UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON D.C., 20460 

OFFICE OF 

PREVENTION, PESTICIDES AND 

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, Senior Biologist 

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. 10163-2731 on hops. The proposed label reports 

a maximum spray interval of 14 days and no minimum application interval. EFED recommends 

modification of the proposed label to report an appropriate minimum application interval. For 

this assessment, the minimum application interval was assumed to be 14 days for aquatic 

exposure estimates. Due to the meteorological conditions of the modeled scenario, exposure 

estimates for the proposed use on hops decrease for minimum spray intervals less than or greater 

than 14 days. For estimating terrestrial exposure, a 3-day application interval was modeled. 

Based on the environmental fate and transport characteristics of fenarimol, the following label 

advisories for ground water and surface water are recommended. 

-1 of 39- l llllll lllll lllll lllll lllll lllll lllll Il1 llll 

2069231 

TEXT SEARCHABLE DOCUMENT
This chemical has properties and characteristics associated with 

chemicals detected in ground water. The use of this chemical in areas 

where soils are permeable, particularly where the water table is shallow, 

may result in ground water contamination. 

This product may contaminate surface water due to runoff of rain water. 

This is especially true for poorly draining soils and soils with shallow 

ground water. 

nis product is classiJied as having high potential for runoff for several 

months or more after application. A level, well-maintained vegetative 

buffer strip between areas to which this product is applied and surface 

water features such as ponds, streams, and springs will reduce the 

potential for contamination of water 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 submitted to 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 guideline requirements. 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. The registrant submitted some of the 

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 aqueous photolysis, aerobic aquatic metabolism, anaerobic aquatic metabolism, and 

terrestrial field dissipation data are not waived. Submission of these GDCI data that remain 

requested may change ecological risk conclusions, depending on the availability of toxicological 

data on identified degradates. 

The lack of acceptable studies under each Subdivision N guideline, except hydrolysis and soil 

photolysis, is the major source of uncertainty in the fate and transport of fenarimol. The 

compound seems to be moderately persistent under most degradation pathways except for 

aqueous photolysis. Submission of acceptable studies conducted under Good Laboratory 

Practice standards that provide the data requested in the GDCI would reduce uncertainty in this 

exposure characterization and could change ecological risk conclusions, depending on 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 estuarinelmarine species as 

it is to freshwater organisms. 

No toxicity data are currently available for aquatic vascular plants 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 following reasons: 
a. One of the registered uses for fenarimol is annual bluegrass (Poa annua) 

management; an herbicidal use. The supplemental Rubigan A.S. label for Poa 

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 of Rubigan A.S. or prolonged exposure, 

a species sensitive to 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 ounces per 1000 square feet may inhibit 

the germination of creeping bentgrass 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 

possibility that acute exposure to fenarimol may damage non-target terrestrial 

plants. 

c. 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). 

Because fenarimol is the only member of the pyrimidine class of hngicides currently registered 

in the U.S., there is no possibility of using submitted toxicity data from closely-related surrogate 

chemicals to fill in potential data gaps. Therefore, until additional data become 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. The proposed 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 13.7 mg/L (25°C). The compound is 

stable to hydrolysis, does not significantly biodegrade, and is moderately mobile in soil. The 

major route of degradation is photolysis in water. The compound is expected to persist under 

most conditions in soil, ground water, and turbid surface water. Fenarimol in clear, near-surface 

water is expected to photolyze readily. 

Toxicity data are not available for degradates of fenarimol; however, most identified 

photodegradates remain chlorinated. Therefore, a total residues of concern (TRC) approach was 

used for all taxa evaluated in this assessment to evaluate the potential exposure to 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 chronic risks, however, could not be excluded. The chronic level of concern 

(LOC) for listed mammals was surpassed for most of the mammalian size-classes and dietary 

categories modeled. 

No toxicity data are currently available for aquatic vascular plants or terrestrial plants. Although 

fenarimol is described as a fungicide, one of the registered uses for fenarimol is annual bluegrass 

(Poa annua) management [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) are reported in 

green algae exposed to 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-listed and 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 of information that 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-eshwater organisms. 
Potential effects to federally-listed endangered and threatened species (listed species) based on 

LOC exceedances require an in-depth listed species evaluation determining the potential cooccurrence of listed species and the areas in which hops are grown. Identified potential risks to 

listed species are summarized in Table1 .l. 

TABLE 1.1. Listed Species Risks Associated with Potential Direct or Indirect Effects Due 

Terrestrial and semi-aquatic 

plants - dicots 

Terrestrial and semi-aquatic 

plants - monocots 

Yes I yes1 

Yes yes1 

Insects 

Birds 

Terrestrial phase 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 

Freshwater crustaceans 

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 species that rely on a specific plant or animal species 

(specifically aquatic vascular plants, terrestriavsemi-aquatic monocots and dicots, or mammals) or multiple plant or 

animal species (specifically terrestriallsemi-aquatic monocots and dicots and mammals) cannot be precluded. 

