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Prothioconazole/Trifloxystrobin

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New York State Department of Environmental Conservation<br />

Division of Materials Management<br />

Bureau of Pest Management<br />

Product Registration & Pest Management Alternatives Section<br />

625 Broadway, Albany, New York 12233-7257<br />

Phone: (518) 402-8788 • Fax: (518) 402-9024<br />

Website: www.dec.ny.gov<br />

E-mail: ppr@gw.dec.state.ny.us<br />

Via UPS (Co. No. 264)<br />

Ms. Karen Cain<br />

Bayer CropScience LP<br />

2 T.W. Alexander Drive<br />

Research Triangle Park, NC 27709<br />

Dear Ms. Cain:<br />

August 10, 2011<br />

Re: Registration of a Major Change in Labeling for the Active Ingredients<br />

<strong>Prothioconazole</strong> and <strong>Trifloxystrobin</strong> as Contained in Stratego YLD<br />

Fungicide (EPA Reg. No. 264-1093)<br />

Joe Martens<br />

Commissioner<br />

The New York State Department of Environmental Conservation (Department) has<br />

evaluated your application (received September 13, 2010) and supplemental materials received<br />

to date in support of the registration of the above-referenced pesticide product.<br />

<strong>Trifloxystrobin</strong> (active ingredient code 113961) was initially registered by the<br />

Department on March 15, 2000 for control of foliar, stem, and root diseases in pome fruits,<br />

grapes, cucurbit vegetables, turfgrass, and ornamentals. The maximum application rate on food<br />

crops was 0.75 pounds active ingredient per acre per year. The maximum application rate on turf<br />

was 1.08 pounds active ingredient per acre per year. The maximum rate for seedlings and plants<br />

grown in greenhouses, containers and other enclosed structures was 3.75 pounds active<br />

ingredient per acre per year.<br />

<strong>Prothioconazole</strong> (active ingredient code 129112) was initially registered by the<br />

Department on August 7, 2009 for control of specific fungal diseases in barley, canola, chickpea,<br />

dried shelled peas and beans subgroup (except soybeans), lentil, rapeseed, Indian rapeseed, field<br />

mustard, crambe, peanut, soybean, sugar beet, and wheat. The maximum application rate was<br />

0.54 pounds active ingredient per acre per year.<br />

The major change in labeling application for Stratego YLD Fungicide proposed to add<br />

ground and aerial broadcast spray and irrigation application to sweet corn, field corn, and<br />

soybeans. The maximum labeled use rate for broadcast spray is 5 fluid ounces of product (0.04<br />

pounds of prothioconazole and 0.12 pounds of trifloxystrobin) per acre per application and 20


Ms. Karen Cain 2.<br />

fluid ounces of product (0.16 pounds of prothioconazole and 0.48 pounds of trifloxystrobin) per<br />

acre per year. Near the end of the technical review process, Bayer CropScience LP (Bayer)<br />

petitioned to add barley and wheat to the list of proposed crops. These crops were previously<br />

approved for prothioconazole but not trifloxystrobin. The proposed use rates for wheat and<br />

barley are less than or equal to the corn and soybean rates. In addition, corn and soybean acreage<br />

in New York State is several times higher than the acreage of wheat and barley in the State.<br />

Therefore, no additional review parameters were required for the wheat and barley use.<br />

The application package was deemed complete for purposes of technical review on<br />

January 27, 2011. Pursuant to the review time frame specified in Environmental Conservation<br />

Law §33-0704.2, a registration decision date of June 24, 2011 was established. Technical<br />

reviews of the proposed uses included on the Stratego YLD label have been performed by the<br />

Department and the New York State Department of Health. On June 2, 2011, the Department<br />

sent a “Technical Issues” letter to Bayer describing concerns with respect to the aerial<br />

application and chemigation methods of application described on the Stratego label. Bayer’s<br />

response was received by the Department on July 12, 2011. The Department has determined that<br />

Bayer’s response sufficiently mitigates the Department’s concerns. The technical reviews are<br />

shown below.<br />

HUMAN HEALTH ASSESSMENT:<br />

The following assessment was prepared by staff within the Bureau of Toxic Substance<br />

Assessment at the New York State Department of Health.<br />

On an acute basis, the formulated product Stratego YLD Fungicide was not very toxic<br />

via the oral, dermal and inhalation routes of exposure. This pesticide product did not cause skin<br />

or eye irritation (tested on rabbits) or skin sensitization (tested on guinea pigs).<br />

