(518) 402-8768 7257 September 20, 2017 Via E-Mail Ms. Susan Person Syngenta Crop Protection, LLC PO Box 18300 Greensboro, NC 27419 Dear Ms. Person: Re: Registration of the New Active Ingredient Oxathiapiprolin (Active Ingredient Code 128111) Contained in the Pesticide Products: 1) Segovis (EPA Reg. No. 100-1533) 2) Orondis Gold 200 (EPA Reg. No. 100-1571) 3) Orondis Ultra A (EPA Reg. No. 100-1572) 4) Orondis Opti A (EPA Reg. No. 100-1572) 5) Orondis Opti (EPA Reg. No. 100-1591) The New York State Department of Environmental Conservation (Department) has evaluated your application (received October 13, 2016) and supplemental materials received to date in support of the registration of the above-referenced pesticide products. Segovis contains 18.7% oxathiapiprolin. It is labeled to control various fungal diseases on ornamental plants grown in greenhouses, outdoor growing structures, nurseries and commercial landscapes. Applications are to be made via foliar spray, soil drench, and in-ground chemigation. The maximum application rates are 19.3 fluid ounces of Segovis (0.25 pounds of oxathiapiprolin) per acre per application and 38.6 fluid ounces of Segovis (0.50 pounds of oxathiapiprolin) per acre per year. Orondis Gold 200 contains 18.7% oxathiapiprolin. It is labeled to control various fungal diseases in cucurbit vegetables, fruiting vegetables, leafy greens and tobacco. Applications are to be made via drip irrigation, transplant water application, surface band or directed application and in-furrow application. The maximum application rates are 19.2 fluid ounces of Orondis Gold 200 (0.25 pounds of oxathiapiprolin) per acre per application and 38.6 fluid ounces of Orondis Gold 200 (0.50 pounds of oxathiapiprolin) per acre per year.
Ms. Susan Person 2 Orondis Ultra A contains 10.2% of the active ingredient oxathiapiprolin. It is labeled to control various fungal diseases on head and stem brassica, bulb vegetables, cucurbit vegetables, fruiting vegetables, ginseng, leafy greens, tobacco and tuberous and corm vegetables. Application is to be made via ground, aerial or chemigation equipment. The maximum application rates are 38.6 fluid ounces (0.25 pounds of oxathiapiprolin) per acre per application and 77.2 fluid ounces (0.50 pounds of oxathiapiprolin) per acre per year. Orondis Opti A contains 10.2% of the active ingredient oxathiapiprolin. It is labeled to control various fungal diseases on head and stem brassica, bulb vegetables, cucurbit vegetables, fruiting vegetables, ginseng and potatoes. Applications are to be made via ground, aerial or chemigation equipment. The maximum application rates are 38.6 fluid ounces of Orondis Opti A (0.25 pounds of oxathiapiprolin) per application and 77.2 fluid ounces of Orondis Opti A (0.50 pounds of oxathiapiprolin) per year. Orondis Opti contains 33.2% chlorothalonil and 0.50% oxathiapiprolin. It is labeled to control various fungal diseases on cucurbit vegetables, fruiting vegetables and tomatoes. Applications are to be made via ground, aerial and chemigation equipment. The maximum application rates are 2.5 pints of Orondis Opti (0.031 pounds of oxathiapiprolin) per acre per application and 10 pints Orondis Opti (0.125 pounds of oxathiapiprolin) per acre per year. Please note that Pesticide Product Registration Section staff hava determined that this is not a Major Change in Labeling application for the active ingredient chlorothalonil. The application package was deemed complete for purposes of technical review on April 26, 2017. Pursuant to the review time frame specified in Environmental Conservation Law 33-0704.2, a registration decision date of September 22, 2017 was established. REGISTRATION SUMMARY Technical reviews of the proposed uses included on the subject product labels have been performed by the Department and the New York State Department of Health. Please see the appendix of this letter for the full technical reviews. The reviews encompassed the expected impacts of labeled use of the subject products with respect to human health, ecological effects, and environmental