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



### PC CODE: 129112 DP BARCODE: 405629

DATE: March 18, 2013 

### MEMORANDUM

SUBJECT: Registration Review -Preliminary Problem Formulation for the Ecological Risk Assessment in Support of Registration Review for Trifloxystrobin



### TO: Moana Appleyard, Chemical Review Manager Linda Arrington, Acting Branch Chief Risk Management and Implementation Branch 5 

### Pesticide Re-evaluation Division

# ~
FROM: Nick Mastrota, Ph.D., Wildlife

# Biologist**~** •

THROUGH: Dana Spatz, Branch C .

_ Rosanna Louie-Juzwiak, RAP Melissa Panger, Ph.D., Senior Sctentist ( James Hetrick, Ph.D., Senior**Adviso\.._.)~** 

### Environmental Risk Branch 3 Environmental Fate and Effects Division (7507P)

EFED has completed the Problem Formulation for the Registration Review oftrifloxystrobin. This document provides the Division's plan for assessing ecological risks and drinking water exposure for all registered uses oftrifloxystrobin. It also summarizes outstanding data requirements for these assessments.

• Page I of60

###  Page 2 of 58 

# Problem Formulation for the Ecological Risk Assessment in Support of the Registration Review of Trifloxystrobin

Trifloxystrobin



### Prepared by: James K. Wolf, Ph.D., E nvironmental Scientist Nicholas Mastrota, Wildlife Biologist

Reviewed by: Melissa Panger, Ph.D., Senior Biologist

James Hetrick, Ph.D., Senior Advisor Rosanna Louie-Juzwiak, RAPL

Approved by: Dana Spatz, Branch Chief Environmental Risk Branch III Environmental Fate a nd Effects Division

###  Page 3 of 58 

## 1.0 Introduction

The purpose of this problem formulation is to provide EFED’s current understanding of the environmental fate and ecological effects of the registered uses of trifloxystrobin [E,E)-alpha- (methoxyimino)-2-[[[[1-[3-(trifluoromethyl) phe nyl] ethylidene]amino] oxy]methyl]-methyl ester]. This document provides a plan for analyz ing data relevant to trifloxystrobin and for assessing potential risk to non-ta rget organisms, including Federa lly-listed endange red/threatened species (hereafter referred to as “listed” species), and potential exposure in drinking water for the human health risk assessment.

Trifloxystrobin is an active ingr edient used in numerous agricu ltural fungicide products used to control fungal pathogens on various grain, vegetable, fruit, nut crops , ornamental plants, and turf. It is classified as an oximino acetate fungicide in the strobilu rin class. It inhibits spore germination and mycelial growth by disrupting mi crobial respiration. The end-use products are formulated with 7.2 to 50% active ingredients, an d are often co-formulate d with other fungicidal active ingredients, such as fluopyram, metalaxyl, propiconazole , prothioconazole, tebuconazole, and triademenol.

Additionally, this problem formulation is inte nded to identify data gaps, uncertainties, and potential assumptions used to address those uncer tainties, relative to characterizing the ecological risk associated with the regist ered uses of trifloxystrobin.



## 2.0 Description of Regulatory Action

The Food Quality Protection Act of 1996 mandate d the Environmental Protection Agency (EPA) to implement a new program for a ssessing the risks of pesticides, i.e ., Registration Review ( http://www.epa.gov/oppsrr d1/registration_review/ ). As part of the implementation of the Registration Review program pursuant to Section 3( g) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), EPA is beginning its evaluation to determine whether trifloxystrobin continues to meet the FIFRA standard for registration.



## 3.0 Mechanism of Action

Trifloxystrobin is a broad spectrum foliar fungicide that is currently us ed to control certain diseases in crops and ornamental plants. It also provides both curative and prot ective properties against a variety of pathogens in a variety of crops. Trifloxystrobin is classified as an oximinoacetate fungicide in the strobilurin (sterol inhibitors) class. It be longs to the Qol (Group 11) target site of action group and acts by interf ering with respiration in plant pathogenic fungi and is a potent inhibitor of spore germination and mycelial growth. The fungicidal properties of trifloxystrobin are derived from th e parent ester, and the acid (the main metabolite) is essentially inactive. It exhibits no k nown cross-resistance to othe r chemical classes including anilinopyrimidines (AP).

###  Page 4 of 58 

## 4.0 Use Characterization

Trifloxystrobin is used to protec t agricultural crops, lawns, and ornamental plants from fungal pathogens. It is registered for use on various agricultural cr ops, including grains, beans, vegetables, fruits, and nuts. It is applied to these crops as a fo liar spray using ground sprayer, air blast sprayer, aircraft, or irrigation systems (chemiga tion). For crops started as transplants, it also may be applied with a drench treatment. Multip le applications may be made during a growing season. Trifloxystrobin is also registered for use as a foliar spray on turf and ornamental plants. Turf and ornamental plant uses may be at resi dential, municipal, or commercial use sites, including golf courses, or on agri cultural use sites, such as sod farms and nurseries. Application to turf and ornamentals may be made using airc raft, ground equipment, or hand-held sprayers. Trifloxystrobin is also registered for treatment of ornamental plants grown in greenhouses. Finally, trifloxystrobin is register ed for use as a seed treatment for numerous agricultural crops, ornamental plants, and turf grasses.

Detailed information on application sites, applicat ion rates, and use restrictions for outdoor foliar uses are given in Table 1. Similar crops with similar use restrictions are grouped and will be assessed together.

###  Page 5 of 58 Table 1. Use Sites and Application Informatio n for Foliar Applications of Trifloxystrobin

Site Description Active Ingredient Maximum Application Rate Active Ingredient Maximum Seasonal Rate 1 Max. Apps/ Crop Cycle 2 Min. Retreat Interval (days) Application Methods Restrictions

Artichoke 0.125 0.25 (2) 7 Aircraft, Ground Sprayer
Asparagus 0.125 0.375 (3) 14 Aircraft, Ground Sprayer

Barley 0.056 0.056 (1) NS Aircraft, Ground Sprayer, Chemigation

0.056 0.113 (2) 14 Aircraft, Ground Sprayer, Chemigation

Chervil 0.094 0.375 (4) 14 Aircraft, Ground Sprayer

Christmas Tree Plantation 0.047 1.08 (23) 14 Aircraft, Ground Sprayer

Clover 0.0625 NS NS NS Ground Sprayer OR only

Corn, Field and Pop 0.122 0.244 2 7 Aircraft, Ground Sprayer, Chemigation

Corn, Sweet 0.122 0.489 4 5 Aircraft, Ground Sprayer, Chemigation Cucurbit vegetables (melons, cucumber, gourds, pumpkin, squash, watermelon, etc.) 0.125 0.50 (4) 7 Aircraft, Ground Sprayer

0.125 0.445 4 (3.6) 7 Ground Sprayer, Chemigation
Chickory 0.094 0.375 (4) 14 Aircraft, Ground Sprayer

Fruiting vegetables (eggplant, peppers, tomato, etc) 0.125 0.50 (4) 7 Aircraft, Ground Sprayer

0.038 0.191 5 7 Aircraft, Ground Sprayer, Chemigation

Fruit Trees, Citrus 0.125 0.50 4 7 Aircraft, Ground Sprayer

Fruit Trees, Pome (apple, crabapple, loquat, pear, mayhaw, and quince) 0.094 0.344 4 (3 2/3) 7 Aircraft, Ground Sprayer, Chemigation

0.054 0.218 4 7 Aircraft, Ground Sprayer Chemigation

Fruit Trees, Stone (apricot, cherry, peach, plum, prune, nectarine) 0.125 0.50 4 7 Aircraft, Ground Sprayer

0.10 0.30 4 (3) 7 Aircraft, Ground Sprayer, Chemigation

0.092 0.183 (2) 7 Aircraft, Ground Sprayer, Chemigation Fruit Trees, Tropical and Subtropical (mango, papaya, etc.) 0.125 (0.50) 4 7 Aircraft, Ground Sprayer, Chemigation

Grape 0.125 0.75 6 7 Aircraft, Ground Sprayer

0.10 0.20 4(2) 14 Aircraft, Ground Sprayer, Chemigation

0.125 0.445 6 (3.6) 12 Aircraft, Ground Sprayer, Chemigation

###  Page 6 of 58 Grasses grown for seed 0.131 0.545 (4.16) NS Aircraft, Ground Sprayer
0.125 0.25 /yr (2) 21 Aircraft, Ground Sprayer Hops 0.125 0.50 4 10 Ground Sprayer Not CA Leafy petiole vegetables (cardoon, celery, Chinese celery, Florence fennel, rhubarb, Swiss chard) 0.094 0.375 (4) 14 Aircraft, Ground Sprayer, Chemigation

Nuts, Almond 0.125 0.50 4 7-10 Aircraft, Ground Sprayer, Chemigation

0.125 0.375 3 7 Aircraft, Ground Sprayer, Chemigation

Nuts, Pecan 0.131 0.785 (3) 7-14 Aircraft, Ground Sprayer, Chemigation

0.125 0.50 (4) 7 Aircraft, Ground Sprayer

0.125 0.75 3 (6) 14 Aircraft, Ground Sprayer

0.125 0.444 6 (3.6) 14 Aircraft, Ground Sprayer, Chemigation

0.081 0.243 3 14

Nuts, Pistachio 0.125 0.375 4 (3) 14 Aircraft, Ground Sprayer, Chemigation

0.10 0.30 4(3) 7 Aircraft, Ground Sprayer, Chemigation Nuts, other (beechnut, Brazil nut, butternut, cashew, chestnut, chinquapin, filbert, hickory nut, macadamia, walnut) 0.125 0.50 4 7 Aircraft, Ground Sprayer, Chemigation

0.125 0.25 2 14 Aircraft, Ground Sprayer

Oat 0.057 0.113 2 14 Aircraft, Ground Sprayer, Chemigation

Ornamental Plants, Woody and Herbaceous 0.0075 oz/g to the point of drip 1.08 NS 14 Aircraft, Ground Sprayer, Hand-Held or Backpack Sprayer 0.02 oz/g to the point of drip 1.08 NS 7 Aircraft, Ground Sprayer

0.00016 lb/g 3.75 NS 21 Ground Sprayer, Drench Plants in containers only, not in CA

Peanuts 0.12 (0.48) 4 10 Aircraft, Ground Sprayer, Chemigation

0.11 0.44 4 10 Aircraft, Ground Sprayer, Chemigation

0.11 (0.66) 6 10 Aircraft, Ground Sprayer, (Chemigation?)

Potato 0.125 0.75 6 7 Aircraft, Ground Sprayer, Chemigation

Rice 0.15 0.30 2 NS or 14 Aircraft, Ground Sprayer

###  Page 7 of 58 Root vegetables (beet, carrot, ginseng, parsnip, radish, rutabaga, turnip, etc.) 0.094 0.375 (4) 14 Aircraft, Ground Sprayer, Chemigation

0.125 0.25 (4) 7 Aircraft, Ground Sprayer

Strawberry 0.10 0.60 (6) 7 Aircraft, Ground Sprayer, Chemigation

Sugar beet 0.11 0.33 3 10 Aircraft, Ground Sprayer, Chemigation

Soybean 0.11 0.31 (3) 10 Aircraft, Ground Sprayer, Chemigation

Turf, Residential, Commercial, or Industrial 0.340 1.08 (3) 14 Aircraft, Ground Sprayer, Hand-held or Backpack Sprayer

Turf, Golf Course 0.340 1.08 (3) 14 Aircraft, Ground Sprayer, Hand-held or Backpack Sprayer

0.31 1.33 6 (4.3) 14 Ground Sprayer, Hand-held or Backpack Sprayer

Triticale 0.081 (0.162) 2 14 Aircraft, Ground Sprayer, Chemigation

Wheat and triticale 0.085 0.085 (1) NS Aircraft, Ground Sprayer, Chemigation

0.11 0.22 (2) 14 Aircraft, Ground Sprayer

0.081 (0.162) 2 14 Aircraft, Ground Sprayer, Chemigation

0.098 NS NS 14 Aircraft, Ground Sprayer 1 Numbers given in parentheses are maximu m per-season rates calculated by multiplying the maximum per application rate by the maximum number of applications allowed per season. 2 Numbers given in parentheses represent the number of applica tions that can be made at the maximum per-application rate to r each the maximum per-season rate. The number not in parentheses is the maxi mum number of applications (at any rate) that are allowed by the label.


### Application rates for seed treatments are given in terms of weight of tr ifloxystrobin applied to weight of seed. Application rates range fr om 0.001 to 0.01 pound active ingredient (a.i.) per pound of seed. EFED will estimat e upper bound application rates in terms of pounds a.i. per acre treated by multiplying these pounds-per-seed rates by maximum expected seed planting rates (seeds per acre), which is specific for each cr op. Use information provided on the labels for trifloxystrobin seed treatm ent is given in Table 2.

###  Page 8 of 58 Table 2. Application Information for Seed Treatment Uses of Trifloxystrobin

Seed Type Maximum Application Rate (lb a.i./lb seed) Maximum Seasonal Rate (lb a.i./lb seed) 1 Max. Apps/ Year
Alfalfa 0.0050 0.005 1 Barley 0.0050 (0.015) 3 Canola 0.010 (0.30) 3 or NS
Conifers 0.010 NS NS
Cotton 0.010 NS 3 or NS Cucurbit Vegetables 0.010 NS NS Fruiting Vegetables 0.010 NS NS Legume Vegetables (Beans, lentils, and peas) 0.0050 NS NS 0.0050 (0.015) 3 Lupine, grain 0.0050 NS NS

Mustard 0.010 NS NS 0.010 (0.030) 3
Potato 0.010 NS NS

Sorghum 0.010 NS NS 0.005 (0.015) 3 Sugarbeet 0.010 NS NS

Wheat and Triticale 0.01 NS NS 0.005 (0.015) 3 1 Numbers given in parentheses represent the number of applica tions that can be made at the maximum per-application rate to r each the maximum per-season rate. The number not in parentheses is the maxi mum number of applications (at any rate) that are allowed by the label.


### For selected major crops, the maximum seed treatm ent rate (lb a.i./lb seed) have been converted to a maximum application rate expressed in terms of pounds of a.i. applied per acre. This is done by multiplying the maximum seed treatment rate by the maximum expected seeding rate (lb seed/A) for that crop (Table 3). The typical ra nge of seeding rates, given in Table 3, were provided to EFED by the Biologi cal and Economic Analysis Divi sion (BEAD) and are available in the seed-treatment worksheet of the T-REX model. A screening-level risk assessment will be conducted based on the maximum pr edicted seeding rates.

