1

**MEMORANDUM December 6**  **, 2012 Subject:**  Registration Review

– Preliminary Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water Assessments for Ip rodione (PC Code 109801 ; DP Barcode D 40 2502 ) **To:** James Parker, Risk Manager Reviewer

Laura Parson s, Team Leader Neil Anderson, Risk Manager Risk Management and Implementation Branch 1 Pesticide Re - evaluation Division **From:** Chuck Peck, Environmental Engineer

Scott Glaberman, Ph.D., Biologist Environmental Risk Branch IV Environmental Fat e and Effects Division **Reviewed By:** Jim Carleton, Ph.D., Senior Scientist

Thomas Steeger, Ph . D., Senior Science Advisor Environmental Risk Branch IV Environmental Fate and Effects Division **Through:** Marietta Echeverria , Branch Chief

Environmental Risk Branch IV Environmental Fate and Effects Division The Environmental Fate and Effects Division (EFED) has completed the preliminary problem formulation (attached) for the ecological risk, environmental fate, endangered species, and drinking water assessments to be conducted as part of the Registration Revi ew of the fungi cide iprodione (PC Code 109801 ). The problem formulation draws on studies submitted by the technical registrant in response to data requirements, studies available in the open literature, and other supporting documents ( e.g ., guidance documents, white papers). This document is intended to provide an overview of what is currently known about the environmental fate and ecological effects associated with total toxic residues of iprodione and its degradates, and outlines uncertainties regarding attributes of the parent compound and its transformation products. It describes the preliminary ecological risk hypothesis and the processes that will be used during the completion of drinking water and ecological risk assessments in support of Registratio n Review. This document also recommends studies that should be included in a data call - in (DCI) to address uncertainties surrounding the environmental fate and potential ecological effects of iprodione . OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION **UNITED STA TES ENVIRONMENTA**  **L PROTECTION A GENCY**  **WA SHINGTON, D.C. 20460** Pag e 2 of 55



# Problem **Formulation for the Environmental Fate and**  **Ecological Risk , Endangered**  **Species, and Drinking Water Assessment**  **s in Support**  **of the R egistration Review of Iprodione** 

3 - (3,5 - dichloropheny

l) -N - (1 - methylethyl ) - 2,4 - dioxo - 1 - imidazolidinecarboxa - mide CAS No. 36734 - 19 - 7 PC Code : 109801 **Prepared by:** Chuck Peck, Environmental Engineer Scott Glaberman , Ph.D., Biologist U. S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division Environmental Risk Branch IV 1200 Penns ylvania Ave., NW Mail Code 7507P Washington, DC 20460 **Reviewed by:** Jim Carleton , Ph.D., Senior Scientist Thomas Steeger, Ph . D., Senior Science Advisor Marietta Ech e verria, Branch Chief **December 6 , 2012** Pag e 3 of 55

**Table of Contents** 1. Introduction ................................ ................................ ................................ ............................ 4 2. Conclusions f

rom Previous Risk Assessments ................................ ................................ ....... 5 **2.1.** Ecological Risk Assessments ................................ ................................ ....................... 5 **2.2.** Drinking Water Exposure Assessments ................................ ................................ ....... 6 **2.3.** Clean Water Act Programs ................................ ................................ .......................... 6 3. Environmental Fate and Transport ................................ ................................ ......................... 6 **3.1.** Parent ................................ ................................ ................................ ........................... 6 **3.2.** Transformation Products of Concern ................................ ................................ ........... 8 4. Receptors ................................ ................................ ................................ ................................ 9 **4.1.** Effects to Aquatic Organisms ................................ ................................ .................... 10 **4.2.** Effects to Terrestrial Organisms ................................ ................................ ................ 13 **4.3.** Ecological Incidents ................................ ................................ ................................ ... 15 5. Exposure Pathway s of Concern and Risk Hy pothesis ................................ .......................... 16 6. Analy sis Plan ................................ ................................ ................................ ........................ 17 **6.1.** Stresso rs of Concern ................................ ................................ ................................ .. 17 **6.1.1.** Ecological Risk Assessment ................................ ................................ ................... 17 **6.1.2.** Drinking Water Assessment ................................ ................................ ................... 18 **6.2.** Measures of Exposure ................................ ................................ ................................ 18 **6. 3.**  Measures of Effect ................................ ................................ ................................ ..... 18 **6.4.** Endangered Species Assessments ................................ ................................ .............. 18 **6.5.** Endocrine Disruptor Screening Program ................................ ................................ ... 19 7. Preliminary

I dentification of Data Gaps ................................ ................................ .............. 19 **7.1.** Environmental Fate Data ................................ ................................ ........................... 19 **7.2.** Effects Data ................................ ................................ ................................ ................ 22 8. References ................................ ................................ ................................ ............................ 30 Appendix A. Chemical Identity Table and Proposed Degradation Pathway ........................... 32 Appendix B. BEAD USE and Usage Reports ................................ ................................ .......... 35 Appendix C. OPPI

N Bibliograph y ................................ ................................ ........................... 38 Appendix D. SIP/STIR Model Results ................................ ................................ ..................... 51 Appendix E. IDS Aggregate Incident Report for Iprodione ................................ .................... 53 Appendix F. Data Call - InJustification T ables for Non - guideline / Special Studies ............... 54Pag e 4 of 55

**1. Introduction**  EFED evaluated the most recent ecological risk and drinking water assessments for iprodione in association with the update d toxicity, exposure, and usage information to determine if sufficient data are available and if further updates are needed to support R egistration R eview. Recent risk assessments include a 2012 asse ssment for the use of iprodione on fruiting vegetables and cucurbits ( DP Barcode: D359480 + , dated 2/2012 ). In addition, EFED considered the latest Agency science policies and risk assessment methodologies. The structure, chemical name, and other identifi ers of iprodione and its major transformation products can be found in the chemical identity table attached to this document (**Appendix A**  ) . Ip rodione (CAS No. 36734 - 19 - 7) is a dicarboximide contact and/or locall y sy stemic fungicide, intended to inhibit germination of fungal spores and the growth of myceli a . In2011, the Residues of Concern Knowledge Subcommittee (ROCKS) included three major degradates ( e.g. , ≥ 10%) of iprodione as residues of concern, based on struc tures similar to the parent : 3 - (1 - methylethyl) - N - (3,5 - dichlorophenyl) - 2,4 - dioxo - 1 - imidazolidine - carboxamide (RP30228); [(dichloro - 3,5 - phenyl ) - 1 - isopropylcarbamo yl - 3] - 2 - acetic acid (RP35606); and 3 - (3,5 - dichlorophenyl ) - 2,4 - dioxo - 1 - imidazolidine - carboxamide (RP32490) (D393960, October 5, 2011). Structurally , iprodione is related to dichloroanilines (DCA) , with one of its degradates being 3,5 - DCA , which is also considered a residue o f concern . Ip rodione is currently

registered for use on a variety of field, fruit, and vegetable crops; and on turf (sod farms, golf courses, and ornamental turf uses) . The chemical can be applied by chemigation, aircraft, and foliar ground spray . Prior assessments have estimated exposure for m aximum annual application rates ranging from 0.27 (c otton) to 24 (turf ) lb s a . i . /A ( D359480 + , 2/2012 ) . The chemical profile produced by the Biological and Economic Assessment Division ( BEAD ) , located in the docket, lists the use patterns of maximum exposure s for the current uses of iprodione. A brief summary of this chemical profile is provided in **Appendix B** . F or risk assessment purposes EFED will employ application scenarios that are expected to result in maximum exposure for e a ch given use. Absence of information on the labels regarding maximum single application rate s , application interval s , allowable annual maximum rate s , or application method s will result in conservative assumptions as illustrated in the following examples:

 If a maximum single application rate is specified with a re - application interval of 7 day s without specifying a maximum annual rate , an assumption of 26 ap plications with 7 - day intervals will be used ;  If a label does not preclude aerial applications , aerial pesticide applications will be assumed ;  If a label does not specify an application interval , an application interval of 3 day s will be assumed .Pag e 5 of 55

**2. Conclusions from Previous Risk Assessments**  **2.1. Ecological Ris**  **k Assessments** The Agency

has conducted ecological risk assessments on iprodione that serve as a basis for this problem formulation , including the 1998 Reregistration Eligibility Decision (RED) (USEPA, 1998) , the 2009 California Red - legged Frog (CRLF; Rana draytonii ) endangered species assessment (USEPA 2009) , and new use assessment s in 2007 . The potential risks identified in these assessments are briefly summarized in **Table 1**  and **Table 2**  below. Ip rodione has been characterized as moderatel y mobile, relativel y nonvolatile , and most likely to degrade via alkaline hydroly sis (USEPA 2009). The 1998 RED for iprodione indicated acute and chronic risks to Federall y- listed threatened and endangered species (hereafter referred to as “listed”) and non - listed terrestrial birds and mammals at the higher application rates ( e.g., greater than 4 lbs ai/A/ye ar), particularl y for granular products. Risk levels for listed and non - listed freshwater and estuarine/marine invertebrates exceeded levels of concern (LOCs) for acute risk for almost all uses, while chronic risks were onl y a concern at the highest application rates on turf for freshwater organisms, and on all uses for estuarine/marine organisms . Freshwater and estuarine/marine vertebrate acute and chronic risk quotient (RQ) values exceed ed LOCs only at the highest application rates used on turf. Nonvascular aquatic plants had LOC exceedences at the highest application rates used on turf and rice. Ip rodione is a member of the imide group of the dicarboximide class of fungicides, as are the active ingredients vinclozolin and procy midone. In the 2000 RED for vinclozolin (USEPA 2000) , the Agency

concluded that, while current data we re limited, certain evidence was available that these compounds may modulate androgens by

a common mechan ism o f toxicity . Because of the complexity of the androge n s ys tem, a careful evaluation wa s needed before a for mal decision could be made. At that time, the Agency did not believe it ha d sufficient reliable information concerni ng common mechanism issues to det ermine whether or not vinclozolin shares a common mechanism of toxicity with iprodione and/or procy midone. F or the purposes of th at risk assessme nt, the Agency assumed that vinclozolin did not share a common mechanism of toxicity with other imide fungicide s. Previous ecological risk assessments ( DP Barcode D315437 , DP Barcode D313332 , USEPA 2007a and DP Barcode D3 39724, USEPA 2007 b ) identified acute risks to listed terrestrial birds and mammals, aquatic vertebrates and invertebrate s , and aquatic plants. Chronic risks were identified for non - listed terrestrial birds and mammals. Risks were also identified for listed aquatic plants. At the time terrestrial plant data were unavailable, so acute and chronic risks to terrestrial plants could not be precluded. The most recent ecological risk assessment was an endangered species assessment conducted for the California Red - legged Frog (USEPA 2009 ). Acute and chronic RQs for the aquatic - phase CRLF exceed ed the LOCs for all iprodione uses. Acute and chronic risk LOCs were also exceeded for the majority of the iprodione uses for the terrestrial - phase CRLF.Pag e 6 of 55

P revious ecological assessments only focused on risks from iprodione and did not include degradates RP 30228, RP35606, and RP32490 . Had exposure values accounted for these residues, RQ values would have been higher and the number of uses/taxa for which acute and/or chronic risk LOCs would have been exceeded likely increased. **Table 1**  **. P**  **otential risk c**  **oncerns i**  **dentified in previous a**  **ssessments for iprodione** 

**Birds Mam**  **mals Terr**  **estrial**

**Invert ebrate**  **s Aquatic** 

**V ert**  **ebrate s**  **Aquatic**

**Invert ebrate**  **s Terr**  **estrial**

**Plants Aquatic** 

**Plants Non**  **- listed**  **C C**  **-- --**  **-- No data**  **-- Listed**  **A, C A, C**  **-- A, C**  **A, C No data**  **A** A - Ac ute risk , C

– Chronic risk, -- - no risk **Table 2**  **. P**  **otential environmental concerns identified in previous assessments for iprodione**  **Bioaccum ulation**  **Groundwater Contam ination**  **Persistence Degrades of Concern**  **√ √**  **W ater**  **, Sed im**  **ent 3,5**  **- DCA (RP32596), RP30228,**  **RP35606, and RP32490 2.2.**  **Drinking Water Exposure Assessments** A drinking water exposure assessment for the proposed new uses of iprodione on fruiting vegetables and cucurbits was conducted in 20 12 (USEPA, 20 12 ). Exposure estimates of iprodione total toxic residues from currentl y labeled uses that produce maximum exposure (turf ) were 92 μg/L (1 - in - 10 - ye ar peak), 31 μg/L (1 - in - 10 - ye ar annual mean), and 18 .0 μg/L (30 - ye ar mean) for surface water and 0.29 μg/L for ground water. Exposure estimates of 3,5 - DCA from currentl y labeled uses that produce maximum exposure (turf) were 115 μg/L (1 - in - 10 - ye ar peak), 42 μg/L (1 - in - 10 - year annual mean), and 27.0 μg/L (30 - year mean) for surface water and 0.81 μg/L for ground water. T he 2012 drinking water assessment included a comprehensive evaluation of all registered uses and characterized available monitoring data , especiall y for turf uses, as well as modeling results . Observed differences in the modeling and monitoring turf concentrations appeared to be driven b y the difference in maximum allowable use specified on the labels and the amount that was used during the monitoring study . **2.3. Clean Water Act Programs**  Ip rodione is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. No Total Maximum Daily L oad s (TMDL) or section 304(a) ambient water quality criteria have been developed for iprodione . Aquatic life benchmarks have been established for iprodio ne and are available at http://www.epa.gov/oppefed1/ecorisk_ders/aquatic_life_benchmark.htm . Any data submitted or otherwise located as part of the R egistration R eview pro cess may be used to update aquatic life benchmarks if applicable. **3. Environmental Fate and Transport**  **3.1. Parent**  Ip rodione is moderately

mobile (FAO soil mobility classification) in soils , with an organic carbon partition coefficient ( Koc ) around 500 m L/g . It is not volatile and, as such, is not subjectPag e 7 of 55

to long - range aerial transport. I prodione is expected to be most persistent in acidic environments (pH 5 ) , with hydrol ys is half - lives around 130 day s in aquatic sy stems; however, in neutral (pH 7) aquatic s ys tems, the hydroly tic half - life is only

4.7 day s, and in alkaline s ys tems (pH 9 ) iprodione hydrolyz es rapidly (half - life 27 minutes). As a result, iprodione degradation is expected to occur primarily via h ydrol ys is in the water in natural aquatic env ironments . It should be noted that the half - life in the aerobic aquatic metabolism study is longer (t 1⁄2 = 9 day s at pH 8.5), indicating that the addition of sediment impedes the degradation of iprodione. As onl y one aerobic aquatic metabolism study has been submitted, additional data could potentially clarify this uncertainty . In an aquatic photol ys is study , iprodione degraded slowly with a half

life of 67 day s in a pH 5 buffered solution, with no major d egradates ( ≥10% of the applied) observed. The iprodione log octanol/water partition coefficient ( log Kow) of 3.1 indicat es limited potential for bioaccumulation. Ac cording to the submitted study (MRID 430910 - 01 ), iprodione does not bioaccumulat e appreciab ly in bluegill sunfish ( Lepomis macrochirus ) , with maximum bioaccumulation factors of only 116X for nonedible tissues, 51X for edible tissues, and 72X for whole fis h. Depuration was rapid (t 1⁄2 < 1 day). Submitted iprodione soil degradation studies show hi gh levels of unextracted and unidentified residues , leading to uncertainty in characterization of the chemical’s degradation. In an aerobic soil degradation study

(MRID 430910 - 02), 75 - 87% of the residues at D ay 276 were un extracted and uncharacterized. Unextract ed residues exceeded 10% of applied between D ay s 14 and 30 of the study . Thus the extent to which these residues constitute parent iprodione or degradates of concern remains unknown. However, based on 3,5 - DCA’s affinity to bind to soil in aged s ys tems or be transformed to other unextracted residues that are not available for off - site transport (see discussion under Section 3.2 Transformation Products of Concern) and that 3,5 - DCA is considered the terminal degradate in iprodione metabolism studies , EFED will assume that the unextracted and uncharacterized residues in the iprodione aerobic soil metabolism soil study (MRID 430910 - 02 ) are 3,5 - DCA . EFED will conservativel y estimate a 75% molar conversion of iprodione to 3,5 - DCA. In terrestrial and a quatic field dissipation studies, iprodione dissipated with half - life ( DT 50 ) values ranging from 3 to 7 day s, at pH values (6.2 - 8) which suggest that hydroly tic degradation may

have been a contributing factor in the observed dissipation . However , due to the presence of substantial unextracted /unidentified residues in the aerobic soil metabolism study , the extent to which these DT 50 values represent de gradation , as opposed to (for example) temporary sequestration of iprodione ( and/ or its degradates of conc ern) is not known. **Table 3**  summarizes the general fate properties of iprodione and the three residues of concern RP30228, RP35606, and RP32490 . **Table 4**  summarizes properties of 3,5 - DCA as ascertained using a combination of registrant - submitted studies and the Estimation Program Interface (EPI)Sui te 1 of tools .

