UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C. , 20460

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

PC Code: 099100 DPBarcodes: D417303, D416704, D416705 Date: July 10,2014
MEMORANDUM Subject: Ecological Risk and Drinking Water Assessment Conclusions for Pyraclostrobin IR-4 ProposedNewUse onHerb Subgroup 19A and Dill
To: Andrew Ertman, Risk Manager Reviewer Barbara Madden, Minor Use Team Leader

From: Risk Integration MinorUse, and Emergency Response Branch Registration Division (7505P) Tony Kish, Product Manager Team 22 Fungicide Branch Registration Division (7505P)
Edom Seifu, Environmental Science Trainee

# ~**~** 7/io/1'1 Meghan Radtke, Ph.D., Acting RAPL 

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### lZ) Sujatha Sankula, Ph.D., Branch Chief 

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## I'<:;:~**~\'o**\\'\. Environmen tal Risk Branch I ' Environmenta l Fate and Effects Division (7507P)
The Environmental Fate and Effects Division (EFED) has evaluated an IR-4 new use proposal for herb subgroup 19A and dill for the product, Pristine Fungicide (BASF; EPA Reg. No 7696- 199). The end use product, Pristine Fungicide, is a dual active ingredient fungicide (Pyraclostrobin 

### + Boscalid). This assessment pertains only to the active ingredient pyraclostrobin in the IR-4 petition, #3E8216. A separate assessment evaluates the ecological risk conclusions for Boscalid (PC Code 128008, DP Barcodes: 417193,416697, and 416698).
Pristine Fungicide is a water-dispersible granule and is proposed for aerial and ground spray treatments, and/or sprinkler irrigation onherb subgroup 19A1and dill. The uses being assessed include crop expansions to all herbs in the new subgroup 19A, crop expansions from the old stone fruit crop group 12 to new group 12-1 2, and expansion from crops in the old tree nut group 14 to the new tree nut group14-12 (except pistachio). The request proposes two applications of

1Herb subgroup 19A proposed use sites include: angelica, balm, basil, borage, burnet, chamomile, catnip, dried chervil, chive, clary, coriander, costmary, cilantro, curry, dillweed, horehound, hyssop, lavender, lemongrass, lovage, marigold, marjoram, nasturtium, parsley, pennyroyal, rosemary, rue, sage, savory, sweet bay, tansy, tarragon, thyme, wintergreen, woodruff , and wormwood

.0.148 lbs a.i./ A at a 7 day interval for a seasonal maximum of 0.296 lbs a.i./ A . While the Biolog i cal Economic Analysis Division (BEAD) considers the proposed use to mean a single season per year , EFED feels there is potential ambiguity in the label language and recommends the lab e l be clarified to include a maximum yearly application rate or the maximum number of seasons that are allowed per year. Ecological Risks The use of Pristine Fungicide on fresh herbs at the proposed application rate was previous l y assessed in 2007 for two aerial or ground applica t ions at 0.148 lb a.i./ A for a seasonal maximum of0 . 296lb a.i./A and an application interval of7 days (2 applicat i ons/season) ( U SEPA 2007, D334534 et al.). In 20 1 3 , a variety of crops were assessed for a new use request, including crops with a c omparable rate to those proposed in this request, but for more than two applications ( U SEPA 2013a, D403456). The 2007 ecological risk assessment for fresh herbs (performed at application rates/methods identical to the proposed new uses) identified acute risk concerns for l isted and non - listed fish,