Table 3. Maximum Application Rates for Seed Treatments Expressed as Pounds a.i. per Acre

Seed Description Max. Seed Treatment Rate (lb a.i./lb seed) Min. Seeding Rate (lb/A) Max. Seed Rate (lb/A) Max. Appl. Rate (lb a.i./A)

Alfalfa 0.15 75.00 90.00 13.50 Barley 0.005 8.00 138.30 0.69 Beans (Unspecified) 0.005 20.00 213.53 1.07 Beans, Dried 0.005 32.02 140.01 0.70 Beans, Lima 0.005 32.02 163.35 0.82 Beans, Green 0.005 20.00 213.53 1.07 Canola 0.01 3.79 30.63 0.31 Corn (Unspecified) 0.0025 2.90 33.19 0.08 Corn, Field 0.01 16.50 27.04 0.27 Corn, Pop 0.01 5.04 27.04 0.27 Corn, Sweet 0.01 2.90 33.19 0.33 Cotton 0.01 6.44 150.00 1.50 Cucurbit Vegetables 0.01 0.04 11.62 0.12

###  Page 9 of 58 Seed Description Max. Seed Treatment Rate (lb a.i./lb seed) Min. Seeding Rate (lb/A) Max. Seed Rate (lb/A) Max. Appl. Rate (lb a.i./A)
Fruiting Vegetables 0.01 0.08 170.00 1.70 Mustard 0.01 0.31 6.00 0.06 Ornamental Lawns and Turf 0.01 2.00 25.00 0.25 Peanuts 0.01 6.22 228.26 2.28 Peas (Unspecified) 0.005 4.23 411.00 2.06 Peas, Field 0.005 4.23 217.80 1.09 Peas, Southern/Black Eyed 0.005 6.22 275.00 1.38 Peas, succulent 0.005 31.11 411.00 2.06 Potato 0.01 0.08 6969.60 69.70 Rice 0.01 6.67 129.00 1.29 Sorghum 0.01 5.00 12.00 0.12 Soybean 0.005 13.90 166.67 0.83 Sugar Beet 0.01 0.80 25.00 0.25 Wheat 0.01 30.00 157.10 1.57



### Trifloxystrobin is widely used on a variety of ag ricultural crops in all re gions of the country. Crops with the highest total usage in the United States are corn, rice, wh eat, soybeans, grapes, peanuts, and pecans, apples, and soybeans. Crops with a high percentage of acres treated with trifloxystrobin ( ≥ 20% on average) include apples, celery, grapefruit, grapes, and hazelnuts. Further details on the usag e of trifloxystrobin are provided in the Screening Level Usage Analysis (SLUA) report (Appendix A).



## 5.0 Conclusions from Previous Risk Assessments

EFED has conducted multiple ecological risk assessm ents on trifloxystrobin that serve as a basis for this problem formulation. EFED has evaluated the most recent (D388189; 12/30/11) ecological risk assessments for tr ifloxystrobin in association with the updated toxicity, exposure, and usage information to determine if sufficient data are available and if further updates are needed to support registration review. Recent ri sk assessments include numerous assessments conducted for registrations of new uses of triflo xystrobin, as described below. In addition, EFED considered the latest Agency science polic ies and risk assessment methodologies.

5.1 Ecological Risk Assessments

Ecological risks of trifloxystrobi n have been previously evaluated by EFED for use on numerous commodities including pome fruits, grapes, cucurb its, peanuts, and turf (New Chemical Review, D244219, D245281, D254206, D254285, D254286); almonds, fr uiting vegetables, hops, potatoes, sugar beets, and wheat (D254215, D254220, D254222); ro ot vegetable subgroup 1B (except beet and radish) and leaf petiole subgroup 4B (D286427); barley, oa ts, sweet corn, and soybeans (D315580, D314187, D318621, D318623, D363130); gr ass grown for seed (D332979, D332982); asparagus, tropical crops, radish, root vegetables, st rawberries (D331915, D339548, D348876), and artichoke (D388189). Detailed summari es of these assessments can be found in

###  Page 10 of 58 

### the following previous risk assessments : D309489, D331915, and D388189. Trifloxystrobin was not subject to reregistration and thus no Reregist ration Eligibility Decision (RED) is available.

Conclusions from previous ecological risk assessm ents are summarized in Table 4. For most uses other than seed treatments, previous risk a ssessments identified risk quotients (RQs) that exceeded the EPA’s level of concern (LOC) for potential adverse effects to endangered and threatened freshwater fish, freshw ater invertebrates and saltwater invertebrates. Risk quotients exceeded the LOC for non-endangered species only fr om the use on turf. For turf use, risk to marine/estuarine invertebrates exceeded the LO C for non-endangered species. For all uses, minimal risk was predicted for terrestrial wildlife and aquatic plants. Risk to non-listed terrestrial plants was not predicted, but recent risk assessmen ts stated that potential adverse direct effects to threatened and endangered species of terrestrial plants could not be precluded because of limitations in the available phytotoxicity data.

Table 4. Summary of Previous Ecological Risk Assessments Conducted by EFED on Trifloxystrobin

Use Reference (Year) Max. Application Rate (lb ai/A) Taxa for which risk was identified at the Agency’s concern levels
Artichokes D388189 (2011) 0.177 Freshwater fish (endangered species LOC), estuarine/marine invertebrates (endangered species LOC)*
Alfalfa Seed D378918 (2010) 0.0047 None* Soybean (New use rate) D361159 (2009) 0.114 None* Asparagus, strawberries, radish, and other minor
crops D331915, D339548, D348876 (2006) 0.10-0.71 Estuarine/marine invertebrates (endangered species LOC)*

Grasses grown for seeds D332979 and D33292 (2006) 0.125 Freshwater fish (endangered species LOC), estuarine/marine invertebrates (endangered species LOC)* Sweet corn, barley, oat, soybean, and seed
treatments D309489, D314187, D315580, D316090, D316091, D318621, and D318623 (2005) 0.057-0.082 None*

Almonds, fruiting vegetables, hops, potatoes, sugar beets, and wheat D254215, D254220, and D254222 (1999) 0.10-0.125 Freshwater fish and invertebrates (endangered species LOC), estuarine/marine invertebrates (endangered species LOC) Pome fruits, grapes, cucurbit vegetables, peanuts, and turf** D244219,D245281, D254206, D254285, and D254286 (1998) 0.056-0.125 Freshwater fish and invertebrates (endangered species LOC for turf), estuarine/marine invertebrates (non-endangered LOC for turf, endangered species LOC only for other crops) *Risk to endangered terrestrial plants is uncertain because phytotoxicity studi es did not establish either an NOAEC or EC 05 value. ** The highest application rate of trifloxystrobin is for tu rf, and turf is the use site associated with the greatest potential environmental exposures of trifloxystrobin.

###  Page 11 of 58 

### In a recent risk assessment conducted for use on al falfa seed, CGA-321113 (fr ee acid degradate of trifloxystrobin) was iden tified as a major degradation produ ct of trifloxystrobin, but because toxicity data indicate that it is considerably less toxic to aquatic orga nisms than the parent compound, the ecological risk assessment will be based on exposure to trifloxystrobin alone (D378918). However, because this major degradat e has been identified by the Health Effects Division as a residue of concern, CGA-321113 will be included in estimation of trifloxystrobin concentrations in drinking water fo r human health risk assessments.

The major environmental fate and ecological risk conclusions of previous assessments were as follows:

Birds Mammals Terr. Plants Terr. Inverts Fish BCF Aquatic Inverts Aquatic Plants Groundwater Contamination Persistence Degradates of Concern



### -- -- -- -- √ 

### -- √ 

### -- -- -- --

“ √ ” signifies that at least one LOC has been exceeded in previous assessments; “--“sign ifies LOCs have not been exceeded in past assessments.



### 5.2 Drinking Water Exposure Assessments

In previous environmental fate reviews, trif loxystrobin has been char acterized as generally degrading rapidly in soil and water through alkaline-catalyzed hydrolysis, microbial-mediated metabolism, and photodegradation. Trifloxystrobin was characterized as having low solubility (0.61 mg/L) and low mobility in soil, and ther efore was expected to pose little risk of contaminating ground water.

A drinking water assessment was initially conduct ed during 1998 for a number of uses including turf during the New Chemical Review (D244219). Th e estimated drinking water concentrations (EDWCs) were determined for the turf use, whic h constituted the highest application rate for trifloxystrobin, using the GENEEC model. The EDWCs were dete rmined with GENEEC (Table 5) for trifloxystrobin plus the degradate (CGA-321113) were 47.98 μg/L for acute exposure and 47.31 μg/L for chronic exposure. The GENEEC model was initially designed to predict pesticide concentrations in a standard farm pond for aquati c exposure assessments. It has been shown to be a good predictor of upper level pe sticide concentrati ons in small but eco logically important upland streams, but not for larger water bodies us ed as a source for drinking water. Therefore, EFED developed the Tier 1 FIRST and Tier 2 PRZM/EXAMS models to estimate pesticide concentrations in drinking water from surface water sources 1



### . In order to ensure that previous estimates of trifloxystrobin plus CGA- 321113 were not exceeded, the EDWCs for the turf use were reassessed due to a change ( i.e. , increase) in the maximum application rate, using the Tier 2 PRZM/E XAMS models (D378919; 11/29/2010). Tier 2 results were less than previous exposure estimates (Table 5) of trifloxystrobin plus the degradate (CGA321113): 29.32 μg/L for the 1-in-10-year peak, 22.67 μg/L for the 1-in-10-year annual mean, and 18.97 μg/L for the 30-year mean for surface wa ter; and, 5.87 μg/L for ground water using the SCI-GROW model. Other drinking water assess ments for more recently requested crops ( e.g. , artichokes) have been conducted, which resulted in lower EDWCs (D309489; D339548).

1 http://www.epa.gov/oppefed1/models/water/models4.htm

###  Page 12 of 58 Table 5. The highest EDWCs for Trifloxystrobin plus degradate CGA-321113 for the revised drinking water assessment on turf (D378919).

Crop Acute Exposure from One in Ten Year Peak Values (μg/L) Chronic Exposure from One in Ten Year Annual Mean (μg/L ) Average of Yearly Average for Cancer

Exposure (μg/L)

Initial Turf Assessment
Surface Water (GENEEC) (D244219, D360307)
Generic Scenario (turf) 47.99 47.31 47.31

Revised Turf Assessment
Surface Water (PRZM/EXAMS)
Turf (EPA Reg No. 432- 1371) 29.324 22.675 18.974

Ground Water (SCI-GROW)
Not Applicable 5.87 5.87 5.87



### 5.3 Clean Water Act Programs

Trifloxystrobin is not identified as a cause of impairment for any wa ter bodies listed as impaired under section 303(d) of the Clean Water Act. No Total Maximum Daily Load (TMDL) criteria have been developed for trifloxystrobin. A quatic benchmarks have been established for trifloxystrobin and the degradat e CGA-321113 and are available at http://www.epa.gov/oppefed1/ecoris k_ders/aquatic_life_benchmark.htm . Any data submitted or otherwise located as part of th e registration review process may be used to update aquatic life benchmarks if applicable.

Aquatic life benchmarks for trif loxystrobin are reported in Table

. Aquatic life benchmarks developed by OPP for baseline risk assessments are estimates of the concentrations below which pesticides are not expected to harm aquatic life. Each aquatic life benchmark is based on the most sensitive, scientifically accepta ble toxicity endpoint available to EPA for a given taxon (for example, freshwater fish) of all available scientifically acceptable toxicity data multiplied by the corresponding level of concern of 0.5 for acute endpoints and 1.0 for chronic and plant endpoints.

Table 6. OPP Aquatic Life Benchmarks for tr ifloxystrobin and CGA-321113 in μg a.i./L

Fish Aquatic Invertebrates Nonvascular Plants Vascular Plants Office of Water Aquatic Life Criteria Trifloxystrobin

Acute Chronic Acute Chronic Acute Acute Maximum Conc. Continuous Conc.
7 4.3 12.5 2.8 37 > 1,930
CGA-321113 > 53,000 — > 47,500 3,200 78,800 —

###  Page 13 of 58 

### The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk A ssessment and Management Process (see: http://www.epa.gov/oppfead1/cb/ppdc/2006/november06/session1-sop.pdf ), in order to ensure they can be used quantitatively or qual itatively in pesticide risk assessments.



## 6.0 Environmental Chemistry, Fate and Transport

6.1 Stereochemistry

A number of isomers of trifloxystrobin and its major degradation/transformation products were observed in the environmental fate studies as described below.

The active geometric isomer in trif loxystrobin is (E,E) isomer of ά -(methoxyiminio)-2-[[[[1-[3- (trifluoromethyl)phenyl] ethylidene] amino] oxy ] methyl]-benzeneacetic acid, methyl ester (CGA-279202). There are also three other geometric isomers with similar molecular formula to the active isomer in trifloxystrobin. These geometric is omers include (Z,E) isomer of ά

- (methoxyiminio)-2-[[[[1-[3-(tri fluoromethyl)phenyl] ethyliden e] amino] oxy] methyl]- benzeneacetic acid, methyl ester (CGA-357261), (E,Z) isomer of ά -(methoxyiminio)-2-[[[[1-[3- (trifluoromethyl)phenyl] ethylidene] amino] oxy ] methyl]-benzeneacetic acid, methyl ester (CGA-331409), and (Z,Z) isomer of ά -(methoxyiminio)-2-[[[[1-[3 -(trifluoromethyl)phenyl] ethylidene] amino] oxy] met hyl]-benzeneacetic acid, methyl ester (CGA-357262). The major route of dissipation for trifloxys trobin (CGA-279202) is de-esterifi cation of the methyl ester to form the free acid of trifloxystr obin (CGA-321113). The other geomet ric isomers are expected to undergo similar de-esterificati on reactions to form their re spective free acid (i.e., CGA-373466 from CGA-357261; CGA-373465 from CGA-331409; and CGA 381318 from CGA-357262). The significance of the chemistry for th e group of geometric isomers of parent trifloxystrobin and its free acid (E,Z; Z,E; E,E; Z,Z) is that they e xhibit the same molecular formula with different conformational orientations. Each of these isomer s is expected to exhibi t different physical and chemical properties as well as different t oxicities. Inter-conve rsion of isomers, i.e. , “isomerism” may be possible if sufficient chemical energy is provided to promote a change in conformational orientation.