1 The EPI (Estimation Programs Interface) SuiteTM is a Windows ®

- based suite of physical/chemical property and environmental fate estimation programs developed by the EPA’s Office of Pollution Prevention Toxics and Syracuse Research Corporation (SRC). EPI SuiteTM uses a single input to run the following estimation programs: KOWWINTM, AOPWINTM, HENRYWINTM, MPBPWINTM, BIOWINTM, BioHCwin, KOCWINTM, WSKOWWINTM, WATERNTTM, BCFBAFTM, HYDROWINTM, KOAWIN and AEROWINTM, and the fate models WVOLWINTM, STPWINTM and LEV3EPITM. ECOSARTM, whi ch estimates ecotoxicity, is also included in EPI SuiteTM.Pag e 8 of 55

**Table 3**  **. Chemical properties and environmental fate parameters of i prodione** 

**Property Value**  **Source/MRID C**  **omments** Molecular formula C 13 H 13 Cl 2N 3 O 3 Form ula reported for iprodione Molecular weight (g/mole) 330.2 Value reported for iprodione Vapor pressure ( T orr, 20 o C) 1.0 x10 - 7 412305 - 03 Value reported for iprodione Henry’s Law Constant (atm m3 /mol) 3.3 x10 - 9 calculated =(vp/760)/(MW/sol); vp in T orr; sol in mg/L; MW in g/mol Octanol/Water Coefficient (Log Kow, 22°C) 3.1 477788 - 02 Value reported for iprodione Solubility in water (mg/L, 20 o C) 13 477788 - 02 Hydroly sis half

- life (days) pH Parent TTR 1 418854 - 01 Study conducted for 30 days (pH 5), 125 hours (pH 7), and 121 minutes (pH 9). 5 7 9 131 4.7 0.02 772 266 56 Aqueous photolysis half

- life (days) 6 4 (parent and TTR) 418619 - 01 Aerobic soil half

- life (day s) Parent TTR 430910 - 02 2 H igh amounts of unextracted material (75 - 87%) . These residues are assumed to be 3,5 -

DCA. 16 19.2 Aerobic aquatic half

- life (day s) Parent TTR 419276 - 01 / 425038 - 01 pH = 8.5 9 60.7 Anaerobic aquatic half

- life (day s) Parent TTR 417558 - 01 pH = 7.4

11 92 Organic carbon partitioning coefficient (Koc ) (mL/g oc ) 223(sandy loam) 432 (loamy sand) 507 (loam) 543 (clay) 433492 - 02 Values reported for iprodione Bioconcentration factor 72 (whole fish) 430910 - 01 Terrestrial field dissipation DT 50 (days) Parent TTR 418774 - 01 CA - silt loam NC - loamy

sand CA 7 28 NC <3 <3 Aquatic field dissipation DT 50 Water 3.7 days (TX) 2.9 days (MS) Sediment 3.4 months (TX) 4.1 months (MS) 437183 - 01 Values reported for iprodione

1. TTR = Total Toxic Residue. I ncludes iprodione, RP30228, RP35606, and RP32490 . 2. A second aerobic soil metabolism study (MRID 445905 - 01) was conducted in 1993. However the study was classified as supplemental because nonextractable [ 14 C] residues and volatiles were not measured, so a material balance could not be determined. **3.2. Transformation Products of Concern**  A summary

of major degrad ates observed in laboratory and field studies, their structures, and degradation pathway s , as proposed b y the registrant, is provided in **Appendix A**  . **Appendix A**  also lists the degradates by study type, and the maximum percent of applied at which each of the degradates was detected. The human Health Effects Division ( HED ) has identified degradates 3,5 - DCA (RP32596), RP30228, RP35606, and RP32490 as residues of concern (D393960, October 5, 2011). By

including the precursor degradates RP30228, RP35606, and RP32490 in the risk assessment with parent iprodione (iprodione TTR) and conducting a separate assessment for 3,5 - DCA, the ROCKS felt the overall approach w ould be sufficientl y conservative andPag e 9 of 55

protective of the assessed risks , including those for cancer. As such, this assessment will also separately consider exposure s to iprodione TTR and to 3,5 - DCA. An aerobic soil metabolism study (MRID 452392 - 01) conducted by appl yi ng 3,5 - DCA to two different soils showed little evidence that 3,5 - DCA appreciably degraded over a 9 - month period at 25oC. Apparent dissipation was caused b y a high level of unextracted residue s . Unextracted residues accounted for 66% and 81% of the applied in the two sy stems. The only residues that were distinguishable from the applied 3,5 - DCA amounted to only 4 to 5% of the applied 14 C. In order to address the issue of unextracted residues, a second study was submitted in 2010 which used more aggressive analy tical m ethods to extract 3,5 - DCA from the soil (MRID 482192 - 01). Based on nonlinear regression analy sis, estimated half - lives ranged from 40 to 107 day s in silt loam and sand soils. Unextractable residues were still high, and averaged 54.4 - 67.8% of the applied at 119 day s posttreatment; however, based on an EPA review of the anal yt ical method, in which sufficientl y exhaustive methods were employed to extract 3,5 - DCA, it was determined that the 3,5 - DCA residues were bound to the soil and assumed unavailable for of f - site transport . **Table 4**  **. Summary of fate properties of the iprodione degradate 3,5 -**  **DCA Property**  **Value Source/MRID**  **C omments**  Molecular formula C 6 H 5 Cl 2N Molecular wt 162 Product chemistry data Solubility (mg/L) 784 EPI Suite Vapor pressure (T orr, 25 o C) 8.5x10 - 3 EPI Suite Henry’s Law Constant (atm m3 /mol) 10 - 6 EPI Suite Aerobic soil half

- life (days) 50.2 (sandy loam) 430910 - 02 H igh levels of unextracted residues (see text) . Half

- lives do not include unextracted residues based on extensive extraction techniques. 7.9 (silt loam) 17.6 (sandy loam) 452392 - 01 49 (silt loam) 107 (sand) 482192 - 01 (8.3 mg/kg applied) 40 (silt loam) 59 (sand) 482192 - 01 (1.47 mg/kg applied) Organic carbon partitioning coefficient (Koc ) (mL/g oc ) 380 (silt loam) 593 (sandy loam) 626 (loamy sand) 788 (pond sediment, sand) 932 (clay) 451141 - 01 **4. Receptors**  The most sensitive endpoint for each group of organisms will be used in the risk assessment. Assessment endpoints include direct toxic effects on the survival, reproduction, and growth of terrestrial and aquatic life, as well as indirect effects, such as reduction in prey base and/or modification of habitat. A summary of the available aquatic and terrestrial toxicity data for iprodione an d its degradates is provided in Sections 4.1 and 4.2 , respectively . In addition, a summary of ecological incidents associated with iprodione is provided in Section 4.3 . Further discussion of potential degradate toxicity is provided in the description of the stressors of concern for iprodione ( Section 6.1 ) .Pag e 10 of 55

Acute t oxicity

to fish and aquatic invertebrates is categorized using the s ys tem shown in **Table 5**  (USEPA 2004) . Acute t oxicity to terrestrial fauna (birds and mammals) is categorized using the sy stem shown in **Table 6** . Acute t oxicity categories for plants have not been defined. **Table 5**  **. Categories of acute toxicity for aquatic a**  **nimals LC**  **50 (**  **m g/L**  **) Toxicity Category**  < 0.1 Very highly toxic > 0.1 - 1 Highly toxic > 1 - 10 Moderately toxic > 10 - 100 Slightly toxic > 100 Practically nontoxic **Table 6**  **. Categories of acute toxicity for terrestrial a**  **nimals LD**  **50 (m**  **g/kg) LC**  **50 (ppm** **) Toxicity Category**  <10 <50 Very highly toxic 10 - 50 50 - 500 Highly toxic 51 - 500 501 - 1000 Moderately toxic 501 - 2000 1001 - 5000 Slightly toxic >2000 >5000 Practically nontoxic **4.1. Effects to**  **Aquatic Organism s** Pag e 11 of 55

**Table** 7 contains a summary of available iprodione toxicity data for aquatic organisms. Ip rodione is highl y toxic to freshwater invertebrates and moderatel y toxic to estuarine/marine invertebrates on an acute exposure basis . No acceptable acute toxicity data are available for freshwater or estuarine/marine fish ; since fish serve as surrogates for aquatic - phase amphibians, there is uncertainty

regarding the potential effects of iprodione to amphibians as well . Chronic exposure to iprodione affected survival, growth, and reproduction in freshwater invertebrates and offspring survival in freshwater fish. Several toxicity

studies with aquatic organisms that were submitted to the Agency in the past have recentl y been re - evaluated and deemed unacceptable due to exposure concentration and/or solubility problems with the test substance (see **Table 12**  for a list of reclassified studies and the rationale for reclassification) . Acceptable aquatic plant toxicity data for iprodione are available for green algae, marine diatoms, and duckweed (

Lemna gibba ) , but not for freshwater diatoms and cyanobacteria. Green algae and duckweed were not adversely affected by

iprodione during limit tests, while a definitive endpoint was derived for marine diatoms.Pag e 12 of 55

**Table 7**  **. Aquatic**  **Toxicity P rofile for**  **I prodione**  **Group Species** 

**(Common Na me)**  **Study Type:**

**Me asured Effect**  **End point**  **(Test Duration)**  **Toxicity Value**

**m g ai/L**  **(Acute Toxicity Category)**  **MRID**

**( Study**  **Classification )**  Freshwater Fish 1 Pimephales

promelas (Fathead Minnow) Chronic early life s tage (Reduced larval survival NOAEC

(3 4 days) **0.26** * 405508 - 01 (Supplemental) Freshwater Invertebrates Daphnia magna Ac ute (Immobilization) EC 50

(48 hours) **0.24** *

(Highly Toxic) 416420 - 01

(Supplemental) Estuarine/ Marine Invertebrates Crassostrea

virginica (Eastern oyster) Ac ute

(Shell deposition) E C 50

(96 hours) **2.3** *

( Moderately Toxic ) 404892 - 02

(Supplemental) Americamysis bahia (My sid shrimp) Chronic/life - cycle NOAEC (28 days) **0.0035** * 408322 - 01 NOAEC (28 days) <0.015 † 405508 - 02 (Supplemental) Vascular Aquatic Plants Lemna gibba

(duckweed) ( Frond number ,

grow th rate, biomass ) EC 50

(7 days) >12.64 † 457413 - 01 (Supplemental) NOAEC 12.64 Non - Vascular Aquatic Plants Pseudokirchneriella

subcapitata (green algae) ( Cell density) EC 50 >0.13 † 416041 - 07 (Supplemental) ‡ NOAEC 0.13 Skeletonema costatum (marine diatom) ( Ce ll density) EC 50 (120 hours) **0.226** * 416041 - 09 (Acceptable) NOAEC (120 hours) **0.0145** * EC 50 Effect concentration for 50% of the organisms tested; NOAEC no observed adverse effect concentration *** Bold values represent most sensitive endpoint and will be used for RQ calculations unless more sensitive data become availa ble.**  **†** Non - definitive study endpoint; cannot be used to calculate RQs for risk estimation. ‡ Fresh water fish may be surrogates for aquatic - phase amphibians. § Study only tested up to 0.13 mg ai/L (0.17 lbs ai/A) Four degradates of iprodione are considered residues of concern for risk assessment: RP30228, RP35606, RP32490, and 3,5 - DCA. No registrant - sponsored toxicity studies have been submitted for these degradates. According to the most recent risk assessment of iprodione, several open - literature toxicity studies are available for 3,5 - DCA which indicate that this degradate is less toxic to aquatic organisms than iprodione (USEPA, 2009). However, these open - literatur e studies have not been thoroughl y reviewed b y EPA . A comprehensive literature review of all relevant toxicity studies for 3,5 - DCA and other degradates of concern using the ECOTOX icology (ECOTOX) database 2 will be carried out during the upcoming Registration Review ecological risk assessment of iprodione. Additionally , EPA will consider data for other dichloroanalines and parachloroanalines ( e.g. , 3,4 - DCA, p - chloroaniline) as surrogates in the absence of data for 3,5 - DCA.

