UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460 OFFICE OF PREVENTION, PESTICIDESAND TOXIC SUBSTANCES PC Code: 206600 DP Barcode: 333335 Date: October 18,2007 MEMORANDUM
SUBJECT: Ecological Risk Assessment for the Fenarimol Section 3 New Use on Hops TO: Mary Waller, Product Manager Lana Coppolino, Team Leader Fungicide Branch Registration Division (7505P) FROM: Melissa Panga, Ph.D., Biologist Greg Orrick, Environmental Scientis Environmental Risk Branch 

### IV Environmental Fate and Effects Division (7507P) REVIEWED /- BY: Anita Pease, SeniorBiologist R. David Jones, Ph.D., Senior Agronomist Environmental Risk Branch IV "-

. " Environmental Fate and Effects Division (7507P) APPROVED BY: Elizabeth Behl, Branch Chief Environmental Risk Branch IV Environmental Fate and Effects Division (7507P)
The Environmental Fate and Effects Division (EFED) has reviewed the proposed label for the use of fenarimol [~ubi~an~~.~., EPA Reg. No. 10163-2731on hops. The proposed label reports a maximum spray interval of 14days and no minimum application interval. EFED recommends modification ofthe proposed label to report an appropriateminimum application interval. For this assessment,the minimum application interval was assumed to be 14days for aquatic exposure estimates. Due to the meteorological conditions ofthe modeled scenario, exposure estimates for the proposed use on hops decrease for minimum spray intervals less than or greater than 14days. For estimatingterrestrial exposure, a 3-day application interval was modeled. Based on the environmental fate and transport characteristicsof fenarimol, the following label advisories for ground water and surfacewater are recommended. -1 of39- 

## lllllllllllllllllllllllllllllllllllllIl1llll 2069231This chemical has properties and characteristics associated with chemicals detected in ground water. The use of this chemical in areas where soils arepermeable, particularly where the water table is shallow, may result inground water contamination. Thisproduct may contaminate surface water due to runoffof rain water. This is especially truefor poorly draining soils and soils with shallow ground water. nis product is classiJied as having highpotentialfor runoff for several months or more after application. A level, well-maintained vegetative buffer strip between areas to which thisproduct is applied and surface water features such as ponds, streams, and springs will reduce the potential for contamination ofwater from runoff of rain water. Runoff of this product will be reduced by avoiding applications when rainfall is forecasted to occur within 

### 48 hours. Most studies submittedto fulfill environmental fate data requirements for fenarimol were received in the late 1970s and early 1980s,were not conducted under Good Laboratory Practice (GLP) standards, and do not satisfy current Subdivision N guidelinerequirements. A generic data call-in (GDCI) was issued in January 2004 as a result of the 2002 TRED for fenarimol in order to fulfill environmental fate data requirements. Theregistrant submitted some ofthe requested data and a waiver request (April 16,2004) for the GDCI. A response document prepared by EFED for the OPP rebuttal (DP 282832+; USEPA 2006a) indicated that the GDCI requests for aqueousphotolysis, aerobic aquatic metabolism, anaerobic aquatic metabolism, and terrestrial field dissipation data are not waived. Submission ofthese GDCI data that remain requested may change ecological risk conclusions, depending on the availabilityof toxicological data on identified degradates. The lack of acceptable studiesunder each SubdivisionN guideline, except hydrolysis and soil photolysis, is the major source ofuncertaintyin the fate and transport of fenarimol. The compound seemsto be moderately persistent under most degradation pathways except for aqueous photolysis. Submission of acceptable studies conducted under Good Laboratory Practice standardsthat provide the data requested in the GDCI would reduce uncertainty in this exposure characterizationand could change ecological risk conclusions, dependingon the availability of toxicological data on identified degradates. In addition to uncertainties regarding the environmental fate of fenarimol, there are also some effects uncertainties and data gaps. The available data for the assessment of acute and chronic risk to aquatic animals is currently limited to freshwater species (i.e.,no guideline toxicity data for estuarinelmarine species are available for fenarimol). In the absence of information that would suggest otherwise,we will assume that fenarimol is as toxic to estuarinelmarinespecies as it is to freshwater organisms. No toxicity data are currently availablefor aquatic vascularplants or terrestrial plants. Although fenarimol is described as a fungicide and is used on a variety of dicots and monocots, risks to some plants are expected for the followingreasons:a. One of the registered uses for fenarimolis annual bluegrass (Poa annua) management; an herbicidal use. The supplemental Rubigan A.S. label forPoa annua management (EPA reg. No. 10163-274) states: "Rubigan A.S. may exert a growth regulating effect in certain plants by reducing the biosynthesis of gibberellic acid. This effect is expressed as a reduction in internode elongation and suppression of overall plant growth. In the presence of sufficiently high rates ofRubigan A.S. or prolonged exposure, a species sensitiveto this effect may be selectively suppressed." An additional statement on this label claims that "(a) single application of Rubigan A.S. in excess of 8.0 fluid ouncesper 1000 square feet may inhibit the germination of creepingbentgrass for up to 30 days after application." b. There are two reported fenarimol ecological incidents involving terrestrial plants; both involving grape plants. Both incidents involved a mixture of several chemicals so it is difficult to ascertain if fenarimol was directly responsible for the plant damage, however, the incidents do indicate the possibilitythat acute exposureto fenarimolmay damage non-target terrestrial plants.

c. Adverse effects (reduced cell count) arereported in green algae exposed to fenarimol at concentrations as low as 0.43 mg a.i./L (MRID: 40777601). Because fenarimol is the only member ofthe pyrimidine class of hngicides currentlyregistered in the U.S., there is no possibility ofusing submitted toxicity data from closely-related surrogate chemicals to fill in potential data gaps. Therefore, until additional databecome available, risks to aquatic vascular plants and terrestrial plants (both Federally-listed and non-listed species)will be assumed in this risk assessments.1. Executive Summary EFED has completed a review of the Section 3 new use request for the use of fenarimol [~ubi~an@E.C., EPA Reg. No. 10163-273 (12 % a.i.)] fungicide on hops. Fenarimol [alpha-(2- chlorophenyl)-alpha-(4-chlorophenyl)-5-pmidinemeanol] is a systemic foliar fungicide. The compound is in the pyrimidine class of fungicides and is a demethylation inhibitor,which inhibits fungal growth by adversely affecting the formation of the fungal sterol ergosterol. Fenarimol is currently registered for use on 

### turf and a variety of ornamentals, fruits, and nuts. It is the sole active ingredient in Rubigan E.C., and its use on hops is limited to foliar application utilizing ground equipment. Theproposed maximum application rates for fenarimol use on hops are 0.05 lbs ailacre (single application rate) and 0.22 lbs a.i./acre (annual application rate is 4 applications at the single application rate). Fenarimol has low volatility and is soluble in water up to 13.7mg/L (25°C). The compound is stable to hydrolysis, does not significantly biodegrade, and is moderately mobile in soil. The major route of degradationis photolysis in water. The compound is expected to persist under most conditionsin soil, ground water, and turbid surfacewater. Fenarimol in clear, near-surface water is expected to photolyze readily. Toxicity data are not available for degradates of fenarimol; however, most identified photodegradatesremain chlorinated. Therefore, a total residues of concern (TRC) approach was used for all taxa evaluatedin this assessment to evaluatethe potential exposureto the residues of risk concern, which include fenarimol and all organic degradates. Based on the proposed maximum application rate to hops, there is a low likelihood of acute and chronic effects to listed and non-listed aquatic animals, terrestrial invertebrates, and birds. No potential acute effects to mammals from the proposed fenarimol use on hops were identified. The potential for chronicrisks, however, could not be excluded. The chronic level of concern (LOC) for listed mammals was surpassed for most ofthe mammalian size-classes and dietary categories modeled. No toxicity data are currently available for aquaticvascular plants or terrestrial plants. Although fenarimolis described as a fungicide, one of the registered uses for fenarimol is annualbluegrass (Poa annua) management [RubiganA.S. label for Poa annua management (EPA reg. No. 101 63-274)l. Additionally, there are two reported fenarimol ecological incidents involving terrestrial plants (both involving grapes), and adverse effects (reduced cell count) arereported in green algae exposedto fenarimol at concentrations as low as 0.43 mg a.i./L (MRID: 40777601). Therefore, until additional data become available, risks to aquatic vascular plants and terrestrial plants (both federally-listedand non-listed species)will be assumed. The available data for the assessment of acute and chronic risk to aquatic animals is currently limited to freshwater species (i.e., no guideline toxicity data for estuarinelmarine species are available for fenarimol). In the absence ofinformationthat would suggest otherwise, and because hops are usually grown inland, and, therefore, use sites are largely outside of estuarinelmarine environments,it is assumed that fenarimol is as toxic to estuarinelrnarine species as it is to fi-eshwaterorganisms.Potential effectsto federally-listedendangered and threatened species (listed species)based on LOC exceedances require an in-depth listed species evaluation determiningthe potential cooccurrenceof listed species and the areas 

### in which hops are grown. Identified potential risks to listed species are summarizedin Table1.l. TABLE 1.1. Listed Species Risks Associated with Potential Direct or Indirect Effects Due

Terrestrialand semi-aquatic plants - dicots Terrestrialand semi-aquatic plants - monocots Yes 

# I yes1 Yes yes1

Insects
Birds
Terrestrialphase amphibians 

### -Reptiles

Mammals Aquatic plants No
No

Freshwater fish



# ( Marinelestuarine fish 

# I No yes1 

# I yes1 yes'
No
No Yes (chronic)
Yes

Aquatic phase amphibians
Freshwatercrustaceans Mollusks 

# 1 Marinelestuarine crustaceans 

# I No 

# I yes1 

# I yes1 yes1 yes1 yes1
No

I I I

he listed chronic LOC was exceeded for mammals and the risks to plants could not be precluded at this time. Therefore,the potential for adverse effects to those speciesthat rely on a specific plant or animal species (specifically aquatic vascular plants, terrestriavsemi-aquaticmonocots and dicots, or mammals) or multiple plant or animal species (specificallyterrestriallsemi-aquatic monocots and dicots and mammals) cannot be precluded. Indirect effectsmay include general habitat modification, host plant loss, and food supply disruption. yes1
No
No
No yes1 yes' yes'

