UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON D.C., 20460 

OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

PC Code: 0991 00 

DP Barcodes: D417303, 

D416704, D416705 

Date: July 10,2014 

MEMORANDUM 

Subject: Ecological Risk and Drinking Water Assessment Conclusions for Pyraclostrobin IR-4 

Proposed New Use on Herb Subgroup 19A and Dill 

To: Andrew Ertman, Risk Manager Reviewer 

Barbara Madden, Minor Use Team Leader 

From: 

Risk Integration Minor Use, 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 A_ ~A f._ a.~~ ~ 'O \ u1_ ( .fo' ~ '[:, \-.c"_, lZ) 

Sujatha Sankula, Ph.D., Branch Chief 1 -\"-.: I'<:;:~ ~\'o \\'\. 

Environmental Risk Branch I ' 

Environmental 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 on herb subgroup 19A1 and 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 12-12, 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 

1 Herb 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 

Biological 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 label 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 previously 

assessed in 2007 for two aerial or ground applications at 0.148 lb a.i./ A for a seasonal maximum 

of0.296lb a.i./A and an application interval of7 days (2 applications/season) (USEPA 2007, 

D334534 et al.). In 2013, a variety of crops were assessed for a new use request, including crops 

with a comparable rate to those proposed in this request, but for more than two applications 

(USEPA 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 listed and non-listed fish, 

amphibians and aquatic invertebrates in fresh and marine water. No Agency acute LOCs were 

exceeded for birds, reptiles, and land-phase amphibians. Chronic risk quotients did not exceed 

the Agency's LOCs for any of the taxonomic groups assessed. Additionally, EFED did not 

quantitatively assess risk to non-target insects, but indicated that pyraclostrobin is classified as 

practically 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 in the label 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 bulb vegetables at six, aerial and ground 

broadcast or sprinkler irrigation applications at the comparable application rate of 0.15 lb a.i./ A 

(7 day intervals). The 2013 risk assessment on bulb vegetables provides conservative risk 

conclusions for the proposed action because of the increased number of allowable applications 

(bulb vegetables= 6; proposed uses = 2) and higher seasonal maximum (bulb vegetables = 0.9 lb 

a.i./ A; proposed uses = 0.296 lb a.i./ A). In addition, the 6 applications are made every 7 days, 

whereas there would likely be a greater application interval between "seasons" of dill or herbs. 

Therefore, the resulting ecological risk concerns of the bulb vegetable assessment are expected to 

be protective of the risk concerns for the proposed herb subgroup 19 A and dill action, if allowed 

for use for multiple crop seasons. 

Aquatic risk concerns in the 2013 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 

exceeded the LOC for all mammal sizes (small, medium, and large). The 2013 assessment also 

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 practically 

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 studies have been 

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performed with Pristine. Two semi-field honeybee studies were completed. The first study 

(MRID 484 70201) 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 of low concern. Nonetheless, in 2014, an 

anonymous beekeeper reported a new incident of adverse effects on honey bee colonies, 

potentially associated with exposure to Pristine in almond orchards (Incident No. !026240-001). 

The 2014 problem formulation for pyraclostrobin 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 

in pollen/nectar. The addressed data gaps are not required for this action, but are a part of the 

Data-Call In (DCI) in registration review that applies to all registered uses. 

Overall Ecological Risk Conclusions 

Based on the assumption that the proposed pyraclostrobin use will occur during a single season 

per year, 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. 

Table 1. Summary of Risk Quotients for Taxa for which LOCs were Exceeded, Based on 

t e h 2007 an d 2013 E co I ogtca . I Ri s k A t ssessmen s. 

Taxonomic Group Risk Quotients Risk Concems1 

Fresh Herbs (2007 Ecological Risk Assessment? 

Freshwater Fish and 0.08 (aerial) Listed species may be affected 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/ Marine 0.16-0. 18 (aerial) Potential for effects to listed species 

Invertebrates from acute exposures. 

Freshwater Fish 0.11-0.12 (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. 

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Mammals 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 

Chronic: 2.35 (15), 2.01 (35), small, medium and large-sized 

1.08 (1000) mammals. 

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 Level of Concern (LOC) for acute 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 

for non-listed 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 together in the 2007 

Risk Assessment for fresh herbs. 

3 Risk quotients 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 pyraclostrobin was conducted in 2013 

in support of the section 3 new uses request for a variety of crops (USEP A, 2013 b, D403 871 + ). 

EDWCs were generated using EFED's standard suite of models including the Pesticide Root 

Zone Model for Groundwater (PRZM- GW, version 1.0, August 31, 2012) and the Surface Water 

Calculator. Estimated concentrations in surface water for use on bulb vegetables at 6 applications 

of 0.15 lbs a.i./ A (comparable scenario) did not result in the highest EDWC value for acute 

ground and aerial application. Also, annual mean and 30-year mean exposure concentrations for 

the bulb vegetable 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 publicO 

shows that pyraclostrobin was not detected in the surface or ground water samples collected in 

Georgia (Limit ofQuantitation (LOQ) = 2.8 ng/L). Based on the reduced proposed use patterns 

of this action in comparison to those previously assessed, a new drinking water assessment is not 

necessary at this time. 

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References: 

USEPA. 2014. Registration Review: Preliminary Problem Formulation for Environmental Fate, 

Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments for 

Pyraclostrobin. Data Package Barcode: 417743. Environmental Fate and Effects Division, Office 

of Pesticide 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 of Pesticide Programs, United 

States Environmental Protection Agency. 

USEPA. 2013b. Addendum of Drinking Water Exposure Assessment for the Section 3 New Use 

of Pyraclostrobin on Various Agricultural Crops and Residential Ornamentals. Data Package 

Barcode: 403871, 405066. Environmental Fate and Effects Division, Office of Pesticide 

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 of Pesticide 

Regulation. 

USEPA. 2007. Environmental Fate and Effects Division Integrated Environmental Risk 

Assessment for the Section 3/IR-4 New Uses Registration ofPyraclostrobin. Data Package 

Barcode: 334535,336190, 340695, 340586, 340587, 342582, and 342583. Environmental Fate 

and Effects Division, Office of Pesticide Programs, United States Environmental Protection 

Agency. 

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