2 The ECOTOXicology database (ECOTOX) is a source for locating single chemical toxicity data for aquatic life, terrestrial plants and wildlife. ECOTOX was created and is maintained by the U.S.EP A. http://cfpub.epa.gov/ecotox/Pag e 13 of 55

**4.2. Effects to Terrestrial Organisms**  **Table 8**  contains a summary of available iprodione toxicity data for terrestrial organisms. Ip rodione is classified as practicall y non - toxic to birds on a sub acute dietary exposure basis and practicall y non - toxic to slightly toxic to birds and mammals on an acute oral exposure basis. Since birds serve as surrogates for reptiles and terrestrial - phase amphibians , and without data to the contrary , toxicity estimates for birds will apply to these other taxa as well. No suitable acute toxicity data are available for young adult honeybees ( Apis mellifera ) , which are used as a surrogate for terrestrial invertebrates; however, it should be noted that a recent in cident with honey bees, which reported large losses in bee colonies (approxi mately 50% of bees), has been attributed to application of iprodione (see Section 4.3 for further description of iprodione - related incidents) . Chroni c exposure to iprodione in bird s resulted in a NOAEC of 300 mg/kg - diet in the Northern bobwhite quail , with a LO AEC of 1000 mg/kg - diet based on reduced number of eggs laid, decreased hatchling body weight and decreased number of hat chlings per number of eggs set. The most sensitive chro nic effects in mammals were during a 2 - ye ar feeding carcinogenicity study in rats which reported a NOAEC of 150 ppm (6.1 in males and 8.4 mg/kg/day in females) and a LOAEC of 300 ppm (12.4 in males and 16.5 mg/kg/day in females) based on reduced sper matozoa in the epididy

mis and reduced secretion of the seminal vesicles of male s. The effects of iprodione on sperm and semen production are considered effects that could potentially reduce male fertility

and impact reproductive success in mammals. No ac ceptable terrestrial plant toxicity data were identified for iprodione . **Table 8**  **. Terrestrial toxicity profile for i**  **prodione Group**  **Species Study Type**  **( Effect** **) Endpoint**  **(Test Duration)**  **Toxicity Value**

**(Acute Toxicity Category** **) MRID** 

**(Study Classification)** 

Birds ‡ Anas

platyrhynchos (mallard duck) A cute oral ( S urvival ) LD 50 (Not Reported) >10,437 mg a.i./kg bw† (Practically non toxic) Acc. No.

00 232703 (Supplemental) Sub - acute dietary ( S urvival ) LC 50

(8 days) >5,620 mg a.i./kg diet † (Practically non toxic) 416041 - 03

(Acceptable) Reproductive toxicity test (Reduction in 14 - day old survivors) NOAEC 300 mg ai/kg - diet Acc. No. 00086840 (Acceptable) Colinus virginianus (Northern Bobwhite Quail) Ac ute oral (Survival) LD 50 (6 days) **930 m g a.i./kg**  **- bw** *

(Slightly toxic) Acc. No.

00232703 (Supplemental) LD 50 (14 days) >2,000 mg a.i./kg bw† (Practically non toxic) 416041 - 01

(Acceptable)Pag e 14 of 55

**Group Species**  **Study Type (**  **Effect )**  **Endpoint (Test**  **Duration) Toxicity Value** 

**(Acute Toxicity Category** **) MRID** 

**(Study Classification)**  Sub - acute dietary (Survival) LC 50

(8 days) >5,620 mg a.i./kg diet † (Practically non toxic) 416041 - 02

(Acceptable) Reproductive to xicity (E ggs laid, hatchling body weight, percentage of hatchlings of eggs set) NOAEC **300 m g ai/kg**  **- diet**  ***** Acc. No. 00099126 (Acceptable)

Mammals Rattus

norvegicus (laboratory rat) Ac ute oral (Survival) LD 50 **1,160 m g ai/kg**  **- bw** * (Slightly toxic) Acc. No.

00 236497 LD 50 3,050 mg ai/kg - bw

(Practically non toxic) Acc. No.

00232701 LD 50 4,468 mg ai/kg - bw

(Practically non toxic) 423063 - 01 Rat 2 - year feeding/ carcinogenicity study ( Testicular hyperplasia, reduced spermatozoa in epididymis ) NOAEC **150 m g ai/kg**  **- diet**  ***** 426378 - 01 Rat 2 - generation reproductive toxicity test (Decreased parental body weight, body weight gain, and food consumption in both sexes) NOAEC 300 mg ai/kg - diet 418716 - 01

Terrestrial Invertebrates No Toxicity Data Available Terrestrial Plants No Toxicity Data Available LC 50 lethal concentration for 50% of the animals tested; LD 50 lethal dose for 50% of the animals tested; NOAEC no observed adverse effect concentration (mg/kg - diet); NOAE C no observed adverse effect concentration (mg/kg - diet) * Bold values represent the most sensitive endpoint and will be used for RQ calculations unless more sensitive data become available. † Non - definitive study endpoint; cannot be used to calculate RQs for risk estimation. ‡ Birds represent surrogates for terrestrial - phase amphibians and reptiles. No iprodione degradate ( e.g. , RP30228, RP35606, RP32490, and 3,5 - DCA ) toxicity data are available for terrestrial organisms ; however, based on the structural similarity between RP30228, RP35606, RP32490 to iprodione, and in the absence of data to the contrary , the degradates are presumed to exh ibit similar toxicity to that of the parent compound . As noted in the RED (USEPA 1998), the degradate 3,5 - DCA is not a registered pesticide; therefore, there are no FIFRA (Federal Insecticide, Fungicide and Rodenticide Act) toxicology data for this compound. In the past, EPA has used p - chloroaniline (PCA) to assess thePag e 15 of 55

carcinogenic risk for other structurally related chloroanilines. The EPA policy specifies that chloroaniline metabolites should be considered to be toxicologically equivalent to PCA unles s there is sufficient evidence that the metabolite is not carcinogenic. Therefore, given the structural similarity

of 3,5 - DCA and PCA, the degradate is considered to be of concern . For the purposes of risk assessment , if suitable toxicity data are not available for 3,5 - DCA, either through registrant - submitted studies or studies located in the ECOTOX database, risks from 3,5 - DCA may

be evaluated by considering toxicity data from PCA and 3,4 - DCA, both of which have similar molecular structures to 3,5 - DCA. EF ED is also recommending, at a minimum, that a chronic reproduction study with Daphnia be carried out with 3,5 - DCA to provide some information on the toxicity of this degradate to aquatic organisms. The results of this study would provide information on the relative toxicity of 3,5 - DCA as compared to iprodione, which would help determine whether 3,5 - DCA is of toxicological concern for risk assessment. Results from this study

would also serve as a basis for comparing the toxicity of 3,5 - DCA to PCA and 3,4 - DCA , which would indicate whether these chemicals are suitable toxicity surrogates for estimating risks from 3,5 - DCA. **4.3. Ecological Incidents**  A review of the Ecological Incident Information Sy stem (EIIS) f or incidents involving iprodione was completed on August 9 , 2012 . A total of 1 9 incidents were identified in the EII S of which f ourteen are from iprodione use on blueberries and took place during March/April, 2003 (I014027 - 001 to I014027 - 014). Except for one incident in Mississippi, the remainder of the i ncidents involving blueberries and occurred in Georgia. The damage to blueberries was due to direct treatment with iprodione, but the nature of the damage was not specified in the incident report. The level of certainty that iprodione was the cause of thes e incidents is listed as “highl y probable.” All incidents involved registered uses of the substance. An incident involving ornamental plants in Washington County , Oregon (IO13636 - 027) , resulted in unspecified damage to 6 acres of tulips following direct application of iprodione on February 4, 2002. Application of iprodione to an unspecified agricultural area in California (IO20302 - 002) resulted in the death of honey

bee brood following application of Rovral to blooming almond trees . The incident report in cluded an unpublished manuscript by Mussen et al. (2008) describing the adverse effects of the formulated iprodione product Rovral ® on honey bee brood development. The certainty

of the bee kill incident being related to iprodione is classified as “probable” . Another bee kill incident was recentl y reported and took place on March 13, 2012 (I 023830 - 001 ). Rovral ® fungicide was reportedl y applied to a cherry orchard b y airblast sprayer during the evening when bees being used for pollination services were in the vicinity . Of the 80 colonies reported to be in the orchard, roughl y 20% exhibited a reduction in forage force (reduced numbers of adult bees), and adult bee populations i n these colonies were estimated at roughly 50%. Although spraying occurred in the evening hours, bees were likel y bearding on the outside of the colonies and were directly sprayed with Rovral ® . This was a registered use of iprodione.Pag e 16 of 55

Application of iprodi one to golf course turf (B000177 - 001) in Arlington, Virginia, in 1992 resulted in the death of a single bluebird (Sialia spp. ). The legality of the use is not reported and the certainty of it being related to iprodione is classified as “unlikel y.” This inc ident is also captured in the Avian Incident Monitoring Sy stem (AIMS; American Bird Conservancy 2 009) 3 in which it is reported that the insecticide chlorp yrifos (CAS No. 2921 - 88 - 2) and the fungicide metalax yl (57837 - 19 - 1) were also in use at the time. Given that chlorp yrifos is considerabl y more toxic to birds than iprodione on an acute oral and subacute dietary exposure basis, the likelihood that the death of the bluebird resulted from iprodione is considered low. Only a single aquatic incident is reporte d in EIIS associated with the registered use of iprodione on golf course turf (I000910 - 001) in St. John the Baptist Parish, L ouisiana, on June 7, 1992. The incident involved the death of an unspecified number of golden shiners ( Notemigonus crysoleucas ), catfish (

Ictaluridae ), needlefish (Strongylura exilis ), minnows ( Cyprinidae ), perch ( Percidae ) and sunfish ( Centrarchidae ) due to runoff. The certainty of the incident being related to the application of iprodione to the golf course is classified as “possibl e”. A search of OPP’s aggregate incident report database on July 24, 2012 revealed a total of 9 minor plant incidents between 2003 and 2006 that were attributed to iprodione (**Appendix E** ). Since little detail is provided about the individual incidents in the aggregate database, it is unclear whether there is overlap with the plant incident entries in the EIIS database. **5. Exposure Pathways of Concern**  **and Risk Hypothesis** The environmental fate properties of iprodione and its transformation products indicate that direct application , spray

drift, and runoff represent potential transport mechanisms of iprodione TTR and 3,5 - DCA exposure to aquatic and terrestrial organisms and plants . Drinking water and inhalation exposure pathway s were screened using the SIP (Screening Imbibition Program) and STIR (Screening Tool for Inhalation Risk) screening methods , respectivel y, and were found to be exposure pathway s of low concern (no LOC exceedances are expected) (**Appendix D** ) . SIP and STIR are described in detai l at: http://www.epa.gov/oppefed1/models/terrestrial/index.htm . Based on previous ecological risk assessments, iprodione has the potential to result in acute risk to listed terrestrial birds and mammals, listed aquatic vertebrates and invertebrates, and aquatic plants, as well as result in chronic risk to listed and non - listed terrestrial birds and mammals and listed aquatic vertebrates and invertebrates. However, as the prior asses sments did not include the new degradates as iprodione residues of concern, the following risk hy pothesis will be used for this risk assessment: Based on environmental fate parameters and potential transport pathways, iprodione total toxic residues and 3 ,5 -DCA have the potential to reduce survival, reproduction, and/or growth in non target terrestrial animals, aquatic vertebrates and invertebrates, and aquatic plants when used in accordance with the current labels. These non - target organisms include Federally listed threatened and endangered species as well as non - listed species.

3 Available at: http://www.abcbirds.org/abcprograms/policy/toxins/aims/aims/index.cfmPag e 17 of 55

**6. Analysis Plan**  **6.1. Stressors of Concern**  **6.1.1. Ecological Risk Assessment**  The stressors of ecologic al concern for terrestrial organisms are iprodione and its ma jor degradate s RP30228, RP35606, RP 32490 , and 3,5 - DCA (RP3 2596), the last of which will be assessed separatel y during risk assessment . Because of their structural similarity to iprodione and in the absence of data to the contrary , RP30228, RP35606, and RP 32490 are expe cted to have toxicity similar to that of iprodione , and will therefore be included with iprodione as part of t otal t oxic residue s (TTR) . A TTR approach for the above three degradates is the default option for risk assessment if suitable toxicity informatio n on these degradates is not available. However, if suitable degradat e toxicity data are submitted or located through the ECOTOX database, there is the potential to derive exposure and risk values for these degradates independently , or eliminate the degradates from the TTR . Conversely , s ince the general structural properties of 3,5 - DCA are different from iprodione , the mode of action in ecological receptors is also likely to be different. Therefore, 3,5 - DCA will be evaluated separately during risk ass essment using a separate set of exposure and toxicity values. A list and discussion of recommended toxicity data for iprodione degradates is provided in Section 7.2 and **Table 13**  . In an effort to generate at least some relative toxicity information for iprodione and its degradates for purposes of problem formulation, t oxicity estimates were obtained using the Assessment Tools for the Evaluation of Risk (ASTER) ( **Table 9**  ) . The ASTER database 4 integrates aquatic and terrestrial toxicity information and quantitative structure activity relationships (QSARs) to assess the environmental toxicity of discrete chemi cals. ASTER is designed to provide high quality data for discrete chemicals, when available in the ECOTOX database, and mechanistically- based QSAR estimates when data are lacking. Based on a comparison of QSAR - predicted toxicity values for parent and degra dates, RP30228 and RP35606 are potentially

more toxic than the parent based on QSAR estimates , while degradate RP32490 appears to be substantially less toxic than the parent. The degradate 3,5 - DCA is also potentially

more toxic than iprodione, but will be assessed separatel y. Itshould be noted that the mode of action basis from QSAR predictions in ASTER was nonpolar narcosis for iprodione and its structurally

similar degradates, and polar narcosis for 3,5 - DCA. Since these modes of action are highl y non - sp ecific, they are of limited utility

for predicting toxicity . **Table 9**  **. ASTER Ecotoxicity Profile for Iprodione and Degradates. Compound**  **Estimated 4 -**  **day LC**  **50 Median**  **Concentration (μg/L)** 

**Pimephales promelas**  **(fathead m innow)**  **Ictalurus punctatus**  **(channel catfish) Daphnia** 

**magna (waterflea)**  **Oncorhynchus**

**my kiss**  **(rainbow trout) Lepomis** 

**macrochirus (bluegill sunfish)**  Iprodione 23 , 3 10 10 , 062 13 , 25 1 9 , 473 18,645 3,5 - Dichloraniline (RP32596) 14 , 19 8 6 , 127 7 , 98 3 5 , 8 20 11 , 307 RP30228 16 , 019 6 , 91 8 9 , 282 6 , 413 12 , 9 10 RP32490 505 , 614 217 , 55 8 243 , 983 233 , 66 4 379 , 25 7

