### 2 registration review and provides an overview of the environmental fate, ecological effects, and potential risks associated with the use of spirom esifen. It describes uncertainties which may be encountered in the risk assessment and identifies additional studies and other information that would be beneficial to its c onduct. Below is a summary of data needs and uncertainties.

The environmental fate database is relatively complete; however, the following studies are recommended to support the risk assessmen t for spiromesifen (40 CFR Part 158.1300):

o Environmental chemistry methods (ECM) for soil and water with associated independent laboratory validation (ILV) (OCSPP Guideline §850.6100) is needed to support field dissipation studies. The ECM/ILVs are a standard data requirement fo r a terrestrial use pattern and are not available for the methods used in the dissipation studies.

The ecological database is incomplete based on the data requirements outlined in the 40CFR158 Subpart G 1 

### . Ecotoxicology data gaps 2 

### include:

 Aquatic:

o OCSPP §850.1400 Estuarine/marine fish early-life stage toxicity

o OCSPP §850.4500 Algal toxicity

 Freshwater diatom ( Navicula pelliculosa ) and a marine diatom ( Skeletonema costatum ) species

o OCSPP §850.4550 Cyanobacteria ( Anabaena flos-aquae ) toxicity

o Non-guideline: Whole sediment chroni c freshwater invertebrate with Hyalella
azteca (42 days) 3



### o Non-guideline: Whole sediment chronic estuarine/marine invertebrate with Leptocheirus plumulosus (28 days) 4



###  Terrestrial

o OECD Test Guideline 237: Honey bee la rval acute toxicity (single exposure) 5 

### (TGAI)

o Non-Guideline: Honey bee larval ch ronic (21-day) to xicity (repeated exposure) (TGAI); see OECD draft guidance document 6



### . o Non-Guideline: Honey bee adult chr onic (10-day) oral toxicity (TGAI)

o Special Study (Tier 2): Field trial of residues in pollen and nectar (TEP)

o Special Study (Tier 2): Semi-field te sting for pollinators (tunnel or colony feeding studies) (TEP)

1 CFR. 2013. Title 40 (Protection of the E nvironment), Chapter 1 (Enviro nmental Protection Agency), Subchapter E (Pesticide Prog rams), Part 158 (Data Requirements for Pesticides), Subpart G (Ecological Effects) http://www.ecfr.gov/cgi-bin/textidx?c=ecfr&SID=ff5c7fef3645e7cd5abceca0b597bccb&rgn= div6&view=text&node=40:25.0.1.1.9.7&idno=40

2 A complete listing of all the environmental fate and ecotoxicolo gy data gaps, along with justification according to 40 CFR, Pa rt 158-Subpart G, are listed in Section 11 of this document.
3,4 A tiered testing approach may be considered for requesting chroni c sediment toxicity testing. Sediment toxicity testing would first be conducted using the subchronic (10-d) sedi ment toxicity test guidelines (OSCPP 850. 175 and 850.1740). Pending a comparison of estimated environmental concentrations (EEC) in sedi ment and pore water with toxicity results from the 10-d sediment toxicity studies, th e need for one or more chronic sediment toxicity studies would be determined.

5 OECD. 2013. OECD Guidelines for the Testing of Chemicals. Honey bee ( Apis mellifera ) larval toxicity test, si ngle exposure. OECD/OCDE 237. Adopted 26 July 2013. http://www.oecd-ilibrary .org/environment/test-no-237-honey-bee-apis -mellifera-larval-toxicity-test-singleexposure_9789264203723-en

6 OECD. 2013. OECD Draft Guidance Document. Honey bee ( Apis mellifera ) larval toxicity test, repeated exposure. Revision of June 2013 draft GD, 25 November 2013. http://www.oecd.org/env/ehs/tes ting/Draft_GD_honeybees_rep_exp_f or_2nd_CR_25_November_2013.pdf

### 3 o 850.3040 (Tier 3) Full-Field test ing for pollinators (TEP)

All studies are to be conducted using technical grade active ingredient (TGAI) unless there is evidence the typical end-product (TEP) enhan ces the toxicity of the formulation.

EPA recently posted its guidance 7 

### for assessing risks of pesticides to bees and consistent with this guidance a suite of tests is recommended for evaluating the potenti al toxicity of pesticides to bees. Although data from the acute contac t toxicity test (OCS PP 850.3020) with young adult honey bees ( Apis mellifera ) indicates spiromesifen is practica lly non-toxic to bees on an acute exposure basis, there is uncerta inty regarding the pot ential acute and chr onic effects of the compound on honey bee larval development and surviv al as well as potentia l for chronic effects of adult bees. Data suggest that spiromesifen is not extensively translocat ed in plants, although it is not clear whether the studies were long enough in duration to capture all potential translocation. Further, there is uncertainty regarding the extent to which adjuvants may increase uptake of the compound by leaves. While autoradiogra phs of plants treated with spiromesifen do not show extensive movement be yond leaves, there appears to be movement within the leaves ( i.e ., translaminar systemicity) (USEPA, 2011). Add itionally, insect pollinators may be exposed if these compounds are applied at bloom or when bees are foraging on ex tra-floral nectaries. Therefore, residues may be present in pollen and/ or nectar and represent a route of exposure for bees through both contact and ingestion. A dditional data on pollinators are needed to characterize the potential risk a ssociated with spiromesifen use to all developmental stages of honey bees, as sensitivity may vary according to life-stage and length of exposure (adult vs. larval and acute vs. chronic, respectively). As described in the guidance for assessing risks to bees, depending on the outcome of the screening-level risk assessment, additional studies of bees at the colony level under semi- and full- field conditions may also be recommended.

In the absence of the above toxici ty data, uncertainties in the a ssessment of spiromesifen include the potential for adverse effects from exposure to spiromesifen for the following non-target organisms: estuarine/marine fish (chronic expo sure), nonvascular aquatic plants and algae, freshwater and estuarine/mari ne benthic invertebrates (chr onic exposure), and terrestrial invertebrates (honey bee larval acute and chroni c toxicity, and adult ch ronic toxicity).

7 USEPA. 2014. Guidance for Assessing Pesticide Risks to Bees. Office of Pesticide Programs. Un ited States Environmental Prote ction Agency. Available at http://www.epa.gov/pesticides/sci ence/efed/policy_guidance/team_authors/terrest rial_biology_tech_team/GuidanceAssessingPesticid eRisk2Bees. pdf

### 4 2. Introduction



### Spiromesifen (3,3-dimethyl-,2-oxo-3-(2,4,6-trim ethylphenyl)-1-oxaspiro[4,4]non 3-en-4-yl ester (CAS No.: 283594-90-1) belongs to the keto-e nol class of pesticides. The compound is a spirocyclic tetronic acid (2,4(3H ,SH)-furandione derivative; clos ely related pesticide include spirodiclofen (PC Code 124871; CAS 148477-71-8), a broad-spectrum acaricide (Fischer and Benet-Buchholz, 2002) and spirotetrama t (PC Code 392201; CAS 203313-25-1). These pesticides act through the inhibiti on of lipid biosynthesis (Arthur et al., 2003), especially triglycerides and free fatty acids. The spirocyclic tetronic acids were developed after it was discovered that a predecessor group of herbicidal ch emicals, the bicyclic tetramic acids, were not only selective against monocotyledonous grasses but were also effective miticides (Fischer and Benet-Buchholz, 2002). Across the keto-enols, the compounds vary with respect to their systemicity, i.e ., the extent to which they are taken up by plants and distributed to various parts of the plant. Spirotetramat is considered fully systemic and under goes transport through both xylem and phloem tissues whereas spirodiclofen is not systemic at all; spiromesifen exhibits limited systemicity and is believed to fall between other chemicals within the class.

Spiromesifen has been classified as an inse ct growth regulator (I GR) by the Insecticide Resistance Action Committee (IRAC) 8 

### . The mechanism of action (MOA) classification scheme developed and endorsed by IRAC is based on th e best available evidence of the MOA of available insecticides. According to the IRAC, details of the listing have been agreed by IRAC companies and approved by internationally recognized industrial and academic insect toxicologists a nd biochemists 9 

### . Based on the IRAC analysis, tetronic and tetramic acid derivatives, which includes spiromesifen, are cl assified as an IGR through inhibition of acetyl CoA carboxylase in the lipid synthesi s and growth regulation pathways.

In support of this preliminary problem formulati on, the Environmental Fate and Effects Division (EFED) examined the most recent environmental fa te and ecological risk assessments as well as the updated toxicity, exposure, and usage informati on for spiromesifen to determine if additional data are needed to support Regi stration Review. In addition, EFED considered the latest Agency science policies and risk assessment methodologies.

3. Use Characterization



### Spiromesifen is formulated as flowable and em ulsifiable concentrate wi th application methods that include: ground spray, aerial spray, and chemiga tion. The pesticide is currently registered for use on wheat, sorghum, dry peas, mint, leafy petioles crop subgroup (4B), almond, apples, artichokes, broccoli, cabbage, cauliflower, cranbe rries, corn, cucumbers, eggplant, lettuce, oats, peppers, potatoes, pumpkin, spinach, squash, strawberries, sweet corn, tomatoes and watermelons. Additionally, it is registered for n on-food crop such as ornamentals and cotton (3 lbs a.i./A/year and 0.50 lbs a.i./A/year, respec tively). The current maximum single application

8 IRAC. 2014. IRAC MoA Classification Scheme. Issued February 2014, version 7.3. Prepared by: IRAC International MoA Working Group. Available at: http://www.irac

‐ online.org/documents/moa

‐ classification/?ext=pdf

9 Ibid IRAC 2014,

### 5 rate is 0.25 pounds of active ingredient per acre per year (lbs a.i./A) for berries, with three applications and a maximum annual app lication of 0.75 lbs a.i./A/year.

A Screening Level Usage Analysis (SLUA) was prepared by Biological and Economical Analysis Division (BEAD) for spiromesifen in 2014 that provides an estimate of pesticide agricultural usage data; EFED will use these data to evaluate different use profiles. Use on corn over the SLUA timeframe (2004-2012) accounted fo r less than 1% of the agricultural spiromesifen usage. However, the average poun ds of active ingredient used on corn was 30,000. Usage of spiromesifen in terms of pounds applie d and number of acres treated both showed a steady increase from 2005 (first registered ~15,000 lbs.) to 2012 (~100,000 lbs a.i.) (USEPA, 2014).

A review of total spiromesifen usage data for the last 5 years indicates that the major use sites are corn, potatoes, and strawberries , accounting for 86% of total us age in terms of pounds applied and 85% of acres treated for these crops. While corn, potatoes, and strawberries have the highest percentages of lbs. applied and acres treated, the crop with the highest percent crop treated is eggplant at 45%. This indicates that spiromesifen pl ays an important role in pest control for some crops grown in relative small amounts. Texas is the state with highe st usage in terms of both total pounds of spiromesifen a pplied and total acres treated. (USEPA, 2014).

According to the SLUA, average single application rates for spiromesifen across all crops from 2008 to 2012 range from 0.094lbs a.i./acre for arti chokes to 0.246 lbs a.i./acre for strawberries.

4. Conclusions from Previous Risk Assessments



### The most recent risk assessment was completed in June 7, 2010 for the use of spiromesifen on wheat, sorghum, dry peas, mint and leafy petiole s crop subgroup (4B) (USEPA, 2010a). Based on previous analyses, the registered uses of sp iromesifen may result in mortality on an acute exposure basis in freshwater fish and mollusks (freshwater and marine) and chronic effects on reproduction/survival in both terrest rial and aquatic animals.

Previous assessments noted that as a new cla ss of pesticide with a purportedly novel mode of action, there are uncertainties a ssociated with risk estimates for spiromesifen. Although the parent is likely to be no n-persistent and immobile, its degradat e (spiromesifen enol) is persistent and mobile. The likelihood of adverse effects to aquatic animals from acute exposure may be limited by the solubility of spiromesifen; however , the current battery of chronic terrestrial animal toxicity tests do not diffe rentiate whether chronic effects are due to parent spiromesifen or its degradates. Uncertainty was also identif ied with respect to th e potential effects of spiromesifen exposure on honey bee ( Apis mellifera ) larval development and how this may impact the colony. In previous ecological as sessments, risk conclusions were based on the parent compound alone and not degradates.

a. Drinking Water Exposure Assessments



### In previous assessments, the uses of spiromesif en on cranberries and ornamentals were expected to pose the highest potential exposure through drinking water due to these uses having the highest annual application rate (0.25 lb a.i. /A x 3 applications/cr op season, 7-day interval)

### 6 cranberries and 0.25 lb a.i./A x 3 applications/season for orna mental (four seasons were assumed; interval not specified) and were theref ore used as the basis for estimated drinking water concentrations (EDWCs) in surf ace as well as ground water (USE PA, 2010b). In addition, these exposure estimates reflected total residues of c oncern that included spir omesifen, BSN2060-enol and the BSN2060-carboxy degradate. The EDWCs were calculated using the Pesticide Root Zone Model coupled with the Exposure Analys is Model System (PRZM/EXAMS) for surface water and the Screening Concentration in Gr ound Water (SCIGROW) m odel for ground water. For surface water, the acute (peak) value was 199 ppb and 86 ppb for cranberries and ornamentals uses, respectively, and chronic values were 188 ppb and 86 ppb, respectively. The ground water screening concentration was 86 ppb for both uses.

b. Clean Water Act Programs



### Spiromesifen 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 Loads (TMDLs) or water quality criteria have been developed for spiromesifen 10



### .
Office of Pesticide Programs’ Aquatic Life Benchmarks 11 

### have been established for spiromesifen. Benchmarks are extracted from the most recent publically available OPP risk assessment for the pesticide and are based on the most sensitive aquatic toxicity data. These values are estimates of the co ncentration below which pesticid es are not expected to harm aquatic life.

