U. S. ENVIRONMENTAL PROTECTION AGENCY Washington, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Date: June 29, 2006 Chemical: Propiconazole PC Code: 122101 DP Barcode: DP 329391 MEMORANDUM SUBJECT: Environmental Fate and Effects Division Revised RED for the Reregistration of propiconazole TO: Christiana Scheltema, Chemical Review Manager Reregistration Branch 3 Special Review and Reregistration Division ( 7505PY)

FROM: William Evans, Biologist James Lin, Environmental Engineer Nancy Andrews, Branch Chief Environmental Risk Branch I Environmental Fate and Effects Division ( 7507PY)

The Environmental Fate and Effects Division ( EFED) have revised the propriconazole EFED Science Chapter to reflect the responses to the Phase 3 comments. The revised risk assessment is attached. Any questions on this document should be directed to Bill Evans or Jim Lin. Page 2 of 206 U. S. ENVIRONMENTAL PROTECTION AGENCY Washington, D. C. 20460 Office of Prevention, Pesticides, and Toxic Substances Ecological Risk Assessment for the Reregistration of Propiconazole [ 1[[ 2( 2,4 dichlorophenyl) 4 propyl 1,3 dioxolan 2 yl] methyl] 1H 1,2,4 triazole] CAS Registry No.: 60207 90 1 PC Code: 122101 Prepared by: Reviewed by: William Evans, Biologist Nancy Andrews, Branch Chief James Lin, Environmental Engineer Edward Odenkirchen, Senior Biologist Thuy Nguyen, Acting RAPL Environmental Risk Branch 1 ( ERB1) Environmental Fate and Effects Division ( EFED) Office of Pesticide Programs ( OPP) United States Environmental Protection Agency ( USEPA) Ariel Rios Building, 1200 Pennsylvania Ave., NW. Mail Code 7507PC Washington, DC 2000 Page 3 of 206 I. EXECUTIVE SUMMARY......................................................................................................... 5 A. Predicted Environmental Exposure ................................................................................ 5 1. Nature of Chemical Stressor........................................................................................... 5 B. Potential Risks to Non target Organisms ...................................................................... 6 1. Risk to Terrestrial Organisms........................................................................................ 6 2. Risk to Aquatic Organisms............................................................................................. 6 C. Conclusions  Exposure Characterization..................................................................... 7 D. Conclusions  Effects Characterization......................................................................... 8 E. Uncertainties and Data Gaps ........................................................................................ 8 II. PROBLEM FORMULATION..................................................................................................... 9 A. Stressor Source and Distribution ................................................................................. 9 1. Source and Intensity....................................................................................................... 9 2. Physical/ Chemical/ Fate and Transport Properties ...................................................... 10 3. Pesticide Type, Class, and Mode of Action................................................................... 10 B. Receptors .................................................................................................................... 11 1. Aquatic Effects ............................................................................................................. 11 2. Terrestrial Effects......................................................................................................... 11 3. Ecosystems at Risk........................................................................................................ 12 C. Assessment Endpoints ................................................................................................ 12 D. Conceptual Model....................................................................................................... 13 1. Risk Hypothesis ............................................................................................................ 13 2. Diagram........................................................................................................................ 14 E. Analysis Plan............................................................................................................... 16 1. Preliminary Identification of Data Gaps and Methods................................................ 16 2. Measures to Evaluate Risk Hypotheses and Conceptual Model .................................. 19 III. ANALYSIS .............................................................................................................................. 22 A. Use Characterization.................................................................................................. 22 B. Exposure Characterization.......................................................................................... 25 1. Environmental Fate and Transport Characterization................................................. 25 2. Measures of Aquatic Exposure..................................................................................... 25 3. Measures of Terrestrial Exposure............................................................................... 34 C. Ecological Effects Characterization........................................................................... 41 1. Aquatic Effects Characterization................................................................................. 42 2. Terrestrial Effects Characterization ............................................................................ 44 IV. RISK CHARACTERIZATION.................................................................................................... 47 A. Risk Estimation  Integration of Exposure and Effects Data ........................................ 47 1. Risk to Aquatic Animals............................................................................................... 47 2. Risk to Aquatic Plants .................................................................................................. 51 3. Non target Terrestrial Animals.................................................................................... 52 4. Non target Terrestrial Plants ....................................................................................... 61 B. Risk Description.............................................................................................................. 62 1. Risks to Aquatic Organisms ......................................................................................... 63 2. Risks to Terrestrial Organisms .................................................................................... 65 3. Endocrine Disruption Assessment................................................................................ 72 4. Review of Incident Data................................................................................................ 72 5. Federally Threatened and Endangered ( Listed) Species Concerns ............................. 73 C. Description of Assumptions, Limitations, Uncertainties, Strengths and Data Gaps ....... 82 LITERATURE CITED.......................................................................................................................... 83 Appendix A   Environmental Fate Discussion ....................................................................................... 85 Page 4 of 206 Appendix B   Modeling Inputs and Attachments ................................................................................... 93 Appendix C   Formulas used to calculate EEC values......................................................................... 128 Appendix D   Ecological Toxicity Tables............................................................................................ 129 Appendix E   RQ Tables ..................................................................................................................... 144 Appendix F   Endangered Species State Listing.................................................................................. 187 Appendix G   Data Requirement Tables .............................................................................................. 203 Page 5 of 206 I. EXECUTIVE SUMMARY A. Predicted Environmental Exposure 1. Nature of Chemical Stressor The active ingredient propiconazole is a triazole fungicide that has protective, curative, and systemic activity. Some trade names for products containing propiconazole include Banner, Benit, Desmel, Orbit, Radar, Tilt, Fidis, Alamo, Spire, Practis, Bumper, Mantis, Restore, Banner Maxx, Taspa, Juno, Novel and Break. Formulations come as emulsifiable concentrates ( EC) and wettable powders ( WP). It can also be formulated with other pesticides. Depending on the crop being treated, end products containing propiconazole as an active ingredient can be applied by aerial or ground broadcast spray, chemigation, sprinkler irrigation, hose end and pump up sprayer, backpack and mist blower, and dip tank. Exposure to aquatic organisms is predominantly from release to the environment by surface runoff and spray drift. Exposure to terrestrial organisms is predominantly from release to the environment by spray drift.

To support the assessment of risks for re registration of propiconazole, this document is dealing with propiconazole parent compound only. This decision was mutually agreed upon in the various chemical team meetings with RD, SRRD, and HED that degradates will not be addressed in this RED. They will be possibly addressed in the new uses. This assessment focused on characterizing potential risks resulting from the registered uses, which have been identified in the Use Closure Memo ( dated 04/ 22/ 2005). The uses can be categorized as agricultural or non agricultural uses. Agricultural uses include use on cereals ( wheat, barley, rye, oats, and triticale), corn ( sweet, field and popcorn), stone fruits ( Apricot, peach, cherry, nectarine, prune and plum), seed crops, rice, wild rice, pecans, peanuts, dry beans and celery. Non agricultural uses include use on turf, ornamentals, lawn, ground cover, golf courses, and sod farms. The maximum annual application rate ranges from a high of 7.2 lb ai/ ac for turf ( based on 4 applications at 1.78 lb ai/ A) use to a low of 0.1125 lb ai/ ac for barley, oats, rye, and triticale. Typical use rates were not provided for this review.

Based on state level estimates of propiconazole use rates for individual crops which have been compiled by the National Center for Food and Agricultural Policy ( NCFAP) from 1995 1998, and on 1997 Census of Agricultural county crop acreage, the top ten agricultural uses comprise 95% of the total amount used for agriculture. Among agricultural uses, the highest amounts are used on wheat ( 53.89%), followed by seed crops ( 12.04%), rice ( 8.05%), pecans ( 8.04%), peaches ( 3.45%), sweet corn ( 3.05%), dry beans ( 2.60%), peanuts ( 2.08%), barley ( 1.51%) and celery ( 1.15%). For non agricultural uses, the use patterns include turf, ornamentals, and lawn; ground cover; and golf course. Application rates for non agricultural uses ( up to 7.2 lb ai/ ac per year) are generally higher than for agricultural uses.

The terrestrial risk assessment was based on the EFED's T REX model ( version 1.2.3). Since propiconazole only has very limited available surface and groundwater monitoring data, the water resource assessment was also based on modeling. To simulate the most conservative surface water exposures for ecological risk assessment ( ERA), PRZM/ EXAMS and SCIGROW, Page 6 of 206 respectively, were modeled on the top ten agricultural uses ( with the exception of the use on rice, for which The Policy for Estimating Aqueous Concentrations from Pesticides Labeled for Use on Rice, dated October 29, 2002 was used instead of PRZM/ EXAMS) and the additional three turf related non agricultural uses.

B. Potential Risks to Non target Organisms 1. Risk to Terrestrial Organisms The screening assessment for propiconazole suggests that the use on turf, for which the highest application rates are allowed, poses the greatest potential for risk to non target terrestrial organisms. Risk quotients for the turf use exceed the acute level of concern ( LOC) for Federally threatened and/ or endangered ( listed) and non listed birds, and chronic risk to small ( 15 gram) birds. The potential for chronic risk is highly uncertain, however, the no effect level used to calculate the risk quotients reflects a laboratory study in which no effects were seen, but in which the highest dose tested was below the highest estimated environmental concentration ( EEC) for propiconazole on turf. Risk quotients for the use of propiconazole on most other crops exceed the acute LOC for small listed birds.

The use of propiconazole on turf also results in risk quotients above the chronic LOC for mammals. The acute LOC for listed mammals is also exceeded for stone fruit, pecan, grasses grown for seed, and peanut.

Risk quotient values from the TERR PLANT model ( version 1.2.1) for the use on turf exceed the acute LOC for terrestrial dicot plants in semi aquatic areas from a single application. The listed species LOC is exceeded for dicot terrestrial plants in semi aquatic areas for single applications of propiconazole to grasses grown for seeds, rice, and peanut. However, since multiple applications are allowed for propiconazole for all uses, it is possible that listed terrestrial plants could be at risk from the corn, celery, and and stone fruit in addition to the turf uses of propiconazole.

2. Risk to Aquatic Organisms The screening assessment for propiconazole indicates that the use on rice might pose the greatest risk to non target aquatic organisms. The RQs for propiconazole use on rice exceed the chronic LOC for freshwater fish and the listed species LOC for freshwater fish, estuarine/ marine fish, and estuarine/ marine invertebrates. In addition, RQs for the use on rice exceed the aquatic plant LOC, based on toxicity to freshwater and marine diatoms. However, the EECs for propiconazole use on rice should be considered to be conservative, as they reflect the concentration of propiconazole in rice paddy discharge water, with no consideration of potential degradation in the paddy itself before release from the paddy.

The use on turf is the only other propiconazole use for which LOCs for aquatic organisms are exceeded. Risk quotients for the turf use exceed the LOC for listed freshwater fish and Page 7 of 206 estuarine/ marine invertebrates. In addition, RQs for the use on turf exceed the aquatic plant LOC, based on toxicity to freshwater and marine diatoms.

C. Conclusions  Exposure Characterization The soil movement and leaching potential of propiconazole is limited. Mobility is restricted in soils high in montmorillonite clay and/ or organic matter. Also, movement of propiconazole is less in acidic soils than in alkaline soils. Leaching in soils that are acidic and high in clay and organic matter will be restricted to the top 2 3 inches. In alkaline, low organic matter soils ( typical of the Southwestern U. S.), propiconazole may leach to a maximum depth of 8 10 inches.

Propiconazole displays moderate soil longevity. The laboratory soil aerobic metabolism studies showed half life values of 43, 47, and 70 days, depending on C14 labeled position. Under field conditions, the longevity is somewhat higher. The half life under these conditions ranged from a low of 96 days in a sandy loam to 575 days in a silt loam in Texas. In North Carolina, the half life in soil dropped to 229 days.

Because of the very limited available monitoring data, the measures of exposure were estimated using standard exposure models. PRZM/ EXAMS models estimate environmental concentrations ( EECs) of propiconazole in the surface water aquatic environments; PRZM/ EXAMS was used for all modeled propiconazole uses except the use on rice. The Policy for Estimating Aqueous Concentrations from Pesticides Labeled for Use on Rice, dated October 29, 2002 was used in estimating the water concentrations from the use of propiconazole on rice. SCIGROW modeling was used to estimate EECs from the ground water sources. T REX model version 1.2.3 was used to estimate propiconazole concentrations on terrestrial food items.

The model simulations were conducted for propiconazole parent compound only. The standard scenarios for the selected uses were used to provide a range of estimated environmental concentrations for selected crops. Maximum application rates as well as application types ( aerial, ground, or chemigation) were selected to estimate environmental concentrations for this screening level deterministic ( risk quotient based) assessment. Application dates were selected based on the expected disease pressures within standard scenario regions.

For surface water exposures, rice use has the highest estimated peak exposure value of 86 µ g/ L ( ppb). Turf use has the second highest estimated peak environmental concentrations ( peak EEC of 40 ppb and 21 day average EEC of 37 ppb), followed by sweet corn ( FL), pecans, and celery. Barley has the lowest estimated environmental concentrations, which are less than 2.0 µ g/ L.

For ground water exposures, the higher estimated concentrations are associated with the higher application rates for the non agricultural uses. Turf and ornamentals uses have the highest EEC of 0.72 µ g/ L ( ppb), whereas barley use has the lowest EEC of 0.01 µ g/ L. Page 8 of 206 D. Conclusions  Effects Characterization Propiconazole had the following LD50s for avian species: mallard duck > 2510 mg/ kg, Peking duck > 1000 mg/ kg, Japanese quail > 1000 mg/ kg, and bobwhite quail 2825 mg/ kg. For mammals, acute oral toxicities were similar for the rat, mouse, and rabbit. LD50s ranged from 1344 mg ai/ kg diet for the rabbit to 1517 mg ai/ kg diet for the rat. The LD50 for the Chinese hamster was 3006 mg ai/ kg diet. A 2 generation rat study with propiconazole was submitted which demonstrated a chronic NOAEC of 500 mg ai/ kg diet. This NOAEC was based on reduced body weight gains in F0 and F1 generations.

Propiconazole had the following EC50/ LC50 values for freshwater fish species: bluegill 1.3 10.2 ppm, brown trout 3.3 ppm, rainbow trout 0.9 13.2 ppm, carp 6.8 21.0 ppm, catfish 2.0 5.1 ppm, and fathead minnow 7.6 ppm. Another laboratory trial found LC50 ( 96 hour) values to be 20 ppm water for brown trout and > 100 ppm for carp.