### 2. Problem Formulation This assessment evaluates the potential risks to non-target species associated with the proposed use of ~ubi~an' E.C. (12 % a.i. fenarimol) fungicide on hops. Theproposed maximum application rate for hops is 0.05 lbs a.i.lacrelapplication, applied by ground spray application when powdery mildew is expected. The maximum proposed yearly application rate to hops is 0.22 lbs a.i./acre with a maximum interval of 14days between applications. No maximum number of applications allowed per year is provided on the proposed label, however, based on the maximum proposed single and yearly applicationrates, a maximum of four applicationsat the maximum single application rate is assumed. Fenarimol is already labeled for several other uses, including (but not limited to) turf and a variety of ornamentals, hits, and nuts (USEPA 2005). This assessment focuses on the total residues of concern (TRC). A drinking water assessment for the tolerance reregistration eligibility decision (TRED) completed in 2002 assumed all of fenarimol's photodegradatesto have similar toxicity to the parent compound (DP 282389+; USEPA, 2002). Similarly, fenarimol and its organic degradates are the residues of concern for all taxa for this assessment, with the toxicities ofthe residues of concern assumed to be similarto the parent compound, as no toxicity data on the degradates of fenarimol havebeen submitted since completion of the TRED. 2.1. Mode of Action Fenarimol is a locally systemic foliar fungicidein the pyrimidine class of fungicides,which also includes dimethirimol,bupirimate, and ethirimol. Fenarimol is a demethylation inhibitor, which inhibits fungal growth by adversely affectingthe formation ofthe fungal sterol ergosterol. Ergosterol is related to cholesterol and is needed for cell membrane formation. 2.2. Use Characterization Fenarimol is used to control fungal diseases, such as rusts, molds, mildews, and scabs and is currently registered for use on apples, filberts, pears, pecans, cherries, grapes, ornamental plants, and ornamental trees. In additionto its fungicidal uses, fenarimol also has a registered herbicidal use [to control annual bluegrass (Poa annua) on golf course greens and tees]. The label [RubiganA.S. label for Poa annua management (EPA reg. No. 10163-274)] states: Applications of Rubigan A.S. in the programs recommended in this label are expected to result in Poa annua control in the range of 75 to 95 percent.. 

### .. A single application of Rubigan A.S. of 8.0 fluid ounces per 1,000 square feet may inhibit the germination of creepingbentgrass for up to 30 days after application..


### . Duringperiod of environmental stress, a singlehigh rate application of Rubigan A.S. may rapidly eliminatePoa annua fi-omgreens, tees or other close cut turf areas..

### .The proposed label for hops recommends applications of 7 

### floz a.i./acre of RubiganB E.C. (0.05 lbs a.i./acre) as a foliar spray via ground application equipment when powdery mildew is expected (Table 2.1). Aerial applications and applications via irrigation systems are prohibited on the proposed label. Theproposed maximum annual application rate is 28 fl oz a.i./acre of RubiganB E.C. (0.22 lbs a.i./acre) and the maximum spray interval is 14 days. Table 2.1. Pro~osed Use Pattern of Fenarimol on Hoas.

- -. .

Because this is a proposed new use, data are unavailableto define the historical extent of fenarimol use on hops in the U.S. 

### In order to characterize potential use sites in the U.S., annual data relevant to harvested acres ofhops were obtained from USDA's National Agricultural Statistical Service (http:/lwww.nass.usda.gov:8080/QuickStats/index2.jsp). Data were available for acres harvested by state for hops in 2005. 

### In 2005, 3 1,032 acres ofhops were harvested in the U.S. in a total of three states, with the highest production from Washington (73% of the total harvested acres), Oregon (17%), and Idaho (10%) (Table 2.2; USDA 2005). It is possible that fenarimol could be applied to hops in any other state in the country;however, it is most likely that this proposed use appliesto the states identified above where hops have historicallybeen grown.

Crop Hops Application Timing Postemergence



### TABLE 2.2. Number of Acres Harvested for Hops in 2005 and the Percent of Total Acres Per State (USDA 2005).

2.3. ConceptualModel STATE United States Washington Oregon

The conceptual model used to depict the potential ecological risk associated with the proposed use of fenarimol on hops assumes that as a fungicide, fenarimol is capable of affecting terrestrial and aquatic animals provided environmental concentrationsare sufficientlyelevated as a result ofproposed label uses. Based on a preliminaryrisk screening and past assessments indicating that fenarimolis highly toxic to freshwater fish on an acute exposure basis and causes potential reproductive effects in mammals when chronicallyexposed, the hypothesis for the risks of fenarimolto non-target animals (depictedin Figure 2.1) focuses on both aquatic and terrestrial environments. Therefore, exposure as a result of direct spray, spray drift, and runoff will be considered. Risk to plants is also considered in this screening-levelassessment. For terrestrial organisms, the major route of exposure considered is the dietaryroute; consumption of food items such as plant leaves or insects that have fenarimol residues as a result of spraying and drift. For aquatic animal species, the major routes of exposure are considered to be via the respiratory surface (gills) or the integument. Aquatic plants may be exposed via direct uptake and Application Method Foliar spray (air-blastassumed)

TOTAL ACRES HARVESTED 

### IIV 21107 31,032 22,749 Idaho 

## I 3,106 

### I 10 5,177 Application Interval (days) 14 (maximum)

% OF TOTALACRES 'WCARVESTED@4 2607 100 73 17 Max. App. Rate (lbs a.i.lAlyr) 0.22adsorption. Estimated exposure concentrationsfor all organisms are obtained through the use of several Agency exposuremodels. The following risk hypothesis ispresumed for this screening level assessment: Based on the application method, mode ofaction, and the sensitivity ofnon-target aquatic and terrestrial species, theproposedfenarimol use on hops has the potential to reduce suwival, reproduction, and/or growth in terrestrial and aquatic organisms. 

### In order for a chemical to pose 

### an ecological risk, it must reach non-target organisms at concentrationsfound to cause adverse effects. The exposurepathway is the means by which a pesticide moves in the environment from the application site to non-target organisms. The assessment of ecological exposurepathways in this assessment includes 

### an examinationofthe source and routes of transport and dissipation for fenarimol, and the determinationofpotential exposure routes to non-target species.Stressor 

# I FenarimolApplied as a Ground Sprayto Hops I 

# I 

# I ----------- I I 

# ,----- L--- Source/ spray Direct Surface Water I Leaching 

# i Transport Drifi Application Runoff (Infiltration/ I I I Pathways Percolation I I---------* Source/ TerrestrialFood Exposure Media Exposure Route
Terrestrial Vertebrates: Birds, Mammals, Receptors Reptiles, Terrestrial Phase Amphibians

Individual Plant Po~~latioIl Vertebrates and ~t.~ib~t~ IndividualAnimals Individual Plants Reduced Invertebrates Reduced survival, Reduced survival, Changes growth or population Reduced survival, growth, or reproduction growth growth or reproduction reproduction Figure 2.1. Conceptual Model of the Transport and Effects of Penarimol in the Environment. *Dotted lines indicate that, althoughthis exposureroutelmedia was considered, its contributionto the fate and transport of fenarimolis expected to be negligible 2.4. Analysis Plan 2.4.1. Integration of Exposure and Effects Available exposure and toxicity data are compared in order to evaluate the risks of adverse ecological effects on non-target species. For this screening-levelassessment, the risk quotient (RQ) method is used to compare exposure and toxicity values. The RQ method involves dividing estimated environmental concentrations(EECs) by acute and chronic toxicity values. The resulting RQs are then compared to the Agency's LOCs (USEPA 2004; Table 2.3). These criteria areused to indicate if applications of fenarimol, as directed on the proposed label, have the potential to cause adverse effects to non-target organisms.TABLE 2.3. Agency Risk Quotient 

### (RQ) Metrics and Levels of Concern 

### (LOC) Per 

### Risk Class. 

# 1 Acute 

# IPotential for effects to non-listed animals from acute 

## ( peak EEC/LC~~~

# 1 0.5 

# 1 L 1 classification 

# 1

Acute Restricted Use

Chronic exposures Potential for effects to animals from acute exposures Risks may be mitigated through restricted use



## , Acute Listed

Species Potential for effects to non-listed and listed animals from chronic exposures 2 1-dayEECINOAEC (invertebrates) I I I Aquatic Plants Peak EECILC~~I Listed species may be potentially affectedby acute exposures


# 1 Non-Listed 

# I Potential for effects to non-listed plants from 

# 1 P~&EEC/LC~~' 

# I 1 

# I 0.1

Peak EEC/LC~~'

Terrestrial Animals (mammals and birds) 0.05

exposures Listed 

## I Potential for effects to listed plants from exposures 

## 1 Acute 

## 1 Potential for effects to non-listed animals from acute 

## I EEC2/~CSn (Dietary) 

## 1 0.5 

## 1

/ 

# I 1 exposures Peak EECINOAEL 1

I I I Acute 

## 1 Potential for effects to animals from acute exposures 

## I EEC~/LCS~ (Dietary) 

# I 0.2 .. -. EEC/LDSo (Dose) 

# I -- . -. 

# 1 Restricted Use Risks may be mitigated through restricted us; classification EEC/LDSo (Dose) 

# I

Acute Listed Listed species may be potentially affectedby acute 

# I EEC 2/~~50 (Dietary) Species exposures 

# 1 Chronic 

# IPotential for effects to non-listed and listed animals 

# I EEC~INOAEC f?om chronic exoosures I I Terrestrial and Semi-Aquatic Plants 

## I Non-Listed ( Potential for effects to non-target, non-listed plants 

## 1 EECi ECZ5 111 

## 1 from exposures 

## I 

# I

LC5,)or ECS0. Based on upper bound Kenaga values. Listed Plant Potential for effects to non-target, listed plants from exposures EECI NOEC EECI ECos 1

### 3. Analysis 3.1. Exposure Characterization 3.1.1. Environmental Fate and Transport Characterization Fenarimol is moderately mobile and rapidly degradesby aquatic photolysis. The compound does not undergo hydrolysis, does not significantly metabolize in soil, and is not expected to significantly metabolize in aqueous environments. Therefore, fenarimolis likelyto degrade quickly in shallow, clear, and well lit water bodies and persist in deep, turbid, poorly illuminated water. Fenarimol residues of concern are expected to persist, as they include all organic degradates of fenarimol. TABLE 3.1. Phvsicochernicaland Fate Pro~erties of Fenarimol.


