Prothioconazole/Trifloxystrobin

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Ms. Karen Cain 2. fluid ounces of product (0.16 pounds of prothioconazole and 0.48 pounds of trifloxystrobin) per acre per year. Near the end of the technical review process, Bayer CropScience LP (Bayer) petitioned to add barley and wheat to the list of proposed crops. These crops were previously approved for prothioconazole but not trifloxystrobin. The proposed use rates for wheat and barley are less than or equal to the corn and soybean rates. In addition, corn and soybean acreage in New York State is several times higher than the acreage of wheat and barley in the State. Therefore, no additional review parameters were required for the wheat and barley use. The application package was deemed complete for purposes of technical review on January 27, 2011. Pursuant to the review time frame specified in Environmental Conservation Law §33-0704.2, a registration decision date of June 24, 2011 was established. Technical reviews of the proposed uses included on the Stratego YLD label have been performed by the Department and the New York State Department of Health. On June 2, 2011, the Department sent a “Technical Issues” letter to Bayer describing concerns with respect to the aerial application and chemigation methods of application described on the Stratego label. Bayer’s response was received by the Department on July 12, 2011. The Department has determined that Bayer’s response sufficiently mitigates the Department’s concerns. The technical reviews are shown below. HUMAN HEALTH ASSESSMENT: The following assessment was prepared by staff within the Bureau of Toxic Substance Assessment at the New York State Department of Health. On an acute basis, the formulated product Stratego YLD Fungicide was not very toxic via the oral, dermal and inhalation routes of exposure. This pesticide product did not cause skin or eye irritation (tested on rabbits) or skin sensitization (tested on guinea pigs). Trifloxystrobin We have previously reviewed the active ingredient trifloxystrobin for the pesticide products Flint Fungicide and Compass Fungicide. The available information on trifloxystrobin indicated that it is not very toxic or irritating following acute exposures in laboratory animals, but is a strong skin sensitizer. Data from chronic and developmental/reproductive toxicity studies showed that trifloxystrobin has the potential to cause some toxicity, principally liver effects. The U.S. Environmental Protection Agency (U.S. EPA) classified this chemical as “not likely to be carcinogenic to humans” based on a lack of evidence of carcinogenicity in rat and mouse chronic feeding studies. The U.S. EPA Office of Pesticide Programs (OPP) established an acute oral reference dose (aRfD) for females 13–49 years of age of 2.5 milligrams per kilogram body weight per day (mg/kg/day) based on a no-observed-effect level (NOEL) of 250 mg/kg/day from a developmental toxicity study in rats (increased fetal skeletal anomalies) and an uncertainty factor of 100. The U.S. EPA OPP additionally established a chronic oral reference dose (cRfD) for trifloxystrobin of 0.038 mg/kg/day based on a NOEL of 3.8 mg/kg/day from a two-generation reproductive toxicity study in rats (decreased body weight, body weight gain and food consumption; liver, kidney and spleen effects) and an uncertainty factor of 100. A current
Ms. Karen Cain 3. search of the toxicological literature did not find any significant new information on the toxicity of trifloxystrobin. The U.S. EPA established tolerances for trifloxystrobin residues in or on field corn, sweet corn and popcorn which ranged from 0.05 parts per million (ppm) to 7 ppm depending on the corn commodity (Federal Register Vol. 67:35,915–35,924, May 22, 2002; Vol. 71:15,597– 15,604, March 29, 2006; and Vol. 75:33,190–33,195, June 11, 2010) and in or on soybeans of 10 ppm (forage), 25 ppm (hay) and 0.08 ppm (seed). The U.S. EPA established an acute population adjusted dose (aPAD) of 2.5 mg/kg/day for females 13–49 years of age that has the same basis as the aRfD. The U.S. EPA estimated that the acute dietary exposure to trifloxystrobin residues from all crops for which there are tolerances, and from drinking water, would be less than one percent of the aPAD for this subgroup. The chronic population adjusted dose (cPAD) for trifloxystrobin for the general public and all population subgroups is 0.038 mg/kg/day and has the same basis as the cRfD. The U.S. EPA estimated that the chronic dietary exposure to trifloxystrobin residues in food and drinking water from all registered uses would be 15 percent of the cPAD for the general population, 34 percent for all infants and 43 percent for children 1–2 years of age, the most highly exposed subgroup. These exposure analyses are based on the conservative assumptions that 100 percent of the crops are treated and that these treated crops contain tolerance level residues. The U.S. EPA conducted an occupational risk assessment for short- (1–30 days) and intermediate-term (1–6 months) dermal and inhalation exposures to trifloxystrobin. Exposure estimates were created for scenarios involving aerial and groundboom application methods to soybeans or corn. For determining margins of exposure (MOEs), the U.S. EPA compared estimated short- and intermediate-term dermal exposures to a NOEL of 100 mg/kg/day from a 28-day dermal toxicity study in rats (increased liver and kidney weights). Short- and intermediate-term inhalation exposures were compared to a NOEL of 3.8 mg/kg/day from a twogeneration reproductive toxicity study in rats (decreased body weight, body weight gain and food consumption; liver, kidney and spleen effects). Estimated short- and intermediate-term dermal MOEs were 2,100 for mixers/loaders, 20,000 for groundboom applicators, 9,600 for aerial applicators and 14,000 for flaggers (supporting aerial applications). The estimated MOEs for short- and intermediate-term inhalation exposures to trifloxystrobin were 1,500 for mixers/loaders, 15,000 for groundboom applicators, 27,000 for aerial applicators and 18,000 for flaggers. These estimates assumed that workers wore long-sleeved shirt and long pants, shoes plus socks and chemical resistant gloves, except for aerial applicators who are assumed not to wear gloves because of lowered expected exposures from engineering controls (enclosed cockpit). The U.S. EPA conducted a screening level assessment of dermal risks to workers 12hours post-application; the estimated MOE for detasseling of corn grown for seed, the highest potential contact activity, was 190. The U.S. EPA considered MOEs of 100-fold or greater for dermal and inhalation exposures to provide adequate worker protection for trifloxystrobin. Prothioconazole In the past, the New York State Department of Health reviewed the toxicological properties of the active ingredient prothioconazole (and prothioconazole-desthio, its primary metabolite/degradate) in the pesticide product Proline 480 SC Fungicide. Prothioconazole and
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Prothioconazole/Trifloxystrobin

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