5. Environmental Fate and Transport



### Spiromesifen is characterized as nonvolatile, relatively hydrophobic, and hardly mobile to immobile (FAO 2000) in soil. The parent compound is not expected persist as its degradation is moderately rapid in the environment (Goring et al . 1975), mainly through biotic ( i.e ., microbially mediated metabolism) and abiotic ( i.e ., hydrolysis, especially under al kaline conditions) routes.

Due to the limited soil mobility of spiromesifen, erosion, i.e. , runoff of sediment-bound residues, will be an important means of transport off of agricultural fields and the compound will associate predominately with the sediment phase of wate r bodies. Spiromesifen pa rent is not a ground water concern due to the chemical’s limited soil mobility and moderate biodegradation half-lives (on the order of weeks). However, its major transformation products ( i.e ., BSN2060-enol and BSN2060-carboxy) are highly mobile and generally more persistent than the parent compound. Therefore, these degradates may reach ground wate r and surface water bodies more readily than spiromesifen parent.

Table 1 summarizes the physicochemical properties of spir omesifen. Briefly, spiromesifen is nonvolatile on dry surfaces due to a low vapor pressure (7.5 x 10 -8 

### torr at 25°C). However, the compound is slightly volatile from water due to its relatively low solubility in water (0.13 mg/L at 25oC).

10 http://iaspub.epa.gov/tmdl_water s10/attains_nation_cy.cause_de tail_303d?p_cause_group_id=885

11 USEPA. 2014. Office of Pesticide Programs’ Aquatic Life Benchmarks. http://www.epa.gov/oppefed1/ecorisk_de rs/aquatic_life_benchmark.htm

### 7 Although, the compound has relatively high K ow 

### (4.6), bioconcentration factors are 916X, 1295X, and 512X for the whole fish, non-edible, a nd edible tissues, resp ectively. However, spiromesifen rapidly depurated from fish tissues in freshwater, with a de puration half-life of 2.3 days. These BCF values suggest that the compound is metabolized/excreted in fish but there is uncertainty as to the extent to which other aq uatic organisms may be able to do the same.

Spiromesifen is characterized as hardly mobile to immobile in soil, with organic carbon partition coefficient (K OC 

### ) values of 45,900 to 106,000 L/kg oc 

### . These sorption values indicate that spiromesifen parent will not readily leach in to ground water, but may move into surface water sorbed to sediment in runoff, especia lly in acidic to neutral environments.

Spiromesifen degrades in the environment ma inly through hydrolysis, although degradation via biotic and other abiotic proces ses may also occur (e.g. photolysis in water). Hydrolysis of spiromesifen is pH-dependent, as the compound de grades readily in alkaline environments (halflife of 4.4 days at pH 9) but more slowly in neut ral to acidic conditions (h alf-lives of 26 days at pH 7 and 48 days at pH 4). The major hydrolytic products are BSN2060-enol (up to 96% of the applied) and 3'3-dimethylbutanoic acid.

Table 1. Chemical Properties and Environ mental Fate Parameters of Spiromesifen

Parameter Value Description Reference

Chemical Classification Keto-enol class

MRID 46059302

Molecular Formula C 23 H 30 O 4

PC Code 024875

Chemical Name (IUPAC) 3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en4-yl 3,3-dimethylbutyrate

Chemical Name (CAS) 2-oxo-3-(2,4,6-trimethylphenyl)-1- oxaspiro[4.4]non-3-en-4-yl 3,3- dimethylbutanoate

CAS Number 283594-90-1
Water Solubility at 25 o C (ppm) 0.13 Hydrophobic MRID 45854501

Pesticide Classification Insecticide

MRID 46059302 Molecular Weight 370.5 g/mol

Vapor pressure (25 o C) 7.5 x 10 -8 torr Non volatile Henry's Law Constant at pH 7 2.8 x 10 -7 atm m 3 /mol Non volatile
Log Octanol/Water Partition coefficient (log K ow ) 3.6 x 10 4 Potential to bioaccumulate

Persistence

Hydrolysis 48 d (pH 4) 26 d (pH 7) 4.4 d (pH 9) Non to slightly persistent MRID 45819734

### 8 Parameter Value Description Reference

Direct photolysis in water at pH 7 6.1 d (dark control-adjusted) Non persistent MRID 45819811

Photolysis on soil No evidence of degradation (dark controladjusted) Stable MRID 45819801

Aerobic soil metabolism 12 d (Hesperia; Calif.; pH 8.5) 16 d (Hesperia; Calif.; pH 9.0) 19 d (not reported; Germany; pH 7.2) 20 d (not reported; Germany; pH 7.1)

45 d (not reported; Texas; pH 7.1) 49 d (not reported; Calif.; pH 6.9) Non to slightly persistent MRID 45819808, MRID 45819824, MRID 45819825

Anaerobic soil

metabolism Not submitted
Anaerobic Aquatic metabolism 18 d (pH 7.1-8.1) Non persistent 

### MRID 45819802 Aerobic aquatic

metabolism 12 d (pH 7.2-8.6) 18 d (pH 3.7-8.3) Non persistent MRID 45819803 MRID 45819804 Field Dissipation

Terrestrial field

dissipation 2.1 d (Hesperia; Calif.; pH 8.1) 4.3 d (Quincy; Wash.; pH 6.9) 4.7 d (Amarillo; Texas; pH 8.1) 9.6 d (Millhopper; Florida; pH 6.9) Non persistent MRIDs 45819805 45819807 45819812 45819813

Mobility

Leaching and absorption/desorption Parent K oc in mL/g 45,296 (sandy loam)

79,472 (silt loam)

46,816 (loam) 106,000 (clay loam) Immobile 45819806

BSN2060-enol Metabolite K oc and K d in mL/g 10 and 0.0549 (sandy loam) 5.6 and 0.083 (silty clay loam) 5.0 and 0.0908 (sandy loam) 2.5 and 0.0659 (silt) Mobile 45819819

BSN2060-4-carboxy Metabolite
K oc and K d in mL/g 3.0 and 0.65 (silty clay loam) Mobile 45819821

Fish Bioconcentration

Bioconcentration in fish (BCF) 916x (whole fish); 512x (edible tissue) 1295(~viscera) Depuration time=2.3 d Prone to bioaccumulate but fast depuration time 45819720

AR=Applied Radioactivity Classification of persistency wa s based on Goring scale, 1975. Mobility was described using FAO, 2000.

### 9 a. Transformation Products



### Two major degradates (occurring at greater than 10% of the applied) were identified in the registrant-submitted studies. These were 1

- oxaspiro[4.4]non-3-en-2-one, 4- hydroxy-3-(2,4,6- trimethylphenyl) [ i. e ., BSN2060-enol] and benzoi c acid, 4-(4-hydroxy-2-oxo-1- oxaspiro[4.4]non-3-en-3-yl)-3,5-dimethyl [i.e., BSN2060-4-carboxy]. BS N2060-enol is a hydrolytic degradate that appeared in all degradation studi es at levels up to 100% of the applied; whereas BSN2060-4-carboxy was only formed at substant ial levels (up to 14% of the applied) in the aerobic soil metabolism studies. An unide ntified conjugate of BSN2060-enol was also formed in an aerobic aquatic system, at up to 11% of the applied. Summary details of the degradates of spiromesifen are listed in Table 2

. Independent studies on degradate properties were submitted only to address sorption of the two major identified degradates. Other properties such as photolysis, hydrolysis, aerobic soil and aerobic aquatic metabolism study have been inferred from studies on the parent.

Relative to the parent compound, sorption coe fficients for both BSN2060-enol and BSN2060-4- carboxy were very low in the studies with K OC 

### values that ranged from 2.5 to 10 mL/g and 3.0 mL/g respectively.

In photolysis studies on the parent, there wa s no indication that either BSN2060-enol or BSN2060-4-carboxy degrades significantly by photolysis or hydrolysis.10Table 2. Spiromesifen and its Environmental DegradatesChemical Name and StructureMaximum Percent ofApplied Dose(interval)Final Percent of AppliedDose(study duration)MRIDStudy Type(OCSPP guideline)Spiromesifen (parent)IUPAC Name:3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrateCAS Name:2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoateCAS. No.:283594-90-1Synonyms:BSN2060BSN2060-enolCAS Name:4-hydroxy-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-oneCAS No.:148476-30-6Synonyms:spiromesifen-enol; enol; BSN0546;BSN0546-dihydrofuranone; tetronic acid BSN 206029.7%(672 hrs) 27.5% (720 hrs) 45819734Hydrolysis (835.2120)54.3%(720 hrs) 54.3% (720 hrs)95.7%(720 hrs) 95.7% (720 hrs)light-12.3%(120 hrs)dark-13.9%(216 hrs)light-12.3% (120 hrs)dark-13.9% (216 hrs)46059301 Aqueous photolysis(835.2240)light-11.6%(10 d)dark-24.1%(10 d)light-11.6% (10 d)dark-24.1% (10 d)45819801 Soil photolysis (835.2410)77.1%(7 d) 22.0% (120 d) 45819825 Aerobic soil metabolism(835.4100)85.0%(14 d) 45.3% (90 d) 45819808102%(120 d) 102% (120 d) 45819802 Anaerobic aquaticmetabolism (835.4400)99.1%(64 d) 85.6% (121 d) 45819803 Aerobic aquaticmetabolism (835.4300)89.0%(45 d)69.9% (90 d) 45819804OCH3CH3OOOCH3CH2CH3CH3CH3COCH3CH3OOHCH311Chemical Name and StructureMaximum Percent ofApplied Dose(interval)Final Percent of AppliedDose(study duration)MRIDStudy Type(OCSPP guideline)BSN2060-4-carboxyCAS Name:4-(4-hydroxy-2-oxo-1-oxaspiro[4.4]non-3-en-3-yl)-3,5-dimethyl-benzoicacidCAS No.:Not reported.Synonyms:BSN-4-carboxy; 4-carboxy; BSN2060acid; KTS 9439-6-2; 4-carboxyl-KTS943911.3%(90 d) 11.1% (120 d) 45819825 Aerobic soil metabolism(835.4100)14.1%(90 d) 14.1% (90 d) 45819808BSN2060-2-hydroxymethylCAS Name:4-hydroxy-3-[2-(hydroxymethyl)-4,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-oneCAS No.:Not reportedSynonyms:WAK 69252.3% (62 d) 2.2% (90 d) 45819808 Aerobic soil metabolism(835.4100)BSN2060-cyclobutyl photoisomerCAS name:3,5'-oxospiro[bicyclo[4.2.0]octa-1,3,5-triene-7,4'(5',H)-furan-2'(3',H),1"-cyclopentan]-3'-yl3,3-dimethylbutanoateCAS No.:Not reportedlight-35.8%(120 hrs)dark-NDlight-35.8% (120 hrs)dark-ND46059301 Aqueous photolysis(835.2240)OCH3CH3OOHHOOCOOHOOHHOOOO12Chemical Name and StructureMaximum Percent ofApplied Dose(interval)Final Percent of AppliedDose(study duration)MRIDStudy Type(OCSPP guideline)BSN2060-enol photoisomerCAS name:8',8'a-dihydro-8'-hydroxy-4',6'-dimethylspiro[cyclopentane-1,1'-[1H]indeno[1,2-c]furan]-3'(3'aH)-oneCAS No.:Not reportedlight-36.7%(120 hrs)dark-NDlight-36.7% (120 hrs)dark-ND46059301 Aqueous photolysis(835.2240)BSN2060-pentanoneCAS name:Not reportedCAS No.:Not reportedSynonyms:BSN2060-ketoenol6.7% (30 d) 0.3% (365 d) 45819824 Aerobic soil metabolism(835.4100)3.8% (30 d) 0.3% (272-365 d)1.4% (7 d) ND (120 d)1.9% (7 d) 0.1% (120 d)5.1% (62 d) 4.6% (120 d) 458198251.4% (62 d) 1.1% (90 d) 45819808Carbon dioxide (radiolabeled)72.3%(272 d) 72.1% (365 d) 45819824 Aerobic soil metabolism(835.4100)78.9%(365 d) 78.9% (365 d)71.0%(90 d) 70.3% (120 d)67.8%(120 d) 67.8% (120 d)30.1%(120 d) 30.1% (120 d) 4581982514.3%(90 d) 14.3% (90 d) 45819808Unidentified BSN2060-enol conjugate11.1%(20 d)3.3% (90 d) 45819804 Aerobic aquaticmetabolism (835.4300)NA = Not analyzed.ND = Not detected.OOHOC OOOCH3CH3OOHCH3O

### 13 6. Receptors



### A receptor is a biological entity that is exposed to a stressor (USEPA 1998). For this assessment, the receptors include terrestr ial and aquatic plants and an imals inhabiting fields where spiromesifen is applied, and those inhabiting n on-target areas to whic h spiromesifen may be transported ( e.g ., via spray drift and runoff) . Consistent with the process described in the Overview Document (USEPA 2004a), the assessment of spiromesifen uses a surrogate species approach. Toxicological data generated from su rrogate test species, which are intended to be representative of broad taxonomic groups, are used to extrapolate to potential effects on a variety of species (receptors) included unde r these taxonomic groupings.