fate. None of the reviews resulted in objections to registration of the subject products. Therefore, Segovis (EPA Reg. No. 100-1533), Orondis Gold 200 (EPA Reg. No. 100-1571), Orondis Ultra A (EPA Reg. No. 100-1572), Orondis Opti A (EPA Reg. No. 100-1572) and Orondis Opti (EPA Reg. No. 100-1591) have been registered in New York. Enclosed for your record are copies of the Certificate of Pesticide Registration and stamped Accepted for Registration labels. Please note that a proposal by Syngenta Crop Protection or any other registrant to register a product that contains oxathiapiprolin, and whose labeled uses are likely to increase the potential for
Ms. Susan Person 3 significant impact to humans, nontarget organisms, or the environment, would constitute a Major Change in Labeling. Such an application must be accompanied by a new application fee and meet the requirements listed in Appendix 1.B. of New York State Pesticide Product Registration Procedures (November 2014). Such information, as well as forms, can be accessed at our website as listed in our letterhead. Please contact Shaun Peterson, of the Pesticide Product Registration Section, at 518-402-8768, if you have any questions regarding this letter. Sincerely, /s/ Enclosures Scott Menrath, P.E. Director Bureau of Pest Management
Ms. Susan Person 4 HUMAN HEALTH ASSESSMENT: APPENDIX The following technical review was produced by staff within the Bureau of Toxic Substance Assessment at the New York State Department of Health (NYSDOH). Toxicity Review In general, neither oxathiapiprolin nor the formulated products were very toxic in acute oral, dermal or inhalation exposure studies in laboratory animals. However, the formulated product Orondis Opti was moderately acutely toxic via the inhalation route of exposure. In addition, neither the active ingredient nor the formulated products were irritating to skin and eyes, except for Orondis Opti which was corrosive to the eye (tested on rabbits). The formulated products Orondis Ultra A and Orondis Opti A were considered skin sensitizers (tested on guinea pigs), whereas the other formulated products and the technical active ingredient were not sensitizing to the skin. Oxathiapiprolin caused very few treatment-related effects in subchronic and chronic laboratory animal toxicity studies. Neither neurotoxic nor systemic effects were seen in acute and subchronic neurotoxicity studies in rats up to dose levels of 2,000 milligrams per kilogram body weight (mg/kg) and 1,300 mg/kg/day, respectively. No treatment related effects were seen in chronic feeding studies with oxathiapiprolin at 1,461 mg/kg/day in dogs, 957 mg/kg/day in rats, and 1,106 mg/kg/day in mice, the highest doses tested. Oxathiapiprolin did not cause any effects in developmental toxicity studies in rats or rabbits up to 1,000 mg/kg/day, the limit dose. In a multi-generation reproduction study in rats, oxathiapiprolin was associated with decreased pup weight and delayed preputial separation at 1,227 mg/kg/day in F1 males; parental toxicity was not seen in this study up to dose levels of 1,013 mg/kg/day in males and 1,210 in females. The U.S. Environmental Protection Agency (U.S. EPA) classified oxathiapiprolin as not likely to be a human carcinogen based on a lack of oncogenic effects in the chronic feeding studies and negative findings in several genotoxicity studies. The U.S. EPA did not conduct occupational, residential or dietary risk assessments for oxathiapiprolin and concluded that due to the limited toxicity in the oxathiapiprolin toxicological database, toxicity endpoints and points of departure were not selected for oxathiapiprolin exposure scenarios and a quantitative risk assessment was not conducted. Drinking Water/Groundwater Standards There are no chemical specific federal or New York State drinking water/groundwater standards for oxathiapiprolin. Based on its chemical structure, this chemical falls under the 50 micrograms per liter New York State drinking water standard for unspecified organic contaminants (10 NYCRR Part 5, Public Water Systems).