Indirect effects may 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. The proposed 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 14 days 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 application rates, a maximum of four applications at 

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 photodegradates to 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 of the residues of concern assumed to be similar to 

the parent compound, as no toxicity data on the degradates of fenarimol have been submitted 

since completion of the TRED. 

2.1. Mode of Action 

Fenarimol is a locally systemic foliar fungicide in the pyrimidine class of fungicides, which also 

includes dimethirimol, bupirimate, and ethirimol. Fenarimol is a demethylation inhibitor, which 

inhibits fungal growth by adversely affecting the formation of the 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 addition to its fungicidal uses, fenarimol also has a registered herbicidal 

use [to control annual bluegrass (Poa annua) on golf course greens and tees]. The label 

[Rubigan A.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 creeping bentgrass for up to 30 days after 

application.. . 

During period of environmental stress, a single high rate application of Rubigan 

A.S. may rapidly eliminate Poa annua fi-om greens, tees or other close cut turf 

areas.. . 
The proposed label for hops recommends applications of 7 fl oz 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. The proposed 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 unavailable to 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 of hops 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 of hops 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 applies to the states identified above where hops have historically been 

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. Conceptual Model 

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 concentrations are sufficiently elevated as a result 

of proposed label uses. Based on a preliminary risk screening and past assessments indicating 

that fenarimol is highly toxic to freshwater fish on an acute exposure basis and causes potential 

reproductive effects in mammals when chronically exposed, the hypothesis for the risks of 

fenarimol to non-target animals (depicted in 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-level assessment. For terrestrial 

organisms, the major route of exposure considered is the dietary route; 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-blast assumed) 

TOTAL ACRES 

HARVESTED IIV 21107 

31,032 

22,749 

Idaho I 3,106 I 10 

5,177 

Application 

Interval (days) 

14 (maximum) 

% OF TOTAL ACRES 

'WCARVESTED @4 2607 

100 

73 

17 

Max. App. Rate 

(lbs a.i.lAlyr) 

0.22 
adsorption. Estimated exposure concentrations for all organisms are obtained through the use of 

several Agency exposure models. 

The following risk hypothesis is presumed for this screening level assessment: 

Based on the application method, mode of action, and the sensitivity of non-target 

aquatic and terrestrial species, the proposedfenarimol 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 

concentrations found to cause adverse effects. The exposure pathway is the means by which a 

pesticide moves in the environment from the application site to non-target organisms. The 

assessment of ecological exposure pathways in this assessment includes an examination of the 

source and routes of transport and dissipation for fenarimol, and the determination of potential 

exposure routes to non-target species. 
Stressor I Fenarimol Applied as a Ground Spray to 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/ Terrestrial Food 

Exposure 

Media 

Exposure 

Route 

Terrestrial Vertebrates: 

Birds, Mammals, Receptors Reptiles, Terrestrial 

Phase Amphibians 

Individual 

Plant Po~~latioIl Vertebrates and 

~t.~ib~t~ Individual Animals 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, although this exposure routelmedia was considered, its contribution to the fate and 

transport of fenarimol is 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-level assessment, 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 are used 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 I Potential 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-day EECINOAEC 

(invertebrates) I I I 

Aquatic Plants 

Peak EECILC~~I 

Listed species may be potentially affected by 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 affected by acute I EEC 2/~~50 (Dietary) 

Species exposures 1 Chronic I Potential 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 degrades by 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, fenarimol is likely to 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. Phvsicochernical and Fate Pro~erties of Fenarimol. 

I Molecular mass 1331.2 dm01 1 Accsn # 248702 1 

Vapor pressure (25°C) 

Water solubility (25"C, pH 7) i I Octanol-water wartition coefficient (Lw) 

2.2 x 1 0-7 torr I MRID 00084923 1 

, -.., I I 

Persistence 

13.7 mg/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 

None 
Fenarimol is soluble in water (1 3.7 mg/L at pH 7,25OC) and has low vapor pressure (2.2 x 

torr at 25OC). The compound shows affinity to organic carbon and is moderately mobile in soil 

according to 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 availability for runoff over extended periods post-application. 

Fenarimol's major degradation pathway 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 significantly in 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 significantly in aquatic environments based on its 

persistence in soil. Therefore, fenarimol is expected to persist under most conditions in soil, 

ground water, and turbid surface water. 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 1-3 years to 20 plots of bare soil in California (loam), Florida (sand), 

Indiana (clay loam), and Maryland (silt loam). Fenaiimol was also applied to four plots in 6-8 

biweekly applications and to one plot in 8 biweekly applications followed by 8 biweekly 

applications on the following year. Core samples were taken to a depth of only 6 inches. For the 

20 plots that received annual treatments, dissipation was fastest in the Florida sand (tin range = 

64 to 172 days, n4) and slowest in the Maryland silt loam (tin range = 483 to >lo00 days, n=6). 