## I Molecular mass 1331.2 dm01 

## 1Accsn # 248702 

## 1 Vapor pressure (25°C) Water solubility (25"C,pH 7) i 

## IOctanol-waterwartition coefficient (Lw) 2.2 x 1 0-7 torr 

## I MRID 00084923

## 1

, -.., I I Persistence 13.7mg/L 4900 Hydrolysis half-life pH 3 (25"C, 37"C, 52°C) pH 6 wH 9 MRID 46413701 MRID 00084927

Aqueous photolysis half-life; Total residues of concern half-life Soil photolysis half-life; Total residues of concern half-life Aerobic soil metabolism half-life Total residues of concern half-life (soil texture) Anaerobic soil metabolism half-life Aerobic aqueous metabolism half-life Anaerobic aqueous metabolism half-life No significant degradation MRlD 00084916 No significant degradation

3920 d; 5270 d (clay loam) MFUD 001 17509 3440 d; 42 10 d (silty loam)

I I Mobility 

# 1 Unknown Unknown
Soil-water distribution coefficient 

### (b); Organic carbon partitioning coefficient(Koc) None NoneFenarimol is soluble in water (13.7 mg/L at pH 7,25OC) and has low vapor pressure (2.2 x torr at 25OC). The compound shows affinityto organic carbon and is moderately mobile in soil accordingto current classification guidance with a mean KFoC of 736 L/kgoc (USEPA 2006). However, its mobility was not assessed below six inches of soil in the submitted terrestrial field dissipation study. The octanol-to-water partition coefficient (&,) of fenarimol is 4900; however, the compound has low potential to bioconcentrate in fish (BCF is 113X for whole fish). In summary, fenarimol is an oleophilic compound that can remain moderately partitioned to water, which maintains its availabilityfor runoff over extended periods post-application. Fenarimol's major degradationpathway is photolysis in water (tln =2.3 hours). However, the compound slowly photolyzes on soil (tl12 = 134 days). Fenarimol does not hydrolyze in water or biodegrade significantlyin soil (tl12 = 3-5 years in aerobic soil; no significant anaerobic degradation). Aquatic biodegradation data were not submitted for fenarimol; however, the compound is not expected to degrade significantlyin aquatic environments based on its persistence in soil. Therefore, fenarimol is expected to persist under most conditionsin soil, ground water, and turbid surfacewater. Fenarimol in clear, near-surface water is expected to photolyze readily. The submitted field dissipation study supports the expected persistence and extended availability for runoff of fenarimol in the field (tic!range = 64 to >I000 days, n=20). In this study, fenarimol was annually applied for 1-3years to 20 plots ofbare soil in California (loam), Florida (sand), Indiana (clay loam), and Maryland (silt loam). Fenaiimol was also applied to four plots in 6-8 biweekly applicationsand to one plot in 8biweekly applicationsfollowed by 8biweekly applicationson the followingyear. Core samples were taken to a depth of only 6 inches. For the 20 plots that received annual treatments, dissipationwas fastest in the Florida sand (tin range = 64 to 172days, n4)and slowestin the Maryland silt loam (tin range =483 to >lo00 days, n=6). Dissipation also correlated with annual rainfall received 

## (3 = 0.850). Dissipationin the five plots that received biweekly applications (tlnrange = 105to 742 days, n=5) was similar to or slightly less slow than dissipation following annual applications. Fenarimol's soleidentified major degradateis the photolysisproduct 4-chloro-2-(5-pyrimidy1)- 2'-chlorobenzophenone (structure in Table 1.A of APPENDIX I). This compound was detectedat up 19% ofthe applied radioactivity onehour after application (Table 1.B ofAPPENDIX I). Its photolysis half-life in water appearsto be twice that of fenarimol parent (MRID 00129103). Because no submitted aqueous photolysis studieshave reported on completemass balance, there is uncertaintyin the identity and rates of formation and decline ofmajor degradates of fenarimol. Over 80 minor photolysisproducts have been observed, most of which are chlorinated (AccessionNo. 70426). No informationis available on the toxicity, fate, andlor transport properties of these or other possible degradates. Due to the substantial uncertainty in the identity, toxicity, fate, and transport of fenarimol's degradates, all of them are assumed to have similar toxicity to the parent compound and are included in the residues of concern. In summary, fenarimol residuespresent surface water and ground water concerns through runoff, spray drift, and leaching. Fenarimol's major degradationpathway is photolysis in water (tin = 2.3 hours). In turbid surface water and ground water, fenarimol will exist 

### in the dissolved phase and bound to suspended particulates and sediment, and may persist with half-lives ranging fiom 3-5 years. The fate, transport, and toxicity properties of the major photodegradate, 4-chloro-2- 

### (5-pyrimidy1)-2'-chlorobenzophenone, and the multiple minor photodegradates areunknown. Therefore, all organic residues of fenarimol are residues of concern and assumed to have similar toxicity to the parent compound. 3.1.2. Measures ofAquatic Exposure The Tier 11-screening simulationmodels Pesticide Root Zone Model (PRZM v3.12.2, May 12, 2005) and Exposure Analysis Modeling System (EXAMS v2.98.04.06, Apr. 25,2005) were coupled with the input shell PE v5.0 (Nov. 15,2006)to generate 1-in- 10-year estimated environmental concentrations(EEC) of fenarimolthat may occur in surface waters adjacent to use sites. The PRZM model simulates pesticide movement and transformation fiom crop applicationthrough dissipationprocesses. The EXAMS model simulates the fate and transport of the pesticide in a receiving water body adjacentto the field of application. The coupled PRZMEXAMS model assumes a standard pond scenario in which a 10-hectare agriculturalfield drains into an adjacent 1-hectarepond of 2-meter depth and no outlet (USEPA 2007a). The EECs listed in Table 3.2 reflect 1 -in-10 year peak and averaged surfacewater concentrations of fenarimol based on the proposed maximum use rate for hops (4 applications per year at 0.055 lbs ailacre). Table 3.2. Tier I1 Surface Water 1-in-10-year EECs (pg a.i./L) of Fenarimol from Use on

Model input parameters used to generate these exposurevalues are listed below in Tables 3.3 and 3.4. The model input file is reproduced in APPENDIX 11.Application Rate in lbs a.i.1acre (kg a.i./ha) TABLE 3.3. PRZMIEXAMS Crop Input Parameters for Fenarimol Use on Hops.


## 1 Applications per Year 1 Application Interval (days) Date of Initial Application Input Parameter

I Amlication Method

- - CAM Input I Value

IPSCND Input Source

Spray Drift Fraction May lSt Ground Foliar applied (CAM=2) 2 Proposed label Proposed label Proposed label USDA crop profiles (USDA, 2007a), and label directions Proposed label Prouosed label USDA crop profiles (USDA, 2007a) Inputparameter guidance (USEPA, 2002a) and Spray Drift Task Force studies1 

## IApplication Efficiency 10.99 

## 1Input parameter guidance 

# I (USEPA, 2002a) 1. Spray Drift Task Force studies were reviewed by the FIFRA Scientific Advisory Panel (SAP meeting, Dec 10-1 1, 1997); online at: http:llwww.epa.govlscipoly/sapll997lindex.htm. The currently approved and nationally protective Oregon hops scenariowas used to model use on hops, as most hops are grown in the Pacific Northwest, with about 18%ofthe total crop in Oregon (USDA 2005). The maximum application rate was obtained fi-omthe proposed label for fenarimol (proposed EPA Reg. No. 10163-273). Applications were modeled with ground application input values. The application date was selected in the Spring,when powdery mildew may be expected. An application interval of 14days was assumed, as a minimum application interval was not provided on the proposed label and shorter intervals yielded lower exposure estimates. 

### TABLE 3.4. 

### PRZMIEXAMS Chemical Input Parameters for Fenarimol Use on Hops. SourceData are 

### in Table 3.1. Input Parameter MolecularMass (glmol) Value

Vapor Pressure at 25OC (torr) Solubility in Water at 25OC (mg/L) MRID 00084923 Source 331.2
2.2~ lo-7 137 Organic Carbon Partition Coefficient (Koc) (Llkgoc) Total Residue Aerobic Soil Metabolism Half-life (days) Total ResidueAerobic Aquatic Metabolism Half-life (days) MRID 464 1370 1 Accsn # 248702

602 6170 12300 - MRID 00133472,00142483, 46259501 MRID 001 17509 Input parameter guidance (USEPA. 2002a) Total Residue Anaerobic Aquatic Metabolism Half-life (days) Stable Inputparameter guidance (USEPA, 2002a)Input Parameter

Chemical property input values were chosen in accordance with current input parameter guidance (USEPA, 2002a). The organic carbon partition coefficient input is the mean ofnine values (602 Llkgoc). Based on analysis oftotal residues of concern, the upper 90% confidence bound on the mean was selected for the aerobic soil metabolism half-life input (6170 d). This half-life input was multipliedby two to account for uncertaintyin the absence of data in order to estimate the aerobic aquatic metabolism half-life input (12,300 d). The single available aqueous photolysis half-life for total residues (32.3 d) was selected for the aqueous photolysis input. HydrolysisHalf-lives (days)

Total Residue Aqueous Photolysis Half-life (days)

The PRZM and EXAMS models have limitations in their abilityto thoroughly account for spray drift, runoff, within-site variability, crop growth, soil water transport, and weather. While PRZM and EXAMS are themselves designed to be best estimators, the selection of scenario and input parameters are such that the simulation results are expected to be greater than concentrations seen at most sites in the environment most ofthe time. These models are intended to provide a reasonable screening-level estimateby which to gauge whether impacts on aquatic organisms are unlikely to occur. An exceedance of a level of concern indicates that there may be potential risk and that additional refinements in exposure modelingmay be necessary. I Value

3.1.2.1. Aquatic Exposure Monitoring Source Stable (pH 5) Stable (pH 7) Stable (pH 9) 32.3

Fenarimol was not analyzed in monitoring conducted for the USGS NAWQA program (USGS 2006), the USGS NASQAN program (USGS 2006a), or the CaliforniaDepartment ofPesticide Regulation (DPR) Surface Water Database (CDPR 2006). Furthermore, fenarimolis not a regulated chemical under the Safe Water Drinking Act (SWDA) or related statutes. Therefore, it is not listed in the EPA Safe DrinkingWater Information System (SDWISIFED) database (USEPA 2007b) nor is it found in the EPA Unregulated Contaminants Monitoring Rules (UCMR) chemical monitoring database (USEPA 2006b). f MRID 00084916

MRID 45659801

Fenarimol was analyzed for in six wells located in Californiain 1989, accordingto the EPA Pesticides in Ground Water Database (USEPA 1992). No detectionswere found. STORET identified 1149 analyses for fenarimol (USEPA 2007~). The compound was detected below the level of quantitation at one fresh water site in Kentucky in 2003 (Table 3.5). Fenarimol was analyzed 87times in the estuarine sediment at a total of 34 sites across 19Florida counties from 2000 to 2002 (Table 3.6). The compound was detected in 100%of samples at concentrations ranging from 6.0 to 19pg/kg. Because it is not possible to identifyhow data were collected in these monitoring studies, the purpose of data collection, and why particular siteswere chosen for sampling, these results are used only descriptivelyand not to assess risks in this assessment.TABLE 

### 3.5. Detections of Fenarimol in Fresh Water Reported in STORET (USEPA 2007~). Station Name

TABLE 3.6. Detections of Fenarimol in Estuarine Sediment Reported in STORET (USEPA 2007~1.