<strong>Trifloxystrobin</strong><br />

We have previously reviewed the active ingredient trifloxystrobin for the pesticide<br />

products Flint Fungicide and Compass Fungicide. The available information on trifloxystrobin<br />

indicated that it is not very toxic or irritating following acute exposures in laboratory animals,<br />

but is a strong skin sensitizer. Data from chronic and developmental/reproductive toxicity<br />

studies showed that trifloxystrobin has the potential to cause some toxicity, principally liver<br />

effects. The U.S. Environmental Protection Agency (U.S. EPA) classified this chemical as “not<br />

likely to be carcinogenic to humans” based on a lack of evidence of carcinogenicity in rat and<br />

mouse chronic feeding studies. The U.S. EPA Office of Pesticide Programs (OPP) established<br />

an acute oral reference dose (aRfD) for females 13–49 years of age of 2.5 milligrams per<br />

kilogram body weight per day (mg/kg/day) based on a no-observed-effect level (NOEL) of 250<br />

mg/kg/day from a developmental toxicity study in rats (increased fetal skeletal anomalies) and an<br />

uncertainty factor of 100. The U.S. EPA OPP additionally established a chronic oral reference<br />

dose (cRfD) for trifloxystrobin of 0.038 mg/kg/day based on a NOEL of 3.8 mg/kg/day from a<br />

two-generation reproductive toxicity study in rats (decreased body weight, body weight gain and<br />

food consumption; liver, kidney and spleen effects) and an uncertainty factor of 100. A current


Ms. Karen Cain 3.<br />

search of the toxicological literature did not find any significant new information on the toxicity<br />

of trifloxystrobin.<br />

The U.S. EPA established tolerances for trifloxystrobin residues in or on field corn,<br />

sweet corn and popcorn which ranged from 0.05 parts per million (ppm) to 7 ppm depending on<br />

the corn commodity (Federal Register Vol. 67:35,915–35,924, May 22, 2002; Vol. 71:15,597–<br />

15,604, March 29, 2006; and Vol. 75:33,190–33,195, June 11, 2010) and in or on soybeans of 10<br />

ppm (forage), 25 ppm (hay) and 0.08 ppm (seed). The U.S. EPA established an acute<br />

population adjusted dose (aPAD) of 2.5 mg/kg/day for females 13–49 years of age that has the<br />

same basis as the aRfD. The U.S. EPA estimated that the acute dietary exposure to<br />

trifloxystrobin residues from all crops for which there are tolerances, and from drinking water,<br />

would be less than one percent of the aPAD for this subgroup. The chronic population adjusted<br />

dose (cPAD) for trifloxystrobin for the general public and all population subgroups is 0.038<br />

mg/kg/day and has the same basis as the cRfD. The U.S. EPA estimated that the chronic dietary<br />

exposure to trifloxystrobin residues in food and drinking water from all registered uses would be<br />

15 percent of the cPAD for the general population, 34 percent for all infants and 43 percent for<br />

children 1–2 years of age, the most highly exposed subgroup. These exposure analyses are based<br />

on the conservative assumptions that 100 percent of the crops are treated and that these treated<br />

crops contain tolerance level residues.<br />

The U.S. EPA conducted an occupational risk assessment for short- (1–30 days) and<br />

intermediate-term (1–6 months) dermal and inhalation exposures to trifloxystrobin. Exposure<br />

estimates were created for scenarios involving aerial and groundboom application methods to<br />

soybeans or corn. For determining margins of exposure (MOEs), the U.S. EPA compared<br />

estimated short- and intermediate-term dermal exposures to a NOEL of 100 mg/kg/day from a<br />

28-day dermal toxicity study in rats (increased liver and kidney weights). Short- and<br />

intermediate-term inhalation exposures were compared to a NOEL of 3.8 mg/kg/day from a twogeneration<br />

reproductive toxicity study in rats (decreased body weight, body weight gain and food<br />

consumption; liver, kidney and spleen effects). Estimated short- and intermediate-term dermal<br />

MOEs were 2,100 for mixers/loaders, 20,000 for groundboom applicators, 9,600 for aerial<br />

applicators and 14,000 for flaggers (supporting aerial applications). The estimated MOEs for<br />

short- and intermediate-term inhalation exposures to trifloxystrobin were 1,500 for<br />

mixers/loaders, 15,000 for groundboom applicators, 27,000 for aerial applicators and 18,000 for<br />

flaggers. These estimates assumed that workers wore long-sleeved shirt and long pants, shoes<br />

plus socks and chemical resistant gloves, except for aerial applicators who are assumed not to<br />

wear gloves because of lowered expected exposures from engineering controls (enclosed<br />

cockpit). The U.S. EPA conducted a screening level assessment of dermal risks to workers 12hours<br />

post-application; the estimated MOE for detasseling of corn grown for seed, the highest<br />

potential contact activity, was 190. The U.S. EPA considered MOEs of 100-fold or greater for<br />

dermal and inhalation exposures to provide adequate worker protection for trifloxystrobin.<br />