Ms. Susan Person 5 Summary/NYS DOH Recommendation The available information on oxathiapiprolin and the formulated products Segovis/Orondis Gold 200, Orondis Ultra A/Orondis Opti A, and Orondis Opti indicates that they are not very acutely toxic or irritating in laboratory animal studies, except for Orondis Opti which was moderately acutely toxic via the inhalation route of exposure and an eye irritant. In addition, the Orondis Ultra A/Orondis Opti formulated product was considered a dermal sensitizer. However, the personal protective equipment required by the labels for Segovis/Orondis Gold 200 (long sleeved shirt and long pants, shoes plus socks), Orondis Ultra A/Orondis Opti A (long sleeved shirt and long pants, shoes plus socks, gloves) and Orondis Opti (long sleeved shirt and long pants, shoes plus socks, gloves, protective eyewear, respirator) should mitigate any potential concerns for toxicity, irritation and/or sensitization from the use of these products. Dietary administration of oxathiapiprolin to laboratory animals in chronic, sub-chronic and developmental/reproductive toxicity studies caused limited treatment related effects. Oxathiapiprolin was not genotoxic and was classified by the U.S. EPA as not likely to be a human carcinogen. Overall, the labeled use of the formulated products does not appear to pose unreasonable risks to workers or the general public. Given the above, NYSDOH does not object to the registration of Segovis/Orondis Gold 200, Orondis Ultra A/Orondis Opti A, and Orondis Opti in New York State. ECOLOGICAL EFFECTS ASSESSMENT: The Department s Bureau of Habitat (BOH) evaluated the proposed use of oxathiapiprolin as contained in the subject products. BOH did not object to registration of the subject products as labeled. A written assessment was not produced. ENVIRONMENTAL FATE ASSESSMENT: Environmental chemistry staff within the Department s Bureau of Pest Management evaluated the proposed use of oxathiapiprolin as contained in Segovis, Orondis Gold 200, Orondis Ultra A, Orondis Opti A and Orondis Opti. Shown below is the assessment. Of the five products noted in the subject line above, the maximum annual application rate is 0.50 pounds of active ingredient per acre per year. This maximum application rate of 0.50 lbs ai/acre/yr will be used in the LEACHP modeling. The LEACHP modeling inputs were taken from studies using a Sassafras loamy sand with ph 5.3 and organic carbon at 0.81%. This soil was the most similar to Riverhead soil for those two characteristics. The LEACHP groundwater model indicates that if oxathiapiprolin was applied to soil at the maximum rate of 0.50 lbs ai/acre/yr, oxathiapiprolin would not result in the leaching
Ms. Susan Person 6 of the active ingredient at concentrations representing a concern to the quality of Long Island groundwater. The LEACHP leaching concentration was 2.8E-9 ppb. At day 90 in an aerobic soil metabolism study using the Sassafras soil, one major transformation product, IN-RAB06, was present at 13.47% of the originally applied oxathiapiprolin. This transformation product was also LEACHP modeled yielding a maximum LEACHP leaching concentration at 0.168 ppb. This concentration should not represent a concern regarding the quality of Long Island groundwater. Based on the findings from the various environmental fate studies and the LEACHP modeling, this groundwater technical review supports the registration of oxathiapiprolin for use in New York State in accordance with the submitted product labels. Overview This groundwater technical review is based on a review from the Pest Management Regulatory Agency (PMRA) of Canada 1 as well as a review from the USEPA 2 (EFED) of the applicable environmental fate studies. This technical review addresses the findings from the following USEPA environmental fate studies: 830.7840 Water Solubility 835.1230 Adsorption/Desorption 835.2120 Hydrolysis 835.2240 Photodegradation in Water 835.2410 Photodegradation in Soil 835.4100 Aerobic Soil Degradation 835.4200 Anaerobic Soil Metabolism 834.4300 Aerobic Aquatic Metabolism 835.4400 Anaerobic Aquatic Metabolism 835.6100 Terrestrial Field Dissipation Summary of Environmental Fate Studies 830.7840, Water Solubility In a table that appears on page 6 of the PMRA environmental fate review is found 0.1749 mg/l for the solubility of oxathiapiprolin in water at 20 C. In a table on page 28 of the USEPA s EFED document is found an aqueous solubility at 0.1844 mg/l at ph7. This value will be used in the LEACHP modeling. 1 Canada, PMRA Primary Review, Monograph of the Fate and Behavior of the Active Substance Oxathiapiprolin, Annex IIA: Section 5: Fate in the Environment, Oct. 24, 2013. 2 USEPA, Environmental Fate and Ecological Risk Assessment for the New Chemical Registration of Oxathiapiprolin for Proposed Uses on Brassica, Leafy, Bulb, Cucurbit, Fruiting, and Tuberous/Corm Vegetables; Ginseng; Peas; Tobacco; Ornamentals; and Turf, July 1, 2015.