Propiconazole had the following EC50/ LC50 values for freshwater invertebrate species: crayfish 42.0 ppm, water flea 3.2 11.5 ppm. The marine species oyster and mysid shrimp had EC50/ LC50 values of 0.3 ppm and 0.5 1.4 ppm, respectively.

Propiconazole does not appear to have any adverse effects on soil microbes as evidenced by soil biochemical analyses. Evaluations were made at concentrations up to and including 100 ppm. At this highest level, no changes were observed in cellulose, starch, or protein decomposition, nitrification, nitrogen fixation, or respiration.

Propiconazole displayed no toxic effects to earthworms.

E. Uncertainties and Data Gaps The following uncertainties have been identified on the environmental fate properties and exposure models for propiconazole. These are discussed in greater detail in the risk assessment.

1. Formulation effects on the dissipation of propiconazole in the environment are not known at this time. For purposes of the risk assessment, it is assumed that formulation types do not alter dissipation rates and pathways when compared to the technical product.

2. The water column metabolism parameter used by EXAMS was estimated from the aerobic soil metabolism by multiplying the aerobic soil metabolism input parameter by 2 to reflect the uncertainty in this extrapolation.

3. The rice model ( Policy for Estimating Aqueous Concentrations from Pesticides Labeled for Use on Rice, dated October 29, 2002) is conservative because it represents the exposure experience by aquatic organisms whose habitat lies close to the discharge from the paddies during and shortly after discharge. The degradation in the rice paddy is considered as the aquatic exposure refinement. Page 9 of 206 A number of areas of uncertainty have been identified in the ecological risk portion of the assessment; since the majority of the risk appears to be with mammals and birds, these risk uncertainties have been identified as important in the risk assessment. These uncertainties are discussed in greater detail in other sections of the risk assessment and summarized here.

1. Other exposure routes are possible for birds in treated areas. These routes include ingestion of contaminated soils, ingestion of contaminated drinking water, preening, dermal contact, and inhalation.

2. The risk assessment only considers the most sensitive species tested.

3. The risk assessment assumes 100% of the avian diet is relegated to single food types foraged only from treated fields.

4. The exposure assessment used 95th percentile reside values. Values selected from points lower on the distribution would yield lower exposure estimates and lower RQs.

5. The potential for endocrine disruptor related effects was observed in mammalian and avian reproduction toxicity studies using tetraconazole. There is also a potential for endocrine distruptor related effects due to the toxicity of the degradates of propiconazole, including 1,2,4 triazole. Toxicity data is not available for the degradates. This risk assessment has not included an evaluation of the relative risk of propiconazole and its degradates for endocrine disruption and as such is a source of uncertainty in this assessment.

There are currently no environmental fate data gaps for propiconazole. The submission of avian chronic data that could produce a definitive LOAEC could reduce avian chronic risk below the LOCs.

II. PROBLEM FORMULATION A. Stressor Source and Distribution 1. Source and Intensity Propiconazole is a systemic broad spectrum fungicide registered for treatment of disease in bananas, barley, celery, corn ( field, pop, and sweet), grasses grown for seed, mint, oats, peanuts, pineapple, plantains, rice and wild rice, rye, stone fruits, sugarcane, wheat, and turf and ornamentals ( lawn, golf course, ground cover, and sod farm). Depending on the use, end products containing propiconazole as an active ingredient can be applied by aerial or ground broadcast spray, chemigation, sprinkler irrigation, hose end and pump up sprayer, backpack and mist blower, and dip tank. Exposure to aquatic organisms is predominantly from release to the environment by surface runoff and spray drift. Page 10 of 206 2. Physical/ Chemical/ Fate and Transport Properties Propiconazole appears to be persistent and moderately mobile to relative immobile in most soil and aqueous environments. Propiconazole degradation in the aquatic environment appears to be dependent solely on aqueous photolysis in the presence of photo sensitizers that are quite common in photolysis studies. In soil environments, propiconazole dissipation appears to be dependent on incorporation or binding to soil organic matter content.

Laboratory and terrestrial field dissipation data indicate that propiconazole is stable in soil and aqueous environments. Propiconazole was stable to hydrolysis ( t ½ > 30 days), aqueous photolysis (< 10% of applied degraded in 30 days), soil photolysis (< 8% of applied degraded in 30 days), aerobic aquatic metabolism ( t ½ > 30 days), aerobic soil metabolism ( t ½ = 30 to 112 days), and anaerobic aquatic metabolism ( t ½ = 363 days). The terrestrial field dissipation data were consistent with laboratory data with reported half lives of > 100 days for four soil textures. However, in supplemental aquatic dissipation data using basin irrigation and flow through irrigation systems in rice fields, propiconazole was found to dissipate rapidly ( t ½ < 5 days). Aqueous photolysis studies using sensitizers indicated rapid degradation ( t ½ < 1 days) of propiconazole that appears to be the case in rice fields. Furthermore, aquatic metabolism and dissipation studies indicate propiconazole dissipates by incorporation or binding to the organic matter content of soil/ sediment.

Propiconazole mobility in soil appears to be dependent on the soil's organic matter content. In general, propiconazole appears to be moderately mobile ( Kd < 5) in soils with a low organic matter content (< 1%). However, in soils with higher organic matter content (> 1%), propiconazole appears to be relatively immobile ( Kd > 5). Therefore, propiconazole may reach ground water in soils with low organic contents. More importantly, propiconazole may contaminate surface water through off site runoff and spray drift.

More detailed environmental fate discussions are included in Appendix A. The physical/ chemical properties and the chemical structure are also included in Appendix A.

3. Pesticide Type, Class, and Mode of Action The active ingredient propiconazole is a triazole fungicide that has protective, curative, and systemic activity. Some trade names for products containing propiconazole include Banner, Benit, Desmel, Orbit, Radar, Tilt, Fidis, Alamo, Spire, Practis, Bumper, Mantis, Restore, Banner Maxx, Taspa, Juno, Novel and Break. Formulations come as emulsifiable concentrates and wettable powders. It is also formulated with other pesticides.

Propiconazole's mode of action is demethylation of C 14 during ergosterol biosynthesis, leading to accumulation of C 14 methyl sterols. In addition, propiconazole is a cytochrome P450 enzyme inhibitor ( and therefore has the potential to adversely affect mammals, birds, fish, amphibians, reptiles, invertebrates, plants, etc. that have cytochrome P 450 detoxification enzymes). The biosynthesis of these ergosterols is critical to the formation of cell walls of fungi. This lack of normal sterol production slows or stops the growth of the fungus, effectively Page 11 of 206 preventing further infection and/ or invasion of host tissues. Therefore, propiconazole is considered to be fungistatic or growth inhibiting rather than fungicidal or killing.

B. Receptors Each assessment endpoint requires one or more " measures of ecological effect," which are defined as changes in the attributes of an assessment endpoint itself or changes in a surrogate entity or attribute in response to exposure to a pesticide. Ecological measurement endpoints for the screening level risk assessment are based on a suite of registrant submitted toxicity studies performed on a limited number of organisms as required for registration in the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA; 40 CFR Part 158). The most sensitive endpoints ( described in Section C. below) from each study of surrogate species are used to estimate risk to the taxonomic group( s) represented by the surrogate tested.

1. Aquatic Effects For aquatic effects, measurement endpoints for the following species were used from the broad groupings of acute, sub acute, and chronic laboratory studies submitted to the Agency.

° Freshwater fish  bluegill sunfish ( Lepomis macrochirus), rainbow trout ( Oncorhynchus mykiss), brown trout, catfish, and used as a surrogate for aquaticphase amphibians, ° Freshwater invertebrates ( Daphnia magna), ° Estuarine/ marine fish  spot, ° Estuarine/ marine invertebrates   eastern oyster ( Crassostrea virginica), crayfish and mysid shrimp ( Americamysis bahia), ° Vascular aquatic plants   duckweed ( Lemna gibba) ° Algae   green algae ( Selenastrum capricornutum), blue green algae ( Anabeana flos aquae), freshwater diatom ( Navicula pelliculosa), and marine diatom ( Skeletonema costatum)

Within each of the very broad taxonomic groups, an acute and chronic endpoint is selected from the available test data, as the data sets allow.

2. Terrestrial Effects For terrestrial effects, measures of effect for the following species were used from the broad groupings of acute, sub acute, and chronic laboratory studies submitted to the Agency.

° Birds  mallard duck ( Colinus virginianus), bobwhite quail ( Anas platyrhynchos), Peking duck, and Japanese quail which are also used as surrogate species for terrestrial phase amphibians and reptiles, ° Mammals ( laboratory rat, house mouse, and laboratory rabbit), ° Terrestrial plants   Four monocots ( including corn) and six dicots ( including soybeans and tomato). Page 12 of 206 Within each of the very broad bird and mammalian taxonomic groups, an acute and chronic endpoint is selected from the available test data, as the data sets allow. Only acute data are required by the Agency for terrestrial plants.

3. Ecosystems at Risk An ecosystem can be defined as a functional unit consisting of all the living organisms ( plants, animals, and microbes) in a given area, and all the non living physical and chemical factors of their environment, linked together through nutrient cycling and energy flow. An ecosystem can be of any size a log, pond, field, forest, or the earth's biosphere but it always functions as a whole unit. Ecosystems are commonly described according to the major type of vegetation, for example, forest ecosystem, old growth ecosystem, or range ecosystem. The ecosystems that could be potentially at risk due to agricultural use of propiconazole include terrestrial and aquatic ( lakes, ponds, streams, estuaries) habitats in proximity to propiconazole use areas. Moreover, these habitats may be at risk from drift and/ or runoff of propiconazole from use areas.

To address specific ecosystems at risk in this screening level assessment is beyond the scope of this effort. Generally, concerns of risk to ecosystems are addressed in the identification of assessment endpoints, which reflect ecological entities and their associated attributes. Functionally, this assessment specifically addresses risks at the individual level. However, given that the toxicity endpoints used in the assessment relate directly to higher levels of biological organization, any risks identified are considered to provide insight into potential risks to ecosystems and ecosystem function.

C. Assessment Endpoints Assessment endpoints are defined as " explicit expressions of the actual environmental value that is to be protected." Defining an assessment endpoint involves two steps: 1) identifying the valued attributes of the environment that are considered to be at risk, and 2) operationally defining the assessment endpoint in terms of an ecological entity ( i. e., a community of fish and aquatic invertebrates) and its attributes ( i. e., survival and reproduction). Therefore, selection of the assessment endpoints is based on valued entities ( i. e., ecological receptors), the ecosystems potentially at risk, the migration pathways of pesticides, and the routes by which ecological receptors are exposed to pesticide related contamination. The selection of clearly defined assessment endpoints is important because they provide direction and boundaries in the risk assessment for addressing risk management issues of concern.

The assessment endpoints typically used in a screening level pesticide risk assessment are reduced survival and reproductive impairment from direct acute and chronic exposure for aquatic and terrestrial animals. Various analyses have indicated that these endpoints provide insights about risk at higher levels of biological organization ( e. g. populations).

The assessment endpoints used for terrestrial plants are seedling emergence and vegetative vigor and the concern is for the perpetuation of populations of both non target crop and non crop plant species. Although these endpoints may not address all the issues with regard Page 13 of 206 to all aspects of the terrestrial plant life cycles, it is assumed that impacts at these stages indicate a potential impact to individual competitive ability and reproductive success.

Measured endpoints used for aquatic plants are alga growth rates and measured plant biomass. These endpoints provide insights into the maintenance and growth of standing crop or biomass of aquatic plant life.

Assessing risks to reptiles and amphibians represents unique challenges. Currently, data on direct toxicity to reptiles and amphibians are not required as part of the standard dataset submitted to the Agency for pesticide registration and these data are only occasionally available from the literature. For ecological risk assessments in the Office of Pesticide Programs ( OPP), if risk quotients for birds are below the level of concern, then risks to reptiles are also assumed to be low. For amphibians, freshwater fish are considered a suitable surrogate for the aquatic lifestage and birds a suitable surrogate for the terrestrial life stage.

D. Conceptual Model In order for a chemical to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a substance moves in the environment from a source to an ecological receptor. For an ecological exposure pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, and a feasible route of exposure. In addition, the potential mechanisms of transformation ( i. e., which degradates may form in the environment, in which media, and how much) must be known, especially for a chemical whose metabolites/ degradates are of greater toxicological concern. The assessment of ecological exposure pathways, therefore, includes an examination of the source and potential migration pathways for constituents and the determination of potential exposure routes ( e. g., ingestion, inhalation, dermal absorption).

Ecological receptors that may potentially be exposed to propiconazole and its degradates include terrestrial and semi aquatic wildlife ( i. e., mammals, birds, and reptiles), terrestrial and semi aquatic plants, and soil invertebrates. In addition to terrestrial ecological receptors, aquatic receptors ( e. g., freshwater and estuarine/ marine fish and invertebrates, amphibians) may also be exposed to propiconazole via potential migration of propiconazole from the site of application to various watersheds and other aquatic environments via runoff and spray drift.

1. Risk Hypothesis Propiconazole's use as a fungicide on numerous crops and turf to rates as high as 7.2 lb ai/ A/ yr involves situations in the environment where potential routes of exposure can be direct contact to food items ( e. g., grass), as well as indirect contamination of adjacent bodies of water. Based on the persistence and mobility, mode of action, direct toxicity and potential indirect effects to plants, it is presumed that propiconazole has the potential to cause reduced survival and reproductive impairment to both terrestrial and aquatic organisms. In addition, propiconazole is a cytochrome P450 inhibitor ( and therefore has the potential to adversely affect mammals, birds, Page 14 of 206 fish, amphibians, reptiles, invertebrates, plants, etc. that have cytochrome P 450 detoxification enzymes).

2. Diagram Propiconazole is released into the environment through chemical irrigation systems ( chemigation) on turf as well as a ground and aerial foliar spray on a wide variety of crops. Assessing the probable dissipation pathways from the application site requires an understanding of propiconazole chemistry and environmental fate.

Runoff to adjacent surface water bodies from areas of application is expected to be controlled by application site conditions such as foliar washoff, soil type, slope, and agronomic practices. Additional site release mechanisms include spray drift, and possibly wind erosion, which may potentially move propiconazole from the application site into the air and surrounding environments.

The conceptual model shown in Figure 1 depicts the potential routes of dissipation of propiconazole, release mechanisms, abiotic receiving media, and biological receptor types. Only potential routes of exposure are considered in a screening level assessment and are presented in the conceptual site model. Routes of exposure not considered in the conceptual model include dermal contact and inhalation. Propiconazole application via aerial, ground spray, and chemigation is expected to result in direct deposition of propiconazole into aquatic environments through spray drift. Page 15 of 206 Figure 1. Conceptual Model for Propiconazole Applications to Ecosystem.

