### - 1 - OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION UNITED STATES ENVIRONMENTAL PROTECTION AGENC Y WASHINGTON, D.C. 20460



### Date: September 17, 2015 PC Code: 129026 DP Barcode: D414537

MEMORANDUM

SUBJECT: Transmittal of Preliminary Environmental Fate and Ecological Risk Assessment for Registration Review of the Insect Growth Regulator, Tebufenozide

TO: Christina Scheltema, Chemical Review Manager Avivah Jakob, Team Leader Kelly Sherman, Branch Chief Risk Management and Implementation Branch III Pesticide Re-evaluation Division (7508P) Office of Pesticide Programs

FROM: Catherine Aubee, Senior Scientist Jim Carleton, Ph.D., Senior Fate Scientist Environmental Risk Branch IV Environmental Fate and Effects Division (7507P) Office of Pesticide Programs

THROUGH: Jean Holmes, D.V.M., M.P.H., Branch Chief Thomas Steeger, Ph.D., Senior Science Advisor Cheryl Sutton, Ph.D. Environmental Scientist Environmental Risk Branch IV Environmental Fate and Effects Division (7507P) Office of Pesticide Programs

The Environmental Fate and Effects Division has completed a preliminary risk assessment (PRA) that examines the risks to wildlife associated with labeled uses of the insect growth regulator (IGR), tebufenozide. The assessment and two associated files (ECOTOX bibliography and data table) are attached. Please contact us with any questions or concerns (Catherine Aubee, aubee.catherine@epa.gov , 703.347.8029; Jim Carleton, carleton.james@epa.gov , 703.347.0335). CATHERINE AUBEE 15:33:56 2015.09.17 '00'04-

T HOMAS STEEGER Digitally signed by THOMAS STEEGER DN: c=US, o=U.S. Government, ou=USEPA, ou=Staff, cn=THOMAS STEEGER, dnQualifier=0000012192 Date: 2015.09.18 08:52:34 -04'00'
JEAN HOLMES for Cheryl Sutton 2015.09.18 11:43:37 -04'00' 

# JEAN HOLMES Digitally signed by JEAN HOLMES DN: c=US, o=U.S. Government, ou=USEPA, ou=Staff, cn=JEAN HOLMES, dnQualifier=0000005813 Reason: for Jim Carleton Date: 2015.09.18 11:48:50 -04'00'

JEAN HOLMES 2015.09.18 11:50:25 -04'00'

# Preliminary Environmental Fate and Ecological Risk Assessment for Registration Review of the Insect Growth Regulator, Tebufenozide

Tebufenozide
CAS 112410-23-8 PC Code 129026



### September 17, 2015

Prepared by Catherine Aubee, Senior Scientist Jim Carleton, Ph.D., Senior Fate Scientist U.S. Environmental Protection Agency Office of Pesticide Programs Environmental Fate and Effects Division (EFED) Environmental Risk Branch IV 1200 Pennsylvania Ave., NW Mail Code 7507P Washington, DC 20460 

### Reviewed by Thomas Steeger, Ph.D., Senior Science Advisor Cheryl Sutton, Ph.D., Environmental Scientist Jean Holmes, D.V.M., M.P.H., Branch Chief 

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CATHERINE AUBEE 2015.09.17 '00'04- 15:29:06

T HOMAS STEEGER Digitally signed by THOMAS STEEGER DN: c=US, o=U.S. Government, ou=USEPA, ou=Staff, cn=THOMAS STEEGER, dnQualifier=0000012192 Date: 2015.09.18 08:50:58 -04'00' JEAN HOLMES for Jim Carleton 2015.09.18 11:53:14 -04'00'

JEAN HOLMES for Cheryl Sutton 2015.09.18 11:58:10 -04'00'

JEAN HOLMES 2015.09.18 11:58:42 -04'00'

### 1 

## Table of Contents

1. Executive Summary ............................................................................................................. . 2 2. Problem Formulation ................................................................................................. ....... 5 2.1. Nature of Regulatory Action ................................................................................................... .................. 5 2.2. Stressor Source and Distribution .............................................................................................. ................ 5 2.2.1 Nature of the Chemical Stressor ............................................................................................... ................ 5 2.3. Receptors ........................................................................................................ .......................................... 7 2.3.1. Aquatic and Terrestrial Effects ............................................................................................... ......... 7 2.3.2. Ecosystems Potentially at Risk ................................................................................. ....................... 7 2.4. Assessment Endpoints .......................................................................................................... ...................... 9 2.5. Conceptual Model and Risk Hypothesis .............................................................................. ................. 10 2.6. Analysis Plan ..................................................................................................... ...................................... 12 2.6.1. Measures of Exposure ........................................................................................... ......................... 12 2.6.2. Measures of Effect ............................................................................................. ............................. 13 2.6.3. Integration of Exposure and Effects ............................................................................ ................. 14 

### 3. Analysis ............................................................................................................ ................. 15 3.1 Use Characterization .......................................................................................................... ..................... 15 3.2. Exposure Characterization ..................................................................................................... ................. 17 3.2.1. Environmental Fate Characterization ........................................................................................... 17 3.2.2. Measures of Aquatic Exposure .................................................................................................. ..... 25 3.2.3. Measures of Terrest rial Exposure .............................................................................................. .... 29 3.3. Ecological Effects Characterization ........................................................................................... ............. 35 3.3.1. Aquatic Toxicity Assessment ................................................................................................... ....... 35 3.3.2. Terrestrial Toxicity Assessment ............................................................................................... ...... 42 3.3.3. Review of Incident Data ....................................................................................................... ........... 47 

### 4. Risk Characterization ......................................................................................................... 47 4.1. Screening-Level Risk Quot ient (RQ) Values ..................................................................................... .... 47 4.1.1. RQ Values for Aquatic Organisms ............................................................................................... . 47 4.1.2. RQ Values for Terres trial Organisms ........................................................................................... 53 4.2. Refinements ................................................................................................................... ........................... 58 4.2.1. RQs for Aquatic Animals Exposed to Tebufenozide Parent Only .............................................. 58 4.2.2. EECs and RQs for Terrestrial Animals Based on Mean and Upper Bound Kenaga EECs for Average Annual Application Rate ............................................................................................... ................... 59 4.3. Risk Description .............................................................................................................. ......................... 63 4.3.1. Risks to Aquatic Organisms .................................................................................................... ....... 63 4.3.2. Risks to Terrestrial Organisms ................................................................................................ ...... 66 

### 5. Endocrine Disruptor Screening Program (EDSP) ........................................................... 70 6. Federally Threatened and Endangered (Listed) Species of Concern ............................ 71 7. Conclusions ................................................................................................................... ....... 72 8. References .................................................................................................................... ........ 73

Appendix A. Chemical Names and Structures of Tebufenozide and its Degradates Appendix B. Provisional Cranberry Model Equations Appendix C. SWCC Sample Input/Output Data Appendix D. Example T-REX (v. 1.5.2) Input and Output for Tebufenozide Appendix E. Example Terrplant (v. 1.2.2) Input and Output for Tebufenozide Appendix F. STIR Input Parameters and Results Appendix G. SIP Input Parameters and Results Appendix H. Classifications of Environmental Fate Studies Submitted for Tebufenozide Appendix I. Classifications of Ecological Effects Studies Cited in the Risk Assessment for Tebufenozide

### 2 Attachments (Separate Electronic Files) Attachment I. Bibliography of ECOTOX Open Literature (June 2014 Refresh) Attachment II. ECOTOX Data Table (June 2014 Refresh)


## 1. Executive Summary

The preliminary risk assessment (PRA) in support of Registration Review for the insect growth regulator (IGR), tebufenozide, examines the risks to wildlife associated with its labeled uses. The risk assessment is based on the best available scientific and commercial information on the use, environmental fate and transport, and effects of tebufenozide on non-target organisms. This PRA includes two major components. First, a screening-level assessment is presented, consistent with prior assessments for tebufenozide pesticide registration actions. Second, where risks of concern are identified at the screening level, a refined analysis is presented and integrated into the risk description to further ch aracterize those risks to wildlife. Additional lines of evidence which may be useful to further refine the risk profile for tebufenozide are identified.

The assessment concludes that the use of tebufenozide in accordance with registered labels may result in chronic risks to mammals that exceed the Agency’s chronic risk Level of Concern (LOC). Adverse effects in mammals following chronic exposure to tebufenozide in laboratory studies include reduced growth and reproductive impairments. Sublethal effects ( i.e ., spleen lesions) in mammals have been observed at lower doses more comparable to environmentally relevant exposures for wildlife. Several uses of tebufenozide result in chronic risks to birds (and to reptiles and terrestrial-phase amphibians for which birds serve as surrogates) exposed to tebufenozide in the diet. The estimated risk is greatest for the labeled uses on tree nuts (almonds, walnuts, and other nuts) and pome fruits. The potential for adverse effects to terrestrial vertebrates from acute exposure from ingestion of tebufenozide residues is considered low. There is uncertainty regarding whether adverse effects may occur in non-target terrestrial invertebrates exposed through direct application and spray drift, consistent with the intended use of tebufenozide as an insect growth regulator. Available data indicate that tebufenozide is practically nontoxic to adult honey bees ( Apis mellifera ) on an acute exposure basis, but thesedata may not capture potential sublethal effects on larval insect growth and development. Semifield studies with methoxyfenozide, a structural analogue of tebufenozide, showed no adverse effects on honey bee colony overwintering survival, but a recently submitted laboratory-based study suggests that honey bee larvae may be sensitive to dietary exposure. Risks to terrestrial and aquatic plants from tebufenozide uses are below LOCs.

Although risk estimates exceed levels of concern for chronic risk to terrestrial vertebrates in cases where maximum application rates are used, refined estimates of exposure and risk (based on average annual usage data for certain crops) suggest that risk is lower on average. When survey-generated data on average annual usage are considered as an alternative to the maximum labeled application rate, chronic risks to growth and reproduction in mammals and in birds are generally at or below LOCs.

Aquatic estimated environmental concentrations (EECs) and risk estimates are presented for maximum labeled rates only. Various uses of tebufenozide present risk estimates that exceed

### 3 LOCs (for acute risk to listed species of estuarine/marine invertebrates and for chronic risk to freshwater animals ( e.g ., fish, amphibians, and invertebrates). For the use on cranberry, where exposure reflects application to areas that are, or that subsequently become, impounded (flooded bogs), risk of mortality also exceeds the LOC for nonlisted species of estuarine/marine invertebrates. The risks for estuarine/marine invertebrates are based upon mollusc toxicity data and extend to freshwater molluscs, which are not directly tested. This assessment considers the potential for aquatic exposure to total toxic residues (tebufenozide plus degradates), as outlined in the Problem Formulation, and exposure to tebufenozide parent compound only, since newly received data indicate that the degradates tested are less acutely toxic to aquatic organisms than parent tebufenozide. When only tebufenozide parent is considered, fewer uses result in LOC exceedances, and chronic risk to freshwater fish and amphibians is below the LOC.

Nonguideline data suggest that benthic organisms, such as freshwater midge larvae (Order: Diptera), may be more sensitive to tebufenozide exposure than fully aquatic and water-column dwelling invertebrates such as daphnia (Order: Cladocera) and mysid shrimp (Order: Mysida). Chronic (28-day) sediment toxicity data are needed to quantitatively assess risks.

Of all tebufenozide’s uses, the cranberry use generated the highest aquatic estimated environmental concentrations (EECs). The cranberry EECs reflect concentrations in undiluted cranberry bog water at a depth of 12 inches. In addition to non-target organisms that reside in cranberry bogs, these risks are conservatively assumed to also reflect risks to organisms that reside in receiving waters near points where cranberry bogs directly discharge to such waters. Based on the range of RQ values (acute <0.55, chronic< 3.65), risk estimates exceed LOCs for aquatic animal species thus exposed, assuming that waters are released immediately following treatment. To the extent that treated waters are held in the bog prior to release, residues would be expected to be somewhat attenuated, however given tebufenozide’s long aquatic half-life (~100 days for parent compound), the amount of attenuation is likely to be small. For the use on cranberries, exposures to non-target organisms may also occur as a consequence of tebufenozide applied to bogs in a pre-flooded state, wherein rainfall-runoff may subsequently result in transport of residues more immediately into adjacent water bodies. This scenario was addressed separately, using the same approach as for other field crops, using standard EFED surface water modeling tools.

Table 1 presents a summary of general risk conclusions for tebufenozide uses at the maximum labeled application rates. A shaded cell (“yes”) indicates that risk exceeds the Agency’s level of concern based on risk estimates or other lines of evidence, such as chemical mode of action. The risk characterization is presented in detail beginning in Section 4

.Table 1. General risk conclusions based on maximum labeled application rates for tebufenozide.Use(s)ÈFish andamphibiansAquaticinvertebratesAquaticplantsBirds, reptiles,and terrestrialamphibiansMammalsTerrestrialinvert.Terrestrialplants

Nonlisted acute Listed acute Chronic Nonlisted acute Listed acute Chronic Nonlisted Listed Nonlisted acute Listed acute Chronic Nonlisted acute Listed acute Chronic Acute Chronic Nonlsited ListedAgricultural UsesBushberries No NoNo NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoCaneberries NoNoNo NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoCanola NoNoYes+NoYes*,¥Yes^, ¥NoNoNoNoYes»NoNoYes»NoIGRNoNoCitrus NoNoYes+NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoCole crops and leafyvegetablesNoNoYes+NoYes*Yes^NoNoNoNoYes»NoNoYes»NoIGRNoNoCotton NoNoYes+NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoCranberries NoYes^Yes+Yes~Yes#Yes^No No No NoYes»No NoYes»NoIGR No NoFruiting vegetables NoNoYes+NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoMint NoNoYes+NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoPastures and rangeland NoNoNo NoYes*Yes^No No No No No No NoYes»NoIGR No NoPome fruits NoNoYes+NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoSugarcane NoNoYes+NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoTree nuts (almond,walnut, other nuts)NoNoYes+NoYes*Yes^NoNoNoNoYes»NoNoYes»NoIGRNoNoTree nuts (pecan) NoNoYes+NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoNon-agricultural UsesOrnamentals NoNoYes+NoYes*Yes^No No No NoYes»No NoYes»NoIGR No NoForest, trees and shrubs NoNoNo No No No No No No No No No NoYes»NoIGR No No^Risk to freshwater species. Uncertainty regarding estuarine/marine species due to lack of data or nondefinitive toxicity endpoints.+Chronic risk to freshwater fish and amphibians but not to estuarine/marine fish. Risk is below the LOC for exposure to tebufenozide parent only.~Acute risk to nonlisted species of freshwater molluscs and estuarine/marine invertebrates, based on estuarine/marine mollusc toxicity data.*Acute risk to listed species of freshwater molluscs and estuarine/marine invertebrates, based on estuarine/marine mollusc toxicity data.¥Risk is below the LOC for exposure to tebufenozide parent only.#Acute risk to listed species of freshwater and estuarine/marine invertebrates.»Level of concern (LOC) for dietary exposure is exceeded at the maximum labeled application rate but not at the highest averageannual application rate reported for tebufenozide(based on walnut use); however, dose-adjusted valuesstill exceed LOCs for mammals at the average rate.IGRTebufenozide is an insect growth regulator (IGR) intended to target lepidopterans (moths and butterflies). Nonguideline datawith honey bees showed mixed effects on honeybee larval development but clear risk assessment endpoints have not been established.

## 2. Problem Formulation

The purpose of problem formulation is to provide the foundation for the environmental fate and ecological risk assessment being conducted for the labeled uses of tebufenozide, which are summarized in the most recent usage report package compiled by the Biological and Economic Analysis Division (BEAD) (August 6, 2014). The problem formulation sets the objectives for the risk assessment and provides a plan for analyzing the data and characterizing the risk (USEPA 1998a). As part of the Registration Review process, a preliminary Problem Formulation (DP Barcode D352989) for this risk assessment was published to the docket [Docket ID: EPA-HQ-OPP-2008-0824] in November 2008. The following section summarizes the key points of that document and discusses any differences between the analysis outlined preliminary problem formulation and the analysis conducted in this risk assessment.

2.1. Nature of Regulatory Action

The risk assessment is conducted as part of the Agency’s Registration Review process for pesticide active ingredients. The Registration Review process was established under the Food Quality Protection Act (FQPA 1996).

2.2. Stressor Source and Distribution

2.2.1 Nature of the Chemical Stressor

Tebufenozide, benzoic acid, 3,5-dimethyl-1-(1,1-dimethylethyl)-2- (4-ethylbenzoyl) hydrazide (CAS No. 112410-23-8), belongs to the diacylhydrazine class of insecticides that mimic the endogenous steroidal molting hormone 20-hydroxyecdysone, binding to its receptor protein complex. As such tebufenozide is referred to as a (non-steroidal) ecdysone agonist (Dhadialla, Carlson, & Le, 1998) (Shimizu, et al., 1997). As an ecdysone agonist, tebufenozide induces a precocious, incomplete molt in insect larvae, particularly lepidopterae. The specificity of tebufenozide against lepidoptera is based on the chemical’s greater affinity for the lepidopteran ecdysone receptor protein complex as compared with other insects, and the ability of other insect orders to actively exclude the ecdysone agonist (Sundaram, Palli, Sohi, Dhadialla, & Retmakaran, 1998). Although most insect orders have been reported to be unaffected, ecdysone agonists have produced lethal effects in lepidopteran, dipteran and coleopteran larvae; symptoms in affected orders are similar to those expected from a state of ecdysone excess, called hyperecdysonism (Dhadialla, Carlson, & Le, 1998). After ingestion of toxic doses, sensitive larvae stop feeding, and the molting process initiates prematurely, leading to desiccation and ultimate death. Besides having larvicidal effects, the diacylhydrazines can cause reduced egg production in lepidopteran, coleopteran and dipteran insects, and can disrupt normal spermatogenic processes in several lepidopteran species (Dhadialla, Carlson, & Le, 1998).

Based on consultation with the Residues of Concern Knowledge-Base Subcommittee (ROCKS), tebufenozide and its major degradates the carboxylic acids RH-112651 and RH-112703, and ketone RH-96595 ( Table 3.4 ) are considered Residues of Concern (ROC) in surface waterderived drinking water. EFED thus included the parent and the three degradates in its drinking water assessment and has included them in the aquatic modeling for this (current) ecological risk

### 6 assessment. However, in the risk description section, a refinement of the assessment using parent tebufenozide only was conducted since newly received data indicate that the degradates tested are less acutely toxic to aquatic organisms than parent tebufenozide.

In the Total Toxic Residues (TTR) approach to model water exposures, the TTR comprise parent tebufenozide plus all three of its major metabolites (RH-112651, RH-112703 and RH-96595). Tebufenozide TTR was conservatively modeled as a single conceptual entity with SWCC and with the Provisional Cranberry Model, using an aerobic soil half-life representing the degradation of parent plus all three degradates, and a soil sorption coefficient (K OC 

### ) reflecting one of the degradates (RH-112651, which is more mobile than the parent), for which data were available. Table 2.1 presents an overview of tebufenozide’s structure and chemical profile.

Table 2.1. Chemical Profile of Tebufenozide. Common name Tebufenozide IUPAC name N-tert-Butyl-N ƍ -(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide

CAS name 3,5-Dimethylbenzoic acid 1-(1,1-dimethylethyl)-2-(4- ethylbenzoyl)hydrazide Structure

Pesticide type Insecticide Chemical class Diacylhydrazine CAS number 112410-23-8 Empirical formula C 22 H 28 N 2 O 2 Molecular mass 352.26



### 2.2.2 Overview of Pesticide Usage

Tebufenozide is an active ingredient in several formulated products registered for control of lepidopteran pests. Tebufenozide is registered for use on bushberries, caneberries, blueberries, brassica vegetables, canola, citrus, cotton, cranberries, fruiting vegetables, mint, ornamentals, pome fruit, sugar cane, tree nuts (including pecans, almonds and walnuts), other nuts, pastures and range land, forests and ornamental trees. Tebufenozide is formulated as a wettable powder and emulsifiable, flowable, and soluble concentrates . According to the Biological and Economic Analysis Division (BEAD) Chemical Profile for Registration Review (2011) for orchard crops, applications may occur at bloom through foliar stages, hull split, or pink through petal fall. For berry crops applications may occur at bloom through foliar stages. For field crops, ornamentals and forest trees, fruiting vegetables and other crops, applications are foliar only. Both aerial and ground spray are allowed for all uses, and a hand sprayer is also allowed for the ornamental use. Application rates and minimum retreatment intervals vary by use, with multiple applications allowed for all uses, and a maximum annual rate of 2.0 lb a.i./A for the fruiting vegetable, mint, and ornamental uses. Specific use rates are discussed in Section 3.1 . According to the most recent Screening Level Usage Analysis (SLUA) report provided by BEAD ( Table 3.2 ), the majority of tebufenozide is used on sugarcane, with 10,000 pounds of active ingredient applied C H 3 O

N N

C H 3 CH 3 CH 3 O CH 3

CH 3 H

### 7 per year to sugarcane over the 2004-2011 period. Tomatoes, almonds, walnuts, pecans and lettuce are also appreciable uses reported in the SLUA.

2.3. Receptors

2.3.1. Aquatic and Terrestrial Effects

The receptor is the biological entity that is exposed to the stressor (USEPA 1998). Consistent with the process described in the Overview Document (USEPA 2004), this risk assessment uses a surrogate species approach in its evaluation of tebufenozide. Toxicity data generated from surrogate test species, which are intended to be representative of broad taxonomic groups, are used to extrapolate potential effects on a variety of species (receptors) included under these taxonomic groupings.

Acute and chronic toxicity data from studies submitted by pesticide registrants along with the available open literature are used to evaluate potential direct effects of tebufenozide to aquatic and terrestrial receptors. The open literature studies are located through EPA’s database ECOTOX ( http://cfpub.epa.gov/ecotox/ ), which provides a source for locating single chemical toxicity data for aquatic life, terre strial plants, and wildlife.

Table 2.2 provides examples of taxonomic groups and the surrogate species tested to evaluate potential ecological effects of pesticides to these non-target taxonomic groups. The table also provides a summary of the acute toxicity classifications of tebufenozide, any tested end-use products (EPs), and any tested degradates for each described taxon; note that ecotoxicity data for animals are routinely required for the technical grade active ingredient (TGAI) only.

2.3.2. Ecosystems Potentially at Risk

The ecosystems at risk are often extensive in scope; therefore, it may not be possible to identify specific ecosystems at the screening level. In general terms, terrestrial ecosystems potentially at risk could include the treated site and areas immediately adjacent to the treated site that may receive drift, runoff, eroded sediment, or discharged subsurface (ground) water. Such areas could include the treatment site itself, other cultivated fields, fencerows and hedgerows, meadows, fallow fields or grasslands, woodlands, riparian habitats, and other uncultivated areas.8Table 2.2. Taxonomic Groups and ExampleTest Species for Effects of Tebufenozide.Taxonomic GroupExample(s) of Surrogate SpeciesAcute Toxicity ClassificationTGAITested EPsDegradates5Birds1Mallard duck (Anas platyrhynchos)Bobwhite quail (Colinus virginianus)Practically nontoxic NA NAMammals2Laboratory rat (Rattus norvegicus) Practically nontoxic NA NAInsects Honey bee (Apis mellifera L.)Practically nontoxic(contact exposure)NA NAFreshwater fish3Bluegill sunfish (Lepomis macrochirus)Fathead minnow (Pimephales promelas)Moderately toxic NANo more thanmoderately toxicFreshwater invertebrates Waterflea (Daphnia magna) Moderately toxicSlightly toxic(HOE 105540, 24.5%)No more thanmoderately toxicEstuarine/marine fish Sheepshead minnow (Cyprinodon variegatus) Highly toxic6NA NAEstuarine/marineinvertebratesEastern oyster (Crassotrea virginicus) Highly toxic NA NATerrestrial plants4Monocots – onion (Allium cepa)Dicots – cabbage (Brassica oleracea)NANot classified(Confirm®2F, 22.8%)NAAquatic plants and algaeDuckweed (Lemna gibba)Green alga (Pseudokirchneriella subcapitata)Not classified NA Not classifiedAbbreviations: EP: End-use product; NA: Not applicable because nodata available; TGAI: Technical grade active ingredient.1Birds represent surrogates for terrestrial-phase amphibians and reptiles.2Based on data reviewed by Office of Pesticide Programs Health Effects Division (HED).3Freshwater fish represent surrogates for aquatic-phase amphibians.4Four species of two families of monocots, of which one is corn; six species of at least four dicot families, of which one is soybeans.5RH-112,651; RH-112,703; RH-96,595.6Based on nondefinitive LC50>720 ug/L.

### 9 Aquatic ecosystems potentially at risk include water bodies adjacent to or downstream from the treated area and may include natural or impounded lentic systems such as ponds, lakes and reservoirs, and lotic (flowing) waterways, i.e. , streams and rivers. For the use on cranberries, the treatment area itself is also considered. Aquatic ecosystems supplied by groundwater, such as cave ecosystems and areas supplied by natural springs, may be at risk if a compound has the potential to leach into the subsurface. For uses in coastal areas, aquatic habitat includes estuarine and marine ecosystems. Within water bodies, the water column, sediment, and pore water are all compartments of potential concern.

Hazard and risk to sediment-associated (epibenthic) organisms may be assessed if the physicochemical characteristics of the pesticide indicate that it partitions to sediment. Specific triggers for sediment toxicity testing are outlined in 40 CFR Part 158.630 and are summarized in Table 2.3 , below. The octanol-water partitioning coefficient (log K ow 

### ) value and aerobic soil and aquatic metabolism half-lives for tebufenozide parent indicate that chronic ( e.g ., 28-day) sediment toxicity testing and risk assessment are needed.

Table 2.3. Sediment toxicity testing triggers.