Kentucky River at Tyrone 

# IAnderson, KY

# I 1 1

Anna Maria Sound County, State
<LOQ means less than the level of quantification (valuenot reported). 100%

\----

~ -I

~
Manatee, FL 

# 1 2 

# 1 100% 

# 1 Jul. 2000, Jul. 2001 # Samples Detection Rate

StationName

Apalachicola Bay Jul. 2003

- - Jul. 2002 Sampling Date <LOQ'

County, State

Franklin, FL 

## I 1 

## 1 100% Concentration @&)

Banana River Brevard,FL 

# 1 3 

# 1 100% # Samples

Dade, FL 5 100% Detection

Rate Sampling Dates

Biscayne Bay Concentration(s) @!it@)

Blackwater Sound Monroe, FL 

## 1 1 

## 1 100% 

## 1 Aug. 2001 

## 1 7.8

Boca Ciega Bay Caloosahatchee River Pinellas, FL Lee, FL Cedar Keys Levy, FL 

## 1 1 

## 1 100% 

## 1 JUI.2000 4 1
Charlotte Harbor Lee, FL 

# 1 2 

# I 100% 

# I ~uu;;;;, 100% 100%

Choctawhatchee Bay Jul. 2000 - Jul. 2002 Jul. 2001

East Bay Okaloosa and Walton,FL

Escambia Bay

Florida Bay 2 Bay and Santa Rosa, FL Santa Rosa, FL

Monroe, FL Hillsborough, FL HillsboroughBay

- Horseshoe Cove 100% 2 1 24 2 Dixie, FL 

## I 1 

## 1 100% 

## 1 Jul. 2002 

### ] 6.7 Sep. 2000, Jul. 2002

Indian River Lagoon Kemp Channel 100% 100% 100% 100% Aug. 2000, 6.1, 6.2 Jul. 2001 Aug. 2000 6.5 Aug. 2000 - 7.0 - 16

Jul. 2002 Jul. 2000, 6.1,7.3 Jul. 2002

Monroe, FL 

## I 1 

## 1 100% 

## 1 Aug. 2000 

## 1 11 Brevard,FL

Man of War Harbor Matlacha Pass 1

Mosquito Lagoon Monroe, FL Lee, FL 100%

Old Tampa Bay Aug. 2000 7.1

1 1 Brevard, FL Hillsborough and Pinellas, FL 100% 100% 1 3 Jul. 2002 10 Jul. 2001 6.0 100% 100% Aug. 2000 7.7 Jul. 2000 - 6.3, 6.5,6.8 Ju1.20023.1.3. Measures of Terrestrial Exposure Sarasota Bay Tampa Bay Torch Key Mangroves Waltz Key Basin Whitewater Bay Total

3.1.3.1. Terrestrial Animals T-REX is used to calculate dietary and dose-based EECs of fenarimol for mammals and birds. Input values for T-REX are located in Table 3.7. Upper-bound Kenaga nomogram values are used to derive EECs for fenarimol exposuresto terrestrial mammals and birds based on dietaryand dose-based exposures (Table 3.8). The default foliar dissipation half-life (35-days) was used because data on the degradationrate on foliagehad not been identified. Because no minimum application interval is provided on the label (only a maximum application interval of 14-daysis provided), a 3-day application interval was modeled. A 1-yeartimeperiod is simulated. Consideration is given to differenttypes of feeding strategies for mammals and birds, includingherbivores, insectivores and granivores. For dose-based exposures, three weight classes of mammals (15,35 and 1000 g) and birds (20, 100, and 1000 g) are considered. Sarasota,FL Hillsborough and

Manatee,FL Monroe, FL Monroe, FL Monroe, FL


### -- 1 3 1 1 1 87 100% 100% 100% 100% 100% 100% Jul. 2002 Aug. 2000 -

Jul. 2002 Aug. 2001 Aug. 2001 Aug. 2001 Jul. 2000 - Jul. 2002 6.4 6.0,6.5,6.5 11 10 18 6.0 - 19TABLE 3.7. Input Parameters for Deriving Terrestrial EECs for Penarimol Use on Hops Using T-REX.

' ' P-ETER $GCRIPTION Fenarimol Application Rate (lbs a.i./A) Foliar Dissipation Half-life (days)' Application Interval (days)

I I Default value I VALiHC

0.05 35 3 I



### ( Short Grass 44

Number of Applications 4

3.1.3.2. Terrestrial Plants Tall Grass Broadleafplantslsm insects Fruits/pods/lginsects

No toxicity data are currently available for terrestrial plants. Although fenarimolis described as a fungicide, one ofthe registered uses for fenarirnol is annual bluegrass (Poa annua) management. Additionally, there are two reported fenarimol ecological incidents involving terrestrial plants (both involving grapes), and adverse effects (reduced cell count) are reported in green algae exposed to fenarimol at concentrations as low as 0.43 mg a.i./L (MRID: 40777601). Therefore, until additional databecome available, risks to terrestrial plants (both federally-listed and non-listed species) will be assumed. 20.2 24.8 2.8

3.2. Ecological Effects Characterization The available acute toxicity data on the active ingredient indicate that fenarimol is practically non-toxic to honey bees and birds; slightlytoxic to mammals; moderately toxic to fi-eshwater invertebrates; and highly toxic to freshwater fish on an acute exposure basis. In a 14-daytoxicity study of green algae (Selenastrum capricornutum), cell count was the most sensitive indicator of fenarimol toxicity and resulted in a LOAEL of 0.43 mg a.i./L (NOAEL = 0.10 mg a.i./L) (MRID: 40777601)(seeTable 3.9).TABLE 3.9. Summary of SpecificAssessment Endpoints for Animals and Plants Consideredin this Assessment.

(length and weight) [based on an acute-tochronic ratio from studies with rainbow trout

Anusplatyrhynchos Mallard duck



## I treatment level tested Chronic Rat ( NOAEC = 12.5mg a.i./kg- 

### 1 Reduced fertility and = >6,250 mglkg-diet

Mammals Chronic Anusplatyrhynchos 

### I NOAEC =>250 mg a.i./kg- 

### I No effects at the highest Mallard duck 

## 1 diet 

## I treatment level tested Acwfe Rat 

### ( LDso =>599 mg a.i./kg-bw 

## I No effects at the highest

Terrestrial Invertebrates 

## I diet 

## I dystocia (difficultbirths) Aewe Apis mellifera 

## I LD50 = >I00 pg/bee (oral) 

### 1 No effects at the highest 

## I one^ Bee . - 

## I treatment level tested3.2.1. Aquatic Effects Characterization Technical grade fenarimolis considered highly toxic to fieshwater fish on an acute exposure basis [bluegill sunfish (Lepomis macrochirus) LCso = 0.9 mg a.i./L; MRID: 560811. Chronic toxicity testing of technical grade fenarimol based on a fish early life-stage toxicity study with rainbow trout (Oncorhynchus mykiss) resulted in significantreduction in fish body size (length and weight) at 0.87 mg a.i.1L (NOAEC=0.43 mg a.i./L) (MRID: 129099). Sinceno toxicity data fi-omchronic exposureto fenarimol are available for the most acutely sensitive species, the bluegill sunfish, an acute to chronic ratio (ACR) was used to calculate a chronic freshwater fish endpoint using acute and chronic data fkom the rainbow trout [the most sensitive acute endpoint available for rainbow trout is an LC50 of 2.1 mg a.i./L (MRID: 56081)l. This resulted in a NOAEC of 0.18 mg a.i./L for the bluegill sunfish [(2.1 mg/L)/(0.43 mg/L) = (0.9 mg/L)/(x mg/L)I. Acute toxicity testing with water fleas (Daphnia magna) resulted in 

### an ECsO value of 6.8 mg/L for a 48-hr test (MRID:00084954). A life-cycle test of chronic toxicity effects of fenarimol to water fleas (Daphnia magna) resulted in a NOAEC of 0.1 13 mg/L (MRID: 40283902). In a 14-daytoxicity study of green algae (Selenastrum capricornutum), cell count was the most sensitive indicator of fenarimol toxicity and resulted in a LOAEL of 0.43 mg/L (NOAEL of 0.10 mg/L) (MRID: 40777601). All available toxicity values for aquaticplants and animals tested are presented in APPENDIX 111. No fenarimol toxicity data are currently available for aquaticvascular plants or estuarinelmarine fish and invertebrates. 3.2.2. Terrestrial Effects Characterization Fenarimol ispractically non-toxic to northern bobwhite quail (Colinusvirginianus) (LCso>6125 ppm; MRID: 84944) and mallard ducks (Anasplatyrhynchos)(LC50 >6250 ppm; MRID: 85064) on an acute exposure basis. No mortality or sublethal effects were reported in either study at the highest treatment level tested. Chronic toxicity testing on bobwhite quail and mallard ducks resulted in NOAEC values of >300 ppm and >250 ppm, respectively. For the bobwhite quail study (MRID: 402839-Ol), 300 ppm was the highest food concentration tested and for the mallard study (MRID: 85066), 250 ppm was the highest food concentration tested; neither study identified any growth or reproductive effects at these concentrations. Therefore,the actual concentration levels where growth or reproductive effects would be observed are likely higher.Fenarimol is slightly toxic to rats on an acute oral exposure basis (LDSa>599 mgkg; MRID: 00125392). No mortality or sublethal effects were observed at the highest treatment levels tested. Multi-generation studies in rats, however, indicate that fenarimol causes reduced fertility and dystocia (difficult births) at levels as low as 1.2 mgkg/day (NOAEL 

## - 0.6 mg/kg/day-bw; NOEAC 

### - 12.5 ppm) (MRID: 45502302). The reduced fertilityis due to an effect in males, and the dystocia is an effect in females. These effects of fenarimol are attributed to inhibition of aromatase (the enzyme that converts androgensto estrogens). In addition, reproduction studies in mice (MRID: 45502307), guinea pigs (Cavia spp.) (MRID: 00126525,00133474, and 00137159), and rabbits (Oryctolagus cuniculus) (MRID: 00084967) show that similar effects are found in mice, but are absent in guinea pigs and rabbits (see U.S. EPA, 2002). Therefore, the reproductive effects were not seen in all the mammal species tested. A study ofhoneybees (Apismellifera) indicated no toxic effects when adults were fed concentrationsof 10or 100ppm (by weight). However, longevity was significantlyreduced when bees were fed 1000ppm (by weight) (MRID: 00084948). A supplemental study indicated no apparent effectsto earthworms exposed for 14 days to 100ppm in the soil (MRID: 00084955). All available toxicity values for terrestrial animals tested are presented in APPENDIX 111. No toxicitydata are currently available for aquatic vascular plants or terrestrial plants. Although fenarimolis classified as a fungicide, one of the registered uses for fenarimol is for management of annual bluegrass (Poa annua) on golf course tees and greens [Rubigan A.S. label for Poa annua management (EPA reg. No. 101 63-274)l. Additionally, there are two reported fenarimol ecological incidents involving terrestrial plants (both involving grapes), and adverse effects (reduced cell count) arereported in green algae exposed to fenarimol at concentrations as low as 0.43 mg a.i./L (MRID: 40777601). Therefore, until additional databecome available, risks to aquatic vascularplants and terrestrial plants (both federally-listed and non-listed species) are assumed. 4. Risk Characterization 4.1. Risk Estimation 4.1.1. Aquatic Organisms The peak EEC in surfacewater generated fiom the PRZM/EXAMS model represents acute exposureto fish, aquatic invertebrates, and algae, and the highest 2 1 -day and 60-day average EEC represents chronic exposureto aquatic invertebrates and fish, respectively. No RQs calculated using these concentrations exceed any LOC for any aquatic animal or plant for which data are available (see Table 4.1).TABLE 4.1. Acute and Chronic Toxicity and 