4 More in formation at: http://www.epa.gov/med/Prods_Pubs/aster.htmPag e 18 of 55

**Compound Estimated 4**  **- day**  **LC 50**  **Median Concentration**  **(μg/L)**

**Pimephales promelas**  **(fathead m innow)**  **Ictalurus punctatus**  **(channel catfish) Daphnia** 

**magna (waterflea)**  **Oncorhynchus**

**my kiss**  **(rainbow trout) Lepomis** 

**macrochirus (bluegill sunfish)**  RP35606 5 , 34 9 2 , 312 3 , 28 7 2 , 045 4 , 41 1 Note: all toxicity estimates in this table are based on QSAR, as ASTER did not identify any empirical toxicity data for degradates through the ECOTOX database. **6.1.2. Drinking Water**  **Assessment** In 2012 a drinking water assessment (USEPA 2012, D359480+) was conducted which modeled separately the estimated drinking water concentrations (EDWCs) for iprodione residues of concern (iprodione and the three degradates RP30228, RP35606, and RP 32490) and 3,5 - DCA in surface water and groundwater. The 3,5 - DCA was assessed separatel y because the mechanism of action for 3,5 - DCA is different from that of iprodione. Pending receipt and review of additional environmental fate and toxicity data for iprodione and its degradates, or changes in labeled use rates, the drinking water assessment will be reevaluated. However, if no new, relevant data regarding the environmental fate, toxicity , or use of iprodione or its degradates are submitted, the EDWCs from the 2012 drinking water assessment will be used in this risk assessment. **6.2. Measures of Exposure**  EFED will use standard available models to evaluate potential exposures to aquatic and terrestrial organisms as described at **http://www.epa.gov/pesticides/science/models_db.htm .**  Iprodione residues of concern (iprodione and the three degradates RP30228, RP35606, and RP 32490) and 3,5 - DCA will be modeled separatel y in aquatic environments . **6.3. Measures of Effect**  Selected t oxicity

data presented in Section 4 of this problem formulation will be used to calculate RQ value s. An y additional information submitted by the registrant or found in the open literature prior to c onduct of the risk assessment will also be considered. The open literature studies are identified using EPA’s ECOTOX 5 database , which employ s a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife . The evaluation of both sources of data can also provide insight into the direct and indirect effects of pesticides on biotic communities from loss of species that are sensitive to the chemical s and from changes in structure and functional characteristic s of the affected communities. **6.4. Endangered Species Assessments**  Consistent with the Agency ’s responsibility under the Endangered Species Act (ESA), the Agency w ill evaluate risks to listed species from registered uses of pesticides in R egistration R eview . These assessments will be conducted in accordance with standard EPA procedures and good scientific judgment . The process for evaluating potential risks to listed species is further

5 http://cfpub.epa.gov/ecotox/Pag e 19 of 55

described in the Overview Document at http://www.epa.gov/oppfead1/endanger/litstatus/riskasses.htm . **6.5. Endocrine Disruptor Screening Program**  As required b y FIFRA and the Federal Food Drug and Cosmetic Act ( FFDCA ) , EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively , these studies include acute, subchronic and chronic toxicity , including assessments of carcinogenicity, neurotoxicity, developmental, reproductiv e, and general or sy stemic toxicity . These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology , organ weights, estrus cyclicity , sexual maturation, fertility , pregnancy rates , reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its reregistration dec ision, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required b y FFDCA section 408(p), iprodione is subject to the endocrine screening part of the En docrine Disruptor Screening Program (EDSP). EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced b y a “naturally occur ring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two - tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assay s to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal sy stems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal sy stems will proceed to the next st age of the EDSP where EPA will determine which, if any , of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine - related effects caused by the substance, and establish a dose - response relationship between the dose and the E, A, or T effect. Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February

2010, EPA issued test orders/data call - ins for the first group of 67 chemicals, which contai ns 58 pesticide active ingredients and 9 inert ingredients. Iprodione was included on that list and an order has been issued to conduct the Tier 1 testing. Once all required Tier 1 and Tier 2 data have been received and reviewed, the endpoints and safety factors used for risk assessment purposes will be examined and a new risk assessment performed if necessary . For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery , please visit our website: http://www.epa.gov/endo/ . **7. Preliminary Identification of Data Gaps**  **7.1. Environmental Fate**  **Data Table**  **10** identifies environmental fate studies b y MRID that provide data on iprodione for each guideline requirement, as well as study classifications and whether or not further data are neededPag e 20 of 55

in order to support risk assessment. Studies identified as needed in **Table 10** should be conducted using the parent ; howev er, the formation and decline of the degradates, particularl y RP30228, RP35606, RP32490 and 3,5 - DCA , should also be monitored to determine if degradate specific half

- life values can be estimat ed. It should be noted that separate environmental fate studies have not been submitted for the iprodione degradates RP30228, RP35606, and RP32490. A s EFED will be evaluating risk to these degradates using a TTR approach , a batch equilibrium study (OCSPP (formerl y OPPTS) Guideline 835. 1230 6 ) should be conduct ed for each of the three degradates to determine if they are more mobile than the parent. If toxicity data are provided indicating that one or all of the degradates are less toxic than the parent, they may be removed from the risk analy sis. **Table 1 1**  provides the same data for the iprodione degradate 3,5 - DCA. Because thi s transformation product has a different mechanism of action than that of iprodione , the following kinds of fate studies stipulated under 40 CFR 158 data requirements would help clarif y the overall risk picture for 3,5 - DCA : OCSPP Guidelines 835.2120 7 (h ydrol ys is), 835.2240 8 (aqueous photol ys is), 835.2410 9 (soil photolysis), 835.4300 10 (aerobic aquatic metabolism), and 835.4400 11 (anaerobic aquatic metabolism). In the absence of such dat a EFED will consider th is degradate stable to these transformation pathways. **Table 10**  **. Submitted e nvironmenta**  **l fate d ata for**  **i prodione**  **OCSPP Guideline**  **Data**

**Requirement Submitted** 

**Studies ( Acc.**  **No. or MRID)**  **Study**

**Classifications Are**  **data**

**needed to conduct risk**  **assessment? Justification and Assumptions EPA** 

**will Make in Absence of Data** 835.2120 Hydroly sis 418854 - 01 Acceptable No 00059481 Acceptable 00068287 Unacceptable 835.2240 Aqueous

photolysis 418619 - 01/

422013 - 01 Acceptable No 835.2410 Soil photolysis 419121 - 01 Unacceptable No 428971 - 01 Acceptable 835.4100 Aerobic soil

metabolism 430910 - 02 Acceptable **Yes** Data are required for four soils. MRID 43091002 was acceptable for one soil,

6 USEPA. 2008 a . Fate, Transport and Transformation Test Guide lines OPPTS 835.1230 Absorption/Desorption (Batch Equilibrium). EPA 712 - C - 08 - 009. October 2008. http://www.regulations.gov/#!documentDetail;D=EPA - HQ - OPPT - 2009 - 0 152 - 0006 7 USEPA 2008 b . Fate, Transport and Transformation Test Guidelines OPPTS 835.2120 Hydrolysis. EPA 712 - C - 08 - 012. October 2008. http://www.regulations.g ov/#!documentDetail;D=EPA - HQ - OPPT - 2009 - 0152 - 0009 8 USEPA 2008 c . Fate, Transport and Transformation Test Guidelines OPPTS 835.2240 Photodegradation in Water. EPA 712 - C 08 - 013. October 2008. http://www.regulations.gov/#!documentDetail;D=EPA - HQ - OPPT - 2009 - 0152 - 0012 9 USEPA 2008 d. Fate, Transport and Transformation Test Guidelines OPPTS 835.2410. Photod egradation on Soil. EPA 712 - C 08 - 015. October 2008. http://www.regulations.gov/#!documentDetail;D=EPA - HQ - OPPT - 2009 - 0152 - 0015 10USEPA 2008

f . Fate, Transport and Transformation Test Guidelines OPPTS 835.4300. A erobic Aquatic Metabolism. OPPTS 835.4400 Anaerobic Aquatic Metabolism EPA 712 - C - 08 - 018 and 712 - C - 08 - 019. October 2008. http://www.regulations.gov/#!documentDetail;D=EPA - HQ - OPPT - 2009 - 0152 - 0039 11 Ibid USEPA 2008

f .Pag e 21 of 55

**OCSPP Guideline**  **Data**

**Requirement Submitted** 

**Studies ( Acc.**  **No. or MRID)**  **Study**

**Classifications Are**  **data**

**needed to conduct risk**  **assessment? Justification and Assumptions EPA** 

**will Make in Absence of Data**

445905 - 01 Supplemental so a study with three additional soils is required. MRID 44590501 cannot be used for half

- life estimates as material balance could not be determined. In lieu of data, EFED will assume a TTR halflife value of 58 days (3x singlevalue). 835.4200 Anaerobic soil

metabolism -- -- No No data submitted. Data not necessary for modeling purposes. Will use information from anaerobic aquatic metabolism for characterization purposes. 835.4300 Aerobic aquatic

metabolism 00162219 Unacceptable **Yes** Data are required for two water/sediments systems. Currently only have one system, so an additional study is required. In lieu of additional data, EFED will assume a TTR half - life value of 183 days (3 x 61 days). 419276 - 01/ 425038 - 01 Acceptable 416002 - 01 Unacceptable 446050 - 01 Unacceptable 835.4400 Anaerobic

aquatic metabolism 00162220 Unacceptable **Yes** Data are required for two water/sediments systems. Currently only have one system, so an additional study is required. In lieu of additional data, EFED will assume a TTR half - life value of 276 days (3 x 92 days). 417558 - 01/ 428541 - 01 Acceptable

835.1230 Adsorption/

desorption 00059479 Acceptable **Yes** Batch equilibrium studies are required for the three degradates RP30228, RP35606, and RP32490 . 00068286 Acceptable 418788 - 01 Unacceptable 433492 - 02 Acceptable 835.1240 Leaching 418896 - 01 Unacceptable No 433492 - 01 Acceptable 835.6100 Terrestrial field

dissipation 00059484 Acceptable No Study conducted with 8 applications at 1 lb ai/A. Other uses have higher single application rates. 00068290 Acceptable 418774 - 01 Acceptable Analytical method in soil 437183 - 02 Acceptable 835.6200 Aquatic field

dissipation 00162218 Unacceptable No

437183 - 01 Acceptable Analytical method in water 452392 - 03 Acceptable 165 - 4 (850.1730) Fish

bioconcentration 00162221 Supplemental No

00162222 Supplemental 430910 - 01 AcceptablePag e 22 of 55

**Table 11**  **. Submitted environmental fate d**  **ata for the i**  **prodione transformation product 3,5 -**  **DCA OCSPP**  **Guideline Data** 

**Requirement Submitted** 

**Studies (M**  **RID) Study** 

**Classifications Are data** 

**needed to conduct risk**  **assessment? Justification and Assumptions EPA** 

**will Make in Absence of Data**  835.2120 Hydroly sis -- -- **Yes** No data submitted. In lieu of data, EFED will assume 3,5 - DCA is stable to hydrolysis. 835.2240 Aqueous

photolysis -- -- **Yes** No data submitted. In lieu of data, EFED will assume 3,5 - DCA is stable to aqueous photolysis. 835.2410 Soil photolysis -- -- **Yes** No data submitted. In lieu of data, EFED will assume 3,5 - DCA is stable to soil photolysis. 835.4100 Aerobic soil

metabolism 430910 - 02 Acceptable No

452392 - 01 Acceptable 482192 - 01 Acceptable 835.4300 Aerobic aquatic

metabolism -- -- **Yes** No data submitted. In lieu of data, EFED will assume a half - life of 129 days (2 x the 9 0 % upper confidence limit around the mean value for the aerobic soil half

- life). 835.4400 Anaerobic

aquatic metabolism -- -- **Yes** No data submitted. In lieu of data, EFED will assume 3,5 - DCA is stable to anaerobic aquatic metabolism. 835.1230 Adsorption/

desorption 451141 - 01 Acceptable No **7.2. Effects**  **Data Table**  **12** identifies all available ecological effect s studies for iprodione by MRID or Accession Number (Acc. No.) , as well as a description of whether further data are needed to support risk assessment. In addition, the following rationale is being used to justify asking for particular non - guideline studies.

 Honeybee Larval Toxicity Study w/ TGAI

– Non -guideline [1 Study ] In cident data ( IO20302 - 002 ; Mussen et al. 2008 ) suggest that iprodione may adversel y affect honey bee brood (larval and pupal bees) development. Inaddition, iprodione has been reported to occur in bee colony wax samples, where it could potentially affect development of young (vanEnglesdorp et al ., 2009) . Therefore, a non - guideline honey bee larval toxicity

study is recommended . Honey

bee brood studies are not currently a data requirement in the U.S., however, a non - guideline honey bee larval toxicity

study is recommended as a special study (see **Appendix F** for DCI justification table). Since this is a non - guideline study, EFED reco mmends that the proposed study

protocol be submitted for review and approval prior to study initiation. The following references may be useful in the design of a larval toxicity test: (1) Aupinel P,Pag e 23 of 55

Fortini D, Michaud B, Marolleau F, Tasei JN, Odoux JF. 20 07. Toxicity of dimethoate and fenox ycarb to honey bee brood (Apis mellifera), using a new in vitro standardized feeding method. Pest Management Science 63:1090 - 1094; (2) Oomen PA, De Ruijter A, Van Der Steen J. 1992 Method for honeybee brood feeding tests with insect growth - regulating insecticides . EPPO Bulletin 22:613 - 616.

 Honeybee Acute Oral Toxicity Study w/ TGAI

– OECD TG213 [1 Study ] Ip rodi one is applied to several pollinated crops, including almonds, which had the highest annual usage of iprodione from 2003 - 2010 (**Apppendix B** ) . Therefore, exposure to foraging worker bees is possible. EFED is also recommending toxicity data for honey

bees on an acute oral exposure basis to account for potential differences in sensitivity when exposed via contact versus oral route s . **Table 12**  **. Submitted terrestrial and aquatic**  **animal ecological effects d**  **ata for i**  **prodione (parent)**  **Guideline Description** **—**

**Test Substance MRID**  **Study Classification**  **Are data**

**Needed for Risk**  **Assessment? Justification and Assumptions** 

**EPA will Make in Absence of**

**Data Avian and Mammalian Testing** 

850.2100 Avian acute oral

toxicity, waterfowl

— TGAI Acc. No.

00 232703 Supplemental No Number of study animals per test level not reported Avian acute oral toxicity, upland game bird species

—TGAI Acc. No.

00 232703 Supplemental No Study recently reclassified from acceptable to supplemental due to lack of reported information about sublethal effects and test conditions 416041 - 01 Acceptable No

Avian acute oral toxicity, passerine species

—TGAI None N/A **Yes** Part of 40 CFR Part 158 data requirements as of December 2007 to address passerine sensitivity . In addition, a passerine study could help resolve uncertainty surrounding toxicity of iprodione to birds, since two acute oral toxicity studies in bobwhite quail yielded conflicting results. Study Acc. No. 00232703 resulted in LD 50 of 930 mg ai/kg - bw , whil e study MRID 416041 - 01 resulted in LD 50 of >2,000 mg ai/kg - bw .Pag e 24 of 55

**Guideline Description** **—**

**Test Substance MRID**  **Study Classification**  **Are data**

**Needed for Risk**  **Assessment? Justification and Assumptions** 

**EPA will Make in Absence of**

**Data**

850.2200 Avian dietary

toxicity , waterfowl species

—TGAI 416041 - 03 Acceptable No Non - definitive endpoint of 5,620 mg a.i./kg - diet is < 10 times the dietary EEC for all food items except fruits, pods, and seeds at current maximum application rate (turf) of 24 lbs ai/A Avian dietary toxicity , upland game bird

— TGAI 416041 - 02 Acceptable No Non - definitive endpoint of 5,620 mg a.i ./kg - diet is <10 times the dietary EEC for all food items except fruits, pods, and seeds at current maximum application rate (turf) of 24 lbs ai/A 850.2300 Avian

reproduction , waterfowl species

—TGAI Acc. No.

00086840 Acceptable No

850.2300 Avian

reproduction, upland game bird species

—TGAI Acc. No.