<strong>Prothioconazole</strong><br />

In the past, the New York State Department of Health reviewed the toxicological<br />

properties of the active ingredient prothioconazole (and prothioconazole-desthio, its primary<br />

metabolite/degradate) in the pesticide product Proline 480 SC Fungicide. <strong>Prothioconazole</strong> and


Ms. Karen Cain 4.<br />

prothioconazole-desthio were not very acutely toxic, irritating to the eyes or skin, nor sensitizers.<br />

Data from chronic and developmental/reproductive animal studies indicate that both<br />

prothioconazole and prothioconazole-desthio have the potential to cause toxicity, with<br />

prothioconazole-desthio generally being more toxic than prothioconazole. However, neither<br />

prothioconazole nor prothioconazole-desthio (unlike many other fungicides in the triazole<br />

chemical class) demonstrated carcinogenic potential in laboratory animals. The U.S. EPA<br />

classified prothioconazole as “not likely to be carcinogenic to humans” based on the absence of<br />

significant tumor increases in two adequate rodent carcinogenicity studies. The U.S. EPA OPP<br />

established an aRfD for females 13–49 years of age of 0.02 mg/kg/day based on a NOEL of 2.0<br />

mg/kg/day from a developmental toxicity study in rabbits with prothioconazole-desthio<br />

(structural alterations and multiple malformations) and an uncertainty factor of 100. The U.S.<br />

EPA OPP additionally established a cRfD for prothioconazole of 0.01 mg/kg/day based on a<br />

NOEL of 1.1 mg/kg/day from a chronic toxicity/oncogenicity study in rats (liver histopathology)<br />

and an uncertainty factor of 100. A current search of the toxicological literature did not find any<br />

significant new information on the toxicity of prothioconazole.<br />

The U.S. EPA established tolerances for prothioconazole residues in or on sweet corn<br />

(kernel plus cob with husks removed) of 0.04 ppm and soybeans of 4.5 ppm (forage), 17 ppm<br />

(hay) and 0.15 ppm (seed). The U.S. EPA established an aPAD of 0.02 mg/kg/day for females<br />

13–49 years of age that has the same basis as the aRfD. The U.S. EPA estimated that the acute<br />

dietary exposure to prothioconazole residues from all crops for which there are tolerances, and<br />

from drinking water, would be 38 percent of the aPAD for this subgroup. The cPAD for<br />

prothioconazole established by the U.S. EPA for the general public and all population subgroups<br />

is 0.01 mg/kg/day and has the same basis as the cRfD. The U.S. EPA estimated that the chronic<br />

dietary exposure to prothioconazole residues in food and drinking water from all registered uses<br />

would be 21 percent of the cPAD for the general population, 35 percent for children 1–2 years of<br />

age and 62 percent for all infants (less than one year of age), the most highly exposed subgroup.<br />

These exposure analyses are based on the conservative assumptions that 100 percent of the crops<br />

are treated and that these treated crops contain tolerance level residues.<br />

The U.S. EPA conducted an occupational risk assessment for short- (1–30 days) and<br />

intermediate-term (1–6 months) dermal and inhalation exposures to prothioconazole and/or<br />

prothioconazole-desthio. Exposure estimates were created for scenarios involving aerial,<br />

chemigation and groundboom application methods to soybeans or corn. For determining MOEs,<br />

the U.S. EPA compared estimated short- and intermediate-term dermal exposures to a NOEL of<br />

30 mg/kg/day from a dermal developmental toxicity study in rats with prothioconazole-desthio<br />

(increased incidence of supernumerary rib). Short- and intermediate-term inhalation exposures<br />

were compared to a NOEL of 2 mg/kg/day from a developmental toxicity study in rabbits with<br />

prothioconazole-desthio (structural alterations and multiple malformations). Estimated short-<br />

and intermediate-term combined dermal and inhalation MOEs for mixers/loaders were 4,000<br />

supporting chemigation or aerial applications and 5,700 supporting groundboom applications to<br />

soybeans. The estimated MOEs for applicators of prothioconazole to soybeans were 11,000 for<br />

groundboom applications and 6,600 for aerial applications. In addition, the MOE for flaggers<br />

supporting aerial applications was 8,200. The estimated MOEs for short- and intermediate-term<br />

combined dermal and inhalation exposures to prothioconazole from application to corn were<br />