The most sensitive acute and chronic toxicity data for spiromesifen across aquatic and terrestrial organisms are summarized in Table 3. Spiromesifen is characterized as practically nontoxic to terrestrial animals (birds, mammals and bees) on an acute exposure basis as median lethal doses exceed the maximum required test thresholds; howe ver, the compound’s acute toxicity to aquatic animals is uncertain. Acute aquatic guideline toxi city studies only tested up to what was deemed the “practical” solubility limit (approximately 50 μg a.i./L) of spiromesifen in some cases, and the median lethal concentrations exceed this test concentration limit. In some cases though, there is evidence to suggest that had testing been con ducted at concentrations slightly exceeding this practical solubility limit, a median effects concen tration may have been obtained. The extent of effects at the highest concentra tion tested for Eastern oyster ( Crassostrea virginica ) suggests that estimated environmental concentrations could reac h levels where a significant effect could occur following acute exposure in spite of the chemical’s limited solubility and propensity to sorb to sediments. Also there is uncertainty regarding the potential acute and chronic effects of the compound on honey bee larval development and surviv al as well as potentia l for chronic effects of adult bees.

Table 3. Summary of Most Sensitive Acute and Chro nic Toxicity Data on Spi romesifen for Aquatic and Terrestrial Organisms

Taxonomic Group Study Type Species Toxicity Value (measured a.i.) Toxicity Classification MRID (Study Classification) Aquatic Toxicity Endpoints

Freshwater Fish & Aquatic-phase Amphibians Acute Rainbow trout ( Oncorhynchus mykiss ) 96 hr LC 50 =16.8 μg/L Very highly toxic 458197-07 (Supplemental)

Chronic NOAEC=0.49 μg a.i./L LOAEC=0.97 μg a.i./L NA 458197-27 (Supplemental)

Freshwater Invertebrates Acute Waterflea ( Daphnia
magna ) 48 hr EC 50 >92.3 μg/L Highly toxic 458197-29 (Supplemental)

Chronic NOAEC=0.25 μg a.i./L LOAEC=0.45 μg a.i./L NA 458197-13 (Supplemental)

Estuarine/Marine Fish Acute Sheepshead minnow ( Cyprinodon variegatus ) 96 hr LC 50 >46.3 μg a.i./L Very highly toxic 458197-08 (Supplemental)

Estuarine/Marine Invertebrates Acute Eastern oyster ( Crassostrea

virginica ) 96 hr EC 50 >26 μg a.i./L (96-hr LC 50 ) Very highly toxic 458197-15 (Supplemental)
Chronic Mysid shrimp NOAEC=11 μg a.i./L NA 458197-11

### 14 ( Americamysis bahia ) LOAEC >11 μg a.i./L (Acceptable)

Freshwater Benthic Invertebrates Chronic Midge ( Chironomus

riparius ) NOAEC=0.25 mg a.i./kg sediment LOAEC=0.80 mg a.i./kg sediment NA 471331-03 (Acceptable)

Aquatic Vascular Plants NA Duckweed ( Lemna gibba ) 7-day EC 50 >101.3 μg a.i./L NA 458197-14 (Acceptable)

Aquatic Nonvascular Plants NA Green algae ( Pseudokirchneriella subcapitata ) 96-hr EC 50 >94 μg a.i./L NA 458197-03 (Acceptable)

Terrestrial Toxicity Endpoints

Birds, Reptiles, & Terrestrial-phase Amphibians Acute (oral) Bobwhite quail ( Colinus virginianus ) LD 50 >2000 mg/kg Practically non-toxic 458197-23 (Acceptable)

Sub-acute (dietary) Mallard duck ( Anas platyrhynchos ) LC 50 >5278 mg a.i./kg diet (5-day study) Practically non-toxic 458197-22 (Acceptable)

Chronic Bobwhite quail ( Colinus virginianus ) NOAEC=698 mg a.i./kg diet LOAEC >698 mg a.i./kg diet NA 471331-01 (Acceptable)

Mammals Acute (oral) Norway rat ( Rattus norvegicus ) LD 50 >2000 mg/kg Practically non-toxic 458195-14

Chronic NOAEC=30 mg a.i./kg diet LOAEC=120 mg a.i./kg diet NA 458196-19

Terrestrial Invertebrate Acute (contact) Adult honey bee ( Apis mellifera ) LC 50 >200 μg a.i./bee Practically non-toxic 458197-18 (Acceptable) Acute (oral) LC 50 =64.1μg a.i./bee 458197-17 (Supplemental)

Terrestrial Plants – Seedling Emergence NA Monocot - Rye
grass NOAEC=14 g a.i./ha EC 25 =27 g a.i./ha NA 458196-29 (Supplemental) Dicot - Turnip NOAEC=57 g a.i./ha EC 25 =220 g a.i./ha

Terrestrial Plants – Vegetative Vigor NA Monocot - Rye
grass NOAEC=114 g a.i./ha EC 25 =200 g a.i./ha NA 458196-29 (Supplemental) Dicot - Turnip NOAEC=57 g a.i./ha EC 25 =180 g a.i./ha NA=not applicable


### Toxicity studies on spiromesifen are not limited to laboratory based studies and previous risk assessments have identified uncertainty regarding the potential effects of spiromesifen on larval honey bee development. Semi-field studies indicat ed statistically significant (p<0.05) increases in larval mortality although these effects did not appear to impair ove rall colony performance. Two full-field studies have also been submitte d for the formulated product, but there were multiple confounding effects that li mited the utility of these st udies in determining whether brood are affected by exposure to spiromesifen and whether overall colony performance is impaired.

### 15 a. Degradate Toxicity Assessment



### Toxicity testing with the primar y degradate of spiromesifen (B SN2060-enol) indi cated that the compound is practically nontoxi c to freshwater fish (LC 50 

### >102 mg a.i./L; MRID 45819628) and freshwater invertebrates (EC 50 

### >101 mg a.i./L; MRID 45819730) on an acute exposure basis. Chronic toxicity testing of BS N2060-enol did not result in any treatment-related effects on growth, reproduction or survival of freshwater fish at the highest concentration tested (NOAEC=9.2 mg a.i./L; MRID 45819627). However, there is uncertainty regarding whether BSN2060-enol may have impacted time to hatch or time to swim-up since no data were provided on either of these endpoints. Ch ronic toxicity testing of BSN2060-enol indica ted an increase in adult mortality of freshwater invertebrates at 0.39 mg a.i./L (NOAEC =0.19 mg a.i./L; MRID 45819701). Aquatic plant toxicity testing of freshwater green alg ae with BSN2060-enol indicated that is orders of magnitude less toxic to aquatic plants than the parent compound, with an EC 05 

### of 1.9 mg a.i./L based on reduced cell density (EC 50 

### of 9.8 mg a.i./L; MRID 45819716). Toxicity information on the biodegradate of sp iromesifen, BSN2060-4-car boxy, is not available.

b. ECOSAR-Predicted vs. Observed Toxicity Endpoints Relative to Parent Spiromesifen



### For ecological exposure, only the parent compound is considered a residue of concern. Major environmental transformation products of a com pound may be of exposure concern. Available environmental fate data indicate that two ma jor transformation products (occurring at greater than 10% of the applied) were identified in the registrant-submitted studies. These transformation products were the BSN2060-enol and BSN2060-4-carboxy a nd may be present in the environment following use of spiromesifen. These degradates of exposure concern were further examined to determine which of them might be a factor in risk (rather than exposure) concern. In the absence of toxicity data, pred icted acute and chronic toxicity values for the major transformation products of bicyclopyro ne were estimated using EPA’s Ecological Structure Activity Relationships (ECOSAR) tool (v 1.11) 12 

### which is based on quantitative structure activity relationships (QSAR) for effects on fish, daphni ds, mysids, and green algae. Predicted toxicity values were also generated for parent bicycl opyrone and compared to observed endpoints from registrant-submitted studies to as sess confidence in ECOSAR predictions of the toxicity of spiromesifen’s transformation products.

ECOSAR-predicted toxicity values for parent sp iromesifen were roughly an order of magnitude less (more toxic) than observed measured toxic ity endpoints for chronic my sids and only slightly lower for acute green algae. In contrast, acute and chronic freshwater and saltwater fish and daphnia, as well as acute mysids and chronic gr een algae, ECOSAR-predicted values were all greater than that of the observe d values. No observed measured data is available for chronic saltwater fish and chronic green al gae for parent spiromesifen.

12 http://www.epa.gov/oppt/newchems/tools/21ecosar.htm

### 16 BSN2060-enol and BSN2060-4-carboxy

While the basic ringed structure is similar to sp iromesifen, removal of the largest side group of the parent produces the BSN2060-enol degradate. Addition of a carboxylic acid group to the BSN2060-enol results in the BSN 2060-4-carboxy degradate. Neit her of these degradates are more toxic than parent spiromesifen, with the BSN2060-4-carboxy de gradate showing less toxicity than BSN2060-enol. Th erefore, the BSN2060-enol and BSN2060-4-carboxy degradates will not be considered a stressors of concer n in the Registration Review ecological risk
assessment.

Table 4: ECOSAR-predict ed and Observed Toxicity Values fo r Spiromesifen and Major Degradates

Taxon Exposure duration Toxicity Value (μg/L) Observed ECOSAR-Predicted (Using ECOSAR Class Esters) Spiromesifen BSN2060-enol BSN2060-4- carboxy

FW fish 96-hr LC 50 Chronic value 16.8 0.49 206 7.0 1905 90 51519 2789

SW fish 96-hr LC 50 Chronic value 46.3 No Data 244 73.0 2527 541 71207 13532
Daphnid 48-hr EC/LC 50 Chronic Value >92.3 0.25 1 277 59.0 3118 1122 90566 39475 Mysid shrimp 96-hr LC 50 Chronic value >26 11 32.0 0.59 828 645 32381 98033 Green algae 96-hr EC 50 Chronic value >94 No Data 62.0 60.0 932 493 30078 12817

1 Based on available data



### c. Ecological Incidents



### The Ecological Incident Information System (E IIS) is an internal OPP database that houses ecological incidents that have b een reported to the Agency. When available, EIIS includes date and location of an incident, type and magnitude of effects observed in various species, use(s) of pesticides known or suspected of contributing to the incident, and results of any chemical residue analysis or other analyses c onducted during incident investig ation. EIIS incidents are categorized according to the certainty that the incident resulted from pesticide exposure. A search of the EIIS for ecological incidents run on October 22, 2014, identified nine incident reports for spiromesifen. All incidences i nvolved plants for either a registered or underdetermined use (registered uses included broccoli, corn, greenhouse, and ornamentals; Appendix B ).

The Avian Monitoring System (AIMS) 13 

### is a database administered by the American Bird Conservancy that contains publicly availabl e data on reported avian incidents involving

13 http://www.abcbirds.org/abcprograms/policy/toxins/aims/aims/login.cfm O

C H 3

C H 3 O O O

C H 3 C H 2 C H 3 C H 3

C H 3 C O

C H 3

C H 3 O O H

C H 3 O

C H 3

CH 3 O O H

HOOC

### 17 pesticides. Many of the incidents listed in this database are also in the EIIS. AIMS was also searched on October 22, 2014 and revealed no incident s to birds associated with spiromesifen. The aggregate incident database report, whic h typically reports non-major or aggregate incidences, was searched on November 26, 2014 and returned 4 plant incidences.

Incidents may have also occurred due to spirom esifen exposures but may not have been reported due to various factors, such as a lack of reportin g, or a lack of observation of effects. Therefore, the lack of incident report s does not necessarily indicate the absen ce of incidents.

7. Exposure Pathways of Concern



### For a pesticide to pose an ecological risk, it must reach ecological r eceptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological recepto r. For an ecological pathway to be complete, it must include a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, an d a feasible route of exposure.

The environmental fate properties of spiromesifen indicate the following transport mechanisms for potential exposure to aquati c and terrestrial organisms:

 Direct contact

 Spray drift

 Runoff

 Ground water discharge

 Consumption of contaminated food (sprayed food)

 Root uptake (plants)

 Bioaccumulation

For terrestrial organisms, the major routes of exposure to spiromesifen are considered to be direct contact as a result of direct application and spray drift and dietary ingestion of plants, animals, and/or soil that have spiromesifen residu es as a result of direct application, spray drift, and runoff.

For aquatic animal species, the major route of e xposure to spiromesifen is considered to be uptake via the respiratory surface (gills) or the integument from surface water/sediment that has spiromesifen residues as a result of spray drift and runoff. Bioaccumulation is another potential exposure pathway for aquatic animal species due to the high log K ow 

### of spiromesifen.

For terrestrial (upland and semi-aquatic) non-targ et plants, the major r outes of exposure to spiromesifen are considered to be direct contact as a result of direct ap plication and spray drift and root uptake via treated soil or soil contaminated via spray drift and runoff.

For aquatic plants, the major routes of exposure to spiromesifen ar e considered to be uptake from surface water/sediment containing spiromesifen resi dues as a result of sp ray drift, runoff, and leaching to ground water from soil where such ground water is used for irrigation purposes.

### 18 Modeling results using STIR indi cate that exposure to spiromesifen thr ough inhalation is not likely to be significant for birds or mammals (no LOC exceedances are expected via this potential route of exposure; Appendix C ).

8. Analysis Plan



### In order to address the risks, the potential for adverse effects on the environment is estimated. The uses, environmental fate, and ecological e ffects of spiromesifen are characterized and integrated to assess the risks. This is accomp lished using a risk quotient (ratio of exposure concentration to effects concentr ation) approach. Although risk is often defined as the likelihood and magnitude of adverse ecological effects, the risk quotient-based approach does not provide a quantitative estimate of likelihood an d/or magnitude of an adverse effect. However, as outlined in the Overview Document (USEPA, 2004), the li kelihood of effects to individual organisms from particular uses of spiromesifen is estimat ed using the probit dose-re sponse slope and either the level of concern (discussed below) or actual calculated risk quotient value.