Parameter (per 40 CFR Part 158.630) Tebufenozide Values Reference (MRID)

Soil partition coefficient (K d ) > 50 1.6 – 8.2 mL/g 42436208 Octanol-water coefficient (log K OW ) > 3 4.25 42436201, 42441201 Organic carbon partiti oning coefficient (K OC ) > 1,000 351 – 894 mL/g OC 42436208 Half-life (aerobic soil or aquatic metabolism) ( t1/2 ) < 10 days* aerobic soil: 27.8 – 153 days aerobic aquatic: 99 – 101 days 42436206, 47881102

42436207 Half-life (aerobic soil or aquatic metabolism) (t 1/2 ) > 10 days**

Sediment EEC > 0.1 x acute EC 50 /LC 50 values*** Not available Not available * For consideration of study dura tion; indicates that an acute ( e.g ., 10-day) test duration may be appropriate. ** For consideration of study dura tion; indicates that a chronic ( e.g ., 28-day) test duration may be appropriate. *** Additional consideration for chronic sediment toxicity data needs.



### 2.4. Assessment Endpoints

Assessment endpoints represent the actual environmental values that are to be protected, defined by ecological entities (species, community, etc. ) and their attributes or characteristics (USEPA 1998). For tebufenozide, the ecological entities assessed include the following: birds, amphibians, reptiles, mammals, freshwater and es tuarine/marine fish, terrestrial and aquatic invertebrates, and terrestrial and aquatic plants. The attributes for each of these entities may include growth, survival, and reproduction. (See Table 2.3 in Section 2.6.2 , the Analysis Plan, for further discussion).

The assessment endpoints are intended to reflect population sustainability and community structure within ecosystems and hence relate to ecosystems at risk. If risks are identified for given species/taxa based on a screening-level assessment, then such risks might be expected to translate to higher levels of biological organization.

### 10 2.5. Conceptual Model and Risk Hypothesis

For a pesticide to pose an ecological risk, it must reach ecological receptors in biologically significant concentrations. An exposure pathway is the means by which a pesticide moves in the environment from a source to an ecological receptor. For an ecological pathway to be complete, it must have a source, a release mechanism, an environmental transport medium, a point of exposure for ecological receptors, and a plausible route of exposure. The conceptual model is intended to provide a description of predicted relationships between tebufenozide, potential routes of exposure, and the effects related to the Agency assessment endpoints. The risk hypothesis is a component of the conceptual model.

The conceptual model used to describe ecological risks associated with the foliar uses of tebufenozide relies on previous assessments and the Agency’s current understanding of the environmental fate and ecological effects of the chemical. Previous risk assessments ( e.g. , DP Barcodes D270058, D255795) have identified direct chronic risks to birds and mammals.

For tebufenozide, the following ecological risk hypothesis is employed for the ecological risk
assessment: Given the registered uses of tebufenozide and its environmental fate properties, there is possible acute and chronic exposure to non-target aquatic and terrestrial organisms. Previous risk assessments have identified chronic risks to birds and mammals. Although the literature suggests that tebufenozide-like compounds have a high affinity for the lepidopteran ecdysone receptor (Sundaram et al. 1998), there is uncertainty regarding the degree to which tebufenozide could potentially affect a wider range of terrestrial invertebrates. Potential risk to other non-target organisms has generally been identified as uncertain or below the Agency’s Levels of Concern. This assessment tests the hypothesis that, when used in accordance with the label, tebufenozide exposure may result in adverse effects upon the survival, growth, and reproduction of non-target aquatic and terrestrial plants and animals.

For terrestrial organisms, the primary route of exposure assessed at the screening level is the dietary route, via consumption of food items such as plant leaves or insects that have tebufenozide residues as a result of spraying. The assessment considers exposure of non-target terrestrial invertebrates through oral ingestion and through contact, e.g., as a result of direct deposition or spray drift. Direct deposition and uptake from soil are the major routes of exposure considered for terrestrial and wetland (riparian) plants.

Based on tebufenozide’s vapor pressure (2.3 x 10 -8 

### torr), the chemical is not expected to readily volatilize. Therefore, this assessment does not evaluate potential atmospheric transport in estimating environmental concentrations. The Screening Tool for Inhalation Risk (STIR) (see Section 2.6.2 ), which compares inhalation exposure estimates to available avian and mammalian toxicity data, indicates that inhalation is not likely a major exposure pathway for tebufenozide. The Screening Imbibition Program (SIP) indicates that drinking water exposure alone is not a pathway of concern for birds or mammals. This assessment does not account for possible

### 11 ingestion of tebufenozide residues in contaminated grit or from preening activities of terrestrial animals, and it does not evaluate potential uptake through dermal absorption.

For aquatic assessments, the major routes of exposure for aquatic animal species are considered to be through the respiratory surface (gills) or the integument. Similar to terrestrial organisms, exposure of aquatic organisms to tebufenozide may also occur through ingestion of residues in sediment and forage. Parent tebufenozide is fairly hydrophobic, with an octanol-water partition coefficient (K ow 

### ) of 17,906 (log K ow 

### = 4.25; MRID 42436201, 42441201); however, its measured bioconcentration factors (BCFs) (up to 151x in whole fish tissue) are less than 1,000x, indicating that it does not appreciably bioconcentrate in fish (MRID 42436209, 42931224). Therefore, although tebufenozide residues may be present in prey and forage, bioaccumulation potential is considered low. Aquatic plants may be exposed via direct uptake and adsorption.

### 12 2.6. Analysis Plan

2.6.1. Measures of Exposure

2.6.1.1. Measures of Aquatic Exposure

Measures of exposure to aquatic animals and plants are pesticide concentrations in surface water and benthic sediment pore water simulated by the Surface Water Concentration Calculator (SWCC) (version 1.106; May 2014), to generate EECs for tebufenozide that may occur from use on crops, typically at maximum label use rates. The EECs used in risk assessment are simulated 1-in-10 year return frequency “peaks” (acute assessments) and mean concentrations over a specified duration (chronic assessments) generated at the modeled site, which is selected to represent a location expected to be more contamination-vulnerable than most locations where the crop is grown. For cranberry use, the Provisional Cranberry Model (v 2.0, December 9, 2010) was used to generate screening-level EECs in water within or released from a cranberry bog. The Provisional Cranberry Model is based on the same assumptions as the Tier I Rice Model (v1.0, May 8, 2007), with the addition of degradation processes in dry and flood conditions and a water depth of twelve inches in the flooded cranberry bog. The cranberry bog water depth of twelve inches is a maximum depth recommended by the Cape Cod Cranberry Growers Association (2001). Degradation of tebufenozide residues of concern is assumed to occur predominantly via aerobic microbial metabolism, whether on dry cranberry bog soil or in bog flood water. The equations used in the Provisional Cranberry Model are briefly described in Appendix B

. 2.6.1.2. Measures of Terrestrial Exposure

Terrestrial wildlife are exposed to tebufenozide via consumption of residues on food items generated by spray applications. For spray applications, the T-REX model (Terrestrial Residue EXposure model; v. 1.5.2; June 6, 2013) is used to predict dietary exposure to tebufenozide residues on foliar surfaces and insects using the Kenaga nomogram as modified by Fletcher (Hoerger & Kenaga, 1972) (Fletcher, Nellessen, & Pfleeger, 1994). The EECs for risk estimation are peak (point-in-time) values based on the 90 th 

### percentile upper bound of the Kenaga nomogram. Median Kenaga nomogram values are used in this assessment to further characterize the range of potential exposures associated with a given use. Foliar dissipation is considered in the calculation of peak values ( e.g. , when multiple applications of tebufenozide are permitted within a year) and to characterize residue decline when adverse effects may be associated non-acute exposures. A default foliar dissipation half-life of 35 days is used forexposure and risk estimates in this assessment, based on Willis and McDowell (1987). This halflife is slightly shorter than those identified in a preliminary review of tebufenozide foliar dissipation half-lives in forestry matrices (30 to 58 days), which were highly variable (MRIDs 43935604, 43935605). It is approximately three times greater than the foliar dissipation half-life value proposed by the registrant (11 days; MRID 44200302) 1



### .

1 See Johnson, M. 1998. Dr aft agenda – CONFIRM meeting with EFED. January 23, 1998. EPA SAN identifier: R2072287.

### 13 The TerrPlant (v. 1.2.2; December 26, 2006) model is used to derive EECs relevant to terrestrial and wetland plants exposed to tebufenozide as a combination of spray drift and runoff. The model employs the assumption that default fractions of the intended application are transported to an adjacent habitat. Measures of exposure to terrestrial plants are expressed as a fraction of the mass of the tebufenozide applied to the treated field.

The Screening Tool for Inhalation Risk (STIR v.1.0, November 19, 2010) was used to calculate an upper bound estimate of exposure using tebufenozide’s vapor pressure and molecular weight for vapor phase exposure as well as the maximum application rate and method of application for spray drift. STIR incorporates results from several toxicity studies including acute oral and inhalation rat toxicity endpoints obtained from the “six-pack” of core studies, which is a series of six guideline studies that are submitted to the the Agency for technical and formulated products of a pesticide (LD 50 

### = 5,000 mg/kg bw/day, MRID 42436212; and inhalation LC 50 

### >1.33 mg/L, MRID 44727705, respectively) as well as the acute oral avian toxicity endpoint (bobwhite quail LD 50 

### > 2,150 mg/kg bw, MRID 42436234). Based on the results of the STIR model ( Appendix F ), exposure through inhalation of spray drift or the vapor phase of tebufenozide was not determined to be a potential pathway of concern for either avian or mammalian species on an acute exposure basis.

The analysis of the inhalation route in STIR does not consider that aggregation with other exposure pathways such as dietary, dermal, or drinking water may contribute to a total exposure that has a potential for effects to non-target animals. However, the Agency considers the relative importance of other routes of exposure in situations where data indicate that pesticide exposures through other routes may be potentially significant contributors to wildlife risk (USEPA 2004). The risk characterization section ( Section 4.3 ), discusses the impact of other routes of exposure that have been identified as potentially important and the degree of certainty associated with screening-level risk assessment conclusions. Detailed information about STIR v.1.0, as well as the tool, can be found on EPA’s website ( http://www.epa.gov/pesticides/science/models_pg.htm#terrestrial ).

The Screening Imbibition Program (SIP v.1.0, released June 15, 2010) was used to calculate an upper-bound estimate of exposure using tebufenozide’s solubility (0.83 mg/L at 25 q C, MRID 42436201, 42441201), and compared to the most sensitive acute and chronic avian and mammalian toxicity endpoints (see Table 3.22 and 3.23 , respectively). Drinking water exposure alone was not a pathway of concern for either birds or mammals. For a sample of the output generated by SIP v.1.0, please see Appendix G

.

2.6.2. Measures of Effect

Measures of effect are obtained from a suite of registrant-submitted guideline studies which were conducted with a limited number of surrogate test species. The test species are not intended to be representative of the most sensitive species, but rather were selected based on their ability to thrive under laboratory conditions. Toxicity testing reported in this risk assessment utilizes surrogate species to represent all freshwater fish (2000+) and bird (680+) species in the U.S. The ECOTOXicology database (ECOTOX), was searched in June 2014 to identify whether

### 14 additional, more sensitive ecological effects data were available for tebufenozide; however, no more useful data were identified (USEPA 2014).

The acute measures of effect used in this screening-level assessment are the LD 50 

### (Lethal Dose), LC 50 

### (Lethal Concentration), EC 50 

### (Effects Concentration), and IC 50 

### (Inhibition Concentration). These are measures of acute toxicity which result in 50% of the respective effect in tested organisms. The endpoints for chronic measures of exposure are the NOAEC (No Observed Adverse Effects Concentration) and the NOAEL (No Observed Adverse Effects Level). Toxicity studies were submitted for freshwater fish and invertebrates, estuarine/marine fish and invertebrates, aquatic plants, birds, mammals, bees, and other terrestrial invertebrates. The endpoints used for risk assessment were derived from studies which underwent review and were classified as “acceptable” (conducted under guideline conditions and considered to be scientifically valid) or “supplemental” (conditions deviated from guidelines but the results were considered to be scientifically valid).

2.6.3. Integration of Exposure and Effects

The exposure and toxicity effects data are integrated in order to evaluate the risks of adverse ecological effects on non-target species. For the risk assessment of tebufenozide, the RQ method is used to compare estimated exposure and measured toxicity values. The RQ method involves dividing EECs by point estimates of the most sensitive acute and chronic toxicity values. The resulting RQs are then compared to the Agency’s LOCs (USEPA 2004) ( Table 2.3 ). These criteria are used to indicate when applications of tebufenozide, as directed on the label, have the potential to cause adverse effects to non-target, federally listed threatened/endangered (hereafter referred to as “listed”) and non-listed species.

Table 2.3. Agency Risk Quotient (RQ) Metrics and Levels of Concern (LOC) Per Risk Class. Risk Class Risk Description RQ LOC Aquatic Animals (fish and invertebrates)

Acute Potential for effects to non- listed animals from acute
exposures Peak EEC/LC 50 1 0.5

Acute Listed Species Listed species may be potentially affected by acute
exposures Peak EEC/LC 50 1 0.05

Chronic Potential for effects to non-lis ted and listed animals from chronic exposures 60-day EEC/NOAEC (fish) 1 21-day EEC/NOAEC (invertebrates) Aquatic Plants
Non-Listed Potential for effects to non-lis ted plants from exposures Peak EEC/LC 50 1 1 Listed Potential for effects to listed plan ts from exposures Peak EEC/NOAEC 1 Terrestrial Animals (mammals, birds, and invertebrates) 2

Acute Potential for effects to non- listed animals from acute
exposures EEC/LC 50 (dietary) 0.5 EEC/LD 50 (dose)
EEC/LD 50 (invertebrate) 0.4

### 15 Risk Class Risk Description RQ LOC
Acute Listed Species Listed species may be potentially affected by acute
exposures EEC/LC 50 (dietary) 0.1 EEC/LD 50 (dose)

Chronic Potential for effects to non-lis ted and listed animals from chronic exposures EEC/NOAEC 1

Terrestrial and Semi-Aquatic Plants

Non-Listed Potential for effects to non-targ et, non-listed plants from
exposures EEC/ EC 25 or IC 25 1

Listed Plant Potential for effects to non-tar get, listed plants from
exposures EEC/ NOAEC 1 EEC/ EC 05

1 LC 50 or EC 50 . 2 EEC based on upper bound Kenaga nomogram values for foliar exposure.



### The Agency uses the probit dose-response relationship as a tool for providing additional information on the potential for acute direct ef fects to individual listed species and aquatic animals that may indirectly affect the listed species of concern (USEPA 2004). As part of this evaluation, the acute RQ for listed species is presented in terms of the chance of an individual event ( i.e. , mortality or immobilization), should exposure at the EEC actually occur for a species with sensitivity to tebufenozide on par with the acute toxicity endpoint selected for RQ calculation. To accomplish this interpretation, the Agency uses the slope of the dose-response relationship available from the toxicity study used to establish the acute toxicity measures of effect for each taxonomic group that is relevant to this assessment. The individual effects probability associated with the acute RQ is ba sed on the mean estimate of the slope and an assumption of a probit dose-response relationship. In addition to a single effects probability estimate based on the mean, upper and lower estimates of the effects probability are also provided to account for variance in the slope, if available. If no dose-response information is available to estimate a slope for this analysis, a default slope assumption of 4.5 is used, with lower and upper bounds of 2 to 9 (USEPA 2004).

Individual effect probabilities are calculated based on a Microsoft  

### Excel spreadsheet tool IECV1.1 (Individual Effect Chance Model Version 1.1) developed by EPA (June 22, 2004). The model allows for such calculations by entering the mean slope estimate (and the confidence bounds of that estimate) as the slope parameter in the spreadsheet. The desired threshold for the probability of an individual effect is entered as the listed species LOC or based on the calculated acute RQ, if available.


## 3. Analysis

3.1 Use Characterization

### 16 Table 3.1 lists the currently registered uses of tebufenozide. Based on the current labels, the maximum single application rate for tebufenozide is 0.47 lbs a.i./A ( Table 3.1 ). The maximum rate per year is 2.0 lbs a.i./A. Table 3.2 lists average annual application rates based on survey data provided through the Biological and Economic Assessment Division (BEAD); in general, the average annual application rates listed in Table 3.2 are lower than the maximum annual rate reported in Table 3.1

.
Table 3.1. Methods and Maximum Rates of Application of Currently Registered Uses of Tebufenozide.

Uses Application type Maximum Number of applications /
year Minimum Retreatment

Interval (days) Maximum rate / single application (lbs a.i./A) Maximum rate / year (lbs a.i./A)
Agricultural Uses

Bushberries foliar 1,2 NS 7 0.25 1.0

Caneberries foliar 1,2 NS 10 0.25 1.0

Canola foliar 1,2 NS 10 0.25 1.0

Citrus foliar 1,2 NS 14 0.25 1.25 Cole crops and leafy vegetables foliar 1,2 NS 10 0.12 1.8

Cotton foliar 1,2 NS 10 0.25 1.0

Cranberries foliar 1,2 4 7 0.25 1.0 Fruiting vegetables foliar 1,2 NS 10 0.25 2.0

Mint foliar 1,2 NS 10 0.25 2.0 Pastures and rangeland foliar 1,2 4 10 0.125 0.50

Pome fruits foliar 1,2 NS 7 0.31 1.875 Sugarcane foliar 1,2 NS 10 0.25 1.0 Tree nuts (almond, walnut, other nuts) foliar 1,2 NS 10 0.47 1.9
Tree nuts (pecan) foliar 1,2 NS 8 0.25 1.9 Nonagricultural Uses

Ornamentals foliar 1,2 NS 10 0.25 2.0
Forest, trees and shrubs foliar 1,2 NS 5 0.12 0.25

N S Not specified

1 ground

2 aerial


### According to the most recent Screening Level Usage Analysis (SLUA) report provided by BEAD ( Table 3.2 ), the majority of tebufenozide is used on sugarcane, with 10,000 pounds of active ingredient applied per year over the 2004-2011 period. Tomatoes, almonds, walnuts, pecans, and lettuce are also appreciable uses reported in the SLUA.

### 17 Table 3.2. Estimates of Agricultural Usage of Tebufenozide (OPP/BEAD).

Crop Average Mass Applied 1 (lbs a.i./yr) Percent Crop Treated Average Annual App. Rate 2 (lbs a.i./A/year) Average 1 (%) Maximum 1 (%) Alfalfa 1,000 <1 <2.5 NC Almonds 4,000 <2.5 5 0.250 Apples 1,000 <1 <2.5 0.257 Blueberries 1,000 10 15 NC
Broccoli <500 <2.5 5 0.111 Cabbage <500 5 5 0.117
Caneberries <500 5 10 0.250 Cauliflower 1,000 5 10 NC Celery <500 5 20 0.125 Cotton 1,000 <1 <2.5 0.228 Grapes+ 1,000 <1 <2.5 0.125 Lettuce 2,000 5 15 0.111 Parsley <500 5 5 NC

Pears <500 <1 <2.5 NC Pecans 2,000 5 10 0.136 Peppers 1,000 5 25 0.107 Pistachios 1,000 <2.5 <2.5 NC
Rice <500 <1 <2.5 NC Spinach <500 <2.5 <2.5 0.125 Squash <500 NR NR 0.125
Strawberries <500 NR NR 0.250 Sugarcane 10,000 15 25 0.102 Tomatoes 7,000 5 15 0.144 Turnips <500 <2.5 5 NC Walnuts 5,000 5 10 0.267 All numbers rounded. App(s).: Application(s). NC: Not calculated. NR: Not reported. + Use site not currently registered.

1. Screening Level Usage Analysis (SLUA), 2004-2012, OPP/BEAD, 6 August 2014;
2. EPA Proprietary Data for Tebufenozide, 2008-2012, email from D. Atwood (OPP/BEAD) to K. Keller (PRD), 25 August 2014.



### 3.2. Exposure Characterization

3.2.1. Environmental Fate Characterization

General physical/chemical properties and submitte d environmental fate data for tebufenozide and its major degradates are summarized in Table 3.3 and are discussed in greater detail in the following sections.

### 18 Table 3.3. Chemical Properties and Environmental Fate Parameters of Tebufenozide.
Property Value Source (MRID) Study Classification Comments

Chemical Name N-tert-Butyl-N ƍ -(4- ethylbenzoyl)-3,5- dimethylbenzohydrazide Molecular Weight (g/mol) 352.26 42436201 42441201 Solubility in Water (mg/L, 25°C) 0.83 mg/L 42436201 42441201 Vapor Pressure (Pa, 25°C) 3 x 10 -6 42436201 42441201 Octanol-water partition coefficient (K O W ) 17,906 (log K ow 4.25) 42436201 42441201 Hydrolysis Half-life (23-25 q C) (days) stable (pH 5) stable (pH7) stable (pH 9) 42436204 Acceptable

Aqueous Photolysis Half-life (pH 7.27) (days) stable 42436205 Supplemental Study was conducted in pond water, not buffer, so calculated half-life of 67 days is

not valid for use in modeling. Photolysis is not expected based

on UV absorbance spectrum. Soil photolysis half-life (days; assuming 12 h light/day) (25 q C) 98 42991512 Acceptable

Aerobic soil metabolism half-lives, parent (20 q C for CA loam and 25 q C for the rest) 153 (CA loam) 42436206 Supplemental Not clear that soil moisture was maintained at field capacity. Data from NJ soil are not valid

due to anomalous degradation profile. 31.1 (Speyer sand) 28.2 (Speyer loamy sand) 27.8 (Speyer sandy loam)

31.4 (SLV sandy loam) 47881102 Supplemental Soil extraction procedure was not demonstrated to be accurate to remove all identifiable residues. Aerobic soil metabolism half-lives, TTR (20 q C for CA loam and 25 q C for the rest) 139 (CA loam) 49.7 (Speyer sand) 41.3 (Speyer loamy sand) 42.1 (Speyer sandy loam)

49.4 (SLV sandy loam) 42436206 47881102 Supplemental Supplemental Not clear that soil moisture was maintained (42436206). Soil extraction procedure was not demonstrated to be accurate to remove all identifiable residues 47881102.

Aerobic aquatic metabolism half-lives, parent (days) (25 q C) 99 (parent) 361 (TTR) 42436207 Acceptable Arkansas silty clay hydrosoil 101 (parent) 176 (TTR) California clay loam hydrosoil Anaerobic aquatic 179 42931216 Acceptable

### 19 Property Value Source (MRID) Study Classification Comments
metabolism half-life, parent (days) (25 q C) Soil-water sorption coefficients, parent (K d, mL/g) 7.8 clay 4.4 loam 1.6 loamy sand 8.2 sandy clay loam

5.7 loamy sand 42436208 Acceptable

Organic-carbon normalized sorption coefficients, parent (K oc ) (mL/g oc ) 894 clay 656 loam 351 loamy sand 391 sandy clay loam

566 loamy sand 42436208 Acceptable

Soil-water sorption coefficients, degradate RH-112651 (K d, mL/g) 0.68 clay 0.68 clay loam 1.54 loamy sand 0.34 sand 42931219 Acceptable

Organic-carbon normalized sorption coefficients, degradate RH-112651 (K oc ) (mL/g OC ) 78 clay 111 clay loam 156 loamy sand 76 sand 42931219 Acceptable

Fish Bioconcentration Factor (44 d) 16x (edible) 333x (nonedible) 151x (whole fish) 42436209 42931224 Acceptable Acceptable

Terrestrial field dissipation Half-lives, parent (days) 39-53 422991514 Acceptable Bare-ground studies in CA sandy loam soils

31, 52 43797703 Supplemental Bare-ground studies in WA sand and

NY silt loam. Incomplete data reported on water balance and soil taxonomic classification.



### 3.2.1.1. Transport and Mobility

Tebufenozide is classified as moderately mobile based on organic carbon (OC) partition coefficient (K oc 

### ) values (351-894 mL/g oc 

### ) and using the Food and Agricultural Organization (FAO) soil mobility classification scheme. The carboxylic acid metabolite RH-112651 is classified as mobile to moderately mobile under the FAO scheme based on its K oc 

### values (76-156 mL/g oc 

### ). A second carboxylic acid metabolite, RH-112703, and the ketone metabolite RH96595, are also mobile based on column leaching study results. Thus, the parent compound and all three major degradates have the potential to contaminate surface water via runoff from treated areas after application, through subsurface ( e.g ., tile drain) flow, and as a consequence of spray drift during application. Tebufenozide and its three major degradates also have the potential to

### 20 leach to groundwater. All four were found to have leached to at least the 45 cm soil depth in at least one TFD study.

3.2.1.2. Degradation

Parent tebufenozide is characterized as persistent to very persistent 2 

### , with laboratory half-lives ofup to 179 days. Based upon limited data, tebufenozide’s major degradates (RH-112651, RH112703 and RH-96595) appear to be somewhat less persistent than the parent, with calculated half-lives for summed degradates ranging from 29.3 to 123.8 days in aerobic soil studies conducted using applied parent chemical (under which conditions the decay of degradates is confounded by their simultaneous formation from the parent compound). Microbially-mediated degradation is the primary dissipation pathway for parent tebufenozide. Parent tebufenozide is stable to hydrolysis (pH 5-9) and is expected to be stable to aqueous photolysis based on its UV absorbance spectrum. The compound is also relatively stable to indirect photolysis in pond water (t 1⁄2 

### = 67 days) and on soil (t 1⁄2 

### = 98 days). No abiotic degradation data are available on any of the major degradates. In an aged soil column leaching study, the parent compound was present in four soils at approximately 52-71% of the applied after 30 days of aerobic aging. Bioaccumulation studies show that the BCF for tebufenozide in fish was 151X for whole-fish tissue and showed 90% depuration within 15 days. Although the parent compound has an octanol-water partition coefficient of 17,906 and might be expected to bioconcentrate, the relatively low measured BCF coupled with the rapid depuration of the compound suggests that tebufenozide is metabolized in fish to more polar compounds and readily excreted.

3.2.1.3. Field Studies

In a terrestrial field dissipation study (MRID 42991514), parent tebufenozide dissipated with registrant-calculated half-lives of 39 to 53 days in a California sandy loam soil, from the upper 15 cm of soil in two bare-ground plots (note that these rates fall within the range of degradation half-lives observed in aerobic soils). Degradate RH-96595 was detected in the upper 15 cm at both sites, and in the 15-30 cm depth at one of the sites. In a separate, supplemental study (MRID 43797703), parent tebufenozide dissipated with registrant-calculated half-lives of 31 and 52 days from the top 15 cm of soil in bare-ground plots in Washington and New York states, respectively. Parent and degradates RH-96595, RH-1126251, and RH-112703 were detected in the soil to depths of 45 cm at the New York site. At the Washington site, parent and degradatesRH-96595 and RH-112703 were detected only within the top 15 cm, although degradate RH112651 was detected at depths of up to 60 cm.