3,800 and 5,300 for mixers/loaders, 10,000 for groundboom applicators, 6,000 for aerial


Ms. Karen Cain 5.<br />

applicators and 7,500 for flaggers. These estimates assumed that workers wore long-sleeved<br />

shirt and long pants, shoes plus socks and mixer/loaders additionally wore chemical resistant<br />

gloves. The U.S. EPA considered MOEs of 100-fold or greater for dermal and inhalation<br />

exposures to provide adequate worker protection for prothioconazole and prothioconazoledesthio.<br />

The U.S. EPA additionally conducted an occupational risk assessment for day zero postapplication<br />

dermal exposures to prothioconazole for several activities to soybean, corn and sweet<br />

corn. For determining MOEs, the U.S. EPA compared short- and intermediate-term dermal<br />

exposures to a NOEL of 30 mg/kg/day from the dermal developmental toxicity study in rats with<br />

prothioconazole-desthio. The estimated dermal MOEs for hand weeding/scouting and<br />

irrigation/scouting soybeans were 11,000 and 740, respectively. For the post-application<br />

activities to corn of scouting/weeding, irrigation/scouting and detasseling, the estimated dermal<br />

MOEs were 4,200, 420 and 590, respectively. The estimated MOEs for sweet corn were 110 for<br />

hand harvesting, 18,000 for scouting/weeding and 1,800 for irrigation/scouting. For this risk<br />

assessment, dermal MOEs of 100-fold or greater were considered by the U.S. EPA to provide<br />

adequate protection for post-application worker exposures to prothioconazole and<br />

prothioconazole-desthio.<br />

There are no chemical specific federal or New York State drinking water/groundwater<br />

standards for trifloxystrobin or prothioconazole (or their degradates). Based on their chemical<br />

structures, these chemicals each fall under the 50 microgram per liter (μg/L) New York State<br />

drinking water standard for “unspecified organic contaminants” (10 NYCRR Part 5, Public<br />

Water Systems). The New York State drinking water standard for the sum of “unspecified<br />

organic contaminants” and “principal organic contaminants” is 100 µg/L.<br />

Summary<br />

The available information on trifloxystrobin, prothioconazole and Stratego YLD<br />

Fungicide indicates that they are not very acutely toxic in laboratory animal studies. Both<br />

trifloxystrobin and prothioconazole were classified by the U.S. EPA as “not likely to be<br />

carcinogenic to humans.” Although data from subchronic, chronic and<br />

developmental/reproductive studies showed that these two chemicals have the potential to cause<br />

some toxicity, especially liver toxicity, trifloxystrobin and prothioconazole have different modes<br />

of action and the effects are not expected to be cumulative. Dietary exposure of the general<br />

public to trifloxystrobin and prothioconazole residues on currently labeled crops is not expected<br />

to pose significant health risks. Also, the estimated risks to workers from use of Stratego YLD<br />

Fungicide are within the range that is generally considered acceptable.<br />

Given the above, we do not object to expanding the uses of trifloxystrobin and<br />

prothioconazole in the state on sweet corn, field corn and soybeans on the basis of direct health<br />

risks from dietary and worker exposure.


Ms. Karen Cain 6.<br />

ENVIRONMENTAL FATE ASSESSMENT:<br />

The following assessment was prepared by Engineering Geology staff within the Bureau<br />

of Pest Management.<br />

Technical Review of <strong>Trifloxystrobin</strong><br />

No environmental fate information was submitted for this active ingredient, so this review was<br />

taken from the November 12, 1999 technical review of trifloxystrobin done for Flint and<br />

Compass.<br />

Solubility: <strong>Trifloxystrobin</strong> has a solubility of 0.61 ppm.<br />

.<br />

Hydrolysis: <strong>Trifloxystrobin</strong> was stable in pH 5, has a half-life of 55.2 days at pH 7, and<br />

19.8 hours at pH 9.<br />

Aqueous Photolysis: <strong>Trifloxystrobin</strong> had a half-life of 14.8 days; however EPA had<br />

problems with this study.<br />

Soil Photolysis: Degradation was too rapid to determine a half-life.<br />

Aerobic Soil Metabolism: The half-life was biphasic with an apparent half-life of 0.72 days.<br />