The submitted studies indicate that trifloxystrobin has low to moderate mobility and degrades rapidly from de-esterification in the soil and aqueous environment into the primary degradate, CGA-321113. CGA-321113 is expected to form rapi dly, be mobile in the environment, and to degrade at a slower rate than trifloxystrobin. In irradiated aq uatic environments, photo- induced isomerism of trifloxystrobin (E,E) was obser ved with the formation of CGA-357261 (Z,E) and CGA-357262 (Z,Z). In soil environments, minor amounts of isomers of parent and acid were detected. Isomers found in soil metabolism studi es include Z,E isomer of parent (CGA-373466), E,Z isomer of parent (CGA-331409), and Z,E isom er of acid degradate (CGA-373466). Although these data do not show extensive isomerism of trifloxystrobin, they do suggest isomerism is possible under some conditions ( i.e ., irradiated water, wet leaf surfaces , or soil). It is anticipated that the impact of isomerism is expected to ha ve minimal impact in assessing the environmental fate and toxicity of the E,E isomer of trifloxystrobin.

###  Page 14 of 58 

### 6.2 Environmental Fate

Trifloxystrobin will enter the envi ronment via spray applied directly onto soil and foliage. It may move off-site via sp ray drift and runoff.

Trifloxystrobin has a low solubili ty (0.61 mg/L @ pH 7) in water. The vapor pressure is 2.55 x 10 -8 

### torr at 25 °C, and the calculate d Henry’s Law Constant is 2.25 x 10 -8 

### atm-m 3 

### mol -1 

### . These values suggest that trifloxystrobin is non-volatil e under field conditions from water and moist soil surfaces. Volatilization is not a likely route of dissipation. Although trifloxystrobin has a log K ow 

### of 4.5, evaluation of all the fate data suggest that the bioaccumulation of trifloxystrobin is unlikely.

The submitted studies indicate that trifloxystrobin has low mobility and transforms rapidly in the soil and aqueous environment into a series of tr ifloxystrobin isomers and the primary degradate, CGA-321113, a carboxylic acid, a number of minor degradates, and CO 2 

### . The environmental fate and physiochemical properties of trifloxystrobi n and the major degradation product CGA-321113 are summarized in Tables 7 and 8.

Trifloxystrobin is non-persistent in the terrestr ial environment. Laborator y studies indicate that biotransformation is an important route of trifloxystrobin transformation in aerobic soil. Hydrolysis is important in alkali ne soils. Trifloxystrobin degraded rapidly in soils with half-lives ranging between 0.41 and 0.91 days. In aerobic so ils the major degradate is CGA-321113. Minor degradates identified include CGA-373466, CGA-357276, and CO 2 

### . Photodegradation is not an important route of transformation of trifloxystrobin, but resulted in the isomerization of the parent isomer CGA-357261 and degradate CGA-321113 are formed. The photo-induced isomerization half-life (t 1/2 

### ) was 2.1days on soils. Further degr adation forms CGA-357276, CGA-373466, CO 2 

### and bound residues.

CGA-321113 is the major transformation product identified in the soil metabolism studies. The fate studies indicate that CGA- 321113 is quite persistent (DT 50 

### 250 to 350 days) in the soil environments (stable to hydrolysis and metabolism); therefore, CGA-321113 is expected to degrade at a lower rate than trifloxystrobin. CGA-321113 is a carboxylic acid, and therefore being anionic, is expected to be more mobile th an parent trifloxystrobin. Th erefore, because of its persistence and mobility, CGA-321113 would have a greater potential for leaching.

Laboratory studies indicated that trifloxystrobin was al so not persistent in the aquatic environment. In water, trifloxystrobin hydr olyzes to CGA-321113 under alkaline conditions (t 1/2 

### = 55.2 days @ pH 7 and 0.83 days @ pH 9), but was stable under acidic conditions (at pH 4). Therefore, hydrolysis is only important under al kaline conditions. In the aquatic environment, trifloxystrobin will undergo photo-isomerization to parent isomer products (CGA-357261: Z,Eisomer; CGA-357262: Z,Z-isomer). The photo-induced isomerization half-life (t 1/2 

### ) was 14.8 days. In an aerobic aquatic sediment syst em, the major transformation product was CGA-321113.

The fate studies indicate that CGA-321113 is quite persistent (DT 50 

### = 289 days) in aquatic environments (stable to hydrolysis and meta bolism). Therefore, CGA-321113 is expected to degrade at a slower rate th an trifloxystrobin. CGA-321113 is a carboxylic acid, and therefore anionic. This, it will be more mobile than pare nt trifloxystrobin. Because of its persistence and mobility, CGA-321113 would have a greater potential for leaching.

###  Page 15 of 58 

### Trifloxystrobin demonstrated a “hockey st ick type” biphasic de gradation pattern ( i.e. , two distinct degradation rates observed in the duration of the study, rate de creasing with time) in field dissipation studies conducted in California, New York, and Georgi a. For the first degradation phase, trifloxystrobin half-life values ranged from 1.9 to 24 days. In the second degradation phase, half-life values ranged fr om 6.5 days to 4 months.

The proposed degradation pathway of trifloxystrobin in an aquatic system is show in Figure 1. This figure gives the structures of the different isomers of trif loxystrobin and its degradation products.

6.3 Mobility

Based upon the soil organic carbon coefficient, K oc 

### (median Koc =2709 mL/g oc 

### ), trifloxystrobin would fall into the slightly mobile cla ss adapted from the FAO by EFED (USEPA, 2006 2 

### ). Studies were also conducted on the mobility of the primary degradate, CGA-321113. The laboratory adsorption/desorption mobility classification of CGA-321113 was mobile to moderately mobile under the FAO classification. However, in l eachates from a field lysimeter study, CGA-321113 was not detected above 0.02% of the applied amount. In field dissipation studies conducted in Georgia, California, and New York, under bare ground and cropped conditions, trifloxystrobin was not detected belo w 6" and CGA-321113 concentrations reached or were slightly above the LOQ of 10 ppb in 12-18 , and 30 -36 inch soil segments. Another degradate CGA-373466 was detected in the 0-6 and 6-12 inch segments.

Adsorption/desorption studies were also conduc ted for the parent isomer CGA-357261 [Koc – 389 to 567 mL/g oc 

### ], CGA-357276 (an isomer of C GA-321113) [Koc - 6587 to 9228 mL/g oc 

### ] and CGA-373466 (an isomer of CG A-321113) [Koc - 31 to 166 mL/g oc 

### ]. Following the FAO mobility classification, CGA-357261 was moderately mobile, CGA-357276 was slightly mobile, and CGA-373466 was classified as moderately mobile to mobile.

2 USEPA, 2006. Standardized Soil Mobility Classificati on Guidance. Memorandum: S. Bradbury, April 21, 2006.

###  Page 16 of 58 

### Figure 1. Proposed degradation pathways of trifloxystrobin (CGA-279202EE) in aquatic systems

###  Page 17 of 58 

### 6.4 Bioconcentration

The log K ow 

### of 4.5 suggests that trifloxystrobin ma y bioaccumulate. Trifloxystrobin has bioconcentration factors in bluegill sunfish edible tissues of 130-166X, 1172-1144X for nonedible tissues, and 542-547X in whole fish. The bio accumulation plateau was rapid (3 days post exposure). However, depuration was rapid, with 96.7-98.1% of the total [ 14 

### C]residues accumulated by exposure day 28 eliminated from all tissues by 7 days in the 0.16 μg/L system, and 98.3-98.5% eliminated from all tissues by 14 days in the 1.6 μg/L system. Due to the relatively low fish bioconcentrati on factors in fish tissue, rapid aquatic biotransformation to CGA32113 (acid) and the rapid depuration of tr ifloxystrobin observed in the fish study, bioaccumulation is unlikely.

Selected chemical and fate properties are summarized in Table 7 and Table 8.

Table 7. Chemical Properties and Environmental Fate and Modeling Inpu t Parameters of Trifloxystrobin for Aquatic Exposure.

Parameter Value Modeling Input Value Source Molecular mass (molecular formula) 408.37 g/mol (C 20 H 19 F 3 N 2 O 4 ) 408.37 (Calculated)

Vapor pressure (25°C) 2.55 x 10 -8 torr a,b 2.55 x 10 -8 torr Aqueous solubility (20  C) 0.61 mg/L @ pH7 0.61 mg/L MRID 44502801

Henry’s Law Constant (25°C) 2.25 x10 -8 atm-m 3 /mol 2.25 x10 -8 atm-m 3 /mol (Calculated)

Log octanol-to-water partition coefficient (log K O W ) (25°C) 4.5 Not Applicable MRID 44502801

Hydrolysis half-life (25±1  C) pH 4: stable pH 7: 55.2 days pH 9: 0.83 days pH4: stable pH7: 55.2 days MRID 44496727

Aqueous photolysis half-life (25±1  C) 14.8 days @pH 5 14.8 days MRID 44496727

Soil photolysis half-life (25±1  C) 2.1 days 2.1 days MRID 44496729

Aerobic soil metabolismhalf-life [dissipation halflife A ] (25±1°C) 0.74, 0.41, and 0.91 days

mean = 0.69 d, std = 0.25 d 90% upper bound half-life = 0.964 days c MRID 44496732 MRID 44496730 MRID 44496731

Anaerobic aquatic metabolism half-life (20- 29  C) 0.72 days 2.16 days (3 times single value) c MRID 44496733

Aerobic aquatic metabolismhalf-life [dissipation halflife A ] (25  C) 0.60 days (supplemental) 1.928 days (2 x aerobic soil metabolism (0.964 days) c MRID 44496734

###  Page 18 of 58 Parameter Value Modeling Input Value Source

Freundlich soil-water partition coefficients (K F ); organic carbon-normalized Freundlich coefficients (K FOC ) K F (mL/g); 6.8, 7.7, 16.0, 59.4, 91.8, 33.2 Mean = 35.82; Std = 33.8 [7.7 is the lowest non-sand]

K FOC ( mL/g OC ) 2354, 951, 3064, 3927, 9871, 951 coefficient of determination (r 2 ) = (K f vs. organic matter = 0.03) Mean K F = 35.82 mL/g

Sorption not correlated with Organic Carbon MRID 44496802

Fish bioconcentration factors (steady-state); depuration rate 130-166 X (edible), 1172-1144 X(non-edible), 542-547 X (whole); 96.7-98.1% depuration in 7 days Not Applicable MRID 44496813

Aerial Spray Drift Application Efficiency (fraction) 0.16 drinking water
0.95 EFED Guidance

FEXTRA - foliar apps PRZM Foliar Extraction 0.5 (frac/cm rain) EFED Guidance

a USEPA Fact Sheet reports 3.4 x 10 -6 torr (@25 °C)
b PMRA Reg2004-03 and Trifloxystrobin (213) report 3.4 x 10 -6 Pa @ (@25 °C

c EFED Model Input Guidance http://www.epa.gov/oppefed1/models/w ater/input_parameter_guidance.htm



### 6.5 Transformation Products

Information is available on trifl oxystrobin degradates. Selected ch emical and fate properties of the degradate CGA-321113 are summarized in Ta ble 8. The degradation/transformation products observed in the environmental fate studies are summarized in Table 9.

Toxicity testing with CGA-321113 indi cates that it has low toxicity to aquatic organisms (Table 10). Based on its acute toxicity, it is classified as “practically nontoxic” to fish and freshwater invertebrates, and the to xicity endpoints for growth and repr oduction of algae, and chronic effects to freshwater vertebrates, are over 1000 times greater than those of the parent compound. Because of this lack of toxicity, EFED does not plan to include exposure to this transformation product quantitatively in the risk assessment that will be conducted in registration review.

###  Page 19 of 58 Table 8. Summary Environmental Fa te Data for CGA-321113 and Model Input Parameters Used to Estimate the Total Toxic Residues or Residues of Concern (R OC) (trifloxystrobin + de gradate CGA-321113) for the Drinking Water Assessment.

Parameter Values 1 Modeling Input Value 2 Source

CGA-321113

Molecular Formula C 19 H 17 F 3 N 2 O 4 MRID 44496801 Molecular Weight 394.35 394.35 MRID 44496801
Solubility @ 20 ◦ C 30.9 mg/L 30.9 mg/L MRID 44496816
Vapor Pressure 7.5 x 10 -08 mm Hg @ 20 ◦ C MRID 44496801
Henry’s Constant 1.26 x 10 -09 atm m 3 mol -1
Hydrolysis Half-life Stable Stable (days) MRID 44496727 Aquatic Photolysis Half-life Stable Stable (days) MRID 44496727

Photolysis on soil Halflife Stable Stable (days) MRID 44496727

Aerobic Aquatic Metabolism Half-life stable Stable (days) MRID 44496734

Anaerobic Aquatic Metabolism Half-life ( Stable Stable (days) MRID 44496733

Organic Carbon Partition Coefficient (Koc) (mL/g) 127, 235, 130, 48, and 80 Coef. Determination (r 2 ) = 0.89 for K f vs. om mean 124.0 mL/g oc median 127 mL/g oc MRID 44496801

Soil Partition Coefficient (K f ) (mL/g) K f (texture class) 4.0 Loam (5.4% om)
1.9 Sand 3.2 Clay loam 0.28 Sandy loam ( 1% om) 0.65 Sandy loam mean = 2.0 mL/g [1/n = 0.81 to 0.85] MRID 44496801

Aerial Spray Drift Application Efficiency (fraction) 0.16 drinking water
0.95 EFED Guidance

FEXTRA - foliar apps PRZM Foliar Extraction 0.5 (frac/cm rain) EFED Guidance

Persistence for Residues of Con cern (Total Toxic Residues) (paren t trifloxystrobin + CGA-321113)(DP D309489 see Table 9)
[Residues of Concern]:
Aerobic Soil Metabolism Half-life 254.8 days 271.3 days 199.7 days 282.75 days (90 th percent upper bound on mean) Median = 254.8 days MRID 44496732
MRID 44496730
MRID 44496731

1,2 Values for environmental fate properties used for modeling were obtained for the degradate CGA-321113 except for the aerobic soil metabolism values which consider the total toxic residues (sum of the concentration of parent plus the degradate CGA-321113 versus time), assumed the most conservative values.

