg bw. In two chronic, avian reproductive toxicity studies, the 20

- week NOAELs ranged from 200 mg/kg

- diet (mallard, highest concentration tested) to 1000 mg/kg

- diet (bob white quail, highest concentration tested). No treatment

- related adverse effects were observed at any test treatment in these studies.

For bees, sulfoxaflor is classified as very highly toxic with acute oral and contact LD 50 values of 0.05 and 0.13 μg a.i ./bee, respectively, for adult honey bees. For larvae, a 7

- d oral LD 50 of >0.2 μg a.i./bee was determined (45% mortality occurred at the highest treatment of 0.2 μg a.i./bee). The primary metabolite of sulfoxaflor is practically non

- toxic to the honey bee. This lack of toxicity is consistent with the cyano

- substituted neonicotinoids where similar cleavage of the cyanide group appears to eliminate their insecticidal activity. The acute oral toxicity of sulfoxaflor to adult bumble bees ( Bombus terrestris ) is similar to the honey bee; whereas its acute contact toxicity is about 20X less toxic for the bumble bee. Sulfoxaflor did not demonstrate substantial residual toxicity to honey bees exposed via treated and aged alfalfa (i.e., mortality

was <15% at maximum a pplication rates).

At the application rates used (3

- 67% of US maximum), the direct effects of sulfoxaflor on adult forager bee mortality, flight activity and the occurrence of behavioral abnormalities is relatively

short

- lived, lasting 3 days or less. Di rect effects are considered those that result directly from interception of spray droplets or dermal contact with foliar residues. The direct effect of sulfoxaflor on these measures at the maximum application rate in the US is presently not known.

When com pared to control hives, the effect of sulfoxaflor on honey bee colony strength whenapplied at 3

- 32% of the US maximum proposed rate was not apparent in most cases. When

compared to hives prior to pesticide application, sulfoxaflor applied to cotton foliage up to the maximum rate proposed in the US resulted in no discernible decline in mean colony strength by 17 days after the first application. Longer

- term results were not available from this study nor were concurrent controls included. For managed bees, the primary exposure routes of concern include direct contact with spray droplets, dermal contact with foliar residues, and ingestion through consumption of contaminated pollen, nectar and associated processed food provisions. Exposure of hive bees v ia contaminated wax is also possible. Exposure of bees through contaminated drinking water is not expected to be nearly as important as exposure through direct contact or pollen and nectar.

In summary, sulfoxaflor is slightly toxic to practically non

- toxi c to fish and freshwater water aquatic invertebrates on an acute exposure basis. It is also practically non

- toxic to aquatic plants (vascular and non

- vascular). Sulfoxaflor is highly toxic to saltwater invertebrates on an acute exposure basis. The high to xicity of sulfoxaflor to mysid shrimp and benthic aquatic insects relative to the water flea is consistent with the toxicity profile of other insecticides with similar MOAs. For birds and mammals, sulfoxaflor is classified as moderately toxic to practical ly non

toxic on an acute exposure basis. The threshold for chronic toxicity (NOAEL) to birds is 200 ppm and that for mammals is 100 ppm in the diet. Sulfoxaflor did not exhibit deleterious effects to terrestrial plants at or above its proposed maximum appl ication rates.

For bees, sulfoxaflor is classified as very highly toxic. However, if this insecticide is strictly used as directed on the Section 18 supplemental label, no significant adverse effects are expected to Texas wildlife. Of course, standard precautions to avoid drift and runoff to waterways of the state are warranted. As stated on the Section 3 label, risk to managed bees and native pollinators from contact with pesticide spray or residues can be minimized when applications are made

before 7 am or after 7 pm or when the temperature is below 55 ◦ F at the site of application.

Environmental Fate Sulfoxaflor is a systemic insecticide which displays translaminar movement when applied to foliage. Movement of sulfoxaflor within the plant follows the direction of water transport within the plant (i.e., xylem mobile) as indicated by phosphor translocation studies in several plants. Sulfoxaflor is characterized by a water solubility ranging from 550 to 1,380 ppm. Sulfoxaflor has a low potential for vol atilization from dry and wet surfaces (vapor pressure= 1.9 x 10 - 8 torr and Henry’s Law constant= 1.2 x 10 - 11 atm m 3 mole - 1 , respectively at 25 °C). Partitioning coefficient of sulfoxaflor from octanol to water (K

ow @ 20 C & pH 7= 6; Log K

ow = 0.802) sugges ts low potential for bioaccumulation. No fish bioconcentration study was provided due to the low K

ow , but sulfoxaflor is not expected to bioaccumulate in aquatic systems. Furthermore, sulfoxaflor is not expected to partition into the sediment due to low K

o c (7

- 74 mL/g).