Dissipation also correlated with annual rainfall received (3 = 0.850). Dissipation in the five 

plots that received biweekly applications (tln range = 105 to 742 days, n=5) was similar to or 

slightly less slow than dissipation following annual applications. 

Fenarimol's sole identified major degradate is the photolysis product 4-chloro-2-(5-pyrimidy1)- 

2'-chlorobenzophenone (structure in Table 1.A of APPENDIX I). This compound was detected 
at up 19% of the applied radioactivity one hour after application (Table 1.B of APPENDIX I). 

Its photolysis half-life in water appears to be twice that of fenarimol parent (MRID 00129103). 

Because no submitted aqueous photolysis studies have reported on complete mass balance, there 

is uncertainty in the identity and rates of formation and decline of major degradates of fenarimol. 

Over 80 minor photolysis products have been observed, most of which are chlorinated 

(Accession No. 70426). No information is 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 residues present surface water and ground water concerns through runoff, 

spray drift, and leaching. Fenarimol's major degradation pathway 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 are unknown. 

Therefore, all organic residues of fenarimol are residues of concern and assumed to have similar 

toxicity to the parent compound. 

3.1.2. Measures of Aquatic Exposure 

The Tier 11-screening simulation models 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 fenarimol that may occur in surface waters adjacent to 

use sites. The PRZM model simulates pesticide movement and transformation fiom crop 

application through dissipation processes. The EXAMS model simulates the fate and transport 

of the pesticide in a receiving water body adjacent to the field of application. The coupled 

PRZMEXAMS model assumes a standard pond scenario in which a 10-hectare agricultural field 

drains into an adjacent 1-hectare pond of 2-meter depth and no outlet (USEPA 2007a). 

The EECs listed in Table 3.2 reflect 1 -in-1 0 year peak and averaged surface water 

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 exposure values 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) 

Input parameter guidance 

(USEPA, 2002a) and Spray 

Drift Task Force studies1 

I Application Efficiency 10.99 1 Input 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 scenario was used to model use 

on hops, as most hops are grown in the Pacific Northwest, with about 18% of the total crop in 

Oregon (USDA 2005). The maximum application rate was obtained fi-om the 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 14 days 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. 

Source Data are in Table 3.1. 

Input Parameter 

Molecular Mass (glmol) 

Value 

Vapor Pressure at 25OC (torr) 

Solubility in Water at 25OC (mg/L) 

MRID 00084923 

Source 

33 1.2 

2.2~ lo-7 

137 

Organic Carbon Partition Coefficient 

(Koc) (Llkgoc) 

Total Residue Aerobic Soil 

Metabolism Half-life (days) 

Total Residue Aerobic 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 Input parameter 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 of nine 

values (602 Llkgoc). Based on analysis of total residues of concern, the upper 90% confidence 

bound on the mean was selected for the aerobic soil metabolism half-life input (61 70 d). This 

half-life input was multiplied by two to account for uncertainty in 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. 

Hydrolysis Half-lives (days) 

Total Residue Aqueous Photolysis 

Half-life (days) 

The PRZM and EXAMS models have limitations in their ability to 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 of the time. These models are intended to provide a 

reasonable screening-level estimate by 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 modeling may 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 California Department of Pesticide 

Regulation (DPR) Surface Water Database (CDPR 2006). Furthermore, fenarimol is not a 

regulated chemical under the Safe Water Drinking Act (SWDA) or related statutes. Therefore, it 

is not listed in the EPA Safe Drinking Water 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 California in 1989, according to the EPA 

Pesticides in Ground Water Database (USEPA 1992). No detections were 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 87 times in the estuarine sediment at a total of 34 sites across 19 Florida counties from 

2000 to 2002 (Table 3.6). The compound was detected in 100% of samples at concentrations 

ranging from 6.0 to 19 pg/kg. Because it is not possible to identify how data were collected in 

these monitoring studies, the purpose of data collection, and why particular sites were chosen for 

sampling, these results are used only descriptively and 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 I Anderson, KY I 1 1 

Anna Maria Sound 

County, State 

<LOQ means less than the level of quantification (value not reported). 

100% 

\---- ~ -I ~ 

Manatee, FL 1 2 1 100% 1 Jul. 2000, 

Jul. 2001 

# Samples Detection 

Rate 

Station Name 

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 Bay Hillsborough, FL 

- 

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 

Ju1.2002 
3.1.3. 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 exposures to 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 degradation rate on foliage had not been identified. Because no 

minimum application interval is provided on the label (only a maximum application interval of 

14-days is provided), a 3-day application interval was modeled. A 1-year time period is 

simulated. Consideration is given to different types of feeding strategies for mammals and birds, 

including herbivores, insectivores and granivores. For dose-based exposures, three weight 

classes of mammals (1 5,35 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 - 19 
TABLE 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 

3 5 

3 I 

( Short Grass 44 

Number of Applications 4 

3.1.3.2. Terrestrial Plants 

Tall Grass 

Broadleaf plantslsm insects 

Fruits/pods/lg insects 

No toxicity data are currently available for terrestrial plants. Although fenarimol is described as 

a fungicide, one of the 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 data become 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; slightly toxic to mammals; moderately toxic to fi-eshwater 

invertebrates; and highly toxic to freshwater fish on an acute exposure basis. In a 14-day toxicity 

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)(see Table 3.9). 
TABLE 3.9. Summary of Specific Assessment Endpoints for Animals and Plants 

Considered in this Assessment. 