### RQ Values for Fenarimol Use on Hops and Aquatic Organisms. 

### TAXA 

### 1 EXPOSURE 

## I

, ' RQ FreshwaterFish 

### 1 Acute 

### I 0.01 

## 1 Chronic 0.05 

## I Freshwater Invertebrates 

## I Acute 

### 1 <0.01 

# 1

Toxicity data are not availableto calculateRQs based on the following measures of effect (e.g., acute or chronic toxicity endpoints) and receptors: ( Chronic 

### I 0.08



## - Acute LCs0toxicity data for estuarinelrnarine fish 

### - ChronicNOAEC toxicity data for estuarinelrnarine fish 

### - Acute LCs0toxicity data for estuarine/marineinvertebrates 

### - ChronicNOAEC toxicity data for estuarinelmarine invertebrates 

## - Acute ECSo toxicity data for aquatic vascular plants Aquatic, Non-vascularPlants 

### I Acute

Therefore, risks to estuarinelrnarineanimals and aquatic vascular plants cannot be quantitatively assessed at this time. Due to fenarimol's registered herbicidal use, the plant incidents associated with the chemical, and its phytotoxic effects on non-vascular aquaticplants, risks to aquatic vascular plants (both federally-listedand non-listed species) are assumed until additional data become available. 0.09

4.1.2. Terrestrial Organisms 4.1.2.1. Birds Fenarimol is classified as 'practically nontoxic' to birds on an acute oral and sub-acute dietary exposurebasis. 

### In the submitted avian acute, sub-acute, and chronic toxicity studies, no mortality or sub-lethal effects were observed at the highest treatment levels tested (i.e., the LDsO, LCso, and NOAEC endpoints are 'greater than' values); therefore,these endpoints are not used to calculateRQ values. They are, however, used to help characterizerisk in the 'Risk Description' section of this assessment. 4.1.2.2. Mammals Fenarimol is classified as 'practically nontoxic' to mammals on an acute oral exposurebasis. Since the LDsois greater than the highest treatment level tested in the acute oral study (i.e., the LDS0 endpointis a 'greater than' value), the 'greater than' endpoint was not used to calculateRQ values here; however, it is used to help characterize the risk in the 'Risk Description' sectionof this assessment. The RQs calculated for chronic exposure range from 0.2 to 3.5 for dietary exposure and 0.2 to 30.1 for dose-based RQs using upper goth percentile Kenaga values (see Table 4.2 and APPENDIX IV). The RQs for most ofthe body-size/dietarycategories exceed the Agency'sLOC for chronic exposure except for fi-uitslpodslseedsllargeinsect dietary category (dietarybased RQ) and ~its/pods/seeds/large insect dietary categoryl1,000 g mammal and granivore dietary categorylall size classes (dose-based RQs).

4.1.2.3. TerrestrialInvertebrates Fenarimol is classified as 'practically nontoxic' to non-target terrestrial insects on an acute exposurebasis. Screening-level risk assessments do not typically evaluate risks to terrestrial invertebrates;however, toxicity information forbeneficial insects is used to develop precautionary label language where necessary. Based on the available data, precautionarylabel language for bees does not appear necessary. 4.1.2.4. Plants No toxicity data are currently available for terrestrial plants. Therefore, risks to terrestrial plants cannotbe quantitatively assessed at this time. However, due to fenarirnol's registered herbicidal use, the plant incidents associated with the chemical, and its phytotoxic effects on non-vascular aquatic plants, risks to terrestrial plants (both federally-listed and non-listed species) are assumed until additional data become available. 4.2. Risk Description The results ofthis screening-level risk assessment indicate that the proposed new use of fenarimol on hops has the potential for direct adverse effects for listed freshwater vascular plants, listed and non-listed terrestrial and semi-aquaticplants, and listed and non-listed mammals (chronic exposure). Therefore, the hypothesis fromp. 4 [


### . . . theproposed fenarimol use on hops has the potential to reduce survival,reproduction,and/orgrowth in terrestrialandaquatic organisms] is supported. These results arebased on a modeled spray application rate of 0.05 lbs a.i./acre/application (4 applicationslyear),which representsthe proposed maximum application rate for hops. Although direct adverse effects to non-mammalian animals (aquatic and terrestrial) from fenarirnol use arenot expected, given the potential for effects on terrestrial and aquaticplant species and mammals, indirect effects to all animals are possible. 4.2.1. Risks toAquatic Organisms Although fenarimolis considered highly toxic to freshwater fish and moderately toxic to freshwater invertebrateson an acute exposure basis, risk quotients indicatethat there is a low likelihood for mortality or growth/reproductive effects to freshwater fish, invertebrates,and aquatic non-vascular plants fiom the proposed use of fenarimol on hops. Since all acute and chronicrisk quotients for freshwater organisms arebelow LOCs, this compound does not appear to pose a direct acute or chronic threat to freshwater organisms. The potential risks of fenarimol use to estuarinelmarineanimals could not be assessed due to a lack of available data. In the absence of information that would suggest otherwise, it is assumed that fenarimol is as toxic to estuarinelmarine species as it is to freshwater organisms. Therefore, the risk pictures for freshwater and estuarinelrnarine animals are expected to be similar (i.e., risks arenot expected). Additionally, hops are usually grown inland, and, therefore, use sites are largely outside of estuarinelmarineenvironments. Due to fenarimol's registered herbicidal use, the plant incidents associated with the chemical, and its phytotoxic effects on non-vascular aquaticplants, risks to aquaticvascular plants (both federally-listedand non-listed species) are assumeduntil additional data become available,. 4.2.2.Risks to Terrestrial Organisms On an acute exposurebasis, fenarimol ispractically non-toxic to honey bees and birds, and no more than slightlytoxic to mammals. Because there was no mortality or sub-lethal effects at the highest treatment levels tested in the avian acute oral, sub-acute dietary, and avian reproduction studies submitted, standard RQ values for acute, sub-acute, and chronic exposures were not calculatedin the Risk Characterization section of this assessment. In order to gain a better understanding ofhow the EECs for the maximum proposed fenarimol application rate for hops relate to the toxicity data currently available forbirds, we used T-REX to calculateRQs using the conservative assumption that the highest values tested in the avian studies represent endpoints [i.e., acute: LDS0 = 2,000 mglkg-bw (northernbobwhite quail); sub-acute:LCs0= 6,125 mg/kg diet (northern bobwhite quail); chronic: NOAEC = 250 mg/kg-diet (mallard duck)]. In this exercise all of the acute and subacute RQs calculated using upper bound Kenaga values ke between 0 and 0.03 for all size and dietary classes. The chronic RQs range from 0 to 0.18. The actual RQs would be much lower than these since no effects were actually identified at the highest treatment levels tested. Therefore, directrisk to birds fiom acute, sub-acute,or chronic exposure to fenarimol from itsproposed use on hops is low. Given the potential for effects on terrestrial and aquaticplant species associated with the use of fenarimol, however, indirect effects on birds arepossible. Because there was no mortality or sub-lethal effects at the highest treatment levelstested in the acute rat study submitted, standard RQ values for acute exposure were not calculated in the Risk Characterization section ofthis assessment. CalculatingRQs using the conservative assumption that the highest value tested in the acute mammalian study represents the endpoint (i.e., acute: LDS0 = 599 mglkg-bw), results in RQs that ranged fiom 0 to 0.03. Therefore, direct risk to mammals f?om acute exposureto fenarimol fi-omits proposed use on hops is low. The RQs for mammals, however, identifiedpotential reproductive effectsto mammals fi-omchronic exposure to fenarimol when used at proposed label rates for hops. Results of chronic reproduction studies in mice and rats show that dietary exposureto fenarimol produces adverse effects on reproductiveparameters. The potential reproductive risks in rats and mice affect both males (reduced fertility) and females (dystocia). These effects of fenarimol are attributedto inhibition of aromatase (the enzyme that converts androgensto estrogens). Although chronic studies on guinea pigs and rabbits failed to identify similar reproductiverisks, the results ofreproduction studies in mice and rats suggest that fenarimol could be a candidate for additional screening andlor testing to better characterize effects related to endocrine disruption. Under the Federal Food, Drug and CosmeticAct (FFDCA), as amendedby the Food Quality Protection Act (FQPA), EPA isrequired to develop a screeningprogram to determine whether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effectproduced by a naturally-occurringestrogen, or other such endocrine effects as the Administrator may designate." Followingthe recommendations ofits Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there was scientific basis for including, as part of the program, the androgen- and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the Program include evaluationsofpotential effects in wildlife. For pesticide chemicals, EPA will use FIFRA, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, and the FFDCA authority to require the wildlife evaluations. As the science develops and the resources allow, screening of additional hormone systemsmay be added to the Endocrine Disruptor ScreeningProgram (EDSP). When the appropriate screeningand or testing protocols being considered under the Agency's Endocrine Disruptor ScreeningProgram have been developed, fenarimol may be subjectedto additional screeningand or testing to better characterize effects related to endocrine disruption. EFED does not currently estimaterisk quotients for terrestrial non-target invertebrates. However, a label statement is required to protect foraging honeybees when the LDS0 is 