2 Based on the Toxic Release Inventory classification system where half-lives greater than 60 days in water, soil, and sediment are considered persistent and half-life greater than 6 months are considered very persistent (USEPA, 2012a)213.2.1.4. Transformation ProductsTable 3.4. Table of Tebufenozide and its Major Transformation Products Formed in Environmental Fate Studies.Code NameChemical NameChemical StructureStudy TypeMRID(s)Max. %ARor conc.(mg/kg)Final %AR (studylength or last intervaldetected)PARENTHoe 105540,RH75992TebufenozideIUPAC:N-tert-Butyl-Nƍ-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide.CAS:3,5-Dimethylbenzoic acid 1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazideCAS No.112410-23-8Formula:C22H28N2O2MW:352.26 g/molSMILES Code:C2=CC(CC)=CC=C2C(=O)NN(C(C)(C)C)C(=O)C1=CC(C)=CC(C)=C1Aerobic SoilMetabolism42436206Not Applicable8.7(365) – CA73.6(365) – NJAerobic SoilMetabolism478811029.6 (120) – Speyer 2.115(120) – Speyer 2.211.5(120) – Speyer 2.38.2(120) – SLVAerobicAquaticMetabolism424362075.83-8.77(366)6.89-10.79(358)AnaerobicAquaticMetabolism4293121630.8(365)Hydrolysis42436204100(30)SoilPhotolysis4299151275(30)TerrestrialFieldDissipation4299151443797703<0.0025(365)<0.0025(365)MAJOR DEGRADATESRH-112651Aerobic SoilMetabolism424362068.615.121.0(365) – CA5.12(365) – NJCH3ONNCH3CH3CH3OCH3CH3H22Code NameChemical NameChemical StructureStudy TypeMRID(s)Max. %ARor conc.(mg/kg)Final %AR (studylength or last intervaldetected)IUPAC: (4-[Nc-(3,5-dimethylbenzoyl)-Nc-(1,1-dimethylethyl)hydrazinocarbonyl]benzoic acidSMILES:C1=CC(=CC=C1C(=O)NN(C(C)(C)C)C(=O)C2=CC(=CC(=C2)C)C)C(=O)OAerobic SoilMetabolism4788110220.012.211.311.6<2.3(120) –Speyer 2.1<1.5(120) – Speyer 2.2<1.6(120) – Speyer 2.3<3.8(120) – SLVAerobicAquaticMetabolism424362079.48-26.39A2.57-14.49B22.92(366)A14.49(366)BAnaerobicAquaticMetabolism42931216 15.2C7.8(365)Hydrolysis 42436204 0 0(30)SoilPhotolysis42991512 0 0(30)TerrestrialFieldDissipation42991514437977030.0120.10<0.0025(365)<0.0025(365)RH-112703IUPAC: 4-[Nc-(3,5-dimethylbenzoyl)-Nc-(1,1-dimethylethyl)hydrazinocarbonyl]phenyl acetic acidAerobic SoilMetabolism424362064.473.43ND(365) – CA2.4(365) – NJSMILES:C(=O)(C1=CC(=CC(=C1)C)C)N(C(C)(C)C)N(C(=O)C2=CC=C(C=C2)CC(=O)O[H])[H]Aerobic SoilMetabolism478811028.84.22.68.01.4(120) –Speyer 2.11.5(120) – Speyer 2.20.8(120) – Speyer 2.31.3(120) – SLVAerobicAquaticMetabolism424362077.05-15.53A2.22-5.57B0.67(366)A0.67(366)BONNCH3CH3CH3OCH3CH3HHO2CONNCH3CH3CH3OCH3CH3HHO2C23Code NameChemical NameChemical StructureStudy TypeMRID(s)Max. %ARor conc.(mg/kg)Final %AR (studylength or last intervaldetected)AnaerobicAquaticMetabolism42931216 <2.7 <2.7(365)Hydrolysis 42436204 0 0(30)SoilPhotolysis42991512 0 0(30)TerrestrialFieldDissipation42991514437977030.0140.015<0.0025(365)<0.0025(365)RH-96595IUPAC: N-(1,1-dimethylethyl)-Nc-(4-acetylbenzoyl)-3,5-dimethylbenzohydrazideSMILES:C1=CC(=CC=C1C(=O)NN(C(C)(C)C)C(=O)C2=CC(=CC(=C2)C)C)C(C)=OAerobic SoilMetabolism424362065.926.371.3(365) – CA3.6(365) – NJAerobic SoilMetabolism478811025.88.66.37.13.4(120) –Speyer 2.13.9(120) – Speyer 2.22.5(120) – Speyer 2.34.6(120) – SLVAerobicAquaticMetabolism424362073.24-5.22A7.81-11.35B0.57(366)A2.25(366)BAnaerobicAquaticMetabolism42931216 9.6 6.3(365)Hydrolysis 42436204 0 0(30)SoilPhotolysis42991512 5.8 5.8(30)TerrestrialFieldDissipation42991514437977030.020.04<0.0025(365)<0.0025(365)AIn floodwaterONNCH3CH3CH3OCH3CH3HOCH324BIn flooded soilCIn sediment and floodwater

### 25 3.2.2. Measures of Aquatic Exposure

3.2.2.1. Aquatic Exposure Modeling

For all non-cranberry uses, tebufenozide aquatic EECs were generated using EFED’s standard suite of models. The Surface Water Concentration Calculator (SWCC version 1.106; May 2014) model was used to generate EECs of tebufenozide that may occur in surface waters (both freshwater and estuarine/marine) impacted by rainfall-runoff and spray drift, where non-target organisms can be exposed. All SWCC modeling employed EFED’s standard pond as a proxy for exposed water bodies. In this approach runoff (and spray drift) from a 10-hectare cropped watershed drains into a 1-hectare pond of 2 meters depth. The approach, which is intended to provide a conservative generic representation of surface waters of all kinds, is likely to be especially conservative as a representation of marine and estuarine waters. Pore water and sediment EECs are reported for the scenario with the highest surface water EECs ( e.g ., fruiting vegetables), other than cranberry. Aquatic EECs for all use scenarios were modeled using the TTR approach based on concerns identified in the problem formulation. Select scenarios were also modeled for tebufenozide parent only, for characterization.

For the cranberry use, two different modeling methodologies were employed, for the following

reason. Some cranberries are grown in bogs that are temporarily flooded to control pests, prevent freezing, and/or facilitate harvest. Cranberries may also be grown in settings that more closely resemble the cultivation of more widely-grown field crops, in which flooding is not employed as a management practice. Water from an intentionally-flooded cranberry bog may be held in a holding system, recirculated to other cranberry growing areas, or released to an adjacent waterbody ( e.g ., river, stream, lake). 

### For the use on cranberries wherein deliberate flooding takes place, aquatic EECs were generated using the Provisional Cranberry Model. T he reported concentrations represent water introduced to the field and not mixed with any additional water ( i.e. , in a receiving water body). See Appendix B for a detailed description of this model. To account for aquatic exposures that occur as the result of rainfall-runoff that occurs after chemical application but before or after deliberate flooding, as well as to represent cranberries that are grown and harvested without the use of flooding at all, the SWCC was used to estimate tebufenozide TTR, with the OR blueberry scenario as a proxy for cranberry cultivation.

3.2.2.2. Selection of Crop Scenarios

The scenarios listed in Table 3.5 are those currently approved for Tier II SWCC modeling which most closely represent the labeled uses for tebufenozide, or those which generated the highest TTR EECs among all available representative scenarios for uses in which multiple representative scenarios were available. Three of the chosen scenarios (canola; fruiting vegetables; and trees, forests, shrubs scenarios) were also used to characterize the range of potential aquatic exposures to tebufenozide parent only. SWCC model summaries of input parameters, application methods and outputs can be found in Appendix C.

3.2.2.3. Aquatic Modeling Inputs

### 26 Application parameters were chosen based on the likely method of application at the maximum application rate as indicated in the label instructions. Chemical property and model input values ( Table 3.6 ) were chosen according to the current Input Parameter Guidance, (USEPA 2009). Based on EFED guidance, aerial spray of liquid formulations are assumed to have 95% efficiency and 12.5% spray drift, and ground spray is expected to have 99% efficiency and 6.6% spray drift. Based on the proposed uses for tebufenozide, a variety of locations and SWCC scenarios were run to simulate national use of the pesticide. Details of simulated scenarios are provided in Appendix C

.
Table 3.5. Aquatic Exposure Inputs in Tebufenozide Ecological Exposure Assessment (SWCC)

Use SWCC Scenario 1 Application Method Single Applic. Rate (lbs a.i./A) [kg/ha] Number of Applications First Applic. Date Bushberries, Caneberries ORberriesOP Aerial/foliar 0.25 [0.28 ] 4 5/15

Canola NDcanolaSTD Aerial/foliar 0.25 [0.28 ] 4 5/15 Citrus FLcitrusSTD Aerial/foliar 0.25 [0.28 ] 5 5/15 Brassica FLcabbageSTD Aerial/foliar 0.12 [0.135 ] 15 2/15 Cotton MScottonSTD, Aerial/f oliar 0.25 [0.28 ] 4 5/15 Cranberry ORberriesOP Aerial/foliar 0.25 [0.28 ] 4 5/15 Fruiting vegetables FLpeppersSTD Aerial/foliar 0.25 [0.28 ] 8 5/15

Mint ORmintSTD Aerial/fo liar 0.25 [0.28 ] 8 5/15 Ornamentals FLnurserySTD_V2 Aerial/foliar 0.25 [0.28 ] 8 5/15

Pome fruit NCappleSTD Aerial/foliar 0.31 [0.347] 6 5/15 Sugarcane LAsugarcaneSTD Aerial/foliar 0.25 [0.28 ] 8 5/15 Almonds, Walnuts, Other
nuts CAalmondWirrigS TD Aerial/foliar 0.47 [0.527] 4 5/15

Pecans GAPecansSTD Aerial/foliar 0.26 [0.291] 7 5/15 Trees, Forests, Shrubs FLnurserySTD_V2 Aerial/foliar 0.12 [0.135] 2 5/15
Pasture, rangeland RangeBSS Aerial/foliar 0.125 [0.14] 4 5/15

1 This column shows the actual scenario (file) names for scenarios used to generate EECs using the Surface Water Concentration Calculator (SWCC). The general syntax for scenario names reflects the state_use site_scenario type_version (if applicable). For example, ORberriesOP reflects a scen ario originally developed to model Oregon (OR) berries for organophosphate (OP) pesticides.

### 27 Table 3.6. Environmental Fate Data Used for Aquatic Exposure Inputs in Tebufenozide Ecological Exposure Assessment (SWCC and Provisional Cranberry Models)



### . Input Parameter TTR Parent only Source/comment

Hydrolysis half-life (t 1⁄2 in days) 0 (stable) 0 (stable) MRID 42436204
Aqueous Photolysis half-life (t 1⁄2 in days) 0 (stable) 0 (stable) MRID 42436205

Aerobic Soil metabolism half-life (t 1⁄2 in days) 93.1 92.1 MRIDs 42436206, 47881102. Represents the 90 percent upper confidence limit on the mean of 5 aerobic soil metabolism half-life values for TTR ( parent plus degradates RH-112651, RH-112703, and RH-96595 1, 2 ) and parent only, respectively.

Aerobic Aquatic metabolism half-life (t 1⁄2 in days) 553.2 135.3 MRID 42436207. Represents the 90 percent upper confidence limit on the mean of two half-life values for TTR (parent plus degradates RH-112651, RH-112703, and RH-96595) and parent only in aerobic silty clay soil:water and clay loam soil:water systems. Anaerobic aquatic metabolism half-life (t 1⁄2 in days) 537 537 MRID 42931216. Represents three times the single available whole-system hal f-life (179 days) for parent 3 in an anaerobic silt-loam sediment:pond water system.

Soil partition coefficient K oc (mL/g) 105 572 MRID 42931219. Mean of four K oc values for degradate RH-112651 [used to represent TTR because it is more conservative (lower) than available K oc values for parent tebufenozide] and for parent only.

1 EFED input parameter guidance is located at: http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm

2 Calculation excludes NJ sandy loam soil

3 Half-lives based on parent + degradates were not employed for this input because although degradates were formed in these studies, their inclusion was found to have minor influence on EECs.



### 3.2.2.4. Estimated Environmental Concentrations in Surface Water

Surface water EECs for tebufenozide TTR are presented in Table 3.9 . Surface water EECs for tebufenozide parent only are presented in Table 3.10 , for characterization. In all SWCC scenarios, aerial application produced higher EECs than ground application. The output file from the model runs including the scenario (LA sugarcane) that produced the highest EECs is provided in Appendix C

. Table 3.9. Tebufenozide TTR EECs for Surface Water
Use Scenario 1 Application Method 1-in-10 year 1- day (“peak”) mean ( μ g/L) 1-in-10 year 21- day mean

( μ g/L) 1-in-10 year 60- day mean

( μ g/L) Bushberries, Caneberries ORberriesOP aerial 37.2 36.8 36.2 ground 20.5 20.3 20.0

Canola NDcanolaSTD aerial 58.6 57.9 56.8 ground 40.1 39.6 38.7

Citrus FLcitrusSTD aerial 60.4 59.2 58.1 ground 51.6 50.8 49.7 Brassica FLcabbageSTD aerial 90.8 89.4 86.8

### 28 Use Scenario 1 Application Method 1-in-10 year 1- day (“peak”) mean ( μ g/L) 1-in-10 year 21- day mean

( μ g/L) 1-in-10 year 60- day mean

( μ g/L) ground 78.8 77.4 75.1

Cotton MScottonSTD aerial 59.6 58.8 56.8 ground 49.9 49.5 47.8

Cranberry ORberriesOP aerial 37.4 37.0 36.5 ground 20.5 20.3 20.0 Fruiting vegetables FLpeppersSTD aerial 112 111 108 ground 99.4 98.1 95.8

Mint ORmintSTD aerial 73.0 72.2 71.4 ground 40.4 39.9 39.5

Ornamentals FLnurserySTD_V2 aerial 84.9 83.4 81.8 ground 70.9 69.7 68.3

Pome fruit NCappleSTD aerial 96.4 95.2 93.5 ground 72.2 71.6 60.0

Sugarcane LAsugarcaneSTD aerial 86.7 85.7 84.3 ground 79.6 78.6 76.9 Almonds, Walnuts, Other
nuts CAalmondWirrigSTD aerial 59.6 58.9 57.6
ground 35.2 34.9 34.1

Pecans GAPecansSTD aerial 69.9 69.0 67.6 ground 52.0 51.3 50.2
Trees, Forests, Shrubs FLnurserySTD_V2 aerial 12.4 12.1 11.7 ground 10.6 10.3 10.0
Pasture, rangeland RangeBSS aerial 30.6 30.2 29.6 ground 26.5 26.3 25.8
Cranberry Provisional Cranberry Model 2 NA 279 106 106

1 This column shows the actual scenario (file) names for scenarios used to generate EECs using the Surface Water Concentration Calculator (SWCC). The general syntax for scenario names reflects the state_use site_scenario type_version (if applicable). For example, ORberriesOP reflects a scenario originally developed to model Oregon (OR) berries for organophosphate (OP) pesticides.

2 Not a SWCC scenario. Reflects a 21-day holding time, post-flood. See Appendix C for details.

Table 3.10. Tebufenozide Parent-Only EE Cs for Surface Water (Selected Uses)
Use Scenario 1 Application Method 1-in-10 year 1- day (“peak”) mean ( μ g/L) 1-in-10 year 21- day mean

( μ g/L) 1-in-10 year 60- day mean

( μ g/L)

Canola NDcanolaSTD aerial 18.4 17.2 16.2 ground 13.0 12.0 10.9 Fruiting vegetables FLpeppersSTD aerial 46.0 42.1 39.4 ground 42.5 38.7 36.3
Trees, Forests, Shrubs FLnurserySTD_V2 aerial 7.44 6.67 5.81 ground 6.67 5.99 5.29

### 29 1 This column shows the actual scenario (file) names for scenarios used to generate EECs using the Surface Water Concentration Calculator (SWCC). The general syntax for scenario names reflects the state_use site_scenario type_version (if applicable). For example, ORberriesOP reflects a scenario originally developed to model Oregon (OR) berries for organophosphate (OP) pesticides.



### 3.2.2.4. Estimated Environmental Concentrations in the Benthic Region

In the benthic region, the SWCC indicates that tebufenozide dissipation is negligible ( Appendix C ). The main source of dissipation in the benthic region is metabolism. The effective average benthic half-lives for tebufenozide TTR range from 577.6 days ( e.g ., fruiting vegetables) to 1,571 days ( e.g ., canola). The majority (91.9%) of tebufenozide TTR in the benthic region issorbed to sediment rather than in the pore water. There is no difference between the one-in-tenyear peak and 21-day moving average values for benthic TTR EECs. For the use on fruiting vegetables, the pore water EEC is 96.3 ug/L and the sediment EEC is 440 ug/kg dry sediment.

3.2.2.5. Monitoring Data

Only limited monitoring data are available for tebufenozide. EFED conducted a search (January 27, 2015) of the U.S. Geological Survey (USGS) National Water Quality Assessment (NAWQA) Program database ( http://cida.usgs.gov/nawqa_queries_public/ ), the USGS Community Water System (CWS) data ( http://pubs.usgs.gov/ds/544/ ), the California Department of Pesticide Regulation (CDPR) surface water and sediment database ( http://cdpr.ca.gov/docs/emon/surfwtr/surfcont.htm ), and the EPA/USGS National Water Quality Monitoring Council (NWQMC) Water Quality Portal database ( http://www.waterqualitydata.us/ ). The CWS, CDPR and Water Quality Portal databases do not include any records of tebufenozide as a sampled constituent. The NAWQA database lists tebufenozide as a constituent, and includes records of 11 “filtered” samples collected from the Rio Grande River, near Brownsville, TX, on various dates in 2013. All results are listed as “<2 ng/L,” which presumably reflects the analytical method limit of quantitation.

3.2.3. Measures of Terrestrial Exposure

3.2.3.1. Ingestion of Dietary Residues by Birds and Mammals

Terrestrial wildlife exposure estimates are typically calculated for birds and mammals by emphasizing the dietary exposure route of uptake of pesticide active ingredients. These exposures are considered to be surrogates for exposures to terrestrial-phase amphibians and reptiles. For exposures to terrestrial organisms, such as birds and mammals, pesticide residues on food items are estimated based on the assumption that organisms are exposed to pesticide residues as a function of the pesticide use pattern. Tebufenozide is applied in spray form, using ground or aerial equipment. Therefore, potential dietary exposure for terrestrial wildlife in this assessment is based on consumption of tebufenozide residues on food items following spray applications.

### 30 T-REX (v. 1.5.2) is used to calculate dietary and dose-based EECs of tebufenozide residues on food items for mammals and birds generated by spray applications for the labeled uses. Input values for deriving EECs using T-REX are located in Table 3.11 . Upper-bound Kenaga nomogram values are used to derive peak (point-in-time) EECs for tebufenozide exposures to terrestrial mammals and birds ( Table 3.12
, Table 3.13 , and Table 3.14 ), based on tebufenozide use within a 1-year time period. Consideration is given to different types of feeding strategies for mammals, including herbivores, insectivores and granivores. Dose-based exposures are estimated for three weight classes of birds (20 g, 100 g, and 1000 g) and three weight classes of mammals (15 g, 35 g, and 1000 g).

Differences in exposures between ground and aerial applications cannot be assessed with the current T-REX model; exposure and risk estimates from the T-REX model are considered relevant to both application scenarios. Other uncer tainties in the terrestrial EECs are primarily associated with a lack of data on interception and subsequent dissipation from foliar surfaces. Foliar dissipation data specific to tebufenozide are not available in Willis and McDowell (1987) or in magnitude of residue data submitted under OCSPP Guideline 860.1500. When data are absent, as in this case, EFED assumes a default 35-day foliar dissipation half-life, based on the work of Willis and McDowell (1987). An example output from the T-REX model is provided in Appendix D

.
Table 3.11. Input Parameters for Deriving Screening-Level Terrestrial EECs for Tebufenozide (T-REX v. 1.5.2; June 6, 2013).

Use(s) Maximum Single App. Rate (lbs a.i./A) Minimum Reapplication Interval (days) Maximum No. of App. 1, 2 Foliar Dissipation

Half-Life Agricultural Uses Bushberries 0.25 7 4

35 3 Caneberries 0.25 10 4 Canola 0.25 10 4 Citrus 0.25 14 5 Cole crops and leafy vegetables 0.12 10 15

Cotton 0.25 10 4 Cranberries 0.25 7 4 Fruiting vegetables 0.25 10 8 Mint 0.25 10 8 Pastures and rangeland 0.13 10 4 Pome fruits 0.31 7 6 Sugarcane 0.25 10 4 Tree nuts (almond, walnut, other nuts) 0.47 10 4
Tree nuts (pecan) 0.25 8 8 4 Non-agricultural Uses Ornamentals 0.25 10 8 35 3 Forest, trees and shrubs 0.12 2 5 2 Abbreviations: App., Application(s).

1 The maximum number of applications at the maximum single application rate, based on the maximum annual application rate. Values are rounded up to the next higher integer. The last application is modeled at a lower rate when necessary to avoid exceeding the maximum annual application rate.

2 Based on registrant-supplied use summary table dated January 13, 2015.
3 The default foliar dissipation half-life value of 35 days is used in the absence of foliar dissipation data.

### 31 Use(s) Maximum Single App. Rate (lbs a.i./A) Minimum Reapplication Interval (days) Maximum No. of App. 1, 2 Foliar Dissipation

Half-Life

4 Assumes seven applications at 0.25 lbs ai/A and one application at 0.15 lbs ai/A to achieve the maximum annual rate of 1.9 lbs ai/A.32Table 3.12. Screening-level Dose-based EECs (mg/kg bw) as Food Residues for Birds, Reptiles, and Terrestrial-Phase Amphibiansfrom Labeled Usesof Tebufenozide (T-REX v. 1.5.2; June 6, 2013).Primary FeedingStrategyÆHerbivores and OmnivoresInsectivoresGranivoresAnimal SizeÆSmallMedLargeSmallMedLargeSmallMedLargeDietary ItemsÆ Short Grass Tall Grass Broad-leaf Plant s Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc .ArthropodsSeeds, grains,etc.Use(s)ÈAgricultural UsesBushberries225103126 14.0 128 58.7 72.1 8.01 57.426.332.3 3.59 88.0 50.2 22.5 3.12 1.78 0.80Caneberries20895.4117 13.0 119 54.4 66.8 7.42 53.124.429.9 3.32 81.5 46.5 20.8 2.89 1.65 0.74Canola20895.4117 13.0 119 54.4 66.8 7.42 53.124.429.9 3.32 81.5 46.5 20.8 2.89 1.65 0.74Citrus21297.0119 13.2 121 55.3 67.9 7.54 54.024.830.4 3.38 82.9 47.3 21.2 2.94 1.68 0.75Cole crops and leafyvegetables17379.4 97.410.898.845.3 55.6 6.17 44.220.324.9 2.76 67.8 38.7 17.3 2.41 1.37 0.61Cotton20895.4117 13.0 119 54.4 66.8 7.42 53.124.429.9 3.32 81.5 46.5 20.8 2.89 1.65 0.74Cranberries225 103 126 14.0 128 58.7 72.1 8.01 57.426.332.3 3.59 88.0 50.2 22.5 3.12 1.78 0.80Fruiting vegetables302 139 170 18.9 172 79.0 97.0 10.8 77.235.443.4 4.82 118 67.5 30.2 4.20 2.39 1.07Mint302139 170 18.9 172 79.0 97.0 10.8 77.235.443.4 4.82 118 67.5 30.2 4.20 2.39 1.07Pome fruits370 169 208 23.1 211 96.6 119 13.2 94.443.353.1 5.90 145 82.6 37.0 5.13 2.83 1.31Pastures andrangeland10849.660.96.7661.728.3 34.7 3.86 27.612.715.5 1.73 42.4 24.2 10.8 1.50 0.86 0.38Sugarcane20895.4117 13.0 119 54.4 66.8 7.42 53.124.429.9 3.32 81.5 46.5 20.8 2.89 1.65 0.74Tree nuts (almond,walnut, other nuts)391 179 220 24.5 223 102 125 13.9 99.945.856.2 6.24 153 87.4 39.1 5.43 3.10 1.39Tree nuts (pecan)313 143 176 19.5 178 81.7 100 11.1 79.836.644.9 4.99 122 69.8 31.3 4.34 2.48 1.11Non-agricultural UsesOrnamentals302139 170 18.9 172 79.0 97.0 10.8 77.235.443.4 4.82 118 67.5 30.2 4.20 2.39 1.07Forest, trees andshrubs62.5 28.7 35.2 3.91 35.6 16.3 20.1 2.23 16.0 7.31 8.98 1.00 24.5 14.0 6.25 0.87 0.50 0.2233Table 3.13. Screening-level Dose-based EECs (mg/kg bw) as Food Residues for Mammals from Labeled Uses of Tebufenozide (T-REX v. 1.5.2; June 6,2013).Primary FeedingStrategyÆHerbivores and OmnivoresInsectivoresGranivoresAnimal SizeÆSmallMedLargeSmallMedLargeSmallMedLargeDietary ItemsÆ Short Grass Tall Grass Broad-leaf Plant s Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc .ArthropodsSeeds, grains,etc.Use(s)ÈAgricultural UsesBushberries18886.210611.8 130 59.6 73.1 8.13 30.113.817.0 1.88 73.7 50.9 11.8 2.61 1.81 0.42Caneberries17479.9 98.010.9 120 55.2 67.7 7.53 27.912.815.7 1.74 68.2 47.2 10.9 2.42 1.67 0.39Canola17479.998.010.9 120 55.2 67.7 7.53 27.912.815.7 1.74 68.2 47.2 10.9 2.42 1.67 0.39Citrus17781.2 99.711.1 122 56.1 68.9 7.65 28.413.016.0 1.77 69.4 48.0 11.1 2.46 1.70 0.39Cole crops and leafyvegetables14566.5 81.69.06 100 45.9 56.4 6.26 23.210.713.1 1.45 56.8 39.2 9.10 2.01 1.39 0.32Cotton17479.998.010.9 120 55.2 67.7 7.53 27.912.815.7 1.74 68.2 47.2 10.9 2.42 1.67 0.39Cranberries18886.2106 11.8 130 59.6 73.1 8.13 30.113.817.0 1.88 73.7 50.9 11.8 2.61 1.81 0.42Fruiting vegetables253 116 142 15.8 175 80.2 98.4 10.9 40.618.622.8 2.53 99.1 68.5 15.9 3.52 2.43 0.56Mint253 116 142 15.8 175 80.2 98.4 10.9 40.618.622.8 2.53 99.1 68.5 15.9 3.52 2.43 0.56Pastures andrangeland90.641.551.05.6662.628.7 35.2 3.91 14.56.658.17 0.91 35.5 24.5 5.69 1.26 0.87 0.20Pome fruits310 142 174 19.3 214 98.0 120 13.4 49.622.727.9 3.10 121 83.8 19.4 4.3 2.97 0.69Sugarcane17479.998.010.9 120 55.2 67.7 7.53 27.912.815.7 1.74 68.2 47.2 10.9 2.42 1.67 0.39Tree nuts (almond,walnut, other nuts)328 150 184 20.5 226 104 127 14.2 52.524.129.5 3.28 128 88.7 20.6 4.55 3.14 0.73Tree nuts (pecan)262 120 147 16.4 181 19.2 23.6 2.62 41.919.223.6 2.62 102 70.8 16.4 3.63 2.51 0.58Non-agricultural UsesOrnamentals253 116 142 15.8 175 80.2 98.4 10.9 40.618.622.8 2.53 99.1 68.5 15.9 3.52 2.43 0.56Forest, trees andshrubs52.3 24.0 29.4 3.27 36.2 16.6 20.3 2.26 8.39 3.84 4.72 0.52 20.5 14.2 3.28 0.73 0.50 0.12