Propiconazole Applications ( Aerial, Ground and Chemigation)

Aquatic Invertebrates Mammals Terrestrial Invertebrates Fish & Amphibians Aquatic Plants Birds, Reptiles & Amphibians Aquatic Environments Runoff Erosion Consumption of Foliage Uptake Through Gills & Integument Spray Drift Terrestrial Environments Foliar Washoff Direct Contact, Systemic Uptake Terrestrial Plants Runoff Erosion Rice Direct Application Page 16 of 206 E. Analysis Plan The initial analysis plan for propiconazole is for a first tier screening level risk assessment. This document characterizes the environmental fate of propiconazole to assess the extent to which non target organisms might be exposed through the proposed uses of this fungicide. The toxicity of propiconazole is characterized, based primarily on registrantsubmitted guideline toxicity tests. Additional information from open literature through the Agency's ECOTOX database ( http:// www. epa. gov/ ecotox/) will be considered in refinements of the screening level assessment. Estimated exposure and effects are integrated to calculate risk quotients ( RQs) for non target endangered/ threatened ( listed) and non listed animals and plants. These RQs are compared to pre determined levels of concern ( LOCs) to screen out those taxa to which propiconazole appears not to pose unacceptable risk. The determination of which nontarget organisms may and should not be at risk from propiconazole exposure will be considered under the requirements of the FIFRA and the Endangered Species Act ( ESA).

Although risk, in the context intended here, is often defined as the likelihood and magnitude of adverse ecological effects, the risk quotient based approach does not provide a quantitative estimate of likelihood and/ or magnitude of an adverse effect. Such estimates may be possible through a more refined, probabilistic assessment. However, the screening level assessment is the first step in the determination of risk.

1. Preliminary Identification of Data Gaps and Methods The primary method used to assess risk in this screening level assessment is the risk quotient ( RQ) method and follows closely methods outlined in the EPA Overview Document ( EPA, 2004). The RQ is the primary risk value for the screening level assessment and is the result of comparing measures of exposure to measures of effect. A commonly used measure of exposure is the estimated exposure concentration ( EEC) and commonly used measures of effect include toxicity values such as the LD50 or NOAEC. Assessment endpoints and their respective measures of exposure and measures of effect are listed in Tables 2.6 and 2.7 of the next section. The resulting RQ is then compared to a specified level of concern ( LOC), which represents a point of departure for concern; if the RQ exceeds the LOC, then risks are triggered.

To evaluate the potential risk to non target organisms from the use of propiconazole, risk quotients ( RQ) are calculated from the ratio of estimated environmental concentrations ( EECs) to toxicity values. Risk quotients are then compared to the LOCs to indicate potential risk to nontarget organisms and the consequent need to consider regulatory action. Risk presumptions, along with the corresponding RQs, equations, and LOCs are summarized in Tables 2.1 2.4. The exposure estimates in this screening assessment are derived using maximum label rates and minimum application intervals for each use. Page 17 of 206 Table 2.1 Risk presumptions for terrestrial animals ( birds and wild mammals).

Risk Presumption RQ LOC Acute EEC1/ LC50 or LD50/ ft2 or LD50/ day3 0.5 Restricted Use EEC/ LC50 or LD50/ ft2 or LD50/ day ( or LD50 < 50 mg/ kg) 0.2 Acute Listed Species EEC/ LC50 or LD50/ ft2 or LD50/ day 0.1 Chronic Risk EEC/ NOAEC 1 1 abbreviation for Estimated Environmental Concentration ( ppm) on avian/ mammalian food items 2 mg/ ft2 3 mg of toxicant consumed/ day LD50 * wt. of bird LD50 * wt. of bird Table 2.2 Risk presumptions for aquatic animals.

Risk Presumption RQ LOC Acute EEC1/ LC50 or EC50 0.5 Restricted Use EEC/ LC50 or EC50 0.1 Acute Listed Species EEC/ LC50 or EC50 0.05 Chronic Risk EEC/ NOAEC 1 1 EEC = ( ppm or ppb) in water Table 2.3 Risk presumptions for terrestrial and semi aquatic plants.

Risk Presumption RQ LOC Acute Risk EEC1/ EC25 1 Acute Listed Species EEC/ EC05 or NOAEC 1 1 EEC = lbs ai/ A Table 2.4 Risk presumptions for aquatic plants. Page 18 of 206 Risk Presumption RQ LOC Acute High Risk EEC1/ EC50 1 Acute Listed Species EEC/ EC05 or NOAEC 1 1 EEC = ( ppb/ ppm) in water Generations of robust RQs are dependent on the quality of data from both fate and toxicological studies. These studies should be conducted following Agency guidelines and are subjected to extensive review to ensure data quality.

Estimates of exposure are generated using maximum label rates and minimum intervals between applications to generate exposure estimates that are within the possible range. Toxicity values used in the risk quotient calculations are based on the most sensitive species tested for a given exposure duration and taxonomic group.

Although the lowest toxicity value from available studies is used for RQ calculations, typically, only data from a few species are available. For example, the Agency usually receives avian toxicity studies for bobwhite quail and mallard ducks. Of the 650 avian species in the United States, it is unlikely that bobwhite quail or mallard ducks are the most sensitive. These species, in fact, were chosen primarily because they are easy to maintain and rear in the laboratory and they have some value as game species. The same argument holds for all toxicity estimates; in all likelihood the representative species are not the most sensitive. Similarly, for reptiles and amphibians, typically no toxicity data are available at all. In accordance with the EPA guidance ( EPA, 2004) birds are used as surrogates for terrestrial amphibians and reptiles and fish are used as surrogates for aquatic amphibians. This is thought to result in conservative estimates of risk for herpetofauna; however, due to the lack of available data, it is difficult to determine whether this is the case or not.

Exposure estimates are generated from chemical fate studies and label information, particularly maximum application rates and minimum application intervals. Although exposure estimates using maximum label rates and minimum interval times generate maximum EECs, they do represent requested use rates and, if approved, could be used. Actual use rates most likely vary over the labeled range, particularly for certain uses.

Exposure estimates for terrestrial species are generated assuming these species feed exclusively on the treated field soon after application of the pesticide. Moreover, the assumption is that these organisms will consume their daily ingestion rate while on the treated field. Although some individuals at particular times may feed exclusively on a treated field, the actual frequency and duration of this type of behavior is a source of uncertainty. While the current approach may overestimate exposure for some individuals, it does capture the potential of possible exposures that may occur. Page 19 of 206 2. Measures to Evaluate Risk Hypotheses and Conceptual Model a. Measures of Exposure Measures of exposure are estimates of exposure for a receptor determined by modeling or monitoring data. In this risk assessment, measures of exposure for propiconazole are obtained from modeling efforts since national scale monitoring data were not identified. Exposure models used for this assessment include the suite of standard exposure models commonly used in pesticide risk assessments ( EPA, 2004). Generally, aquatic exposure estimates are generated from EFED models and incorporate maximum proposed application rates and empiricallyderived fate properties. Measures of exposure to aquatic animals and plants are concentrations in surface water simulated by PRZM/ EXAMS. PRZM/ EXAMS uses half lives derived from registrant submitted environmental fate data and proposed application rates, frequencies, and intervals between application for crops on which propiconazole is being considered for registration or reregistration to simulate runoff and spray drift to a standard pond. The standard pond is intended to represent a sitewhich is more vulnerable than most sites in the United States. PRZM/ EXAMS makes a deterministic estimate of the concentration that would be equaled or exceeded in the pond once every ten years. Further details of the exposure models can be found in Section III. B and on the web at http:// www. epa. gov/ oppefed1/ models/ water/ index. htm.

Measures of exposure for terrestrial mammals, birds, reptiles, and amphibians similarly incorporate maximum proposed use rates but rely less on fate properties. Instead, terrestrial exposure estimates are derived directly from empirically determined observations of pesticide residues on various terrestrial food items. The Kenaga nomogram, as modified by Fletcher et al. ( Kenaga and Hoerger, 1972; Fletcher et al., 1994), is used to relate pesticide application rates to residues on terrestrial food items. For numerous applications for a given use, the exposure model incorporates a first order decay rate from foliar surfaces that is dependent on the soil halflife of the chemical. In the absence of data, a default foliar dissipation half life of 35 days is used. The current terrestrial exposure model used by EFED is T REX version 1.2.3.

Measures of exposure to terrestrial plants are expressed as a fraction of the mass of propiconazole applied to a treated field. The screening model TerrPlant ( version 1.0) assumes that default fractions of the intended application will be transported to an adjacent field through runoff and spray drift. A refinement of the exposure from spray drift is accomplished using the spray drift model AgDrift ( version 2.01).

b. Measures of Effect Each assessment endpoint requires one or more " measures of ecological effect," which are defined as changes in the attributes of an assessment endpoint itself or changes in a surrogate entity or attribute in response to exposure to a pesticide. A complete discussion of all toxicity data available for this risk assessment and the resulting measurement endpoints selected for each taxonomic group are included in the Ecological Effects section of this document. A summary of the assessment and measurement endpoints selected to characterize potential ecological risks associated with exposure to propiconazole is provided in Table 2.5. Page 20 of 206 Table 2.5. Assessment endpoints with associated toxicity and exposure measurement endpoints. The toxicity and exposure endpoints are used in a risk quotient assessment.

Assessment Endpoint Associated Toxicity Endpoint Exposure Endpoint Terrestrial Avian Survival Acute Avian Oral LD50, Dietary LC50 from most sensitive bird tested, adjusted for size for 20 g bird maximum concentration on food items ( foliar) or dose on planted seeds consumed by 20 g bird Avian Growth/ Reproduction/ Survival Growth or Reproduction NOAEC/ LOAEC from avian chronic study from most sensitive bird tested maximum residue on food items ( foliar) or planted seeds Mammalian Survival acute oral LD50, dietary LC50 for most sensitive mammal tested, adjusted for 20 g mammal maximum concentration on food items ( foliar) or dose on planted seeds consumed by 20 g mammal Mammalian Growth/ Reproduction/ Su rvival growth/ reproduction NOAEC/ LOAEC from chronic mammalian study from most sensitive mammal tested maximum concentration on food items.

Non target Beneficial Insect Survival Honey bee acute contact LD50 none Aquatic Freshwater Fish Survival 96 hr LC50 for most sensitive species tested 1 in 10 year peak concentration at 90% ile site Freshwater Fish Growth/ Reproduction/ Survival Fish Early Life Stage NOAEC/ LOAEC for Growth 1 in 10 year 60 day mean concentration Freshwater Invertebrate Survival 48 hr EC50 based on mortality ( immobility) for most sensitive species tested 1 in 10 year peak concentration at a 90% ile site Freshwater Invertebrate Growth/ Reproduction / Survival Invertebrate Life Cycle NOAEC for growth or reproductive effect 1 in 10 year 21 day mean concentration at a 90% ile site Marine/ Estuarine Fish Survival 96 hr LC50 for most sensitive species tested 1 in 10 year peak concentration at 90% ile site Marine/ Estuarine Fish Growth/ Reproduction / Survival Estuarine/ Marine Fish NOAEC for growth 1 in 10 year 60 day mean concentration at a 90% ile site Page 21 of 206 Marine/ Estuarine Invertebrate Survival 48 hr EC50 based on mortality ( immobility) for most sensitive species tested 1 in 10 year peak concentration at a 90% ile site Marine/ Estuarine Invertebrate Growth/ Reproduction/ Survival Estuarine/ Marine Invertebrate NOAEC for reproduction for most sensitive species 1 in 10 year 21 day mean concentration at a 90% ile site.

Explicit endpoints for reptiles and amphibians, two classes of organisms that may be at risk, are not explicitly considered in this assessment. Data on direct toxicity to reptiles and amphibians are not required as part of the standard dataset submitted to the Agency for pesticide registration and these data are only occasionally available from the literature. For the purposes of risk assessments in OPP, if risk quotients for birds are below the level of concern, the reptiles are also assumed to be low. For amphibians, freshwater fish are considered to be a suitable surrogate for the aquatic phase and birds for the terrestrial phase.

c. Measures of Ecosystem and Receptor Characteristics Because of its intended wide spread use on such a wide variety of crops and turf, many diverse ecosystems are likely to be exposed to propiconazole. Generally, ecosystems at risk are those proximal temporally and spatially to the use areas. However, due to the persistence and moderate mobility of propiconazole ( as subsequently discussed), exposure may occur at times and locations far removed from the use site. As exposure is strongly linked to application rate, higher use rate sites, such as turf, lawn, and golf courses, representing greater potential sources of exposure to ecosystems.

Beyond direct mortality, exposure may apply selective pressure to plant communities, potentially altering population distributions. These effects may be beneficial or adverse. Certainly, any listed plant species ( direct effect) or listed animal species with an obligate or dependent relationship with a sensitive plant species ( indirect effect) could be at potential risk if it is exposed. Page 22 of 206 III. ANALYSIS A. Use Characterization There are two parts in the analysis plan. The first part identifies all the registration uses and how they were arranged to complete a comprehensive assessment for the ecological risk for propiconazole. The second part describes how the information of the use patterns was used to estimate EECs for both aquatic and terrestrial assessment.

A Use Closure Memo ( dated 04/ 22/ 2005) provided all the section 3 uses for propiconazole. There are a total of twenty five use patterns, including: ( 1) Barley, ( 2) Celery, ( 3) Corn, field, pop, sweet, ( 4) Grasses Grown for Seed ( forage fodder grasses), ( 5) Non bearing Apple, ( 6) Non bearing Cherry, Nectarine, Peach, Plum, ( 7) Nonbearing Pecan, ( 8) Non bearing Citrus, ( 9) Oats, ( 10) Peanuts, ( 11) Pecans, ( 12) Pineapple ( HI only), ( 13) Rice, ( 14) Rice, wild, ( 15) Rye, ( 16) Stone Fruits   Apricot, Cherry, Nectarine, Peach, and Plum, ( 17) Sugarcane, ( 18) Triticale, ( 19) Turf and Ornamentals   Ground Cover, ( 20) Turf and Ornamentals   Lawns and Turf, Golf Course, ( 21) Turf and Ornamentals   Shade Trees ( injection), ( 22) Turf and Ornamentals   Shade Trees ( outdoor spray), Herbaceous Plants, ( 23) Ornamental Woody Shrubs and Vines, ( 24) Turf and Ornamentals Sod Farm ( Turf), and ( 25) Wheat.