### < 11 pghee. Based on the acute oral toxicity study to honeybees, the LD50for fenarimol is >I00 pghee. Therefore, direct adverse effectsto terrestrial invertebrates are not expected. However, due to the risk to plants, the potential for indirect effectsto terrestrial invertebratesfi-om fenarimol use cannot be discounted.4.2.3. Review of Incident Data A search of the EIIS (Environmental Incident Information System) database for ecological incidents (run on January 4,2007) identified a total ofthree ecological incidents involving fenarimol;two involving terrestrial plants (Incident Nos.: I013563-009 and I0147 19-008) and one involving fish (IncidentNo.: 1000799-008). The two plant incidents, both involving grapes, indicated that the damage to the plants reported in the incident waspossibly related to fenarimol. The fish incident report, involving appleuse, concluded that it was unlikely that fenarimol contributedto the fish kill. In all three incidents, the legality of the fenarimol use was undetermined, therefore, it is unclear ifthe incidentswere due to misuse or to labeleduse. 4.2.4. Federally Threatened and Endangered (Listed) Species Concerns The results of this screening-level risk assessment indicate that the proposed new use of fenarimol on hops has the potential for direct adverse effects on listed and non-listed mammals fiom chronic exposure. Direct adverse effects cannot be precluded for listed fieshwater vascular plants or listed and non-listed terrestrial and semi-aquaticplants, given that no data are available for these taxa. Because of the potential risk fiom direct effectsto the listed and non-listed taxa described above, listed species in all taxa may potentially be affected indirectly due to alteration ofhabitat (e.g., food sources, shelter, and areas to reproduce) should exposure occur. 4.2.4.1. Co-occurrence Analysis The goal of the analysis for co-locationis to determine whether sites ofpesticide use are geographicallyassociated with known locations of listed species [followingthe convention of the Services, the word 'species' in this assessment may actually apply to a 'species', 'subspecies', or an Evolutionary SignificantUnit (ESU)]. At the screening level, this analysis is accomplished using the LOCATES (version 2.10.3) database. The database uses location information for listed species at the county level and compares it to agriculturalcensus data (fiom 2002) for crop production at the same county level ofresolution. The product is a listing of federally-listed species that are located within counties known to produce the crops upon which the pesticide will be used, in this case hops. For direct effects, only listed terrestrial plants, aquatic vascular plants, and mammals are considered, because they were the onlytaxa to have RQs abovethe listed species LOC or risks that could not be precluded at this time. For indirect effects, all other taxa are considered, given that there is a potential for indirect effectsto taxa that might rely on plants andlor mammals for some stage of their life-cycle. LOCATES identified a total of 63 listed speciesthat overlapped at the county-level with areas where hops are grown. Among these species, 16 are plants and 5 are mammals (see APPENDIX V for a complete species list). Therefore, at the county-level, there is the potential for a total of 21 listed speciesto be directly and/or indirectly affectedby the proposed fenarimolhops use,while 42 species may be indirectly affected by the use ofthe chemical. The number of county co-occurrencesby taxa per state can be found in Table 4.3. TABLE 4.3. Tabulation by State and Taxonomic Group of Listed Species that Occur in

This preliminary analysis indicates that there is a potential for fenarimol use on hops to overlap with listed species (and their designated critical habitat, if applicable) and that a more refined assessment is warranted. The more refined assessment should involve clear delineation ofthe action area associated with fenarimol uses and best availableinformation on the temporal and spatial co-location oflisted specieswith respect to the action area. This analysis has not been conducted for this assessment. 5. Literature Cited CDPR. 2006. SurfaceWater Database. CaliforniaDepartment of Pesticide Regulation, SurfaceWater ProtectionProgram. Online at: http://www.cd~r.ca.novldocslsw/surfdata.htm USDA. 2005. Agricultural Atlas ofthe United States: 2002 Census of Agriculture. United States Department ofAgriculture, National Agricultural Statistics Service. Online at: http://www.anc;census.usda.gov/Publications/2002/index.asp