(length and weight) 

[based on an acute-tochronic ratio from studies 

with rainbow trout 

Anus platyrhynchos 

Mallard duck 

I treatment level tested 

Chronic 

Rat ( NOAEC = 12.5 mg a.i./kg- 1 Reduced fertility and 

= >6,250 mglkg-diet 

Mammals 

Chronic 

Anus platyrhynchos 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 (difficult births) 

Aewe 

Apis mellifera I LD50 = >I00 pg/bee (oral) 1 No effects at the highest I one^ Bee . - I treatment level tested 
3.2.1. Aquatic Effects Characterization 

Technical grade fenarimol is considered highly toxic to fieshwater fish on an acute exposure 

basis [bluegill sunfish (Lepomis macrochirus) LCso = 0.9 mg a.i./L; MRID: 5608 11. Chronic 

toxicity testing of technical grade fenarimol based on a fish early life-stage toxicity study with 

rainbow trout (Oncorhynchus mykiss) resulted in significant reduction in fish body size (length 

and weight) at 0.87 mg a.i.1L (NOAEC=0.43 mg a.i./L) (MRID: 129099). Since no toxicity data 

fi-om chronic exposure to 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-day toxicity 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 aquatic plants and animals tested 

are presented in APPENDIX 111. 

No fenarimol toxicity data are currently available for aquatic vascular plants or estuarinelmarine 

fish and invertebrates. 

3.2.2. Terrestrial Effects Characterization 

Fenarimol is practically non-toxic to northern bobwhite quail (Colinus virginianus) (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 fertility is 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 androgens to estrogens). In addition, reproduction studies 

in mice (MRID: 45502307), guinea pigs (Cavia spp.) (MRID: 00126525,00133474, and 

001371 59), 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 of honey bees (Apis mellifera) indicated no toxic effects when adults were fed 

concentrations of 10 or 100 ppm (by weight). However, longevity was significantly reduced 

when bees were fed 1000 ppm (by weight) (MRID: 00084948). A supplemental study indicated 

no apparent effects to earthworms exposed for 14 days to 100 ppm in the soil (MRID: 

00084955). All available toxicity values for terrestrial animals tested are presented in 

APPENDIX 111. 

No toxicity data are currently available for aquatic vascular plants or terrestrial plants. Although 

fenarimol is 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) are reported in green algae exposed to 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-listed and non-listed species) are 

assumed. 

4. Risk Characterization 

4.1. Risk Estimation 

4.1.1. Aquatic Organisms 

The peak EEC in surface water generated fiom the PRZM/EXAMS model represents acute 

exposure to fish, aquatic invertebrates, and algae, and the highest 2 1 -day and 60-day average 

EEC represents chronic exposure to 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 

Freshwater Fish 1 Acute I 0.01 

1 Chronic 0.05 I Freshwater Invertebrates I Acute 1 <0.01 1 

Toxicity data are not available to calculate RQs based on the following measures of effect (e.g., 

acute or chronic toxicity endpoints) and receptors: 

( Chronic I 0.08 

- Acute LCs0 toxicity data for estuarinelrnarine fish 

- Chronic NOAEC toxicity data for estuarinelrnarine fish 

- Acute LCs0 toxicity data for estuarine/marine invertebrates 

- Chronic NOAEC toxicity data for estuarinelmarine invertebrates 

- Acute ECSo toxicity data for aquatic vascular plants 

Aquatic, Non-vascular Plants I Acute 

Therefore, risks to estuarinelrnarine animals 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 aquatic plants, risks to aquatic 

vascular plants (both federally-listed and 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 

exposure basis. 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 

calculate RQ values. They are, however, used to help characterize risk 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 exposure basis. 

Since the LDso is greater than the highest treatment level tested in the acute oral study (i.e., the 

LDS0 endpoint is a 'greater than' value), the 'greater than' endpoint was not used to calculate RQ 

values here; however, it is used to help characterize the risk in the 'Risk Description' section of 

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 of the body-size/dietary categories exceed the Agency's 
LOC for chronic exposure except for fi-uitslpodslseedsllarge insect 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. Terrestrial Invertebrates 

Fenarimol is classified as 'practically nontoxic' to non-target terrestrial insects on an acute 

exposure basis. Screening-level risk assessments do not typically evaluate risks to terrestrial 

invertebrates; however, toxicity information for beneficial insects is used to develop 

precautionary label language where necessary. Based on the available data, precautionary label 

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 

cannot be 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 of this 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-aquatic plants, and listed and non-listed 

mammals (chronic exposure). Therefore, the hypothesis from p. 4 [ . . . the proposed fenarimol use 

on hops has the potential to reduce survival, reproduction, and/or growth in terrestrial and 
aquatic organisms] is supported. These results are based on a modeled spray application rate of 

0.05 lbs a.i./acre/application (4 applicationslyear), which represents the proposed maximum 

application rate for hops. Although direct adverse effects to non-mammalian animals (aquatic 

and terrestrial) from fenarirnol use are not expected, given the potential for effects on terrestrial 

and aquatic plant species and mammals, indirect effects to all animals are possible. 