Additionally, there are nine use patterns for section 24C, including ( 1) Bananas and Plantain ( Hawaii and Puerto Rico), ( 2) Corn ( post silk, IL), ( 3) Grasses Grown for Seed ( forage fodder grasses, ID, WA, NV), ( 4) Mint ( OR), ( 5) Non bearing Blueberries ( FL), ( 6) Non bearing Hazelnuts ( OR), ( 7) Sugarcane Seed Piece ( FL), ( 8) Sunflower Breeder's Seed ( IL, MI, TX), and ( 9) Wheat ( past Feekes 8, NV).

The maximum annual application rate ranges from 7.2 lb ai/ ac for turf use to 0.1125 lb ai/ ac for barley, oats, rye, and triticale.

For agricultural uses, the annual use map of propiconazole is shown on the next page. It is based on state level estimates of propiconazole use rates for individual crops, which have been compiled by the National Center for Food and Agricultural Policy ( NCFAP) from 1995 1998, and on 1997 Census of Agricultural county crop acreage. Based on the estimated total annual applied amount of about 480,000 lb, the map provides the percent national use for the top ten use patterns, which is about 95% of agricultural uses. Among these uses, wheat use has the highest value of 53.89%, followed by seed crops ( 12.04%), rice ( 8.05%), pecans ( 8.04%), peaches ( 3.45%), sweet corn ( 3.05%), dry beans ( 2.60%), peanuts ( 2.08%), barley ( 1.51%) and celery ( 1.15%). [ Note   the legend is wrong in the map, which has been confirmed by Gail Thelin of USGS].

For non agricultural uses, the use patterns include turf, ornamentals, lawn, ground cover and golf course. Comparing with agricultural uses, the non agricultural uses in general have a higher application rate ( up to 7.2 lb ai/ ac per year). Page 23 of 206 ( http:// ca. water. usgs. gov/ cgi bin/ pnsp/ pesticide_ use_ maps_ 1997. pl? map= W5020 ) [ Note   the legend is wrong in the map, which has been confirmed by Gail Thelin of USGS. Seed_ Crops should have been included as the number 2 crop between wheat and rice].

The use practices actually simulated for this assessment are in the following table. In addition to the top ten agricultural uses, three turf related non agricultural uses are also included in this ecological risk assessment.

Ideally all the label uses should have been addressed for this ecological risk assessment. However, the following uses have not been addressed: ( 1) Non bearing Apple, ( 2) Non bearing Cherry, Nectarine, Peach, Plum, ( 3) Non bearing Pecan, ( 4) Nonbearing Citrus, ( 5) Oats, ( 6) Pineapple ( HI only), ( 7) Rye, ( 8) Sugarcane ( HI), ( 9) Triticale, ( 10) Bananas and Plantain ( HI and Puerto Rico only), ( 11) Mint ( OR), ( 12) Non bearing Blueberries ( FL), ( 13) Non bearing Hazelnuts ( OR), ( 14) Sugarcane Seed Piece ( FL), and ( 15) Sunflower Breeder's Seed ( IL, MI, TX). The main reason is due to Page 24 of 206 the lack of modeling scenarios. Among the 6 uses for non bearing fruits ( 1, 2, 3, 4, 12, 13), there is a restriction in the various labels that specifies do not apply within 12 months of bearing harvestable fruits. So the potential propiconazole exposure will be limited to the first one or two years. For Oats ( 5), Rye ( 7), and Triticale ( 9) uses, the maximum annual allowable application amount is 0.1125 lb ai/ ac, which is the same use rate as for barley. The barley use can be used as the surrogate. The Pineapple use ( 6) is limited to HI, and only allowed as dipping during planting, so the potential exposure should be minimum for both aquatic and terrestrial concerns. The case is similar for sugarcane ( 8, 14), which is limited to HI and FL and only allowed for seed treatment. Bananas and Plantain ( 10) uses are limited to HI and Puerto Rico. The maximum application scheme is 8 applications of 0.084 lb/ ac for a total of 0.675 lb/ ac per year. Due to the lack of aquatic modeling scenarios for banana and plantain, no aquatic modeling effort was attempted. As a rough estimate, the exposure can be estimated with modeling of the pecans use ( which has a total annual application rate of 0.90 lb/ ac). The use rates are 2 applications of 0.1125 lb/ ac for the Mint ( 11) use and 4 applications of 0.1125 lb/ ac for the Sunflower Breeder's Seed ( 15) use. As a rough estimate, modeling for the sweet corn use ( with a total annual application rate of 0.45 lb/ ac) can be used as a surrogate for these two uses.

Application practices simulated for propiconazole risk assessment Use Scenario Maximum Single Application Rate ( lb ai/ A) Maximum Annual/ Seasonal Rate ( lb ai/ A) Application Interval ( days) Method*

Agricultural Use Wheat 0.1125 0.225 14 G, C, A Seed Crops ( Grasses) 0.225 0.90 14 G, C, A Rice 0.225 0.34 10 A Pecans 0.225 0.90 14 G, A Peaches 0.1125 0.56 5 G, A Sweet Corn 0.1125 0.45 7 G, C, A Dry Beans 0.1125 0.3375 14 G, C, A Peanuts 0.225 0.45 10 G, C, A Barley 0.1125 0.1125 NA G, C, A Celery 0.1125 0.45 7 G, C, A Non Agricultural Use Turf and Ornamentals   Lawn and Turf, Golf Course 1.78 7.2 14 G, C Ground Cover 1.78 7.2 10 G, C Sod Farm 1.78 7.2 21 G, C * G = Ground spray; C = Chemigation ( w/ irrigation); A = Aerial spray. Page 25 of 206 B. Exposure Characterization 1. Environmental Fate and Transport Characterization Propiconazole appears to be persistent and moderately mobile to relative immobile in most soil and aqueous environments. Propiconazole degradation in the aquatic environment appears to be dependent solely on aqueous photolysis in the presence of photo sensitizers. In soil environments, propiconazole dissipation appears to be dependent on incorporation or binding to soil organic matter content.

Laboratory and terrestrial field dissipation data indicate that propiconazole is stable in soil and aqueous environments. Propiconazole was stable to hydrolysis ( t ½ > 30 days), aqueous photolysis (< 10% of applied degraded in 30 days), soil photolysis (< 8% of applied degraded in 30 days), aerobic aquatic metabolism ( t ½ > 30 days), aerobic soil metabolism ( t ½ = 30 to 112 days), and anaerobic aquatic metabolism ( t ½ = 363 days). The terrestrial field dissipation data were consistent with reported half lives of > 100 days for four soil textures. However, in supplemental aquatic dissipation data using basin irrigation and flow through irrigation systems in rice fields, propiconazole was found to dissipate rapidly ( t ½ < 5 days). Aqueous photolysis studies using sensitizers indicated rapid degradation ( t ½ < 1 days) of propiconazole which appears to be the case in rice fields. Furthermore, aquatic metabolism and dissipation studies indicate propiconazole dissipates by incorporation or binding to the organic matter content of soil/ sediment.

Propiconazole mobility in soil appears to be dependent on the soil's organic matter content. In general, propiconazole appears to be moderately mobile ( Kd < 5) in soils with a low organic matter content (< 1%). However, in soils with higher organic matter content (> 1%), propiconazole appears to be relatively immobile ( Kd > 5). Therefore, propiconazole may reach ground water in soils with low organic contents. More importantly, propiconazole may contaminate surface water through off site runoff and spray drift.

Bioaccumulation and biomagnification should not be a significant concern for propiconazole, which has an octanol/ water partition coefficient ( log Kow) of 2.95 and bioconcentration factor ( BCF) values of 24x, 138 516x, and 68 203x, respectively for edible, viscera, and whole body of bluegill.

Propiconazole is readily absorbed by plant tissues, and is transported systemically within the plant. It affects the cell walls of target fungi and inhibits the production of sterol synthesis. Thus, leaves that emerge following the application will also be protected from fungal infection. Systemic movement is predominately upward ( from roots to foliage, or lower leaves to upper leaves), but limited downward translocation also occurs.

2. Measures of Aquatic Exposure Page 26 of 206 Measures of exposure are estimates of exposure for a receptor determined by modeling or monitoring data. In this risk assessment, measures of exposure for propiconazole are obtained from modeling efforts since national scale monitoring data were not available.

a. Aquatic Exposure Modeling Models, Scenarios, and Input Parameters Used To Estimate Concentrations of Propiconazole For all uses examined with the exception of the rice use, the estimated environmental concentrations in surface water were calculated using Tier II PRZM ( Pesticide Root Zone Model) and EXAMS ( Exposure Analysis Modeling System). PRZM is used to simulate pesticide transport as a result of runoff, erosion, and off target spray drift from an agricultural field and EXAMS estimates environmental fate and transport of pesticides in surface water and using the linkage program shell  PE4V01, which incorporates the standard scenarios developed by EFED.

Linked crop specific scenarios and meteorological data were used to estimate exposure as a result of uses on various field crops and vegetables. Simulations were done using the standard farm pond scenario in EXAMS, which is a surrogate for a permanent surface aquatic environment. Weather and agricultural practices are simulated over 30 years so that the 1 in 10 year exceedence probability at the site can be estimated.

The estimated environmental concentrations in ground water were calculated using the Tier I SCIGROW ( Screening Concentration In Ground Water) model. It is a regression approach model, based on the results of several perspective ground water monitoring studies. SCIGROW was developed using Koc values ranging from 32  180 mL/ g and half lives from 13  1000 days. Extrapolation beyond these values will increase the uncertainty of the predicted ground water concentrations.

For further information on these models see the following EPA Web site: http:// www. epa. gov/ oppefed1/ models/ water/ index. htm Rice Use The Policy for Estimating Aqueous Concentrations from Pesticides Labeled for Use on Rice, dated October 29, 2002 was used in estimating the water concentrations from rice use.

The estimated concentration ( EEC in µ g/ L) represents the dissolved concentration occurring in the water column and the concentration in water released from the paddy. Movement of pesticide on suspended sediment is not considered. The equation to use for this calculation is: Page 27 of 206 EEC M V m K T T sed d = + 109 where MT is the total mass of pesticide in kg applied per ha of paddy, VT is 1.067 x106 L/ ha which is the volume of water in a paddy 4 inches ( 10.16 cm) deep, and includes the pore space in a 1 cm sediment interaction zone. The mass of sediment, msed, is the amount found in the top 1 cm interaction zone and is 130,000 kg/ ha when the sediment bulk density was assumed to be 1.3 kg/ L, a standard assumption for the bulk density of surface horizons of mineral soils. The 109 constant converts the units of mass from kg to µ g. For chemicals that have a valid Koc, the Kd can be calculated using a sediment carbon content of 2% ( Koc* 0.02). An organic carbon content of 2% represents a typical value for a high clay soil that might be used to grow rice in the Mississippi Valley or Gulf Coast regions.

The above equation calculates the concentration of rice paddy water with adsorption and dilution. Since propiconazole degrades quickly in the rice paddy environment with a halflife of 5 days, which is equivalent of a first order degradation rate of 0.139/ day. This degradation rate was used in simulating the continuing degradation in the rice paddy environment.

Surface water Several of EFED's standard scenarios were simulated for this aquatic exposure assessment. These scenarios are briefly identified in Table 3.1. For each specific use, the maximum allowable single label application rate was inputted to PE4V01, except for the rice scenario where the total annual application rate was used for the rice water calculation.

Table 3.1   Modeling scenarios for propiconazole aquatic exposure assessment Use Scenario Crop Region, Met File and Soil Info ED, MD, HD*:

Wheat / ND MLRA ( Major Land Resource Area): 56, Cass Co. Metfile: W. 14914dvf, Soil: Bearden silty clay loam 05/ 15, 07/ 25, 08/ 05 Grass Seed / OR MLRA: 2, Willamette Valley Metfile: W24232. dvf, Soil: Dayton silty loam 09/ 15, 05/ 15, 06/ 30 Rice Based on EFED policy on rice use dated Oct. 29, 2002 with modification of aquatic degradation.

Pecans / GA MLRA: 133A, Mitchell and Dougherty Counties Metfile: W93805. dvf, Soil: Greenville sandy loam 04/ 21, 09/ 21, 10/ 01 Peaches / GA MLRA: 133A, Peach County Metfile: W03813. dvf, Soil: Greenville sandy loam 03/ 01, 05/ 15, 08/ 31 Page 28 of 206 Sweet Corn / FL MLRA: 156B, Palm Beach County Metfile: W12844. dvf, Soil: Riviera sand 10/ 15, 01/ 05, 01/ 15 Sweet Corn / OR MLRA: 2, Marion County Metfile: W24232. dvf, Soil: Woodburn silt loam 05/ 10, 08/ 21, 09/ 10 Dry Beans / MI MLRA: 99, Huron County Metfile: W14826. dvf, Soil: Toledo silt clay 06/ 05, 07/ 27, 09/ 04 Peanuts / NC MLRA: 133, East Pitt County Metfile: W13737. dvf, Soil: Craven silt loam 05/ 10, 10/ 01, 10/ 10 Barley ( use ND Wheat Scenario) MLRA ( Major Land Resource Area): 56, Cass Co. Metfile: W. 14914dvf, Soil: Bearden silty clay loam 05/ 15, 07/ 25, 08/ 05 Celery ( use FL Carrots Scenario) MLRA: 156B, Western Palm Beach County Metfile: W12833. dvf, Soil: Riviera sand 10/ 15, 01/ 15, 01/ 22 Turf / PA MLRA: 148, York County Metfile: W14737. dvf, Soil: Glenville silt loam 04/ 01, 04/ 15, 11/ 01 Turf / FL MLRA: 156A, Osceola County Metfile: W12834. dvf, Soil: Adamsville sand 02/ 01, 02/ 15, 12/ 15 * ED = emergence date, MD = maturation date, HD = harvest date Ground Water SCIGROW is neither scenario nor crop specific. The only input requirements are application rate, number of applications, Koc, and aerobic soil metabolism half life.

Input Parameters The appropriate PRZM, EXAMS, and SCIGROW input parameters were selected from the environmental fate data submitted by the petitioner and in accordance with US EPA OPP EFED water model parameter selection guidelines, Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides, Version II, February 28, 2002.

The input parameters used in the PRZM, EXAMS, and SCIGROW models are tabulated below as well as in Appendix B. The output files of PE4 ( PRZM/ EXAMS) runs and the SCIGROW outputs are also listed in Appendix B.