The registrant calculated half-life was 2.0-2.4 days. Degradate CGA 321113 was found at 85.2%<br />

at 7 days in one study, at 93.2% at day 14 in a second study, and at 84.7% at 28 days and 39.5%<br />

at one year in a third study. CGA-357276 was found at 4.9% at 270 days, CGA-373466 and<br />

CGA-357262 were each found at < 4.1% from days 90 to 365 in the second study. CGA-<br />

373466, CGA-357261, CGA-331409 and CGA-320299 were each found at 1% throughout the<br />

third study.<br />

Aerobic Aquatic Metabolism: EPA was not satisfied with this study, but did state that the<br />

study indicated that trifloxystrobin degraded rapidly in aquatic aerobic environments.<br />

Anaerobic Aquatic Metabolism: The half-life was 0.72 days<br />

Aged Leaching: EPA did not accept this study, but did indicate that degradate CGA-321113 was<br />

very mobile in loamy sand, sandy loam and silt loam as well as mobile in loam and clay loam.<br />

CGA-356276 was present in quantities too low to assess mobility.<br />

Adsorption-Desorption Parent:<br />

Soil Type Adsorption Koc Desorption Koc<br />

Loamy sand 2354 3294<br />

Sandy loam 951 1387<br />

Low OM sand 3064 3528<br />

High OM sand 3927 2202<br />

Clay loam 9871 2504<br />

Silt loam 951 1203


Ms. Karen Cain 7.<br />

Adsorption-Desorption for CGA-321113:<br />

Soil Type Adsorption Koc Desorption Koc<br />

Loam 127 194<br />

Sandy soil 235 335<br />

Clay loam soil 130 188<br />

Sandy loam 48 70<br />

Sandy loam 80 109<br />

Adsorption-Desorption for CGA-357276:<br />

Soil Type Adsorption Koc Desorption Koc<br />

Sandy loam 8345 15169<br />

Loam 6587 8386<br />

Sandy loam 9228 11206<br />

Sand soil 9756 13575<br />

Clay soil 6934 8434<br />

Adsorption-Desorption for CGA-357261:<br />

Soil Type Adsorption Koc Desorption Koc<br />

Loam 476 587<br />

Clay loam 526 813<br />

Sandy loam 479 996<br />

Sandy loam 389 645<br />

Sand 567 864<br />

Adsorption-Desorption for CGA-373466:<br />

Soil Type Adsorption Koc Desorption Koc<br />

Sandy loam 31 39<br />

Loam 98 142<br />

Sandy loam 63 82<br />

Sand 166 220<br />

Clay loam 81 130<br />

Terrestrial Field Dissipation: Three field dissipation studies were performed, but the EPA did<br />

not accept any of them. The first study indicated that dissipation was biphasic with an initial<br />

half-life of 15.6 days and a second half-life of 182 days in a loamy sand. The parent was found<br />

at 158.2 ppb at day 14, dropping to 11.2 ppb at day 364, CGA-321113 was found at 156.1 ppb at<br />

day 78, dropping to 16.8 ppb at 364 days. It was found at the 6-12 inch depth at 32.2 ppb on day<br />

91, dropping to 12.4 ppb at 364 days in the 12-18 inch depth at 19.9 ppb at day 124, dropping to<br />

126 ppb at day 364. CGA-357262 was found in the 0-6 inch depth at a maximum of 15.8 ppb on<br />

day 7, dropping to 10.3 ppb on day 364. CGA-357261 was found in the 6-12 inch depth at 13.2<br />

ppb on day 7. CGA-373466 was found in the 0-6 inch depth at 11.6 ppb at day 92. CGA<br />

331409 was found in the 0-6 inch depth at 10.8 ppb on day 7.


Ms. Karen Cain 8.<br />

The second study indicated an initial half-life of 1-3 days. The parent was found in the 0-6 inch<br />

depth at 80 ppb at 3 days, dropping to 10.2 ppb at 62 days. CGA-357261 was found in the 0-6<br />

inch depth at 31.4 ppb at day one, dropping to 10.5 ppb at day 13. CGA-321113 was found in<br />

the 0-6 inch depth at a maximum of 62.5 ppb at day one, dropping to 11.4 ppb on day 360.<br />

CGA-373466 was found in the 0-6 inch depth at 15.7 ppb at day 27.<br />

In the third study in a loamy sand, the parent was found at the 0-6 inch depth at a maximum of<br />