### 34 Table 3.14. Screening-level Dietary-based EECs (mg/kg diet) as Food Residues for Birds, Reptiles, Terrestrial-phase Amphibians, and Mammals from Labeled Uses of Tebufenozide (T-REX v. 1.5.2; June 6, 2013). Primary Feeding Strategy Æ Herbivores, Omnivores, and Granivores Insectivores

Dietary Items ÆShort GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Arthropods

Use(s) È

Agricultural Uses

Bushberries 197 90.4 111 12.3 77.3

Caneberries 183 83.8 103 11.4 71.6

Canola 183 83.8 103 11.4 71.6

Citrus 186 85.2 105 11.6 72.8
Cole crops and leafy vegetables 152 69.7 85.5 9.50 59.6

Cotton 183 83.8 103 11.4 71.6

Cranberries 197 90.4 111 12.3 77.3
Fruiting vegetables 265 122 149 16.6 104

Mint 265 122 149 16.6 104
Pastures and rangeland 95.0 43.6 53.5 5.94 37.2

Pome fruits 325 149 183 20.3 127
Sugarcane 183 83.8 103 11.4 71.6
Tree nuts (almond, walnut, other nuts) 344 157 193 21.5 135
Tree nuts (pecan) 274 126 154 17.2 107 Non-agricultural Uses

Ornamentals 265 122 149 16.6 104 Forest, trees and shrubs 54.9 25.2 30.9 3.43 21.5



### 3.2.3.2. Runoff and Spray Drift to Terrestrial and Semi-Aquatic Plants

Exposure of non-target terrestrial and semi-aquatic (wetland) plant species is estimated using OPP’s TerrPlant (v. 1.2.2) model. Loading via spray drift to dry, non-target, adjacent areas is assumed to occur from one acre of treated land to one acre of the non-target area. Runoff is also expected to be a source of pesticide loading to non-target areas. TerrPlant calculates EECs as a function of application rate, solubility, and default assumptions regarding spray drift. The default spray drift assumptions are 1% of the application rate for ground spray applications and 5% for aerial spray applications (USEPA 2006b). The EECs for terrestrial and semi-aquatic plants for a single application of tebufenozide at the maximum labeled rate ( i.e. , to tree nuts) are presented in Table 3-15 (see example output in Appendix E ). Non-target terrestrial plant EECs for all other uses (based on a single application) are expected to be less than the values for tree
nuts.

### 35 Table 3.15. EECs for Terrestrial and Semi-Aquatic Plants Near Tebufenozide Use Areas (TerrPlant v. 1.2.2).

Crop Single Max. Application Rate (lbs ai/A) EECs (lbs ai/A)

Spray Drift Only Runoff and Spray Drift (Dry Areas) Runoff and Spray Drift (Semi-Aquatic Areas) Ground

spray Aerial spray Ground spray Aerial spray Ground spray Aerial spray Agricultural Uses

Tree nuts 1 0.47 0.0047 0.024 0.0094 0.028 0.052 0.071

1 Based on the maximum single application rate for the use on tree nuts (almond, walnut, and other nuts).



### 3.3. Ecological Effects Characterization

The ecological effects characterization for tebufenozide is based upon registrant-submitted toxicity data for the TGAI and for specified formulations. Appendix I lists these studies, their review classifications, and associated deficiencies. The ecotoxicity data for tebufenozide and its associated products have been reviewed previously in multiple ecological risk assessments ( e.g., USEPA 2007, 2005) and in a Preliminary Problem Formulation for Registration Review (USEPA 2008). These data are summarized briefly in Sections 3.3.1 and 3.3.2. Various studies with terrestrial and aquatic plants, birds, and aquatic animals exposed to either the TGAI or formulated tebufenozide have been received since the Problem Formulation was issued; the results of these studies are described briefly in this section

. Ecotoxicity data recently submitted for tebufenozide degradates indicate that these degradates are generally equally or less toxic than parent tebufenozide to freshwater fish, invertebrates, and algae.

The results of a 2014 review of the Ecological Incident Information System (EIIS) are described in Section 3.3.3 (USEPA 2014). A search of the ECOTOXicology database on June 3, 2014, yielded no new data from suitable studies with more sensitive toxicity endpoints than theregistrant-submitted guideline studies described below. The endpoints from the ECOTOXcatalogued open literature studies are provided in Attachment 2 , for reference.

3.3.1. Aquatic Toxicity Assessment

A summary of the most sensitive aquatic toxicity data for tebufenozide, based on a current Agency review of all submitted data, is provided in Table 3.16 through Table 3.24 and discussed further in Sections 3.3.1.1 through 3.3.1.5 . The available data indicate that tebufenozide TGAI is moderately toxic to freshwater fish (and thus to aquatic amphibians) and to freshwater and estuarine/marine invertebrates on an acute exposure basis. Tebufenozide is highly toxic to estuarine/marine fish. Chronic exposure to tebufenozide affected reproductive endpoints in freshwater fish and freshwater invertebrates. The NOAEL values for freshwater vascular and nonvascular plants were equal to the highest concentrations tested. The endpoints affected by tebufenozide exposure are described in more detail below.

### 36 3.3.1.1. Toxicity to Freshwater Fish

As shown in Table 3.16 , tebufenozide TGAI is moderately toxic to bluegill sunfish ( Lepomis macrochirus ) and the rainbow trout ( Oncorhynchus mykiss ) under acute exposure conditions (MRIDs 42436239 and -40). The acute toxicity values reported for the TGAI exceed the solubility limit (830 μ g ai/L) and reflect the enhanced solubility obtained through the use of a cosolvent. Tebufenozide degradates have been tested up to their apparent limits of water solubility and have shown no acute toxicity to freshwater fish; they are classified as no more than moderately toxic based on the upper limit of concentrations tested (MRIDs 47926502, -03, -04, and -09).

Table 3.16. Summary of Acute Toxicity Data for Fres hwater Fish Exposed to Tebufenozide and its Degradates.

Species Study Type Test Substance (Purity) LC 50 ( 

### μ g/L) 1 (95% CL) Toxicity Classification (MRID)

Bluegill sunfish ( Lepomis macrochirus ) 96-hr, static TGAI (96.1%) 3,000 2 (2,200-4,000) Moderately toxic (42436239)

96-hr, static RH-112,651 (100%) Degradate >4,690 3 (N/A) No more than moderately toxic (47926502)

Rainbow trout ( Oncorhynchus mykiss ) 96-hr, static TGAI (96.1%) 5,380 4 (4,580-6,590) Moderately toxic (42436240)

96-hr, static RH-112,651 (94.7%) Degradate >4,400 3 (N/A) No more than moderately toxic

(47926503)

96-hr, static RH-96,595 (96.8%) Degradate >1,400 5,6 (N/A) No more than moderately toxic (47926504)

96-hr, static RH-112,703 (82.9%) Degradate >5,400 7,8 (N/A) No more than moderately toxic (47926509)
Abbreviations : ai: Active ingredient. CL: Confidence limits. LC 50 : Lethal concentration to 50% of the population. N/A: Not applicable or available. Bolded values represent the most sensitive toxicity endpoints for freshwater fish exposed to parent tebufenozide.

1 Based on mean measured concentrations, unless otherwise indicated.

2 Precipitate was observed in the three highest treatment levels (5,700, 9,400, and 18,000 μ g a.i./L, mean measured) and they were excluded from the analysis.

3 Water solubility was estimated as 5.3 mg/L (EPI Suite TM v. 4.0).

4 Precipitate was observed at the four highest tr eatment levels (4,700, 7,200, 10,000, and 17,000 μ g a.i./L, mean measured); the two highest treatment levels were excluded from analysis.

5 Precipitate was observed at the two highest treatment levels (2,300 and 3,700 μ g/L) and they were excluded from the analysis.

6 Water solubility was estimated as 8.0 mg/L (EPI Suite TM v. 4.0).

7 Precipitate was observed at the highest treatment level (5,400 μ g/L).

8 Water solubility was estimated as 10,400 μ g/L (EPI Suite TM v. 4.0).



### Although an early life stage toxicity test with fathead minnows ( Pimephales promelas ) resulted in a definitive NOAEC of 360 μ g ai/L, a fish full life cycle study with the same species failed to establish a NOAEC (NOAEC<48 μ g ai/L) for the most sensitive endpoint ( i.e ., number of eggs per spawn) and was confounded by significant differences between the solvent and negative controls. Subsequently, the registrant submitted a fathead minnow short-term reproduction assay consistent with OCSPP Guideline 890.1350 and OECD 229 (MRID 48702201). The assay identified a slight-but-statistically significant (p<0.05) advance in ovarian stage, i.e ., a

### 37 histological indication of treatment-related difference in the female reproductive cycle, at concentrations of 101 μ g ai/L and above (NOAEC=51.1 μ g ai/L). No effects were observed on other reproductive parameters, body weight, or survival. ( Table 3.17 ).

Table 3.17. Summary of Chronic Toxicity Data for Freshwater Fish Exposed to Tebufenozide.

Species Study Type Test Substance (Purity) NOAEC LOAEC ( 

### μ g/L) 1 Endpoints (MRID)

Fathead minnow ( Pimephales promelas ) 35-day, flowthrough, early life stage TGAI (97.5%) 360 710 2 Juvenile survival (42436242) 21-day, flow through, short
term reproduction TGAI (98.9%) 51.1 101 Ovarian stage (48702201)

219-day, flowthrough, full

life cycle TGAI (96.1%) <48 48 Number of eggs
per spawn (44221901) Bolded values are used in risk estimation. Abbreviations : ai: Active ingredient. CL: Confidence limits.

1 Based on mean measured concentrations.

2 Water solubility was reported in the study as 840 μ g/L.



### 3.3.1.2. Toxicity to Freshwater Invertebrates

Technical-grade tebufenozide is moderately toxic to freshwater invertebrates (daphnid, Daphnia
magna ) on an acute exposure basis (MRID 42436241). One tebufenozide end-use product (EP) has been tested with daphnid: the water miscible formulation (HOE 105540 240 g/L 3 

### , 24.5% a.i.) is slightly toxic (MRID 43699701). Tebufenozide degradates have shown no acute toxicity to daphnid when tested up to their apparent limits of water solubility; they are classified as no more than moderately toxic based on the upper limit of concentrations tested (MRIDs 47926501, -05, and -07). ( Table 3.18 ). An open literature study with first-instar larvae of the caddisfly ( Cheumatopsyche brevilineata ) determined a 48-hour immobilization EC 50 

### of 830 ug a.i./L (ECOTOX No. E152279). The endpoint is used in risk characterization but not in risk estimation ( e.g ., for RQ calculation) for sediment-associated organisms because exposure concentrations were only reported in terms of overlying water.

3 Formulation name as identified in the study report.

### 38 Table 3.18. Summary of Acute Toxicity Data for Freshwater Invertebrates Exposed to Tebufenozide and its Degradates.

Species Study Type Test Substance (Purity) EC 50 ( 

### μ g/L) 1 (95% CL) Toxicity Classification (MRID)

Water flea ( Daphnia magna ) 48-hr, static TGAI (96.1%) 3,800 2,3 (2,900-5,100) Moderately toxic (42436241)
48-hr, static EP (24.5%) HOE 105540 12,000 4 (8,000-30,000) 5 Slightly toxic (43699701)

48-hr, static RH-112,703 (83%) Degradate >5,500 (N/A) No more than moderately toxic (47926501)

48-hr, static RH-112,651 (94.7%) Degradate >5,200 (N/A) No more than moderately toxic (47926507)

48-hr, static RH-96,595 (96.8%) Degradate >1,500 6 (N/A) No more than moderately toxic (47926505) Caddisfly ( Cheumatopsyche brevilineata ) Nonguideline, 48-hr TGAI (> 99%) 830 (NR) Highly toxic (E152279)

Abbreviations : ai: Active ingredient. CL: Confidence limits. EP: End-use product. N/A: Not available or applicable. Bolded values represent the most sensitive toxicity endpoints for freshwater invertebrates exposed to parent tebufenozide.

1 Based on mean-measured concentr ations, unless otherwise indicated.

2 Precipitate or cloudiness was observed in the four highest treatment levels (1,800, 4,700, 6,400, and 35,000 μ g ai/L, mean measured); the highest treatment level was excluded from analysis.

3 Water solubility was reported as 830 μ g/L.

4 Based on nominal concentrations, adjusted for purity of test substance (% ai).

5 Probit slope reported as 1.9.
6 Precipitate was observed at the two highest treatment levels (1,800 and 4,600 μ g/L, mean measured); these treatments were excluded from the analysis.



### Growth (reduced dry weight) was the most sensitive chronic toxicity endpoint in daphnids exposed to technical-grade tebufenozide in a life cycle study ( Table 3.19 ); reproductive endpoints, including reduced number of offspring per female, and reduced survival were detected at higher test concentrations (MRID 42436243). A separate study with formulated tebufenozide (HOE 105540 4 

### ) also identified reductions in the number of offspring at lower test concentrations (when adjusted for purity) than the test with TGAI (MRID 43699702).

A nonguideline emergence study with the benthic invertebrate midge ( Chironomus riparius ) showed that tebufenozide exposure delayed development and adult emergence, particularly in males, at all treatment levels ( i.e ., NOAEC< 3.3 μ g/L in overlying water, <0.44 ug/L in pore
water ; 

### MRID 44198301). Tassou and Schulz (E166013, 2013) 5 

### followed a similar 28-day test design with two successive generations of midge and detected significantly lower fertility at mean-measured concentrations of 13 ug ai/L in overlying water, which corresponded to 1.1 ug ai/L pore water. Tebufenozide treatment alone did not affect development or emergence, although differences were seen among the parental and offspring generations. Comparisons were made only to a solvent control (0.84 uL/L dimethyl sulfoxide, DMSO) in the open literature

4 Formulation name as identified in the study report.

5 Throughout this document, “E” preceding a reference number indicates an ECOTOX database identification number.

### 39 study (E166013) 6 

### . In both experiments, there are uncertainties regarding actual exposure because tebufenozide was spiked into overlying water instead of directly into sediment, and changes in measured concentrations over time demonstrate that the test systems had not reached equilibrium prior to test initiation. Given these uncertainties, the data in these two studies are not used for risk estimation.

Table 3.19. Summary of Chronic Toxicity Data for Freshwater Invertebrates Exposed to Tebufenozide.

Species Study Type Test Substance (Purity) NOAEC LOAEC ( μ g ai/L) Endpoints (MRID)

Water flea ( Daphnia magna ) 21-day, flowthrough TGAI (97.5%) 29 1 59 Dry weight (42436243)21-day, flowthrough EP (24.5%) HOE 105540 7.8 2 13.7 Number of offspring (43699702)

Midge ( Chironomus riparius ) Nonguideline 28-day, static TGAI (96.1%) Overlying
water: <3.3 3.3 3

Pore water: <0.44 0.44 3

Sediment (ug/kg dry sediment): < 5.5 5.5 3 Development rate,
emergence (44198301)

Nonguideline 28-day, static TGAI (99.9%) Overlying
water:

6.4 13 4

Pore water: 0.1 1.1 4 Fertility (E166013)

Abbreviations : ai: Active ingredient. CL: Confidence limits. EP: End-use product. N/A: Not applicable or available. Bolded values are used in risk estimation.

1 Based on mean measured concentrations.

2 Based on nominal concentrations, adjusted for purity of test substance (% ai or % degradate).
3 Based on time-weighted average concentrations.
4 Based on arithmetic mean-measured concentrations and comparison to solvent control (0.84 uL/L DMSO),



### 3.3.1.3. Toxicity to Estuarine/Marine Fish

No adverse effects were observed in sheepshead minnow ( Cyprinodon variegatus ) acutely exposed to tebufenozide TGAI at concentrations approaching its limit of solubility in freshwater (MRID 42991504) of 830 μ g ai/L; its solubility in estuarine/marine environments would likely be reduced. Tebufenozide is classified as no more than highly toxic to sheepshead minnow based

6 Throughout this document, “E” preceding a reference number indicates an ECOTOX database identification number.

### 40 on the upper limit of concentrations tested ( Table 3.20 ). Growth (juvenile length) was reduced in an early life stage test with the same species (MRID 44080901). No other effects were observed ( Table 3.21 ).

Table 3.20. Summary of Acute Toxicity Data for Estuarine/Marine Fish Exposed to Tebufenozide.

Species Study Type Test Substance (Purity) LC 50 ( μ g/L) 1 (95% CL) Toxicity Classification (MRID) Sheepshead minnow ( Cyprinodon variegatus ) 96-hr, flowthrough TGAI (97.5%) > 720 2 (NA) No more than highly toxic (42991504)

CL Confidence limits, NA Not available. Bolded values represent the most sensitive toxicity endpoints for estuarine/marine fish exposed to parent tebufenozide.

1 Based on mean measured concentrations.

2 Water solubility was reported as 830 μ g/L.

Table 3.21. Summary of Chronic Toxicity Data for Estuarine/Marine Fish Exposed to Tebufenozide.

Species Study Type Test Substance (Purity) NOAEC LOAEC ( μ g/L) 1 Endpoints (MRID) Sheepshead minnow ( Cyprinodon variegatus ) 32-day, flowthrough, early life stage TGAI (96.1%) 550 1,200 Juvenile length (44080901)

Bolded values represent the most sensitive toxicity endpoints for estuarine/marine fish exposed to parent tebufenozide.

1 Based on mean measured concentrations



### 3.3.1.4. Toxicity to Estuarine/Marine Invertebrates

Tebufenozide TGAI is moderately toxic to estuarine/marine crustaceans (MRID 42991505) and highly toxic to molluscs (MRID 42087701), based on acute toxicity tests with the mysid shrimp ( Americamysis bahia ) and eastern oyster ( Crassotrea virginica ), respectively ( Table 3.22 ). One mortality and one abnormality ( i.e ., lost claw) were seen in young adult lobsters ( Homarus americanus ) exposed to formulated tebufenozide (Confirm ® 

### 2F, 23.2% a.i.) at concentrations up to 76 μ g a.i./L; it was unclear whether the effects in this nonguideline study were treatmentrelated given that they were limited in number and only observed in the highest test concentration, and a definitive EC 50 

### value was not determined (MRID 44945701). The young adult life stage tested in the lobster may not be sensitive to the type of effects generally associated with an insect growth regulator ( e.g ., effects on molting).

Table 3.22. Summary of Acute Toxicity Data for Estuar ine/Marine Invertebrates Exposed to Tebufenozide.

Species Study Type Test Substance (Purity) EC 50 or IC 50 ( μ g/L) 1 (95% CL) Toxicity Classification (MRID) Mysid shrimp ( Americamysis bahia formerly Mysidopsis bahia ) 96-hr, static TGAI (97.5%) 1,400 (820-2,200) Moderately toxic (42991505)

Eastern oyster ( Crassotrea virginica ) 96-hr, flowthrough, shell

deposition TGAI (97.5%) 505 (436-589) Highly toxic (42807701) Northern lobster Nonguideline, EP (23.2%) >76 Very highly toxic 2

### 41 Species Study Type Test Substance (Purity) EC 50 or IC 50 ( μ g/L) 1 (95% CL) Toxicity Classification (MRID) ( Homarus americanus ) 96-hr, flowthrough Confirm ® 2F (NA) (44945701)

CL Confidence limits, EP End-use product, NA Not available. Bolded values represent the most sensitive toxicity endpoints for estuarine/marine invertebrates.

1 Based on mean-measured concentrations.

2 Based on the upper limit of concentrations tested. One mortality and one abnormality (lost claw) were observed at the highest test concentration.


### Adverse effects on survival and reproduction (number of offspring) were observed at all test concentrations in mysid shrimp ( Americamysis bahia ) exposed to tebufenozide TGAI in a 28-day life cycle study (MRID 42991505). Exposure at the lowest treatment level, 22 μ g a.i./L, resulted in statistically significant mortality and a 27% reduction in reproductive success (p<0.05) when compared to the negative control. Male mysids in the highest treatment level (270 μ g a.i./L) were significantly shorter (-12%) than those in the negative control (p<0.05). A definitive NOAEC was not established ( i.e ., NOAEC<22 μ g a.i./L), and it is unclear to what extent solvent interference may have confounded the results ( Table 3.23 ).

Table 3.23. Summary of Chronic Toxicity Data for Estuarine/Marine Invertebrates Exposed to Tebufenozide.

Species Study Type Test Substance (Purity) NOAEC LOAEC ( μ g ai/L) Endpoints (MRID) Mysid shrimp ( Americamysis bahia formerly Mysidopsis bahia ) 28-day, flowthrough TGAI (97.5%) <22 1 22 Survival and reproduction (42991505)

Eastern oyster ( Crassotrea virginica ) Estimate TGAI (97.5%) < 7.9 2 NA Acute-to-chronic ratio (ACR) (42991505) (42807701)

NA Not available. Bolded values represent the most sensitive toxicity endpoints for estuarine/marine invertebrates.

1 Based on mean-measured concentrations.

2 Nondefinitive chronic toxicity estimate from acute-to-chronic ratio between myid shrimp acute toxicity endpoints (LC 50 = 1,400 μ g a.i./L) and NOAEC < 22 μ g a.i./L., applied to IC 50 value for Eastern oyster (505 μ g a.i./L).


### 3.3.1.5. Toxicity to Aquatic Plants

As shown in Table 3.24. , technical grade tebufenozide had no significant effect on vascular aquatic plant survival or growth in a seven-day static-renewal test with duckweed ( Lemna gibba ) (MRID 48533003) or in a 96-hour nonvascular aquatic plant toxicity test with green algae ( Pseudokirchneriella subcapitata ) (MRID 42436245). Tebufenozide degradates had no effect on the green algae at concentrations up to their apparent limits of water solubility (MRIDs 47926506, -08, and -10), which were at least five times greater than the water solubility limit of parent tebufenozide (830 μ g ai/L).

### 42 Table 3.24. Summary of Toxicity Data for Vascular and Nonvascular Aquatic Plants Exposed to Tebufenozide and its Degradates.

Species Study Type Test Substance (Purity) NOAEL & IC 50 ( 

### μ g ai/L) (95% CL) Effect (MRID)

Duckweed ( Lemna gibba ) 7-day, static renewal TGAI (98.6%) 940 1 >940 (NA) None (48533003)

Green alga ( Pseudokirchneriella subcapitata ) 96-hr, static TGAI (97.5%) 740 2 >740 (NA) None (42436245)

96-hr, static RH-112,651 (98.2%) Degradate 4,500 2 >4,500 (NA) None (47926506)

96-hr, static RH-112,703 (92.0%) Degradate 5,100 2 >5,100 (NA) None (47926508)

96-hr, static RH-96,595 Degradate 7,000 1 >7,000 (NA) None (47926510)

CL Confidence limits, NA Not available. Bolded values represent the most sensitive toxicity endpoints for va scular and nonvascular aquatic plants exposed to parent tebufenozide.

1 Based on mean-measured concentrations.

2 Based on initial measured concentrations

.



### 3.3.2. Terrestrial Toxicity Assessment

Tebufenozide is practically nontoxic toxic to birds, terrestrial-phase amphibians, reptiles and mammals on an acute oral and subacute dietary exposure basis; the chemical is also classified as practically nontoxic to honey bees ( Apis mellifera ) and an acute contact exposure basis. Chronic exposure to tebufenozide resulted in decreased reproduction in certain birds and mammals.

3.3.2.1. Toxicity to Birds

No effects were seen in bobwhite quail ( Colinus virginianus ) exposed to technical grade tebufenozide by oral gavage or in the diet (MRIDs 42436234 and 42436235, Table 3.25 ). Avian reproduction tests with bobwhite quail have produced different results ( Table 3.26 ). No effects were seen in one study, but it did not provide offspring body weights, and certain other data in the report were considered unreliable (MRID 43781701). A second study yielded reproductive effects (reduced number of 14-day hatchling survivors) at exposures greater than 100 mg/kg diet (MRID 42991501). No effects were seen in an avian reproduction study with mallard duck ( Anas platyrhynchos ) that tested up to 980 mg ai/kg diet (MRID 42991503).

Table 3.25. Summary of Acute Toxicity Data for Birds Exposed to Tebufenozide.