00099126 Acceptable No 850.2400 Wild mammal

toxicity

—TGAI None N/A No Not trig gere d based on ecotoxicity data, predicted EECs, fate properties, and use pattern criteria. 850.2500 Simulated or

actual field testing

—TEP None N/A No Not trig gere d based on ecotoxicity data, predicted EECs, fate properties, and use pattern criteria. **Aquatic Animal Testing**

850.1010 Freshwater

invertebrate, acute toxicity

— TGAI 416420 - 01 Supplemental No Study recently reclassified from unacceptable to supplemental

Freshwater invertebrate, acute toxicity

— TEP None N/A **Yes** Study required when product(s) are applied directly to water, as in the case of the iprodione rice use. A study should be performed on one representative end use product used on rice ( e.g. , EPA Reg. No. 264 - 689, 66222 - 144, 264 - 482, 264 - 524,

264 - 532 ) 850.10 2 5 Estuarine/Marine

Mollusk acute toxicity

—TGAI 404892 - 02 Supplemental NoPag e 25 of 55

**Guideline Description** **—**

**Test Substance MRID**  **Study Classification**  **Are data**

**Needed for Risk**  **Assessment? Justification and Assumptions** 

**EPA will Make in Absence of**

**Data**

850.1035 Estuarine/Marine

crustacean acute toxicity

—TGAI 404892 - 04 Unacceptable **Yes** Precipitate observed during test and filtration was not reported . Estuarine/marine invertebrate acute toxicity data is a standard data requirement in Part of 40 CFR Part 158. In addition, a new

study is also recommended because iprodione can be applied directly to water for use

on rice.

850.1075 Freshwater fish,

ac ute toxicity

— TGAI Acc. No.

00 162224 Unacceptable No Study recently reclassified from supplemental to unacceptable; precipitate was observed during test and filtration was not reported Freshwater fish, acute toxicity, warm water species

—TGAI 416041 - 04 Unacceptable **Yes** Precipitate observed at all test concentrations and filtration was not

reported Freshwater fish, acute toxicity, cold water species

—TGAI 416041 - 05 Unacceptable **Yes** Test substance concentrations not consistent between sampling time

points Freshwater fish, acute toxicity, warm water species

—TEP (Rovral 50 WP) 404892 - 03 Unacceptable No Study recently reclassified from supplemental to unacceptable; precipitate was observed at all test concentrations and filtration was not

reported Estuarine/Marine fish acute toxicity

—TGAI 404892 - 05 Unacceptable **Yes** Study recently reclassified from supplemental to unacceptable; p recipitate observed during test and filtration was not reported 850.1300 Freshwater

invertebrate, reproduction test

—TGAI 404892 - 01 Unacceptable **Yes** The test concentrations varied substantially thro ughout the test period (i.e., the highest measured co ncentration in three treatments wa s more than twice the lowest in the same concentration). 850.1350 Estuarine/marine

invertebrate, reproduction test

—TGAI 408322 - 01/

405508 - 02 Supplemental **Yes** Reproductive effects occurred at all test levels, indicating need for additional testing. Test is triggered according to 40 CFR §158.630 15(ii): test is required if acute LC 50 or EC 50 <1 mg/l. 850.1400 Freshwater fish ,

early life stage test

—TGAI 405508 - 01 Supplemental No Study recently reclassified from acceptable to supplemental due to lack of information provided in study reportPag e 26 of 55

**Guideline Description** **—**

**Test Substance MRID**  **Study Classification**  **Are data**

**Needed for Risk**  **Assessment? Justification and Assumptions** 

**EPA will Make in Absence of**

**Data**

Saltwater fish, early life stage test

—TGAI None N/A **Yes** Need for this test cannot be determined until an acceptable acute toxicity study (850.1075) with an estuarine/marine fish species is submitted. If a saltwater fish ELS study is not submitted, an acute - to chronic ratio using freshwater fish acute and chronic data and sal twater fish acute data will be used to derive a saltwater fish chronic endpoint during risk assessment.

850.1500 Freshwater fish

life cycle test None N/A **Yes** Aquatic EECs are > 0.1 of the estuarine/marine invertebrate life cycle test NOAEC of 0.003 5 mg a.i./L ; EECs are > 0.1 of the NO AE Cs from the freshwater fish ELS study (NOAEC=0.26 mg a.i./L) and the daphnid life cycle study (NOAEC=0.26 mg a.i./L) for ornamental uses of iprodione . An additional rationale for recommending this study includes the potential anti - androgenic effects of iprodione as well as the potential exposure to aquatic organisms through direct application of iprodione to water during use on

rice . Estuarine/marine f ish life cycle test None N/A No 850.1950 Simulated or

actual field testing for aquatic organisms None N/A No Higher tier testing to address risk uncertainties have not been identified at this time **Sediment Testing**

850.1735 Whole sediment

10 - d freshwater invertebrate

— TGAI None N/A No Data requirement not triggered since Kd <50 and Koc <1,000. Although log Kow of 3.1 is slightly greater than trigger value (KOW > 3), the short hydrolysis half lives (5 - 9 days) indicate that the compound is not expected to persist in aquatic environments.Pag e 27 of 55

**Guideline Description** **—**

**Test Substance MRID**  **Study Classification**  **Are data**

**Needed for Risk**  **Assessment? Justification and Assumptions** 

**EPA will Make in Absence of**

**Data**

850.1740 Whole sediment

10 - d estuarine/marine invertebrate

— TGAI None N/A No Data requirement not triggered since Kd <50 and Koc <1,000. Although log Kow of 3.1 is slightly greater than trigger value (Kow > 3), the short hydrolysis half lives (5 - 9 day s) indicate that the compound is not expected to persist in aquatic environments. Agency wide guideline Whole sediment

chronic freshwater and/or marine invertebrate

— TGAI None N/A No Data requirement not triggered since Kd <50 and Koc <1,000. Although log Kow of 3.1 is slightly greater than trigger value (Kow > 3), the short hydrolysis half lives (5 - 9 day s) indicate that the compound is not expected to persist in aquatic environments. **Insect Pollinator Testing**

850.3020 Honeybee acute

contact toxicity

— TGAI 442620 - 01 Supplemental No An acute contact toxicity study is available for honeybees that originated in the open - literature (MRID 44262001) ; this study provides insufficient information on methods and results to make it useful for risk assessment ; however, an acute oral study is being requested in lieu of an additional acute contact study.

OECD 213 Honeybee acute

oral toxicity study

—TGAI None N/A Yes Study guideline can be found at: http://www.oecd ilibrary.org/docserver/download/full text/9721301e.pdf?expires=134512 6780&id=id& accname=freeContent &checksum=3D3E8D93D5EB11D6 F751673FFFC8725F 850.3030 Honeybee

toxicity of residues on foliage

—TEP None N/A No Data requirement not triggered

Non guideline Larval Toxicity

Test

—TGAI None N/A **Yes** Recommended based on incident data from larval bees as well as detection of iprodione in bee hives where larvae may be exposed. It is recommended that a protocol be submitted before conducting this

test.Pag e 28 of 55

**Guideline Description** **—**

**Test Substance MRID**  **Study Classification**  **Are data**

**Needed for Risk**  **Assessment? Justification and Assumptions** 

**EPA will Make in Absence of**

**Data** 850.3040 Field testing for

pollinators None N/A No Field testing to address risk uncertainties have not been identified at this time **Terrestrial Plant Testing** 850. 4100 Tier I and/or II Seedling

emergence (10 species)

—TEP None N/A **Yes** Submitted study should test up to highest currently registered application rate of iprodione. 850. 41 50 Tier I and/or II Vegetative vigor

(10 species)

— TEP None N/A **Yes** Submitted study should test up to highest currently registered application rate of iprodione. **Aquatic Plant Testing** 850.4400 Tier I and/or II Tier II Aquatic

plant growth, vascular plant

— TGAI 457413 - 01 Supplemental No Test evaluates up to 12.64 mg a.i./L ( i.e. , 16.8 lbs a.i./A). However, maximum iprodione application rate is 24 lbs a.i./A, and aquatic EECs range from 0.014 to 51 mg a.i./L for various registered uses of iprodione. However , solubility limit of iprodione is 13 mg/L.

850.4500 * Tier I and/or II Tier II Aquatic

Plant, freshwater green alga species

—TGAI 416041 - 07 Acceptable **Yes** Test evaluates up to 0.13 mg a.i./L ( i.e. , 0.17 lbs a.i ./A). However, maximum iprodione application rate is 24 lbs a.i./A for turf use. In addition, aquatic EECs range from 0.014 to 51 mg a.i./L for various registered uses of iprodione. Therefore additional testing at higher concentrations is needed. 850.4500 * Tier I and/or II Tier II Aquatic

Plant, freshwater diatom

—TGAI 416041 - 11 Unacceptable **Yes** Study deemed unacceptable due to cell adhesion to flasks during test. Note: new study should test up to highest application rate and/or aquatic EECs as defined in this problem formulation or previous risk

assessments. 850.4500 * Tier I and/or II Tier I Aquatic

Plant, marine diatom

— TGAI 416041 - 09 Acceptable No <50% reduction in growth observed a limit dose. Also, the maximum peak EEC is more than 10 times lower than the limit concentration tested. Tier II testing is not recommended.Pag e 29 of 55

**Guideline Description** **—**

**Test Substance MRID**  **Study Classification**  **Are data**

**Needed for Risk**  **Assessment? Justification and Assumptions** 

**EPA will Make in Absence of**

**Data** 850.45 5 0 † Tier I and/or Tier II Tier II Aquatic

Plant, cyanobacterium

— TGAI 416041 - 10 Unacceptable **Yes** Study deemed unacceptable due to erratic cell counts during test. Note: new study should test up to highest application rate and/or aquatic EECs as defined in this problem formulation or previous risk

assessments. TGAI = Technical Grade Active Ingredient TEP = technical end product * Algal toxicity tests are now under guideline O CSPP 850.4500 (formerly 850.5400) † Cyanobacterium tests are now under guideline 850.4550 (formerly 850.5400) For the major degradate s RP30228, RP35606, and RP32490, no toxicity data are available for any animal or plant taxa. Therefore, there are insufficient data to evaluate these degradates in the Registration Review risk assessment for iprodione. In the absence of any new toxicity data for these degradates , a TTR approach will be used in which total residue data for iprodione, RP30228, RP35606 , and RP32490 will be compared to available toxicity data for the parent compound. A TTR approach is appropriate for these three degradates since they have very similar molecular structures as the parent and would likely result in similar levels of toxicity. No ecological effects data have been submitted for 3,5 - DCA (RP32596) , which is another degradate of concern for iprodione . S ince 3,5 - DCA likely has a different mode of action in ecological receptors as compared to iprodione, including this degradate in the TTR approach is not appropriate . Therefore, during the risk assess ment, if suitable toxicity data are not available for 3,5 - DCA , either through registrant - submitted studies or studies located in the ECO TOX database, risk s from 3,5 - DCA may be evaluated by considering toxicity data from PCA and 3,4 - DCA , both of which have similar molecular structures to 3,5 - DCA . EFED is recommending , at a minimum, that a chronic reproduction study with Daphnia be carried out with 3,5 - DCA to provide some i nformation on the toxicity of this degradate to aquatic organisms . The results of this study would provide information on the relative toxicity of 3, 5 - DCA to iprodione , which would help determine whether 3,5 - DCA is of toxicological concern for risk assessm ent . Results from this study

w ould also serve as a basis for comparing the toxicity of 3,5 - DCA to PCA and 3,4 - DCA , which would indicate whether these chemicals are suitable toxicity surrogates for estimating risks f

rom 3,5 - DCA (see **Appendix F** for DCI justi fication table) .Pag e 30 of 55

**Table 13**  **. E cological effects d**  **ata for iprodione transformation products**  **Guideline Description**  **MRID Study**  **Classification Are data** 

**Needed for Risk**  **Assessment? Comments** 

850.1 300 Freshwater invertebrate,

reproduction test

— RP32596 (3,5 - DCA) None N/A **Yes** In the absence of this or other submitted data, risks to aquatic organisms will based on ECOTOX open literature studies or toxicity endpoints for 4 - chloroaniline and 3,4 - d ichloroaniline, which have similar structures to 3,5 - DCA **8. References**  Mussen EC, L opez JE, Peng CYS. Effects of Selected Fungicides on Growth and Development of Larval Honey

Bees, Apis mellifera L. (Hy menoptera: Apidae). Environmental Enty mology 33(5):1151 - 1154. United States Environmental Protection Agency (USEPA). 1998. Registration Eligibility Decision (RED) Iprodione. USEPA, Prevention, Pesticides, and Toxic Substances. EPA - 738 - R 98 - 019. November 1998 USEPA. 2000. Registration Eligibility Decision (RED) Vincl ozalin. USEPA, Prevention, Pesticides, and Toxic Substances. EPA - 738 - R - 00 - 023. October 2000 USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency. January 23, 2004 USEPA. 2007 a . Memorandum: Review of Iprodione (PC Code 109801) Revised Application Rates and New IR - 4 Use. Environmental Fate and Effects Division. March 31, 2007 . DP Barcodes: D315437 and D313332 USEPA. 2007b. Memorandum: Section 18 Emergency Exemption Request for Use of Iprodione (PC Code 109801) on Almonds in California . Environmental Fate and Effects Division. May 10, 2007. DP Barcodes: D339724 USEPA. 2009. Risks of Iprodione Use to Federally Threatened California Red - legged Frog ( Rana aurora draytonii ) . Pe sticide Effects Determination. Environmental Fate and Effects Division. October 16, 2009 USEPA. 2011. Memorandum: Ip rodione; Report of the Residues of Concern Knowledgebase Subcommittee (ROCKS) . Health Effects Division. October 5, 2011. DP Barcode: D39396 0.Pag e 31 of 55

USEPA. 2012. Memorandum: Refined iprodione drinking water assessment for label amendments and proposed new uses on fruiting vegetables and cucurbits. Environmental Fate and Effects Division. February 28, 2012. DP Barcodes: D359480 and D357471 VanEngel sdorp DJ, Evans D, Saegerman S, Mullin C, Haubruge E, Nguye n BK, Frazier M, Frazier J, Cox - Foster D, Chen Y, Underwood R, Tarp y DR, Pettis JS. 2009. Colony Collapse Disorder: A Descriptive Study . PLoS ONE 4(8): e6481.doi: 10.1371/journal.pone.0006481.Pag e 32 of 55

**9. Appendi**  **x A. Chemical Identity Table and**  **Proposed Degradation Pathway**  **Nam e**  **Chemical Name**

**SMILES CAS Number**  **Structure Study Type**  **MRID Max % AR**  **or Concentration**  **(day) Final % AR**  **or Concentration**  **(Time interval)**

Iprodione 3 - (3,5 - dichlorophenyl) -

N - (1 - methylethyl) - 2,4 - dioxo - 1 - imidazolidinecarboxa mide SMILES: c1c(Cl)cc(Cl)cc1N2C(= O)CN(C(=O)NC(C)C)C 2(=O) CAS No. 36734 - 19 - 7 Hydroly sis 418854 - 01 -- 82% (pH 5, Day 30)

-- 41% (pH 7, 125 hrs)