Ms. Susan Person 7 The major transformation product from the aerobic soil study, which will be discussed later, was IN-RAB06 and its solubility is listed in the EFED review at 32 mg/l. This value will be used in the LEACHP modeling. 835.1230, Adsorption/Desorption In a table that appears on page 311 of the PMRA environmental fate review is found an adsorption Koc for oxathiapiprolin using the Sassafras soil at 6,927 ml/g. The Kfoc from the Sassafras soil that is listed on page 43 in the EFED review is 7,289. This value will be used in the LEACHP modeling. On page 50 of the EFED review, the major degradate IN- RAB06 has a Kfoc with Sassafras soil at 460. This value will be used in the LEACHP modeling. 835.2120, Hydrolysis In a table that appears on page 6 of the PMRA review it is noted that oxathiapiprolin is stable at ph 4, 7, and 9 so hydrolysis is not expected to be a significant degradation pathway in the environment. 835.2240, Photodegradation in Water In a table that appears on page 6 of the PMRA review it is noted that the photolysis of oxathiapiprolin is not expected to be a significant degradation pathway in the environment. It is also noted on page 5 of the PMRA review that the maximum UV absorption capacity (ʎ max) for oxathiapiprolin is 257 nm (ph 7, water), which is below the visible spectrum (290 750 nm) so photolysis is not expected to be a significant degradation pathway for oxathiapiprolin in the environment. Under continuous radiation at 257 nm, the half-life was found to be 15.4 days 835.2410, Photodegradation in Soil It is noted on page 141 of the PMRA review that phototransformation of oxathiapiprolin was limited in moist irradiated soils resulting in an extrapolated half-life at 28.2 days. In dry irradiated soils the half-life was 36.3 days. It is also noted that environmental half-lives were determined based on mid-summer irradiance and day length values at northern latitudes. The equivalent environmental half-lives at 30 50 N latitude would range from 82 87 days. 835.4100, Aerobic Soil Degradation There were seven studies submitted in the environmental fate documentation with a variety of half-life determinations for oxathiapiprolin. An EPA EFED reviewer, using a study using the Sassafras loamy sand from Maryland (ph 5.3, organic carbon 0.87%), determined that the aerobic soil metabolism half-life for oxathiapiprolin was 154 days. This number will be used in LEACHP modeling. At the bottom of page 31 in the Conclusions section it is noted that there were at least 16 extractable metabolites observed in soil samples treated with oxathiapiprolin but
Ms. Susan Person 8 only three were formed at greater than or close to 10% of the original applied oxathiapiprolin. One transformation product exceeded 10% and that was IN-RAB06 at 13.47%. This transformation product will be LEACHP modeled and the application rate (lbs/acre/growing season) for this transformation product will be: 0.50 0.1347 569.51 0.071 539.53 On page 47 of the EFED review is listed an aerobic soil transformation half-life for IN-RAB06 using the Sassafras soil at 215 days and this value will be used in the LEACHP modeling. 835.4200, Anaerobic Soil Metabolism On page 138 of the PRMA Canada document it is noted that oxathiapiprolin degrades slowly under anaerobic conditions in the Sassafras soil with the half-life at 1505 days and no major transformation products were formed. On page 34 of the EPA document the same 1,505 day half-life is listed. 834.4300, Aerobic Aquatic Metabolism Aerobic water from two lakes, Swiss Lake, UK and Calwich Abbey Lake, UK, were used in this study and on page 38 of the EFED review the following is noted: a. The parent transformed into five transformation products: a. Two with a maximum formation among them at 12% and showing no decline over time and b. Three with a maximum formation among them at 16% and showing some decline over time 835.4400, Anaerobic Aquatic Metabolism It is noted on page 37 of the EFED document that it appears that oxathiapiprolin is more stable in aerobic water/sediment systems than it is to anaerobic systems with halflives ranging from 45-158 days to 45-93 days, respectively. Aerobic water from two lakes, Swiss Lake, UK and Calwich Abbey Lake, UK, were used in this study and on page 38 of the EFED review the following is noted: a. The parent transformed into five transformation products: a. Four showing no decline over time with a maximum formation among them at 33% and b. One showing no apparent decline with a maximum formation over time at 20% 835.6100, Terrestrial Field Dissipation Studies were conducted at ten sites, four in the U.S.A., two in Canada, and one in France, Germany the U.K., and Spain. All studies were conducted on bare ground plots.