Input Parameters for PRZM with Propiconazole ( version 3.12)

Variable ( units) Variable Description Input Value Source of Info/ Reference Page 29 of 206 DWRATE( 1) 1 ( day 1) Dissolved phase pesticide decay rate in surface horizon DSRATE( 1) 1 ( day 1) Adsorbed phase pesticide decay rate in surface horizon DWRATE( 1) = DSRATE( 1)

The 90th percentile half life value of 69.2 days Aerobic soil metabolism half life values of 70, 43 and 47 days ( MRID: 129912, 129914)

DWRATE( 2) ( day 1) DWRATE( 3) ( day 1) Dissolved phase pesticide decay rate in 1st, and 2nd subsurface horizon DSRATE( 2) ( day 1) DSRATE( 3) ( day 1) Adsorbed phase pesticide decay rate in 1st and 2nd subsurface horizon DWRATE( 2) = DSRATE( 2)

The 90th percentile half life value of 69.2 days DWRATE( 3) = DSRATE( 3)

The 90th percentile half life value of 69.2 days same as above KD( 1) KD( 2) KD( 3) ( cm3 gm 1 or mL g 1 or L kg 1) Pesticide partition or distribution coefficients for each horizon assume average KOC of 648 Mobility  Adsorption/ Desorptio n study : KOC values of 685, 436, 382, 604 and 1134. ( MRID: 41727001)

PLDKRT ( day 1) Foliar decay rate 35 days ( only applicable to foliar applications) default value TAPP ( kg ha 1) Application rate Depending on the labels with the maximum rate and number of applications Product label APPEFF ( decimal) Application efficiency 0.95 for aerial spray; 0.99 for ground spray input guidance document DRFT Spray drift fraction 0.05 for aerial spray; 0.01 for ground spray input guidance document Page 30 of 206 Input Parameters for EXAMS with Propiconazole ( Version 2.98)

Variable ( units) Variable Description Input Value Source of Info/ Reference HENRY ( atm m3mole 1) Henry's law constant no input, let EXAMS compute KBACW1 ( cfu/ mL) 1 hour 1 Bacterial biolysis in water column 138.4 days 2 x aerobic soil metabolism half life KBACS1 ( cfu/ mL) 1 hour 1 Bacterial biolysis in benthic sediment stable aquatic anaerobic halflife = 363 days ( MRID: 42347902)

KDP ( hour 1) Direct photolysis 0.0 Stable ( MRID: 41811901)

KBH ( mole 1 hour 1) KNH ( hour 1) KAH ( mole 1 hour 1) Base hydrolysis Neutral hydrolysis Acid hydrolysis 0.0 0.0 0.0 Stable ( MRID: 00067901 / 42238201)

KOC ( mL g 1 O. C.) Partition coefficient for organic carbon assume a mean KOC of 648 Mobility  Adsorption/ Desorption study : KOC values of 685, 436, 382, 604 and 1134. ( MRID: 41727001)

MWT ( g mole 1) Molecular weight 342.23 product chemistry SOL ( mg L 1) Aqueous solubility 100 product chemistry QUANT Reaction quantum yield for direct photolysis 1.0 VAPR ( torr) Vapor pressure 1.0 x 10 6 product chemistry Page 31 of 206 Input Parameters for SCIGROW Variable Description Input Value Soil half life ( day) Aerobic soil metabolism half life values of 70, 43 and 47 days ( MRID: 129912, 129914)

Use the average value of 53 days Pesticide partition or distribution coefficients, Koc KOC values of 685, 436, 382, 604 and 1134. ( MRID: 41727001)*

Use the median value of 604 Application rate Depending on the labels with the maximum rate and number of applications   The Koc value is outside the range of 32  180 mL/ g.

Estimated Environmental Concentrations in Surface Water The estimated environmental concentrations of propiconazole based on 1 in 10 year return period in surface water are summarized in Table 3.2. In general, the higher use rate produces the higher concentrations. Rice use predicts the highest water concentration of 138 ppb ( µ g/ L) for both acute and chronic concerns. It represents paddy discharge water, therefore the upper bound on the environmental concentration.

After rice, turf use has the second highest estimated environmental concentrations, followed by sweet corn ( FL), pecans, and celery. Barley use has the lowest estimated environmental concentrations, which are less than 2.0 µ g/ L. Page 32 of 206 Table 3.2   Estimated Environmental Concentrations in Surface Water Use Scenario Peak ( µ g/ L) 96 hour average ( µ g/ L) 21 day average ( µ g/ L) 60 day average ( µ g/ L) 90 day average ( µ g/ L)

Wheat / ND 3.67 3.61 3.38 3.09 3.05 Grass Seed / OR 5.69 5.63 5.41 5.06 4.95 Rice 86.49 71.10 34.24 17.81 11.88 Pecans / GA 12.15 11.93 11.21 10.15 9.49 Peaches / GA 3.35 3.28 3.01 2.55 2.35 Sweet Corn / FL 13.28 13.00 12.32 10.70 9.77 Sweet Corn / OR 4.49 4.46 4.30 4.09 4.06 Dry Beans / MI 6.49 6.41 6.17 5.83 5.64 Peanuts / NC 7.00 6.89 6.49 6.16 5.75 Barley ( use ND Wheat Scenario) 1.92 1.89 1.79 1.66 1.61 Celery ( use FL Carrots Scenario) 9.83 9.68 9.12 7.07 5.97 Turf / PA 40.35 39.59 37.28 34.83 33.98 Turf / FL 34.77 34.09 31.14 27.93 27.04 Page 33 of 206 Estimated Environmental Concentrations in Ground Water Table 3.3 summarizes the estimated environmental concentrations of propiconazole in ground water. Due to the fact that the input value of 604 for soil adsorption Koc used in SCIGROW runs is outside the model development range of 32 to 180 mL/ g, the uncertainties of these estimated values are great. For these SCIGROW runs, all the fate input parameters are identical to those used in PRZM/ EXAMS, except the propiconazole application information. The higher estimated concentrations are associated with the higher rate. Turf and ornamentals uses have the highest concentration of 0.72 µ g/ L ( ppb), whereas barley use has the lowest value of 0.01 µ g/ L.

Table 3.3   Estimated Environmental Concentrations from Ground Water Sources Use Scenario Acute Value ( ppb, µ g/ L) Chronic Value ( ppb, µ g/ L)

Wheat 2.27E 02 2.27E 02 Seed Crops ( Grasses) and Pecans 9.11E 02 9.11E 02 Rice 3.44E 02 3.44E 02 Peaches 5.70E 02 5.70E 02 Sweet Corn and Celery 4.56E 02 4.56E 02 Dry Beans 3.42E 02 3.42E 02 Peanuts 4.56E 02 4.56E 02 Barley 1.14E 02 1.14E 02 Turf and Ornamentals 7.21E 01 7.21E 01 b. Aquatic Exposure Monitoring and Field Data Monitoring data are from the U. S. Geological Survey National Water Assessment Data Warehouse ( link: http:// infotrek. er. usgs. gov/ servlet/ page?_ pageid= 543&_ dad= portal30&_ schema= PORTA L30); however, there are not many samples analyzed for propiconazole. Among the samples analyzed, none of the samples exceed the detection limits ( from 0.001 to 0.021 µ g/ L). Also, the monitoring effort by Minnesota Department of Agriculture shows no detections ( at the reporting limit of 0.20 µ g/ L) in surface and ground water during calendar year 2003 and 2004 ( the pdf file through the link: http:// www. mda. state. mn. us/ appd/ ace/ reports/ 2005annual. pdf). Page 34 of 206 A registrant submitted monitoring study, " Monitoring of Propiconazole ( CGA 64250) Residues in Surface Water at Selected US Community Water Systems," showed few detections among a total of thirty eight selected CWSs located in twelve states ( California, Florida, Georgia, Iowa, Illinois, Indiana, North Dakota, New Jersey, Oregon, Texas, Washington, and Wisconsin). The study design assumed that detections of propiconale would be expected during the propiconazole use months, therefore the sampling frequency was decided to take two samples during the use months and only one sample for the remaining months. The highest detection was reported during the non use months. Therefore, the results suggest that the sampling scheme has missed possible higher residue detections by only collect 18 samples per year. The sampling scheduling of this monitoring study is not rigorous enough to be used for drinking water assessment ( March 26, 2006, DP325258). Since the monitoring studies did not provide good quality data, this aquatic exposure assessment is based on the model predicted environmental concentrations.

3. Measures of Terrestrial Exposure As discussed in the Use Characterization section of this document, there are a total of 25 use patterns for propiconazole. These uses are ( 1) Barley, ( 2) Celery, ( 3) Corn, field, pop, sweet, ( 4) Grasses Grown for Seed ( forage fodder grasses), ( 5) Nonbearing Apple, ( 6) Non bearing Cherry, Nectarine, Peach, Plum, ( 7) Non bearing Pecan, ( 8) Non bearing Citrus, ( 9) Oats, ( 10) Peanuts, ( 11) Pecans, ( 12) Pineapple ( HI only), ( 13) Rice, ( 14) Rice, wild, ( 15) Rye, ( 16) Stone Fruits   Apricot, Cherry, Nectarine, Peach, and Plum, ( 17) Sugarcane, ( 18) Triticale, ( 19) Turf and Ornamentals   Ground Cover, ( 20) Turf and Ornamentals   Lawns and Turf, Golf Course, ( 21) Turf and Ornamentals   Shade Trees ( injection), ( 22) Turf and Ornamentals   Shade Trees ( outdoor spray), Herbaceous Plants, ( 23) Ornamental Woody Shrubs and Vines, ( 24) Turf and Ornamentals Sod Farm ( Turf), and ( 25) Wheat.

The maximum annual use rate ranges from 7.2 lb ai/ ac for turf use to 0.1125 lb ai/ ac for barley, oats, rye, and triticale. The proposed application methods for propiconazole are broadcast ground or aerial sprays, chemigation, and seed/ dipped treatments. These application methods can result in various routes of exposure to nontarget terrestrial organisms, including ingestion of treated foods, spray drift and runoff.

Additionally, there are nine use patterns for section 24Cs, including ( 1) Bananas and Plantain ( Hawaii and Puerto Rico), ( 2) Corn ( post silk, IL), ( 3) Grasses Grown for Seed ( forage fodder grasses, ID, WA, NV), ( 4) Mint ( OR), ( 5) Non bearing Blueberries ( FL), ( 6) Non bearing Hazelnuts ( OR), ( 7) Sugarcane Seed Piece ( FL), ( 8) Sunflower Breeder's Seed ( IL, MI, TX), and ( 9) Wheat ( past Feekes 8, NV).

With regard to terrestrial exposure, special considerations should be given to some of these uses. For example, among the 6 uses for non bearing fruits, there is a restriction in the various labels that specifies that the products should not apply be applied within 12 months of bearing harvestable fruits. Hence, the potential Page 35 of 206 propiconazole exposure will be limited to the first one or two years. For oats, rye, and triticale uses, the maximum annual allowable amount is 0.1125 lb ai/ ac, which has the same use rate as barley. Therefore, the barley use can be used as the surrogate. The pineapple use is limited to HI, and only allowed as dipping during planting, so the potential exposure should be minimum for both aquatic and terrestrial concerns. The case is similar for sugarcane which is limited to HI and FL and only allowed for seed treatment. Bananas and plantain uses are only limited to HI and Puerto Rico. The maximum application scheme is 8 applications of 0.084 lb/ ac for a total of 0.675 lb/ ac per year. Mint and sunflower breeder's seed is applied at a rate of 0.1125 lb ai/ A at 2 and 4 times throughout the growing season, respectively.

a. Terrestrial Exposure Modeling   Birds and Mammals Birds and mammals in the field may be exposed to broadcast spray applications of pesticides by ingesting material directly with the diet. They also may be exposed by other routes, such as incidental ingestion of contaminated soil, dermal contact with treated plant surfaces and soil during activities in the treated areas, direct impingement of sprayed material on the body at the time of application, preening activities, inhalation of pesticide vapor and contaminated particulate, and ingestion of drinking water contaminated by the pesticide. Currently, EFED estimates terrestrial wildlife exposures via the dietary route alone.

For the purposes of this risk assessment, propiconazole exposures were modeled using the data derived from the Kenaga nomogram, as modified by Fletcher et al. ( 1994) 1, based on a large set of field residue data. The upper limit values from the nomogram represent the 95th percentile of residue values from actual field measurements ( Hoerger and Kenaga, 1972). The Fletcher et al. ( 1994) modifications to the Kenaga nomogram are based on measured field residues from 249 published research papers, including information on 118 species of plants, 121 pesticides, and 17 chemical classes. These data establish concentrations of pesticides on wildlife food items, normalized for a unit application of 1 lb a. i./ acre. For single applications of a pesticide, the Fletcher et al. ( 1994) residues are commonly adjusted for the labeled application rate. For multiple applications, not only are single application rates considered, but the number of the applications, the time interval between applications, and the potential for residue dissipation between applications must be considered. To incorporate these latter factors, EFED employs the T REX model ( version 1.2.3), an in house computer model that uses a first order dissipation relationship to account for residue dissipation of the pesticide between applications. The peak residue concentration from either the single or multiple application models is used for both acute and chronic risk assessments. Uncertainties in the terrestrial EECs are primarily associated with a lack of data on interception and subsequent dissipation from foliar surfaces. Based on the review of HED's DER on " propiconazole ( 122101): Magnitude of Residue in/ on wheat for the Registration of 1Fletcher, J. S., J. E. Nellsen, T. G. Pfleeger. 1994. Literature review and evaluation of the EPA food chain ( Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Env. Toxicol. Chem. 13: 1381 1391. Page 36 of 206 Stratego use on wheat," EFED concludes that it is justifiable to use the default foliar dissipation half life of 35 days. This conclusion is due to the following reasoning:

1. Among the 21 field trials, only two trials have " zero" time samples, which include only forage samples in Fresno, CA and Payne, OK. The residue samples for other food matrix ( hay, straw, and grain) do not have any " zero" time samples.

2. For Fresno, CA forage samples ( 0, 16, 23, 30, and 37 days) and Payne, OK samples ( 0, 15, 22, 29, 35 days), no records of weather information were provided, so there is no way to verify that no other path ( such as wash off) could occur.

However, this study was found adequate by HED and two of the studies have time 0 data and at least three sampling points. Further, these two decline studies ( Payne OK and Fresn, CA) are forage studies, and it was pointed out that there was no mention of rainfall during the study. Data from the registrant on propiconazole suggest the half life is 7.05 days with an SD of 1.15. N is 2 and the resulting degrees of freedom is 1. The tcritical value for a one tailed 5 per cent upperbound probability is 6.314. So the an estimate of the 95th percentile value of the population half lives , based on a sample population of 2 values is 14.41 days ( 7.05 + 1.15( 6.314)). Although there is much uncertainty with this estimate, this value can be used to further characterize the risk to propiconazole. However, it must be emphised that the resulting reduction in exposure, and ultimately risk, should not be taken as a definitive value.