-- 5.6% (pH 9, 2 hrs) Aqueous photolysis 418619 - 01 4

-- 68% (Day 33) Aerobic soil 430910 - 02 -- 0.75% (Day 276) Aerobic soil 445905 - 01 1

-- 6.85% (Day 100) Aerobic aquatic 425038 - 01 3

-- 7.8% (Day 30) Anaerobic aquatic 417558 - 01 -- 3.4% (Day 365) Terrestrial field 418774 - 01 -- <0.01 ppm (Day 538) Aquatic field (H 2 O) Aquatic field (soil) 437183 - 01 --

-- 0.008 ppm (Day 44)

0.007 ppm (Day 44) RP32596 3,5 - dichloroaniline

(3,5 - DCA) SMILES: Nc(cc(cc1CL)CL)c1 CAS No. 626 - 43 - 7 Aerobic soil 430910 - 02 9% (Day 30) ND 7 (Day 276) Aerobic soil 445905 - 01 1 3.9% (Day 50) ND 7 (Day 100) Aerobic aquatic 425038 - 01 **11.7 % (Day 30)**  **11.7 % (Day 30)**  Anaerobic aquatic 417558 - 01 3.6% (Day 275) 2.4% (Day 365) Aquatic field (H 2 O) Aquatic field (soil) 437183 - 01 <0.005 ppm (Day 44) <0.005 ppm (Day 44) <0.005 ppm (Day 44)

<0.005 ppm (Day 44)

RP30228 3 - (1 - me thylethyl) -N -

(3,5 - dichlorophenyl) - 2,4 - dioxo - 1 - imidazolidine carboxamide SMILES: c1c(CL)cc(CL)cc1NC(= O)N2CC(=O)N(C(C)(C) )C2(=O) CAS No. NA Hydroly sis 418854 - 01 **46% (pH 7, 125 hrs) 46% (pH 7, 125 hrs)**  **93% (pH 9, 2 hr) 93% (pH 9, 2 hr)**  Aqueous photolysis 418619 - 01 4 2.7% (Day 17) 2% (Day 33) Aerobic soil 430910 - 02 6.9% (Day 14) 2% (Day 276) Aerobic soil 445905 - 01 1 **29% (Day 30) 15% (Day 100)**  Aerobic aquatic 425038 - 01 **65% (Day 14) 56% (Day 30)**  Anaerobic aquatic 417558 - 01 **70% (Day 14) 21% (Day 365)**  Terrestrial field 418774 - 01 0.47 ppm (Day 28) 0.15 ppm (Day 538) Aquatic field (H 2 O) Aquatic field (soil) 437183 - 01 0.057 ppm (Day 2) 0.13 ppm (1 mon) 0.016 ppm (Day 44)

0.012 ppm (Day 44)Pag e 33 of 55

**Nam e**  **Chemical Name**

**SMILES CAS Number**  **Structure Study Type**  **MRID Max % AR**  **or Concentration**  **(day) Final % AR**  **or Concentration**  **(Time interval)**

RP32490 1 3 - (3,5 - dichlorophenyl) -

2,4 - dioxo - 1 - imidazolidine carboxamide SMILES: c1c(CL)cc(CL)cc1N2C( =O)CN(C(=O)N)C2(=O) CAS No. NA Aerobic soil 430910 - 02 0.28% (Day 1) ND 7 (Day 276) Aerobic aquatic 425038 - 01 **15% (Day 1)** 4% (Day 30) Anaerobic aquatic 417558 - 01 8.4 % ( Day 30 ) 0.8% (Day 365) Terrestrial field 418774 - 01 0.09 ppm ( Day 7 ) <0.01 ppm (Day 538) Aquatic field (H 2 O) Aquatic field (soil) 437183 - 01 0.006 ppm (Day 2) <0.005 ppm (Day 44) <0.005 ppm (Day 44)

<0.005 ppm (Day 44)

RP35606 1,2 [(dichloro - 3,5 -phenyl) - 1 -

isopropylcarbamoyl - 3] - 2 - acetic acid SMILES: c1c(CL)cc(CL)cc1NC(= O)N(CC(=O)(O))C(=O) NC(C)(C) CAS No. NA Hydroly sis 418854 - 01 **12% (pH 5, Day 30) 12% (pH 5, Day 30)**  **10% (pH 7, 40 hrs)** 5.5% (pH 7, 125 hrs) 2% (pH 9, 107 hrs) 2% (pH 9, 107 hrs) Aerobic soil 430910 - 02 1.2% (Day 7) ND 7 (Day 276) Aerobic soil 445905 - 01 1 1.7% (Day 7) ND (Day 100) Aerobic aquatic 419276 - 01 8.9% (Day 30) 8.9% (Day 30) **Bold** indicates major degradate. 1. Analyzed for in aqueous photolysis study (MRID 418619 - 01 ), but not found. 2. Analyzed for in aerobic aquatic metabolism study (MRID 425038 - 01), but not found.Pag e 34 of 55

**Proposed Degradation Pathway (Aerobic Soil Metabolism Study, MRID**  **430910 -**  **02 )** Pag e 35 of 55

**10. Appendix B. BEAD USE and Usage Reports**  **Iprodione (109801) Screening Level Usage Analysis (SLUA)**  **Date: January 31, 2012 What is a**  **Screening Level Usage Analysis (SLUA)?**   Available estimates of pesticide usage data for a particular active ingredient that is used on **agricultural** crops in the United States.  Pesticide usage data obtained from various sources. The data are then merged, averaged, and rounded so that the presented information is not proprietary , business confidential, or trade secret. **What does it contain?**  Pesticide usage data for a **single** active ingredient only .  Agricultural use sites (crops) that the pesticide is reported to be used on.  Avail able pesticide usage information from U.S. states that produce 80% or more of a crop, in most cases, or less than 80%, in rare cases, depending on the scope of the survey and available resources.  Annual percent of crop treated **(average &**  **maximum)** for each agricultural crop.  Average annual pounds of the pesticide applied for each agricultural crop (i.e., for the states surveyed, not for the entire United States). **What assumptions can I make about the reported data?**  **Average pounds of active ingredient applied** - Values are calculated b y merging pesticide usage data sources together; averaging across all observations, then rounding. **Note:** If the estimated value is less than 500, then that value is labeled <500. Estimated values between 500 & <1,000,000 are ro unded to 1 significant digit. Estimated values of 1,000,000 or greater are rounded to 2 significant digits.)  **Average percent of crop treated** - Values are calculated by merging data sources together; averaging b y ye ar, averaging across all years, & roundin g to the nearest multiple of 5. **Note:** If the estimated value is less than 2.5, then the value is labeled <2.5. If the estimated value is less than 1, then the value is labeled <1.  **Maximum percent of crop treated** - Value is the single maximum value repor ted across all data sources, across all years, & rounded up to the nearest multiple of 5. **Note:** If the estimated value is less than 2.5, then the value is labeled <2.5. **What are the data sources used?**  **USDA -**  **NASS** (United States Department of Agriculture’s National Agricultural Statistics Service)

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

– pesticide usage data from 2003 to 2010.  **California Department of Pesticide Regulation (DPR) Pesticide Use Reporting (PUR)**  data for 2003 to 2009. **What are the limitations to the data?**  Additional registered uses may exist but are not included because the available survey s do not report usage (e.g., small acreage crops).  Lack of reported usage data for the pesticide on a crop **does not imply** zero usage.Pag e 36 of 55

 Usage data on a particular site may be noted in data sources, but **not quantified** . In these instances, the site would not be reported in the SLUA.  Non - agricultural use sites (e.g., turf, post - harvest, mosquito control, etc.) are not reported in the SLUA. A separate request must be made to receive these estimates.  Some sites show some use, even though they are not on the label. This usage could be due to various factors, including, but not limited to Section 18 requests, existing stocks of the chemical, data collection errors, and experimental use permits (EUPs). **Screening Level Estimates of Agricultural Uses of Iprodione (109801) Sorted Alphabetically**  **Reported Years: 2003 -**  **2010 Crop**  **Pounds of Active**  **Ingredient Average** 

**Percent of Crop**  **Treated Maximum** 

**Percent of Crop Treated** 1 Almonds 200,000 45 55 2 Apricots 6,000 45 75 3 Beans, Green 20,000 5 15 4 Blueberries 1,000 5 10 5 Broccoli <500 <1 <2.5 6 Cabbage 1,000 <2.5 <2.5 7 Caneberries 2,000 5 20 8 Carrots 20,000 25 40 9 Cauliflower <500 <1 <2.5 10 Cherries 20,000 15 25 11 Cotton 6,000 <1 <2.5 12 Dry Beans/Peas 2,000 <1 <2.5 13 Garlic 7,000 10 25 14 Grapes 5,000 <1 <2.5 15 Lettuce 70,000 20 35 16 Nectarines 8,000 30 35 17 Onions 40,000 20 30 18 Peaches 20,000 15 25 19 Peppers 1,000 <1 <2.5 20 Plums/Prunes 7,000 10 25 21 Pluots * <500 60 70 22 Potatoes 20,000 <2.5 10 23 Rice 1,000 <1 <2.5 24 Spinach 2,000 <2.5 <2.5 25 Strawberries 2,000 5 10 26 Tobacco+ 20,000 <2.5 <2.5

All numbers rounded. <500 Less than 500 pounds of active ingredientPag e 37 of 55

<2.5 Less than 2.5 percent of crop treated <1 Less than 1 percent of crop treated * Based on CA DPR data only (valid because 95% or more of U.S. acres grown are in California) + Crops not known to be listed on active end use product registrations or as Section 18 emergency exemp tions when this report was run SL UA data sources include: USDA -NASS (United States Department of Agriculture's National Agricultural Statistics Service) Private Pesticide Market Research California DPR (Department of Pesticide Regulation) These results reflect amalgamated data developed by the Agency and are releasable to the public.

Ad obe Ac robat Do cum en t **BEAD Use Report for Iprodione**Pag e 38 of 55

**11. Appendix C.**  **OPPIN Bibliography (a) Environmental Fate Studies**  **Guideline: 63 -**  **0 Reports of Multiple Physical/chemical Characteristics**  MRID: 41230503 Weiler, D.; Russell, D.; Oden, K. ( 1988) Vapor Pressure Determination of Iprodione: Report No. 40426. Unpublished study prepared by

Rhone - Poulenc Ag Co. 22 p. MRID: 47778802 Miller, R. (2009) Product Properties: Color, Phy sical State, Odor, Stability to Normal and Elevated Temperatures, Oxidation/Reduction: Chemical Incompatibility , pH, UV/Visible Absorption, Melting Point/Melting Range, Density, Partition Coefficient (n - Octan ol/Water), Water Solubility, and Vapor Pressure (Iprodione Technical). Project Number: CHB/EX/609/011/P/1. Unpublished study prepared by

PhibroWood, LLC. 37 p. **Guideline: 161 -**  **1 Hydrolysis** MRID: 00059481 Laurent, M.; Buys , M.; Charassol , Y.; et al. (1976) 26 019 R.P.: Degradation in Water: R.P./R.D./C.N.G. - An -- Report no. 3036. (Translation; unpublished study received May

24, 1977 under 359 - EX - 55; prepared by Societe des Usines Chimiques Rhone - Poulenc, submitted by Rhone - Poulenc Chemica l Co., Monmouth Junction, N.J.; CDL :230241 - F) MRID: 00068287 Laurent, M.; Buys , M.; Aublet, ?; et al. (1976) 26019 R.P.: Solubility and Stability

in Water: S.U.C.R.P. -- D.S.An. Nord. No. 2585. (Translation; unpublished study received Jan 24, 1977 under 359 - EX - 55; prepared by Societe des Usines Chimiques Rhone - Poulenc, France, submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :227614 - E) MRID: 41885401 Das, Y. (1990) Hydrol ys is of ?Phenyl(U) - ?carbon 14||Iprodione in Aqueous Solution s Buffered at pH 5, 7 and 9: Lab Project Number: 89100. Unpublished study prepared by

Innovative S cientific Services, Inc. 96 p. **Guideline: 161 -**  **2 Photodegradation -** **water** MRID: 41861901 Adrian, P.; Robles, J. (1991) Carbon 14 - Ip rodione: Aqueous P hotolysis: Lab Project Number: 90/22: AG/CBLD/AN/9115524. Unpublished study prepared by

Rhone - Poulenc Secteur Agro. 97 p. MRID: 42201301Pag e 39 of 55

Adrian, P.; Robles, J. (1992) Carbon 14 - Ip rodione Aqueous Photoly sis Addendum to MRID No. 41861901: L ab Project Number: 90 - 22. Unpublished study prepared by

Rhone - Poulenc Secteur Agro. 13 p. **Guideline: 161 -**  **3 Photodegradation -**  **soil** MRID: 41912101 Ayliffe, J.; Outram, J.; Reeves, G. (1991) Iprodione - ?carbon 14| : Soil Photoly sis Study : Lab Project Number: P91/048. Unpublished study prepared by

Rhone - Poulenc Agric., Ltd. 86 p. MRID: 42897101 John, A.; French, N.; Lowden, P. (1993) Fungicides: (Carbon 14) Iprodione: Soil Photolysis: L ab Project Number: P93 /073. Unpublished study prepared by

Rhone - Poulenc Agriculture Ltd. 128 p. **Guideline: 162 -**  **1 Aerobic soil metabolism** MRID: 43091002 Waring, A. (1993) (carbon 14) -- Ip rodione: Aerobic Soil Metabolism: Final Report: L ab Project Number: 68/132: 68/132 - 1015. Unpublished study prepared by

Hazleton Europe. 105 p. MRID: 44590501 Waring, A. (1993) (carbon 14) - Iprodione: Soil Degradation: Fi nal Report: Lab Project Number: 68/139 - 1015. Unpublished study prepared by

Hazleton UK. 73 p. MRID: 45239201 Quarm y, D. (2000) Iprodione Metabolite: (carbon - 14) - 3,5 - Dichloroaniline Aerobic Soil Metabolism: L ab Project Number: 99R16743. Unpublished study prepared by

Springborn Laboratories, Inc. 282 p. **Guideline: 162 -**  **3 Anaerobic aquatic metabolism** MRID: 00162220 Thomas, R.; Cunningham, W. (1983) Anaerobic Aquatic Metabolism of [Carbon 14] - RP - 26019: Final Report: Project No. 3/2202. Unpubli shed study prepared by

Borriston L aboratories, Inc. 35 p. MRID: 41600201 Spare, W. (1989) Aerobic Aquatic Metabolism of Iprodione: Final Report: Project Number: 1509. Unpublished study prepared by

Agrisearch Inc. 4 p. MRID: 41755801 Spare, W. (199 0) Anaerobic Aquatic Metabolism of Iprodione: Lab Project Number: 1510. Unpublished study

prepared by

Agrisearch Inc. 114 p. MRID: 42854101Pag e 40 of 55

Spare, W. (1993) Anaerobic Aquatic Metabolism of Iprodione: Supplemental: L ab Project Number: 1510. Unpublish ed study prepared by