This analysis plan may be revised depending upon the information submitted by the public in response to the opening of the Registra tion Review docket for spiromesifen.

a. Stressors of Concern

i. Ecological Risk Assessment



### Spiromesifen only will be considered in the eco logical risk assessment as available data on the primary degradate indicate that it is practical ly nontoxic on an acute exposure basis. Due to limited data on degradates they wi ll be characterized as an uncer tainty. There are currently no ecotoxicity data for terrestrial wildlife exposed to spiromesifen degradates. ECOSAR results of the two major degradates, BSN2060-enol a nd BSN2060-4-carboxy, indicat ed they were less toxic than parent spiromesifen by more than an order of magnitude. Therefore, the BSN2060- enol and BSN2060-4-carboxy degradates will not be considered a stressors of concern in the Registration Review ecological risk assessment.

ii. Drinking Water



### The drinking water assessments conducted to suppor t the Registration Review human health risk assessments of spiromesifen will incorporate m odel estimates of residues of concern, which are parent compound, BSN2060-enol and BSN2060-4-car boxy, in surface and ground water source drinking water. These degradates are mobile and more persis tent than the parent compound.

b. 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

.

### 19 i. Available Monitoring Data



### The Agency is not aware of su rface or ground water monitoring conducted by federal and state agencies. However, if monitoring data of spiromesif en become available, they will be considered in the assessment.

c. Measures of Effect



### Toxicity data presented in Section 6 of this problem formulation wi ll be used to calculate risk quotients. Any additional information submitted by th e registrant or found in the open literature meeting the standards established by the Agency prior to conduct of the risk assessment will also be considered. The open literature studies ar e identified using EPA’s ECOTOXicology database (ECOTOX) 14 

### , which employs a literature search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife. Th e evaluation of both sour ces 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 chemicals and from changes in structure and functional characteristics of the affected communities.

9. Endangered Species Assessments



### Consistent with the Agency’s responsibility under the Endangered Sp ecies Act (ESA), the Agency will evaluate risks to listed species from registered uses of pesticides in Registration Review. The process for evaluatin g potential risks to listed species is further described at http://www.epa.gov/oppfead1/enda nger/litstatus/riskasses.htm

.

10. Endocrine Disruptor Screening Program (EDSP)



### Spiromesifen was not included in the first or second group of chemicals for which orders to conduct Tier 1 EDSP testing were issued. For additional information th e EDSP program, visit http://www.epa.gov/endo/

.

11. Preliminary Identification of Data Gaps

a. Environmental Fate



### Table 4 identifies environmental fate studies, by master record identification (MRID) number, that provide data for each guide line requirement, as well as study classifications and whether or not further data are needed in order to support risk assessment.

14 http://cfpub.epa.gov/ecotox/

### 20 Table 4. Submitted Environmental Fate Data for Spiromesifen.

OCSPP Guideline Data Requirement Submitted MRIDs Study Classification Are additional data needed to

conduct risk assessment? Justification

835.2120 Hydrolysis 45819734 Acceptable No

--
835.2370 Aqueous Photolysis 45819811 Acceptable No

--
835.2410 Soil Photolysis 45819801 Supplemental No

--

835.4100 Aerobic Soil Metabolism 45819808 Supplemental

No -- 45819824 Acceptable

45819825 Acceptable

835.4200 Anaerobic Soil Metabolism Not submitted No --

835.4300 Aerobic Aquatic Metabolism 45819803
45819804 Supplemental No --

835.4400 Anaerobic Aquatic Metabolism 45819802 Supplemental No --

835.1230 Adsorption/ Desorption batch equilibrium 45819806 Supplemental

No -- 45819810 Supplemental

45819820 Invalid
45819819 Acceptable
45819821 Acceptable

835.1240 Aged Column Leaching 45819826 Supplemental No --

835.1410 Lab Volatility Not submitted No --

835.6100 Terrestrial; Field Dissipation 45819805 Acceptable

No -- 45819807 Acceptable
45819812 Acceptable
45819813 Acceptable

835.6200 Aquatic Field Dissipation Not submitted No --

835.1730 Bioaccumulation in Fish 45819720 Acceptable No --

850.6100 Environmental Chemistry Methods (ECM) and Independent Laboratory Validation (ILV) in soil Not submitted Yes This is a standard data requirement for field dissipation and ground water monitoring studies. ECM and associated ILV are not available for the method used in the field dissipation studies, though

this is a requirement for acceptance of such studies.

### 21 OCSPP Guideline Data Requirement Submitted MRIDs Study Classification Are additional data needed to

conduct risk assessment? Justification

850.6100 Environmental Chemistry Methods (ECM) and Independent Laboratory Validation (ILV) in
water Not submitted Yes This is a standard data requirement for field dissipation and ground water monitoring studies. ECM and associated ILV are not available for the method used in the field dissipation studies, though

this is a requirement for acceptance of such studies.

835.4399 Ground water-small prospective 47133102 Supplemental No --



### b. Effects



### Table 5 identifies ecological effects studies with spiromesifen, by MRID for each guideline requirement, as well as study classi fications and whether or not a dditional data are needed in order to support risk assessment. Rationales for any additional da ta are also presented. For nonguideline studies, data justification tables follow Table 5

.
Table 5. Submitted Ecological Effects Data for Spiro mesifen (TGAI=technical grade active ingredient; TEP=technical end product).

OCSPP Guideline Species Tested Submitted MRIDs Study Classifications Are additional data needed to

conduct risk assessment? Justification

Aquatic Organisms

850.1075 Freshwater fish

acute toxicity Rainbow trout Oncorhynchus mykiss 458197-07 Supplemental No --

Fathead Minnow Pimephales promelas 458197-09 Supplemental No --

Rainbow trout O. mykiss (TEP) 458197-25 Supplemental No --

Bluegill sunfish Lepomis macrochirus (TEP) 458197-26 Supplemental No --

850.1075 Saltwater fish acute toxicity Sheepshead minnow Cyprinodon variegatus 458197-08 Supplemental No --

### 22 OCSPP Guideline Species Tested Submitted MRIDs Study Classifications Are additional data needed to

conduct risk assessment? Justification

850.1010 Freshwater invertebrate acute toxicity Water flea Daphnia magna 458545-12 Supplemental No --

Water flea D. magna (TEP) 458197-29 Supplemental No --

850.1025 Estuarine/marine

mollusk acute toxicity Eastern oyster Crassostrea

virginica 458197-15 Supplemental No --

850.1035 Saltwater invertebrates acute toxicity Mysid shrimp Americamysis bahia 458197-02 Supplemental No --

850.1400 Freshwater fish early-life stage

toxicity test Rainbow trout O. mykiss 458197-27 Supplemental No --

850.1400 Saltwater fish early-life stage

toxicity test -- None -- Yes No data are available with which to assess chronic risk to estuarine/marine fish. Data are recommended due to spiromesifen’s outdoor use patterns, chronic effects to freshwater fish, potential forbioaccumulation, and a halflife in water >4 days. The sheepshead minnow ( Cyprinodon variegatus ) is a recommended test species.

850.1500 Fish full life

cycle test Fathead Minnow Pimephales promelas 458197-12 Supplemental No --

850.1300 Chronic toxicity

to freshwater invertebrates Water flea D. magna 458197-05 Supplemental No --

Water flea D. magna (TEP) 458197-10 Supplemental No Submitted data with spiromesifen formulated product (BSN 2060 240 SC;

23.1% ai) showed a nondefinitive endpoint less (<) than the lowest concentration tested. Therefore, a chronic test is needed to characterize the toxicity of the formulated product to D. magna

. Water flea D. magna (-enol degradate) 458197-01 Acceptable No --

### 23 OCSPP Guideline Species Tested Submitted MRIDs Study Classifications Are additional data needed to

conduct risk assessment? Justification

850.1350 Aquaticinvertebrate lifecycle test Mysid shrimp Americamysis bahia 458197-11 Acceptable No --

Benthic Invertebrates

OECD 218 Spiked sediment chronic freshwater invertebrate Midge Chironomus

riparius 471331-03 Acceptable No Sediment toxicity testing is recommended because spiromesifen is expected to partition to sediment (K oc =45,900-106,000 L/kg oc ;

K ow = 3.6x10 4 ). Chronic studies are recommended due to the aerobic soil metabolism half-life of >10 days

(anaerobic aquatic metabolism half-life = 18 days).

Studies of one additional freshwater species ( Hyalella
azteca ) and one estuarine/marine species ( Leptocheirus plumulosus ) are recommended. OECD 219 Spiked water chronic freshwater invertebrate Midge Chironomus

riparius 458197-28 Supplemental No

Non-guideline Whole sediment chronic freshwater invertebrate 15 -- None -- Yes

Non-guideline Whole sediment chronic estuarine/marine

invertebrate 16 -- None -- Yes

Aquatic Plants and Algae

850.4400 Aquatic plant toxicity, Lemna gibba Duckweed ( Lemna gibba ) 458197-14 Acceptable No --

15 An alternative approach for whole sediment chronic studies for Hyalella azteca may be considered. Sediment toxicity testing could first be conducted using the subchronic (10-d) sediment toxicity test guidelines (OSCPP 850.1735). Pending a comparison of estimated environmental concentrations (EEC) in sediment and pore water with toxicity results from the 10-d sediment toxicity studies, the need for one or more chronic sediment toxicity studies would be determined.

16 An alternative approach for whole sediment chronic studies for Leptocheirus plumulosus may be considered. Sediment toxicity testing could first be conducted using the subchronic (10-d) sediment toxicity test guidelines (OSCPP 850.1740). Pending a comparison of estimated envi ronmental concentrations (E EC) in sediment and pore water with toxicity results from the 10-d sediment toxicity studies, the need for one or more chronic sediment toxicity studies would be determined.

### 24 OCSPP Guideline Species Tested Submitted MRIDs Study Classifications Are additional data needed to

conduct risk assessment? Justification

850.4500 Algal toxicity Green algae Pseudokirchnerie

lla subcapitata 458197-03 Acceptable Yes Toxicity data on a marine diatom and a freshwater

diatom are needed for evaluation of risk to nonvascular aquatic plants. The marine diatom Skeletonema costatum and freshwater diatom Navicula pelliculosa are recommended test species.

850.4550 Aquatic plant growth: cyanobacteria -- None -- Yes Toxicity data on cyanobacteria are needed for evaluation of risk to nonvascular aquatic plants. Cyanobacteria ( Anabaena flos-aquae ) are recommended for this test. Terrestrial Organisms

850.2100 Avian acute oral toxicity Bobwhite Quail Colinus virginianus 458197-23 Acceptable No No data have been submitted to assess effects on passerine species. However, the lack of acute or sub-acute effects on the tested species indicates

that additional data are unlikely to impact the risk
assessment.

850.2200 Avian dietary toxicity Bobwhite Quail C. virginianus 458197-21 Supplemental No --

Mallard Duck Anas platyrhynchos 458197-22 Acceptable No --

850.2300

Avian reproduction test Bobwhite Quail C. virginianus 458197-24 Supplemental No -- 471331-01 Acceptable

Mallard Duck A. platyrhynchos 458196-26 Supplemental No -- 471422-01 Acceptable

850.3020 Adult honey bee

acute contact toxicity Honey Bee Apis mellifera 458197-18 Acceptable No --

Honey Bee A. mellifera (TEP) 458197-17 Acceptable No --

Non-guideline Adult honey bee Honey Bee A. mellifera 458197-18 Supplemental No --

### 25 OCSPP Guideline Species Tested Submitted MRIDs Study Classifications Are additional data needed to

conduct risk assessment? Justification

acute oral

toxicity TGAI Honey bee ( A. mellifera ) 458197-17 Supplemental No --

Non-Guideline

acute larval

toxicity TGAI Honey bee ( Apis mellifera)

None -- Yes Although data indicate spiromesifen is practically non-toxic to young adult honey bees on an acute exposure basis, no data are available on the acute and chronic toxicity for honey bee

larvae. Therefore, data are needed on acute and chronic toxicity of TGAI to honey bee larvae 1

. Non-Guideline chronic larval toxicity TGAI Honey bee ( Apis mellifera)

Non-guideline adult chronic oral (10-day) toxicity TGAI Honey bee ( Apis mellifera) None -- Yes This test is needed to evaluate the chronic toxicity of spiromesifen to adult honey bees 1

. Special study 17 (Tier II) Semi-field

Testing

TEP Honey bee ( Apis mellifera)

None -- Yes 2 Insect pollinators may be exposed if these compounds are applied at bloom or when

bees are foraging on extrafloral nectaries. Therefore, residues may be present in

pollen and/or nectar and represent a route of exposure for bees through both contact and ingestion. Field testing conducted with TEP. Special study

(Tier II) 18 Field trial of residues in pollen

and nectar with TEP Honey bee ( Apis mellifera)

850.3040 Field testing for pollinators Honey Bee A. mellifera (Greenhouse) 480335-01 Supplemental Yes 2
--

Honey Bee A. mellifera (Cotton field) 473444-01 Supplemental Yes 2
--

Honey Bee A. mellifera (Melon field) 479172-01 Supplemental Yes 2
--

Terrestrial Plants

850.4100 10 sp. (Tier I) 458197-06 Supplemental No --

17 Semi-field testing for pollinators with TEP would be needed based on the evaluation of the lower tier studies and the submitted field testing for pollinators studies.

18 Field trial of residues of residues in pollen and nectar with TEP would be needed based on the evaluation of the lower tier studies and the submitted fiel d testing for pollinators studies.