###  Page 20 of 58 Table 9. Trifloxystrobin and Its Major Environmental Transformation Products and Degradates

Study Type Hydrolysis Photolysis (water) Photolysis (soil) Aerobic Soil Anaerobic Aquatic Aerobic Aquatic Terrestrial Field Studies (detections)

MRID 44406727 44496727 44496728 44496729 44496730 44496731 44496732 44496733 44496734 44496808 44757204 44657203 Trifloxystrobin CGA-279202 CAS# 141517-21-7

C 20 H 19 F 3 N 2 O 4
MW: 408.5 g/mol Degradates CGA-321113 E,E isomer CGA-279302 acid

C 19 H 17 F 3 N 2 O 4
MW: 394.32 g/mol pH 5: 0%

pH 7: 29.2%

pH 9: 100% irradiated: 9.1% irradiated: 17.2%

dark:72.3% 93.2% aqueous 69.3%

sediment:

33.8% aqueous: 82.3%

soil: 23.3% detected 30” -36”

CGA-357261 Z,E isomer Z,E parent irradiated: 63.8% not detected below 18”

CGA-357262 Z,Z isomer Z,E parent irradiated: 9.1% irradiated: 4.1% <4.1% not detected below 18” (12” – 18” –once)

CGA-373466 Z,E isomer CGA-357261 acid irradiated: 24.8% dark: 3.8% <4.1% detected 6” – 12”

NOA-409480 & CGA-357251 irradiated: 18.5% dark: 2.5% CGA-331409

E,Z isomer E,Z parent

CAS# 141493-03-0 irradiated: 4.1% <1.0% .4%

CGA-320299 <1.0%

CGA-357276 dark: 1.9% 5.6% detected 3" -6"

Unidentified dark 13.6% CO 2 5.1% 0.4% 2.5% Non-extractable 27.4% 13.8%



### 6.6 Monitoring Data

The following databases and sources were search ed for monitoring information on trifloxystrobin and CGA-321113 on January 28, 2013:

 

### The United States Geological Survey (U SGS) National Water-Quality Assessment (NAWQA) Program Data Warehouse ( http://infotrek.er.usgs.gov /traverse/f?p=NAWQA:HOME:1405517206944567 )

 

### The USGS National Stream Quality A ccounting Network (NASQAN) program ( http://water.usgs.gov/nasqan /)

 

### California Department of Pesticide Regulation (CDPR) Surface Water Database ( http://www.cdpr.ca.gov/docs/ emon/surfwtr/surfdata.htm )

 

### California Environmental Data Exchange Network (CEDEN; http://www.ceden.org/ )

###  Page 21 of 58 

### Trifloxystrobin and its degradates have not been included in these monitoring programs.



## 7.0 Receptors

Table 10 and Table 12 provide a summary of the toxi city of trifloxys trobin aquatic and terrestrial taxonomic groups, respectively, based on toxicity measured in the most sensitive surrogate species. Table 11 provides information for th e degradate CGA-321113. In addition, the tables provide a preliminary overview of the potential acute toxicity of trifloxystrobin by providing the acute toxicity cl assifications.

7.1 Effects to Aquatic Organisms

Available toxicity data indicate that trifloxystrobin is hi ghly toxic to fish a nd aquatic invertebrates on an acute exposure basis. Data for green algae ( Pseudokirchneriellasubcapitata ) indicate toxicity to algae occurs at rela tively low exposure levels, with t oxicity endpoints comparable to the acute toxicity endpoints for fish and aquatic invertebrates. On a chronic basis, the most sensitive test species was the waterflea ( Daphnia magna ), in which significant growth and reproduction was observed at 5.98 μg ai/L. The waterflea NOAEC was established at 2.76 μg ai/L.

###  Page 22 of 58 Table 10. Summary of the Most Sensitive Endpoints from Aquatic Toxicity Studies for Trifloxystrobin

Taxonomic Group Study Type Surrogate Species Toxicity Value (all units in terms of

measured active ingredient) Acute Toxicity Classification Source

Freshwater fish 1 Acute Rainbow Trout ( Oncorhynchus mykiss ) 96-hr LC 50 = 14.3 μg/L Very highly toxic MRID 44502803

Chronic (EarlyLifeStage) Rainbow Trout NOAEC = 4.3 μg/L LOAEC = 7.7 μg/L Endpoint: Post-hatch survival -- MRID 44502804

Freshwater invertebrates Acute Water Flea ( Daphnia magna ) 48-hr EC 50 = 25.3 μg/L Very highly toxic MRID 44496611

Chronic Water Flea NOAEC = 2.76 μg/L LOAEC = 5.98 μg/L Endpoint: Dry weight and fecundity -- 44496615

Estuarine/marine fish Acute Sheepshead Minnow ( Cyprinodon variegatus ) 96-hr LC 50 = 78.0 μg/L Very highly toxic MRID 44496612

Estuarine/marine invertebrates Acute Mysid ( Americamysis bahia ) 96-hr EC 50 = 8.62 μg/L Very highly toxic 44496614

Aquatic plants and algae Vascular Duckweed ( Lemna gibba ) NOAEC = 410 μg/L 2 14-d EC 50 >1930 μg/L 2 -- MRID 44496725

Nonvascular Green Algae ( Pseudokirchneriella subcapitata ) NOAEC = 10.5 μg/L 5-d EC 50 = 37.1 μg/L -- MRID 44496724
1 Freshwater fish may be surroga tes for aquatic-phase amphibians. 2 These results are uncertain because the test material was uns table and renewals were not done, resulting in dramatic declines of the test material during the dur ation of the exposure period. The study was classified as Supplemental

. 

### Available toxicity data for CGA-321113, the major degradation product of trifloxystrobin, are given in Table 11. The data indicate that th is compound is much less toxic to fish, aquatic invertebrates, and algae than the parent com pound. CGA-321113 is classified as practically nontoxic to fish and aquatic invert ebrates on an acute basis. A supplemental life-cycle study with CGA-32113 established an NOAEC for chronic e ffects at 3.2 mg/L. The chronic toxicity endpoints derived from this study were greater th an 3 orders of magnitude greater than that obtained for this species when tested with the parent compound. Although the lack of evaluation of growth endpoints (dry weight or length) may make this study less sensitive than a study that adhered to the test guideline, the study provide s sufficient evidence to conclude that this degradation product has much less chroni c toxicity than the parent compound.

###  Page 23 of 58 Table 11. Summary of the Most Sensitive Endpo ints from Aquatic Toxicity Studies for CGA-321113

Taxonomic Group Study Type Surrogate Species Toxicity Value (all units in terms of measured active ingredient) Acute Toxicity Classification Source (MRID No.)

Freshwater fish 1 Acute Rainbow trout 96-hr EC 50 > 106 mg/L Practically nontoxic 44527502

Freshwater invertebrates Acute Water Flea ( Daphnia magna ) 48-hr EC 50 > 95.3 mg/L Practically nontoxic 44527503

Chronic Water Flea NOAEC= 3.2 mg/L 2
LOAEC= 10.0 mg/L 2 Endpoint: Survival -- 44869701

Aquatic plants and algae Nonvascular Green Algae ( Pseudokirchneriella subcapitata ) NOAEC = 15.7 mg/L 5-d EC 50 = 77.1 mg/L -- 44496724

1 Freshwater fish may be surroga tes for aquatic-phase amphibians. 2 This study was classified as Supplemental because it did not follow the experimental design prescribed by the test guideline. The study did not evaluate growth parameters (dry weight or length) and thus the results may not be as sensitive as a fully acceptable study.



### 7.2 Effects to Terrestrial Organisms

All available acute oral and subacute dietary stud ies indicate that trifloxystrobin is practically nontoxic to birds, mammals, and bees on an acu te basis. Acute testing with the rat ( Rattus norvegicus ) show that acute toxicity to mammals fr om the dermal and inhalation routes of exposure is also low. With chronic exposure, trifloxystrobin did not cau se any observable toxic effect to birds at dietary concentrations up to 32 0 mg a.i./kg-diet. Chroni c toxicity to birds at exposures greater than 320 mg a i/kg-diet is not known; however, maximum residues on terrestrial food items are not expected to reach this concen tration with current registered uses. Chronic toxicity studies with the laborat ory rat showed frank toxic effect s to adult and young with chronic exposures of 750 mg a.i./kg-diet and above, with an NOAEL established at 500 mg a.i./kg-diet. No reproductive impairment, however, was noted in rats exposed to up to 1500 mg a.i./kg-diet. Testing with the honey bee found th at trifloxystrobin is practica lly nontoxic to bees. Tier-1 phytotoxicity studies found that e xposure of trifloxystrobi n to terrestrial plants at approximately 0.25 lb a.i./A caused some inhibition of growth ( no more than 13% inhibition). These studies are adequate for demonstrating that most uses of tr ifloxystrobin would have lit tle toxicity to target plants that are sprayed directly at the maximum label application rate. However, these tier-1 studies are not adequate for pred icting risk to plants from use on turf, for which the maximum single application rate is 0.34 lb a.i./A.

###  Page 24 of 58 Table 12. Summary of the Most Sensitive E ndpoints from Terrestrial Toxicity Studies for Trifloxystrobin

Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in terms of

measured active ingredient) Acute Toxicity Classification Source (MRID No.)

Birds 1 Acute Bobwhite ( Colinus virginianus ) LD 50 > 2000 mg/kgbw Practically nontoxic 44496606

Sub-acute dietary Bobwhite and Mallard ( Anas platyrhynchos ) LC 50 > 5050 mg/kgdiet Practically nontoxic 444966-07 444966-08

Chronic Bobwhite quail NOAEC = 320 ppm LOAEC > 320 ppm -- 444966-09

Mammals Acute Oral Laboratory rat ( Rattus norvegicus ) LD 50 > 5000 mg/kgbw practically nontoxic 44496622

Acute Dermal Laboratory rat LD 50 > 2000 mg/kgbw ToxicityCategory IIIIV 44496627

Acute Inhalation Laboratory rat LC 50 > 4.65 mg/L Toxicity Category IV 44496630

Chronic (2-Gen. Repro.) Laboratory rat ( Rattus norvegicus ) Parental: NOAEL: 50 ppm LOAEL: 750 ppm Endpoint: Reduced body weight, body weight gain, and food consumption

Offspring: NOAEL: 50 ppm LOAEL: 750 ppm Endpoint: Reduced body weight

Reproduction: NOAEL: 1500 ppm LOAEL: >1500 ppm -- 44496710

Insects Acute
contact Honey bee ( Apis mellifera L. ) LD 50 > 200 μg/bee Practically nontoxic 444967-26

Terrestrial plants Seedling Emergence Dicot – cabbage 13% inhibition in dry weight at 0.249 lb a.i./A -- 44496723
Monocot –
ryegrass 7% inhibition in dry weight at 0.249 lb a.i./A

###  Page 25 of 58 Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in terms of

measured active ingredient) Acute Toxicity Classification Source (MRID No.)

Vegetative vigor Dicot – tomato 10% inhibition in dry weight at 0.249 lb a.i./A 44496723
Monocot –
ryegrass 9% inhibition in dry weight at 0.249 lb a.i./A

1 Birds represent surrogates for terrest rial-phase amphibians and reptiles.
2 Study was conducted with USF 2004 500 SC (43.9% trifloxy strobin). Results were adjusted for the percent a.i.



### No in vivo studies are available on th e toxicity of CGA-321113 to terrestrial organisms. However, an in vitro study of this compound using rat hepatocyte cultures has been submitted to the EPA (MRID 44496720). This study found th at CGA-321113 does not express the toxic mechanism of action of the parent compound, i.e ., inhibition of mitochondrial respiration, and is much less toxic to hepatocyte cells than is the parent. The NOAEL was 600 μM for CGA-321113 compared to <30 μM for trifloxystrobin. These resu lts agree with the findi ngs of aquatic toxicity studies which also showed that CGA-321113 is mu ch less toxic to anim als and plants than trifloxystrobin.

7.3 Ecological Incidents

The ecological incident information system (E IIS) was queried in October 2012 for incidents linked to trifloxystrobin exposure. EIIS is an OPP database that houses ecological incidents that have been reported to the Agency. When availa ble, EIIS includes date and location of an incident, type and magnitude of effects observed in various species, use(s) of pesticides known or suspected of contributing to the incident, and resu lts of any chemical residue analysis or other analyses conducted during incident investigation. EIIS incidents are categoriz ed according to the certainty that the incident resulte d from pesticide exposure.

The query of EIIS identified 18 ecological incide nts that were associated with trifloxystrobin exposure. These incidents are summarized in Ap pendix D. Seventeen of the incidents involved damage to a crop after direct a pplication of a product containing trifloxystrobin to the crop. One of these incidents (I016036-004) was attributed to contamination of the tank mixture with an herbicide, and the exposure to tr ifloxystrobin was thought to be unrelated to the damage. Other than this incident (which was assigned a certainty of “unlikely” ), 4 incidents were assigned a certainty of “possible” and 12 incidents we re assigned a certainty of “probable” for trifloxystrobin. Some of the “possible” incident s also involved exposure to a second pesticide, and thus the cause was uncertain. Plants that were damaged in these trifloxystrobin incidents include grape, wheat, leatherleaf fern, and other ornamental plants . While these incidents do not necessarily indicate risk to plants growing off the treatment site, they do demonstrate that trifloxystrobin can be toxic to some sensitive plants.

There was one incident involving bee mortalit y, which was associated with exposure to trifloxystrobin and othe r pesticides (I022340-001). Trifloxystr obin was one of nine pesticides identified in the bee pollen collected from the affected hives. One of the pesticides was

###  Page 26 of 58 

### clothianidin, an insecticide which is highly toxic to bees. This insecticide is believed to be the primary cause of the bee kill, with possible cont ribution of toxicity from a second insecticide, thiamethoxam. Exposure to the other seven pest icides, including trifl oxystrobin, was thought to be incidental to the incident a nd was assigned a certainty level of “unlikely.” Thus, this incident does not indicate that trifloxys trobin is toxic to bees.

Registrants of trifloxystrobin have reported 7 additional minor plant damage incidents in aggregated reports submitted to the EPA. Th ese incidents occurred between 2006 and 2012. No additional information is available on these inci dents. Unless additional information on these aggregated incidents becomes available, they will be assumed to be representative of registered uses of trifloxystrobin in the risk assessment.

The Avian Monitoring System (AIMS) is a da tabase administered by the American Bird Conservancy that contains publicly availabl e data on reported avia n incidents involving pesticides. Many of the incidents li sted in this database are also in the EIIS. As of October 2012, AIMS did not contain any records of ecologi cal incidents associat ed with exposure to trifloxystrobin.



## 8.0 Exposure Pathways of Concern

Based on the use pattern and environmental fate ch aracteristics of this pesticide, the following exposure pathways are expected to be most rele vant for determining exposure and potential risk to nontarget organisms:

 Direct spray

 Spray drift

 Runoff

 Consumption of treated wildlife food items

All of these routes of exposure ar e relevant for foliar spray applica tions. For seed treatments and drench applications, only runoff and consumpti on of contaminated food items are relevant.