Registrants tests indicate that hydrolysis, and both aqueous and soil photolysis are not expected to be important in sulfoxaflor dissipation in the natural environment. In a hydrolysis study, the parent was shown to be stable in acidic/neut ral/alkaline sterilized aqueous buffered solutions (pH values of 5, 7 and 9). In addition, parent chemical as well as its major degradate, were shown to degrade relatively slowly by aqueous photolysis in sterile and natural pond water (t 1⁄2 = 261 to >1,000 da ys). Furthermore, sulfoxaflor was stable to photolysis on soil surfaces. Sulfoxaflor isexpected to biodegrade rapidly in aerobic soil (half

- lives <1 day). Under aerobic aquatic

conditions, biodegradation proceeded at a more moderate rate with half

- lives ranging from 37 to 88 days. Under anaerobic soil conditions, the parent compound was metabolized with half

- lives of 113 to 120 days while under anaerobic aquatic conditions the chemical was more persistent

with half

- lives of 103 to 382 days. In contrast to its short

- lived parent, the major degradate is expected to be more persistent than its parent in aerobic/anaerobic aquatic systems and some aerobic soils. In other soils, less persistence is expected due to mineralization to CO 2 or the

formation of othe r minor degradates.

In field studies, sulfoxaflor has shown similar vulnerability to aerobic bio

- degradation in nine out of ten terrestrial field dissipation studies on bare

- ground/cropped plots (half

- lives were <2 days in nine cropped/bare soils in CA, F L, ND, ON and TX and was 8 days in one bare ground soil in TX). The chemical can be characterized by very high to high mobility (Kf

oc ranged from 11

- 72 mL g - 1 ). Rapid soil degradation is expected to limit chemical amounts that may potentially leach

and co ntaminate ground water. Contamination of groundwater by sulfoxaflor will only be expected when excessive rain occurs within a short period (few days) of multiple applications in vulnerable sandy soils. Contamination of surface water by sulfoxaflor is expec ted to be mainly related to drift and very little due to run

- off. This is because drifted sulfoxaflor that reaches aquatic systems is expected to persist while that reaching the soil system is expected to degrade quickly with slight chance for it to run

- of f.

When sulfoxaflor is applied foliarly on growing crops it is intercepted by the crop canopy. Data presented above appear to indicate that sulfoxaflor enters the plant and is incorporated in the plant foliage with only limited degradation. It appears tha t this is the main source of the insecticide sulfoxaflor that would kill sap sucking insects. This is because washed

- off sulfoxaflor, that reaches the soil system, is expected to degrade.

In summary, sulfoxaflor has a low potential for volatilization from dry and wet surfaces. This chemical is characterized by relatively higher water solubility. Partitioning coefficient of sulfoxaflor from octanol to water suggests low potential for bioaccu mulation in aquatic organisms such as fish. Sulfoxaflor is resistant to hydrolysis and photolysis but transforms quickly in soils. In contrast, sulfoxaflor reaching aquatic systems by drift is expected to degrade rather slowly. Partitioning of sulfoxaflo r to air is not expected to be important due to the low vapor pressure and Henry’s Law constant for sulfoxaflor. Exposure in surface water results from drifted parent as only minor amounts is expected to run

- off only when rainfall and/or irrigation

immedia tely follow application. The use of this insecticide is not expected to significantly adversely impact Texas ecosystems with use according to the Section 18 label with this application. Of course, caution is needed to prevent exposure to water systems be cause of toxicity issues to aquatic invertebrates. As state d on the Section 3 label, this product should never be applied directly to water, to areas where surface water is present or to intertidal areas

below the mean water mark. Do not contaminate wate r when disposing of equipment rinsates.