93 ppb. CGA-321113 was found in the 6-12 inch depth once at 11 ppb; CGA-474366 was found<br />

in the 0-6 inch depth at a maximum of 24 ppb; CGA-257261 was found once in the 0-6 inch<br />

depth at 18 ppb, and once in the 12-18 inch depth at 19 ppb; CGA-357262 was found once in the<br />

12-18 inch depth at 23 ppb.<br />

Technical Review of <strong>Prothioconazole</strong><br />

PARENT<br />

Solubility: <strong>Prothioconazole</strong> has a solubility of 5 ppm at pH 4 and 300 ppm at pH 8.<br />

Hydrolysis: (MRID 46246505 acceptable) <strong>Prothioconazole</strong> was stable in pH 4 (>10 years), 7<br />

(>1 year), and 9 (>1 year) aqueous buffer solutions.<br />

Aqueous Photolysis: (MRID 46246507 supplemental) <strong>Prothioconazole</strong> had an environmental<br />

phototransformation half-life of 9.7 days with major transformation products JAU6476-desthio<br />

at 54.8% and JAU6476-thiazocine at 14.1% on the phenyl label, and JAU6476-desthio at 55.7%<br />

and 1,2,4-triazole at 11.9% in the triazole label.<br />

Soil Photolysis: (MRID 46246510 acceptable) <strong>Prothioconazole</strong> data indicated the same half-life<br />

for the irradiated samples as the dark samples, therefore phototransformation on soil does not<br />

appear to be a route of degradation. Major transformation product JAU6476-desthio was found<br />

in the irradiated sample at 38%.<br />

Aerobic Soil Metabolism:<br />

Soil<br />

Silt 1<br />

Loamy sand 1<br />

Sandy loam 2<br />

pH % OC Observed T 2<br />

Transformation products<br />

7.1 2.14 0-1 days JAU6476-desthio 49.4%<br />

JAU6476-S-methyl 12.8%<br />

6.8 0.79 0-3 days JAU6476-desthio 41.2%<br />

JAU6476-S-methyl 14.6%<br />

7.2 2.0 0-1 days JAU6476-desthio 42.3%<br />

Silty clay loam 2<br />

5.9 1.66 0-1 days JAU6476-desthio 20.9%<br />

1 2<br />

MRID 46246511 acceptable; MRID 46246512 acceptable.


Ms. Karen Cain 9.<br />

Aerobic Aquatic Soil Metabolism:<br />

Soil<br />

Water/loam 1<br />

Water/loamy<br />

sand 1<br />

Water/sandy<br />

clay loam 2<br />

pH<br />

Soil<br />

6.6<br />

8.5<br />

% OC<br />

Soil<br />

Observed T 2<br />

water/soil/system<br />

4.8 14.9 days water<br />

48.5 days system<br />

1.37 17.8 days water<br />

33.6 days system<br />

1-3 days water<br />

91-120 days system<br />

1 MRID 46246515 supplemental; 2 MRID 46246515 acceptable.<br />

Transformation products<br />

JAU6476-desthio 32.3<br />

JAU6476-desthio 21.9<br />

1,2,4-triazole 37.2<br />

JAU6476-S-methyl 26.9<br />

JAU6476-desthio 32.9<br />

JAU6476-S-methyl 77.0<br />

Aged Leaching: (MRID 46246539 supplemental) Sorption coefficients could not be<br />

determined due to instability of the compound in the systems.<br />

(MRID 46246504 acceptable) Kocs could not be calculated due to low column resolution.<br />

However, U.S. EPA went on to say that prothioconazole showed very little potential for leaching<br />

as very low total radioactive residues were detected in the leachate and very little unchanged<br />

parent compound was translocated below the aged soil layer. The studies also indicate that the<br />

parent has lower mobility than the degradates JAU6476-desthio, and JAU6476-S-methyl, and<br />

batch studies for these two transformation products indicate that they have low mobility.<br />

Terrestrial Field Dissipation: (MRID 46246517 supplemental) Field dissipation studies<br />

performed on a sandy loam-loam (pH 7.9, % OC 0.27) indicated an observed half-life of 7 days.<br />