Trifloxystrobin is moderately to highly lipophilic (log K ow 

### 4.5) and the bioconcentration factors measured in fish are moderate (BCFs 542- 547x for whole fish and 1172-1144x for nonedible tissue). However, the rapid degradation of this compound is expected to preclude the potential for bioaccumulation in aquatic ecosystems. Ther efore, use of the KABAM model to model bioconcentration of tr ifloxystrobin through the aquatic food chain will not be necessary.

Due to the low persistence, low solubility, and re latively low mobility, trifloxystrobin has little potential for contamination of groundwater. Therefore, movement through groundwater and irrigation from groundwater sources are not expected to be a significant route of exposure. The degradation product of trifloxys trobin, CGA-321113, is expected to leach, but it has very low toxicity and is therefore not cons idered to be an environmental st ressor. Likewise, due to the low persistence and low volatility, expo sure from atmospheric deposition is expected to be minimal.

Drinking water and inhalation e xposure pathways were screen ed using the SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods and were

###  Page 27 of 58 

### found to be exposure pathways of low concern (no LOC exceedances are expected). SIP and STIR are described in detail at: http://www.epa.gov/oppefed1/m odels/terrestrial/index.htm . The SIP model determined that, based on the solubility and toxicity of trifloxystrobin, drinking water exposure alone does not have potenti al to be a pathway of concern for acute or chronic risk to wildlife. Likewise, the STIR model determined th at, based on the vapor pr essure and toxicity of trifloxystrobin, inhalation exposur e alone does not have potential to be a pathway of concern for acute or chronic risk to wildlife. Thus, neith er drinking water nor i nhalation exposure will be included in the risk assessment for terrestrial anim als. Output from the SIP and STIR models are provided in Appendix C.



## 9.0 Analysis Plan

9.1 Stressors of Concern

Ecological Risk Assessment

The only stressor of ecological concern is the parent compound, trifloxystrobin. The primary environmental transformation product, CGA-321113, ha s been shown to be much less toxic than trifloxystrobin and therefore is not considered an eco logical stressor. Mo del input values for aquatic exposure are summarized in Table 7.

Drinking Water

The Health Effects Division (HED) has previously determined that parent trifloxystrobin and the degradation product CGA-321113 should be considered as the residues of concern (ROC) for drinking water. Therefore any drinking water assessments conducted to support future human health risk assessments of tr ifloxystrobin will incorporate mode l estimates of trifloxystrobin residues of concern and any av ailable monitoring data, whic h are parent compound and the degradation product CGA-321113. For drinking water th e Total Toxic Residue approach is used which considers the persistence (half-life) of trifloxystrobin plus CGA-321113 and the most mobile chemical species. The values used for the drinking water assessment are summarized in Table 8.

EFED will use standard available models 3 

### to evaluate potential exposur e to pesticides in surface water (PRZM and EXAMS) and ground wate r (PRZM-GW) sources as described at http://www.epa.gov/pesticides /science/models_db.htm

. The versions used by the Agency at the time the risk assessment is completed will be used in the assessment.

9.2 Measures of Exposure

EFED will use standard mode ls and methodology to evaluate potential exposures of trifloxystrobin to aquatic and terrestrial organisms. Exposure to aquatic animals will be estimated

3 PRZM and EXAMS are Tier II models used to estimate e nvironmental exposure concentrations in surface water. A

description of these models and the guidelines for selecting input parameters can be found at http://www.epa.gov/oppefed1/models/water/

###  Page 28 of 58 

### using the Pesticide Root Zone Model (PRZM) c oupled with the Exposure Analysis Model System (EXAMS). EFED will use the most current version of these models available at the time of the assessment. EFED’s PE5 program will be used as the user interface to manage parameter inputs and to run these models. For ecological risk, th e aquatic EECs will be determined for parent trifloxystrobin. Model i nput values are summarized in Tabl e 7. Exposure to terrestrial animals will be estimated using the most current versi on of the Terrestrial Residue Exposure (T-REX) model. Exposure to terrestrial plants will be estimated using the most current version of the TerrPlant model. These models are described at http://www.epa.gov/pesticides/science/models_db.htm

. Aquatic and terrestrial exposure will be modeled assuming the ma ximum single application rates and the maximum number of applications in a gi ven year. Estimates will be made for uses or groups of uses that have unique site-specific model inputs, such as maximum application rate, number of applications, and appl ication intervals, as given in Table 1 

### . For uses of trifloxystrobin other than seed treatment, exposure will be asse ssed for ground applications and, as permitted per the labels, aerial applications. Ground applicati on will be assumed to be made with an airblast sprayer for tree and vine crops, and by boom sp rayer for other agricultu ral crops. Exposure estimates for aquatic animals and terrestrial plants will be based on exposure for runoff and spray drift. Exposure estimates for terrestrial animal s will be based on the dietary dose obtained from consuming food items directly sp rayed with trifloxystrobin.

For seed-treatment uses, exposure will be asse ssed based on the maximum seed treatment rates ( i.e ., maximum pounds of a.i. applied to pound of seeds) and the ranges of expected seeding rate (lb seed/A) for selected major cr ops, as shown in Table 3. A scr eening-level risk assessment first will be conducted based on the predicted maximu m application rates (lb a.i./A), which are calculated by multiplying the maximum seed-tre atment rates by the maximum seeding rates (Table 3). If the screening level a ssessment indicates potential risk ( i.e. , exceeds the level of concern) for these maximum application rates, then risk based on the entire range of seeding rates will be considered. For seed treatment uses, exposure to terrestrial plants and all aquatic organisms will be based on the calculated maximu m application rates, and will assume exposure from runoff but not spray drift. For terrestrial animals, the calculated maximum application rate will be used to estimate the LD 50 

### -per-square-foot risk index. This index is calculated by dividing the amount of a.i. available per square foot of planted cropland by the acute LD 50 

### of trifloxystrobin. In addition, risk quotients will be calculated based on th e predicted dietary dose from direct consumption of treated seeds from a planted field. Finally, risk will be further characterized by calculating the number of treated seeds animals need to consume to reach a dose equal to the acute LD 50 

### and chronic NOAEL.

Screening level calculations have suggested that drinking water a nd inhalation exposure pathways will not be significant. Therefore, these exposure pathways will not be further considered at the time of the risk assessment.

9.3 Measures of Effect

Toxicity data presented in Section 3 of this pr oblem formulation will be used to calculate risk quotients. Any additional information submitted by th e registrant or found in the open literature prior to conduct of the risk assessment will also be considered. The open literature studies are

###  Page 29 of 58 

### identified using EPA’s ECOTOXicology database (ECOTOX) (USEPA, 2007 c ), which employs a literature search engine for locat ing chemical toxicity data for a quatic life, terrestrial plants, and wildlife. The evaluation of both sources of data can also pr ovide insight into the direct and indirect effects of pesticides on biotic communities from loss of species that are sensitive to the chemicals and from changes in structure and functional characteristics of the affected communities.

9.4 Endangered Species Assessments

Consistent with the Agency’s responsibility under the Endangered Species Act (ESA), the Agency will evaluate risks to federally threat ened and/or endangered (listed) species from registered uses of pesticides in registration re view. The process for evaluating potential risks to listed species is further described at http://www.epa.gov/oppfead1/enda nger/litstatus/riskasses.htm

.

9.5 Endocrine Disruptor Screening Program

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain su bstances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine eff ects as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required determinations. Tier 1 consists of a battery of 11 scr eening assays to identify the potential of a chemical substance to interact with the estrogen, andr ogen, and or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening a nd are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine related effect s caused by the substance, and establish a doseresponse relationship between the do se and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and water, residential activity, and certain po st-application agri cultural scenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Trifloxystrobin was not among the group of 58 pest icide active ingredients that received EDSP test orders. For information on the status of the orders issued under the EDSP for each chemical, please visit our website at http://www.epa .gov/endo/ and click on the "Status of EDSP Orders/DCIs" in the Highlights Box. Additiona l information on the EDSP, including the policies and procedures, the list of 67 chemicals, the test guidelines and the Tier 1 screening battery, can also be found at this website.

###  Page 30 of 58 

## 10.0 Preliminary Identification of Data Gaps

10.1 Environmental Fate

Table 13 identifies environmental fate studies wi th trifloxystrobin that have been submitted for each guideline, as well as provides the classifica tions and whether further data are needed to support risk assessment. Table 14 provides in formation for studies conducted with the degradation product, CGA-321113. Rationale for the additional data requ ested is presented.

Table 13. Submitted Environmental Fate Data for Trifloxystrobin

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? 835.2120 Hydrolysis 4 4496727 Acceptable No 835.2240 Aqueous photolysis 44496727 Supplemental No

835.2410 Soil photolysis 44496728 Acceptable No 44496729 Acceptable 835.4100 Aerobic soil metabolism 44496730 44496731 44496732 Acceptable No Acceptable Acceptable 835.4200 Anaerobic soil metabolism No study No

835.4300 Aerobic aquatic metabolism 44496734 Supplemental No

835.4400 Anaerobic aquatic metabolism 44496733 Acceptable No

835.1230 835.1240 Adsorption/ desorption and leaching 44496802 Acceptable No 44496803 Supplemental 835.1410 Volatility – laboratory No study No 835.6100 Terrestrial field dissipation 44496897 Supplemental No 44657203 Supplemental 44496808 Supplemental 44757204 Supplemental 44496809 Supplemental 44757205 Supplemental 850.6100 Analytical method in soil 44496811 No

850.6100 Analytical method in
water 44757206 In Review

835.6200 Aquatic field dissipation 45080803 Supplemental No 44496814 Supplemental 44496810 44496811 44496815

###  Page 31 of 58 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? 165-4 (850.1730) Fish bioconcentration 44496813 Supplemental No



### Table 14. Submitted Environmental Fate Data for the Trifloxystrobin Degradate, CGA-321113

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct risk assessment? 835.2120 Hydrolysis 4 4496727 Acceptable No 835.2240 Aqueous photolysis 44496727 Supplemental No 835.2410 Soil photolysis 44496728 Acceptable No 44496729 Acceptable 835.1230 835.1240 Adsorption/ Desorption 44496801 Acceptable No

835.4100 Aerobic soil metabolism 44496730 44496731 44496732 Acceptable No Acceptable Acceptable 835.4300 Aerobic aquatic metabolism 44496734 Supplemental No

835.4400 Anaerobic aquatic metabolism 44496733 Acceptable No

835.6200 Aquatic Field Dissipation 45080803 Supplemental No 835.1230 Adsorption/ desorp tion 44496801 Acceptable No



### 10.2 Effects

Tables 15 and 16 identify studies that have been submitted on the ecological effects of trifloxystrobin to aquatic and terrestrial organisms, respectively. These tables also provide the classifications of these studies and indicate whether further da ta are needed to support risk assessment. The ecological effects database for trifloxystrobin is complete except for the following studies, which are needed for ecological risk assessment:

 Guideline 850.4500, Algal Toxicity (The guideline is satisfied for freshwater green algae, but additional testing is needed for a, a fr eshwater diatom, and a saltwater diatom.)

 Guideline 850.4550, Cyanobacteria Toxicity (Add itional testing is needed for a bluegreen algae.)

 Guideline 850.4100, Terrestrial Plant T oxicity, Seedling Emergence Test

 Guideline 850.4150, Terrestrial Plant T oxicity, Vegetative Vigor Test

The algal toxicity testin g with four species is needed for assessing risk for all outdoor uses of trifloxystrobin. To date, acceptable data ha ve been provided for only one of the four recommended algal species ( Selenastrum capricornutum ). This study showed that trifloxystrobin

###  Page 32 of 58 

### is toxic to algae at fairly low concentrations (EC 50 

### = 37.1 μg/L), and is considerably more toxic to algae than it is to vascular a quatic plants like duckweed (EC 50 

### > 1930 μg/L). Algal toxicity data are available for a closely related fungicidal active ingredient, kres oxim-methyl (PC Code 129111). For this chemical, the algal toxicity leve ls were highly variable among species, ranging from 29.2 to > 233 μg a.i./L. The most sensitive species was Navicula pelliculosa (EC 50 

### = 29.2 μg/L), which was more sensitive than Selenastrum capricornutum (EC 50 

### = 55.1 μg/L). Therefore, obtaining additional toxicity data for trifloxystrobin with other algal species may result in a lower endpoint than was obtained with Selenastrum capricornutum and may alter the risk conclusions for aquatic plants.

The two terrestrial plant toxicity studies are needed only for assessing risk from uses of trifloxystrobin with maximum singl e-application rates greater than 0.25 lb a.i./A. Currently only turf uses are registered with si ngle-application rates above this level (maximum rate for turf uses is 0.34 lb a.i./A). As discussed in Section 7.3, 12 incidents of plant damage have been reported that have been attributed to exposure to trifloxys trobin, with a certainty leve l of “probable.” This indicates that trifloxystrobin has the potential to be phyt otoxic to sensitive pl ants. Furthermore, the phytotoxicity studies which have been subm itted found some inhibition of plant growth in plants treated at a rate of 0.249 lb a.i./A (7- 13% inhibition compared to the control). Thus, exposure at the 0.34 lb a.i./A rate could potentially result in in hibition above the 25% threshold for concluding risk to terrestrial plants.