Some of the uncertainties with the use of this study include:

1) The study was only performed on wheat at CA and OK and with only one application at a rate of 0.11 lb ai/ A. When applying these results to other regions in the U. S. the uncertainties could be enormous. 2) The rainfall information was based on NOAA station records. For this type of field study, records from local weather station should be used. 3) The time zero residues for the data analyzed ( 2 samples) are very different ( 3.9 and 6.9 for CA and 11 and 12 for OK).

The estimated wildlife exposure residues from the T REX model ( version 1.2.3) are presented below.

Table 3.4   Wildlife Estimated Exposure Concentrations of Propiconazole ( Acute and Chronic Birds and Mammals) Page 37 of 206 Avian Food Item Maximum Avian Food Item Residue ( mg/ kg @ 1 1b ai/ A) 1 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Multiple Applications ( mg/ kg) 2 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Multiple Applications ( mg/ kg) 3 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Single Application ( mg/ kg)

Agricultural Uses Barley ( maximum 0.1125 lb ai / A; one application)

short grass 240 27 27 tall grass 110 12.375 12.375 broadleaf forage/ small insects 135 15.1875 15.1875 fruit, pods, seeds, large insects 15 1.6875 1.6875 Rye ( maximum 0.1125 lb ai/ A; 1 application)

short grass 240 27 27 tall grass 110 12.375 12.375 broadleaf forage/ small insects 135 15.1875 15.1875 fruit, pods, seeds, large insects 15 1.6875 1.6875 Wheat ( maximum 0.1125 lb ai/ A; 2 applications; 14 day interval between applications)

short grass 240 33.75 19.2 tall grass 110 15.47 8.8 broadleaf forage/ small insects 135 18.98 10.8 fruit, pods, seeds, large insects 15 2.11 1.2 Triticale ( maximum 0.1125 lb ai/ A; 1 application)

short grass 240 27 27 tall grass 110 12.375 12.375 broadleaf forage/ small insects 135 15.1875 15.1875 fruit, pods, seeds, large insects 15 1.6875 1.6875 Pecans, Grasses grown for seed ( forage fodder grasses) ( maximum 0.225 lb ai/ A; 4 applications; 14 day interval)

short grass 240 149.44 54 tall grass 110 68.5 24.75 broadleaf forage/ small insects 135 84.06 30.375 fruit, pods, seeds, large insects 15 9.34 3.375 Corn, Celery ( maximum 0.1125 lb ai/ A; 4 applications; 2 days interval between applications)

short grass 240 49.52 27 Page 38 of 206 Table 3.4   Wildlife Estimated Exposure Concentrations of Propiconazole ( Acute and Chronic Birds and Mammals)

Avian Food Item Maximum Avian Food Item Residue ( mg/ kg @ 1 1b ai/ A) 1 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Multiple Applications ( mg/ kg) 2 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Multiple Applications ( mg/ kg) 3 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Single Application ( mg/ kg)

tall grass 110 22.7 12.375 broadleaf forage/ small insects 135 27.86 15.1875 fruit, pods, seeds, large insects 15 3.10 1.6875 Peanut ( maximum 0.225 lb ai/ A; 2 applications; 10 day interval)

short grass 240 93.72 54 tall grass 110 42.95 24.75 broadleaf forage/ small insects 135 52.72 30.375 fruit, pods, seeds, large insects 15 5.86 3.375 Rice, Wild rice ( Maximum 0.225 lb ai/ A; second application at 0.115 lb ai/ A; 10 day between applications) 4 short grass 240 77.09 54 tall grass 110 35.33 24.75 broadleaf forage/ small insects 135 43.37 30.38 fruit, pods, seeds, large insects 15 4.82 3.38 stone fruits ( apricot, cherry, nectarine, peach, and plum) and non bearing crops ( maximum 0.1125 lb ai/ A; 5 appl.; 5 day intervals)

short grass 240 111.83 27 tall grass 110 51.26 12.375 broadleaf forage/ small insects 135 62.91 15.1875 fruit, pods, seeds, large insects 15 6.99 1.6875 Non agricultural Uses turf and ornamentals   ground cover, ( maximum 1.78 lb ai/ A; 4 appl.; 10 day intervals)

short grass 240 1300.97 427.2 tall grass 110 596.28 195.8 broadleaf forage/ small insects 135 731.79 240.3 fruit, pods, seeds, large insects 15 81.31 26.7 Page 39 of 206 Table 3.4   Wildlife Estimated Exposure Concentrations of Propiconazole ( Acute and Chronic Birds and Mammals)

Avian Food Item Maximum Avian Food Item Residue ( mg/ kg @ 1 1b ai/ A) 1 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Multiple Applications ( mg/ kg) 2 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Multiple Applications ( mg/ kg) 3 Maximum Wildlife Food Item Residue at Seasonal Maximum Application Rate Single Application ( mg/ kg) turf and ornamentals   lawns and turf, golf course ( maximum 1.78 lb ai/ A; 4 appl.; 14 day intervals)

short grass 240 1182.27 427.2 tall grass 110 541.87 195.8 broadleaf forage/ small insects 135 665.03 240.3 fruit, pods, seeds, large insects 15 73.89 26.7 turf and ornamentals sod farm ( maximum 1.78 lb ai/ A; 4 appl.; 21 day intervals)

short grass 240 1007.68 427.2 tall grass 110 466.44 195.8 broadleaf forage/ small insects 135 572.44 240.3 fruit, pods, seeds, large insects 15 63.6 26.7 1 maximum residues as per Fletcher et al. 1994 2 maximum residues using T REX model version 1.2.3 pseudo first order dissipation kinetics dissipation default half life of 35 days 3 maximum residues using T REX model version 1.2.3 pseudo first order dissipation kinetics dissipation default half life of 14.41 days 4 maximum residues at day 1 ( first application) + maximum residues at day 9 ( second application)

b. Terrestrial Plant Exposure Modeling In the screening level risk assessment, terrestrial plant exposure is estimated using the spreadsheet based TerrPlant model ( version 1.2.1).). Terrestrial plants inhabiting dry and semi aquatic ( wetland) areas may be exposed to pesticides from runoff and/ or spray drift. Resulting EECs from a single application are presented in Table 3.5. The model estimates EECs based on application rate, a solubility factor, and default assumptions of drift. A description of the model is in Appendix C.

Table 3.5. Estimated environmental concentrations ( EECs) derived from the TerrPlant screening model assuming a single application at maximum label rate. Page 40 of 206 Crop Application Rate lbs a. i./ A; Single application Application Method Total loading to adjacent areas1 Total loading to semi aquatic areas2 Drift EEC Ground spray 0.0034 0.0236 0.0011 Barley, rye, triticale, stone fruit, corn, celery 0.1125 Aerial spray 0.0079 0.0281 0.0056 Ground spray 0.0024 0.0168 0.0008 Wheat 0.1125 Aerial spray 0.0056 0.020 0.004 Ground spray 0.0068 0.0473 0.0023 Grasses grown for seed ( forage fodder grasses, Rice, Wild rice, Peanut 0.225 Aerial spray 0.0168 0.0563 0.0113 Ground spray 0.0534 0.3738 0.0178 turf and ornamentals   ground cover 1.78 chemigation 0.1246 0.4450 0.089 1 EEC for ground applications = drift + runoff = total load Drift = application rate ( lbs. a. e./ acre) x 0.01 ( drift) Runoff = application rate ( lbs. a. e./ acre) x 0.02 ( based on solubility) 2 EEC for aerial/ chemigation applications = drift + runoff = total load Drift = application rate ( lbs. a. e./ acre) x 0.05 ( drift) Runoff = application rate ( lbs. a. e./ acre) x 0.02 ( based on solubility)

The TERR PLANT version 1.2.1 exposure model calculates the potential exposure for terrestrial plants for only a single application of propiconazole and EFED does not have data to show residue accumulation from multiple applications over time for all the uses of propiconazole. As explained above, EFED has but two decline studies for one crop ( wheat) with only one application at only two sites ( Payne, OK and Freno, CA) with no mention of rainfall during the studies. Such decline studies provide limited data for multiple applications of propiconazole. Since propiconazole labels allow multiple applications to each crop, the magnitude of the risk to plants is uncertain, and potentially underestimated. At this time EFED The upper bound to the magnitude of the exposure for terrestrial plants would be to sum the exposures from each application as if the effect to non target plants were additive. Such EECs are presented below.

The uncertainty in the magnitude of exposure to multiple applications of propiconazole is great. It is unlikely that the same plant( s) will receive the same drift and runoff following each application, and a significant rainfall event after each application may not occur. However, the exposure calculations for terrestrial plants assume exposure both through spray drift and runoff from a treated field after a heavy rain event. The likelihood of co occurrence of such events is uncertain, especially for multiple applications, and as a result the estimated exposure values may be conservative. In addition, while the likelihood of exposure to non target plants through drift alone is significantly greater, the same plants may not be exposed to spray drift from each application, because wind speed and direction could be different at the time of each application. Page 41 of 206 Table 3.6. Estimated environmental concentrations ( EECs) derived from the TerrPlant screening model assuming the total number of applications per season at maximum label rate.

Crop Application Rate lbs a. e./ A; Total # appl.; Intervals in days Application Method Total loading to adjacent areas1 Total loading to semi aquatic areas2 Drift EEC Ground spray 0.0169 0.1181 0.0055 Stone fruit 0.1125 / 5 / 5 Aerial spray 0.0394 0.1406 0.028 Ground spray 0.0048 0.0336 0.0016 Wheat 0.1125 / 2 / 14 Aerial spray 0.0112 0.040 0.008 Ground spray 0.027 0.189 0.0092 Grasses grown for seed ( forage fodder grasses 0.225 / 4 / 14 Aerial spray 0.0630 0.2250 0.0452 Ground spray 0.0135 0.0935 0.0045 Corn, Celery 0.1125 / 4 / 2 Aerial spray 0.0315 0.1125 0.0225 Ground spray 0.0102 0.0714 0.0034 Rice, Wild rice 0.225 / 2 / 103 Aerial spray 0.0238 0.0805 0.017 Ground spray 0.2136 1.4952 0.7712 turf and ornamentals   ground cover 1.78 / 4 / 10, 14, or 21 chemigation 0.4984 1.78 0.356 1 EEC for ground applications = drift + runoff = total load Drift = application rate ( lbs. a. e./ acre) x 0.01 ( drift) Runoff = application rate ( lbs. a. e./ acre) x 0.02 ( based on solubility) 2 EEC for aerial/ chemigation applications = drift + runoff = total load Drift = application rate ( lbs. a. e./ acre) x 0.05 ( drift) Runoff = application rate ( lbs. a. e./ acre) x 0.02 ( based on solubility) 3 Maximum annual rate is 0.34 lb ai/ A. Assumed maximum single rate of 0.225 lb ai/ A applied, followed by 0.115 lb ai/ A at a 10 day interval between applications.

c. Residue Studies As discussed above, extremely limited data from the registrant regarding foliar residues were submitted for review, so the Agency's default foliar dissipation half life value ( 35 days) was primarily used. In addition, the 14.41 day foliar dissipation half life as discussed above was also considered in the assessment for avian and mammalian assessments. Terrestrial exposure estimates for avian and mammalian risk assessments were derived using the T REX model ( version 1.2.3).

C. Ecological Effects Characterization In screening level ecological risk assessments, effects characterization describes the types of effects a pesticide can produce in an organism or plant. This characterization is based on registrant submitted studies that describe acute and chronic effects toxicity information for various aquatic and terrestrial animals and plants. In addition, other Page 42 of 206 sources of information, including reviews of the Ecological Incident Information System ( EIIS), are conducted to further refine the characterization of potential ecological effects.

Appendix D summarizes the results of the registrant submitted toxicity studies used to characterize effects for this risk assessment. All formulated product toxicity values were adjusted to 100% of the active ingredient for this analysis. Toxicity testing reported in this section does not represent all species of birds, mammals, or aquatic organisms. Only a few surrogate species for both freshwater fish and birds are used to represent all freshwater fish ( 2000+) and bird ( 680+) species in the United States. For mammals, acute studies are usually limited to Norway rat or the house mouse. Estuarine/ marine testing is usually limited to a crustacean, a mollusk, and a fish. Also, neither reptiles nor amphibians are tested. The risk assessment assumes that avian and reptilian toxicities are similar. The same assumption is used for fish and amphibians.

1. Aquatic Effects Characterization The registrant has submitted a battery of studies, as required by CFR 40 Part 158, that examine the toxicity of propiconazole to representative aquatic organisms that serve as surrogates for organisms that may be exposed. Acute effects were determined for freshwater and estuarine/ marine fish, aquatic invertebrates, and aquatic vascular and nonvascular plants. The results from these studies are presented in Appendix D.

a. Aquatic Animals ( 1). Acute Effects Fish and Aquatic Phase Amphibians Studies for several species of fish were submitted including the rainbow trout ( Oncorhynchus mykiss), bluegill sunfish ( Lepomis macrochirus), brown trout ( Salmo trutta), catfish ( Ictalurus punctatus), and carp ( Cyprinus carpio). These studies included the testing of the propiconazole technical ( CGA 64250) and the formulated products Tilt 3.6E, Tilt EC 250 ( A 6079 A), and Tilt CGA 64250 SCW 125 ( A 6079 A). In addition, the propiconazole metabolite 1,2,4 triazole ( CGA 98032) was tested on the rainbow trout.

An acceptable rainbow trout study on the technical indicated the highest toxicity with an LC50 of 850 µ g/ L ( highly toxic) while an acceptable bluegill sunfish study revealed the lowest toxicity with an LC50 of 5500 µ g/ L ( moderately toxic). Although no sub lethal effects were noted in either study, NOAEC occurred at the 320 µ g/ L treatment level in the rainbow study and at the 2000 µ g/ L level for the bluegill.

The toxicity values for the formulated products were generally found to be less toxic than the technical and ranged from 1000 to 5750 µ g/ L ( moderately to slightly toxic). These studies were performed with formulations Tilt 3.6 E, Tilt EC 250 and Tilt CGA 64250 SCW 125 between 1979 and 1983. It is not clear whether the formulants that Page 43 of 206 comprised these tested formulations are the same as those used in formulations of propiconazole today.

A single rainbow trout study using the metabolite 1,2,4 triazole ( CGA 98032) resulted in an LC50 value of 506,000 µ g/ L ( practically non toxic). No environmental fate data is currently available on this compound, and is presently under review with other triazole compounds.