amphib i ans and aquatic invertebrates in fresh and marine water. No Agency acute LOCs were exceed e d for birds, reptiles, and l and - phase amphibians. Chronic risk quotients did not exceed the Agency's LOCs for any of the taxonom i c groups assessed. Additiona ll y, EF E D did not quantitatively assess risk to non - target insects , but indicated that pyraclostrobin is class i fied as practic a ll y non - toxic to honeybees on an acute contact basis. A summary ofEFED's ecological risk findings for the herb use ecological risk assessment and the more recent assessment on bulb vegetables are presented in Table 1. To address the ambiguity i n the l abel language regarding the number of seasons per year, EFED considered results from the 2013 risk assessment. The 2013 ecological risk assessment did not specifically assess herbs or dill; however it did assess bu l b vegetables at six, aerial and ground broadc a st or sprinkler irrigation applications at the comparab l e app li cat i on rate of 0.15 lb a.i./ A (7 day i nterva l s). The 2013 risk assessment on bulb vegetables provides conservative risk conclusions for the proposed action because of the increased number of allowab l e applications (bu l b vegetab l es= 6; proposed uses = 2) and higher seasonal maximum (bulb vegetables = 0.9 l b a.i./ A; p roposed uses = 0.296 lb a.i./ A). In addition, the 6 applications are made every 7 days, whereas there would likely be a greater appl i cation interval between "seasons" of dill or herbs . Therefore, the resu l t i ng ecological risk concerns of the bulb vegetable assessment are expected to be prot e ctive of the risk concerns for the proposed herb subgroup 19 A and dill action, if a ll owed for use for multiple crop seasons. Aquati c risk concerns in the 20 1 3 assessment were similar to those reported in the 2007 assessment. Acute risk concerns for listed fish, amphibians and aquatic invertebrates in fresh and marine water were identified and were within range of risk quotients based on fresh herbs. However; no aquatic vascular plant RQs exceeded the Agency ' s risk to plants LOC (1) at the bulb vegetable use rate . Acute RQs exceeded the LOC for listed birds; acute and chronic RQs exceed e d the LOC for all mammal sizes (small, medium, and large). The 2013 assessment a l so included an in-depth pollinator analysis, based on the Agency's 2012 Pollinator Risk Assessment Framework (USEP A, 20 12). Although toxicity data indicate that pyraclostrobin is practica ll y non - toxic to honeybees on an acute contact basis, a number of honeybee incidents have been reported specifically for Pristine Fungicide. As a consequence, higher tiered stud i es have been 2performed with Pristine. Two semi

-field honeybee studies were completed. The first study (MRID 48470201) found no significant effects on egg laying and brood development at 26 days after application. Similarly, the second study (MRID 49009303) found no significant effects to adult, pupal, and larval mortality, foraging behavior, queen cell production, and number of hatched queens. Overall, the available laboratory and semi-field data indicate that acute and chronic risks to honeybees from Pristine are oflow concern. Nonetheless, in 2014, an anonymous beekeeper reported a new incident ofadverse effects onhoney bee colonies, potentially associated with exposure to Pristine in almond orchards (Incident No. !026240-001). The 2014 problem formulation for pyraclost robin identified a few ecotoxicity data gaps involving pollinators (USEPA, D417743). Data gaps for the pyraclostrobin a.i. include a guideline semi

-field/field test for pollinators (OCSPP 850

.3040), and non-guideline adult honeybee oral toxicity test, chronic adult and larval honeybee toxicity tests, and a residue testing inpollen/nectar. The addressed data gaps are not required for this action, but are a part ofthe Data-Call In (DCI) in registration review that applies to all registered uses. 

### OverallEcologicalRisk Conclusions Based on the assumption that the proposed pyraclostrobin use will occur during a single season peryear, acute risk concerns are possible for listed freshwater and estuarine/marine fish and invertebrates for both ground and aerial applications. If multiple application seasons are assumed within a year, additional risk concerns are identified for birds (acute) and mammals (acute and chronic). Aquatic risks, as described above, are also identified for multiple application seasons, but only for aerial applications

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### Table 1. 

### Summary ofRisk Quotients for Taxa for which LOCswere Exceeded, Based on

h 2007 d 20 13 E I

. IRi k A t t e an co ogtca s ssessmen s.

Taxonomic Group Risk Quotients RiskConcems1 Fresh Herbs (2007 Ecological Risk Assessment? Freshwater Fish and 0.08 (aerial) Listed species may be aff ected by Invertebrates acute exposures. 0.054 (ground) Estuarine/ Marine Fish 0.12 (aerial) Potential for effects to listed species and Invertebrates from acute exposures. 0.08 (ground) Bulb Vegetables (2013 Ecological Risk Assessment) Estuarine/ Mar ine 0. 16-0. 18 (aerial) Potential for effects to listed species Invertebrates from acute exposures. Freshwater Fish 0. 1 1-0

. 12 (aerial)

Freshwater 0.04

-0.05 (aerial) Invertebrates Birds Short Grass Listed species may be affected by 0.15 acute exposures. Acute exceedance for small birds only.
3Mammals Short Grass 3 Listed and non-listed animals may be Acute: 1.12 (15), 0.96 (35), affected by acute and chronic 0.51 (1000) exposures. Acute exceedances for Chron ic : 2.35 (15), 2.01 (35), small, medium and l arge-sized