Table 15. Submitted Aquatic Ecological Effects Data for Trifloxystrobin

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct

risk assessment? Comments

850.1010 Freshwater invertebrate acute toxicity 44496611 Acceptable No --

850.1035 850.1045 Saltwater
crustacean acute toxicity 44496614 Acceptable No --

850.1025 850.1055 Saltwater bivalve acute toxicity 44496613 Acceptable No --

850.1075 Freshwater fish acute toxicity 44502802 Acceptable No -- 44502803 Acceptable

850.1075 Saltwater fish acute toxicity 44496612 Acceptable No --

850.1300 Freshwater invertebrate life cycle 44496615 Acceptable No --

###  Page 33 of 58 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct

risk assessment? Comments

850.1350 Saltwater invertebrates life cycle -- -- No Chronic toxicity testing with a saltwater invertebrate was waived in 2011 because trifloxystrobin rapidly degrades in water to a degradation product with low toxicity, and because a risk assessment based on previously calculated aquatic EECs and a mysid EC 05 estimated using the ACR method indicated that the chronic risk quotient would be below the LOC (see D389402)

850.1400 Freshwater fish early-life stage 44502804 Acceptable No --

850.1400 Saltwater fish early-life stage No The acute toxicity data indicate that the freshwater test species (rainbow trout) is more sensitive to trifloxystrobin than the saltwater fish species (sheepshead minnow). Therefore, results of the rainbow trout early-life stage study should be protective of saltwater species as well. 850.1500 Fish life cycle No A fish full life-cycle study is not required because trifloxystrobin degrades rapidly in aerobic and anaerobic aquatic environments (half-lives < 1 day) and because previous risk assessments (based on the fish early-life stage toxicity endpoint) have found that the chronic RQ for fish is less than 1. 850.4400 Aquatic plant toxicity test using Lemna
spp. 44496725 Supplemental No The study was classified as Supplemental because the test material was unstable. Because the test solutions were not renewed, concentrations of the test material declined dramatically during the exposure period. Nevertheless, the results demonstrate that duckweed is likely less sensitive to trifloxystrobin than is algae. Therefore this test does not need to be repeated

###  Page 34 of 58 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed to conduct

risk assessment? Comments

850.4500 Algal Toxicity 44496724

45561701 Acceptable

Invalid Yes The submitted study with Selenastrum capricornutum was acceptable, but satisfies the test guideline only for testing of freshwater green algae. Testing is also needed with a bluegreen alga, a freshwater diatom, and a saltwater diatom. 850.4550 Cyanobacteria Toxicity None None Yes Testing is also needed with a bluegreen alga



### Table 16. Submitted Terrestrial Ecol ogical Effects Data for Trifloxystrobin

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Current Additional Data Need

850.2100 Avian oral toxicity 44496605 Acceptable No An acu te toxicity study with a passerine is not requested because acute and subacute testing with the bobwhite and mallard indicate that trifloxystrobin is practically nontoxic to birds. Considering the low use rates of trifloxystrobin, acute risk to passerine birds is extremely unlikely. 44496606 Acceptable

850.2200 Avian dietary toxicity 44496607 Acceptable No -- 44496608 Acceptable

850.2300 Avian reproduction 44496609 Acceptable No -- 44496610 Acceptable

Nonguideline Avian inhalation -- -- No The STIR model determined that inhalation exposure alone does not have potential to be a pathway of concern for acute or chronic risk to wildlife. 850.3020 Honey bee
acute contact toxicity 44496726 Acceptable No --

850.3030 Honey bee residue on foliage -- -- No Because trifloxystrobin was found to be practically nontoxic to bees on an acute basis, and does not have a mode of action that suggests reproductive or developmental effects in insects would be likely, higher tier testing with bees is not required. 850.3040 Field testing for pollinators -- -- No

###  Page 35 of 58 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Current Additional Data Need

850.4100 Terrestrial plant toxicity: Tier I seedling
emergence 44496723 Acceptable Yes While these submitted tier-1 studies are acceptable for showing lack of phytotoxicity for uses with application rates up to 0.25 lb a.i./A, new tier-1 plant toxicity studies are needed that test plants up to the 0.34 lb a.i./A, the maximum application rate for use on turf. 850.4150 Terrestrial plant toxicity: Tier I vegetative vigor 44496723 Acceptable Yes



### The only degradation product of trif loxystrobin that is expected to occur in the environment in significant quantities is CGA-32111 3. Information on available in vivo toxicity studies is provided in Table 17. While these studies have deficiencies that introduce uncerta inty in their findings, they are adequate to show that this degradation product is mu ch less toxic than the parent compound. Toxicity endpoints in these st udies were over three orders of magnitude greater than those for trifloxystrob in (see Tables 7 and 8). This conclusion is further supported by the findings of an in vitro cytotoxicity study using rat hepatocyte cultures (MRID 44496720). This study found that CGA-321113 is much less toxic to hepatocyte cells than trifloxystrobin and does not cause inhibition of ce llular respiration as does the pa rent compound. Taken together, these studies provide adequate evidence that CGA-321113 exhibits much less toxicity to nontarget organisms than does the parent compound, trifloxystrobin. Theref ore, this degradation product will not be considered a stressor of concern in the ecologica l risk assessment for trifloxystrobin, and no additional toxi city data on CGA-321113 are needed.

Table 17. Aquatic Ecological Effects Data for the Trifloxystrobin Degradate, CGA-321113

OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Current Additional Data Need

850.1010 Freshwater invertebrate acute toxicity 44527503 Supplemental No Although water parameters deviated from ranges recommended by our test guidelines, the study is sufficient to demonstrate that this degradation product is practically nontoxic to freshwater invertebrates and is significantly less toxic than the parent compound.

850.1075 Freshwater fish acute toxicity 44527502 Supplemental No Although water parameters deviated from ranges recommended by our test guidelines, the study is sufficient to demonstrate that this degradation product is practically nontoxic to freshwater fish and is significantly less toxic than the parent compound.

###  Page 36 of 58 OCSPP Guideline Data Requirement Submitted Studies (MRID) Study Classifications Are data needed for risk assessment? Current Additional Data Need

850.1300 Freshwater invertebrate life cycle 44869701 Supplemental No This study did not follow the experimental design prescribed by the test guideline and did not evaluate growth parameters (dry weight or length). It nevertheless provides evidence that the chronic toxicity of this degredation product is much less than that of the parent compound. 850.5400 Aquatic Plant Growth: Tier II algae 4452704 Supplemental No Although water parameters deviated from ranges recommended by our test guidelines, the study is sufficient to demonstrate that this degradation product has much less toxicity to algae than the parent compound.



## 11.0 References

USEPA. 2004. Overview of the Ecological Risk Assessm ent Process in the Office of Pesticide Programs . United States Environmental Protection Agency (USEPA). Environmental Fate and Effects Division. Office of Pesticide Programs. Available at http://www.epa.gov/espp/consultation/ecorisk-overview.pdf

.

### 37 

## 12.0 Appendices


# Appendix A

Screening Level Usage Analysis (SLUA) Trifloxystrobin (129112) Date: 15 May 2012

What is a Screening Level Usage Analysis (SLUA)?

 Available estimates of pesticide usage data for a particular active ingredient that is used on agricultural crops in the United States.

 Pesticide usage data obtained from various sources. The data are then merged, averaged, and rounded so that the presente d information is not proprietary, business confidential, or trade secret. What does it contain?

 Pesticide usage data for a single active ingredient only.

 Agricultural use sites (cr ops) that the pesticide is reported to be used on.

 Available pesticide usage information from U. S. states that produce 80% or more of a crop, in most cases, or less than 80%, in rare cases, depending on the scope of the survey and available resources.

 Annual percent of crop treated (average & maximum) for each agricultural crop.

 Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United States). What assumptions can I make about the reported data?

 Average pounds of active ingredient applied - Values are calculated by merging pesticide usage data sources together; averaging across all observations, then rounding. Note: If the estimated value is less th an 500, then that value is labeled <500. Estimated values between 500 & <1,000,000 are rounded to 1 significant digit. Estimated values of 1,000,000 or grea ter are rounded to 2 significant digits.)

 Average percent of crop treated - Values are calculated by merging data sources together; averaging by year, averaging acr oss all years, & rounding to the nearest multiple of 5. Note: If the estimated value is less than 2.5, then the value is labeled <2.5. If the estimated va lue is less than 1, then th e value is labeled <1.

 Maximum percent of crop treated - Value is the single maximum value reported across all data sources, across all years, & rounded up to the nearest multiple of 5. Note: If the estimated valu e is less than 2.5, then th e value is labeled <2.5. What are the data sources used?

 USDA-NASS (United States Department of Agriculture’s National Agricultural Statistics Service) – pesticid e usage data from 2003 to 2010.

 Private pesticide market research – pesticide usage data from 2003 to 2010.

 California Department of Pesticide Regu lation (DPR) Pesticide Use Reporting (PUR) data for 2003 to 2010. What are the limitations to the data?

 Additional registered uses may exist but are not included because the available surveys do not report usage (e.g., small acreage crops).

### 38  Lack of reported usage data for the pesticide on a crop does not imply zero usage.

 Usage data on a particular site may be noted in data sources, but not quantified . In these instances, the site would not be reported in the SLUA.

 Non-agricultural use sites (e.g., turf, post-ha rvest, mosquito control, etc.) are not reported in the SLUA. A separate request must be made to receive these estimates.

 Some sites show some use, even though they are not on the label. This usage could be due to various factors, including, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors , and experimental use permits (EUPs).

### 39 15 May 2012 Screening Level Estimates of Agricult ural Uses of Trifloxystrobin (129112) Reporting Time: 2003-2010 Percent Crop Treated Crop Lbs. A.I. Average Maximum

1 Almonds 3,000 5 10

2 Apples 9,000 25 35

3 Apricots <500 10 20

4 Cantaloupes 1,000 10 15

5 Celery 1,000 20 30

6 Cherries 2,000 15 30

7 Corn 60,000 <2.5 <2.5

8 Cotton (Seed Treatment) <500 5 10

9 Cucumbers <5 00 <1 <2.5

10 Dry Beans/Peas <500 <1 <2.5

11 Grapefruit 3,000 20 40

12 Grapes 20,000 25 40

13 Hazelnuts 2,000 55 75

14 Nectarines ** <500 N/C N/C

15 Oranges 3,000 5 10

16 Peaches <500 <2.5 5

17 Peanuts 10,000 10 15

18 Peanuts (Seed Treatment) 1,000 5 10

19 Pears 1,000 15 30

20 Pecans 10,000 15 20

21 Peppers 1,000 5 10

22 Pistachios 1,000 10 15

23 Plums/Prunes <500 <2.5 <2.5

24 Potatoes <500 <1 <2.5

25 Pumpkins <500 5 15

26 Rice 50,000 10 20

27 Soybeans 30,000 <1 <2.5

28 Soybeans (Seed Treatment) 9,000 5 10

29 Squash <500 <2.5 5

30 Strawberries <500 5 5

31 Sugar Beets 7,000 5 10

32 Tangelos <500 <1 <2.5

33 Tangerines <500 5 10

34 Tomatoes <500 <1 <2.5

35 Walnuts <500 <1 <2.5

### 40 36 Watermelons 1,000 5 10

37 Wheat 30,000 <2.5 <2.5

All numbers rounded. <500 Less than 500 pounds of active ingredient <2.5 Less than 2.5 percent of crop treated

<1 Less than 1 percent of crop treated N/C Not calculated

** Based on CA DPR data only (valid because a majority of U.S. acres grown are in California) ++ Crops not known to be listed on active end use product registrations or as Section 18 emergency exemptions when this report was run

SLUA data sources include: USDA-NASS (United States Departme nt of Agriculture's National Agricultural Statistics Service) Private Pesticide Market Research California DPR (Department of Pesticide Regulation)

These results reflect amalgamated data developed by the Agency and are releasable to the public.

### 41 

## Appendix B Trifloxystrobin Bibliography PART A: Ecological Effects



## Avian Single Dose Oral Toxicity

MRID Citation Reference

44496605 Palmer, S.; Beavers, J. (1996) An Acute Oral Toxicity of CGA-279202 with the Mallard: Lab Project Number: 108-381: 116-96. Unpublished study prepared by Wildlife International Ltd. 41 p.

44496606 Redgrave, V. (1995) Acute Oral Toxicity (LD50) of CGA-279202 to the Bobwhite Quail: Lab Project Number: 703/942994: 479-94. Unpublished study prepared by Huntingdon Research Centre. 37 p.



## Avian Dietary Toxicity

MRID Citation Reference

44496607 Rodgers, M. (1995) Subacute Dietar y Toxicity (LC50) of CGA-279202 to the Bobwhite Quail: Lab Project Number: 700/942798: 480-94. Unpublished study prepared by Huntingdon Research Centre. 34 p.

44496608 Rodgers, M. (1995) Subacute Dietar y Toxicity (LC50) of CGA-279202 to the Mallard Duck: Lab Project Number: 701/942791: 481-94. Unpublished study prepared by Huntingdon Research Centre. 34 p.



## Avian Reproduction

MRID Citation Reference

44496609 Rodgers, M. (1996) CGA-279202: E ffects on Reproduction in Bobwhite Quail after Dietary Administration: Lab Project Number: 712/952489: 478-94: CBG 712. Unpublished study prepared by Huntingdon Life Science, Ltd. 258 p.

44496610 Mitchell, L.; MacGregor, J.; Beavers, J. et al. (1996) CGA-279202: A Reproduction Study with the Mallard: Lab Project Number: 108-382: 117-96. Unpublished study prepared by Wildlife International Ltd. 178 p.

### 42 

## Acute Toxicity to Freshwater Fish

MRID Citation Reference

44502802 Rufli, H. (1997) Acute Toxicity Test of CGA-279202 to Bluegill (Lepomis macrochirus) Under Flow-Through Conditions: Lab Project Number: 963541: 723-97: 23788. Unpublished study prepar ed by Novartis Crop Protection AG. 63 p.

44502803 Rufli, H. (1997) Acute Toxicity Test of CGA-279202 to Rainbow Trout (Oncorhynchus mukiss) in the Flow-Through System: Lab Project Number: 963564: 484-96: 23788. Unpublished study prepared by Novartis Crop Protection AG. 56 p.

44527502 Rufli, H. (1996) Acute Toxicity Test of CGA-321113 (Metabolite of CGA279202) to Rainbow Trout (Oncorhy nchus mykiss) in the Flow-Through System: Lab Project Number: 953568: 787-95: AN2-95-02. Unpublished study prepared by Ciba-Geigy Limited. 45 p.



## Fish acute toxicity test, freshwater and marine

MRID Citation Reference

47567514 Dorgerloh, M. (2007) Acute Toxicity of Fluopyram & Trifloxystrobin SC 500 (250+250) G to Fish (Oncorhynchus myki ss) Under Static Co nditions. Project Number: M/294350/01/2, EBGMP030, E/280/3307/3. Unpublished study prepared by Bayer CropScience AG. 72 p. Reviewer Note: Fluopyram still pending registration on 10/02/11



## Acute Toxicity to Fr eshwater Invertebrates

MRID Citation Reference

44496611 Boeri, R.; Magazu, J.; Ward, T. ( 1997) Acute Toxicity of CGA-279202 to the Daphnid, Daphnia magna: Lab Project Number: 1116-CG: 133-94. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 30 p.

44527503 Neumann, C. (1996) Acute Toxicity Test of CGA-321113 ( Metabolite of CGA279202) to the Cladoceran Daphnia magna STRAUS Under Static Conditions: Lab Project Number: 953569: 785-95: AN2-95-02. Unpublished study prepared by Ciba-Geigy Limited. 43 p.