### 26 OCSPP Guideline Species Tested Submitted MRIDs Study Classifications Are additional data needed to

conduct risk assessment? Justification

Seedling Emergence Ryegrass, onion, turnip (Tier II) 458196-29 Supplemental No --

850.4150 Vegetative Vigor 10 sp. (Tier I) 458197-06 Supplemental No -- Ryegrass, turnip (Tier II) 458196-29 Supplemental No --

1 Data on TEP is required if the formulation may enhance the toxicity of the chemical.

2 Data requirement is dependent on a re-review of the submitted field studies with spiromesifen. TGAI=Technical Grade Ac tive Ingredient; TEP=typ ical End-Use Product



### Guideline Number: None (Agency-Wide Guidelines found in USEPA 2000 and 2001 19 

### ) Study Title: Whole sediment: Chronic toxi city, invertebrates freshwater and marine Rationale for Requiring the Data Only one chronic sediment toxicity test for freshwa ter or marine invertebrates has been submitted to satisfy the Agency’s updated data requirements for outdoor uses in 40 CFR Part 158 (October 26, 2007). Benthic organisms may be exposed residues in sediments as a result of run-off or spray drift from applications in terrestrial settings and based on the fate properties of spiromesifen. The following lines of evidence suggest the potential for exposure of benthic-dwelling organisms to spiromesifen: a K oc 

### of 45,900-106,000 L/kgoc and K ow 

### of 3.6x10 4 

### indicate that spiromesifen is likely to partition to sediment in aquatic environments. For freshwa ter sediment testing, a test on an amphipod ( e.g., Hyalella azteca) is preferred. The freshwater species, Hyalella and Chironomus, differ substantially in their ecological niche ( i.e., epibenthic vs. infaunal species), life history, and phylogeny. For estuarine/marine sediment testing, tests on one amphipod species is requested ( e.g., Leptocheirus plumulosus ).

In some situations, a tiered testing strategy may be considered for requesting chronic sediment toxicity testing. In this approach, sediment toxicity tes ting would first be conducted with the aforementioned species using the subchronic (10-d) sediment toxicity test guidelines (OSCPP 850.175 and 850.1740). Then, pending a comparison of estimated environm ental concentrations (EEC) in sediment and pore water with toxicity results from the 10-d sediment to xicity studies, the need for one or more chronic sediment toxicity studies would be determined. This tiered testing approach has the potential advantage of reducing the number of chronic (life cycle) studies that would be needed when results of the 10-d (subchronic) tests in conjunction with sedim ent EECs indicate chronic testing is not likely to alter risk assessment conclusions. In some cases, ho wever, this tiered testing approach may result in the conduct of both a 10-d (subchronic) and chronic (lif e cycle) study. Since no guideline is available for chronic testing, a protocol should be subm itted for EPA review and approval prior to study initiation. Practical Utility of the Data How will the data be used? Data from sediment toxicity studies will be used to estimate potential risks to benthic organisms associated with uses of spiromesifen. The data w ill reduce uncertainties associated with the current risk assessment for benthic species and will impr ove our understanding of the potential effects of

19 Benthic invertebrate guidance: http://www.epa.gov/pesticides/science/efed/policy_guida nce/team_authors/aquatic_biology_tech_team/ToxTesting_ EcoRiskAssessmentForBenthicInvertebrates.pdf

### 27 spiromesifen on aquatic ecosystems.

How could the data impact the Agency’s future decision-making? If the data indicate that registered spiromesifen u ses may pose a risk of adverse effects to non-target benthic organisms above the Agency Level of Con cern, the Agency may explore decision options to mitigate this risk. The lack of these data will limit the flexibility the Agency and registrants have in coming into compliance with the Endangered Species Act, and could result in use restrictions for spiromesifen which may otherwise be av oided, or which are unnecessarily severe.



### Study Title: Pollinator Acute Toxicity, Larvae Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings. Pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to the hive where developing larvae and pupae may be exposed. Therefore, potential adverse effects to developing bees could result from exposure to pesticide residues. Available toxicity studies do not address possible effects on brood (larvae a nd pupae) survival/development. Because of the potential for pollen and nectar to be contaminated with pesticide residues, and subsequently brought back to the hive, it is important to determine the acute toxicity of this compound to bee brood.

The Office of Pesticide Programs has made availa ble a guidance regarding ecological testing for terrestrial invertebrates using the honeybee as a surroga te test species. The guidance discusses Tier I laboratory-based acute toxicity studies of individual honeybee larvae as a critical component of the screening-level risk assessment process for examining potential risks from specific routes of exposure. The guidance be found at: http://www2.epa.gov/pollinator-prot ection/pollinator-risk-assessmentguidance . Additional guidance on larval honeybee toxicity test design can be found in OECD Test Guideline 237 ( http://www.oecdilibrary.org/docserver/download/9713171e.pdf?e xpires=1422485600&id=id&accname=guest&checksu m=D8E07C2B1DF77BF096C3B29F55BF86A7 ). Practical Utility of the Data How will the data be used? The Tier 1 acute toxicity data on honeybee larvae serve as a foundation for the screening-level assessment of potential risk to non-target organism s including federally listed threatened or endangered and non-listed terrestrial invertebrates, including pol linators, and/or modify their designated critical habitat from acute exposures to pesticides. The da ta will be used to reduce uncertainties associated with the risk assessment for terrestrial invertebrates and will improve EPA’s understanding of the potential effects on terrestrial species and whether th ere is a differential sensitivity of larval bees relative to adult bees. If acute effects data for larv ae are not available, risks to terrestrial insects from acute exposure will be assumed.

How could the data impact the Agency’s future decision-making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unr easonable adverse effects to non-target species or is likely to adversely affect listed threatened or enda ngered species and/or modify their designated critical habitat. Without these data, EPA may need to presu me risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restrictions.

### 28 Study Title: Pollinator Ch ronic Oral Toxicity, Adult Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if exposed to pesticides in various use settings. Pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to the hive. Therefore, potential chronic e ffects to adult honeybees and other pollinators from oral exposure to some pesticides could exist. Current ly available toxicity studies do not address possible lethal and sublethal effects of chronic oral exposure on adult terrestrial invertebrates and will assist in determining whether the sensitivity of adult bees differ s from that of earlier life stages. Because of the potential for pollen and nectar to be contaminated with pesticide residues, and subsequently brought back to the hive, it is important to determine the chronic oral toxicity of this compound to adult honeybees and other pollinators.

The Office of Pesticide Programs has made availa ble a guidance regarding ecological testing for invertebrates with the honeybee. The guidances discus ses Tier I laboratory-based chronic oral toxicity studies of individual adult honeybees as a critical co mponent of the screening-level risk assessment process for examining potential risks from specific rout es of exposure. The guidance can be found at: http://www2.epa.gov/pollinator-protecti on/pollinator-risk-assessment-guidance . Although study design elements for the chronic 10-day oral toxicity t est with honey bees are similar to the OECD TG 213 acute oral toxicity test ( http://www.oecdilibrary.org/docserver/download/9721301e.pdf?e xpires=1422484908&id=id&accname=guest&checksu m=C38495D2A570AC2216CFB1F223D24AA7 ), the proposed protocol for this study must be submitted for review and approval by EPA prior to initiating the test. Practical Utility of the Data How will the data be used? The Tier 1 chronic toxicity data on adult bees ser ve as a foundation for the screening-level assessment of potential risk to non-target organisms including federally listed threatened or endangered species and non-listed terrestrial invertebrates, including pollinators, from chronic oral exposu res to pesticides. The data will be used to reduce uncertainties associated wi th the risk assessment for terrestrial invertebrates and will improve EPA’s understanding of the potential di rect and indirect lethal and sublethal effects on a broad range of terrestrial species, particularly insect pollinators and to determine whether adult toxicity differs substantially from other life stages evalua ted in other Tier 1 tests. If chronic oral effects data for adults are not available, risks to terr estrial insects from chronic exposure will be assumed.

How could the data impact the Agency’s future decision-making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unr easonable adverse effects to non-target species or is likely to adversely affect listed threatened or endang ered species and/or their designated critical habitat. Without these data, EPA may need to presume risk wh ich will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restrictions.



### Study Title: Pollinator Chronic Toxicity, Larvae Rationale for Requiring the Data Terrestrial invertebrates are likely to be impacted if expos ed to pesticides in various use settings. Pesticide residues may be transferred to pollen and/or nectar of treated plants and subsequently brought back to the hive where la rvae and pupae may be exposed. Therefore, potential effects to developing b ees could result from chronic e xposure to pesticide residues. Available toxicity studies do not address possi ble chronic effects on br ood (larvae and pupae)

### 29 survival. Because of the potential for pollen a nd nectar to be contaminated with pesticide residues, and subsequently brough t back to the hive, it is im portant to determine chronic larval/pupal toxicity and whet her adult emergence is advers ely affected. This study will provide information on whether honeybee larvae differ in sensitivity from adult bees following chronic exposure.

The Office of Pesticide Programs has made ava ilable a guidance regarding ecological testing for invertebrates with the honeybee. The guida nce discusses Tier I la boratory-based chronic toxicity studies of individual honeybee larvae as a cri tical component of the screening-level risk assessment process for examining potential risks from specific routes of exposure. The guidance can be found at: http://www2.epa.gov/pollinator-p rotection/pollinator-riskassessment-guidance. Additional information on larval honeybee toxicity repeat exposure test design can be found in the OECD draft guidance ( http://www.oecd.org/env/eh s/testing/Draft_GD_honeyb ees_rep_exp_for_2nd_CR_25_Nove mber_2013.pdf ). Although study design elements for th e chronic 21-day toxicity test with honey bee larvae have been drafted, the proposed protocol for this study must be submitted for review and approval by EPA pr ior to initiating the test. Practical Utility of the Data How will the data be used? The Tier 1 chronic toxicity data on bee larv ae serve as a foundation fo r the screening-level assessment of potential risk to non-target organisms including fede rally listed threatened or endangered and non-listed terrestr ial invertebrates, including in sect pollinators, from chronic exposures to pesticides. These data will be us ed to reduce uncertainties associated with the risk assessment for terrestrial invertebrate s and will improve EPA’s understanding of the potential direct and indi rect lethal and sublethal effects on a broad range of terrestrial species, particularly insect pollinators. These data will also assist in determining whether early life stages of the bee differ in their sensitivity to pe sticides relative to adults. If chronic effects data for larvae are not availabl e, risks to terrestrial insect s from chronic exposure will be assumed.

How could the data impact the Agency’s future decision-making? The data will inform the determination requi red under FIFRA or the ESA as to whether continued registration of a pest icide is likely to result in un reasonable adverse effects to nontarget species or is likely to adversely affect listed threatened or e ndangered species and/or modify their designated critical habitat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in use restrictions.

Study Title: Tier II Semi-Field Toxicity Test ing for Pollinators (tunnel or colony feeding studies) Rationale for Requiring the Data The decision to move to more refined effects testing and to transiti on from laboratory-based studies with individual bees ( i.e.

, Tier 1 ) to colony-based studies (i.e.

, Tier 2 or Tier 3) depends on whether Tier 1 LOCs are exceeded, the availability of data, and the nature of the uncertainties that warrant further testing. The Tier 2 studies are typically considered “semi-

### 30 field,” studies where small coloni es are enclosed in tunnels, along with pesticide-treated crops. Tier 2 studies may also include feeding studies in which whole colonies are tested; however, the colonies are not confined to enclosures. The design of the Tier 2 tunnel study should be flexible in addressing the specific risks identified in the Tier 1 risk assessment for either foliar application, seed or soil trea tments, or other exposure routes of concern with reasonable modifications. The registrant should consult the Agency on the design of the protocol prior to the initiation of the study. Practical Utility of the Data How will the data be used? Tier II colony-level data will be used to asse ss potential risk to non-ta rget organisms including listed and non-listed terrestrial social invertebrate species and to determine whether effects observed in the screening-level (Tier I) laborato ry-based studies of indi vidual bees are evident in colony-level studies under semi-field conditi ons. The Tier II semi-field test of whole colonies is a relati vely controlled study, i.e ., bees are confined to a specific area, that is designed to represent potential field-level e xposure and account for hive dynamics, which are not achievable from other pollinator studies. This study will be used to determine whether adverse effects to insect polli nators at the whole colony le vel, may result for the use of pesticides and will help to refine risk estimates derived in the screening-level risk assessment for beneficial terrestrial inverteb rates. Measured residues in polle n/nectar can also be used to refine risk estimates derived from model-base d or default values in the screening-level
assessment.

How could the data impact the Agency’s future decision-making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pest icide is likely to result in unreasonable adverse effects to nontarget species or is likely to adversely affect federally listed threatened or endangered species or their designated critical hab itat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in significant use restrictions.

Study Title: Tier II Field trial of residues in pollen and nectar Rationale for Requiring the Data Pesticide residues may be transfer red to pollen and/or nectar of treated plants and subsequently brought back to the hive and may adversely affect developing brood (egg, larvae, and pupae) and adult bees. Since bee colonies are not confin ed to enclosures, colonies can be exposed for longer duration periods without subj ecting the bees to stress that typically results from Tier II tunnel studies. Available toxicity studies of individual bees (Tier 1) conducted to support screening-level assessments do not address po ssible effects and/or exposure to pesticide residues at the colony-level. Because of the pot ential for pollen and nectar to be contaminated with pesticide residues, and subs equently brought back to the hive , it is important to determine whether bee colonies may be negatively affect ed where bees are free foraging and have the option to collect/consume alternative forage items beyond the spiked food. Since multiple dose levels can be more readily tested, feedi ng studies can help to define dose-response relationships at the whole colony level.