1.08 (1000) mamma l s. Tall Grass Acute: 0.51 (15), 0.44 (35), 0.24 (1000) Chronic: 1 . 08 (15) Broadlea(_Plants Acute: 0.63 (15), 0.54 (35), 0.29 (1000) Chronic : 1.32 (15), 1.13 (35) Anthropods Acute: 0.44 (15), 0.37 (35), 0.20 (1000) 1 The Agency's L eve l of Concern (LOC) for ac u te exposures to aquatic listed and non - listed species are 0.05 and 0.1, respectively. The acute LOCs for mammals and birds are 0.5 and 0. 1 fo r non -li sted and listed species, respectively. The Agency's chronic LOC for mammals and birds is 1 . 2 Freshwater and estuarine/marine fish and invertebrate RQs were grouped toge ther in the 2007 Risk Assessment for fresh herbs. 3 Risk q uotients recorded as "Dose-based RQs (grams of exposure substance)". N! A: Not Applicable. Drinking Water Assessment The most recent drinking water assessment for the use of pyraclostrob i n was conducted in 2013

in support of the section 3 new uses request for a va riety of crops (USEP A, 2013 b, D403 871 + ). EDWCs we re generated u sing EFED's standard s uite of models in cluding the Pesticide Root Zone Model for Groundwater (PRZM- GW, version 1.0 , August 3 1 , 20 1 2) and the Surface Water Calcu l ator. Estimated concentrations i n surface water for use on bulb vegetables at 6 applications of 0.15 lbs a.i./ A (comparable scenario) did no t result in the high est EDWC value for acute ground and aerial applicat i on. A l so, annual mean and 30-year mean e x posure concentrations for the bul b vegetab l e use pattern were both 0.1 Jlg /L, the lowest of all assessed uses. Monitoring data available on the United States Geological Survey (USGS) National Water-Quality Assessment (NAWQA) Program Data Warehouse (http: // cida.usgs.gov/nawga queries pub li cO shows t h a t pyraclostrobin was not detected in the surface or gro und water samples collected in Georgia (Limit ofQuant i tation (LOQ) = 2 . 8 ng/L). Based on the reduced proposed use patterns of this act ion in comparison to those previously assessed, a new drinking water assessment is not necessary at this time . 4References:
USEPA. 2014. Registration Review: Preliminary Problem Formulation for Environmenta l Fate, Ecologica l Risk, Endangered Species, and Dr inking Water Exposure Assessments for Pyraclostrobin. DataPackage Barcode: 417743. Environmental Fate and Effects Division, Office ofPesticide Programs, United States Environmental Protection Agency.
USEPA. 2013a. Environmental Fate and Effects Division Integrated Environmental Risk Assessment for the Proposed New Uses on Tomato Transplants Grown for the Home Consumer Market, Sugarcane. Artichoke, Belgian Endive, Persimmon, Citrus, Oilseed Crops, Bulb Vegetable Group, Bushberry and Caneberry Groups, Fruiting Vegetable Group, Low Growing Berry Subgroup (Except Cranberry), Pome Fruit Group, Small Fruit, Vine Climbing Subgroup (Except Fuzzy Kiwifruit), Root Vegetables lB (Except Sugarbeets), Turnip Greens, Homeowner Ornamentals and Landscape Gardens Section 3/IR

-4 New Uses Registration ofPyraclostrobin. Data Package Barcode: 403456, 403457, 403458, 403459,403460, 403461, 406508, 405666, 406475, 406508. Environmental Fate and Effects Division, Office ofPesticide Programs, United States Environmental Protection Agency.
USEPA. 2013b

. Addendum ofDrinking Water Exposure Assessment for the Section 3 New Use ofPyraclostrobin on Various Agricultural Crops and Residential Ornamentals. Data Package Barcode: 403871, 405066. Environmental Fate and Effects Division, Office ofPesticide Programs, United States Environmental Protection Agency.
USEPA. 2012. White Paper in Support ofthe Proposed Risk Assessment Process for Bees

. Environmental Protection Agency, Health Canada, and California Department ofPesticide Regulation.
USEPA. 2007. Environmental Fate and Effects Division Integrated Environmenta l Risk Assessment for the Section 3/IR-4 NewUses Registration ofPyraclostrobin

. DataPackage Barcode: 334535,336190, 340695, 340586, 340587, 342582, and 342583. Environmental Fate and Effects Division, Office ofPesticide Programs, United States Environmental Protection Agency.



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