Major transformation product JAU6476-desthio was found at 21.5%. Observed major<br />

transformation half-lives were JAU6476-desthio at 63 days and JAU6476-S-methyl at 14-29<br />

days.<br />

(MRID 46246518 supplemental) Field dissipation studies performed on a loamy sand-sandy<br />

loam (pH 6.2, % OC 1.1) indicated an observed half-life of


Ms. Karen Cain 10.<br />

(MRID 46246523 supplemental) <strong>Prothioconazole</strong> dissipated in paddy water with a calculated<br />

half-life of 4.8 days. The half-life in the sediment/soil could not be determined due to too few<br />

detections.<br />

(MRID 46246524 supplemental) <strong>Prothioconazole</strong> dissipated in paddy water with a calculated<br />

half-life of 0.6 days. The half-life in the sediment/soil could not be determined due to too few<br />

detections.<br />

TRANSFORMATION PRODUCTS:<br />

Solubility JAU6476-desthio: The solubility of JAU6476-desthio is 22 ppm.<br />

Hydrolysis JAU6476-desthio: (MRID 46246506 supplemental) JAU6476-desthio was stable at<br />

pH 5, 7, and 9.<br />

Aerobic Metabolism JAU6476-desthio: (MRID 46246513 supplemental). No major<br />

transformation products found.<br />

Soil<br />

Silt loam<br />

Silt loam<br />

Sandy loam<br />

Silty clay<br />

pH<br />

7.3<br />

7.9<br />

7.2<br />

6.3<br />

% OC<br />

T 2 JAU6476-desthio<br />

linear/nonlinear/empirical<br />

1.55 55.5/29.4/3-7 days<br />

0.98 45.3/29.0/14-30 days<br />

1.02 22.6/6.8/3-7 days<br />

1.46 30.3/18.6/7-14 days<br />

T 2 JAU6476-desthio<br />

and bound residues<br />

linear/nonlinear/empirical<br />

165.0/144.4/


Ms. Karen Cain 11.<br />

Aerobic Metabolism JAU6476-S-methyl: (MRID 46246514 supplemental).<br />

Soil<br />

Silt loam<br />

Silt loam<br />

Sandy loam<br />

pH<br />

7.3<br />

7.9<br />

7.2<br />

% OC T 2 JAU6476-S-methyl<br />

linear/nonlinear/empirical<br />

1.55 25.1/5.6/1-3 days<br />

0.98 47.5/26.1/14 days<br />

1.02 28.4/7.5/3 days<br />

T 2 JAU6476-S-methyl<br />

and bound residues<br />

linear/nonlinear/empirical<br />

86.6/74.5/7-14 days<br />

173.3/154/>125 days<br />

123.8/92.4/14 days<br />

Silty clay* 6.3 1.46 55.0/44.4/14-30 days 128.4/111.8/125 days<br />

*Major transformation products found only in silty clay were M2 at 10.0% and M6 24.7%.<br />

Adsorption/Desorption Transformation Product JAU6476-S-methyl: (MRID 462464501<br />

acceptable)<br />

Soil type<br />

Sandy loam<br />

Silt<br />

Silty clay loam<br />

Loamy sand<br />

pH %OC Adsorption Koc<br />

7.2 2.02 2772<br />

7.1 2.14 2995<br />

5.9 1.66 2484<br />

6.8 0.79 1973<br />

Desorption Koc<br />

3124<br />

3358<br />

2926<br />

2532<br />

Label statements: A<strong>Prothioconazole</strong>-desthio (a degradate of prothioconazole) is known to leach<br />

through soil into groundwater under certain conditions as a result of labeled use. Use of this<br />

chemical in areas where soils are permeable, particularly where the water table is shallow, may<br />

result in ground-water contamination.<br />

Drift and runoff are hazardous to aquatic organisms in water adjacent to treated areas. This<br />

product has a high potential for runoff for several months or more after application. Poorly<br />

draining soils and soils with shallow water tables are more prone to produce runoff that contains<br />

this product. A level, well maintained vegetative buffer strip between areas to which this<br />

product is applied and surface water features such as ponds, streams, and springs will reduce the<br />

potential for contamination of water from rainfall-runoff. Runoff of this product will be reduced<br />

by avoiding applications when rainfall is forecasted to occur within 48 hours.@<br />

Environmental Fate Summary: Given that the use rates for this product are less than those<br />

already allowed for use in NYS, and neither active ingredient was found to be a groundwater<br />

concern in past reviews, staff do not object to the use of this product on sweet corn, field corn<br />

and soybeans.