4.2.1. Risks to Aquatic Organisms 

Although fenarimol is considered highly toxic to freshwater fish and moderately toxic to 

freshwater invertebrates on an acute exposure basis, risk quotients indicate that 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 

chronic risk quotients for freshwater organisms are below LOCs, this compound does not appear 

to pose a direct acute or chronic threat to freshwater organisms. 

The potential risks of fenarimol use to estuarinelmarine animals 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 

are not expected). Additionally, hops are usually grown inland, and, therefore, use sites are 

largely outside of estuarinelmarine environments. 

Due to fenarimol's registered herbicidal use, the plant incidents associated with the chemical, 

and its phytotoxic effects on non-vascular aquatic plants, risks to aquatic vascular plants (both 

federally-listed and non-listed species) are assumed until additional data become available,. 

4.2.2. Risks to Terrestrial Organisms 

On an acute exposure basis, fenarimol is practically non-toxic to honey bees and birds, and no 

more than slightly toxic 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 calculated in the Risk Characterization 

section of this assessment. In order to gain a better understanding of how the EECs for the 

maximum proposed fenarimol application rate for hops relate to the toxicity data currently 

available for birds, we used T-REX to calculate RQs using the conservative assumption that the 

highest values tested in the avian studies represent endpoints [i.e., acute: LDS0 = 2,000 mglkg-bw 

(northern bobwhite 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, direct risk to birds fiom acute, sub-acute, or chronic exposure to fenarimol from its 
proposed use on hops is low. Given the potential for effects on terrestrial and aquatic plant 

species associated with the use of fenarimol, however, indirect effects on birds are possible. 

Because there was no mortality or sub-lethal effects at the highest treatment levels tested in the 

acute rat study submitted, standard RQ values for acute exposure were not calculated in the Risk 

Characterization section of this assessment. Calculating RQs 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 exposure to fenarimol fi-om its proposed use on hops is low. The RQs for 

mammals, however, identified potential reproductive effects to mammals fi-om chronic exposure 

to fenarimol when used at proposed label rates for hops. 

Results of chronic reproduction studies in mice and rats show that dietary exposure to fenarimol 

produces adverse effects on reproductive parameters. The potential reproductive risks in rats and 

mice affect both males (reduced fertility) and females (dystocia). These effects of fenarimol are 

attributed to inhibition of aromatase (the enzyme that converts androgens to estrogens). 

Although chronic studies on guinea pigs and rabbits failed to identify similar reproductive risks, 

the results of reproduction 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 Cosmetic Act (FFDCA), as amended by the Food Quality 

Protection Act (FQPA), EPA is required to develop a screening program to determine whether 

certain substances (including all pesticide active and other ingredients) "may have an effect in 

humans that is similar to an effect produced by a naturally-occurring estrogen, or other such 

endocrine effects as the Administrator may designate." Following the recommendations of its 

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 evaluations of potential 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 systems may be added to the Endocrine Disruptor Screening Program 

(EDSP). When the appropriate screening and or testing protocols being considered under the 

Agency's Endocrine Disruptor Screening Program have been developed, fenarimol may be 

subjected to additional screening and or testing to better characterize effects related to endocrine 

disruption. 

EFED does not currently estimate risk 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 LD50 for fenarimol is >I00 

pghee. Therefore, direct adverse effects to terrestrial invertebrates are not expected. However, 

due to the risk to plants, the potential for indirect effects to terrestrial invertebrates fi-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 of three ecological incidents involving 

fenarimol; two involving terrestrial plants (Incident Nos.: I01 3563-009 and I01 47 19-008) and 

one involving fish (Incident No.: 1000799-008). The two plant incidents, both involving grapes, 

indicated that the damage to the plants reported in the incident was possibly related to fenarimol. 

The fish incident report, involving apple use, concluded that it was unlikely that fenarimol 

contributed to the fish kill. In all three incidents, the legality of the fenarimol use was 

undetermined, therefore, it is unclear if the incidents were due to misuse or to labeled use. 

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-aquatic plants, given that no data are available 

for these taxa. 

Because of the potential risk fiom direct effects to the listed and non-listed taxa described above, 

listed species in all taxa may potentially be affected indirectly due to alteration of habitat (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-location is to determine whether sites of pesticide use are 

geographically associated with known locations of listed species [following the convention of the 

Services, the word 'species' in this assessment may actually apply to a 'species', 'subspecies', or 

an Evolutionary Significant Unit (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 agricultural census data (fiom 2002) for crop 

production at the same county level of resolution. 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 only taxa to have RQs above the 

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 effects to taxa that might rely on 

plants andlor mammals for some stage of their life-cycle. 