### 31 The Office of Pesticide Programs has made ava ilable a guidance regardin g ecological testing f o invertebrates with the honeybee. This guidance describes the tiered te sting process and can b e found at: http://www2.epa.gov/pollinator-protectio n/pollinator-risk-assessment-guidanc e Additional information on honey bee colony feedi ng studies can be found in the EPPO Guidanc e 170 ( www.nationalbeeunit.com/downloadDocument.cfm?id=191 )

. 

### Although study design element for the feeding study are available through the EPPO Guidance 170, EPA requires that th e proposed protocol for this study be submitted fo r review and approval by EPA prior to initiatin g the test. Practical Utility of the Data How will the data be used? The data will be used to asse ss exposure and risk of spiromes ifen to non-target listed and nonlisted terrestrial invertebrate species, including bee pollinators. These data would allow the Agency to refine the screening level risk asse ssment for pollinating bees. Exposure data is an integral part of determining th e potential for risk to pollinat ing bees through direct exposure from their food sources.

How could the data impact the Agency’s future decision-making? The Tier II colony-level data will be used to refi ne screening-level risk estimates derived using Tier I laboratory-based data on individual bees. The Tier II data will help to inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unreasonable adverse effects to non- target species or is likely to adversely affect federally listed threatened or endangered species or th eir designated critical habitat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in significant use restrictions. Study Title: Tier III Full-Field T oxicity Testing for Pollinators Rationale for Requiring the Data Tier III studies are conditional on the outcome of the screenin g-level assessment (Tier 1) where acute and/or chronic risk levels of concern have been exceeded for terrestrial invertebrates and where Tier II studies either under semi-field tunnel conditions and/or feeding studies have indicated potential adverse effects at the colony level. Available toxicity studies from existing studies do not addr ess possible effects and/or expos ure to pesticide residues at the colony-level under actual pesticide use conditions and where specific uncertainties regarding the likelihood of exposure and/or effects remain. Full-field studies also provide an opportunity to measure residues in pollen and nectar as well as various matrices (beebread, honey, wax) within the colony to obtain a mo re realistic understa nding of exposure.

The Office of Pesticide Programs has made ava ilable a guidance regardin g ecological testing fo r invertebrates with the honeybee. This guidance describes the tiered testing process and can be found at: http://www2.epa.gov/pollinator-pro tection/pollinator-risk- assessment-guidance. Additional information on honey bee colony studies under full-field conditions can be found in the OCSPP 850.3040 ( http://www.regulations.gov/#!doc umentDetail;D=EPA-HQ-OPPT-2009- 0154-0018 ). Useful guidance is also availa ble through OCSPP 850.2500 (F ield Testing of Terrestrial Wildlife; http://www.epa.gov/ocspp/pubs/frs/public ations/Test_Guide lines/series850.htm ) Although

### 32 design elements for the full-field colony-le vel study are available through the 850.3040 and 850.2500, the proposed protocol for this study must be submitted for review and approval by EPA prior to initiating the test; the protocol should attempt to address specific uncertainties identified in lower-tier studies. Practical Utility of the Data How will the data be used? Tier III colony-level data will be used to furt her characterize potential risk to non-target organisms including listed and non-listed terrestria l social invertebrate species and to refine screening-level risk estimates that were based on individual bee re sponses. The full-field test is utilizes free-foraging bees and is designed to represen t potential field-level exposure under actual use conditions and account for hive dynamics, which are not achievable from lower-tier pollinator studies. This study will be used to determine whether adverse effects to insect pollinators at the whole colony level, may resu lt for the use of pesticides; residue data collected during field studies can be used to refine the screening-level risk estimates for beneficial terrestrial invertebrates.

How could the data impact the Agency’s future decision-making? The data will inform the determination required under FIFRA or the ESA as to whether continued registration of a pesticide is likely to result in unreasonable adverse effects to nontarget species or is likely to adversely affect federally listed threatened or endangered species or their designated critical hab itat. Without these data, EPA may need to presume risk which will limit the flexibility of pesticide products to comply with FIFRA and the ESA, and could result in significant use restrictions.

12. References

Arthur, E., L. Bowers, L. Buckelew, R. Christenson, V. Dorr, F. Duah, J. Fisher, T. Gould, I. Kelly, C. Lenz, J. Mixson, L. Russo, K. Shearer, V. Standart, and L. Stocky. 2003. Reduced Risk Rationale for the Use of Spiromesifen on Field Corn, Cotton, Vegeta ble and Fruit Crops, Cucurbit Vegetables, Fruiting Vegetables, Leafy Vegetables, Tuber Vegetables, Strawberry and Nursery, Greenhouse and Landscape Ornamentals. Bayer Crop Science, Research Triangle Park, NC 27709.

Fischer, R. and J. Benet-Buchholz. 2002. Chemistr y and stereochemistry of spirodiclofen (BAJ 2740). Pflanzenschutz-Nachrichten Bayer 55: 137-148.

Food and Agriculture Organization of the United Nati ons. FAO Pesticide Disposal Series 8. Assessing Soil Contamination: A Reference Manual. Appendix 2. Pa rameters of pesticides that influence processes in the soil. Editorial Group, FAO Information Division: Rome, 2000. http://www.fao.org/docrep/003/X2570E/X2570E00.htm.

Goring, C.A. I.; Laskowki; D.A., Hamaker, J.H.; and Meikle, R.W. 1975. Principles of pesticide degradation in soil. pp. 135-172 in (Haque, R. and Freed, V.H. eds.) Environmental dynamics of pesticides. Plenum Press, NY.

USEPA 2000. Methods for Measuring the Toxicity and Bioaccumulation of Sediment-associated Contaminants with Freshwater Invert ebrates. EPA 600/R-99/064. March.

### 33 USEPA 2001. Methods for Assessing the Chronic Toxicity of Marine and Estuarine Sediment-associated Contaminants with the Amphipod Leptocheir us plumulosus. EPA 600/R-01/020. March.

USEPA 2004. Overview of the Ecological Risk Assess ment Process in the Office of Pesticide Programs, U.S. Environmental Protection Agency. Endangered and Threatened Species Effects Determinations. Office of Prevention, Pesticides and Toxic Substances, Office of Pesticide Programs, Washington, D.C. Available online at http://www.epa.gov/oppfead1/en danger/consultation/ecorisk-overview.pdf.

USEPA 2005. Young, D. and Steeger, T. Environmen tal Fate and Ecological Risk Assessment for the Registration of Spiromesifen. DP Barcode 289953. U.S. Environmental Protection Agency, Office of Chemical Safety and Pesticides Program, Environmen tal Fate and Effects Division. May 10, 2005.

USEPA 2010a. Clock- Rust, M. and Orrick, G. Envi ronmental Fate and Ecologi cal Risk Assessment for Proposed New Uses of Spiromesifen on Wheat, Sorghum , Dry Peas, Mint, and the Leafy Petioles Crop Subgroup (4B). DP Barcode 368560. U.S. Environmen tal Protection Agency, Office of Chemical Safety and Pesticides Program, Environm ental Fate and Effects Division. Memorandum to the Registration Division. June 7, 2010.

USEPA 2010b. Orrick, G. and Sutton, C. Drinking Water Exposure Assessment for Proposed New Uses of Spiromesifen on Wheat, Sorghum, Dry Peas, Mint , and the Leafy Petioles Crop Subgroup (4B). DP Barcode 368558, 373896, 374900. U.S. Environmental Pr otection Agency, Office of Chemical Safety and Pesticides Program, Environmental Fate and Effects Division. Memora ndum to the Registration Division. March 25, 2010.



### USEPA 2011. Clock- Rust, M. and Steeger, T. Response to Registrant Submissions on Systemicity of Keto-enols Spiromesifen, Spirodiclofen and Spir otetramat. DP Barcodes 385088, 384526. U.S. Environmental Protection Agency, Office of Chemical Safety and Pesticides Program, Environmental Fate and Effects Division. Memorandum to the Registration Division. April 4, 2011.



### USEPA 2014 BEAD Chemical Profile (BCP) for Registration Review: Spiromesifen (PC Code: 024875). Memorandum from Biological and Economic Analysis Division to Pesticide Re-evaluation Division. October 30.

### 34 13. Appendix A. Submitted Environmental Fate and Effects Studies of Spiromesifen

PC 024875- 

### SUBMITTED FATE STUDIES (as of 10/28/14)

161-1 Hydrolysis

MRID Citation Reference

45819734 Arthur, E.; Shepherd, J.; Parker, G. (2001) Hydrolysis of BSN2060 in pH 4,7, and 9 Sterile Aqueous Buffer Solutions at 25 and 50 (Degrees) C: Lab Project Number: BS072401: 109481. Unpublished study prepared by Bayer Corporation. 116 p.

46556601 Arthur, E.; Shepherd, J.; Parker, G. (2005) Hydrolysis of BSN2060 in pH 4, 7, and 9 Sterile Aqueous Buffer Solu tions at 25 and 50 Degrees Celsius. Project Number: 109481/1, BS072401. Unpublished study prepared by Bayer Cropscience LP. 116 p.

161-2 Photodegradation-water

45819809 Shepherd, J.; Arthur, E. (2001) Aqueous Photolysis of (Cyclopentyl-1-(Carbon 14)) BSN2060-Enol in pH 7 Sterile Buffer Solution at 25 (Degrees) C: Lab Project Number: BS082402: 110596. Unpublished study prepared by Bayer Corporation. 71 p.

45819811 Arthur, E.; Shepherd, J. (2001) Aqueous Photolysis of BSN2060 (Dihydrofuranone-3-(Carbon 14)) in pH 4 Sterile Aqueous Buffer at 25 (Degrees)

### 35 C: Lab Project Number: BS082401: 110962. Unpublished study prepared by Bayer Corporation. 92 p.

45819823 Hellpointer, E. (2001) Determination of the Quantum Yield and Assessment of the Environmental Half-Life of the Direct Photodegradation in Water of BSN2060: Lab Project Number: M 143 0944-5: MR-120/01: HPO-216. Unpublished study prepared by Bayer AG. 34 p.

46059301 Arthur, E.; Shepherd, J. (2003) Aqueous Photolysis of BSN2060 [Dihydrofuranone-3-(Carbon 14)] in pH 4 Sterile Aqueous Buffer at 25 Degrees C. Project Number: 110962/1, BS082401. Unpublished study prepared by Bayer Corp. 92 p.

45819818 Fisher, J.; Sabbagh, G. (2002) BSN2060 Aqueous Photolysis Exposure Assessment: Lab Project Number: 220262: 110962: 110044. Unpublished study prepared by Bayer Corporation. 19 p.

161-3 Photodegradation-soil

45819801 Shepherd, J.; Arthur, E.; Ripperger, R. (2001) Soil Photolysis of (Dihydrofuranone-3- (Carbon 14)) BSN2060: Lab Project Number: BS082101: 11028. Unpublished study prepared by Bayer Corporation. 90 p.

161-4 Photodegradation-air

45819822 Hellpointer, E. (1999) Calculation of the Chemical Lifetime of BSN2060 in the Troposphere: Lab Project Number: HP0169: MR-090/99. Unpublished study prepared by Bayer AG. 12 p.

162-1 Aerobic soil metabolism

45819808 Ripperger, R.; Hall, L. (2001) Aerobic Soil Metabolism of (Cyclopentyl-1-(Carbon 14)) BSN2060 in Fresno, California Soil: Lab Project Number: BS042101: 110450. Unpublished study prepared by Bayer Corporation. 97 p.
45819824 Brumhard, B.; Elke, K. (2001) Aerobic Degradation and Metabolism of (Dihydrofuranone-3-(Carbon 14)) BSN2060 in Soils: Lab Project Number: M1250959-1: MR-229/01. Unpublished study prepared by Bayer AG. 101 p.

45819825 Baczinski, P. (2001) Aerobic Degradation and Me tabolism of (Phenyl-UL-(Carbon 14)) BSN2060 in Soil: Lab Project Number: M 1251034-6: MR-361/00. Unpublished study prepared by Bayer AG. 64 p.
45819827 Schad, T. (2001) Calculation of Degr adation Rates of BSN2060 and its Metabolites BSN2060-Enol and BSN2060-4-Carboxy Based on Aerobic Soil Degradation Studies: Lab Project Number: MR-501/01: P668 01 6778. Unpublished study prepared by Bayer AG. 27 p.

162-3 Anaero bic aquatic metabolism.

45819802 Arthur, E.; Desmarteau, D.; Wujcik, C. ; et. al. (2001) Anaerobic Aquatic Metabolism

### 36 of (Dihydrofuranone-3-(Carbon 14)) BSN2060 in a Fresno, California, Water and Sediment System: Lab Project Number: BS042401: 110039. Unpublished study prepared by Bayer Corporation. 123 p.

162-4 Aerobic aquatic metabolism.

45819803 Desmarteau, D.; Wujcik, C.; Arthur, E. (2001) Aerobic Aquatic Metabolism of (Dihydrofuranone-3-(Carbon 14)) BSN2060 in a Fresno, California, Water and Sediment System: Lab Project Number: BS042402: 110044. Unpublished study prepared by Bayer Corporation, ABC Laboratories and Agvise Laboratories, Inc. 141
p. 45819804 Desmarteau, D.; Wujcik, C.; Arthur, E. (2001) Aerobic Aquatic Metabolism of (Dihydrofuranone-3-(Carbon 14)) BSN2060 in a German Water and Sediment System: Lab Project Number: BS042403: 110045. Unpublished study prepared by Bayer Corporation. 140 p.