Ms. Susan Person 9 The soil that more closely resembled Riverhead, Long Island soil was a sandy soil from Citra, FL with ph 6.6 and %OC = 0.6. The half-life dissipation from the soil profile was found to be 81 days, which is roughly half as long as the half-life from the aerobic soil study using the Sassafras soil (154 days). The findings from these terrestrial dissipation studies suggests that the parent is relatively stable with dissipation half-lives ranging from 27 to 212 days. There was one major degradate found (IN-ES72) with a maximum concentration at 11.5 percent of the originally applied parent. The decline over time of the degradate IN- ES72 was in the range from 0.5 to 2.9% of the originally applied parent over a time ranging from 181 to 692 days, which exceeds the length of the study (100 days). There was one near major transformation product (IN-RTD31) that ranged from 2.4 to 8.2 percent of the initially applied parent. The decline over time of the degradate IN- RTD31 was in the range from 0.5 to 2.9% of the originally applied parent over a time ranging from 181 to 692 days, which exceeds the length of the study (100 days). In six out of 10 soils, no leaching of the parent, transformation products, or degradates were observed below 30 cm, and sometimes below 15 cm. In the other four soils, studies suggest low leaching potential for the parent oxathiapiprolin, the transformation products, and degradates. One of these soils was from Wayne County, NY and the other from British Columbia, Canada. In the other two soils, one from Texas and one from Manitoba, it was found that there was low leaching potential of some transformation products and degradates, but the levels below 30 cm were low and ranging from 0.2 to 2 percent of the applied parent, although these low levels were found as low as 70 cm. LEACHP Modeling The following table lists the LEACHP modeling input variables that were covered in the preceding sections for the parent, oxathiapiprolin, and the one major degradate from the aerobic soil metabolism study, IN-RAB06. Soil Charateristics and LEACHP Modeling Input Variables. Compound Soil Type ph %OC Solubility Kfoc Half-Life Oxathiapiprolin IN-RAB06 Sassafras sandy loam Sassafras sandy loam App. Rate 5.3 0.81 0.1844 7,289 154 0.50 4.8 0.9 32 460 215 0.071 Attachments: Figure 1 Oxathiapiprolin LEACHP leaching profile for Riverhead Soil Figure 2 IN-RAB06 LEACHP leaching profile for Riverhead Soil
Oxathiapiprolin LEACHP Modeling Results Riverhead Soil Series LEACHP LEACHING CONCENTRATION (PPB) 3.00E 09 2.50E 09 2.00E 09 1.50E 09 1.00E 09 5.00E 10 LEACHP Model Parameters K oc = 7,289 ml/g T 1/2 = 154 days Solubility = 0.1844 mg/l Application Rate = 0.50 lbs/acre/yr Oxathiapiprolin Maximum Leaching Concentration: 2.8E 09 ppb 0.00E+00 0 1 2 3 4 5 6 7 8 9 10 TIME (YEARS) 1.80E 01 IN RAB06 LEACHP Modeling Results Riverhead Soil Series LEACHP Model Parameters LEACHP LEACHING CONCENTRATION (PPB) 1.60E 01 1.40E 01 1.20E 01 1.00E 01 8.00E 02 6.00E 02 4.00E 02 2.00E 02 K oc = 460 T 1/2 = 215 days Solubility = 32 mg/l Application Rate = 0.071 lbs/acre/yr IN RAB06 Maximum Leaching Concentration: 1.68E 01 ppb 0.00E+00 0 1 2 3 4 5 6 7 8 9 10 TIME (YEARS)