LOCATES identified a total of 63 listed species that 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 species to be directly and/or indirectly affected by the proposed fenarimol hops use, 
while 42 species may be indirectly affected by the use of the chemical. The number of county 

co-occurrences by 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 of the 

action area associated with fenarimol uses and best available information on the temporal and 

spatial co-location of listed species with respect to the action area. This analysis has not been 

conducted for this assessment. 

5. Literature Cited 

CDPR. 2006. Surface Water Database. California Department of Pesticide Regulation, Surface Water 

Protection Program. Online at: http://www.cd~r.ca.novldocslsw/surfdata.htm 

USDA. 2005. Agricultural Atlas of the United States: 2002 Census of Agriculture. United States 

Department of Agriculture, 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 

Agricultre Pest 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 of Monitoring Studies: 1971 -1 991 : 

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, Memorandum to SRRD. Jul. 3 1,2002. 

USEPA. 2002a. Guidance for Selecting Input Parameters in Modeling the Environmental Fate and 

Transport of Pesticides. U.S. Environmental Protection Agency, 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.htd 
USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide 

Programs, U.S. Environmental Protection Agency. Endangered and Threatened Species Effects 

Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide 

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): Environmental Fate and Effects Risk 

Assessment. DP Barcode: 240868+. EFED Memorandum to RD. Oct. 17,2005. 

USEPA. 2006. Standardized Soil Mobility Classification Guidance. U.S. Environmental Protection 

Agency, Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, 

Environmental Fate and Effects Division, Memorandum. Apr. 21,2006. 

USEPA. 2006a. Fenarimol: Response to 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 of Fenarimol. DP Barcode: 336002. U.S. Environmental Protection Agency, Office 

of Pesticide Programs, Environmental Fate and Effects Division, Memorandum to 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 SystemRederal Version (SDWISIFED). U.S. 

Environmental Protection Agency. Last updated: May 7,2007. Online at: 

http:llwww.epa.~ovlsafewater/datajp;etdata.html 

USEPA. 2007c. STORET Data Warehouse. U.S. Environmental Protection Agency. Last Updated Jun. 

20,2007. Online at: htt~://www.epa.gov/storet/dw home.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: 70426 
Althaus, W.; Bewley, G. 1978. Isolation and Identification of Photodegradation Products of 14c 

Fenarimol. Unpublished study prepared by Lilly Research Laboratories; submitted by Elanco Products 

Company, Div. of Eli Lilly and Co., Indianapolis, IN. 31 p. 

Accession Number: 130586 

Althaus, W. 1983. Memorandum to the U.S. Environmental Protection Agency regarding the Fenarimol 

Bluegill Bioconcentration Study (Study: ABC-0113). CD: 0122A. Jun. 21,1983. 3 p. 

Accession Number: 248702 

Author not furnished. Undated. Basic Physical and Chemical Properties of the Technical Chemical. 

Unpublished study prepared by Lilly Research Laboratories; submitted by Elanco Products Co., Div. of 

Eli Lilly and Co., Indianapolis, IN. 1 p. 

Accession Number: 2498 10 

Althaus, W., J. Beaty, D. Negilski, and J. Seacat. 1981. Bioconcentration of 14c Fenarimol by Bluegill 

Sunfish. Study: ABC-0 1 13. Unpublished study performed by Lilly Research Laboratories, Greenfield 

IN; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN. 20 p. 

MRID: 00084916 

Author not furnished. 1975. Rate of Hydrolysis of EL-222. Unpublished study submitted by Elanco 

Products Company, Div. of Eli Lilly and Co., Indianapolis, IN. 3 p. 

MRID: 00084917 

Day, Jr., E. Undated. Preliminary Photochemical Studies with the Fungicide EL-222. Unpublished 

study submitted by Elanco Products Company, Div. of Eli Lilly and Co., Indianapolis, IN. 7 p. 

MRID: 00084923 

Decker, 0. 1979. Vapor Pressure of Fenarimol. Unpublished study prepared 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 of Fenarimol. Unpublished study performed 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 study performed by Lilly Research Laboratories; submitted by Elanco Products 

Co., Div. of Eli Lilly and Co., Indianapolis, IN. 19 p. 

MRID 001 1751 1 

Day, E. 1982. Fenarimol Three-year Soil Dissipation Studies: I- EWD-82-22. Unpublished study 

performed by Lilly Research Laboratories; submitted by Elanco Products Co., Div. of Eli Lilly and Co., 

Indianapolis, IN. 15 1 p. 

MRD: 00129103 

Mosier, J.; Saunders, D. 1976. Photochemical Studies with Fenarirnol. Unpublished study performed by 

Lilly Research Laboratories, Div. of Eli Lilly and Co., Greenfield, IN. 27 p. 