163-1 Leach/adsorption/desorption

45819735 Malekani, K.; Ripperger, R. (2000) Leaching Potential of Aged (Dihydrofuranon-3- (Carbon-14))BSN2060 Residues in Hesperia Sandy Loam: Lab Project Number: 109483: 99-B-166: BS092101. Unpublished study prepared by Bayer Corporation. 51
p. 45819806 Arthur, E.; Shepherd, J. (2002) Mob ility Determination of BSN2060 by Soil ThinLayer Chromatography in Four Soils: Lab Project Number: BS182101: 110342. Unpublished study prepared by Bayer Corporation. 54 p.
45819810 Desmarteau, D.; Aga, S. (2001) Estimat ion of the Adsorption Coefficients (Koc) of BSN2060, BSN2060-Cyclobutyl and BSN2060-Enol Photoisomers on Soil Using High Performance Liquid Chromatography (HPLC): Lab Project Number: BS184001: 110750. Unpublished study prepared by Bayer Corporation. 25 p.
45819819 Burhenne, J. (1998) Adsorption-Desorption of BSN 0546 (Tetronic Acid BSN 2060) on Soils: Lab Project Number: MO-99-001080: IM-1978: 1310010-6. Unpublished study prepared by University of Kassel. 41 p.
45819820 Hein, W. (1999) Adsorption-Desorption of (Dihydrofuranon-3-(Carbon 14)) BSN 2060 on Four Different Soils: Lab Project Number: BAY 32: IM-1981. Unpublished study prepared by Staatliche Lehr- und Forschungsanstalt. 21 p.
45819821 Hellpointer, E. (2001) Adsorption/Desorption of (Carbon 14)- BSN2060-4-Carboxy on Four Different Soils: Lab Project Number: BAY51: IM-1991. Unpublished study prepared by Staatliche Lehr-und Forschungsanstalt. 28 p.

45819826 Baczinski, P. (2001 ) Soil Column Leaching of BSN2060: Lab Project Number: M 1321075-9: MR-362/00. Unpublished study prepared by Bayer AG. 113 p.

164-1 Terrestrial field dissipation

45819415 Leimkuehler, W.; Ripperger, R. (2002) Analytical Method for the Determination of BSN2060 and Metabolite Residues in Soil: Lab Project Number: 110478.

### 37 Unpublished study prepared by Bayer Corporation. 37 p. {OPPTS 850.7100}
45819805 Dyer, D.; Wood, S.; Leimkuehler, W.; et. al. (2002) Terrestrial Field Dissipation of BSN2060 on Texas Soil, 1999: Lab Project Number: BS022101: 110327. Unpublished study prepared by Bayer Corporation, A & L Great Lakes Laboratories, Inc. and South Texas Ag Research. 100 p.
45819807 Dyer, D.; Wood, S.; Leimkuehler, W.; et al. (2002) Terrestrial Field Dissipation of BSN2060 on California Soil, 1999: Lab Project Number: BS022102: 110348. Unpublished study prepared by Bayer Corporation, A & L Great Lakes Laboratories, Inc. and Bayer Research Farm. 96 p.
45819812 Dyer, D.; Wood, S.; Leimkuehler, W.; et al. (2002) Terrestrial Field Dissipation of BSN2060 on Florida Soil, 1999: Lab Project Number: 110978: BS022103. Unpublished study prepared by Bayer Corporation, A & L Great Lakes Laboratories and Weed Systems Inc. 97 p.
45819813 Dyer, D.; Wood, S.; Leimkuehler, W.; et al. (2002) Terrestrial Field Dissipation of BSN2060 on Florida Soil, 1999: Lab Project Number: BS022104: 110986. Unpublished study prepared by Bayer Corporation, A & L Great Lakes Laboratories and Qualls Agricultural Laboratory. 89 p.
46059302 Arthur, E. (2003) Fate of BSN2060 in the Environment: Summary. Project Number: 200152/1. Unpublished study prepared by Bayer Corp. 68 p.

165-1 Confined rotational crop

45819409 Aikens, P. (2002) BSN 2060: Accumulation in Confined Rotational Crops: Lab Project Number: BAG 291: 200337: BAG 291/003753. Unpublished study prepared by Huntingdon Life Sciences, Ltd. 127 p. {OPPTS 860.1850}
45819503 Lemke, V. (2002) BSN 2060 240 SC--Magnitude of the Residue in Wheat (Rotational Crop Tolerance): Lab Project Number: BS19WH01: 200185: BS126- 00R. Unpublished study prepared by Bayer Corp. and Battelle--AgriFood. 597 p. {OPPTS 860.1900}
45819504 Lemke, V. (2002) BSN 2060 240 SC--Magnitude of the Residue in Barley (Rotational Crop Tolerance): Lab Project Number: BS19BA01: 200186: BS147- 00R. Unpublished study prepared by Bayer Corp. and Battelle--AgriFood. 427 p. {OPPTS 860.1900}

165-2 Field rotational crop

45819424 Beedle, E. (2002) BSN 2060 240 SC--Magnitude of the Residue in Alfalfa (Rotatational Crop Tolerance): Lab Project Number: BS19AL01: 200112: BS114- 00R. Unpublished study prepared by Bayer CropScience and Battelle--AgriFood. 311 p. {OPPTS 860.1900}
45819428 Harbin, A. (2002) BSN 2060 240 SC--Magnitude of the Residue in Sugar Beets (Rotational Crop Tolerance): Lab Project Number: BS19SB01: 200161: BS163- 00R. Unpublished study prepared by Bayer Corporation and Battelle-AgriFood. 316 p. {OPPTS 860.1900}

165-4 Bioaccumulation in fish

### 38 45819720 Caldwell, E. (2001) (Carbon 14)-(BSN 2060)--Bioconcentration in Rainbow Trout: Lab Project Number: BAG 317: BAG 317/994679. Unpublished study prepared by Huntingdon Life Sciences Ltd. 134 p. {OPPTS 850.1730}

166-1 Ground water-small prospective

835.4300 47133102 Shepherd, J.; Allan, J. (2007) Fate of Spiromesifen-Dihydrofuranone-3-[14- Carbon] Applied to a Laboratory Sediment Followed by Flooding and Incubated for 28 Days. Project Number: MEBSX019. Unpublished study prepared by Bayer CropScience LP. 52 p. *Conducted in conjunction with Chironomid 28 Day study

Non-Guideline Study Selections 45819430 Bauer, M. (2002) Independent Laboratory Validation of "Determination of BSN 2060 and Four Metabolites in Soil by LC-MS/MS": Lab Project Number: AG010018: BS112101: 200168. Unpublished study prepared by Bayer Corporation. 97 p. {OPPTS 850.7100}
45819432 Leimkuehler, W.; Woodard, D. (2002) Analytical Method for the Determination of BSN2060 and BSN2060-Enol in Water: Lab Project Number: 200173. Unpublished study prepared by Bayer Corporation. 23 p. {OPPTS 860.1400}
45819527 Moore, K. (2001) A Liquid Chromatographic Method for the Determination of BSN 2060 in Dose Preparations: Lab Project Number: 00-Q99-BG: 110219. Unpublished study prepared by Bayer Corp. 13 p.

45819814 Fisher, J.; Sabbagh, G. (2002) Estimation of Soil Adsorption Koc for BSN2060: Lab Project Number: 111039. Unpublished study prepared by Bayer Corporation. 24 p.

46059302 Arthur, E. (2003) Fate of BSN2060 in the Environment: Summary. Project Number: 200152/1. Unpublished study prepared by Bayer Corp. 68 p.



### SUBMITTED EFFECT STUDIES (as of 11/5/2014)

71-1 Avian Single Dose Oral Toxicity

MRID Citation Reference

45819723 2021802 Barfknecht, R. (1999) BSN 2060 Techn. a.i.: Acute Oral Toxicity for Bobwhite Quail (Colinus virginianus): Lab Project Number: BAR/LD026: E 292 1540-3. Unpublished study prepared by Bayer Ag Crop Protection. 35 p.

71-2 850.2200 Avian Dietary Toxicity

### 39 MRID Citation Reference

45819721 2021800 Barfknecht, R. (2001) BSN 2060 Techn.: 5- Day-Dietary LC50 to Bobwhite Quail (Colinus virginianus): Lab Project Number: BAR/LC004: E 296 1507-0. Unpublished study prepared by Bayer Ag Crop Protection. 39 p.

45819722 2021801 Barfknecht, R. (2001) BSN 2060 Techn.: 5-Day-Dietary LC50 to Mallard Duck (Anas platyrhynchos): Lab Project Number: BAR/LC008: E 297 1506-0. Unpublished study prepared by Bayer Ag Crop Protection. 39 p.

71-4 850.2300 Avian Reproduction

MRID Citation Reference

45819626 2021778 Mach, J.; Medlicott, B. (2001) Avian Repr oduction Study with BSN 2060 Technical in Mallard Ducks (Anas platyrhynchos): Amended Final Report: Lab Project Number: BS740801: 00021: 110119. Unpublished study prepared by Genesis Laboratories, Inc. 156 p. {OPPTS 850.2300}

45819724 2021803 Barfknecht, R. (2001) BSN 2060 Techn. a.i.: Effects of a Subchronic Dietary Exposure to the Northern Bobwhite Quail Including Effect s on Reproduction and Behavior: Lab Project Number: E 298 1505-0: BAR/REP003. Unpublished study prepared by Bayer Ag Crop Protection. 112 p.

47133101 2066626 Barfknecht, R. (2007) Effects of a Subchr onical Dietary Exposure to Northern Bobwhite Quails Including Effects on Reproduction and Behaviour. Project Number: E/205/3146/1, BAR/REP012. Unpublished study prepared by Bayer Ag. 260 p.

47142201 2066628 Christ, M.; Lam, C. (2007) Effect of Technical BSN 2060 (Spiromesifen) on Mallard Reproduction. Project Number: EBBSX044. Unpublished study prepared by Bayer CropScience. 73 p.

46260001 Registrant suggested results Bowers, L.; Fischer, D. (2004) Proposed NO EC and LOEC for the Avian Reproduction Study: "BSN 2060 Technical: Effects of a Subchronic Dietary Exposure to the Northern Bobwhite Quail Including Effects on Reproduc tion and Behavior". Project Number: 201034. Unpublished study prepared by Bayer Corp. 9 p.

46260002 Registrant suggested results Bowers, L.; Fischer, D. (2004) Proposed NO EC and LOEC for the Avian Reproduction Study: "Avian Reproduction Study with BSN 2060 Technical in Mallard Ducks (Anas platyrhynchos)". Project Number: 201033. Unpub lished study prepared by Bayer Corp. 9 p.

72-1 Acute Toxicity to Freshwater Fish

MRID Citation Reference

45819628 2021780 Peither, A. (2000) Acute Toxicity of BSN 2060-Enol to Rainbow Trout ( Oncorhynchus mykiss ): Lab Project Number: 737392: 110324. Unpublished study prepared by RCC Ltd. 37 p. {OPPTS 850.1075}
45819704 2021786 Hancock, G.; Lam, C. (2002) Acute Toxicity of BSN 2060 Technical to the Bluegill ( Lepomis macrochirus ) Under Flow-Through Conditions : Lab Project Number: BS810301: 110408. Unpublished study prepared by Bayer Corporation. 33 p.

45819707 2021789 Kern, M.; Hall, A.; Lam, C. (2002) Acute Toxicity of BSN 2060 Technical to the Rainbow Trout ( Oncorhynchus mykiss ) Under Flow-through Conditions: Lab Project Number: BS812201: 110970. Unpublished study prepared by Bayer Corporation. 34 p.

45819709 2021791 Hancock, G.; Lam, C. (2002) Acute Toxicity of BSN 2060 Technical to the Fathead Minnow ( Pimephales promelas ) Under Flow-through Conditions: Lab Project Number: BS811201: 110975. Unpublished study prepared by Bayer Corporation. 32 p.
45819725 2021804 Dorgerloh, M. (1999) BSN 2060 SC 240--Acute Toxicity (96 Hours) to Rainbow Trout

### 40 2025442 ( Oncorhynchus mykiss ) in a Static Test: Lab Project Number: DOM 99024: E 250 1546-3: 00482. Unpublished study prepared by Bayer Ag Crop Protection. 45 p.
45819726 2021805 Dorgerloh, M. (1999) BSN 2060 SC 240--Acute Toxicity (96 Hours) to Bluegill ( Lepomis macrochirus ) in a Static Test: Lab Project Number: DOM 99088: E 252 1697-2: 00482. Unpublished study prepared by Bayer Ag Crop Protection. 44 p.

72-2 Acute Toxicity to Freshwater Invertebrates

MRID Citation Reference

45819729 2021808 Heimbach, F. (1999) Acute Toxicity of BSN 2060 SC 240 to Waterfleas ( Daphnia magna ): Lab Project Number: E 320 1672-1: HBF/DM 213: MR-442/99. Unpublished study prepared by Bayer Ag Crop Protection. 29 p.

45819730 2021809 Heimbach, F. (2000) Acute Toxici ty of BSN 2060-Enol to Waterfleas ( Daphnia magna ): Lab Project Number: E 320 1716-0: HBF/DM 219: MR-602/99. Unpublished study prepared by Bayer Ag Crop Protection. 35 p.

45854512 2021782 Kern, M.; Lam, C. (2000) Acute Toxici ty of BSN 2060 Technical to the Waterflea ( Daphnia magna ) Under Static Conditions: Lab Projec t Number: BS820701: 109247. Unpublished study prepared by Bayer Corporation. 30 p.