Agrisearch Inc. 55 p. **Guideline: 162 -**  **4 Aerobic aquatic metabolism** MRID: 00162219 Thomas, R.; Fletcher, C. (1983) Aquatic Metabolism of [Carbon 14] - RP - 26019: Project No. 3 - 2201. Unpublished study prepared by

Borriston Laboratories, Inc. 41 p. MRID: 41927601 Spare, W. (1991) Aerobic Aquatic Metabolism of Iprodione: Lab Project Number: 1514. Unpublished study

prepared by

Agrisearch Inc. 147 p. MRID: 42503801 Spare, W. (1992) Aerobic Aquatic Metabolism of Iprodion e: Supplemental Report ?MRID #41927601| : Lab Project Number: 1514. Unpublished study prepared by

Agrisearch Inc. 117 p. MRID: 44605001 Purser, D. (1992) (Carbon 14) - Iprodione: Degradation and Retention in Water/Sediment Sy stems: Amended Final Report: L ab Project Number: 68/113: 7397: P6876D. Unpublished study prepared by

Hazleton UK. 160 p. **Guideline: 163 -**  **1 Leach ing** **/adsorp tion**  **/desorption** MRID: 00059479 Gouot, J.M.; L acroix, L .; Sauli , M.; et al. (1976) A Study to Investigate the Leaching of 26 019 R.P. in Soil, Using ^14I C - Labelled 26 019 R.P.: R.P./R.D./C.N.G. - An no. 18845. (Translation; unpublished study

received May

24, 1977 under 359 - EX - 55; prepared by Societe des Usines Chimiques Rhone - Poulenc, submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :230241 - D) MRID **:** 00068286 Gouot, J.M.; L acroix, L ; Sauli, M.; et al. (1976) A Study To Investigate the L eaching of 26 019 R.P. in Soil, Using (14C) - Labelled 26 019 R .P. (Translation; unpublished study received Jan 24, 1977 under 359 - EX - 55; prepared b y Rhone - Poulenc, France, submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL : 227614 - D) MRID: 41878801 Outram, J.; Reeves, G.; Smith (1991) Iprodione - ?Carbon 14| : Adsorption/Desorption on Four Soils: L ab Project Number: P91 - 049. Un - published study prepared by

Rhone - Poulenc Ag. Ltd. 87 p. MRID: 41889601 Doble, M.; Outram, J.; Reeves, G. (1991) Iprodione - [carbon 14]: Aged Leaching Study with Four S oils: L ab Project No: P91/050. Unpublished study prepared by

Rhone - Poulenc Agric., Ltd. 78 p.Pag e 41 of 55

MRID: 43349201 Newb y, S.; Ayliffe, J.; Jones, M. (1994) Iprodione: Aged Leaching Study i n Four Soils: L ab Project Number: P 94/013. Unpublished study prepared by

Rhone - Poulenc Agriculture Ltd. 107 p. MRID: 43349202 Burr, C.; Newb y, S. (1994) Iprodione: Adsorption/Desorption to and from Four Soils and an Aquatic Sediment: Lab Project Number: P94/014. Unpublished study prepared by

Rhone Poulenc Agriculture Ltd. 81 p. MRID: 45114101 Feung, C. (1999) Iprodione Metabolite: (carbon - 14) - 3,5 - Dichloroaniline Soil Adsorption/Desorption Study : Lab Project Number: 99R16 744. Unpublished study prepared by Rhone Poulenc Ag Company . 165 p. **Guideline: 164 -**  **1 Terrestrial field dissipation** MRID: 00059484 Rhodia , Incorporated (1976) RP 26019 and Metabolites: Residue Study in/on Turf Soil: Report No. 76/069/NB/AG. (Unpublished study received May

24, 1977 under 359 - EX - 55; submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :230241 - I) MRID: 0006 8290 Rhodia, Incorporated (1976) RP 26019 and Metabolites: Residue Study in/on Turf Soil, 1976 Program: Lab. Ref. No. 76/069/NB/AG. (Unpublished study received Jan 24, 1977 under 359 - EX - 55; sub - mitted by

Rhone - Poulenc Chemical Co., Monmouth Junction, N.J. ; CDL :227614 - I) MRID: 00162218 Gemma, A.; Heinzelmann, G.; Wargo, J. (1986) Iprodione Aquatic Field Dissipation and Field Irrigated Crop Study. Unpublished study prepared by

Rhone - Poulenc Inc. 300 p. MRID: 41877401 Norris, F. (1991) A Terrestrial F ield Soil Dissipation Study with Iprodione: L ab Project Number: 40644: EC/P - 89 - 0013. Unpublished study prepared by

Rhone - Poulenc A g Co.; A & L Eastern Agricultural Labs, Inc.; Morse Labs., Inc. 275 p. MRID: 43718302 Citation: Hudson, J. (1995) Validation of Method of Anal ys is for Iprodione (RP26019) and its Metabolites (RP32490, RP32596, RP36221, and RP30228) in Soil: Final Report: L ab Project Number: EC - 94 - 258: EC - 95 - 298: EC - 95 - 296. Unpublished study prepared by

Rhone - Poulenc Ag Co. 180 p.Pag e 42 of 55

**Guideline: 164 -**  **2 Aquatic field dissipation** MRID: 43718301 Chancey , E. (1995) An Aquatic Field Dissipation Study with Iprodione: Lab Project Number: 44729: EC - 92 - 187: FAD - IP R - RI - MS - 92. Unpublished study prepared by

Rhone - Poulenc Ag Co.; Agvise, Inc .; and South Texas Ag Research Inc. 374 p. MRID: 45239203 Citation: Carringer, S. (1999) Iprodione: Validation of Method of Anal ys is of Iprodione and its Metabolites RP 30228 and RP 32596 in Ground Water: Final Study Report: L ab Project Number: EC - 98 - 432: 45593. Unpublished study prepared by

Rhone - Poulenc Ag Company and Agvise Laboratories. 123 p. {OPPTS 850.7100} MRID: 45239204 Citation: Sweeney , R. (1999) Independent Laboratory Validation of Method of Anal ys is for Ip rodione and its Metabolites RP 30228 and RP 32596 in Ground Water According to Ecological Effects Test Guidelines OPPTS 850.7100: L ab Project Number: 45380: 99R17181: ACFS 45380. Unpublished study prepared by

ABC Laboratories, Inc. 72 p. {OPPTS 850.7100} **Guideline: 165 -**  **4 B ioaccumulation in fish**  MRID: 00162221 McAllister, W.; Bunch, B.; Burnett, J. (1986) Bioconcentration and Depuration of [Carbon 14] - Ip rodione b y Crayfish (Procambarus simulans, Faxon) under Static Uptake Conditions with a Treated Soil Substrate: Final Bioconcentration Report No. 33438. Unpubli shed study prepared by Analy tical Bio - Chemistry

L aboratories, Inc. 297 p. MRID: 00162222 Gemma, A.; Heinzelmann, G.; Wargo, J. (1986) Identification of Iprodione Residues in Crayfish. Unpublished study

prepared by

Rhone - Poulenc In c. 23 p. MRID: 43 091001 Pottinger, T. (1994) Final Report: A Fish Bioaccumulation and Depuration Study on Iprodione: Lab Project Number: FH - OECD - 34FT/BR: 68/134 - 1011R. Unpublished study prepared by Windermere Laboratory , Institute of Freshwater Ecology . 172 p. **(b) Ecol ogical Effects Studies**  **Guideline: 71 -**  **1 Avian Single Dose Oral Toxicity** MRID: 48589 McGinnis, C.H., Jr.; Johnson, C.A. (1973) The Determination of the Acute Oral LDI50^ in Bobwhite Quail for 26019 RP: Research Report No. CHM 73:93. (Unpublished study received Jan 24, 1977 under 359 - EX - 55; submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :227615 - K)Pag e 43 of 55

MRID: 48590 McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Determination of the Acute Oral LDI50^ in Mallard Ducks for 26019 RP: Research Report No. CHM 74:49. (Unpublished study received Jan 24, 1977 under 359 - EX - 55; submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :227615 - L) MRID: 41604101 Culotta, J.; Hoxter, K.; Smith, G. et al. (1990) Iprodione: An Acute Oral Toxicity Study with the Northern Bobwhite: Lab Pro ject Number: 171 - 120. Unpublished study prepared by

Wildlife International Ltd. 4 3 p. **Guideline: 71 -**  **2 Avian Dietary Toxicity** MRID: 48591 McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effects of Dietary 26019 R.P. and Technical Dieldrin on Young Mallard Ducks -- an 8 Day Subacute Toxicity

Test: Research Report No. CHM 74:64. (Unpublished study received Jan 24, 1977 under 359 - EX - 55; sub - mitted by Rhone Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :227615 - M) MRID: 48592 McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effects of Dietary 26019 RP and Technical Dieldrin on Youn g Bobwhite Quail -- a 12 Day Subacute Toxicity

Test: Report No. CMH 74:14. (Unpublished study

received Jan 24, 1977 under 359 - EX - 55; submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL : 227615 -N) MRID: 68740 McGinnis, C.H., Jr.; Johnson , C.A. (1974) The Effects of Dietary 26019 RP and Technical Dieldrin on Young Bobwhite Quail -- A 12 Day Subacute Toxicity

Test: Report No. CHM 74.14. (Unpublished study

received Jan 13, 1978 under 359 - 684; submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL : 232703 - J) MRID: 68741 McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effect of Dietary 26 019 RP on Body

Weight, Feed Consumption, Reproduction and the Production of 26 019 RP Residues in Body Tissues and Eggs of Bobwhite Quail: Rese arch Report No. CHM 74:105. (Unpub lished study received Jan 13, 1978 under 359 - 684; submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL : 232703 - K) MRID: 86839 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1980) Final Report: Subacute F eeding -- Reproduction Screening Bioassay-- Bobwhite Quail: I prodione Technical: Project No. 171 - 101. (Unpublished study received Oct 26, 1981 under 46153 - 1; prepared by Wildlife International, Ltd., submitted by Precision Compounding, Inc., Newark, N.J.; CD L: 246150 - A)Pag e 44 of 55

MRID: 41604102 Driscoll, C.; Foster, J.; Hoxter, K. et al. (1990) Iprodione Technical: A Dietary L C50 Study

with the Northern Bobwhite: Lab Project Number: 171 - 118. Unpublished study prepared b y Wildlife International Ltd. 73 p. MRID: 41604103 Driscoll, C.; Foster, J.; Hoxter, K . et al. (1990) Iprodione Technical: A Dietary L C50 Study

with the Mallard: Lab Project Num - ber: 171 - 119. Unpublished study prepared by

Wildlife International Ltd. 73 p. **Guideline: 71 -**  **4 Avian Reproduct ion**  MRID: 68741 McGinnis, C.H., Jr.; Johnson, C.A. (1974) The Effect of Dietary 26 019 RP on Body

Weight, Feed Consumption, Reproduction and the Production of 26 019 RP Residues in Body Tissues and Eggs of Bobwhite Quail: Research Report No. CHM 74:105. (Unpub lished study received Jan 13, 1978 under 359 - 684; submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL : 232703 - K) MRID: 86840 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report One - generation Reproduction Study-- Mall ard Duck: Iprodione Technical: Project No. 171 - 103. (Unpublished study received Oct 26, 1981 under 46153 - 1; prepared b y Wildlife International, Ltd., and Rhone - Poulenc, Inc., submitted by

Precision Compounding, Inc., Newark, N.J.; CDL :246150 - C) MRID: 9 9126 Fink, R.; Beavers, J.B.; Joiner, G.; et al. (1981) Final Report: One - generation Reproduction Study-- Bobwhite Quail: Iprodione Technical: Project No. 171 - 102. (Unpublished study received Oct 26, 1981 under 46153 - 1; prepared b y Wildlife International, Ltd. and Rhone - Poulenc, Inc., submitted by

Precision Compound - ing, Inc., Newark, N.J.; CDL :246150 - B) MRID: 92083002 Gregg, B. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 00099126. Ip rodione - One - generation Reproduction Study - Bobwhite Qu ail: Project 171 - 102. Prepared b y WI LDLIFE INTERNATIONAL LTD. 36 p. MRID: 92083003 Gregg, B. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 00086840. Ip rodione - One - generation Reproduction Study - Mallard Duck: Project 171 - 103. Prepared b y WI LDLIFE INTERNATIONAL. 37 p. **Guideline: 72 -**  **1 Acute Toxicity to Freshwater Fish** MRID: 70148 Calmbacher, C.W.; Vilkas, A.G. (1978) The Acute Toxicity of RP26019 Technical (Assay 95.06%, L ot #77103 - 01) to the Bluegill Sunfish (~Lepomis macrochirus~Rafinesque): UCESPag e 45 of 55

Proj. No. 11506 - 48 - 02. (Unpublished study received Sep 1, 1978 under 359 - 684; prepared b y Union Carbide Corp., submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :234810 - A) MRID: 70149 Calmbacher, C.W.; Vilkas, A.G. (1978) The Acute Toxicity of RP26019 Technical (Assay 95.06%, L ot #77103 - 01) to the Rainbow Trout (~Salmo gairdneri~Richardson): UCES Proj. No. 11506 - 48 - 03. (Unpublished study received Sep 1, 1978 under 359 - 684; prepared by Union Carbide Corp., submitted b y Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :234810 - B) MRID: 162223 McAllister, W.; Bunch, B. (1986) Dy namic Acute Toxicity

of Iprodione Technical to Juvenile Crayfish (Procambarus simulans, Faxon): Flow - through Acute Toxicity Report #3343 4. Unpublished study

prepared by

Anal yt ical Bio - Chemistry L aboratories, Inc. 148 p. MRID: 162224 Swigert, J.; Franklin, B.; Seidel, A.; et al. (1986) Acute Flow - through Toxicity of Iprodione Technical to Channel Catfish (Ictalurus punctatus): Report # 34385. Unpublished study pre pared b y Anal yt ical Bio - Chemistry L aboratories, Inc. 109 p. MRID: 40489203 Surprenant, D. (1987) Acute Toxicity of Rovral 50 WP to Bluegill (Lepomis macrochirus) under Flow - through Conditions: SL S Report #87 - 12 - 2578: SL S Study #10566.1087.6111.105. Unpublished study

prepared by

Springborn Life Sciences, Inc. 47 p. MRID: 41604104 Sousa, J. (1990) I

prodione Technical: Acute Toxicity to Bluegill sunfish (Lepomis macrochirus) under Flow - Through Conditions: Lab Project Number: 90 - 5 - 3329: 10566.1089.6140.105. Unpublished study

prepared by

Springborn Laboratories, Inc. 55 p. MRID: 41604105 Sousa, J. (1990) I

prodione Technical: Acute Toxicity to Rainbow Trout (Oncorh ynchus m ykiss) under Flow - through Conditions: Lab Projec t Number: 90 - 5 - 3331: 10566.1089.6139.108. Unpublished study

prepared by

Springborn Laboratories, Inc. 54 p. MRID: 92083004 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 40489203. Acute Toxicity of ROVRAL 50 WP to Bluegill (Lepom is macrochirus) under Flow - through Conditions: Project 87 - 12 - 2578. Prepared b y Springborn Life Sciences Inc. 16 p. MRID: 92083069 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 00162224. Ip rodione - Acute Flow - through Toxicity : Channel Catfish (Ictalurus punctatus): Project 34385. Prepared b y ANALYT IC ALBIO - CHEMISTRY LABORATORIES. 16 p.Pag e 46 of 55