Endangered and Threatened Species in Texas No impacts are expected on endangered and threatened species by this very limited use of this insecticide as delineated in the Section 18 application. Sulfoxaflor demonstrates a very favorable ecotoxicity and fate profile as stated above and should not di rectly impact any protectedmammal, fish, avian, or plant species. This product does adversely affect insects and aquatic

invertebrates, especially bees, but the limited exposure to these species should not negatively affect endangered and threatened speci es in Texas. As always, the label precautions need be strictly adhered to.

For more information, see Attachment H

.

The following state/federal agencies were notified of the Texas Department of Agriculture’s (TDA’s) actions to submit an application for a specific exemption to EPA

- Texas Commission on Environmental Quality (TCEQ), Air Quality Control

- Texas Commission on Environmental Q uality (TCEQ), Water Quality

- Texas Parks and Wildlife Department

- U.S. Fish and Wildlife Department

See Attachment I for a copy of these letters.

Dow AgroScience has been notified of this agency’s intent regarding this application (see attached letter of support). They have also provided a copy of a label with the use directions for this use (although this use is dependent upon the approval of this sec tion

- 18 by EPA).

The State Legislature has endowed TDA with the authority to regulate the distribution, storage, sale, use and disposal of pesticides in the state of Texas. In addition, the EPA/TDA grant enforcement agreement provides the Department with the authority to enforce the provisions of the FIFRA, as amended, within the state. Therefore, the Department is no lacking in authority to enforce the provisions of an EPA Pesticide Enforcement Specialist will make a number of random, unannounced calls on applicators to check for compliance with provisions of the specific exemption. If violations are discovered appropriate enforcement will be taken.

This is the third time TDA has applied for this specific exemption. SECTION 166.20(a)( 8 ): COORDINATION WITH OTHER AFFECTED STATE OR

FEDERAL AGENCIES

SECTION 166.20(a)( 9 ): ACKNOWLEDGEMENT BY THE REGISTRANT

SECTION 166.20(a)( 10 ): DESCRIPTION OF PROPOSED ENFORCEMENT

PROGRAM

SECTION 166.20(a)( 11 ): REPEAT USES

SECTION 1 66.20(b )( 1 ): NAME OF THE PESTMelanaphis s acchari

In the fall of 2013, unusually high populations of aphids were discovered near Beaumont, Texas, by Dr. Mo Way. The population was soon detected along the Texas Gulf Coast and the Texas Lower Rio Grande Valley. The aphid soon spread and was identified in Louisiana, Mississipp i

and Oklahoma. Since it’s outbreak in grain sorghum fields, the aphid was identified taxonomically by Dr. Susan Halbert and other homopteran taxonomist as the sugarcane aphid, Melanaphis sacchari (SCA), however, this species affecting sorghum might be a new biotype that switched host or a new invasive strain recently introduced into the U.S. This aphid has been found in sorghum (both grain and forage) as well as johnsongrass ( sorghum halepense ) in great numbers successfully reproducing. In 2014, alate S CA forms were detected in fields of sugarcane or corn neighboring heavily infested sorghum fields in the Rio Grande Valley in South Texas. These SCA alates started to deposit nymphs in sugarcane or corn plants, however, nymphs and alates SCA vanished from these plants in two or three days.

Since widespread detection in South Texas and Louisiana in 2013, a Sugarcane Aphid Task Force was formed to effectively communicate and address this pest issue. The pest has since spread to ten states, eight of which h ave received Section 18 exemptions for the use of sulfoxaflor in sorghum. The issue is further complicated in Texas by the ongoing drought.

Recent rains have provided some relief to farmers. However, rice farmers in the Texas Gulf Coast rely on water pro vided by lakes in the Texas Hill Country. Because of the historically low

levels of these lake s , the farmers have been cut off from lake water for the past three years. Rice farmers have relied on other crops like grain sorghum, whi ch requires much less water. This has increased the sorghum acreage in the Texas Gulf Coast. In 2013, over 3 million acres of sorghum was planted in Texas, up from a low of 1.5 million in 2011 (National Agriculture Statistics Service, http://quickstats.nass.usda.gov/results/F3F8C65B

- 0696

- 3C91

- B805

- 29F290D1B4FA ).