-, USDA. 2007a. Crop Profiles. NSF Center for Integrated Pest Management (host). U.S. Department of AgricultrePest Management Centers. Last updated: Aug. 27,2007. Online at: htt~://www.ipmcenters.orrr/crop~rofiles/CP form.cfm USEPA. 1992. Pesticides in Ground Water Database: A Compilation ofMonitoring Studies: 1971 -1991 : National Summary. U.S. Environmental Protection Agency. Washington, DC. USEPA. 2002. Updated Drinking Water Assessment to Support TRED for Fenarimol. DP Barcode 282389,284487. U.S. Environmental Protection Agency, Office of Pesticide Programs, Environmental Fate and Effects Division, Memorandumto SRRD. Jul. 3 1,2002. USEPA. 2002a. Guidancefor SelectingInput Parameters in Modeling the Environmental Fate and Transport of Pesticides. U.S. Environmental ProtectionAgency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Environmental Fate and Effects Division, Feb. 28,2002. Online at: htt~:llwww.e~a.~ovlo~pefedl/modelslwater/in~ut midance2 28 02.htdUSEPA. 2004. Overview ofthe Ecological Risk AssessmentProcess in the Office of Pesticide Programs, U.S. EnvironmentalProtectionAgency. Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office ofPesticide Programs, Washington, D.C. January 23,2004. Online at: htt~://~~~.epa.gov/oppfeadl /endanger/consultation/ecorisk-overview.pdf USEPA. 2005. Fenarimol New Use (Eastern Grapes and Filberts): EnvironmentalFate and Effects Risk Assessment. DP Barcode: 240868+. EFED Memorandum to RD. Oct. 17,2005. USEPA. 2006. Standardized SoilMobility Classification Guidance. U.S. Environmental Protection Agency, Office of Prevention, Pesticides and Toxic Substances, Office ofPesticide Programs, EnvironmentalFate and Effects Division,Memorandum. Apr. 21,2006. USEPA. 2006a. Fenarimol: Responseto TRED Generic Data Call-In Comments. DP Barcode: 282832+. EFED Memorandum to SRRD. May 22,2006. USEPA. 2006b. Unregulated Contaminant Monitoring Rules (UCMR). U.S. Environmental Protection Agency, Unregulated Contaminant Monitoring Program. Last updated: Nov. 24,2006. Online at: http://www.epa.rov/safewater/data/ucmmetdata.htrnl USEPA. 2007. Registration Review -Preliminary Problem Formulation for the Ecological Risk Assessment ofFenarimol. DP Barcode: 336002. U.S. Environmental Protection Agency, Office of PesticidePrograms, Environmental Fate and Effects Division,Memorandumto SRRD. Mar. 26,2007. USEPA. 2007a. Water Models. U.S. Environmental Protection Agency, Pesticides: Science and Policy, Models and Databases. Last updated Sep. 20,2007. Online at: http://www.epa.rrov/opvefedl/models/water/. USEPA. 2007b. Safe Drinking Water Information SystemRederalVersion (SDWISIFED). U.S. Environmental Protection Agency. Last updated: May 7,2007. Online at: http:llwww.epa.~ovlsafewater/datajp;etdata.html USEPA. 2007c. STORETData Warehouse. U.S. Environmental Protection Agency. Last Updated Jun. 20,2007. Online at: htt~://www.epa.gov/storet/dwhome.htm1 USGS. 2006. National Water-Quality Assessment (NAWQA) Program. U.S. Geological Service. Last updated: Oct. 19,2006. Online at: http://infotrek.er.usgs.gov/traverse/f;=l36: 1:1779537078393353::NO::: USGS. 2006a. Kelly, V., R. Hooper, B. Aulenbach, and M. Janet. Concentrations and Annual Fluxes for Selected Water-Quality Constituents fiom the USGS National Stream Quality Accounting Network (NASQAN), 1996-2000. U.S. Geological Survey. Last updated: Nov. 20,2006. Online at: ht~://pubs.usgs.rov/wri/wri0l4255/results/detect.htm Submitted Studies:Environmental Fate Accession Number: 70426Althaus, W.; Bewley, G. 1978. Isolation and Identification of Photodegradation Products of 14c Fenarimol. Unpublished studyprepared by Lilly ResearchLaboratories; submitted by Elanco Products Company, Div. of Eli Lilly and Co., Indianapolis, IN. 31 p. AccessionNumber: 130586 Althaus, W. 1983. Memorandum to the U.S. Environmental ProtectionAgency regarding the Fenarimol Bluegill Bioconcentration Study (Study: ABC-0113). CD: 0122A. Jun. 21,1983. 3 p. AccessionNumber: 248702 Author not furnished. Undated. Basic Physical and Chemical Properties ofthe Technical Chemical. Unpublished study prepared by Lilly ResearchLaboratories; submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,IN. 1p. AccessionNumber: 2498 10 Althaus, W., J. Beaty, D. Negilski, and J. Seacat. 1981. Bioconcentrationof 14c Fenarimolby Bluegill Sunfish. Study: ABC-0 1 13. Unpublished studyperformed by Lilly Research Laboratories, Greenfield IN; submittedby Elanco Products Co., Div. ofEli Lilly and Co., Indianapolis,IN. 20 p. MRID: 00084916 Author not furnished. 1975. Rate of Hydrolysis of EL-222. Unpublished study submittedby Elanco Products Company, Div. of Eli Lilly and Co., Indianapolis,IN. 3 p. MRID: 00084917 Day, Jr., E. Undated. PreliminaryPhotochemical Studies with the Fungicide EL-222. Unpublished study submittedby Elanco Products Company, Div. of Eli Lilly and Co., Indianapolis,IN. 7 p. MRID: 00084923 Decker, 0. 1979. Vapor Pressure ofFenarimol. Unpublished studyprepared by Lilly Research Laboratories; submitted by Elanco Products Co., Div. of Eli Lilly and Co, Indianapolis,IN. 5 p. MRID: 00084927 Loh, A. 1976. n-Octanol-To-Water Partition Coefficient ofFenarimol. Unpublished studyperformed by Lilly Research Laboratories; submitted by Elanco Products Company, Div. of Eli Lilly and Co., Indianapolis,IN. 8 p. MRID: 001 17509 Althaus, W.; Beaty, J. 1982. 14c Fenarimol Aerobic and Anaerobic Laboratory Soil Degradation Study: ABC-0 132. Unpublished studyperformed by Lilly Research Laboratories; submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,IN. 19p. MRID 001 17511 Day, E. 1982. Fenarimol Three-year SoilDissipation Studies: I- EWD-82-22. Unpublished study performed by Lilly Research Laboratories; submitted by Elanco Products Co., Div. ofEli Lilly and Co., Indianapolis,IN. 151p. MRD: 00129103 Mosier, J.; Saunders, D. 1976. Photochemical Studies with Fenarirnol. Unpublished studyperformed by Lilly Research Laboratories, Div. of Eli Lilly and Co., Greenfield,IN. 27 p. MRID: 00133471Day, E.; Sieck,R.; Shuey, E. 1983. Soil Characteristicsfrom Fenarimol Field Dissipation Studies: Lilly Report Nos. I-EWD-82-22, I-EWD-82-25. Unpublished studyperformed by Lilly Research Laboratories; submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,IN. 11p. MRID 00133472 Saunders, D.; Smith, S.; Mosier, J. 1983. An Aged Soil Leaching Study with 14c-~enarimol: I-EWD-83- 6. Unpublished studyperformed by Lilly Research Laboratories; submittedby Elanco Products Co., Div. ofEli Lilly and Co., Indianapolis,IN; CDL: 25 1940-C. 1 8 p. MRID: 00142483 Smith, S.; Saunders, D. 1982. Soil Adsorption and Desorption ofFenarimol: I-EWD-81-03. Unpublished studyprepared and submitted by Eli Lilly and Co., Greenfield, IN. 13p. MRID: 00250612 Smith, S.; Saunders,D. 1982. Quantitation ofFenarimol Aqueous Photoproducts: S-AAC-81-27. Unpublished studyprepared and submitted by Eli Lilly and Co., Greenfield,IN. 27 p. MRID: 45659801 Smith, J. 1998. Aqueous Photolysis ofFenarimol in Natural Water. 980076. Unpublished study performed by Global Environmental ChemistryLaboratory -IndianapolisLab; submitted by Dow AgroSciences LLC. 48 p. MRID: 45716302 Kabler, K.; Carpenter, M. 1988. Photodegradation Study of 14c-~enarimol on Soil Surface. ABC Amended Final Report #36924. Unpublished studyperformed by Analytical Bio-Chemistry Laboratories, Inc.; submittedby Eli Lilly and Company. 41 p. MRID: 46259501 Saunders, D.; Powers, F. 1987. Adsorption and Desorption of ~enarimol on Soil. EWD8718. Unpublished studyperformed by Lilly Research Laboratories; submitted by Gowan Company. 61 p. MRID: 46413701 Decker, 0. 1987. Solubility of Fenarimol in Water. ODD8711. Unpublished study performed by Lilly Research Labdratories; submitted by Gowan Company. 9 p. Submitted Studies: Effects MRID: 56081 Bentley,R.E.; Macek, K.J. (1975) Acute Toxicity ofEL-222 to Blue- gill (-Lepomis rnacrochirus-) and Rainbow Trout (-Salrno -gairdneri-). (Unpublishedstudy received Dec 3,1975 under unknown admin. no.; prepared in cooperation with Bionomics,Inc., submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:222246-C). MRID: 71920 Hoffman, D.G.; Pierce, E.C.; Ernmerson,J.L.; et al. (1978) Twenty- four Month Chronic Oral Toxicity of EL-222 (56722) in Mice: StudiesM-9135 and M-9145. (Unpublished studyreceived Sep 22, 1978under 1471-EX-50; submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:235 174-B). MRID: 84943Kehr, C.C.; West, H.C.; Hamelink, J.L.; et al. (1978) The Toxicity of Compound 56722 (EL-222) to Bobwhite Quail in a 14-dayAcute Oral Study: Study 70 10-78.(Unpublished study received Oct 19, 1981 under 1471-EX-75; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070429-M). MRID: 84944 Kehr, C.C.; Karnak, R.E.; Hamelink, J.L.; et al. (1978)The Toxic- ity of Compound 56722 (EL-222) to Bobwhite Quail in an Eight Day Dietary Study: Study No. 7009-77. (Unpublished studyreceived Oct 19, 1981 under 1471-EX-75;submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070429-N). MRID: 84946 Kehr, C.C.; Hamelink, J.L.; Hoffman, D.G.; et al. (1980) The Toxic- ity of Compound 56722 (Fenarimol) in a One-generation Reproduc- tion Study with Bobwhite Quail: Study No. 7002-77. (Unpublished study received Oct 19, 1981under 1471-EX-75; submitted by Elan- co Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070429-P). MRID: 84949 LeBlanc, G.A.; Wilson, B.F.; Sleight,B.H., I11 (1980) The Acute Toxicity of Compound 56722 to Bluegills in a 96-hour Static Test: Bionomics Report No. BW-80-1-593; Eli Lilly Study No. F13679. (Unpublished study received Oct 19, 1981under 1471 -EX-75; prepared by EG & G, Bionomics, submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070429-T). MRID: 84950 LeBlanc, G.A.; Wilson, B.F.; Sleight,B.H., 111(1980) The Acute Toxicity of Compound 56722 to Bluegills in a 96-hour Static Test with Continuous Aeration: Bionomics Report No. BW-80-1-592; Eli Lilly Study No. F14479. (Unpublished studyreceived Oct 19, 1981under 1471 -EX-75; prepared by EG & G, Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapo- lis, Ind.; CDL:070429-U). MRID: 84951 LeBlanc, G.A.; Sousa, J.; Sleight,B.H., I11 (1980) The Acute Toxicity of Compound 56722to Rainbow Trout in a 96-hour StaticTest: Bionomics Report No. BW-80-2-615; Eli Lilly StudyNo. F13779. (Unpublished studyreceived Oct 19, 1981under 1471 -EX-75; prepared by EG & G, Bionomics, submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070429-V). MRID: 84952 LeBlanc, G.A.; Sousa, J.; Sleight,B.H., I11 (1980) The Acute Toxicity of Compound 56722 to Rainbow Trout in a 96-hour StaticTest with Continuous Aeration: Bionomics Report No. BW-80-2-616; Eli Lilly StudyNo. F14379. (Unpublished studyreceived Oct 19, 1981 under 1471-EX-75; prepared by EG & G, Bionomics, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapo- lis, Ind.; CDL:070429-W). MRID: 84953 Kehr, C.C.; Hamelink, J.L.; Hoffman, D.G.; et al. (1978) The Toxic- ity of Compound 56722 (EL-222) to Bluegills in a 7 Day, Contin-uous Flow-through Bioassay: Study 2013-77. Includes pro- cedure no. 580 1705. (Unpublished study received Oct 19, 1981under 1471 -EX-75; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070429-Y). MRID: 84954Karnak, R.E.; Kehr, C.C.; Hamelink, J.L.; et al. (1 978) The Toxic- ity of Compound 56722 (EL-222) to-Daphnia magna-in a 48-hour Static Test: Study 5017-78. (Unpublished studyreceived Oct 19,1981 under 1471-EX-75; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL1070429-Z). MRID: 84955 Karnak, R.E.; Kehr, C.C.; Hamelink, J.L.; et al. (1978) The Toxic- ity of Compound 56722 (EL-222) to Ea~%hworms in a 14-daySoilIncorporated Study: Study No. 5013-6. (Unpublished study re- ceived Oct 19, 1981under 1471 -EX-75; submitted by Elanco Prod- ucts Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL: 070429-AA). MRID: 84965 Hoffman, D.G.; Arthur, B.H.; Gibson, W.R.; et al. (1 977) The Acute Derrnal and Ocular Toxicity of TechnicalEL-222 in Rabbits. (Unpublished studyreceived Oct 19,1981under 1471 -EX-75; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070425-F). MRID: 85064 Kehr, C.C.; Karnak, R.E.; Hamelink, J.L.; et al. (1978) The Toxic- ity of Compound 56722 (EL-222) to Mallard Ducks in an Eight-day Dietary Study: Study 7010-77. Includes method AW dated Nov 4, 1977. (Unpublished study received Oct 19,1981under 1471-EX-75; submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070430-D). MRID: 85066 Fink, R. (1977) Final Report: One-generation Reproduction Study-- Mallard Duck: Project No. 151-101. (Unpublished study received Oct 19, 1981under 147 1 -EX-75; prepared by Wildlife Interna-tional Ltd., submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,Ind.; CDL:070430-F). MRID: 85067 Citation Reference: Morton, H.L.; Moffett, J.O. (1978) Influence of Two Fungicides on Honeybees, a ConfidentialReport to Elanco. (U.S. Agricultural Research Service; unpublished study; CDL:070430-G). MRID: 125392 Gomez, S.; Negilski, D.; Quarles, J.; et al. (1983) The Acute Oral, Dermal, Ocular and Inhalation Toxicity of Rubigan EC, an Emulsifiable Concentrate Formulation (FN-5 110)Containing 12.6% Fenarimol (EL-222,56722): StudiesR-0-289-82, B-D-2-83, B-E- 196-82, R-H-102-82. (Unpublished study received Mar 7, 1983under 1471 -EX-5 1;submittedby Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,IN; CDL:071453-A). MRID: 129099 Meyerhoff,R.; Sauter, S.; Hoffman, D.; et al. (1 982) The Toxicity of Fenarimol (EL-222, Compound 56722) in Water to Rainbow Trout
... in a 69-day Early Life-stage Study: F-3382. (Unpublished study received Jun 24,1983under 1471-134; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,IN; CDL: 250612-B). MRID: 129100 Meyerhoff, R.; Sauter, S.; Hofhan, D.; et al. (1 982) The Toxicity of Fenarimol (EL-222, Compound 56722) inWater to Fathead Min- nows


### ... in a 30-day Early Life-stage Study: StudyF06282. (Unpublished study received Jun 24,1983 under 1471-134; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis,IN; CDL:250612-C).\ MRID: 45213601 Pedersen, C. (2000) Rubigan: Avian Acute Oral Toxicity Test with Northern Bobwhite (Colinus virginianus): Lab Project Number: 153-025-03: 000024. Unpublished study prepared by Bio-Life Associates, Ltd. 40 p. MRID: 45213602 Bell, G. et al. (1994) Fenarimol: Acute Toxicity Test to Honey Bees (Apis mellifera): Lab Project Number: GHE-P-4001. Unpublished study prepared by Huntingdon Research Centre Ltd. 29 p. MRID: 45213603 Hahne, R. (2000) Rubigan: Acute Oral Toxicity Test with the Honey Bees (Apis mellifera): Lab Project Number: 4588 1:000025. Unpublished study prepared by ABC Laboratories, Inc. 21 p. MRID: 45502307 Hoffman, D.; Markham, J.; Owen, N. et al. (1978) A Multi-Generation Study with EL-222 (Lilly Compound 56722) in the Mouse: Lab Project Number: M-9086: M-9296: M-9326. Unpublished study prepared by Lilly Research Laboratories. 53 p. MRID: 45502301 Hoffman, D.; Adams, E.; Markham, J. (1977) A Multi-Generation Reproduction Study with EL-222 in the Rat. Unpublished study prepared by Lilly Research Laboratories. 74 p. MRID: 45502302 Hoffman, D.; Owens,N.; Markham, J. et al. (1 978) A Second Multi-Generation Reproduction Study with EL-222 (Lilly Compound 56722)in the Rat. Unpublished study prepared by Lilly Research Laboratories. 71 p. MRID: 45502303 Hoffman, D.; Adams, E.; Harris, P. et al. (1978) A One-Year Toxicity Study with EL-222 in the Rat (StudyR-715): Lab Project Number: 235 175: 33418: R-715. Unpublished study prepared by Lilly Research Laboratories. 1 97 p. MRID: 45502304 Hoffman, D.; Gibson, W.; Pierce, E. et al. (1978) Eighteen-Month Chronic Oral Toxicity of EL-222 (56722) in Rats StudyR-435: Lab Project Number: 235 175: 33419. Unpublished study prepared by Lilly Research Laboratories. 286 p. MRID: 45502305 Hoffman,D.; Gibson, W.; Pierce, E. et al. (1978) Twenty-Four Month Chronic Oral Toxicity of EL-222 (56722) in Rats StudiesR-405 and R-415: Lab ProjectNumber: 33428: 235 173A.Unpublished study prepared by Lilly Research Laboratories. 399 p.APPENDIX I. Chemical Names, Structures, and Maximum Reported Amounts of Fenarimol and Its Degradates.