45561701 Desjardins, D.; Kendall, T.; Krueger, H. (2001) Trifloxystrobin (CGA-279,202): A 96-Hour Toxicity Test with the Freshw ater Diatom (Navicula pelliculosa): Lab Project Number: 149-132A. Unpublished study prepared by Wildlife International, Ltd. 51 p. {OPPTS 850.5400}



## Aquatic invertebrate acute toxi city, test, freshwater daphnids

### 43 MRID Citation Reference

47567513 Bruns, E. (2007) Acute Toxicity of AE C656948 + Trifloxystrobin SC 250 + 250 G to the Waterflea Daphnia magna in a St atic Laboratory Test System. Project Number: M/292365/01/2, EBGMP031, 320/3236/9. Unpublished study prepared by Bayer CropScience AG. 73 p.

48055701 Grade, R. (1999) Acute Toxici ty of CGA 279202 Tech. to the Cladoceran Daphnia magna STRAUS in the Static System: Final Report. Project Number: 993543, MO/01/008203. Unpublished study prepared by Novartis Crop Protection, AG. 51 p.


## Acute Toxicity to Estuarine/Marine Organisms

MRID Citation Reference

44496612 Boeri, R.; Magazu, J.; Ward, T. ( 1996) Acute Toxicity of CGA-279202 to the Sheepshead Minnow, Cyprinodon varieg atus: Lab Project Number: 672-CG: 3- 95. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 30 p.

44496613 Boeri, R.; Magazu, J.; Ward, T. (1996) Acute Flow-Through Mollusc Shell Deposition Test with CGA-279202: Lab Project Number: 674-CG: 5-95: AT871B. Unpublished study prepared by T.R. Wilbury Labs., Inc. 31 p.

44496614 Boeri, R.; Magazu, J.; Ward, T. ( 1996) Acute Toxicity of CGA-279202 to the Mysid, Mysidopsis bahia: Lab Project Number: 673-CG: 4-95: AT871B. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 31 p.


## Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study

MRID Citation Reference

44496615 Boeri, R.; Magazu, J.; Ward, T. ( 1996) Chronic Toxicity of CGA-279202 to the Daphnid, Daphnia magna: Lab Project Number: 1117-CG: 134-94. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 44 p.

44502804 Rufli, H. (1997) Early-Life St age Toxicity of CGA-279202 to Rainbow Trout (Oncorhynchus mykiss) Using Newly Fe rtilized "Green" Eggs in a FlowThrough System: Lab Project Number: 943530: 483-96. Unpublished study prepared by Novartis Crop Protection AG. 103 p.

44869701 Memmert, U. (1998) Influence of CGA-321113 ( Metabolite of CGA-279202) on Survival and Reproduction of Daphnia Magna in a Semi-Static Test Over 22 Days: Lab Project Number: 690502: 1157-98: 690513. Unpublished study prepared by RCC Umweltchemie AG. 41 p.

### 44 

## Mysid chronic toxicity test

MRID Citation Reference

48424601 Ortego, L. (2011) Waiver Reques t for a Mysid Life-Cycle Study with Trifloxystrobin. Project Number: US01 68. Unpublished study prepared by Bayer CropScience LP. 4 p.



## Simulated or Actual Field Testing

MRID Citation Reference

44496616 Cairns, S.; Kennedy, J.; Melloh, A. et al. (1996) Assessment of the Potential Biological Effects of CGA-279202 Exposures on Aquatic Ecosystems as Measured in an Outdoor Fiberglass Tank System (Microcosms): Lab Project Number: CGA-279202: 94-96: 279202. Unpublished study prepared by Univ. of North Texas and ABC Laboratories, Inc. 951 p.

44496617 Cairns, S. (1997) Assessment of the Potential Biological Effects of CGA279202 Exposures on Aquatic Ecosystems as Measured in an Outdoor Fiberglass Tank System: Lab Project Number: 43274: 304-96: 279202. Unpublished study prepared by ABC Laboratories, Inc. 357 p.



## Seed Germination/Seedline Em ergence and Vegetable Vigor

MRID Citation Reference

44496723 Schwab, D. (1997) Evaluati ng the Effects of CGA-279202 on the Emergence and Vegetative Vigor of Non-Target Terrestrial Plants: Lab Project Number: 43964: 385-97. Unpublished study prepared by ABC Laboratories, Inc. 56 p.


## Terrestrial plant toxicity, Tier 1 (seeding emergence)

MRID Citation Reference

47567516 Gosch, H.; Nguyen, D. (2007) Non- target Terrestrial Plants: an Evaluation of the Effects of AE C656948 + Trifloxystrobin SC 250 + 250 g/L in the Seedling Emergence and Growth Test (Tier 1). Project Number: M/289525/01/2, SE07/03, EBGMP028. Unpublished study prepared by Bayer Cropscience AG. 20 p.

47567517 Gosch, H.; Nguyen, D. (2007) Non- target Terrestrial Plants: an Evaluation of

### 45 the Effects of AE C656948 + Trifloxystrob in SC 250 + 250 g/L in the Vegetative Vigour Test (Tier 1). Project Number: M/289527/01/2, VV07/03, EBGMP026. Unpublished study prepared by Bayer Cropscience AG. 19 p.



## Terrestrial plant toxicity, Tier 1 (vegetative vigor)

MRID Citation Reference

47567517 Gosch, H.; Nguyen, D. (2007) Non- target Terrestrial Plants: an Evaluation of the Effects of AE C656948 + Trifloxystrob in SC 250 + 250 g/L in the Vegetative Vigour Test (Tier 1). Project Number: M/289527/01/2, VV07/03, EBGMP026. Unpublished study prepared by Bayer Cropscience AG. 19 p.



## Aquatic plant growth

MRID Citation Reference

44527504 Grade, R. (1996) Growth Inhibition Test of CGA-321113 ( Metabolite of CGA279202) to Green Algae (Selenastrum capr icornutum) in a Static System: Lab Project Number: 953570: 786-95. Unpublished study prepared by Ciba-Geigy Limited. 43 p.



## Aquatic plant growth

MRID Citation Reference

44496724 Ward, T.; Magazu, J.; Boeri, R. (1996) Toxicity of CGA-279202 to the Freshwater Alga, Selenastrum capricornutum CGA-279202: Lab Project Number: 670-CG: 8-95. Unpublished study prepared by T.R. Wilbury Laboratories, Inc. 32 p.

44496725 Ward, T.; Magazu, J.; Boeri, R. (1996) Toxicity of CGA-279202 to the Duckweed, Lemna gibba G3: Lab Project Number: 671-CG: 7-95. Unpublished study prepared by T.R. Wilbur y Laboratories, Inc. 32 p.



## Algal toxicity, Tiers 1 and II

MRID Citation Reference

### 46 47567518 Dorgerloh, M. (2007) Pseudokirchneri ella subcapitata Growth Inhibition Test with Fluopyram & Trifloxystrobin SC 500 (250 + 250)G. Project Number: M/292579/01/2, EBGMP032, E/323/3111/4. Unpublished study prepared by Bayer CropScience AG. 61 p.



## Honey bee acute contact

MRID Citation Reference

44496726 Kleiner, R. (1995) Testing Toxicity of CGA-279202 to Honey Bee--Apis mellifera L: Lab Project Number: 95 10 48 023: 77 4-95. Unpublished study prepared by BioChem GmbH Karlsruhe 20 p.



## Honey bee acute contact toxicity

MRID Citation Reference

47567515 Schmitzer, S. (2007) Effects of AE C656948+trifloxystrobin SC 250+250 g/L (Acute Contact and Oral) on Honey Bees (Apis mellifera L.) in the Laboratory. Project Number: M/288193/01/2, 34491035, EBGMP034. Unpublished study prepared by Institut fuer Biologische Analytik und Consulting IBACON. 33 p.



## Earthworm subchronic toxicity test

MRID Citation Reference

47567519 Leicher, T. (2007) AE C656948 & Trif loxystrobin SC 250 & 250: Acute Toxicity to Earthworms (Eisenia fetida) Tested in Artificial Soil with 5 Percent Peat. Project Number: M/284363/01/2, LRT/RG/A/77/06, E/310/3224/5. Unpublished study prepared by Bayer CropScience AG. 24 p.

47567520 Leicher, T. (2007) AE C656948 & Trifloxystrobin SC 250 & 250 G: Effects on Survival, Growth and Reproduction on the Earthworm Eisenia fetida Tested in Artificial Soil with 5 Percent Peat. Project Number: M/283637/01/2, LRT/RG/R/28/06, E/312/3217/9. Unp ublished study prepared by Bayer CropScience AG. 43 p.



## Non Target Beneficial Insect Toxicity

MRID Citation Reference

47567521 Roehlig, U. (2007) Dose-response Toxicity (LR50) of AE C656948 & Trifloxystrobin SC 250 + 250 g/L to the Predatory Mite Typhlodromus pyri (Scheuten) Under Laboratory Condit ions. Project Number: M/283552/01/2, 06/10/48/190, EBGMP036. Unpublished study prepared by Biochem Agrar,

### 47 Labor fuer Biologische und Chemische. 26 p.

47567522 Roehlig, U. (2007) Dose-response Toxicity (LR50) of AE C656948 & Trifloxystrobin SC 250 + 250 g/L to the Parasitic Wasp Aphidius rhopalosiphi (Destefani-Perez) Under Laboratory Conditions: Final Report. Project Number: M/283599/01/2, 06/10/48/189, EBGMP037. Unpublished study prepared by Biochem Agrar, Labor fuer Bi ologische und Chemische. 25 p.

47567523 Barth, M. (2007) Dose-response To xicity of AE C656948 & Trifloxystrobin SC 250 + 250 to the Predatory Bug Orius laevigatus (FIEBER) (Heteroptera: Anthocoridae) Under Extended Laboratory Conditions. Project Number: M/297476/01/2, 07/10/48/049/A. Unpublishe d study prepared by Biochem Agrar, Labor fuer Biologische und Chemische. 31 p.

47567526 Barth, M. (2008) Toxicity of AE C656948 & Trifloxystrobin SC 250 + 250 to the Predatory Bug Orius laevigatus (FIEBER ) (Heteroptera: Anthocoridae) UnderExtended Laboratory Conditions Using Semi-field-aged Residues on Grapevine: Final Report. Project Number: M/297471/01/2, 07/10/48/005/A, EBGMP120. Unpublished study prepared by Biochem Agrar, Labor fuer Biologische und Chemische. 48 p.



## Non Guideline Selections

MRID Citation Reference
44496618 Pugsley, R.; Williams, W. (1997) Pr obabilistic Modeling of CGA-279202 Exposure to Aquatic Nontarget Organisms Associated with use on Six Crops: Turf, Cucurbits, Grapes, Potatoes, Apples, and Peanuts: Lab Project Number: WEI 242.20: 399-97. Unpublished study prepared by Waterborne Environmental, Inc. 212 p.
44496846 Warren, J. (1997) Terrestrial and Aquat ic Ecological Risk Assessment for: CGA279202: Lab Project Number: 738-97. Unpubl ished study prepared by Novartis Crop Protection, Inc. 9 p.

### 48 

## Trifloxystrobin Bibliography PART B: Environmental Fate



## Hydrolysis

MRID Citation Reference

44496727 Cohen, S. (1997) Photodegradat ion of (phenyl(A)-(U)-(carbon 14))-CGA279202 in an Aqueous Buffered Solution under Artificial Sunlight and Hydrolysis in pH 5, 7 and 9 Buffered Solution : Lab Project Number: ME 9600199: 273-96. Unpublished study prepared by Pittsburgh Environmental Research Laboratory, Inc. 399 p.



## Photodegradation-water

MRID Citation Reference

44496727 Cohen, S. (1997) Photodegradation of (phenyl(A)-(U)-(carbon 14))-CGA279202 in an Aqueous Buffered Solution under Artificial Sunlight and Hydrolysis in pH 5, 7 and 9 Buffer ed Solution: Lab Project Number: ME 9600199: 273-96. Unpublished study prepared by Pittsburgh Environmental Research Laboratory, Inc. 399 p.



## Photodegradation-soil

MRID Citation Reference

44496728 Cohen, S. (1997) Photodegrad ation of (phenyl(A)-U-(carbon 14))-CGA279202 on a Loamy Sand under Artificial Sunlight Irradiation: Lab Project Number: ME 9400174: 367-94. Unpublished study prepared by Pittsburgh Environmental Research Laboratory, Inc. 278 p.

44496729 Cohen, S. (1997) Photodegrad ation of (phenyl(B)-U-(carbon 14))-CGA279202 on a Loamy Sand under Artificial Sunlight Irradiation: Lab Project Number: ME 9500196: 31-95. Unpublis hed study prepared by Pittsburgh Environmental Research Laboratory, Inc. 398 p.



## Aerobic soil metabolism

MRID Citation Reference

44496730 Pike, S. (1997) Metabolism of (phenyl(B)-U-(carbon 14))-CGA-279202 in a Typical Sandy Loam Soil Under Aerobic Conditions: Lab Project Number:

### 49 1781.1295.6520.760: 670-95: 97-2-6873. Unpublished study prepared by Springborn Laboratories, Inc. 379 p.
44496731 Fackler, P. (1997) Metabolism of (phenyl(A)-U-(carbon 14))-CGA-279202 in a Typical Sandy Loam Soil Under Aerobic Conditions: Lab Project Number: 1781.1295.6518.760: 516-95. Unpublish ed study prepared by Springborn Laboratories, Inc. 462 p.
44496732 Fathulla, R. (1997) Aerobic So il Metabolism of (U)(carbon 14)-PhenylGlyoxylat-CGA-279202 in a Loamy Sand Soil: Lab Project Number: HWI 6117-268: 277-94. Unpublished study pr epared by Hazleton Wisconsin, Inc. 302 p. 44757201 McLaughlin, S. (1999) Metabolism of (Phenyl(B)-(car bon-14)-CGA-279202 in a Typical Sandy Loam Soil under Aerobic Conditions: Amended Final Report: Lab Project Number: 1781.1295.6520.00760: 670-958: 97-5-6. Unpublished study prepared by Springborn Laboratories, Inc. 401 p.



## Anaerobic aquatic metab.

MRID Citation Reference

44496733 Fathulla, R. (1996) Anaerobic A quatic Metabolism of (U)(carbon 14)-PhenylGlyoxylat-CGA-279202 in a Loamy Sand Soil/Water System: Lab Project Number: HWI 6117-266: 0278-94: 6117-266. Unpublished study prepared by Hazleton Wisconsin, Inc. 212 p.



## Aerobic aquatic metab.

MRID Citation Reference

44496734 Atkins, R.; Nixon, W.; Coody, P. (1997) Aerobic Aquatic Metabolism of (phenyl(A)-U-(carbon 14))-CGA-279202: Lab Project Number: 1057: 290-96. Unpublished study prepared by PTRL East, Inc. and Agvise Laboratories. 183 p.