MRID: 92083070 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 00162223. Ip rodione - Acute Flow - through Toxicity : Juvenile Crayfish (Procambarus simulans, Faxon): Project 33434. Prepared by ANALYTICAL BIO - CHEMI STRY LABORATORIES. 16 p. **Guideline: 72 -**  **2 Acute Toxicity to Freshwater Invertebrates** MRID: 68738 Ambrosi, D.; Desmoras, J.; L aCroix, L . (1977) Fungicides: Tox icity of R.P. 26 019 to Daphnia (~Daphnia pulex~): R.P./R.D./ C.N.G. No. 19 168. (Unpublished study received Jan 13, 1978 under 359 - 684; prepared by Rhone - Poulenc, France, submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL : 232703 - F) MRID: 68739 Roberts, S.; Parke, G.S.E. (1977) Report: 48 - hour Static L C50 of RP 26019 Technical in~Daphnia magna~: Laboratory No. 7E - 8445. (Unpublished study received Jan 13, 1978 under 359 - 684; pre - pared b y C annon Laboratories, Inc., submitted by Rhone - Poulenc, Chemical Co., Monmouth Junction, N.J.; CDL :232703 - G) MRID: 79633 Vilkas, A.G. (1977) The Acute Toxicity of RP 26019 Technical to the Water Flea~Daphnia magna~Straus: UCES Proj. # 11506 - 48 - 01. (Unpublished study received Jan 13, 1978 under 359 - 6 84; pre - pared b y Union Carbide Corp., s ubmitted by Rhone - Poulenc Chem ical Co., Monmouth Junction, N.J.; CDL :232703 - H) MRID: 40489206 Surprenant, D. (1988) Acute Toxicity of Rovral 50 WP to Daphnids (Daphnia magna) under Flow - through Conditions: Report #87 - 12 - 2597: SLS Study #10566.1087.6112.115. Unpublished study

pre - pared b y Springborn Life Sciences, Inc. 47 p. MRID: 41642001 McNamara, P. (1990) Iprodione Technical -- Acute Toxicity to Daphnids (Daphnia magna) during a 48 - Hour Flow - through Exposure: Final Report: Lab Project Number: 90 - 7 - 3380: 10566.1086.6138.115. Unpublished study prepared by

Springborn Laboratories, Inc. 6 p. MRID: 92083005 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 40489206. Acute Toxicity of ROVRAL 50 WP to (Daphnia magna) under Flow - through Conditions: Project 87 - 12 - 2597. Prepared b y SPRI NGBORN LIFE SCIENCES, I NC. 17 p.Pag e 47 of 55

**Guideline: 72 -**  **3 Acute Toxicity to Estuarine/Marine Organisms** MRID: 40489202 Surprenant, D. (1987) Acute Toxicity o f Iprodione Technical to Eastern Oysters (Crassostrea virginica) under Flow - through Con ditions: SL S Report #87 - 12 - 2584: SL S Study #10566.1087.6115.504. Unpublished study prepared by

Springborn Life Sciences, Inc. 45 p. MRID: 40489204 Surprenant , D. (1987) Acute Toxicity of Iprodione Technical to M ys id Shrimp (My sidopsis bahia) under Flow - through Conditions: SL S Report #87 - 12 - 2580: SL S Study #10566.1087.6113.515. Unpublished study prepared by

Springborn Life Sciences, Inc. 45 p. MRID: 404892 05 Surprenant, D. (1988) Acute Toxicity of Iprodione Technical to Sheepshead Minnow (Cy prinodon variegatus) under Flow - through Conditions: SL S Report #87 - 11 - 2583: SL S Study #10566.1087.6114. 505. Unpublished study prepared by

Springborn Life Sciences, Inc . 44 p. MRID: 42169301 Surprenant, D. (1991) Response to EPA FIFRA 88 Phase 4 Data Call - in on Iprodione (...) -- Acute Toxicity to M ys id Shrimp: L ab Project Number: EMM1/2/92. Unpublished study prepared by Springborn Labs., Inc. 6 p. MRID: 92083006 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 40489205. Acute Toxicity of Iprodione Technical to Sheepshead Minnow (Cy prinodon variegatus) under Flow through Conditions: Project 87 - 12 - 2583. Prepared by SPRI NGBORN LIFE SCIENCES, INC. 17 p. MRID: 92083007 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 40489202. Acute Toxicity of IPRODIONE Technical to Eastern Oysters (Crassostrea virginica) under Flow through Conditions: Project 87 - 12 - 2584. Prepared by SPRI NGB ORN LIFE SCIENCES, INC. 19 p. MRID: 92083008 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 40489204. Acute Toxicity of Iprodione Technical to My sid Shrimp (My sidopsis bahia) under Flow - through Conditions: Project 87 - 12 - 2580. Prep ared b y SPRI NGBORN LIFE SCIENCES, I NC. 17 p. **Guideline: 72 -**  **4 Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study** MRID: 48593 Rausina, G.; McCollum, K.; Goode, J.W.; et al. (1974) Report to Rhodia, Inc., Chipman Division: Four - Day

Static F ish Toxicity

Studies with RP26019 Technical in Rainbow Trout, Bluegills, and Channel Catfish: IBT No. 621 - 05132. (Unpublished study received Jan 24, 1977Pag e 48 of 55

under 359 - EX - 55; submitted by Rhone - Poulenc Chemical Co., Monmouth Junction, N.J.; CDL :227615 - O) M RID: 40489201 Surprenant, D. (1988) The Chronic Toxicity of Iprodione Technical to Daphnia magna under Flow - through Conditions: Report #87 - 12 - 2573: Study #10566 - 1087 - 6116 - 130. Unpublished study prepared by

Springborn L ife Sciences, Inc. 59 p. MRID: 40550801 Surprenant, D. (1988) The Toxicity of Iprodione Technical to Fathead Minnow (Pimephales promelas) Embryos and Larvae: Rept. No. 88 - 2 - 2639. Unpublished study prepared by Springb orn Life Sciences, Inc. 59 p. MRID: 40550802 Surprenant , D. (1988) Chronic Toxicity of Iprodione Technical to My sid Shrimp (My sidopsis bahia): Report #88 - 3 - 2640. Unpublished study prepared b y Springborn L ife Sciences, Inc. 64 p. MRID: 40832201 Surprenant, D. (1988) Chronic Toxicity of Iprodione Technical to My sid Shrimp (My sidopsis bahia): Supplement Study : Report #88 - 6 - 2761: Study #10566.0388.6117.530. Unpublished study prepared by

Springborn L ife Sciences, Inc. 65 p. MRID: 92083009 Gregg, B. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 4 0550801. Ip rodione - Toxicity

to Fathead Minnow (Pimephales promelas) Embryos and Larvae - Project 88 - 2 - 2639. Prepared b y SPRI NGBORN LIFE SCIENCES, INC. 20 p. MRID: 92083010 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 40489201. The Chronic Toxicity

of IP RODIONE Technical to Daphnia magna under Flow - through Conditions: Project 87 - 12 - 2573. Prepared b y SPRINGBORN LIFE SCIENCES, INC. 22 p. MRID: 92083011 Mihaich, E. (1990) Rhone - Poulenc Ag Company Phase 3 Summary of MRID 4083220 1. The Chronic Toxicity

of IP RODIONE Technical to My sid Shrimp (My sidopsis bahia): Project 88 - 6 - 2761. Prepared b y SPRINGBORN LIFE SCIENCE, I NC. 23 p. **Guideline: 81 -**  **1 Acute oral toxicity in rats** MRID: 42306301 Cummins, H. (1989) I

prodione: Acute Oral Toxicity Study in the Rat: Lab Project Number: RHA/255: 89/RHA255/0391. Unpublished study prepared by

L ife Science Research Lt d. 46 p.Pag e 49 of 55

**Guideline: 81 -**  **3 Acute inhalation toxicity in rats** MRID: 42946101 Nachreiner, D. (1993) Iprodione: Acute Dust Inhalation Toxicity Study in Rats: L ab Project Number: 93N1216. Unpublished study prepared by

Bushy Run Research Center, Union Carbide. 58 p. **Guideline: 83 -**  **4 2 -**  **generation repro. -**  **rat** MRID: 41871601 Henwood , S. (1991) Two - generation Reproduction Study with Iprodione Technical in Rats: Final Report: Lab Project I d.: HLA 6224 - 154. Prepared b y Hazleton Laboratories America, Inc. 1669 p. **Guideline: 122 -**  **2 Aquatic plant growth** MRID: 41604108 Giddings, J. (1990) Iprodione Technical: Toxicity to the Duckweed Lemna gibba G3: Lab Project Number: 90 - 06 - 3351: 10566.1089.614. 410. Unpublished study prepared b y Springborn Laboraotries, Inc. 40 p. **Guideline: 123 -**  **2 Aquatic plant growth** MRID: 41604107 Gi ddings, J. (1990) Iprodione Technical: Toxicity to the Freshwater Green Alga Selenastrum Capricornutum: Final Report: L ab Project Number: 90 - 06 - 3346: 10566 - 1089 - 6141 - 430. Unpublished study

pre - pared b y Springborn Laboratories, Inc. 50 p. MRID: 416041 09 Giddings, J. (1990) Iprodione Technical: Toxicity to the Marine Diatom Skeletonema Costatum: Lab Project Number: 90 - 06 - 3347: 10566.1089.6141.450. Unpublished study prepared by Springborn Laboratories, Inc. 50 p. MRID: 41604110 Giddings, J. (1990) Iprodione Technical: Toxicity to the Freshwater Bluegreen Alga Anabaena Flos - Aquae: Lab Project Number: 90 - 05 - 3338: 10566 - 1089 - 6141 - 420. Unpublished study prepared b y Springborn Laboratories, Inc. 47 p. MRID: 41604111 Giddings, J. (1990) Iprodione Tec hnical: Toxicity to the Freshwater Diatom Navicula Pelliculosa: Final Report: L ab Project Number: 90 - 6 - 3340: 10566 - 1089 - 6141 - 440. Unpublished study prepared by

Springborn Laboratories, Inc. 49 p. MRID: 43575601 Suprenant, D. (1995) Supplement Data for : Iprodione Technical: Toxicity to the Freshwater Diatom Navicula pelliculosa. Addendum to MRID No. 41604111: Lab Project Number:Pag e 50 of 55

90/6/3340: 10566/1089/6141/440. Unpublished study prepared by

Springborn Laboratories Inc. 12 p. MRID: 45741301 Sowig, P. (2002) Duckweed (Lemna gibba G3) Growth Inhibition Test I prodione; Substance, Technical: Lab Project Number: CE02/033: C022577. Unpublished study prepared by

Aventis CropScience GmbH. 47 p.Pag e 51 of 55

**12. Appendix D.**  **SIP /STIR**  **M odel**  **Resul ts**  **(a) SIP Model Output**Pag e 52 of 55

**(b) STIR Model Output**Pag e 53 of 55

**13. A**  **ppendix E. IDS Aggregate Incident Report for Iprodione** Pag e 54 of 55

**14. Appendix F. Data Call**  **- In Justifi**  **cation Tables for Non -**  **guideline/ Degradate**  **Studies and**  **Study Title: Honeybee Larval Toxicity Study Guideline Number: Non**  **- guideline**  **Test Substance: Iprodione —** **TGAI Rationale for Requiring the Data**  In cident data suggest that iprodione may adversel y affect honey

bee ( Apis mellifera ) brood (larval and pupal) development. In an unpublished manuscript submitted as an incident report, increased mortality as well as abnormal morphological development occurred in female (worker) bee pupae. Although iprodione is practicall y non - toxic to adult worker bees on an acute contact exposure basis, a larval toxicity

study is needed to determine the toxicity of the compound to developing brood. In addition, iprodione has been reported to occur in bee colony wax (comb) samples, where it could potentially

affect development of young. Submitted studies of iprodione do not provide information on the potential toxicity to developing honey

bee brood. Therefore, a non - guideline honey bee larval toxicity

study is recommended. The registrant should submit a proposed protocol for review and approval by EFED prior to initiation of the study . **Practical Utility of the Data**  **How will the data be used?** Data will be used to assess risk to non - target listed and non - listed terrestrial invertebrate species. This study

would allow the Agency to refine the screening - level hazard assessment for beneficial terrestrial invertebrates. The effects data will be used to determine the potential for adverse effects on beneficial terrestrial invertebrates through direct effects on larval bees. **How could the data impact the Agency’s future decision -**  **making?** EPA is required b y section 7(a)(2) of the Endangered Species Act (ESA) to ensure that any action it authorizes or takes “... is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of criti cal habitat” and “ to use the best scientific data available ” in carrying out this obligation. The data EPA intends to call in are necessary

to inform the determination required by ESA as to whether continued registration of a pesticide is or is not likely to jeopardize the species or its designated critical habitat. The lack of these data will limit the flexibility that the Agency

has in coming into compliance with ESA and could result in use restrictions that are unnecessarily severe. In addition, the lack of these data may result in an uncertain assumed risk and potential mitigation of iprodione formulations under FIFRA.Pag e 55 of 55

**Study Title: Daphnid Reproduction Study**  **Guideline Number: 850.1300 Test Substance: 3,5**  **- Dichloroaniline**  **Rationale for Requiring the Data**  3,5 - DCA (RP32596) is considered a degradate of concern of iprodione . Since 3,5 - DCA likel y has a different mode of action in ecological receptors as compared to iprodione, it will be assessed separately during risk assessment. No ecological effects data have been submitted for 3 ,5 - DCA . EFED is recommending that a chronic reproduction study with Daphnia be carried out with 3,5 - DCA to provide some information on the toxicity of this degradate to aquatic organisms. The results of this study

woul d provide information on the relative toxicity of 3,5 - DCA to iprodione, which would help determine whether 3,5 - DCA is of toxicological concern for risk assessment. Results from this study

would also serve as a basis for comparing the toxicity of 3,5 - DCA to p chloroaniline and 3,4 - DCA, which would indicate whether these chemicals are suitable toxicity surrogates for estimating risks from 3,5 - DCA. The justification for requesting a chronic rather than an acute toxicity

study to represent 3,5 - DCA is because th e slow rate of degradation of 3,5 - DCA in soil metabolism studies indicates that it is of chronic concern . **Practical Utility of the Data How will the data be used?**  D ata will be used to compare toxicity of 3,5 - DCA to the parent compound (iprodione) and potentially

to calculate separate risk quotients for 3,5 - DCA during risk assessment. **How could the data impact the Agency’s future decision -**  **making?** This data will provide information on relative toxicity between a degradate (3,5 - DCA) and its parent compo und (iprodione). Since this data may be used to evaluate this degradate separatel y from the parent during risk assessment, such data may generally help inform how risk assessors evaluate degradates as residues of concern in risk assessment.