IUPAC name: (RS)-2,4'-Dichloro-abyrimidin-5-y1)benzhydryl alcohol CAS name: a-(2-Chloropheny1)-a-(4- chloropheny1)-5-pyrimidinemethanol

Table 1.B. MalRimm R&portcd Amounts ofFenak5mal I)egradaticm.Iprradueks, / I Degrzldate 4-chloro-2-(5-pyrimidy1)- 2'-chlorobenzophenone Unidentified residues Ma;ai*mum O/s ofApplied MEWtD 17 (4 hr) 19 (1 hr) 97.9 (24 d) 17.1 (21 d) 18.0 (52 wk) Aqueous photolysis Aqueous photolysis Aqueousphotolysis Soil photolysis Aerobic soil metabolism MRID 00250612 MRID 00129103 MRTD 45659801 MRID 45716302 MRID 00 1 17509APPENDIX 11. PRZMIEXAMS Input Data for Ecological Risk Assessment. ORHops OutputFile: Fen-May 1 Metfile: PRZM scenario: EXAMS environment file: ChemicalName: Description Molecular weight Henry's Law Const. Vapor Pressure Solubility Kd Koc Photolysishalf-life Aerobic Aquatic Metabolism AnaerobicAquatic Metabolism Aerobic Soil Metabolism Hydrolysis: Hydrolysis: Hydrolysis: Method: IncorporationDepth: ApplicationRate: ApplicationEficiency: Spray Drift Application Date Interval 1 aPP. app. rate 1 Interval 2 aPP. app. rate 2 Interval 3 aPP. app. rate 3 Record 17:
Record 18: Flag for Index Res. Run Flag for runoff calc. w24232.dvf 0RhopsSTD.txt pond298.e~~ Fenarimol Variable Name mwt henry vapr sol Kd Koc kdp kbacw kbacs asm pH 5 pH 7 pH 9 CAM DEPI TAPP APPEFF DRFT Date interval apprate interval apprate interval apprate FILTRA IPSCND UPTKF PLVKRT PLDKRT FEXTRC IR RUNOFF Value 331.2 Units Comments glmol atrn-mA3/mol torr mg/L mg/L mg/L days Half-life days Halfife days Halfife days Halfife days Half-life days Half-life days Half-life integer See PRZM manual cm kg/ha fkaction fraction of application rate applied to pond ddlmm or ddmmm or dd-mm or dd-mmm days Set to 0 or delete line for single kg/ha days Set to 0 or delete line for single k&a days Set to 0 or delete line for single

0.5 EPA Pond none none, monthly or total(average of entirerun)

### APPENDIX 111: Summary of Submitted Toxicity Studies for Animals Exposed to Fenarimol.



# I MRID: 84950

Lepomis macrochirus

Bluegill Sunfish Lepomis macrochirus

Bluegill Sunfish Oncorhynchusmykiss Rainbow Trout Oncorhynchusmykiss Rainbow Trout Oncorhynchusmykiss Rainbow Trout Oncorhynchusmykiss Rainbow Trout Pzmephales promelm Fathead Mmow

Quail 

# I LD50 

# I >2000 l4&yS 

# I m@g 

# 1 -- 

# I Acceptable 

# I MRID: 84943 

# I Mortality
Mortality Moaality

Mortality Body Size



### --

Freshwater Invertebrates LC50

LC50
LC50
LC50
LC50
NOAEC
,om,

Daphnia magna

Water Flea Daphnia magna

WaterFlea 96

96
96
96
96 69 day

life-stage)
33 day (early

life-stage)

IMBL



### --- EstuarineIMarine Fish 1.8 (1.5-2.4)

r5.17

3.1 (2.4-4.1)

2.1 (1.8-2.4)

4.1 (3.2-5.3)

0.43 0.98 (highest

conc. tested)

EC50
NOAEC

NONE S

F
S
S
S



### -

-

48
2 1days



### - EstuarineIMarine Invertebrates Supplemental (low DO during testing) Supplemental Acceptable Acceptable Acceptable Acceptable
Supplemental

6.8 (6.0-7.8)

0.1 13

--

NONE 

# I -- MRID: 84949

MRID: 84953
MRD84951
MRID: 56081
MRID: 84952
MRID: 129099

MRID: 129100

S
S

--



### - Birds Acceptable Supplemental



### --

-

Anasplatyrhnchos

MallardDuck

platyrhnchos Mallard Duck Colinus virginianus Northem Bobwhite MRID: 84954
MRID: 40283902



### --

-

Mortality
~~~~~d~~~~~~ --



### -

Mortality LC50
NOAEL 

## -

-

8 days
22 weeks --

>6250
>250 --



### - Acceptable Acceptable MRJD: 85064
MRID: 85066Colinus virginianus Northern Bobwhite 

# I Mortality Quail Species

Colinus virginianus Northern Bobwhite Mortality
Colinw virginianus Measurement

Colinus virginianus


## I Rat 

## I MotTality Endpoint

Growth/ Reproduction 

# I Rat 

# I OmMN Reproduction Duration (hours)



# 4 Reproduction
Reproduction 

# ll Conc. Mean @pm)



## I Mouse 

## I - Exposure Type'



# I Guideline LD50

LC50



### --

NOAEC

NOAEL 

# I 1year 

# 1 50 

# 1
-- 

# I Acceptable Catei?o~ Ref#

Mammals l4
8 days

26 weeks

30 weeks

NOAEL 

# I 1year 

# 1 130 

# 1 - 

# I AcceptableMultigeneliltion
I

NOAEL 

# I 18months 

# 1 50 

# 1

-- 

# I Acceptable 22000 mg/kg

>6125

--
>300 (>24.2 mgflcg)

NOAEL 

## 1 2 year 

## 1 <50 

## 1 -- 

## 1 Acceptable 12.5 

### -

--

-

--

Terrestrial Invertebrates Acceptable
Acceptable

Invalid
Acceptable



### --

NOAEL NOAEL
- MRID: 84944 

# I

Acceptable MRID: 84946 

# I

1 Year 2 year



### -- MRID: 40283901

MRID: 

# I
00125392

170 170 >35 mgkg MRID: 45502301 

# I

MRID: 

# I
45502302

-- 

### - - MRID: 45502303 

# I

- - --

Acceptable Acceptable Supplemental MRID: 45502304 

# I

MRID: 71920 MRID: 84965 

## 1

Lurnbricus terrestris Earthworm Apis mell$era

Honey Bee Apis mellifra

Honey Bee Apis rnellifra

Honey Bee Apis rnell$era

Honey Bee "S" (static) and "F" (flowthrough) Mortality Mortality Mortality Mortality MotTality Ecso

--
LDso
LDso
LDso 14 days



### --
48
48
48 >lo0
>lo0
>10 &bee

>loo p&roee >loo --



### -

--



### -

- Supplemental Acceptable Acceptable Acceptable Acceptable MRID: 84955
MRID: 85067 MRID: 45213602

MRID: 4521 3602

MRID: 4521 3603APPENDIX IV. 

### T-REX Input and Output Parameters (Mammal - Chronic Exposure).

ent CalculationsBased on

Summary of Risk Quotient CalculationsBased on Mean Kenega EECs IAPPENDIX V. Listed Species that Co-Occur, at the County Level, with Hops Acreage. Inverse Name:

Butterfly, Behren's Silverspot Butterfly, Fender's Blue Butterfly, Lotis Blue Caribou, Woodland Chub, Oregon Daisy,Willamette Evening-primrose, Antioch Dunes Goby, Tidewater Goldfields, Burke's Goldfields, Contra Costa Grass, Sacramento Orcutt Lomatium, Bradshaw's Mountain Beaver, Point Arena Navarretia, Few-flowered Navarrctia, Many-flowered Pelican, Brown Rabbit, Pygmy Rock-cress, McDonald's Salamander, California Tiger Salmon, Chinook (Sacramento River WinterRun) Salmon, Chinook (Upper Columbia River Spring) Salmon, Coho (CentralCalifornia Coast population) Salmon, Sockeye (Snake Riverpopulation) Spineflower, Howell's Stonecrop, Lake County Sturgeon, White Tadpole Shrimp, Vernal Pool Wallflower, Menzie's Wolf, Gray Bear, Grizzly Beetle, ValleyElderbeny Longhorn Checker-mallow, Nelson's Fairy Shrimp, Vernal Pool Grass, SanJoaquin Valley Orcutt Grass, Slender Orcutt Lupine, Kincaid's Murrelet, Marbled Owl, Northern Spotted Plover, Western Snowy Salmon, Chinook (California CoastalRun) Salmon, Chinook (CentralValley Fall Run) Salmon, Chinook (CentralValley SpringRun) Salmon, Chinook (Lower ColumbiaRiver) Salmon, Chinook (Snake River Fall Run) Salmon, Chinook (Snake River springlsummer) Salmon, Chinook (UpperWillamette River) Salmon, Coho (SouthernOR/NorthernCA Coast) Sea turtle, oliveridley Smelt, Delta Snake, Giant Garter Steelhead, (California CentralValley population) Steelhead, (Central CaliforniaCoast population) Steelhead, (Lower Columbia Riverpopulation) Steelhead, (Middle Columbia Riverpopulation) Steelhead, (NorthernCalifornia population) Steelhead, (Snake River Basin population) Steelhead, (Upper Columbia Riverpopulation) Steelhead, (Upper Willamette Riverpopulation) Steelhead, Puget Sound sturgeon, green Trout, Bull Trout, Bull (Columbia Riverpopulation) Trout, Bull (KlamathRiver population) Taxa: Insect Insect Insect Mammal Fish Dicot Dicot Fish Dicot Dicot Dicot Dicot Mammal Dicot Dicot Bird Mammal Dicot Amphibian Fish Fish Fish Fish Dicot Dicot Fish Crustacean Dicot Mammal Mammal Insect Dicot Crustacean Monocot Dicot Dicot Bird Bird Bird Fish Fish Fish Fish Fish Fish Fish Fish Reptile Fish Reptile Fish Fish Fish Fish Fish Fish Fish Fish Fish Fish Fish Fish Fish Co. occuren 1 1 1 1 3 2 1 1 1 1 1 2 1 1 1 1 1 1 1 1 2 1 1 1 1 1 1 ice: Status: Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Endangered Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened Threatened