MRID: 00133471 
Day, E.; Sieck, R.; Shuey, E. 1983. Soil Characteristics from Fenarimol Field Dissipation Studies: Lilly 

Report Nos. I-EWD-82-22, I-EWD-82-25. Unpublished study performed by Lilly Research Laboratories; 

submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN. 11 p. 

MRID 00133472 

Saunders, D.; Smith, S.; Mosier, J. 1983. An Aged Soil Leaching Study with 14c-~enarimol: I-EWD-83- 

6. Unpublished study performed by Lilly Research Laboratories; submitted by Elanco Products Co., Div. 

of Eli Lilly and Co., Indianapolis, IN; CDL: 25 1940-C. 1 8 p. 

MRID: 00142483 

Smith, S.; Saunders, D. 1982. Soil Adsorption and Desorption of Fenarimol: I-EWD-81-03. 

Unpublished study prepared and submitted by Eli Lilly and Co., Greenfield, IN. 13 p. 

MRID: 00250612 

Smith, S.; Saunders, D. 1982. Quantitation of Fenarimol Aqueous Photoproducts: S-AAC-81-27. 

Unpublished study prepared and submitted by Eli Lilly and Co., Greenfield, IN. 27 p. 

MRID: 45659801 

Smith, J. 1998. Aqueous Photolysis of Fenarimol in Natural Water. 980076. Unpublished study 

performed by Global Environmental Chemistry Laboratory - Indianapolis Lab; 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 study performed by Analytical Bio-Chemistry Laboratories, 

Inc.; submitted by Eli Lilly and Company. 41 p. 

MRID: 46259501 

Saunders, D.; Powers, F. 1987. Adsorption and Desorption of ~enarimol on Soil. EWD8718. 

Unpublished study performed by Lilly Research Laboratories; submitted by Gowan Company. 61 p. 

MRID: 46413701 

Decker, 0. 1987. Solubility of Fenarimol in Water. ODD871 1. 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 of EL-222 to Blue- gill (-Lepomis rnacrochirus-) and 

Rainbow Trout (-Salrno -gairdneri-). (Unpublished study 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: Studies M-9135 and M-9145. (Unpublished study received Sep 22, 1978 under 

1471-EX-50; submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; 

CDL:235 174-B). 

MRID: 84943 
Kehr, C.C.; West, H.C.; Hamelink, J.L.; et al. (1978) The Toxicity of Compound 56722 (EL-222) to 

Bobwhite Quail in a 14-day Acute Oral Study: Study 70 10-78. (Unpublished study received Oct 19, 198 1 

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 study received Oct 19, 

1981 under 1471-EX-75; submitted by 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, 1981 under 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, 198 1 under 1471 -EX-75; prepared by EG & G, Bionomics, 

submitted by 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 study received Oct 19, 198 1 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-U). 

MRID: 84951 

LeBlanc, G.A.; Sousa, J.; Sleight, B.H., I11 (1980) The Acute Toxicity of Compound 56722 to Rainbow 

Trout in a 96-hour Static Test: Bionomics Report No. BW-80-2-615; Eli Lilly Study No. F13779. 

(Unpublished study received Oct 19, 198 1 under 1471 -EX-75; prepared by EG & G, Bionomics, 

submitted by 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 Static Test with Continuous Aeration: Bionomics Report No. BW-80-2-616; Eli Lilly 

Study No. F14379. (Unpublished study received 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, 198 1 under 1471 -EX-75; submitted by Elanco Products 

Co., Div. of Eli Lilly and Co., Indianapolis, Ind.; CDL:070429-Y). 

MRID: 84954 
Karnak, 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 study received 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-day Soil Incorporated Study: Study No. 5013-6. (Unpublished study re- ceived Oct 

19, 198 1 under 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 

Technical EL-222 in Rabbits. (Unpublished study received Oct 19,198 1 under 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 19,1981 under 1471-EX- 75; submitted by Elanco Products Co., Div. of 

Eli Lilly and Co., Indianapolis, Ind.; CDL:070430-D). 

MRID: 85066 

Fink, R. (1 977) Final Report: One-generation Reproduction Study-- Mallard Duck: Project No. 15 1-101. 

(Unpublished study received Oct 19, 198 1 under 147 1 -EX-75; prepared by Wildlife Interna- tional Ltd., 

submitted by 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 Confidential Report 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 1 10) Containing 12.6% 

Fenarimol (EL-222,56722): Studies R-0-289-82, B-D-2-83, B-E- 196-82, R-H-102-82. (Unpublished 

study received Mar 7, 1983 under 1471 -EX-5 1 ; submitted by 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 24,1983 under 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) in Water to Fathead Min- nows ... in a 30-day Early Life-stage Study: Study F06282. 

(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 

(Study R-715): Lab Project Number: 235 175: 3341 8: 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 Study R-435: Lab Project Number: 235 175: 3341 9. Unpublished study prepared by Lilly 

Research Laboratories. 286 p. 