Species Study Type Test Substance (Purity) LD 50 (mg/kg bw)

or LC 50 (mg ai/kg diet) 1 Toxicity Classification (MRID)

Bobwhite quail ( Colinus virginianus ) Acute oral toxicity TGAI (96.8%) LD 50 >2,150 Practically nontoxic (42436234) 8-day, subacute TGAI (96.8%) LC 50 >5,000 Practically nontoxic

### 43 Species Study Type Test Substance (Purity) LD 50 (mg/kg bw)

or LC 50 (mg ai/kg diet) 1 Toxicity Classification (MRID) dietary toxicity (42436235) 2

Mallard duck ( Anas platyrhynchos ) 8-day, subacute dietary toxicity TGAI (96.8%) LC 50 >5,000 Practically nontoxic (42436237) 3

Bolded values represent the lowest definitive toxicity endpoint and are used in risk estimation ( i.e. , RQ calculation). Other values are used in risk characterization.

1 Based on nominal dose or dietary concentration, adjusted for purity.

2 Analytical results for measured dietary concentrations are reported in MRID 42436236 and are considered to be within the range of nominal concentrations.
3 Analytical results for measured dietary concentrations are reported in MRID 42436238 and are considered to be within the range of nominal concentrations.

Table 3.26. Summary of Chronic Toxicity Data for Birds Exposed to Tebufenozide.

Species Study Type Test Substance (Purity) NOAEC LOAEC (mg ai/kg

diet) 1 Endpoints (MRID)

Bobwhite quail ( Colinus virginianus ) Avian reproduction TGAI (97.5%) 100 300 Number of 14-day survivors (42991501) Avian reproduction TGAI (96.1%) 615 >615 None (43781701)
Mallard duck ( Anas platyrhynchos ) Avian reproduction TGAI (97.5%) 980 2 >980 None (42991503)

Bolded values represent the lowest definitive toxicity endpoint and are used in risk estimation ( i.e. , RQ calculation). Other values are used in risk characterization.

1 Based on nominal dose or dietary concentration, ad justed for purity, unle ss otherwise indicated.

2 Based on mean measured concentrations.



### 3.3.2.2. Toxicity to Mammals

Mammalian toxicity data considered in the ecological risk assessment are summarized in Table 3.27 . Tebufenozide is practically nontoxic to mammals on an acute oral exposure basis, with an LD 50 

### value of 5,000 mg/kg bw (MRID 42436212). The inhalation LC 50 

### value is greater than 1.33 mg/L; no mortalities were observed during the four-hour exposure (MRID 44727705 ). 

### Chronic dietary exposure of rats to tebufenozide in a two-generation reproduction study (MRID 42931207) resulted in fewer total implantations and increased gestation length in first generation offspring (F1) dams and decreased pup viability during the first four days of lactation in both F1 and F2 generations. These effects occurred at the highest treatment level ( i.e ., 2,000 mg/kg diet or 153 mg/g bw/day). Adverse effects on the spleen were noted at the next lower treatment rate (150 mg/kg diet or 12.1 mg/kg bw/day). No effects were seen at the lowest treatment level (25 mg/kg diet).

The two-generation reproduction study was repeated (MRID 43797701) and yielded similar

### 44 overall results. Adverse effects on the spleen were noted at the intermediate treatment level (200 mg/kg diet or ƃ 12.6 mg/kg bw/day, Ƃ 14.6 mg/kg bw/day). The frequency of dead pups during the first four days of lactation was significantly increased at this treatment level but not at the higher treatment level; therefore, the HED reviewer determined that the observation was not treatment-related in this study. Body weight and body weight gain were lower in parents and offspring at the 2,000 mg/kg diet ( ƃ 126 mg/kg bw/day, Ƃ 143 mg/kg bw/day) than in controls. No adverse effects were observed at the lowest treatment level (25 mg/kg diet).

The nature (histological versus apical) and dose-response of effects in both two-generation studies are comparable. The Health Effects Division (HED), which reviews the mammalian toxicity data, currently recommends use of the NOAEC and NOAEL values for apical endpoints in the second study (MRID 43797701) for ecological risk estimation. The LOAEC for adverse apical effects is the same in both studies (2,000 mg/kg diet), although the type of effects observed at this treatment level differed somewhat in each case. The broader range of effects in both studies is considered when further describing potential risk to wild mammals from tebufenozide exposure.

Table 3.37. Summary of Acute and Chronic Mammalian Toxicity Data 1 for Rats Exposed to Tebufenozide.

Species Study Type Acute Chronic

LD 50 (mg/kg bw)

LC 50 (mg/L) Toxicity Classification (MRID) NOAEC (mg/kg diet)

NOAEL (mg/kg bw/day) Endpoints (MRID)
Norway rat ( Rattus norvegicus ) Acute oral toxicity 5,000 Practically nontoxic (42436212) 200 mg/kg diet 2 12.6 mg/kg bw/day Lower body weight and body

weight gain in

parents and

offspring (43797701) Acute inhalation toxicity > 1.33 NA (44727705)

Bolded values represent the most sensitive toxicity endpoints available for ecological risk assessment.

ND Not determined.

1 Mammalian toxicity data for tebufenozide TGAI are provided and reviewed by EPA Health Effects Division.

2 The associated LOAEC was 2,000 mg/kg diet (126 mg/kg bw/day).

### 45 3.3.2.3. Toxicity to Beneficial Insects and Other Invertebrates

Although tebufenozide is practically non-toxic to honeybees on an acute contact exposure basis, the acute toxicity study was conducted using adult bees and did not examine potential effects on brood development. While tebufenozide is intended to target lepidopteran insects, the availabledata indicate that chemical has chronic effects across a number of taxa (birds, fish, and nonlepidopteran aquatic invertebrates). Tebufenozide is intended to induce a precocious molt and as such larval insects would be more susceptible. Therefore, the Problem Formulation recommended submission of a field pollinator study (Guideline 850.3040) to examine the potential effects of tebufenozide on brood development. Subsequently, the registrant submitted a semi-field study which identified a transient, significant (p<0.05) effect on bee mortality associated with the application of tebufenozide at 545 g a.i./ha (0.486 lbs a.i./A) (MRID 49158701). No other significant effects were observed. However, interpretation of the study is complicated by the detection of the reference toxicant, fenoxycarb (CAS No. 72490-01-8), which is an insect juvenile hormone agonist, in samples from the tebufenozide treatment colony.

Multiple nonguideline submissions on honey bee developmental toxicity were submitted by the registrant in support of a waiver request for the field pollinator study ( Table 3.28 ). The nonguideline submissions were difficult to interpret due methodological deficiencies, uncertainties regarding treatment rates, and generally poor performance of bees ( e.g ., individual bee survival and metrics of honey bee colony success in controls may have been lower than recommended). Thus, the studies provide only limited information for risk characterization, and the waiver request was denied (DP Barcode D372576, 2010). Overall, however, the data suggest a pattern of adverse effects on larval honey bee development (US EPA, 2010).

No effects were observed in earthworms exposed to the tebufenozide degradate RH 112,651 for 14 days at soil concentrations of up to 100 mg/kg dry weight (MRID 47911502) ( Table 3.28 ).

Table 3.48. Summary of Acute Toxicity Data for Terrestrial Invertebrates Exposed to Tebufenozide.

Species Study Type (TGAI or EP) Endpoint Toxicity Classification/ Effects (MRID)

Honey bee ( Apis mellifera ) Acute contact toxicity (TGAI, 96.8%) LD 50 > 234 ȝ g a.i./bee 1 Practically nontoxic (42436244) Semi-field tunnel test (EP 22.8%, Confirm 2F ) NOAEC 0.256 lbs a.i./A LOAEC 0.486 lbs a.i./A Transient adult mortality (49158701) 29-day semi-field and oral toxicity (EP 24%, Mimic 240 SC ) ND Adult bee mortality, fewer capped brood 2 (47929602) 21-day semi-field test (EP 3

, Mimic 240 SC ) NOAEC < 80 mL/hL LOAEC 80 mL/hL Mortality of egg and larval cells (47929603) 20-day field test (EP 3

, Mimic 2F ) NOAEL < 0.5 L/ha LOAEL 0.5 L/ha Fewer capped brood 4 (47929605) 20-day field test (EP 3

, Mimic 2F ) NOAEL < 10 g a.i./ha LOAEL 10 g a.i./ha 5 Transient mortality (47929606)

### 46 Earthworm ( Eisenia foetida ) 14-day acute toxicity in soil (Degradate > 99.9%, RH 112,651 ) NOAEC 100 mg/kg dw LOAEC > 100 mg/kg dw None (47911502)

hL Hectoliter. ND Not determined. NR Not reported.

1 Based on nominal dose, adjusted for purity.

2 Exposure was unquantified, and results were not analyzed statistically.
3 Purity of the test substance was not reported.

4 Effect was observed at one of two sites.

5 Reported as equivalent to 200 g EP/ha (0.18 lbs EP/A, or 0.009 lbs ai/A). Actual treatment rates varied considerably across sites ( i.e ., from 190 to 940 g EP/ha, 0.17 to 0.85 lbs EP/A, or 0.009 to 0.042 lbs ai/A).



### 3.3.2.4. Toxicity to Terrestrial Plants

Terrestrial plant toxicity studies are required for pesticides that have terrestrial use patterns or may move off of the application site

. The NOAEL and IC 25 

### (concentration that causes an inhibitory effect in 25% of the population for the monitored endpoint) values are established for markers of seedling emergence and vegetative vigor. As shown in Table 3.29 , toxicity in the form of reduced growth (dry weight) was observed in terrestrial dicotyledonous (dicot) plants ( i.e ., radish) exposed to tebufenozide at 0.97 lbs a.i./A (-14%) and 1.97 lbs a.i./A (-7%) in a vegetative vigor study; the effect was statistically significant (p<0.05) and a NOAEL was not established (MRID 48533002). Similarly, a NOAEL was not established for dicot plants in the seedling emergence test where cabbage emergence was significantly (p<0.05) reduced by 14% compared to the negative control when treated with the lowest treatment rate of 0.98 lbs a.i./A (measured) (MRID 48533001). No other statistically significant effects were observed either study. No effect greater than 25% was observed in either test. Monocotyledonous (monocot) plants did not exhibit any adverse effect at the treatment levels tested in either the vegetative vigor or seedling emergence studies. The experimental design of both tests was inadequate to establish point estimates ( e.g ., IC 05 

### and IC 25 

### ) because only two treatment levels were used.

Table 3.59. Toxicity of Tebufenozide to Non-target Terrestrial Plants.
Crop Type of Study Species IC 25 * (lbs ai/A) NOAEL* (lbs ai/A) Endpoint Affected MRID Vegetative Vigor (EP 22.8% ai, Confirm ® 2F )

Monocots Corn

>1.97 1.97 None

48533002 Onion Ryegrass

Wheat

Dicots Cabbage >1.97 1.97 None Lettuce Radish >1.97 <0.97 Dry weight Soybean >1.97 1.97 None Sugar beet

Tomato Seedling Emergence (EP 22.8% ai, Confirm ® 2F )

Monocots Corn >1.94 1.94 None

48533001 Oat Onion > 1.95 1.95 Ryegrass >1.94 1.94

Dicots Cabbage >1.94 < 0.98 Emergence Cucumber >1.94 1.94 None

Lettuce

### 47 Radish Soybean Tomato >1.95 1.95 * Based on measured application rates. Bolded values are the most sensitive endpoints from each study.

1 Less than the lowest treatment rate of tebufenozide tested.



### 3.3.3. Review of Incident Data

The Ecological Incident Information System (EIIS) , which is maintained by the Agency’s Office of Pesticide Programs, was searched to determine if ecological incidents have been reported for tebufenozide. Based on a search of EIIS conducted in September 2014, one incident associated with tebufenozide was reported between 1999 and 2014. This incident, resulting in “deformities” in 23 acres of walnut, was categori zed as having a possible association with the registered use of tebufenozide (Confirm  

### 2F at 16-20 oz/A) in a tank mix with KINETIC  

### , a nonionic surfactant, that was applied directly to the walnut orchard (Incident No. I013563-013, 1999).

Because of limitations in the incident reporting system, the lack of additional incident reports cannot be construed as the absence of incidents from the registered use of tebufenozide. At the time of the search, EIIS contained information on incidents reported through 2014.

The American Bird Conservancy (ABC) Avian Incident Monitoring System, which contains information on bird-related incidents for the years 1968 through 2005, was searched in September 2014. No records of incidents were reported to be associated with tebufenozide (ABC 2013).



## 4. Risk Characterization

4.1. Screening-Level Risk Quotient (RQ) Values

4.1.1. RQ Values for Aquatic Organisms

Risk quotient (RQ) values are calculated for acute and chronic risk to freshwater fish and amphibians and invertebrates, for chronic risk to estuarine/marine fish, and for acute risk to estuarine/marine invertebrates. For acute risk to estuarine/marine fish and chronic risk to estuarine/marine invertebrates, RQ values are not calculated because the available toxicity endpoints are nondefinitive ( i.e ., outside the range of concentrations tested) (see Table 4.1 ). Risks are described in Section 4.3

.

### 48 Table 4.1. Overview of RQ Calculation for Aquatic Animals Exposed to Tebufenozide.

Taxonomic Group(s) RQ Calculation Acute RQ

(Y/N) Endpoint and Justification, if RQs are not calculated Chronic RQ (Y/N) Endpoint and Justification, if RQs are not calculated Freshwater fish and amphibians Y Bluegill sunfish LC 50 = 3,000 μ g a.i./L Y Fathead minnow 1 NOAEC = 51.1 μ g a.i./L Freshwater invertebrates Y Water flea LC 50 = 3,800 μ g a.i./L Y Water flea NOAEC = 29 μ g a.i./L

Estuarine/marine fish N Nondefinitive toxicity endpoint Sheepshead minnow LC 50 >720 μ g a.i./L Y Sheepshead minnow NOAEC = 550 μ g a.i./L

Estuarine/marine invertebrates Y Eastern oyster IC 50 = 505 μ g a.i./L N Nondefinitive toxicity endpoint Est. from acute-to-chronic ratio 2 NOAEC < 7.9 μ g a.i./L

1 Different species in acute and chronic toxicity tests; comparative toxicity across species has not been established.

2 Nondefinitive chronic toxicity estimate from acute-to-chronic ratio between mysid shrimp acute toxicity endpoint (LC 50 = 1,400
μ g a.i./L) and NOAEC < 22 μ g a.i./L., applied to IC 50 value for Eastern oyster (505 μ g a.i./L).



### Across all of the registered used of tebufenozide, the use on cranberry results in the highest EECs for exposure to undiluted bog water; RQ values exceed LOCs for acute risks to listed species of freshwater fish, amphibians, and invertebrates ( Table 4.2 ); acute risk to listed and non-listed species of estuarine/marine invertebrates ( Table 4.2 ); and chronic risks to freshwater fish, amphibians, and invertebrates ( Table 4.3 and Table 4.4 ). Most other uses present RQ values that exceed the LOC for acute risk to listed species of estuarine/marine invertebrates. Acute risk from exposure from ground application to bushberries, caneberries, cranberry, and forestry uses (ground and aerial) is below the estuarine/marine invertebrate listed species LOC. Various uses present chronic risk that exceeds the LOC for freshwater invertebrates, fish and amphibians ( Table 4.3 and Table 4.4).

Table 4.2. Acute RQ Values for Aquatic Animals Exposed to Tebufenozide TTR in Surface Water.
Use Application Method Peak EEC ( μ g a.i./L) Freshwater Fish and Amphibians Freshwater Invertebrates Estuarine/Marine Invertebrates RQ Probability of Effect Bushberries, Caneberries aerial 37.2 0.01 <0.01 0.07 1 in 10 x 10 6 ground 20.5 <0.01 <0.01 0.04 Not calculated

Canola aerial 58.6 0.02 0.02 0.12 1 in 6 x 10 4 ground 40.1 0.01 0.01 0.08 1 in 3 x 10 6

Citrus aerial 60.4 0.02 0.02 0.12 1 in 6 x 10 4 ground 51.6 0.02 0.01 0.10 1 in 3 x 10 5

Brassica aerial 90.8 0.03 0.02 0.18 1 in 2 x 10 3 ground 78.8 0.03 0.02 0.16 1 in 6 x 10 3

Cotton aerial 59.6 0.02 0.02 0.12 1 in 6 x 10 4 ground 49.9 0.02 0.01 0.10 1 in 3 x 10 5

Cranberry aerial 37.4 0.01 <0.01 0.07 1 in 10 x 10 6 ground 20.5 <0.01 <0.01 0.04 Not calculated Fruiting vegetables aerial 112 0.04 0.03 0.22 1 in 6 x 10 2 ground 99.4 0.03 0.03 0.20 1 in 1 x 10 3

### 49 Use Application Method Peak EEC ( μ g a.i./L) Freshwater Fish and Amphibians Freshwater Invertebrates Estuarine/Marine Invertebrates RQ Probability of Effect

Mint aerial 73.0 0.02 0.02 0.14 1 in 2 x 10 4 ground 40.4 0.01 0.01 0.08 1 in 3 x 10 6

Ornamentals aerial 84.9 0.03 0.02 0.17 1 in 4 x 10 3 ground 70.9 0.02 0.02 0.14 1 in 2 x 10 4
Pome fruit aerial 96.4 0.03 0.03 0.19 1 in 2 x 10 3 ground 72.2 0.02 0.02 0.14 1 in 2 x 10 4 Sugarcane aerial 86.7 0.03 0.02 0.17 1 in 4 x 10 3 ground 79.6 0.03 0.02 0.16 1 in 6 x 10 3 Almonds, Walnuts, Other nuts aerial 59.6 0.02 0.02 0.12 1 in 6 x 10 4 ground 35.2 0.01 <0.01 0.07 1 in 10 x 10 6

Pecans aerial 69.9 0.02 0.02 0.14 1 in 2 x 10 4 ground 52.0 0.02 0.01 0.10 1 in 3 x 10 5 Trees, Forests, Shrubs aerial 12.4 <0.01 <0.01 0.02 Not calculated ground 10.6 <0.01 <0.01 0.02 Not calculated Pasture, rangeland aerial 30.6 0.01 <0.01 0.06 1 in 5 x 10 7 ground 26.5 <0.01 <0.01 0.05 1 in 4 x 10 8 Cranberry NA 279 a 0.09 b 0.07 c 0.55 1 in 8

Bold values exceed the LOC (0.05) for acute risk to listed species of aquatic animals. Shaded cells indicate that the RQ exceeds the LOC (0.5) for acute risk to non-listed species of aquatic animals.

1 Reflects a 21-day holding time, post-flood.
b Probability of an acute effect to freshwater fish or amphibians at RQ = 0.09: 1 in 7.1 x 10 5

. c Probability of an acute effect to freshwater invertebrates at RQ = 0.07:1 in 9.9 x 10 6

.
Table 4.3. Chronic RQ Values for Freshwater Inverteb rates Exposed to Tebufe nozide TTR in Surface Water.

Use Application Method 21-Day EEC ( μ g a.i./L) Freshwater Invertebrates

Bushberries, Caneberries aerial 36.8 1.27 ground 20.3 0.70

Canola aerial 57.9 2.00 ground 39.6 1.37

Citrus aerial 59.2 2.04 ground 50.8 1.75

Brassica aerial 89.4 3.08 ground 77.4 2.67

Cotton aerial 58.8 2.03 ground 49.5 1.71

Cranberry aerial 37.0 1.28 ground 20.3 0.70 Fruiting vegetables aerial 111 3.83 ground 98.1 3.38

### 50 Use Application Method 21-Day EEC ( μ g a.i./L) Freshwater Invertebrates

Mint aerial 72.2 2.49 ground 39.9 1.38

Ornamentals aerial 83.4 2.88 ground 69.7 2.40

Pome fruit aerial 95.2 3.28 ground 71.6 2.47

Sugarcane aerial 85.7 2.96 ground 78.6 2.71 Almonds, Walnuts, Other
nuts aerial 58.9 2.03
ground 34.9 1.20

Pecans aerial 69.0 2.38 ground 51.3 1.77
Trees, Forests, Shrubs aerial 12.1 0.42 ground 10.3 0.36
Pasture, rangeland aerial 30.2 1.04 ground 26.3 0.91 Cranberry NA 106 a 3.65 Bold, shaded values exceed the LOC (1) for chronic risk to listed and nonlisted species of aquatic animals.

a Reflects a 21-day holding time, post-flood.

Table 4.4. Chronic RQ Values for Fish and Amphibians Exposed to Tebufenozide TTR in Surface Water.

Use Application Method 60-Day EEC ( μ g ai/L) Freshwater Fish and Amphibians Estuarine/Marine Fish

Bushberries, Caneberries aerial 36.2 0.71 0.07 ground 20.0 0.39 0.04

Canola aerial 56.8 1.11 0.10 ground 38.7 0.76 0.07

Citrus aerial 58.1 1.14 0.11 ground 49.7 0.97 0.09

Brassica aerial 86.8 1.70 0.16 ground 75.1 1.47 0.14

Cotton aerial 56.8 1.11 0.10 ground 47.8 0.94 0.09

Cranberry aerial 36.5 0.71 0.07 ground 20.0 0.39 0.04 Fruiting vegetables aerial 108 2.11 0.20 ground 95.8 1.87 0.17

Mint aerial 71.4 1.40 0.13 ground 39.5 0.77 0.07

Ornamentals aerial 81.8 1.60 0.15 ground 68.3 1.34 0.12

### 51 Use Application Method 60-Day EEC ( μ g ai/L) Freshwater Fish and Amphibians Estuarine/Marine Fish

Pome fruit aerial 93.5 1.83 0.17 ground 60.0 1.17 0.11

Sugarcane aerial 84.3 1.65 0.15 ground 76.9 1.50 0.14 Almonds, Walnuts, Other
nuts aerial 57.6 1.13 0.10
ground 34.1 0.67 0.06

Pecans aerial 67.6 1.32 0.12 ground 50.2 0.98 0.09
Trees, Forests, Shrubs aerial 11.7 0.23 0.02 ground 10.0 0.20 0.02
Pasture, rangeland aerial 29.6 0.58 0.05 ground 25.8 0.50 0.05 Cranberry NA 106 a 2.07 0.19

Bold. shaded cells indicate that the RQ exceeds the LOC (1.0) for chronic risk to non-listed and listed species of aquatic animals.

a Reflects a 21-day holding time, post-flood.


### The RQ values are calculated for risks to listed species of aquatic vascular and nonvascular plants. For risks to non-listed species of aquatic plants, RQ values are not calculated because the available toxicity endpoints are non-definitive ( i.e ., IC 50 

### not achieved within the range of concentrations tested) (see Table 4.5 ). However, the RQ values for listed plants in this assessment are calculated using a lower toxicity endpoint ( i.e ., NOAEL as opposed to an IC 50 

### ). Risks are described in Section 4.3

.
Table 4.5. Overview of RQ Calculation for Aquatic Plants Exposed to Tebufenozide.

Taxonomic Group(s) RQ Calculation

Listed Species RQ (Y/N) Endpoint and Justification, if RQs are not calculated Nonlisted Species RQ (Y/N) Endpoint and Justification, if RQs are not calculated

Aquatic vascular plants Y Duckweed NOAEL = 940 μ g a.i./L N Nondefinitive endpoint Duckweed IC 50 >940 μ g a.i./L Aquatic nonvascular plants Y Green alga NOAEL = 740 μ g a.i./L N Nondefinitive endpoint Green alga IC 50 >740 μ g a.i./L



### As shown in Table 4.6 , the RQ values for aquatic plants exposed to tebufenozide a.i. in surface water are all below LOCs.

Table 4.6. RQ Values for Listed Species of Aquatic Plants Exposed to Tebufenozide TTR in Surface Water.

Use Application Method Peak EEC ( μ g a.i./L) Aquatic Vascular Plants (Listed Species) a Aquatic Nonvascular Plants (Listed Species) b
Bushberries, Caneberries aerial 37.2 0.04 0.05 ground 20.5 0.02 0.03

### 52 Use Application Method Peak EEC ( μ g a.i./L) Aquatic Vascular Plants (Listed Species) a Aquatic Nonvascular Plants (Listed Species) b

Canola aerial 58.6 0.06 0.08 ground 40.1 0.04 0.05

Citrus aerial 60.4 0.06 0.08 ground 51.6 0.05 0.07

Brassica aerial 90.8 0.10 0.12 ground 78.8 0.08 0.11

Cotton aerial 59.6 0.06 0.08 ground 49.9 0.05 0.07

Cranberry aerial 37.4 0.04 0.05 ground 20.5 0.02 0.03 Fruiting vegetables aerial 112 0.12 0.15 ground 99.4 0.11 0.13

Mint aerial 73.0 0.08 0.10 ground 40.4 0.04 0.05

Ornamentals aerial 84.9 0.09 0.11 ground 70.9 0.08 0.10

Pome fruit aerial 96.4 0.10 0.13 ground 72.2 0.08 0.10

Sugarcane aerial 86.7 0.09 0.12 ground 79.6 0.08 0.11 Almonds, Walnuts, Other
nuts aerial 59.6 0.06 0.08
ground 35.2 0.04 0.05

Pecans aerial 69.9 0.07 0.09 ground 52.0 0.06 0.07
Trees, Forests, Shrubs aerial 12.4 0.01 0.02 ground 10.6 0.01 0.01
Pasture, rangeland aerial 30.6 0.03 0.04 ground 26.5 0.03 0.04 Cranberry NA 279 c 0.30 0.38

a RQ values for listed species of aquatic plants can be used as a conservative metric of risk to nonlisted species.
b RQ values for listed species of aquatic plants can be used as a conservative metric of risk to nonlisted species. There are currently no federally listed species of aquatic nonvascular plants in the United States.

c Reflects a 21-day holding time, post-flood.

### 53 4.1.2. RQ Values for Terrestrial Organisms

The risk estimation includes RQ values for chronic risk to birds and for acute and chronic risk to mammals from registered uses of tebufenozide. It does not include RQ values for acute risk to birds or hone bees because the toxicity endpoints are nondefinitive ( i.e ., LD 50 

### > 2,150 mg/kg bw, LC 50 

### >5,000 mg/kg diet for birds; LD 50 

### >234 ȝ g ai/bee for acute contact toxicity in adult honey bees). Similarly, RQ values are not calculated for terrestrial plants because toxicity tests endpoints were nondefinitive ( Table 4.7 ). The potential risks to birds (as well as reptiles and terrestrial-phase amphibians for which birds serve as surrogates), mammals, and terrestrial plants are discussed in the Risk Description ( Section 4.3 ).