45080802 Merritt, A. (2000) Response to the US EPA EFED OPP July 28, 1999 Review of the Trifloxystrobin Aerobic Aquatic Metabolism Study: Lab Project Number: 937-99: 1057. Unpublished study prepared by Novartis Crop Protection, Inc. 55 p.



## Aerobic aquatic metabolism

MRID Citation Reference

48441901 Kitschmann, P. (1997) Degradation and Metabolism of [Trifluoromethyl-Phenyl- (U)-(Carbon 14)] Labeled CGA 279202 in Two Aquatic Systems. Project Number: MO/01/001631, 95PK03. Unpub lished study prepared by Novartis

### 50 Crop Protection, AG. 149 p.

48441902 Ulbrich, R. (1997) Degradation and Metabolism of (U)-(Carbon 14)-PhenylGlyoxylat-Labeled CGA 279202 in Two Aquatic Systems. Project Number: 95UL02, MO/01/001628. Unpublished study prepared by Novartis Crop Protection, AG. 132 p.



## Leach/adsorp/desorption

MRID Citation Reference

44496801 Heim, L.; Velagaleti, R. (1997) Ad sorption-Desorption of (phenyl (A)-U-(carbon 14)-CGA-321113 in Soil: Lab Project Number: 43333: 274-96: ABC 43333. Unpublished study prepared by Analytical Bio-Chemistry (ABC) Labs., Inc. 387 p.

44496802 Heim, L.; Velagaleti, R. (1997) Soil Adsorption/Desorption of (carbon 14)-CGA279202 by the Batch Equilibrium Method: Lab Project Number: 42456: 69-95: ABC 42456. Unpublished study prepared by Analytical Bio-Chemistry (ABC) Labs., Inc. 371 p.

44496803 Fackler, P. (1997) (Phenyl(A)-U -(carbon 14)-CGA-279202 --Determination ofMobility in Seven Soils by the Aged-Soil Column Leaching Method and MiniSoil Metabolism Study on Each Soil: Lab Project Number: 437-95: 1781.0695.6507.780: 96-9-6691. Unpublishe d study prepared by Springborn Labs., Inc. 975 p.

44496804 Heim, L.; Velagaleti, R. (1997) Ad sorption-Desorption of (phenyl (B)-U-(carbon 14)-CGA-357276 in Soil: Lab Project Number: 43840: 210-97: ABC 43840. Unpublished study prepared by Analytical Bio-Chemistry (ABC) Labs., Inc. 348 p.

44496805 Heim, L.; Velagaleti, R. (1997) Ad sorption-Desorption of (phenyl (B)-U-(carbon 14)-CGA-357261 in Soil: Lab Project Number: 43839: 211-97: ABC 43839. Unpublished study prepared by Analytical Bio-Chemistry (ABC) Labs., Inc. 419 p.

44496806 Heim, L.; Velagaleti, R. (1997) Ad sorption-Desorption of (phenyl (B)-U-(carbon 14)-CGA-373466 in Soil: Lab Project Number: 43658: 397-96: ABC 43658. Unpublished study prepared by Analytical Bio-Chemistry (ABC) Labs., Inc. 430 p.

44496814 Heim, L.; Velagaleti, R. (1997) Mobility and Degradation of (phenyl (A)-U- (carbon 14)-CGA-279202 as Determined Using Field Lysimeters: Lab Project Number: 41925: 294-94: ABC 41925. Unpublished study prepared by Analytical Bio-Chemistry (ABC) Labs., Inc. 313 p.

44757202 Damon, A. (1999) Supplemental Inve stigation of the Adsorption-Desorption Properties of (carbon-14)-CGA-279202 to Soils Z and 144: Lab Project Number: 44775: 518-98. Unpublished st udy prepared by Analytical BioChemistry (ABC) Laboratories, Inc. 270 p.

### 51 

## Terrestrial field dissipation

MRID Citation Reference

44496807 Judy, D.; Manuli, P. (1997) Dissipation of CGA-279202 in Soil Under Field Conditions with and without Peanuts in Georgia: Final Report: Lab Project Number: 22-96: 43289: ABC 43289. Unpublished study prepared by Analytical Bio-Chemistry (ABC) Labs., Inc., Re search Options, Inc., and En-Cas Analytical Labs. 428 p.

44496808 Leppert, B.; Hofen, J. (1997) Terr estrial Field Dissipation Study for CGA279202 in New York: Lab Project Numb er: 23-96: SARS-96-NY-87: AG-654. Unpublished study prepared by Stewart Agricultural Research Services, Inc., ACDS Research, Inc., and EPL Bio-A nalytical Services, Inc. 450 p.

44496809 Belcher, T. (1997) Terrestrial Field Dissipation of CGA-279202 on Crop (Cucurbits) and Bare Soil in California: Lab Project Number: 24-96: 96574: ADPEN-901-24-96-001. Unpublished study prepared by ABC Labs., Califorinia, ADPEN Labs., Inc. and Plant Sciences, Inc. 287 p.

44757203 Winkler, D. (1998) Dissipation of CGA-279202 in Soil Under Field Conditions with and without Peanuts in Georgia: Addendum to Final Report: Lab Project Number: 22-96: 96-0067. Unpublished st udy prepared by EN-CAS Analytical Laboratories. 69 p.

44757204 Mayer, J.; Gold, B. (1998) Terrestrial Field Dissipation Study for CGA-279202 in New York: Final Report Addendum: Lab Project Number: 23-96: 110S37. Unpublished study prepared by EPL Bio-Analytical Services, Inc. 58 p.

44757205 Perez, R.; Gold, B. (1998) Terrestrial Field Dissipation of CGA-279202 on Crop (Cucurbits) and Bare Soil in California: Final Report Addendum: Lab Project Number: 24-96: ADPEN-901-96-24-96: ADPEN-901-24-96-001. Unpublished study prepared by ADPEN Laboratories, Inc. 75 p.



## Aquatic field dissipation

MRID Citation Reference

45080803 Manuli, P.; Jacobson, B. (2000) Aq uatic Field Dissipation of CGA-279202 Under Field Conditions with Rice in Arkansas: Final Report: Lab Project Number: 242.40: 283-98: 003-034. Unpublished study prepared by Waterborne Environment, Inc. 533 p.

### 52 

## Fish Bioaccumulation

MRID Citation Reference

44496813 Mollova, N. (1997) (Phenyl(A) -U-(carbon 14)-CGA-2 79202--Flow-Through Bioconcentration and Metabolism Study with Bluegill Sunfish (Lepomis macrochirus): Lab Project Number: 1781.1195.6517.140: 19-96: 96-8-6608. Unpublished study prepared by Springborn Labs., Inc. 552 p.



## Non Guideline Selections

44496815 Atkins, R. (1997) Characteriza tion of (phenyl(A)-U-(carbon 14)-CGA-279202 and its Degradation Products in So il Extracts and Water Phases of Environmental Fate Studies: Lab Project Number: 1072: 373-96. Unpublished study prepared by PTRL East, Inc. 122 p.

45080801 Merritt, A. (2000) Ecochemistry Summary of Trifloxystrobin: Amended Report: Lab Project Number: 588-97. Unpublished study prepared by Novartis Crop Protection, Inc. 148 p.

47567524 Leicher, T. (2007) Fluopyram + trifloxystrobi n SC 500 (250+250) G : Determination of Effects on Carbon Tran sformation in Soil. Project Number: M/294811/01/2, LRT/C/80/07, E/330/3364/ 2. Unpublished study prepared by Bayer CropScience AG. 35 p.

47567525 Leicher, T. (2007) Fluopyram + Trifloxystrobin SC 500 (250+250) G: Determination of Effects on Nitrogen Tr ansformation in Soil. Project Number: M/295282/01/2, LRT/N/91/07, E/337/3361/ 6. Unpublished study prepared by Bayer CropScience AG. 32 p.

N.A. 

### Method Evaluation (ECME) on CGA 302371 (metabolite of CGA 184927) in soil using the method, "Method of Analysis for the Determination of CGA 302371 (UE Metabolite) in soil 

## by LCIMS".

44757206 

### Williams, R. (1998) Analytical Me thod AG-688 for the Determination of CGA-279202 and its Metabo lites CGA-373466, CGA-321113, CGA-357261, CGA-357262, and CGA-331409 in Water and Sediment by Liquid Chromatography with Mass Spectrometric Detection, Including Validation Data: Lab Project Number: 509-98: AG-688: 433000. Unpublished study prepared by N ovartis Crop Protection, Inc. 104 p.

44496810 

### Chamkasem, N. (1996) Analytical Method for the Determination of CGA-279202 and its Metabol ites CGA-357261, CGA-357262. CGA331409, CGA-373466 and CGA-321113 in Soil by High Performance Liquid Chromatography with UV Det ection Including Validation Data: Lab Project Number: 654: 14-96: AG -654. Unpublished study prepared by Novartis Crop Protection, Inc. 182 p.

44496811 

### Chamkasem, N. (1997) Analytical Method for the Determination of CGA-279202 and its Metabol ites CGA-357261, CGA-357262. CGA-

### 53 331409, CGA-373466 and CGA-321113 in Soil by High Performance Liquid Chromatography with UV Det ection Including Validation Data: Lab Project Number: 654A: 14-96. Unpublished study prepared by Novartis Crop Protection, Inc. 182 p.

### 54 Appendix C Output from SIP and STIR Models Output from Screening Imbibition Program (SIP)

Table 1. Inputs

Parameter Value
Chemical name Trifloxystrobin Solubility (in water at 25 o C; mg/L) 0.61

Mammalian LD 50 (mg/kg-bw) 5000 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Mammalian NOAEL (mg/kg-bw) 50 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg-bw) 5000 Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15

Mallard NOAEC (mg/kg-diet) 5050 Bobwhite quail NOAEC (mg/kg-diet) 5050 NOAEC (mg/kg-diet) for other bird species Body weight (g) of other avian species NOAEC (mg/kg-diet) for 2nd other bird species Body weight (g) of 2nd other avian species

Table 2. Mammalian Results

Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 0.1049 0.1049 Adjusted toxicity value (mg/kg-bw) 3845.8028 38.4580 Ratio of exposure to toxicity 0.0000 0.0027

Conclusion* Drinking water exposure alone is NOT a potential concern for mammals Drinking water exposure alone is NOT a potential concern for mammals

Table 3. Avian Results

Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 0.4941 0.4941 Adjusted toxicity value (mg/kg-bw) 3602.1476 250.5434 Ratio of exposure to acute toxicity 0.0001 0.0020

Conclusion* Drinking water exposure alone is NOT a potential concern for birds Drinking water exposure alone is NOT a potential concern for birds

*Conclusion is for drinking water exposure al one. This does not combine all routes of exposure. Therefore, when aggregated wi th other routes (i.e., diet, inhalation, der mal), pesticide exposure through drinking water may contribute to a total exposure tha t has potential for effects to non-target animals.

### 55 Output from Screening Tool for Inhalation Risk (STIR)

This tool is designed to provi de the risk assessor with a rapid method for determining the potential significance of the inhalation exposure route to birds and mammals in a risk assessment.



# Input
Application and Chem ical Information

Enter Chemical Name trifloxystrobin
Enter Chemical Use all Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air Enter Chemical Molecu lar Weight (g/mole) 408.4 Enter Chemical Vapor Pressure (mmHg) 2.55E-08 Enter Application Rate (lb a.i./acre)

Toxicity Properties
Bird
Enter Lowest Bird Oral LD 50 (mg/kg bw) 2000 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178 Mammal Enter Lowest Rat Oral LD 50 (mg/kg bw) 5000 Enter Lowest Rat Inhalation LC 50 (mg/L) 4.65 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35

### 56 

# Output Results Avian (0.020 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 5.60E-04 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 7.05E-05 Adjusted Inhalation LD 50 1.04E+01

Ratio of Vapor Dose to Adjusted Inhalation LD 50 6.79E-06 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 0.00E+00 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 0.00E+00 Exposure not Likely Significant



### Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 5.60E-04 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 8.86E-05 Adjusted Inhalation LD 50 2.77E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 3.20E-07 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 0.00E+00 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 0.00E+00 Exposure not Likely Significant

### 57 

## Appendix D Summary of Ecological Incidents Attributed to Trifloxystrobin EIIS Pesticide Summary Re port: General Information

Trifloxystrobin (129112)

Incident # Date County State Certainty Legal. Formul. Appl. Method Total Magnitude



### PLANTS Bell peppers

I016036-004 5/17/2004 Stanislaus CA 1 RU Spray 40 acres


### Cereal

I023302-024 6/24/2011 Pennington MN 2 RU SC Broadcast 100% of 230 acres 

### Grape
I010837-005 4/4/2000 YOLO CA 3 RU DF Air blast 44acres

I010837-011 5/10/2000 SAN JOAQUIN CA 3 RU DF Air blast 343 acres


### Ornamental

I010837-010 4/27/2000 VOLUSIA FL 3 RU DF AIRBLAST; ALL

BROADCAST

I010837-085 10/26/2000 LAKE FL 3 UN DF N/R ALL

I010837-083 10/26/2000 VOLUSIA FL 3 UN DF N/R ALL

I010837-081 10/26/2000 VOLUSIA FL 3 UN DF N/R ALL

I010837-080 10/26/2000 VOLUSIA FL 3 UN DF N/R ALL

I010837-084 10/26/2000 VOLUSIA FL 3 UN DF N/R ALL

I010837-079 10/26/2000 VOLUSIA FL 3 UN DF N/R ALL

Wednesday, October 10, 2012 Certainty Code: 0=Unrelated, 1=Unlikely, 2=Possible, 3= Probable, 4=Highly Probable. Legality Code: RU=Registered Use, M=Mi suse, MA=Misuse (Accidental), MI=Misuse (Intentional), U=Unknown.

### 58 Incident # Date County State Certainty Legal. Formul. Appl. Method Total Magnitude

I010837-078 10/26/2000 VOLUSIA FL 3 UN DF N/R ALL

I010837-077 10/26/2000 VOLUSIA FL 3 UN DF N/R ALL

I010837-082 10/26/2000 VOLUSIA FL 3 UN DF N/R ALL 

### Tree farm/plantation

I012110-001 8/13/2001 DADE FL 2 RU N/R N/R UNKNOWN 

### Wheat, spring
I015291-045 Cass ND 2 RU EC Broadcast 120 acres 

### Wheat, winter
I014029-006 4/5/2003 King William VA 2 RU Broadcast 51 acres



### TERRESTRIAL Agricultural area

I022340-001 4/23/2010 IN 1 UN NR 4 apiaries, 1 hive