72-3 Acute Toxicity to Estuarine/Marine Organisms

MRID Citation Reference

45819702 2021784 Lima, W. (2001) BSN 2060--Acute Toxicity to Mysids ( Americamysis bahia ) Under FlowThrough Conditions: Lab Project Number: BS833101: 110404: 13507.6133. Unpublished study prepared by Springborn Laborator ies, Inc. 48 p. {OPPTS 850.1035}

45819708 2021790 Hancock, G.; Woodard, D. (2002) Acute Toxicity of BSN 2060 Technical to the Sheepshead Minnow ( Cyprinodon variegatus ) Under Flow-through Conditions: Lab Project Number: 110974: BS812801. Unpublished study prepared by Bayer Corporation. 31 p.

45819715 2021796 Dionne, E. (2002) BSN 2060--Acute Toxicity to Eastern Oysters ( Crassostrea virginica ) Under Flow-through Conditions: Lab Proj ect Number: 13507.6132: BS861501: 200174. Unpublished study prepared by Springborn Laboratories, Inc. 56 p. {OPPTS 850.1025}

72-4 Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study

MRID Citation Reference

45819627 2021779 Sousa, J. (2001) BSN 2060 Enol (BSN 0546)--E arly Life-Stage Toxicity Test with Rainbow Trout ( Oncoryhnchus mykiss ): Lab Project Number: 13507.6136: BS842201: 110284. Unpublished study prepared by Springborn Laboratories, Inc. 71 p.

45819701 2021783 Kern, M.; Hall, A.; Mattern, G. (2002) Chronic Toxicity of BSN 2060 Enol to the Waterflea ( Daphnia magna ) Under Flow-Through Conditions: Lab Project Number: BS880701: 110349. Unpublished study prepared by Bayer Corporation. 60 p.

45819705 2021787 Kern, M.; Hall, A.; Lam, C. (2002) Chronic Toxicity of BSN 2060 Technical to the Waterflea ( Daphnia magna ) Under Flow-Through Conditions: Lab Project Number: BS820702: 110612. Unpublished study prepared by Bayer Corporation. 60 p.

45819710 2021792 Hall, A.; Kern, M.; Mattern, G. (2002) Chronic Toxicity of BSN 2060 240 SC to the Waterflea ( Daphnia Magna ) Under a Two Pulse Exposure Regime: Lab Project Number: 110992: BS820703. Unpublished study prepared by Bayer Corporation. 117 p.

### 41 45819711 2025446 Lima, W. (2002) BSN 2060--Life Cycle Toxicity Test with Mysids ( Americamysis bahia ): Lab Project Number: BS843101: 111024: 13507.6134. Unpublished study prepared by Springborn Laboratories, Inc. 71 p.
45819727 2021806 Dorgerloh, M.; Sommer, H. (2001) BSN 2060--Early Life Stage Toxicity to Rainbow Trout ( Oncorhynchus mykiss ) Under Flow-Through Conditions: Lab Project Number: DOM 99124: E 284 1484-1: 00482. Unpublished study prepared by Bayer Ag Crop Protection. 90 p.

45819713 2021794 Hall, A.; Hancock, G.; Leimkuehler, W. (2002) BSN 2060 240 SC Extended Laboratory Test to Assess Effects on a Population of Daphnia magna Under a Two Pulse Exposure Regime: Lab Project Number: BS880702: 200062. Unpublished study prepared by Bayer Corporation. 104 p.

72-5 Life cycle fish

MRID Citation Reference

45819712 2021793 Dionne, E. (2002) BSN 2060--The Full Life-Cycle Toxicity Test with Fathead Minnow ( Pimephales promelas ): Lab Project Number: 200052: BS851201: 13507.6138. Unpublished study prepared by Springborn Smithers Laboratories. 141 p.

122-1 Seed Germination/Seedline Emergence and Vegetable Vigor

MRID Citation Reference

45819706 2021788 2025445 Bowers, L. (2002) Tier 1 Seedling Emergence and Vegetative Vigor Non-target Phytotoxicity Study Using BSN 2060 SC 240: Lab Project Number: 110851: BS451601: BS451602. Unpublished study prepared by Bayer Corporation. 111 p.

123-1 Seed germination/seedling emergence and vegitative vigor

MRID Citation Reference

45819629 2021781 Bowers, L. (2002) Tier 2 Seedling Emergenc e and Vegetative Vigor Non-target Phytotoxicity Study Using BSN 2060 SC 240: Lab Project Number: BS451603: BS451605: BS451604. Unpublished study prepared by Bayer Corporation. 101 p.

123-2 Aquatic plant growth

MRID Citation Reference

45819703 2021785 2025443 Hancock, G.; Lam, C. (2002) Toxicity of BSN 2060 Technical to the Green Alga Pseudokirchneriella subcaptitat formerly Selenastrum capricornutum : Lab Project Number: 110407: BS823501. Unpublished study prepared by Bayer Corporation. 42 p.

45819714 2021795 2025444 Kern, M.; Lam, C. (2002) Toxicity of BSN 2060 Technical to Duckweed ( Lemna gibba G3): Lab Project Number: 200072: BS883701. Unpublished study prepared by Bayer Corporation. 45 p. {OPPTS 850.4400}

45819716 2021797 Seyfried, B. (2000) Toxicity of BSN 2060-Enol to Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum ) in a 96-Hour Algal Growth I nhibition Test: Lab Project Number: 737414: 200188: 737425. Unpublished study prepared by RCC Ltd. 48 p. {OPPTS 850.5400}

141-1 Honey bee acute contact

### 42 MRID Citation Reference

45819717 2021798 Wilhelmy, H. (2000) BSN 2060 SC 240 Acute Effects on the Honeybee Apis mellifera (Hymenoptera, Apidae): Lab Project Number: 200195: IBA63641: 990222BN. Unpublished study prepared by Dr. U. Noack Laboratorium. 34 p.
45819718 2021799 Wilhelmy, H. (2000) BSN 2060 a.i. Acute Effects on the Honeybee Apis mellifera (Hymenoptera, Apidae): Lab Project Number: 200196: IBA64031: 980708BN. Unpublished study prepared by Dr. U. Noack Laboratorium. 36 p.

141-4 Honey Bee Subacute Dietary Toxicity

MRID Citation Reference

45819718 2021799 Wilhelmy, H. (2000) BSN 2060 a.i. Acute Effects on the Honeybee Apis mellifera (Hymenoptera, Apidae): Lab Project Number: 200196: IBA64031: 980708BN. Unpublished study prepared by Dr. U. Noack Laboratorium. 36 p.

850.3030 Honey bee toxicity of residues on foliage

MRID Citation Reference

47737801 Flonicamid. Walsh, D. (2009) Pollinator Pesticide Safety Trials 2007: Flonicamid. Project Number: IB/2009/PH/002/01. Unpublished study prepared by Washington State University. 19 p.

850.3040 Field testing for pollinators

MRID Citation Reference

47093201 2063654 memo + DER Richards, K. (2007) Evaluation of inci 2SC when Applied to the Food Source of Honeybees ( Apis mellifera L.). Project Number: CAR/155/05, EBBSX046. Unpublished study prepared by Bayer CropScience LP and California Agricultural Research Inc. 131 p.

47344401 2079145- memo + DER as appendix Richards, K. (2008) Evaluation of OBERON 2SC When Applied to a Commercial Cotton Field Food Source on Honeybee ( Apis mellifera L) Hives. Project Number: CAR/121/07, EBBSL001. Unpublished study prepared by Californi a Agricultural Research Inc. and Bayer Cropscience. 114 p.

47917201 2081101 = protocol review Rogers, R.; Williams, G.; Binns, M. (2009) Honey Bee Field Study in Melons Treated with Oberon 2SC: Final Report. Project Number: EBBSY008, EBBSY008/1. Unpublished study prepared by Wildwood Labs, Inc. 316 p.

48033501 2085156 2085152 -

memo Bakker, F. (2010) A Greenhouse Study to Determine the Effects of Spiromesifen SC 240 on the Honeybee, under Particular Consideration of Effects to the Development of Honeybee Brood. Project Number: M/360890/02/1, B149AMS. Unpublished study prepared by MITOX Consultants. 98 p.

142-1 Acute Toxicity to Aquatic Insects

MRID Citation Reference

45819728 2021807 Heimbach, F. (1999) Influence of BSN 2060 (tech.) on Development and Emergence of

### 43 Larvae of Chironomus riparius in a Water-Sediment System: Lab Project Number: HBF/CH32: E 416 1525-4. Unpublished study prepared by Bayer Ag Crop Protection. 47 p.

47133103 2066627 Dorgerloh, M. (2007) Chironomus riparius 28-Day Chronic Toxicity Test with Spiromesifen (tech.) in a Water-Sediment System Us ing Spiked Sediment. Project Number: M/287709/01/1, E/416/3278/1, EBBSX045. Unpublished study prepared by Bayer Ag. 145 p.

Non Guideline Selections 45819731 2021810 Heimbach, F. (1999) Acute Toxici ty of BSN 2060 (tech.) to Earthworms Eisenia fetida : Lab Project Number: HBF/RG 292: E 310 1536-9. Unpublished study prepared by Bayer Ag Crop Protection. 17 p.

45819732 2021812 Heimbach, F. (1999) Influence of BSN 2060 SC 240 on the Reproduction of Earthworms Eisenia fetida : Lab Project Number: E 312 1653-1: HBF/RG 304. Unpublished study prepared by Bayer Ag Crop Protection. 23 p.

45819733 2021811 Heimbach, F. (1999) Acute Toxicity of BSN 2060 SC 240 to Earthworms Eisenia fetida : Lab Project Number: HBF/RG311: E 310 1656-2. Unpublished study prepared by Bayer Ag Crop Protection. 17 p.

46360501 Registrant response Bowers, L. (2004) Proposed Half-Life for Us e in the Terrestrial Vertebrate Exposure Assessment for Spiromesifen. Project Number: 201159. Unpublished study prepared by Bayer Corp. 18 p.

47133102 Fate study? Shepherd, J.; Allan, J. (2007) Fate of Spiromesifen-Dihydrofuranone-3-[14-Carbon] Applied to a Laboratory Sediment Followed by Floodi ng and Incubated for 28 Days. Project Number: MEBSX019. Unpublished study prepared by Bayer CropScience LP. 52 p.44/13844APPENDIX B. Ecological Incident Information System and Aggregate IncidentDatabase Report for SpiromesifenPC Codeommon NamType Incident ID Use Site Start Date Legality Certainty Country State County Yearotal Magnitu Appl. RateAppl. MethodAir/Gnd FormulationProduct Season024875Spiromesifen PLANTSI016912-017 Broccoli 12-Oct-05 Undetermined Probable USA AZ Yuma 2005 166 acres7.5oz/acre Spray AirSolubleconcentrate Oberon Autumn024875Spiromesifen PLANTSI016912-021Greenhouse 01-Jun-05 Registered use Possible USA CA San Diego 2005 unknown 4 lb/galFlowableconcentrate Judo Summer024875Spiromesifen PLANTSI017073-005Greenhouse 09-Jan-06 Registered use Possible USA FL 200650% ofareatreated 4 lb/gal NR Gnd SC Judo Winter024875Spiromesifen PLANTSI017245-008 Dracaena 09-Dec-05 Registered Use Possible USA MN Rice 2005121,000plantsSolubleConcentrate Judo Winter024875Spiromesifen PLANTSI017358-032Ornamental,herbaceous 13-Apr-06 Registered Use Possible USA PA 20063 fl oz/100gal Spray GndSolubleConcentrate Judo Spring024875Spiromesifen PLANTSI017496-017Greenhouse 12-Dec-05 Registered Use Possible USA HI Hawaii 2005$20,000-30,0003 fl oz/100gal Spray GndSolubleConcentrate Judo Spring024875Spiromesifen PLANTSI018502-018Greenhouse 18-Apr-07 Undetermined Possible USA FL 2007 200/gal A Spray GndSolubleConcentrate Judo024875Spiromesifen PLANTSI018718-036Ornamental, woody 01-Jun-07 Registered Use Probable USA VA Fauquier 2007 Unknown4 lb/100gal Spray Gnd Forbid Spring024875SpiromesifenTERRESTRIALI020741-001 Corn 19-Jul-06 Undetermined Unlikely USA CO Larimer 200622 beehives Air Oberon Summer45

### 46 Appendix C. Results from the Screening Tool for Inhalation Risk Assessment (STIR)



## Welcome to the EFED Screening Tool for Inhalation Risk This tool is designed to provide the risk assessor with a rapid method for determining the potential significance of the inhalation exposure route to birds and mammals in a risk assessment.


## Input

Application and Chemical Information Enter Chemical Name Spiromesifen Enter Chemical Use insecticide Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) ground Enter Chemical Molecular Weight (g/mole) 370.5 Enter Chemical Vapor Pressure (mmHg) 7.50E-08 Enter Application Rate (lb a.i./acre) 3

Toxicity Properties

Bird Enter Lowest Bird Oral LD 50 (mg/kg bw) 2000 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178 Mammal Enter Lowest Rat Oral LD 50 (mg/kg bw) 2000 Enter Lowest Rat Inhalation LC 50 (mg/L) 4.873 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.35


## Output Results Avian (0.020 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 1.50E-03 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 1.88E-04 Adjusted Inhalation LD 50 2.72E+01 Ratio of Vapor Dose to Adjusted Inhalation LD 50 6.92E-06 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 3.17E-01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 1.17E-02 Exposure not Likely Significant

Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 1.50E-03 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 2.36E-04 Adjusted Inhalation LD 50 2.90E+02 Ratio of Vapor Dose to Adjusted Inhalation LD 50 8.14E-07 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 3.98E-01 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 1.37E-03 Exposure not Likely Significant **NOTE**: When entering values, pres s order to update linked cells.