Ms. Karen Cain 12.<br />

ECOLOGICAL EFFECTS ASSESSMENT:<br />

The following assessment was produced by the Department’s Bureau of Habitat<br />

(BOH) within the Division of Fish, Wildlife, & Marine Resources:<br />

Both active ingredients in Stratego YLD Fungicide have been reviewed previously by<br />

BOH, trifloxystrobin most recently in May 2010 and prothioconazole in May 2009.<br />

USE PATTERN:<br />

Stratego YLD Fungicide is a broad spectrum fungicide for use on corn (sweet, pop, and<br />

field varieties) and soybeans. Applications of 4-5 fl oz. (4.65 fl oz. upper limit on soybeans) per<br />

acre (/A) are made using water as the carrier.<br />

On sweet corn sequential applications are not allowed. Each Stratego YLD application<br />

must be alternated with a fungicide with a different mode of action. No more than 20 fl oz. /A<br />

may be applied per season.<br />

On field corn and soybeans two sequential applications are allowed before rotating to a<br />

different mode of action. The retreatment interval is 7-14 days for field corn and 10-21 days for<br />

soybeans. No more than 10 fl oz./A may be applied to field corn per season. The seasonal limit<br />

for soybeans is 13.95 fl oz/A.<br />

The label allows aerial, ground, and chemigation applications.<br />

Application rates for both Stratego YLD active ingredients individually are lower than<br />

those reviewed previously. The total seasonal maximum Stratego YLD combined ai application<br />

rate is lower than previously reviewed trifloxystrobin rates. It is 0.1 lb ai/A higher than the<br />

maximum previous prothioconazole rate reviewed.<br />

EXPOSURE MODELING & RISK ASSESSMENT:<br />

Terrestrial- Standard BOH post application food-item residue exposure modeling for<br />

birds and mammals showed no potential for acute or chronic toxicity. These two groups are not<br />

discussed further.<br />

Aquatic- Application of Stratego YLD directly to the surface of a water body, the<br />

condition by which aerial application threat is evaluated, results in trifloxystrobin concentrations<br />

that far exceed lethal values. As described in previous trifloxystrobin reviews, trifloxystrobin is<br />

a rapidly lethal aquatic toxin. While its half-life in water is relatively short at 14.4 hours, the<br />

very high toxicity, rapid lethality, and resulting multiples of LC50s far outweigh its short resident<br />

time. Therefore, aerial applications of Stratego YLD pose an unacceptable risk to aquatic nontarget<br />

organisms.


Ms. Karen Cain 13.<br />

Runoff of the two active ingredients was modeled separately assuming the seasonal<br />

maximum rate of Stratego YLD had been applied. The resulting fish and invertebrate chronic<br />

toxicity is somewhat misleading. That toxicity is primarily a result of the trifloxystrobin content<br />

which degrades fairly rapidly in water. Exposures will not be of sufficient duration to result in<br />

chronic toxicity.<br />

One other issue requires attention. All previous prothioconazole labels, and the EPA<br />

<strong>Prothioconazole</strong> Pesticide Fact Sheet state that it may not be applied through any type of<br />

irrigation system. The Stratego YLD label allows chemigation applications. While not a<br />

significant fish or wildlife issue, it should be determined if this is a regulatory oversight. None<br />

of the materials submitted in support of registration of Stratego YLD give any explanation of this<br />

change. Based on the issues stated above with respect to aerial application and chemigation,<br />

Bureau of Habitat staff objected to the registration of the Stratego YLD as then labeled.<br />

In response to BOH concerns, Bayer has added a New York State aerial application<br />

prohibition to the label for Stratego YLD. The Bureau of Habitat has reviewed the revised<br />

labeling and other materials submitted and is satisfied with their content. The NY specific aerial<br />

application prohibition and the explanation of the chemigation label language resolve the only<br />

concerns BOH had with Statego YLD registration. Therefore, Bureau of Habitat staff does not<br />

object to registration of Stratego YLD in New York State.<br />

REGISTRATION DECISION<br />

Bayer CropScience LP has sufficiently mitigated the Department’s concerns expressed<br />

during the technical review of the Stratego product. Specifically, a New York State aerial<br />

application prohibition has been added to the Stratego YLD Fungicide label to protect aquatic<br />

species from a direct spray of trifloxystrobin to a water body. Therefore, the Department has<br />

registered Stratego YLD Fungicide (EPA Reg. No. 264-1093) for use in New York State.<br />

Enclosed for your record are copies of the Certificate of Pesticide Registration and stamped<br />

“Accepted for Registration” label.<br />

Please contact the Pesticide Product Registration Section, at (518) 402-8768, if you have<br />

any questions regarding this letter.<br />

Enclosures<br />

Sincerely,<br />

Scott Menrath<br />

Scott Menrath<br />

Director<br />

Bureau of Pest Management

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