Tests on estuarine/ marine fish indicate that the LC50 toxicity of 2244 µ g/ L is less toxic than freshwater fish. The formulated product LC50 of 3900 µ g/ L appears to be less toxic than the most toxic freshwater fish. LC50 for the formulated product ( LC50 = 1000 µ g/ L). These studies are summarized in table 3 of Appendix D.

Aquatic Invertebrates Freshwater invertebrate data on daphnids indicate LC50s for the technical and formulated product are 4800 and 1300 µ g/ L, respectively. Although these data are not as robust as for fish, the data submitted show the formulated product Tilt 3.6 E to be more acutely toxic than the parent. As with the formulation data done for freshwater fish, it is not clear how the 1983 study represents the current formulations of propiconazole.

Estuarine/ marine invertebrate testing indicates the same trend as the freshwater invertebrate in that the formulated product appears to be more toxic than the technical propiconazole. The EC50 for the eastern oyster shell deposition study was 113 µ g/ L for the formulated product Tilt 3.6 E, compared to an EC50 for the technical ingredient of 1700 µ g/ L. A mysid shrimp LC50 of 510 µ g/ L was observed for the technical propiconazole in an acceptable study. These studies are summarized in table 4 of Appendix D.

( 2). Chronic Effects Fish and Aquatic Phase Amphibians A fathead minnow early life stage study was submitted in 1981 ( MRID 072210). This study has been classified as acceptable with a NOAEC and LOAEC of 95 and 184

g/ L, respectively. The chronic endpoints for this study were fish mortality, length and weight.

Aquatic Invertebrates A daphnid life cycle study was submitted in 1981 on the formulated product CGA 64250 ( MRID 00163165). Unfortunately this study was deemed unsound because replicate and/ or raw data were not submitted of any of the tested endpoints. In addition, raw data to verify the validity of the mean measured concentration were not submitted. This study could be up graded to supplemental status if the results could be verified by Page 44 of 206 the submission of the missing data. However, at this time EFED can not use this study in a risk assessment.

( 3). Field Studies No field studies are currently available for propiconazole.

b. Aquatic Plants Several aquatic plant studies have been conducted for propiconazole and satisfy the OPP data requirements. These include the vascular plant EC50 for the duckweed Lemna gibba and the non vascular algae and diatoms. The results from these studies are list in Appendix D and show that in all cases a definitive NOAEC ( 51 µ g/ L) was only reached for the freshwater diatom, Navicula pelliculosa. However, this alga was not the most sensitive of the non vascular algae. The most sensitive was the marine diatom ( Skeletonema costatum) with a NOAEC of 18 µ g/ L. The vascular plant EC50 and NOAEC indicated a much lower toxic level than the non vascular plant studies. The EC50 and NOAEC were 4828 and < 2240 µ g/ L, respectively.

2. Terrestrial Effects Characterization The registrant has submitted a battery of studies, as required by CFR 40 Part 158, that examine the toxicity of propiconazole to representative terrestrial organisms that serve as surrogates for organisms that may be exposed. Both acute and chronic effects were determined for birds and mammals. In addition acute effects were determined for terrestrial plants. The results from these studies are presented in Appendix D.

a. Terrestrial Animals A number of studies were submitted for birds and mammals for the active ingredient. The results from these studies are presented in Appendices XX.

( 1). Acute and Sub lethal Effects Birds In an acute oral toxicity study ( MRID 79689) of northern bobwhite quail, Colinus virginianus, the LD50 is 2825 mg a. i./ kg body weight. Sub lethal signs included lethargy, loss of coordination, lower limb weakness, wing droop, and body weight gain. The NOAEC was 631 mg ai/ kg bw. A second acute oral study was performed with the surrogate waterfowl species, the mallard duck ( MRID 67926), and similar results were obtained. The LD50 is > 2510 mg ai/ kg bw and lethargy was observed but there was full recovery from the lethargy after six hours. The results from these studies classify propiconazole as practically non toxic to birds. Page 45 of 206 Several sub acute dietary toxicity tests with bobwhite quail, mallard duck, Peking duck, and Japanese quail indicated that the 8 day LC50 values exceed the maximum concentrations tested, i. e., LC50> 5620 mg a. e./ kg of diet for the bobwhite quail and mallard duck and LC50> 1000 mg a. i./ kg of diet for the Peking duck and Japanese quail. No sub lethal effects were noted for the Peking duck or Japanese quail, but body weight gain and reduction in feed consumption were observed in the bobwhite quail and mallard duck. For the purposes of this assessment, propiconazole is considered to be practically non toxic to birds on an acute dietary basis.

Mammals Acute oral mammalian data were submitted on the active ingredient for the rat, mouse, Chinese hamster, and rabbit. The toxicities were similar for the rat, mouse, and rabbit, and ranged from LD50s of 1344 to 1517 mg ai/ kg diet for the rabbit and rat, respectively. The Chinese hamster LD50 was 3006 mg ai/ kg diet.

( 2). Chronic Effects Birds Chronic data for the bobwhite quail ( MRID 00133369) showed that no treatment related effects were observed at any of the test levels up to 1000 ppm diet. In addition, one mortality was observed at this test level. The results from this study are somewhat deceptive in that the birds were only tested to 1000 mg/ kg diet, and consequently a definitive LOAEC was not obtained. A chronic study was also performed on the mallard duck ( MRID 00134502), but was found to be unsound because the treated feed was not analyzed to verify test concentration, homogeneity of the mixing procedure, and stability under actual use conditions. In addition, replicate data for hatching and survivor weight were not provided and adult body weight data were not reported by sex.

Mammals A two generation rat study ( MRIDs 00163164, 00151514) with propiconazole technical was submitted which demonstrated a chronic NOAEC of 500 mg ai/ kg diet ( ppm). This NOAEC was based on reduced body weight gains in F0 and F1 generations. In addition, the NOAEL was reported as 43 mg/ kg bw/ day. No clinical mortality was observed in this study but reduced body weight gains occurred in both the F0 and F1 generations. Hepatic " clear cell change" was additionally observed in the F0 generation. Decreased offspring survival and body weights and increased incidence of hepatic lesions ( cellular swelling) at the 2500 mg ai/ kg diet level were also observed.

( 3). Field Studies Page 46 of 206 No field studies were submitted.

b. Terrestrial Plants Terrestrial plant testing ( seedling emergence and vegetative vigor) is required for herbicides that have terrestrial non residential outdoor use patterns and that may move off the application site through volatilization ( vapor pressure > 1.0 x 10 5mm Hg at 25oC) or drift ( aerial or irrigation) and/ or that may have endangered or threatened plant species associated with the application site. Currently, terrestrial plant testing is not required for pesticides other than herbicides except on a case by case basis ( e. g., labeling bears phytotoxicity warnings incident data or literature that demonstrate phytotoxicity).

For seedling emergence and vegetative vigor testing the following plant species and groups should be tested: ( 1) six species of at least four dicotyledonous families, one species of which is soybean ( Glycine max) and the second is a root crop, and ( 2) four species of at least two monocotyledonous families, one of which is corn ( Zea mays).

Tier 1 tests measure the response of plants, relative to a control, at a test level that is equal to the highest use rate ( expressed as lbs ai/ A). If effects are observed in this test, the registrant is required to proceed to the Tier 2 level. Terrestrial Tier 2 studies are required for any pesticide showing a negative response equal to or greater than 25% in Tier 1 tests. The registrant may opt to proceed directly to Tier 2 testing. Tier 2 tests measure the response of plants, relative to a control, and five or more test concentrations.

Tier 2 Terrestrial plant data were submitted for both the seedling emergence and the vegetative vigor tests for technical propiconazole ( MRID 41673201, 41673203). The seedling emergence study considered percent emergence, plant height, and plant dry weight to determine the EC25 and NOAEC for each of the species tested, and propiconazole was applied at use rates of 0.0185, 0.056, 0.167, 0.5, and 1.5 lb ai/ A. The monocots tested included onion, corn, oats, and ryegrass. The dicot species included carrot, soybean, lettuce, cucumber, tomato, and cabbage. Only one of the dicots ( cabbage) exhibited enough of a dose response to obtain an EC25. Consequently, the EC25 is > 1.5 lb ai/ A for all of these species except cabbage. The EC25 for cabbage is 0.18 lb ai/ A, and the NOAEC was 0.056 lb ai/ A based on plant dry weight.

The vegetative vigor study was performed using the same species as the seedling emergence studies ( onion, corn, oat, and ryegrass as representatives of moncots and soybean, lettuce, carrot, tomato, cabbage, and cucumber). The same application concentrations were applied to the plants. Plant height and plant dry weight were the parameters considered to measure dose response to plants. Lettuce, carrot, tomato, and oat EC25s could not be determined and these species appeared to be unaffected by the treatments. The most sensitive monocot based on plant height was ryegrass ( EC25 = 0.315 lb ai/ A, NOAEC = 0.0185 lb ai/ A). The most sensitive dicot based on plant dry weight was cabbage ( EC25 = 0.039 lb ai/ A, NOAEC = 0.056 lb ai/ A). Page 47 of 206 IV. RISK CHARACTERIZATION A. Risk Estimation  Integration of Exposure and Effects Data Results of the exposure and toxicity effects data are used to evaluate the potential for adverse ecological effects on non target species. For the assessment of propiconazole risks, the risk quotient ( RQ) method is used to compare exposure and measured toxicity values. Estimated environmental concentrations ( EECs) are divided by acute and chronic toxicity values. The RQs are compared to the Agency's levels of concern ( LOCs). These LOCs are the Agency's interpretive policy and are used to analyze potential risk to nontarget organisms and the need to consider regulatory action. These criteria are used to indicate when a pesticide's use as directed on the label has the potential to cause adverse effects on non target organisms.

1. Risk to Aquatic Animals Among the aquatic exposures described previously, the rice use represents the most conservative estimates, which estimates the concentrations in rice paddy discharge water. In addition, propiconazole label specifically forbids rice use in California, so the potential rice exposures will occur in Texas, Arkansas, and Louisiana. As for turf exposure, propiconazole can be used on lawn, sod farm, golf course, and others. EFED just published ( June 1, 2005) a guidance document   " Golf Course Adjustment Factors for Simulated Aquatic Exposure Concentrations." These golf course adjustment factors should only be used to refine EECs for turf in a golf course use scenario. Unless the golf course is treated 100% ( tees, greens, fairways and roughs), the aquatic exposure values from golf course use need to be adjusted by 0.05, 0.29, 0.66, and 0.34, respectively for tees and greens, fairways, roughs, and the combination of tees, greens, and fairways.

Based on the maximum estimated 1 in 10 year peak surface water concentration on turf and the most sensitive 96 hour LC50 values for fish, propiconazole does not appear to pose an acute risk to non listed freshwater and estuarine/ marine fish. Only the freshwater fish RQ is equivalent to the acute listed species LOC. The peak concentration below was estimated from the maximum use rate and minimum application interval for use of propiconazole on turf, using a Pennsylvania scenario in the PRZM model. The listed species level of concern is not exceeded for the Florida turf scenario, from which an estimated 1 in 10 year peak surface water concentration of 34.77 µ g/ L was derived.

The acute restricted use and listed species LOCs were exceeded for use on rice for the most sensitive freshwater fish LC50 value. In addition, the listed species LOC was exceeded for use on rice for estuarine/ marine fish. No levels of concern are exceeded for any other crop to which propiconazole is applied, since the EECs from the other applications range from 1 in 10 year peak concentrations of 1.92 ppb ( barley) to 13.28 ( corn). Page 48 of 206 The propiconazole formulations Tilt 3.6 E, Tilt EC 250 and Tilt CGA 64250 SCW 125 do not appear to pose a risk to listed or non listed freshwater fish, since toxicity data for these formulations showed them to be less toxic than technical propiconazole. These toxicity studies, which were performed between 1979 and 1983 and are detailed in Appendix D, indicate that Tilt 3.6 E is the most toxic of the three formulations, with a most sensitive 96 hour LC50 value of 1000 : g/ L for rainbow trout. As mentioned in the Effects Characterization, however, it is not clear whether the formulants that comprised these tested formulations are the same as those used in formulations of propiconazole today. Current formulations of propiconazole could be more or less toxic than they were more than 20 years ago.

The 1,2,4 triazole degradate ( CGA 98032) of propiconazole is much less toxic than the parent or any of the formulated products ( LC50 = 506,000 µ g/ L). This degradate is currently under separate review with other triazole compounds, and at this time no environmental fate data is available. This degradate is expected to be in very low concentrations in the soil, and since the toxicity is quite low, the resulting acute effects to freshwater fish would also be expected to be low.

These maximum RQs are presented in the table below.

Aquatic Animal Acute Toxicity (: g/ L) Peak Water Concentration  Turf Use (: g/ L) Peak Water Concentration   Rice Use (: g/ L) Acute RQ   Turf Use Acute RQ   Rice Use Freshwater fish 850 40.35 86.49 0.05*** 0.1**

Estuarine/ marine fish 2244 40.35 86.49 0.02 0.04***

Risk Presumption * Acute Risk 0.5 ** Acute Restricted Use 0.1 *** Acute Listed Species 0.05 Based on the maximum estimated 1 in 10 year 60 day surface water concentration and the NOAEC from the fathead minnow early life stage study of 95 : g/ L, propiconazole does not appear to pose a chronic risk to freshwater fish and aquaticphase amphibians when used on turf and rice. These results are presented below.

Aquatic Animal Chronic NOEC (: g/ L) 60 day Water Concentration   Turf Use (: g/ L) Water Concentration   Rice Use (: g/ L) Chronic RQ Turf Use Chronic RQ Rice Use Page 49 of 206 Freshwater fish 95 34.8 17.81 0.36 < 1 Estuarine/ marine fish N/ A 34.8 17.81 N/ A N/ A Risk Presumption + Exceeds Chronic LOC As explained in the Effects Characterization section, valid chronic data are not available for estuarine/ marine fish life cycle study, and chronic risk for a 90 day exposure period can not be evaluated at this time. However, if there is some possibility that this fish full life cycle study could be up graded to supplemental status as described in the Aquatic Effects characterization section above, the results from this study could be useful in this risk assessment.

The results from this study show that the most sensitive parameter was reproductive success ( eggs/ female/ day) and the NOAEC from the study author's analysis is 68 µ g/ L. Since the surface water EECs were 40.35 to 33.98 µ g/ L for peak and 90 day time periods respectively, the chronic levels of concern would not be exceeded for any of the turf uses. However, the chronic LOC would be exceeded for rice since the EEC for the rice use is 86.49 µ g/ L. Consequently, EFED will await the results of this submission before recommending that this study be repeated.