Table 4.7. Considerations for RQ Calculation fo r Terrestrial Plants Exposed to Tebufenozide.

Taxonomic Group(s) RQ Calculation Listed Species RQ (Y/N) Endpoint and Justification, if RQs are not calculated Nonlisted Species RQ (Y/N) Endpoint and Justification, if RQs are not calculated

Seedling
emergence N Nondefinitive endpoint NOAEL <0.97 Radish dry weight N Nondefinitive endpoint IC 25 >1.97

Vegetative vigor N Nondefinitive endpoint NOAEL <0.98 Cabbage emergence N Nondefinitive endpoint IC 25 >1.94



### Nearly all registered agricultur al uses of tebufenozide result in RQ values that exceed the LOC (RQ >1) for chronic risk to birds (and by proxy to reptiles and terrestrial-phase amphibians) that forage primarily on items like short grass or broadleaf plants ( Table 4.8 ). The exceptions are the use on pasture and rangeland, for up to two seasons per year, and the forestry use, which result in RQ values ranging from 0.04 (residues on fruits, pods, and seeds) to 0.95 (residues on short grass). The RQ values for certain agricultural uses (fruiting vegetables, mint, pome fruit,sugarcane, and tree nuts) also exceed the chronic risk LOC for birds, reptiles, and terrestrialphase amphibians eating tall grass or arthropods.

Table 4.8. Screening-level Dietary-based (mg/kg diet) RQ values as Food Residues for Chronic Risk to Birds, Reptiles, and Terrestrial-phase Amphibians from Labeled Uses of Tebufenozide (T-REX v. 1.5.2; June 6, 2013). Primary Feeding Strategy Æ Herbivores, Omnivores, and Granivores Insectivores

Dietary Items ÆShort GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Arthropods

Use(s) È

Agricultural Uses
Bushberries 1.97 0.90 1.11 0.12 0.77

Caneberries 1.83 0.84 1.03 0.11 0.72

Canola 1.83 0.84 1.03 0.11 0.72

Citrus 1.86 0.85 1.05 0.12 0.73 Cole crops and leafy vegetables 1.52 0.70 0.86 0.10 0.60

### 54 Primary Feeding Strategy Æ Herbivores, Omnivores, and Granivores Insectivores

Dietary Items ÆShort GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Arthropods

Use(s) È

Cotton 1.83 0.84 1.03 0.11 0.72

Cranberries 1.97 0.90 1.11 0.12 0.77 Fruiting vegetables 2.65 1.22 1.49 0.17 1.04

Mint 2.65 1.22 1.49 0.17 1.04 Pastures and rangeland 0.95 0.44 0.53 0.06 0.37

Pome fruits 3.25 1.49 1.83 0.20 1.27 Sugarcane 1.83 0.84 1.03 0.11 0.72 Tree nuts (almond, walnut, other nuts) 3.44 1.57 1.93 0.21 1.35 Tree nuts (pecan) 2.74 1.26 1.54 0.17 1.07 Non-agricultural Uses

Ornamentals 2.65 1.22 1.49 0.17 1.04 Forest, trees and shrubs 0.55 0.25 0.31 0.03 0.21
Shaded cells indicate that RQ values exceed the LOC for chron ic risk to listed and nonlisted species (RQ > 1).


### The RQ values for all registered agricultural uses of tebufenozide are below LOCs for acute risk to listed (RQ > 0.1) and non-listed (RQ > 0.5) species of mammals ( Table 4.9 ). However, chronic risk LOCs for mammals are exceeded (RQ >1) for all size classes of mammals eating short grass, tall grass, broadleaf plants, and (for certain uses) fruits, pods, and seeds; only RQ values for strict granivores are below the chronic risk LOC for all uses ( Table 4.10 and Table 4.11 ). When not adjusted for dose, only the uses on pasture and rangelands and for forestry result in RQ values below the LOC for chronic risk to mammals. The highest RQ values result from uses on fruiting vegetables, mint, pome fruit, and tree nuts, which have the highest application rates.Table 4.9. Screening-level Dose-based (mg/kg bw) RQ values as Food Residues for Acute Risk to Mammals from Labeled Uses of Tebufenozide (T-REXv. 1.5.2; June 6, 2013).Primary FeedingStrategyÆHerbivores and OmnivoresInsectivoresGranivoresAnimal SizeÆSmallMedLargeSmallMedLargeSmallMedLargeDietary ItemsÆ Short Grass Tall Grass Broad-leaf Plant s Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc .ArthropodsSeeds, grains,etc.Use(s)ÈAgricultural UsesBushberries 0.02 0.01 0.01<0.010.01 0.01 0.01<0.010.01<0.01<0.01 <0.010.01 0.01<0.01<0.01 <0.01 <0.01Caneberries0.02 0.01 0.01<0.010.01 0.01 0.01<0.010.01<0.01<0.01 <0.010.01 0.01<0.01<0.01 <0.01 <0.01Canola0.020.010.01<0.010.010.010.01<0.010.01<0.01<0.01<0.010.010.01<0.01<0.01<0.01<0.01Citrus0.02 0.01 0.01<0.010.01 0.01 0.01<0.010.01<0.01<0.01 <0.010.01 0.01<0.01<0.01 <0.01 <0.01Cole crops and leafyvegetables0.01 0.01 0.01<0.010.01 0.01 0.01<0.010.01<0.01<0.01<0.010.01<0.01<0.01<0.01<0.01<0.01Cotton0.020.010.01<0.010.010.010.01<0.010.01<0.01<0.01<0.010.010.01<0.01<0.01<0.01<0.01Cranberries0.020.01 0.01<0.010.010.010.01<0.010.01<0.01<0.01<0.010.010.01<0.01<0.01<0.01<0.01Fruiting vegetables0.020.010.01<0.010.020.010.01<0.010.01<0.010.01<0.010.010.01<0.01<0.01<0.01<0.01Mint0.020.010.01<0.010.020.010.01<0.010.01<0.010.01<0.010.010.01<0.01<0.01<0.01<0.01Pastures andrangeland0.01<0.010.01<0.010.01<0.01<0.01<0.01 <0.01<0.01<0.01<0.01 <0.01<0.01<0.01<0.01<0.01<0.01Pome fruits0.030.010.02<0.010.020.010.01<0.010.010.01 0.01<0.010.010.010.01 <0.01<0.01<0.01Sugarcane0.020.010.01<0.010.010.010.01<0.010.01<0.01<0.01<0.010.010.01<0.01<0.01<0.01<0.01Tree nuts (almond,walnut, other nuts)0.03 0.01 0.02<0.010.030.01 0.01<0.010.010.010.01<0.010.01 0.010.01<0.01 <0.01 <0.01Tree nuts (pecan)0.02 0.01 0.01<0.010.02 0.01 0.01<0.010.01<0.010.01<0.010.01 0.01<0.01<0.01 <0.01 <0.01Non-agricultural UsesOrnamentals0.02 0.01 0.01<0.010.02 0.01 0.01<0.010.01<0.010.01<0.010.01 0.01<0.01<0.01 <0.01 <0.01Forest, trees andshrubs<0.01 <0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01<0.01Shaded cellsindicate that RQ values exceed the LOC for chronic risk to listed and nonlisted species (RQ > 1)Table 4.10. Screening-level Dose-based (mg/kg bw) RQ Values as Food Residues for Chronic Risk to Mammals from Labeled Uses ofTebufenozide (TREX v. 1.5.2; June 6, 2013).Primary FeedingStrategyÆHerbivores and OmnivoresInsectivoresGranivoresAnimal SizeÆSmallMedLargeSmallMedLargeSmallMedLargeDietary ItemsÆ Short Grass Tall Grass Broad-leaf Pl a n ts Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc .ArthropodsSeeds, grains,etc.Use(s)ÈAgricultural UsesBushberries6.793.113.820.425.802.663.260.363.111.431.750.192.662.271.220.09 0.08 0.04Caneberries6.292.883.540.395.372.463.020.342.881.321.620.182.462.101.130.09 0.07 0.04Canola6.292.883.540.395.372.463.020.342.881.321.620.182.462.101.130.090.070.04Citrus6.402.933.600.405.472.503.070.342.931.341.650.182.512.141.150.09 0.08 0.04Cole crops and leafyvegetables5.242.402.950.334.472.052.520.282.401.101.350.152.051.750.94 0.07 0.06 0.03Cotton6.292.883.540.395.372.463.020.342.881.321.620.182.462.101.130.090.070.04Cranberries6.793.113.820.425.802.663.260.363.111.431.750.192.662.271.220.09 0.08 0.04Fruiting vegetables9.144.195.140.577.813.584.390.494.181.922.350.263.583.061.640.13 0.11 0.06Mint9.144.195.140.577.813.584.390.494.181.922.350.263.583.061.640.130.110.06Pastures andrangeland3.271.501.840.202.791.281.570.171.500.690.84 0.091.281.090.59 0.05 0.04 0.02Pome fruits11.25.126.290.709.554.375.370.605.122.352.880.324.383.742.000.16 0.13 0.07Sugarcane6.292.883.540.395.372.463.020.342.881.321.620.182.462.101.130.090.070.04Tree nuts (almond,walnut, other nuts)11.85.426.650.7410.14.635.680.635.422.483.050.344.633.962.120.16 0.14 0.08Tree nuts (pecan)9.454.335.310.598.073.704.540.504.331.982.430.273.703.161.690.13 0.11 0.06Non-agricultural UsesOrnamentals9.144.195.140.577.813.584.390.494.181.922.350.263.583.061.640.13 0.11 0.06Forest, trees andshrubs1.890.871.060.121.610.74 0.91 0.10 0.87 0.40 0.49 0.05 0.74 0.63 0.34 0.03 0.02 0.01

### 57 Table 4.11. Screening-level Dietary-based (mg/kg diet) RQ values as Food Residues for Chronic Risk to Mammals from Labeled Uses of Tebufenozi de (T-REX v. 1.5.2; June 6, 2013). Primary Feeding Strategy Æ Herbivores, Omnivores, and Granivores Insectivores

Dietary Items ÆShort GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Arthropods

Use(s) È

Agricultural Uses

Bushberries 0.99 0.45 0.55 0.06 0.39

Caneberries 0.91 0.42 0.51 0.06 0.36

Canola 0.91 0.42 0.51 0.06 0.36

Citrus 0.93 0.43 0.52 0.06 0.36
Cole crops and leafy vegetables 0.76 0.35 0.43 0.05 0.30

Cotton 0.91 0.42 0.51 0.06 0.36

Cranberries 0.99 0.45 0.55 0.06 0.39
Fruiting vegetables 1.33 0.61 0.75 0.08 0.52

Mint 1.33 0.61 0.75 0.08 0.52
Pastures and rangeland 0.48 0.22 0.27 0.03 0.17

Pome fruits 1.62 0.74 0.91 0.10 0.64
Sugarcane 0.91 0.42 0.51 0.06 0.36
Tree nuts (almond, walnut, other nuts) 1.72 0.79 0.97 0.11 0.67
Tree nuts (pecan) 1.37 0.63 0.77 0.09 0.54 Non-agricultural Uses

Ornamentals 1.33 0.61 0.75 0.08 0.52 Forest, trees and shrubs 0.27 0.13 0.15 0.02 0.11
Shaded cells indicate that RQ values exceed the LOC for chronic risk to listed and nonlisted species (RQ >1).

### 58 4.2. Refinements

Nearly all registered agricultural uses of tebufenozide result in RQ values that exceed the LOCs for acute risk to listed species of estuarine/marine invertebrates, for chronic risks to estuarine/marine and freshwater invertebrates, and for chronic risks to freshwater fish and amphibians. Terrestrial exposure presents chronic risks of concern for birds (and by proxy to reptiles and terrestrial-phase amphibians) that forage primarily on items like short grass or broadleaf plants. Chronic risk LOCs for mammals are also exceeded for all size classes of mammals eating short grass, tall grass, broadleaf plants, and (for certain uses) fruits, pods, and seeds. In this section refinements are made to the screening-level assessment by considering risk from aquatic exposure to tebufenozide parent only (versus TTR) and, for terrestrial risks, by using average rather than maximum application rates to further characterize potential exposures.

4.2.1. RQs for Aquatic Animals Exposed to Tebufenozide Parent Only

For characterization purposes, RQ values for exposure to tebufenozide parent only are calculated for acute and chronic risk to freshwater fish and amphibians and invertebrates, for chronic risk to estuarine/marine fish, and for acute risk to estuarine/marine invertebrates. For acute risk to estuarine/marine fish and chronic risk to estuarine/marine invertebrates, RQ values are not calculated because the available toxicity endpoints are nondefinitive ( i.e ., outside the range of concentrations tested) (see Table 4.1 ). In Table 4.12 through Table 4.14 , a shaded cell indicates that risk exceeded the level of concern based on exposure to tebufenozide TTR.

When only exposure to the tebufenozide parent compound is considered, the use on fruiting vegetables (0.25 lbs ai/A, 2.0 lbs/A/year) presents RQ values that exceed levels of concern for acute risk to listed species of estuarine/marine invertebrates ( e.g ., fruiting vegetables) and for chronic risk to freshwater invertebrates. Chronic risks to freshwater fish and amphibians are below levels of concern for exposure to only the parent compound. These risks and others for which RQs are not calculated are described in Section 4.3

.
Table 4.12. Acute RQ Values for Aquatic Animals Exposed to Tebufenozide Parent Only in Surface Water.

Use Application Method Peak EEC ( μ g a.i./L) Freshwater Fish and Amphibians Freshwater Invertebrates Estuarine/Marine Invertebrates

Canola Aerial 18.4 0.01 0.01 0.04
Ground 13 <0.01 <0.01 0.03 Fruiting vegetables Aerial 46 0.02 0.01 0.09
Ground 42.5 0.01 0.01 0.08 Trees, forests, shrubs Aerial 7.44 <0.01 <0.01 0.02
Ground 6.67 <0.01 <0.01 0.01
Bold values exceed the level of concern for acute risk to listed species of aquatic animals (LOC = 0.05). Shaded cells indicate that risk exceeded the acute risk-to-listed species LOC for exposure to tebufenozide TTR.

### 59 Table 4.13. Chronic RQ Values for Freshwater Invertebrates Exposed to Tebufenozide Parent Only in Surface Water.

Use Application Method 21-Day EEC ( μ g a.i./L) Freshwater Invertebrates

Canola aerial 17.2 0.59 ground 12 0.41 Fruiting vegetables aerial 42.1 1.45 ground 38.7 1.33 Trees, forests, shrubs aerial 6.67 0.23 ground 5.99 0.21
Bold values exceed the level of concern for chronic risk to aquatic animals (LOC = 1). Shaded cells indicate that risk exceeded the chronic risk LOC for exposure to tebufenozide TTR.

Table 4.14. Chronic RQ Values for Fish and Amphibians Exposed to Tebufenozide Parent Only in Surface Water.

Use Application Method 60-Day EEC ( μ g ai/L) Freshwater Fish and Amphibians Estuarine/Marine Fish

Canola Aerial 16.2 0.32 0.03
Ground 10.9 0.21 0.02 Fruiting vegetables Aerial 39.4 0.77 0.07

Ground 36.3 0.71 0.07
Trees, forests, shrubs Aerial 5.81 0.11 0.01

Ground 5.29 0.10 0.01 Shaded cells indicate that risk exceeded the chronic risk LOC for exposure to tebufenozide TTR.



### 4.2.2. EECs and RQs for Terrestrial Animals Based on Mean and Upper Bound Kenaga EECs for Average Annual Application Rate

Average annual application rates for specific crops are provided by BEAD ( Table 4.15 ) and can be used to generate terrestrial RQ values for risk characterization ( Table 4.16 and Table 4.17 ). In this assessment, the RQ values using average annual application rates are based on the mean and upper-bound Kenaga nomogram EECs for the use on walnut (0.27 lbs a.i./A) because this was the highest annual rate reported; the average annual application rate was lower for all other crops surveyed. The average annual application rate for walnut is less than the maximum single application rate permitted by the label (0.47 lbs a.i./A) for that use.

Refined EECs and RQ values are calculated for chronic risk to birds and for chronic risk to mammals; no refinements are conducted for acute risk to mammals because none of the screening-level RQ values for acute risk exceeded the LOC. Consistent with the screening-level risk estimation, RQ values are not calculated for acute risk to birds because the toxicity endpoints are non-definitive (LD 50 

### >2,150 mg/kg bw, LC 50 

### > 5,000 mg/kg diet). Therefore, andbecause chronic avian toxicity data are presented on a dietary (not dose-adjusted) basis, dosebased EECs and RQ values for birds are omitted from this section. In the absence of data on average number of applications, refined EECs and RQ values for characterizing chronic risk to terrestrial vertebrates were calculated for a single application of tebufenozide at the average annual application rate (lbs a.i./A/year).

### 60 Table 4.15. Average Annual Application Rates and Input Parameters for Deriving Refined Terrestrial EECs for Tebufenozide (T-REX v. 1.5.2; June 6, 2013).

Use(s) Crop Surveyed Highest Annual App. Rate

(lbs a.i./A/year) FoliarDissipation HalfLife Agricultural Uses Bushberries and caneberries Caneberries 0.12

35 2 Canola NR NR Citrus NR NR

Cole crops and leafy vegetables Broccoli 0.11 Cabbage 0.12 Lettuce 0.11 Spinach 0.13 Cotton Cotton 0.23 Cranberries NR NR Fruiting vegetables Pepper 0.11 Squash 0.13 Tomato 0.14 Mint NR NR Pastures and rangeland Alfalfa NR Pome fruits Apple 0.26 Sugarcane Sugarcane 0.10 Tree nuts (almond, walnut, other nuts) Almond 0.25 Walnut 0.27 1 Tree nuts (pecan) Pecan 0.14 Non-agricultural Uses Ornamentals NR NR 35 3 Forest, trees and shrubs NR NR Abbreviations: App. Application(s). NR Not reported.

1 In this assessment, refined EECs are calculated assuming a single application at the highest average annual application rate across registered uses, which is for walnuts

. 2 The default foliar dissipation half-life value of 35 days is used in the absence of foliar dissipation data.



### As shown in Table 4.16 , the upper-bound dietary EECs (mg a.i./kg diet) for the use of tebufenozide at the average annual application rate for walnuts are less than 20% of the EECs resulting from the maximum labeled rate for that use. Similarly, mean EECs for the average annual rate for walnuts are slightly less than 7% of the upper-bound EECs for the maximum labeled rate. The associated dietary RQ values for average use patterns do not exceed LOCs for chronic risk to birds or mammals.

Table 4.16. Mean and Upper Bound Kenaga Dietary EECs (mg a.i./kg diet) and RQ Values for Birds, Reptiles, Terrestrial-phase Amphibians, and Mammals Using the Average Annual Application Rate for Walnut (T-REX v. 1.5.2; June 6, 2013). Primary Feeding Strategy Æ Herbivores, Omnivores, and Granivores Insectivores

Dietary Items ÆShort GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Arthropods

Use(s) È

EECs

### 61 Primary Feeding Strategy Æ Herbivores, Omnivores, and Granivores Insectivores

Dietary Items ÆShort GrassTall GrassBroad-leafPlantsFruits, pods,seeds,etc.Arthropods

Use(s) È

Mean (average annual rate) 23.0 9.72 12.2 1.89 17.6 Upper bound (average annual rate) 64.8 29.7 36.5 4.05 25.4 Upper bound (maximum labeled rate) 344 157 193 21.5 135
RQ Values: Chronic Risk to Birds, Reptiles, and Terrestrial-phase Amphibians Mean (average annual rate) 0.23 0.10 0.12 0.02 0.18 Upper bound (average annual rate) 0.65 0.30 0.36 0.04 0.25 Upper bound (maximum labeled rate) 3.44 1.57 1.93 0.21 1.35
RQ Values: Chronic Risk to Mammals Mean (average annual rate) 0.11 0.05 0.06 0.01 0.09 Upper bound (average annual rate) 0.32 0.15 0.18 0.02 0.13 Upper bound (maximum labeled rate) 1.72 0.79 0.97 0.11 0.67
Shaded cells indicate that RQ values exceed the LOC for chronic risk to listed and non-listed species (RQ > 1).



### Dose-adjusted EECs (mg a.i./kg bw) for mammals are similarly reduced ( Table 4.17 ) whenbased on the average annual application rate to walnuts. However, the RQ values for upperbound EECs continue to exceed the LOC for chronic risk to small (10 g) and medium (100 g) mammals that consume primarily short grass, tall grass, and broadleaf plants, and to large mammals (1,000 g) that consume short grass. The highest RQ value is 2.23 for small mammals consuming short grass. The RQ values for mean EECs from average usage on walnuts do not exceed the chronic risk LOC for mammals.62Table 4.17. Mean and Upper Bound, Dose-Adjusted Kenaga EECs (mga.i./kg bw) and RQ Values for Mammals Using Average Annual ApplicationRate for Walnut (T-REX v. 1.5.2; June 6, 2013).Primary FeedingStrategyÆHerbivores and OmnivoresInsectivoresGranivoresAnimal SizeÆSmallMedLargeSmallMedLargeSmallMedLargeDietary ItemsÆ Short Grass Tall Grass Broad-leaf Plant s Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc . Short Grass Tall Grass Broadleaf Plants Fruits, pods, seeds, etc .ArthropodsSeeds, grains,etc.Use(s)ÈEECsMean(average annual rate)21.9 9.27 11.6 1.80 15.1 6.40 8.01 1.25 3.51 1.49 1.86 0.29 16.7 11.6 2.68 0.40 0.28 0.06Upper bound(average annual rate)61.8 28.3 34.8 3.86 42.7 19.6 24.0 2.67 9.90 4.54 5.57 0.62 24.2 16.7 3.88 0.86 0.59 0.14Upper bound(max. labeled rate)32815018420.522610412714.252.524.129.53.2812888.720.64.553.140.73RQ Values: Chronic Risk to MammalsMean(average annual rate)0.79 0.33 0.42 0.07 0.67 0.29 0.36 0.06 0.36 0.15 0.19 0.03 0.60 0.52 0.28 0.01 0.01 0.01Upper bound(average annual rate)2.231.021.250.141.910.871.070.121.020.47 0.57 0.06 0.87 0.75 0.40 0.03 0.03 0.01Upper bound(max. labeled rate)11.85.426.650.7410.14.635.680.635.422.483.050.344.633.962.120.16 0.14 0.08Shaded cellsindicate that RQ values exceed the LOC for chronic risk to listed and non-listed species (RQ > 1).

### 63 4.3. Risk Description

4.3.1. Risks to Aquatic Organisms

This assessment considered tebufenozide parent compound and transformation products (TTR) as outlined in the Problem Formulation and based on intra-Agency regarding residues of concern. The TTR RQ values for most tebufenozide uses exceed the Agency’s LOCs for acute risk to listed species of estuarine/marine invertebrates and for chronic risks to freshwater animals, including invertebrates, fish, and amphibians. Risk conclusions for estuarine/marine invertebrates also apply to freshwater molluscs in this assessment because they are based upon estuarine/marine mollusc toxicity data.

The risk estimates for aquatic organisms may overestimate risk from exposure to parent tebufenozide since degradates were also considered in the exposure calculations but were found to be less toxic than tebufenozide, up to their limit of water solubility. Therefore, parent only EECs and RQ values were calculated for three scenarios representing a range of tebufenozide application rates. These values illustrate the contribution of tebufenozide parent to TTR EECs used in risk estimation, across the range of registered uses (Figures 4.1 through 4.3) . For the use on trees, forests, and shrubs, which is the lowest labeled use rate for tebufenozide (0.125 lbs a.i./A with an annual maximum of 0.25 lbs a.i./A/year), exposure to tebufenozide parent only does not present aquatic risks of concern. For uses in the mid-range of application scenarios, such as canola (0.25 lbs a.i./A with an annual maximum of 1.0 lb a.i./A/year), consideration of parent only brings certain aquatic risks below levels of concern, but chronic risks to estuarine/marine invertebrates are still expected to exceed the LOC. For uses with higher annual application rates, such as fruiting vegetables (0.25 lbs a.i./A with an annual maximum of 2.0 lbs a.i./A), chronic risks to freshwater fish and amphibians are below the LOC when considering parent only. However, acute risks to listed estuarine/marine invertebrates, chronic risks to estuarine/marine invertebrates, and chronic risks to freshwater invertebrates are of concern regardless of the exposure calculation used. Thus, the consideration of TTR versus parent only in exposure and risk estimation has only minimal impact on the risk conclusions in this assessment. Nonetheless, since the transformation products are less toxic than the parent compound, future ecological risk assessments may consider modeling tebufenozide parent only.

Figure 4.1. Comparison of peak surface water EECs for tebufenozide TTR and parent only to the acute risk to listed species level of concern for estuarine/marine invertebrates and freshwater molluscs. 0 20 40 60 80 100 120

Canola (aerial) Canola (ground) Fruiting vegetables

(aerial) Fruiting vegetables

(ground) Trees, forests, shrubs (aerial) Trees, forests, shrubs (ground)PeakSurfaceWaterEEC(ug/L)

Parent TTR (Remainder) Acute risk to listed species LOC = 25 ug/L (based on Eastern oyster)

### 64 Figure 4.2. Comparison of 21-day surface water EECs for tebufenozide TTR and parent only to the chronic risk levels of concern for aquatic invertebrates.

Figure 4.3. Comparison of 60-day surface water EECs for tebufenozide TTR and parent only to the chronic risk level of concern for freshwater fish.



### Exposure to undiluted bog water from the use on cranberry (calculated using the provisional cranberry model) results in TTR RQ values that exceed LOCs for all aquatic animals. Specifically, there is concern for acute risks to listed species of freshwater fish, amphibians, and invertebrates; acute risks to listed and non-listed species of estuarine/marine invertebrates; and chronic risks to freshwater fish, amphibians, and invertebrates; should they be exposed to treated cranberry bog water. In the SWCC simulations spray drift constituted a substantial portion (16.2to 94.7%) of the pesticide loadings to the water body, and is thus an important contributor to offsite exposure.