MRID: 45502305 

Hoffman, D.; Gibson, W.; Pierce, E. et al. (1 978) Twenty-Four Month Chronic Oral Toxicity of EL-222 

(56722) in Rats Studies R-405 and R-415: Lab Project Number: 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 of Fenak5mal I)egradaticm. Iprradueks, / 

I 

Degrzldate 

4-chloro-2-(5-pyrimidy1)- 

2'-chlorobenzophenone 

Unidentified residues 

Ma;ai*mum O/s of Applied MEWtD 

17 (4 hr) 

19 (1 hr) 

97.9 (24 d) 

17.1 (21 d) 

18.0 (52 wk) 

Aqueous photolysis 

Aqueous photolysis 

Aqueous photolysis 

Soil photolysis 

Aerobic soil metabolism 

MRID 00250612 

MRID 00129103 

MRTD 45659801 

MRID 45716302 

MRID 00 1 17509 
APPENDIX 11. PRZMIEXAMS Input Data for Ecological Risk Assessment. 

OR Hops 

Output File: Fen-May 1 

Metfile: 

PRZM scenario: 

EXAMS environment file: 

Chemical Name: 

Description 

Molecular weight 

Henry's Law Const. 

Vapor Pressure 

Solubility 

Kd 

Koc 

Photolysis half-life 

Aerobic Aquatic Metabolism 

Anaerobic Aquatic Metabolism 

Aerobic Soil Metabolism 

Hydrolysis: 

Hydrolysis: 

Hydrolysis: 

Method: 

Incorporation Depth: 

Application Rate: 

Application Eficiency: 

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 

33 1.2 

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 entire run) 
APPENDIX 111: Summary of Submitted Toxicity Studies for Animals Exposed to 

Fenarimol. 

I 

MRID: 84950 

Lepomis macrochirus 

Bluegill Sunfish 

Lepomis macrochirus 

Bluegill Sunfish 

Oncorhynchus mykiss 

Rainbow Trout 

Oncorhynchus mykiss 

Rainbow Trout 

Oncorhynchus mykiss 

Rainbow Trout 

Oncorhynchus mykiss 

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 

Water Flea 

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 1 days 

- 

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 

MRD 84951 

MRID: 56081 

MRID: 84952 

MRID: 129099 

MRID: 129100 

S 

S 

-- 

- 

Birds 

Acceptable 

Supplemental 

-- 

- 

Anas platyrhnchos 

Mallard Duck 

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: 85066 
Colinus 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 1 year 1 50 1 -- I Acceptable 

Catei?o~ Ref# 

Mammals 

l4 

8 days 

26 weeks 

30 weeks 

NOAEL I 1 year 1 130 1 - I Acceptable 

Multigeneliltion I 

NOAEL I 18 months 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 

NO AEL 

- 

MRID: 84944 I 

Acceptable 

I MRID: 84946 

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 3603 
APPENDIX IV. T-REX Input and Output Parameters (Mammal - Chronic Exposure). 

ent Calculations Based on 

Summary of Risk Quotient Calculations Based on Mean Kenega EECs I 
APPENDIX 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 Winter Run) 

Salmon, Chinook (Upper Columbia River Spring) 

Salmon, Coho (Central California Coast population) 

Salmon, Sockeye (Snake River population) 

Spineflower, Howell's 

Stonecrop, Lake County 

Sturgeon, White 

Tadpole Shrimp, Vernal Pool 

Wallflower, Menzie's 

Wolf, Gray 

Bear, Grizzly 

Beetle, Valley Elderbeny Longhorn 

Checker-mallow, Nelson's 

Fairy Shrimp, Vernal Pool 

Grass, San Joaquin Valley Orcutt 

Grass, Slender Orcutt 

Lupine, Kincaid's 

Murrelet, Marbled 

Owl, Northern Spotted 

Plover, Western Snowy 

Salmon, Chinook (California Coastal Run) 

Salmon, Chinook (Central Valley Fall Run) 

Salmon, Chinook (Central Valley Spring Run) 

Salmon, Chinook (Lower Columbia River) 

Salmon, Chinook (Snake River Fall Run) 

Salmon, Chinook (Snake River springlsummer) 

Salmon, Chinook (Upper Willamette River) 

Salmon, Coho (Southern OR/Northern CA Coast) 

Sea turtle, olive ridley 

Smelt, Delta 

Snake, Giant Garter 

Steelhead, (California Central Valley population) 

Steelhead, (Central California Coast population) 

Steelhead, (Lower Columbia River population) 

Steelhead, (Middle Columbia River population) 

Steelhead, (Northern California population) 

Steelhead, (Snake River Basin population) 

Steelhead, (Upper Columbia River population) 

Steelhead, (Upper Willamette River population) 

Steelhead, Puget Sound 

sturgeon, green 

Trout, Bull 

Trout, Bull (Columbia River population) 

Trout, Bull (Klamath River 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