Risk to Aquatic Invertebrates Based on the maximum estimated 1 in 10 year peak surface water concentration for turf use and the most sensitive 48 or 96 hour EC50 values for invertebrates ( daphnia and mysid shrimp), propiconazole does not appear to pose an acute risk to non listed freshwater and estuarine/ marine invertebrates. Only the estuarine/ marine invertebrate RQs exceed the acute listed species LOC. The peak concentration below was estimated from the maximum use rate and minimum application interval for use of propiconazole on turf, using Florida and Pennsylvania scenarios in the PRZM model. Acute restricted use and listed species LOCs are exceeded for use on rice for estuarine/ marine invertebrates. No other acute levels of concern are exceeded for any other crop to which propiconazole is applied, since the EECs from the other applications range from 1 in 10 year peak concentrations of 1.92 ppb ( barley) to 13.28 ppb ( corn). The results are presented in the table below.

Aquatic Animal Acute Toxicity Value (: g/ L) Peak Water Concentration   Turf (: g/ L) Peak Water Concentration   Rice (: g/ L) Acute RQ Turf Acute RQ Rice Freshwater Invertebrate 4800 40.35 86.49 0.008 0.02 Page 50 of 206 40.35 ( FL turf) 0.08***

Estuarine/ marine invertebrate 510 34.77 ( PA turf) 86.49 0.07*** 0.17**

Risk Presumption * Acute Risk 0.5 ** Acute Restricted Use 0.1 *** Acute Listed Species 0.05 The propiconazole formulation Tilt 3.6 E appears to be more toxic to estuarine/ marine invertebrates than technical propiconazole. These toxicity studies, which were performed between 1979 and 1983 and are detailed in Appendix D, indicate that Tilt 3.6 E is most toxic to the eastern oyster, with a shell deposition EC50 value of 113 : g a. i./ L. As mentioned in the Effects Characterization, however, it is not clear whether the formulants which comprised this formulation are the same as those used in formulations of propiconazole today. Current formulations of propiconazole could be more or less toxic than they were more than 20 years ago.

Based on an evaluation of potential drift of propiconazole to an adjacent water body, this formulation does not pose a risk to listed or non listed freshwater or estuarine/ marine invertebrates. Formulated products are mixtures, and while the mixture can be transported as a whole via spray drift, individual formulants would not be expected to runoff together to the same degree.

The maximum EEC based on drift from the use on turf is 1 ppb, which results in an RQ well below the LOC. This EEC was calculated by assuming instantaneous loading and complete mixing of propiconazole in drift in a 20,000,000 liter pond.

concentration ( mg/ L) = application rate ( mg product/ ha or mg ai / ha a. i.) X 0.01 or 0.05 ( drift percentage) X 1 ha / 20,000,000 L For the proper RQ calculations, the units of EEC ( Concentration in 20,000,000 L pond  mg product/ L or mg ai/ L) and LC50 ( mg product/ L or mg ai/ L) need to be compatible.

An acceptable mysid shrimp life cycle study found the NOAEC and LOAEC based on mortality and the number of offspring produced to be 205 and 507 µ g/ L, respectively ( MRID 072210). The resulting chronic RQs of 0.16 ( rice) and 0.18 ( turf) do not exceed the chronic LOC using the 21 day or peak water concentrations on turf or rice. This is illustrated in the table below. Page 51 of 206 Aquatic Animal Chronic NOAEC (: g/ L) 30 day Water Concentration   Turf Use (: g/ L) Water Concentration   Rice Use (: g/ L) Chronic RQ Turf Use Chronic RQ Rice Use Freshwater Invertebrate N/ A 34.24 86.49 N/ A N/ A Estuarine/ marine invertebrate 205 34.24 86.49 0.18 0.16 Risk Presumption + Exceeds Chronic LOC Acceptable chronic data have not been submitted for freshwater invertebrates. However, if the current daphnid life cycle study ( MRID 00163165) is up graded to acceptable, the resulting NOAEC and LOAEC based on mortality and number of offspring produced would be 310 and 690 µ g/ L, respectively. The resulting RQs would not exceed any chronic freshwater invertebrate LOCs.

2. Risk to Aquatic Plants Based on the toxicity to the marine diatom ( Skeletonema costatum), the use of propiconazole on turf and rice may pose an acute risk to nonvascular estuarine/ marine plants. The EECs from both the PA turf and FL turf scenarios result in RQs which exceed the acute and listed species LOCs. The EECs for other crops do not result in RQs that exceed the acute LOC, since the highest 1in 10 year peak concentration is 13.28 : g/ L ( corn) is far below all aquatic plant toxicity values. However, since a NOAEC could not be established in the marine diatom test, one cannot preclude the possibility that exposure to propiconazole from all uses could potentially exceed the listed species LOC. The risk quotients for the freshwater vascular plant Lemna gibba do not exceed any aquatic plant levels of concern. These results are summarized in the table below.

Table 4 1. Aquatic Plant Risk Quotient Calculations for Multiple Aerial Applications Plant type Toxicity Value (: g/ L) Listed Species Toxicity (: g/ L) Peak Water Conc.  Turf (: g/ L) Peak Water Conc.  Rice (: g/ L) Acute RQ  Turf Acute RQ  Rice Listed Species RQ  Turf Listed Species RQ  Rice Vascular Plants Duckweed ( Lemna gibba) 4828 < 2540 40.35 86.49 0.008 0.02 > 0.016 > 0.03 Nonvascular Plants Freshwater Aquatic Plants 93 51 40.35 86.49 0.43 0.93 0.79 1.7** Page 52 of 206 Table 4 1. Aquatic Plant Risk Quotient Calculations for Multiple Aerial Applications Plant type Toxicity Value (: g/ L) Listed Species Toxicity (: g/ L) Peak Water Conc.  Turf (: g/ L) Peak Water Conc.  Rice (: g/ L) Acute RQ  Turf Acute RQ  Rice Listed Species RQ  Turf Listed Species RQ  Rice 40.35 ( PA turf) 86.49 1.92* 4.12 * > 2.24** > 4.81** Estuarine/ Marine Aquatic Plants 21 < 18 34.88 ( FL turf) 86.49 1.66 * 4.12 * > 1.93** > 4.81**

Risk Presumption Level of Concern * Acute risk 1 ** Acute Listed Species 1 3. Non target Terrestrial Animals Risk to birds and mammals were evaluated using the risk quotient methold for dietary and dose based exposure scenarios using the T REX program ( version 1.2.3). As discussed in the Measure of Exposure Section, a 35 day foliar dissipation half life was deemed most appropriate for use with this model. However, it should be noted that some of these RQs are reduced below all levels of concern when a foliar disspation half life of 14.41 days is used in TREX The 14.41 day half life is derived from the 95th percentile from time zero data is used in the calculation of a foliar dissipation half life. is used. There are many uncertainties associated with this estimate. These uncertainties are discussed in the Measure of Exposure Section.

Birds A definitive dietary LC50 was not obtained in any of the dietary studies, and no mortality was seen up to doses of 5620 mg/ kg diet in the acceptable bobwhite quail and mallard duck studies. These studies suggest that propiconazole is practically non toxic to birds on an acute basis. Risk quotients of < 0.2 on turf indicate that acute listed species LOCs may be triggered when a 35 day foliar half life is used. However, if a 14.41 day foliar half life is used to calculate the RQs, no LOCs are exceeded using the dietary studies.

On the other hand, a definitive LD50 of 2825 mg ai/ kg bw was obtained in the testing of the bobwhite quail. In addition to mortality, effects observed included lethargy, loss of coordination, lower limb weakness, wing droop, and reduced body weight gain. Regardless of the foliar dissipation half life used ( 35 day or 14.41 day, most of the RQs Page 53 of 206 indicate that the listed species LOCs are equivalent for maximum residue concentrations for 20 g birds foraging in short grass for grasses grown for seed and pecan. The listed species LOC is equivalent for 1000 g birds foraging short grass for stone fruit and peanut. Turf and ornamental uses exceed the acute risk LOCs for all weight classes of birds by somewhat higher margins. These RQs are summarized in the table below.

Avian Risk Quotients Exceeding LOC Based on Multiple Applications with LD50 of 2825 mg ai/ kg bw Use site Food Type Weight Class of Bird ( g) Maximum Residue RQ Mean Residue RQ Pecan, Grasses grown for seed ( forage fodder grasses ( maximum 0.225 lb ai/ A; 4 applications; 14 day interval Short grass 20 0.08 ***

Stone fruits   ( apricot, cherry, nectarine, peach, and plum) and nonbearing crops ( maximum 0.1125 lb ai/ A; 5 appl.; 5 day intervals) Short grass 1000 0.06 ***

Peanut   ( maximum 0.225 lb ai/ A; 2 appl.; 10 day intervals) Short grass 1000 0.06 ***

20 0.7 * 0.25 ** 100 0.31 ** 0.11 *** Short grass 1000 0.1 *** 20 0.32 ** 0.1 *** Tall grass 100 0.14 *** 0.1**** 20 0.28 ** turf and ornamentals   ground cover, ( maximum 1.78 lb ai/ A; 4 appl.; 10 day intervals)

Broadleaf forage, small insects 100 0.13 *** 20 0.63 * 0.22 ** 100 0.28 ** 0.1 *** Short grass 1000 0.1 *** 20 0.29 ** Tall grass 100 0.13 *** 20 0.26 ** 0.1 *** turf and ornamentals   lawns and turf , golf course, ( maximum 1.78 lb ai/ A; 4 appl.; 14 day intervals)

Broadleaf forage, small insects 100 0.12 *** 20 0.54 * 0.19 ** 100 0.24 ** 0.1 *** Short grass 1000 0.1 *** 20 0.25 ** 0.1 *** Tall grass 100 0.11 *** 20 0.22 ** 0.1 *** 100 0.1 *** 0.1**** turf and ornamentals   sod farm ( maximum 1.78 lb ai/ A; 4 appl.; 21 day intervals)

Broadleaf forage, small insects 1000 0.1****

* indicates an exceedance ( or equivlence) of Acute Risk LOC; RQ > 1.0. ** indicates an exceedance of Acute Restricted Use LOC; RQ > 0.20 *** indicates an exceedance of Listed Species Level of Concern ( LOC); RQ > 0.10. * LOC not exceeded if 14.41 day foliar dissipation half life is calculated from T REX. Page 54 of 206 Chronic data for birds showed no treatment related effects at any of the test levels up to 1000 mg/ kg diet, and as described above, a definitive LOAEL could not be determined. Consequently, the actual NOAEL could be much greater than observed in the study. Hence, there is a great uncertainty when this information is used to evaluate chronic risk to birds.

The dietary based chronic risk quotients, which are presented below, show that the chronic level of concern is exceeded for birds on multiple application turf use sites when the NOAEL of 1000 mg/ kg diet is used to assess chronic risk. The turf risk quotients are summarized in the table below and range from 1.0 to 1.3. These RQs can be reduced below the chronic LOCs if the 14.41 day foliar half life is used. To reduce uncertainty and reduce the chronic RQs below the level of concern, a chronic study following the EPA guidelines should be completed which includes testing to higher test levels. Due to the uncertainty with regard to the avian chronic NOAEL and LOAEL a dose based risk quotient analysis was not done.

Table 4 2. Avian Chronic Risk Quotient Calculations based on chronic NOAEC 1000 mg/ kg diet Wildlife Food Item Wildlife Food Item Residue Single Application ( mg/ kg diet) Wildlife Food Item Residue Multiple Applications ( mg/ kg diet) Chronic NOAEC ( mg/ kg diet) Single Application Chronic RQ Multiple Application Chronic RQ turf and ornamentals   ground cover, ( maximum 1.78 lb ai/ A; 4 appl.; 10 day intervals)

short grass 427 1301 1000 0.427 1.3 *^

tall grass 196 596 1000 0.196 0.596 broadleaf forage/ small insects 240 732 1000 0.24 0.732 fruit, pods, seeds, large insects 27 81 1000 0.027 0.081 turf and ornamentals   lawns and turf, golf course ( maximum 1.78 lb ai/ A; 4 appl.; 14 day intervals)

short grass 427 1182 1000 0.427 1.18 *^

tall grass 196 542 1000 0.196 0.542 broadleaf forage/ small insects 240 665 1000 0.24 0.665 fruit, pods, seeds, large insects 27 74 1000 0.027 0.074 turf and ornamentals sod farm ( maximum 1.78 lb ai/ A; 4 appl.; 21 day intervals)

short grass 427 1008 1000 0.427 1.01 *^

tall grass 196 466 1000 0.196 0.466 broadleaf forage/ small insects 240 572 1000 0.24 0.572 Page 55 of 206 Table 4 2. Avian Chronic Risk Quotient Calculations based on chronic NOAEC 1000 mg/ kg diet Wildlife Food Item Wildlife Food Item Residue Single Application ( mg/ kg diet) Wildlife Food Item Residue Multiple Applications ( mg/ kg diet) Chronic NOAEC ( mg/ kg diet) Single Application Chronic RQ Multiple Application Chronic RQ fruit, pods, seeds, large insects 27 64 1000 0.027 0.064 Risk Presumption Level of Concern * Chronic Risk 1 ^ LOC not exceeded if 14.41 day foliar dissipation half life is calculated from T REX.

Mammals The mammalian acute LD50 values are 1344, 1490, and 1517 mg/ kg bw for the rabbit, mouse, and rat, respectively. Since the T REX model currently does not adjust the bodyweight for any other mammals other than laboratory rats, it was necessary to adjust for the bodyweight of the laboratory rabbit and mouse.

Since the weight of the rabbits and mice were not referenced in the studies ( MRID 058594, 058592), EFED assumes typical weights of 2.0 and 0.02 kg, respectively. 2 The typical weight of the laboratory rat is 0.35 kg. The LD50s are then adjusted according to the following equation:

Adjusted LD50= LD50* ( TW/ AW) 0.25 where TW = test animal weight AW = body weight of the rat Adj. LD50 = dose in mg/ kg/ bw for the rat The adjusted LD50s for the rabbit and mouse from this equation are 2078 and 729 mg/ kg bw, respectively. Therefore, when mammalian LD50 data are adjusted for bodyweight, the mouse is the most sensitive ( LD50 = 729 mg/ kg bw), and this value and the Fletcher residue values obtained from T REX ( version 1.2.3) were used to calculate the acute mammalian RQs based on the fraction of the body weight consumed daily for 15, 35, and 1000 g mammals.