In South Texas, the Sugarcane aphid does not lay eggs, they are viviparous. During the winter months, temperatures in the South Texas only reach a minimum of around 28oF . During normal cold spells, the daytime temperature rises above 40oF, which does not hinder the SCA, as they can seek shelter in the abundance of volunteer sorghum and johnsongrass. This provides a valid

p opulation as sorghum acreage is planted in February in March in the southernmost areas of Texas. With the last harvest date of late November/early December in some areas, the population has a large timeframe to establish itself. The South Texas area prov ides a n optimal

environment for the SCA to overwinter.

The populations of SCA begin feeding on the lower leaves of sorghum plants the n rapidly

advance to the upper leave s and even colonize in the sorghum head. Mexican scientist s reported high populations of the aphid in Mexico in Rio Bravo and San Fernando in the fall of 2013

. SECTION 1 66.20(b )( 2 ): DISCUSSION OF EVENTS OR CIRCUMSTANCES WHICH

BROUGHT ABOUT THE EMERGENCY SITUATIONUnsuccessful treatments including chlorpyrifos, methomyl and cypermethrin were applied in

Mexico during 2013 . Entire fields were lost in Mexico and Texas A&M AgriLife scientist

fear ed that populations would rapidly spread northward during the 2014 growing season . That

fear came to fruition, as the pest spread into northward into Oklahoma and southern Kansas and

on to the Southeastern U.S

.

Natural enemies h ave been observed feeding on the sugarcane aphid, but they apparently had difficulty responding quickly enough to prevent damage. Progress is being made on developing

resistan t /tolerant sorghum lines, but sufficient quantities of agronomically acceptable cultivars

will be years away from commercial use

.

As discussed previously, it is not anticipated that there should be any anticipated risks to endangered or threatened species, beneficial organisms or the environment if the application is made according to the section 18 use directions. This is the latest list as provided by Texas Parks and Wildlife Department.

See Attachmen t H

- Endangered and Threatened Species List 2011

Dr. Michael Brewer, Texas A&M AgriLife Research Specialist in Corpus Christi, has reported losses rangeing from 25

– 75% along the Gulf Coast. Similar yield loss has been reported

thro u ghout Texas. Texas A&M AgriLife Extension Specialist have confirmed SCA in most sorghum producing counties of Texas. Dr. Mo Way reported producer s in Chambers and Liberty

counties did not harvest their grain sorghum because the aphid d amage was so severe. He also reported a nother producer in Liberty County suffered a y ie ld loss of 50% in an infested field as compared to another field where the aphid did not damage the crop. Dr. Raul Villanueva

report ed two seed increase plots at the Texas A&M AgriLife Center in Weslaco were completely lost due to the aphid in 2013 . Dr. Villanueva has also received information from Mexico that research plots at the Rio Bravo Agricultural Station were all devastated by t his aphid and the growers had up to 60% loss in San Fernando and Ciudad Victoria.

Below is the 2013 data from Texas A&M AgriLife Extension Service crop budgets.

Region Irr/dl CWT Price $/cwt $/ac $/ac w/o

Rent High Plains dl Income 18 9.00 162

Cost 176.18 146.18

High Plains irr Income 60 9.00 540.00

SECTION 1 66.20(b )( 3 ): DISCUSSION OF ANTICIPATED RISKS TO
ENDANGERED OR THREATENED SPECIES, BENIFICIAL ORGANISMS, OR

THE ENVIRONMENT

SECTION 1 66.20(b )( 4 ): DISCUSSION OF SIGNIFICANT ECONOMIC LOSSCost 572.00 472.00

Rolling Plains dl Income 22 11.10 244.20

Cost 152.53 117.53

Blacklands dl Income 45 10.00 450.00

Cost 299.73 254.85

Coastal Bend dl Income 40 10.00 400.00

Cost 302.00 190.50

The cost of production for grain sorghum is approximately $325

- $375 per acre. According to the Texas Almanac, the avg yield of grain sorghum in Texas in 2010, 2011 and 2012 was 70, 49 and 59 bu/acre, respectively, for a 3

- year avg of approximately 59 bu/ac re (56 lb/bu for grain sorghum) which is about 3300 lb/acre. The avg price for grain sorghum in Texas in 2010, 2011 and 2012 was approximately $7.26, $10.40 and $11.20/cwt. The current price for grain sorghum is about $7.50/cwt. Also, the relatively slim p rofit margin means unexpected and uncontrolled pest infestations, like the sugarcane aphid, can have a devastating impact on the profitability of the crop.