Chronic exposure to tebufenozide caused reproductive impairments in fish at test concentrations that are approximately one-half of the 21-day and 60-day mean TTR EECs for the use on cranberry. These impairments included alterations in ovarian stage in female fathead minnow exposed to tebufenozide for 21 days and reductions in the number of eggs per spawn in a full life cycle study with fathead minnow. In freshwater invertebrates, tebufenozide exposure for 21- days in separate studies resulted in a lower number of offspring produced (formulated tebufenozide) and reduced growth (dry weight), respectively. Each of these studies was conducted under flow-through conditions. Cranberry EECs reflect concentrations of TTR in undiluted bog water at depth 12 inches, with degradation processes assumed to occur under both dry (pre-flood) and flooded conditions. Partitioning to sediments is also accounted for in the 0 20 40 60 80 100 120

Canola (aerial) Canola (ground) Fruiting vegetables

(aerial) Fruiting vegetables

(ground) Trees, forests, shrubs (aerial) Trees, forests, shrubs (ground)21ͲDaySurfaceWaterEEC(ug/L)

Parent TTR (Remainder) Chronic risk to freshwater invertebrates LOC = 29 ug/L (based on water flea) Chronic risk to estuarine/marine invertebrates LOC < 7.9 ug/L (based on acute

Ͳ to

Ͳ chronic ratio)

0 20 40 60 80 100 120

Canola (aerial) Canola (ground) Fruiting vegetables

(aerial) Fruiting vegetables

(ground) Trees, forests, shrubs (aerial) Trees, forests, shrubs (ground)60ͲDaySurfaceWaterEEC(ug/L)

Parent TTR (Remainder) Chronic risk to freshwater fish and amphibians LOC = 50 ug/L (based on fathead minnow)

### 65 model, and EECs are estimates of concentrations in cranberry bogs, and generally conservative estimates of concentrations in waters to which cranberry bogs may discharge.

Although RQ values were not calculated for acute risks to estuarine/marine fish or for chronic risk to estuarine/marine invertebrates, it is likely that these risks will parallel those that are quantified with RQ values. For estuarine/marine fish, the available data may be conservatively interpreted to conclude that acute risk exceeds the LOC for listed species from use on cranberry, but not for other uses. Actual risk to estuarin e/marine fish may be somewhat lower than for freshwater fish. The LC 50 

### for sheepshead minnow (>720 ȝ g a.i./L) was empirically determined to be greater than the solubility of tebufenozide in water and thus at least 21 times greater than peak surface water EECs for most uses. However, for the use on cranberry, this highest test concentration is only 2.6 times the peak surface water EEC (TTR).

Chronic risk to estuarine/marine invertebrates is likely to exceed the LOC for use on cranberry. Tebufenozide exposure over 28-days significantly reduced reproduction and survival in mysid shrimp at exposure concentrations of 22 ȝ g a.i./L and above. The LOAEL is approximately onefifth of the 21-day EEC for cranberry. Refinements to the cranberry model are not currently available. However, to the extent that residues from cranberry bog water are diluted via mixingwith waters from other (uncontaminated) sources upon release of bog water, exposures to nontarget aquatic organisms are likely to be overestimated by the Provisional Cranberry model’s EECs.

There is uncertainty regarding chronic risk to estuarine/marine invertebrates from non-cranberry uses of tebufenozide (21-day TTR EECs: 1.39 to 12.3 ȝ g a.i./L) because a lower bound (NOAEC) was not established for adverse effects in mysid shrimp and because chronic toxicity data are not available for the mollusc. The mollusc was more sensitive in the acute shell deposition test than the mysid under acute exposure conditions. Estimation of a chronic mollusc toxicity endpoint, based on the non-definitive acute-to-chronic ratio for mysid shrimp (> 64), yields a NOAEC of < 7.9 ȝ g a.i./L; this estimated value is within the range of 21-day TTR EECs for non-cranberry uses at maximum labeled application rates.

The existing toxicity data for invertebrates may under predict hazard and risk from tebufenozide exposure at certain developmental stages, since the guideline laboratory studies with the honey bee do not explicitly test exposure at molting. There is also an incomplete understanding of potential adverse effects on sediment-dwelling invertebrates. Two nonguideline toxicity studies with the freshwater midge (Order: Diptera, Chironomus riparius ), which undergoes four aquatic larval instars prior to pupating into an adult fly, suggest the potential for adverse effects at surface water concentrations lower than those currently identified as risk assessment endpoints. The measured concentrations associated with effects in both studies (> 3.3 ug/L overlying water, > 0.44 ug/L pore water, > 5.5 ug/kg dry sediment) are below the peak and chronic ( e.g ., 21-day moving average) TTR EECs for registered uses of tebufenozide (112 ug/L overlying water, 96.3 ug/L pore water, 440 ug/kg dry sediment). However, the studies tested a sediment-associated (epibenthic) species with only water column exposure, the test systems had not reached equilibrium, and one of the two studies presented effects at all treatment levels. Therefore, chronic ( e.g ., 28-day) spiked sediment toxicity data which establish definitive NOAEC values are needed to quantitatively assess risk to epibenthic organisms. Such data may also address

### 66 uncertainties regarding potential developmental effects on non-target ( i.e ., non-lepidopteran) invertebrates.

For aquatic plants, tebufenozide exposure in laboratory experiments had no significant effects on duckweed (vascular plants) or algae (nonvascular plants). The RQ values for all tebufenozide uses are below LOCs for listed species of aquatic vascular and nonvascular plants. Therefore, risk to non-listed aquatic plant species is also below LOCs.

4.3.2. Risks to Terrestrial Organisms

4.3.2.1. Birds, Reptiles, and Terrestrial-phase Amphibians

Screening-level RQ values are calculated in the Risk Estimation section for chronic risk to birds, which serve as surrogates in this assessment for reptiles and amphibians exposed to tebufenozide in the terrestrial diet. RQ values for acute and sub-acute exposures were not calculated becauseno mortality was observed at the highest treatment levels tested in the avian acute oral and subacute dietary studies. To gain a better understanding of how the EECs for the maximum tebufenozide application rates for the assessed uses relate to the toxicity data currently available for birds, dietary- and dose-based EECs from the T-REX model are compared to the highest treatment concentrations in the avian acute and sub-acute toxicity tests, where no mortality or sublethal effects were observed.

For agricultural uses of tebufenozide, the maximum avian dose-based EEC is 391 mg a.i./kg bw (small birds consuming short grass) for use on tree nuts, including walnuts. The maximum avian dose-based EEC for non-agricultural uses is 302 mg/kg bw (small birds consuming short grass) for ornamentals. These EECs are approximately 18% and 14%, respectively, of the maximum dose tested (2,150 mg/kg bw) in the acute oral toxicity test with bobwhite quail. The maximum dietary-based EECs (not dose-adjusted) for agricultural and non-agricultural uses of tebufenozide are 344 mg/kg diet (short grass) and 265 mg/kg diet (short grass) for tree nuts and ornamentals, respectively. The dietary EECs reach 7% of the maximum concentration tested (5,000 mg/kg diet) in the sub-acute dietary toxicity tests with bobwhite quail and mallard duck.

It is unknown whether passerine species may be more sensitive to tebufenozide exposure than the bobwhite quail and mallard duck. Although acute toxicity testing with a passerine species is now required per 40 CFR Part 158.630 (2008), a data call-in for passerine testing was not issued at the time of Problem Formulation. However, given the absence of mortality or sublethal effects at limit doses which are approximately five-to-ten times greater than maximum EECs, the risk of acute mortality in birds from ingestion of tebufenozide residues is likely low. No ecological incidents with birds, reptiles, or terrestrial-phase amphibians have been reported (ABC 2007, USEPA 2012). While the absence of incident reports cannot be construed as indicative of the absence of incidents, the lack of incident reports is consistent with the apparent low acute toxicity of tebufenozide to birds.

Tebufenozide use consistent with labeled application rates result in chronic risk LOC exceedances for animals that forage on items similar to short grass, tall grass, and broadleaf plants. The RQ values for chronic risk to birds, reptiles, and terrestrial-phase amphibians exceed

### 67 the LOC for most uses of tebufenozide. Additionally, chronic risk to insectivores exceeds the LOC for uses with a maximum annual application rate greater than 1.25 lbs a.i./A ( i.e ., fruiting vegetables, mint, pome fruits, tree nuts, and ornamentals).

Tebufenozide exposure at 300 mg/kg diet during the pre-egg-laying and egg laying phase was associated with fewer 14-day hatchling survivors in bobwhite quail (NOAEC = 100 mg/kg diet). No effects were reported in mallard duck or in a second study with bobwhite quail, although body weight data were not provided for verification. Figure 4.4 compares mean and upperbound dietary EECs for each labeled use with adverse effect concentrations in bobwhite quail. The EECs shown represent residues on short grass, which are expected to be higher than residues on other types of forage items.

Figure 4.4. Comparison of dietary EECs to the concentration causing adverse effects on avian reproduction in the laboratory.



### The upper-bound EECs for the uses on pome fruits and tree nuts, including almond, walnut, and other nuts, exceed the concentration associated with fewer 14-day hatchling survivors in bobwhite quail. For the use on tree nuts, the NOAEL is exceeded with the first application of 0.47 lbs ai/A and the LOAEL is exceeded with the fourth application ( Figure 4.5 ). Residues on short grass remain above the NOAEL for the first seven days following the first application and then continuously for the second and all subsequent applications. Similarly, residues remain above the LOAEL for the first seven days following the fourth application. 0 100 200 300 400EECs(mg/kgdiet)

Labeled Uses

Mean Kenaga EEC (Max Label Rate) Upper Bound Kenaga EEC (Max Label Rate)

Fewer 14

Ͳ d hatchling survivors at 300 mg/kg diet

No effects at 100 mg/kg diet

### 68 Figure 4.5. Duration of exposure to dietary residues fr om use on tree nuts (almonds, walnuts, and other nuts) compared to chronic avian toxicity endpoints for tebufenozide.



### 4.3.2.2. Mammals

The uses on tree nuts and pome fruit result in the highest RQ values for acute risk to mammals (0.03) which are below LOCs for acute risk to listed and non-listed species. Thus, there are no acute risks of concern to mammals exposed to tebufenozide as a result of its registered uses.

However, all assessed uses at the maximum labeled application rates result in RQ values that exceed the LOC for chronic risk to mammals, when dose-adjusted EECs are considered (mg/kg bw/day). When EECs are expressed in terms of dietary concentrations (mg/kg diet) only, and not adjusted for body weight, most of the resulting RQ values for residues on short grass either approach or slightly exceed the chronic risk LOC. The chronic RQ value for forestry use is the lowest (0.27), and the chronic RQ value for use on tree nuts, including almond, walnut, and other nuts, is the highest (1.72). These dietary (non-dose-adjusted) EECs and RQ values are most relevant to mammals with similar body weight (range: 120-174 g) and food intake rate as those tested in the laboratory study (MRID 43797701).

The effects observed above the NOAEC that was used to generate RQ values include adverse effects on body weight and body weight gain in parents and offspring, and, in a different study, adverse effects on reproduction ( e.g ., fewer implantations, longer gestation period). Lesions of the spleen were identified in both studies at the treatment level identified as the NOAEC for risk estimation. Although HED determined that these lesions were of toxicological significance, risk estimates for wild mammals are historically based on apical effects on survival, growth, and reproduction, and not on histological observations alone.

For tebufenozide, the LOAEC value for apical effects was ten times greater than the NOAEC value. Therefore, for RQ values between 1 and 10 (all uses except tree nuts and pome fruit), there is less certainty as to whether adverse apical effects may occur based on the laboratory studies. 0 100 200 300 400

0 28 56 84 112 140 168 196 224 252 280 308 336 364EECs (mg/kg diet)

Short Grass Tall Grass Broadleaf plants Fruits/pods/seeds Arthropods Time (Days; Day 0 = 1st application) Fewer 14

Ͳ d hatchling survivors at 300 mg/kg diet

No effects at 100 mg/kg diet

### 69 Tebufenozide use at the maximum labeled rates on tree nuts and pome fruit results in chronic RQ values of 11.7 and 11.2, which reflect dose-adjusted EECs above the LOAEC.

When dietary EECs are based on the average annual application rate instead of the maximum ratepermitted by the label, all resulting dietary RQ values are below the chronic risk LOC. For doseadjusted EECs, the average use on tree nuts results in RQ values of 0.79 (mean Kenaga nomogram EEC) to 2.23 (upper-bound Kenaga nomogram EEC) for residues on short grass. Survey data indicate that average application rates for other registered uses are lower than that for the use on tree nuts. Therefore, RQ values are also expected to be lower.

The RQ values for mammals that eat strictly fruits, pods, and grains, are below the chronic risk LOC for all uses.



### 4.3.2.3. Terrestrial Invertebrates

The honey bee is used as a representative species to assess the risks of tebufenozide use to of terrestrial invertebrates, particularly bees. Risk quotient values for honey bees were not calculated because only one Tier 1 endpoint was available (acute contact toxicity to adult honey bees) and that value was nondefinitive (LD 50 

### > 234 

### ȝ g ai/bee). For characterization purposes, a Tier 1 exposure estimate (EEC) for contact toxicity was calculated according to methods in the 

### Guidance for Assessing Pesticide Risks to Bees (US EPA 2014) by multiplying the maximum single application rate (0.47 lbs ai/A for use on tree nuts) by a constant of of 2.7 ȝ g a.i./bee, which yields an EEC of 1.27 ȝ g a.i./bee

. When the EEC is divided by the nondefinitive honey bee toxicity endpoint, the resulting value is < 0.01, which is below the LOC for acute risk to terrestrial invertebrates (RQ >0.4).

Tebufenozide is registered as an insect growth regulator. Although intended to target lepidopterans, there is uncertainty as to whether it may have adverse effects on other developing insects, including the honey bee. Nonguideline data submissions by the registrant showed mixed effects but suggested a pattern of adverse effects on larval development, including instances of fewer capped brood and transient larval and adult mortality events in various studies. Data for methoxyfenozide, a structural analog of tebufenozide, 

### generally showed no adverse effects to honey bee larvae and pupaedevelopment colony overwintering survival at the exposure concentrations tested under semifield and field conditions (MRIDs 45065501, 48962201, and 48962202). However, preliminary review of a recently submitted larval toxicity study with methoxyfenozide suggests that honey bee larvae may be sensitive to dietary exposure under laboratory feeding conditions (MRID 49672801). Additional data on honey bee larval toxicity and brood development following exposure to tebufenozide would help resolve this uncertainty. The EECs and acute contact toxicity data for adult honey bees exposed to tebufenozide indicate low risk of mortality to adult honey bees.



### 4.3.2.4. Terrestrial Plants

Treatment with tebufenozide in a greenhouse study resulted in statistically significant differences (p<0.05) in seedling emergence and vegetative vigor endpoints in one out of ten species tested in each study. Although the effects in these two dicot species were statistically significant, no inhibition equal to or greater than 25% was observed in either study. 

### Specifically, dry weight was lower in radish exposed to tebufenozide in a vegetative vigor study at 0.97 lbs a.i./A (-14%) and 1.97 lbs a.i./A (-7%), when compared to controls. A statistically supported NOAEL was not

### 70 established. Similarly, a NOAEL was not established for dicot plants in the seedling emergence test: cabbage emergence was reduced by 14% compared to the negative control when treated with the lowest treatment rate of 0.98 lbs a.i./A (measured).

The lowest treatment rate in the terrestrial plant toxicity tests (0.97 lbs ai/A) is two-to-eight times greater than the maximum single application rates for registered uses. Notably, the lowest rate is for cole crops and leafy vegetables (maximum single application rate: 0.12 lbs ai/A).

The absence of a definitive NOAEL for the most sensitive dicot species may result in greater uncertainty in risk assessments for listed plants. However, risk may be characterized based on labeled application rates by using the assumption that off-site exposure via runoff is 50% of the maximum application rate (or 0.47 lbs ai/A x 50% = 0.24 lbs ai/A). (This assumption is more conservative than TerrPlant EEC calculations, which result in a maximum EEC (runoff and spray drift combined) of 0.07 lbs ai/A.) If the concentration-response for cabbage is linear, then the conservative potential exposure from runoff adjacent to the field (0.24 lbs ai/A) may result in 7% reduction in seedling emergence of the most sensitive dicots. Overall, r isk to non-listed species of terrestrial plants and risk to listed species in areas adjacent to the field is uncertain but likely low based on labeled application rates.


## 5. Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of the Preliminary Problem Formulation for Registration Review of tebufenozide, EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), tebufenozide is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other su ch endocrine effects as the Administrator may designate.” The EDSP employs a two-tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine-related effects caused by the substance and establish a dose-response relationship between the dose and the E, A, or T effect.

### 71 Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013, and includes some pesticides scheduled for registration review and chemicals found in water 7 

### . Neither of these lists should be construed as a list of known or likely endocrine disruptors. Tebufenozide is not on List 1. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and Tier 1 screening battery, please visit our website 8



### . 

## 6. Federally Threatened and Endangered (Listed) Species of Concern

In November 2013, the EPA, along with the U.S. Fish & Wildlife Service (USFWS), the National Marine Fisheries Service (NMFS) (colle ctively, the Services), and the U.S. Department of Agriculture (USDA), released a summary of their joint Interim Approaches for assessing risks to listed species from pesticides. The Interim Approaches were developed jointly by the agencies in response to the National Academy of Sciences’ (NAS) recommendations. They reflect a common approach to risk assessment shared by the agencies as a way of addressing scientific differences between the EPA and the Services. The NAS report outlines recommendations on specific scientific and technical issues related to the development of pesticide risk assessments that EPA and the Services must conduct in connection with their obligations under the Endangered Species Act (ESA) and FIFRA.

The joint Interim Approaches were released prior to a stakeholder workshop held on November 15, 2013. In addition, the EPA presented the joint Interim Approaches at the December 2013 Pesticide Program Dialogue Committee (PPDC) and State-FIFRA Issues Research and Evaluation Group (SFIREG) meetings, and held a stakeholder workshop in April 2014, allowing additional opportunities for stakeholders to comment on the Interim Approaches. As part of a phased, iterative process for developing the Interim Approaches, the agencies will also consider public comments on the Interim Approaches in connection with the development of upcoming Registration Review decisions. The details of the joint Interim Approaches are contained in the white paper “Interim Approaches for National-Level Pesticide Endangered Species Act Assessments Based on the Recommendations of the National Academy of Sciences April 2013 Report,” dated November 1, 2013.

Given that the agencies are continuing to develop and work toward implementation of the Interim Approaches to assess the potential risks of pesticides to listed species and their designated critical habitat, this preliminary risk assessment for tebufenozide does not contain a complete ESA analysis that would include effects determinations for individual listed species or designated critical habitat. Although EPA has not yet completed effects determinations for individual species or habitats, for this preliminary assessment, EPA conducted a screening-level assessment for all taxa of non-target wildlife and plants. The assessment assumes that listed species and designated critical habitats may be present in the vicinity of the application of

7 Available online at https://federalregis ter.gov/a/2013-14232

. 8 Endocrine Disruptor Screening Program: http://www.epa.gov/endo

.

### 72 tebufenozide. The screening level assessment will allow EPA to focus its future evaluations on the types of species where the potential for effects exists once the scientific methods being developed by the agencies have been fully vetted. This screening-level risk assessment for tebufenozide TTR indicates potential risks of di rect effects to listed terrestrial and aquatic animals, including vertebrates and certain species of sensitive invertebrates, on some of its registered use sites; however, chronic risks to aquatic vertebrates are below levels of concern for tebufenozide parent compound (as opposed to TTR). Other listed species may be affected through indirect effects because of the potential for direct effects on listed and non-listed species upon which such species may rely. Additionally, potential direct effects on listed species from the use of tebufenozide may be associated w ith modification of Primary Constituent Elements (PCEs) of designated critical habitats, where such designations have been made. Once the agencies have fully developed and implemented the scientific methods necessary to complete risk assessments for endangered and threatened (listed) species and their designated critical habitats, these methods will be applied to subsequent analyses for tebufenozide as part of completing this registration review.



## 7. Conclusions

Tebufenozide is an insect growth regulator registered for use on a variety of field and orchard crops, pastures, forests, trees, shrubs, and other ornamentals. The draft ecological risk assessment hypothesizes that tebufenozide residues may reach ecological receptors in both aquatic and terrestrial habitats and that exposure to these residues may cause adverse effects in vertebrates, invertebrates, and plants in these environments.

When the best available data on tebufenozide use, environmental fate and transport, and ecotoxicity are considered, risks to most terrestrial wildlife taxa (including plants) are below levels of concern (LOCs). However, as an insect growth regulator, tebufenozide may pose risks to non-target terrestrial invertebrates which are not captured by the existing acute mortality tests. Tebufenozide use at maximum labeled rates presents chronic risks of adverse effects on growth and reproduction in terrestrial vertebrates, although risks at average application rates are lower and generally below LOCs. Most uses present risks that exceed LOCs for mortality of listed estuarine/marine invertebrates (and freshwater molluscs, by proxy) and for chronic risks to freshwater vertebrates and invertebrates, based on exposure to tebufenozide TTR. Risk of mortality from the use on cranberry also exceeds the nonlisted species LOC for estuarine/marine invertebrates exposed to undiluted bog flood water. Nonguideline data suggest that benthic organisms, such as freshwater midge larvae (Order: Diptera), may be more sensitive to tebufenozide exposure than fully aquatic invertebrates such as daphnia (Order: Cladocera) and mysid shrimp (Order: Mysida). Chronic (28-day) sediment toxicity data are needed to quantitatively assess risks. When only tebufenozide parent is considered, fewer uses result in LOC exceedances, and chronic risk to freshwater fish and amphibians is below the LOC. Future ecological risk assessments may consider modeling exposure to tebufenozide parent only, since data described in this assessment indicate that the aquatic toxicity of tebufenozide degradates is less than that of the parent compound.

Refinements to the cranberry model are not currently available. However, to the extent that residues from cranberry bog water are diluted via mixing with waters from other,

### 73 uncontaminated sources upon bog release, exposures to non-target aquatic organisms are likely to be overestimated by the Provisional Cranberry model’s EECs.



## 8. References

Cape Cod Cranberry Growers Association. 2001. Cranberry Water Use: An Information Fact Sheet. June, 2001. Online at: http://www.cranberries.org/pdf/wateruse.pdf . Accessed Mar. 17, 2010. Dhadialla, T., Carlson, G., & Le, D. (1998). New insecticides with ecdysteroidal and juvenile hormone activity. Annual Reviews in Entomology, 43 , 545-569. Fletcher, J., Nellessen, J., & Pfleeger, T. (1994). Literature review and evaluation of the EPA food-chain (Kenaga) nomogram, an instrument for estimating pesticide residues on plants. Environmental Toxicology and Chemistry, 13 , 1383-1391. Hoerger, F., & Kenaga, E. (1972). Pesticide residues on plants: Correlation of representative data as a basis for estimation of their magnitude in the environment. In F. Coulston, & F. Korte (eds.), Environmental Quality and Safety: Chemistry, Toxicology, and Technology (pp. 9-28). Stuttgart: Gerog Thieme Publ. Shimizu, B., Nakagawa, Y., Hattori, K., Nishimura, K., Kurihara, N., & Ueno, T. (1997). Molting hormonal and larvicidal activities of aliphatic acyl analogs of dibenzoylhydrazine insecticides. Steroids, 62 , 638-642. Sundaram, M., Palli, S., Sohi, S., Dhadialla, T., & Retmakaran, A. (1998). Basis for selective action of a synthetic molting hormone agonist, RH-5992, on lepidopteran insects. Insect Biochemistry and Molecular Biology, 28 , 693-704. Tassou, K., & Schulz, R. (2013). Low field-relevant tebufenozide concentrations affect reproduction in Chironomus riparius (Diptera: Chironomidae) in a long-term toxicity test. Environmental Science and Pollution Research , 3735-3742. US EPA. (2010). Tebufenozide: Review of a request for waiver for guideline 850.3040 Field testing for pollinators using Apis mellifera (honey bee). Washington, DC: US EPA Office of Pesticide Programs, Environmental Fate and Effects Division. Willis, G., & McDowell, L. (1987). Pesticide persistence on foliage. Reviews of Environmental Contamination and Toxicology, 100 , 23-73.

### 74 OPPIN Bibliographies by Subpart or Test Guideline

Part 161(x) – 165(x)

161-1 Hydrolysis

MRID Citation Reference

42436204 Reynolds, J.; Wang, W. (1992) Hydrolysis of ?carbon 14|-RH-5992 in Water at pH 5, pH 7, and pH 9: Lab Project Number: XBL 90001: XBL RPT0056: RH 34-91-33. Unpublished study prepared by XenoBiotic Labs, Inc. 63 p.

161-2 Photodegradation-water

MRID Citation Reference

42436205 Reynolds, J. (1992) Photolysis of ?carbon 14|-RH-5992 in Pond Water: Lab Project Number: XBL 92003: XBL RPT 0095: RH 34P-92-04. Unpublished study prepared by XenoBiotic Labs, Inc. 82 p.

161-3 Photodegradation-soil

MRID Citation Reference

42991512 Reynolds, J. (1991) Soil Photolysis of (carbon 14)-RH-5992: Lab Project Number: XBL 91001: RPT0072: 34P-90-65. Unpublished study prepared by XenoBiotic Labs, Inc. 87 p.

162-1 Aerobic soil metabolism

MRID Citation Reference

42436206 Reynolds, J. (1992) Aerobic Soil Metabolism of ?carbon 14|-RH-5992: Lab Project Number: XBL 90003: XBL RPT0077: RH 34P-90-46. Unpublished study prepared by XenoBiotic Labs, Inc. 194 p.

162-3 Anaerobic aquatic metab.

MRID Citation Reference

42931216 Reynolds, J. (1992) Anaerobic Aquatic Metabolism of (Carbon 14) RH-5992: Lab Project Number: XBL 91003: RPT0097: 34-92-53. Unpublished study prepared by XenoBiotic Labs, Inc. 99 p.

162-4 Aerobic aquatic metab.

MRID Citation Reference

### 75 42436207 Reynolds, J. (1992) Aerobic Aquatic Metabolism of ?carbon 14|-RH-5992: Lab Project Number: XBL 89051: XBL RPT0034: 34P-89-30. Unpublished study prepared by XenoBiotic Labs, Inc. 296 p.

163-1 Leach/adsorp/desorption

MRID Citation Reference

42931218 Reynolds, J. (1992) Aged Leaching of (Carbon 14)-RH-5992: Lab Project Number: XBL 92001: RPT00108: 34-92-74. Unpublished study prepared by XenoBiotic Labs, Inc. 106 p. 42931219 Dong, L. (1992) RH-112651: Soil Adsorption and Desorption: Lab Project Number: 34-92-82: TR34-92-82: 34P-92-50. Unpublished study prepared by Rohm and Haas Co. 182 p. 43517602 Hawkins, D. (1995) RH-5992: Aged Leaching Study, Supplemental to Technical Report 34-92-74 "Aged Leaching of (carbon 14)-RH-5992" MRID No. 42931218: Lab Project Number: 34/95/12. Unpublished study prepared by Rohm and Haas Co. 7 p.

164-1 Terrestrial field dissipation

MRID Citation Reference

42931222 Hawkins, D. (1992) RH-5992 Terrestrial Field Dissipation: Interim Report: Lab Project Number: 34-92-61: TR34-92-47: 34P-91-04. Unpublished study prepared by Rohm and Haas Co. 128 p. 42931223 Yajima, K. (1992) Dissipation Study of RH-5992 in Upland Soil (English Translation): Lab Project Number: 34-92-81: TR34-92-81. Unpublished study prepared by Agricultural Chemical Technical Center. 106 p.
42991514 Hawkins, D. (1993) RH-5992: Terrestrial Field Dissipation at Two Sites in California: Lab Project Number: 34-93-59: 34P-91-04: TR34-93-59. Unpublished study prepared by Pan-Agricultural Labs, Inc. and Centre Analytical Lab. 675 p.
43517601 Deakyne, R.; Chen, J. (1995) Supplemental Report (Including 24 Month Data) to "RH5992 Soil Storage Stability" MRID 42991513: Lab Project Number: 43/95/11. Unpublished study prepared by Centre Analytical Laboratories. 151 p.
43797703 Hawkins, D. (1994) RH 5992: Terrestrial Field Dissipation in New York and Washington: Lab Project Number: 34/94 /139. Unpublished study prepared by PanAgricultural Labs, Inc. and Centre Analytical Lab. 741 p.
44414302 Hawkins, D. (1997) RH-5992: Soil Dissipation in New York and Washington: Supplemental to Technical Report 34-94-139: Lab Project Number: 34-97-123: 34-94- 139: TR34-97-123. Unpublished study prepared by Rohm and Haas Co. 57 p.

164-2 Aquatic field dissipation

MRID Citation Reference

44125402 Keller, L. (1996) Tebufenozide (RH-5992): Rapid Dissipation in Aquatic Matrices and Safety to Aquatic Nontarget Organisms in Forestry and Other Environments: Lab

### 76 Project Number: 96R-1069: 34-95-144: 93RC-1003. Unpublished study prepared by Rohm and Haas Co. 321 p.

164-3 Forest field dissipation

MRID Citation Reference

43935604 Burnett, T. (1995) RH-5992 Terrestrial Dissipation Study on Forestry Matrices (in a Deciduous Environment): Lab Project Number: 34-95-97: TR 34-95-97: 34P-92-53. Unpublished study prepared by American Agricultural Services, Inc.; Centre Analytical Labs, Inc. and Rohm and Haas Co. 969 p.
43935605 Sharma, A. (1995) RH-5992 Forestry Dissipation Study in New York: Lab Project Number: 34-95-144: 34P-94-42: 34-95-90. Unpublished study prepared by A.C.D.S. Research, Inc.; Centre Analytical Labs; and Rohm and Haas Co. 904 p.
44125402 Keller, L. (1996) Tebufenozide (RH-5992): Rapid Dissipation in Aquatic Matrices and Safety to Aquatic Nontarget Organisms in Forestry and Other Environments: Lab Project Number: 96R-1069: 34-95-144: 93RC-1003. Unpublished study prepared by Rohm and Haas Co. 321 p.

164-5 Long term soil dissipation

MRID Citation Reference

43517601 Deakyne, R.; Chen, J. (1995) Supplemental Report (Including 24 Month Data) to "RH5992 Soil Storage Stability" MRID 42991513: Lab Project Number: 43/95/11. Unpublished study prepared by Centre Analytical Laboratories. 151 p.

165-1 Confined rotational crop

MRID Citation Reference

44221904 Sharma, A.; Bergin, N. (1996) Confined Accumulation Study on Rotation Crops with (carbon 14)-RH-5992: Lab Project Number: 34-96-39: 34P-91-03. Unpublished study prepared by Rohm and Haas Co.; ABC Labs.; and Xenobiotics Labs. 833 p.

165-2 Field rotational crop

MRID Citation Reference

44679102 Dong, L. (1998) RH-5992 Field Rotational Crop Studies (Residues in High Moisture Rotational Crops Including Leafy, Root, Fruiting, and Bulb Vegetables and Cucurbits): Lab Project Number: 1404. 46: 34P-95-69: 34P-96-69A. Unpublished study prepared by Rohm & Haas Company, and Centre Analytical Laboratories, Inc. 599 p. {OPPTS 860.1900} 44769503 Dong, L. (1999) RH-5992 (Tebufenozide) Field Rotational Crop Studies (Residues in Cereal Grains and Legumes): Supplemental to TR 34-98-153: Lab Project Number: 34P-95-69: 34P-95-69A: 34P-95-104. Unpublished study prepared by Rohm and Haas Company, and Centre Analytical Laborat ories, Inc. 628 p. {OPPTS 860.1900}

### 77 45893202 Jones, G. (2003) RH-5992 2F Field Accumulation Study in Rotational Wheat and Soybean Crops Following Application to Leaf Lettuce: Lab Project Number: 34P-01- 02: 21801029: 21801030. Unpublished study prepared by Dow AgroSciences, LLC. 452 p. {OPPTS 860.1900}

165-4 Bioaccumulation in fish

MRID Citation Reference

42436208 Hawkins, D. (1992) RH-5992: Soil Adsorption and Desorption: Lab Project Number: 34-92-52. Unpublished study prepared by Rohm & Haas Co. 265 p.
42436209 Reynolds, J. (1992) RH-5992 Bioconcentration and Elimination of ?carbon 14| Residues by Bluegill Sunfish (Lepomis macrochirus): Lab Project Number: 86.0491.6136.140: 91-7-3880: 34-91-76. Unpublished study prepared by Springborn Labs, Inc. 82 p. 42931224 Dong, L; Hawkins, D. (1993) Dynamic Bioconcentration Study of RH-5992 with Bluegill Sunfish Metabolite Identification Phase: Lab Project Number: 34-93-45: TR34- 93-45: 92-7-4342. Unpublished study prepared by Rohm and Haas Co. 497 p.

165-5 Bioaccum-aquatic non-target

MRID Citation Reference

43215301 Hawkins, D. (1994) RH-5992: Request for Waiver from the Requirement for an Accumulation in Aquatic Nontarget Organism Study: Lab Project Number: 34-94-26. Unpublished study. 7 p.

### 78 Series 835

835.4100 Aerobic soil metabolism

MRID Citation Reference

47881101 Knowles, S. (2009) Waiver for US Aerobic Soil Study Requirement for Tebufenozide. Project Number: 091136. Unpublished study prepared by Dow AgroSciences, LLC. 17 p

### 79 Part 71(x) - 72(x)

71-2 Avian Dietary Toxicity

MRID Citation Reference

42436234 Fletcher, D. (1987) 21-Day Acute Oral Toxicity Study with RH-5992 Technical in Bobwhite Quail: Lab Project Number: 87RC-0024: 87P-032: BLAL 87 QD 86. Unpublished study prepared by Bio-Life Assoc. 27 p.
42436235 Fletcher, D. (1990) 8-Day Dietary LC50 Study with RH-5992 Technical in Bobwhite Quail: Final Report: Lab Project Number: 87RC-0054: 87P-211: BLAL-87 QC 92. Unpublished study prepared by Bio-Life Assoc. 34 p. 42436236 Hohing, L. (1992) Analytical Chemistry Report of Analyses to Determine RH-5992 Technical in Dietary Samples Administered in the 8-Day LC50 Bobwhite Quail Study (Supp): Lab Project Number: 417-483: 87RC-054A. Unpublished study prepared by Hazleton Washington, Inc. 27 p. 42436237 Fletcher, D. (1992) 8-Day Dietary LC50 with RH-5992 Technical in Mallard Ducklings: Lab Project Number: 87RC-0055|: 87P-210: BLAL 87 DC 93. Unpublished study prepared by Bio-Life Assoc. 33 p. 42436238 Hohing, L. (1992) Analytical Chemistry Report of Analyses to Determine RH-5992 Technical in Dietary Samples Administered in the 8-Day LC50 Mallard Ducklings Study. (Supp): Lab Project Number: 417- 483: 87RC-055A. Unpublished study prepared by Hazleton Washington, Inc. 27 p.

71-4 Avian Reproduction

MRID Citation Reference

42991501 Beavers, J.; Ross, T.; Jaber, M. (1993) RH-5992 Technical: A One-Generation Reproduction Study with the Bobwhite (Colinus virginianus): Lab Project Number: 129-147: 90RC-0267: HWA 417-481. Unpublished study prepared by Wildlife International Ltd. 165 p.
42991502 Reinert, K. (1993) RH-5992 Technical: Supplemental Report--One Generation Reproduction Study with the Bobwhite Quail (Colinus virginianus): Lab Project Number: 90RC-0267D: RH93-01: 90RC-267C . Unpublished study prepared by Rohm and Haas Co. 37 p.
42991503 Beavers, J.; Ross, T.; Jaber, M. (1993) RH-5992 Technical: A One Generation Reproduction Study with the Mallard (Anas platyrhynchos): Lab Project Number: 129- 148: 90RC-0222: 91P-222. Unpublished study prepared by Wildlife International Ltd. 161 p. 43781701 Williams, B. (1995) RH-5992 Technical: Reproduction Study in Bobwhite Quail: Lab Project Number: 94RC-0023: RH59BWR-394: HWA 417-492. Unpublished study prepared by Ecological Planning and Toxicology, Inc. 160 p.
46090101 Beavers, J.; Ross, T.; Jaber, M. (1993) RH-5992 Technical: A One-Generation Reproduction Study with the Bobwhite (Colinus virginianus). Project Number: 129/147, 90RC/0267, 91RP/267. Unpublished study prepared by Wildlife International, Ltd. 165 p.

### 80 46090102 Reinert, K. (1993) RH-5992 Technical: Supplemental Report - One Generation Reproduction Study with the Bobwhite Quail (Colinus virginanus). Project Number: 90RC/0267D, TD/93M/486, RH93/01. Unpublished study prepared by Rohm and Haas Co. 37 p.

72-1 Acute Toxicity to Freshwater Fish

MRID Citation Reference

42436239 Graves, W.; Smith, G. (1992) RH-5992 Technical: A 96-Hour Static Acute Toxicity Test with the Bluegill (Lepomis macrochirus): Final Report: Lab Project Number: 129A-108: 90RC-0063. Unpublished study prepared by Wildlife Intl. Ltd. 123 p.
42436240 Graves, W.; Smith, G. (1992) RH-5992 Technical: A 96-Hour Static Acute ToxicityTest with the Rainbow Trout (Oncorrhynchus mykiss): Lab Project Number: 129A110: 90RC-0064. Unpublished study prepared by Wildlife Intl. Ltd. 123 p.
47926502 Madsen, T. (2003) RH-11 2651: An Acute Toxicity Study with the Bluegill, Lepomis macrochirus Rafinesque. Project Number: 47587, 021258. Unpublished study prepared by ABC Laboratories, Inc. 50 p.

72-2 Acute Toxicity to Freshwater Invertebrates

MRID Citation Reference

42436241 Graves, W.; Smith, G. (1992) RH-5992 Technical: A 48-Hour Static Acute ToxicityTest with the Cladoceran (Daphnia magna): Final Report: Lab Project Number: 129A109: 90RC-0065. Unpublished study prepared by Wildlife Intl. Ltd. 122 p. 43699701 Heusel, R. (1995) HOE 105540-Water Miscible Suspension Concentrate 240 g/L: Effect to Daphnia magna (Waterflea) in a Static-Acute Toxicity Test (Method OECD): Lab Project Number: CE93/078: A53747. Unpublished study prepared by Hoechst Schering AgrEvo GmbH. 37 p.

72-3 Acute Toxicity to Estuarine/Marine Organisms

MRID Citation Reference

42807701 Dionne, E. (1993) RH-5992 Technical--Acute Toxicity to Eastern Oyster (Crassostrea Virginica) Under Flow-Through Conditions: Final Report: Lab Project Number: 93-3- 4700: 86.1192.6156.504: 92P-145. Unpublished study prepared by Springborn Labs, Inc. 67 p. 42991504 Machado, M. (1993) RH-5992 Technical--Acute Toxicity to Sheepshead Minnow (Cyprinodon variegatus) Under Flow-Through Conditions: Final Report: Lab Project Number: 93-3-4695: 86.1192.6157.505: 92RC-0146. Unpublished study prepared by Springborn Labs, Inc. 74 p.
44945701 Dionne, E. (1998) Confirm 2F--Acute Toxicity to Northern Lobsters (Homarus americanus) Under Static Conditions: Final Report: Lab Project Number: 98-11-7561: 86.1098.6226.585: 98RC-0210. Unpublished study prepared by Springborn Laboratories, Inc. 67 p.

### 81 72-4 Fish Early Life Stage/Aquatic Invertebrate Life Cycle Study

MRID Citation Reference

42436242 Bettancourt, M. (1992) RH-5992 Technical: Toxicity to Fathead Minnow (Pimephales promelas) Embryos and Larvae: Final Report: Lab Project Number: 91-9-3923: 86.0291.6133.120: 90RC-0212. Unpublished study prepared by Springborn Labs, Inc. 80 p. 42436243 McNamara, P. (1991) RH-5992 Technical: The Chronic Toxicity to Daphnia magna under Flow-thru Conditions: Final Report: Lab Project Number: 91-7-3821: 86.0291.6128.130: 90RC-0207. Unpublished study prepared by Springborn Labs, Inc. 101 p. 42991505 Machado, M. (1992) RH-5992 Technical--Chronic Toxicity to Mysid Shrimp (Mysidopsis bahia) Under Flow-through Conditions: Amended Final Report: Lab Project Number: 91-8-3899: 86.0291.6129.530: 90RC-0208. Unpublished study prepared by Springborn Labs, Inc. 122 p.
43145701 Surprenant, D. (199 4) Supplement to: RH-5992 Technical--Toxicity to Fathead Minnow (Pimephales promelas) Embryos and Larvae: Lab Project Number: 91-9- 3923: 86.0291.6133.120: 90RC-212B. Unpublis hed study prepared by Springborn Labs., Inc. 6 p. 44080901 Sousa, J. (1996) RH-5992 Technical--Early Life-Stage Toxicity Test with Sheepshead Minnow (Cyprinodon variegatus): Final Report: Lab Project Number: 96-4-6452: 86.0196.6201.520: 96RC-0005. Unpublished study prepared by Springborn Labs., Inc. 101 p. 44414301 Drottar, K.; Krueger, H. (1997) RH-5992 Technical: A Flow-Through Life-Cycle Toxicity Test with the Saltwater Mysid (Mysidopsis bahia): Final Report: Lab Project Number: 129A-148A: 97RC-0118: 129/041197/MYS-LC/SU. Unpublished study prepared by Wildlife Int'l. Ltd. 169 p. Relates to letter L0000256.

72-5 Life cycle fish

MRID Citation Reference

44221901 Rhodes, J.; Leak, T. (1996) Full Life-C ycle Toxicity of RH-5992 Technical to the Fathead Minnow (Pimephales promelas) Under Flow-Through Conditions: Lab Project Number: 42408: 94RC-0025. Unpublished study prepared by ABC Laboratories, Inc. 1000 p.
44831501 Reinert, K.; Robertson, J.; Dhadialla, T. (199 9) Full Life Cycle Toxicity of RH-5992 Technical to the Fathead Minnow (Pimephales promelas) Under Flow--Through Conditions: Lab Project Number: 94RC-0025A. Unpublished study prepared by Rohm and Haas Company. 68 p.

### 82 Part 122(x)

122-2 Aquatic plant growth

MRID Citation Reference

42436245 Hoberg, J. (1992) RH-5992 Technical: Toxicity to the Freshwater Green Alga,Selenastrum capricornutum: Final Report: Lab Project Number: 91-11-4002: 90RC0210: 86.0291.6131.430. Unpublished study prepared by Springborn Labs, Inc. 59 p.
42629501 Hoberg, J. (1992) RH-5992 Technical--Toxicity to the Freshwater Green Alga,Scenedesmus subspicatus: Final Report: Lab Project Number: 91-11-4010: 90RC0209: 86.0291.6130.460. Unpublished study prepared by Springborn Labs, Inc. 69 p.
42822201 Reinert, K. (1993) Supplement to (RH-5992 Technical)--Toxicity to the Freshwater Green Alga, Selenastrum capricornutum: Lab Project Number: 90RC-0210A. Unpublished study prepared by Rohm and Haas Co. 11 p.

### 83 Series 850

850.1010 Aquatic invertebrate acute toxicity, test, freshwater daphnids

MRID Citation Reference

47926501 Hicks, S.; Leak, T. (2001) Acute Toxicity of RH-112, 703 Technical to the Water Flea, Daphnia magna, Under Static Conditions. Project Number: 46623, 01RC/0174, 01P/174. Unpublished study prepared by ABC Laboratories, Inc. 55 p.
47926505 Hicks, S.; Leak, T. (2001) Acute Toxicity of RH-96, 595 Technical to the Water Flea, Daphnia magna, Under Static Conditions. Project Number: 46619, 01RC/0108, 01P/108. Unpublished study prepared by ABC Laboratories, Inc. 56 p.
47926507 Hicks, S.; Leak, T. (2001) Acute Toxicity of RH-112, 651 Technical to the Water Flea, Daphnia magna, Under Static Conditions. Project Number: 46621, 01RC/0163, M102. Unpublished study prepared by ABC Laboratories, Inc. 55 p.

850.1075 Fish acute toxicity test, freshwater and marine

MRID Citation Reference

47926503 Hicks, S.; Leak, T. (2001) Acute Toxicity of RH-122,651 Technical to the Rainbow Trout, Oncorhynchus mykiss, Under Static Conditions. Project Number: 46620, 01RC/0162, M104. Unpublished study prepared by ABC Laboratories, Inc. 60 p.
47926504 Hicks, S.; Leak, T. (2001) Acute Toxicity of RH-96, 595 Technical to the Rainbow Trout, Oncorhynchus mykiss, Under Static Conditions. Project Number: 46618, 01RC/0107, 01P/107. Unpublished study prepared by ABC Laboratories, Inc. 58 p.
47926509 Hicks, S.; Leak, T. (2001) Acute Toxicity of RH-112, 703 Technical to the Rainbow Trout, Oncorhynchus mykiss, Under Static Conditions. Project Number: 46622, 01RC/0173, 01P/173. Unpublished study prepared by ABC Laboratories, Inc. 59 p.

850.1400 Fish early-life stage toxicity test

MRID Citation Reference

48792201 Hicks, S. (2012) Tebufenozide: Short Term Reproduction Assay with the Fathead Minnow, Pimephales promelas, Determined Under Flow-through Conditions. Project Number: 65280. Unpublished study prepared by ABC Laboratories, Inc. and Experimental Pathology Laboratories. 150p.

850.1500 Fish life cycle toxicity

MRID Citation Reference

47890301 ABC Laboratories, Inc. (2009) Tebufenozide: Short Term Reproduction Assay with the Fathead Minnow, Pimephales promelas, Determined under Flow-Through Conditions. Unpublished study. 17 p.

### 84 850.3020 Honey bee acute contact toxicity

MRID Citation Reference

47929602 Labs, G. (1995) Side Effects of MIMIC 240SC on Honey Bee (Apis mellifera) Brood. Project Number: 95RC/1077. Unpublished study prepared by Royal Research Station of Gorsem. 24 p. 47929603 Halsall, N. (2003) A Semi-Field Test to Evaluate the Effects of Mimic 2F, a 240 g/L SC Formulation of Tebufenozide on Brood Development of the Honeybee, Apis mellifera (Hymenoptera: Apidae). Project Number: DOW/03/08. Unpublished study prepared by Mambo-Tox, Ltd. 114 p. 47929604 Bock, K. (1993) Hoe 105540; SC Water Miscible Suspension; 240 g/l (Hoe 105540 00 SC23 A 103) Effects on the Honey Bee Apis mellifera L in a Cage Test (Semi-Field): (A51719: Translation of Doc No A51581). Project Number: CW93/024, A51719, A51581. Unpublished study prepared by Hoechst Marion Roussel Deutschland Gmbh. 37 p.

850.3040 Field testing for pollinators

MRID Citation Reference

47929601 Norman, S. (2009) Tebufenozide: Request for Waiver of Field Testing for Pollinators Using Apis mellifera (Honeybee) . Project Number: 091146. Unpublished study prepared by Dow AgroSciences, LLC. 38 p. 47929605 Nengal, S. (1996) Assessment of Side Effects of Rh-5992 2 F (Mimic 2 F) on the Honey Bee (Apis mellifera L.) in the Field by Application during Bee-Flight): Final Report. Project Number: 96173/01/BFEU, 96RC/1057. Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 60 p.
47929606 Nengal, S. (1997) Assessment of Side Effects of Rh-5992 2F on the Honey Bee (Apis mellifera L.) in the Field by Application during Bee-Flight): Final Report. Project Number: 97078/01/BFEU, 97RC/1029. Unpublished study prepared by Arbeitsgemeinschaft GAB Biotechnologie. 58 p.
49158701 Bocksch, S. (2013) Assessment of Side Effects of Tebufenozide on the Honeybee (Apis mellifera L.) in the Semi-Field after One Application in Phacelia tanacetifolia in Germany 2012. Project Number: S12/02218. Unpublished study prepared by Eurofins - GAB GmbH. 220p.
49158702 Kreidler, D. (2013) Analytical Phas e Report: Assessment of Side Effects of Tebufenozide on the Honeybee (Apis Mellifera L. ) in the Semi-Field after One Application in Phacelia tanacetifolia in Germany 2012. Project Number: S12/02218. Unpublished study prepared by Eurofins AgroScience Services EcoChem GmbH. 81p.

850.4100 Terrestrial plant toxicity, Tier 1 (seeding emergence)

MRID Citation Reference

48533001 Porch, J. (2011) Confirm 2F TEP: Toxicity Effects on the Seedling Emergence of Ten Species of Plants. Project Number: 437/120. Unpublished study prepared by Wildlife

### 85 International, Ltd. 80 p.

850.4150 Terrestrial plant toxicity, Tier 1 (vegetative vigor)

MRID Citation Reference

48533002 Porch, J. (2011) Confirm 2F TEP: A Toxicity Test to Determine the Effects of the Vegetative Vigor of Ten Species of Plants. Project Number: 437/121. Unpublished study prepared by Wildlife International, Ltd. 102 p.

850.4400 Aquatic plant toxicity test using Lemna spp. Tiers I and II

MRID Citation Reference

48533003 Porch, J. (2011) Tebufenozide: A 7-Day Static-Renewal Toxicity Test with Duckweed (Lemna gibba G3). Project Number: 437A/122A. Unpublished study prepared by Wildlife International, Ltd. 68 p. 48533004 Chafey, K. (2011) Determination of the Percent Active Ingredient of Tebufenozide in Tebufenozide Technical Material. Project Number: 437C/107. Unpublished study prepared by Wildlife International, Ltd. 28 p.

### 86 Appendix A. Chemical Names and Structures of Tebufenozide and its Degradates

Chemical Name Chemical Structure Tebufenozide, Hoe 105540, RH-75992

IUPAC name - N-tert-Butyl-N ƍ -(4-ethylbenzoyl)-3,5- dimethylbenzohydrazide

RH-112651

IUPAC name - (4-[N c -(3,5-dimethylbenzoyl)-N c -(1,1- dimethylethyl)hydrazino carbonyl]benzoic acid

RH-112703

IUPAC name - 4-[N c -(3,5-dimethylbenzoyl)-N c -(1,1- dimethylethyl)hydrazinocarbonyl]phenyl acetic acid

RH-96595

IUPAC name - N-(1,1-dimethylethyl)-N c -(4- acetylbenzoyl)-3,5-dimethylbenzohydrazide C H 3 O

N N

C H 3 CH 3 CH 3 O CH 3

CH 3 H

O

N N

C H 3 CH 3 CH 3 O CH 3

CH 3 H HO 2 C

O

N N

C H 3 CH 3 CH 3 O CH 3

CH 3 H HO 2 C

O

N N

C H 3 CH 3 CH 3 O CH 3

CH 3 H O

C H 3

### 87 Appendix B. Provisional Cranberry Model Equations

The Provisional Cranberry Model is a refinement of the Tier I Rice Model v1.0 (Equations 1 and 2), which is a simple equilibrium partitioning equation that calculates a single, screening-level concentration in rice paddy water and released tailwater based on a compound’s application rate and soil mobility.

Equations 1-2: Tier I Rice Model v1.0 (USEPA, 2007b).

d b sed sed w ai

w 

## K d d m C U T 3 2

0 

## 10 ' 10

 

##   (1)

and, if appropriate:

OC d 

### K K 01

. 0 (2) where, C w0 

### = initial water concentration [ μ g/L]

m ai 

### ' = mass applied per unit area [kg/ha] K d 

### = water-sediment partitioning coefficient [L/kg] K OC 

### = organic carbon partitioning coefficient [L/kg] d w 

### = water column depth = 0.10 m d sed 

### = sediment depth = 0.01 m ș sed 

### = porosity of sediment = 0.509
ȡ b 

### = bulk density of sediment = 1300 kg/m 3



### First, the Tier I Rice Model was provisionally modified (Equation 3) to include as inputs degradation rate constants in order to estimate single, screening-level concentrations in paddy water or tailwater at a given time after application.

Equation 3: Provisional Modified Rice Model (Jones, 2006).

d kt ai

w 

## K e m C 00013

. 0 00105

. 0 '

  

### (3)

where, C w 

### = water concentration [ μ g/L] t = interval since last application [d] k = upper 90 th 

### percentile degradation rate constant [1/d]

Then, the Provisional Modified Rice Model water column depth was increased to a depth that is used to flood cranberry bogs ( i.e. , 12 inches; Cape Cod Cranberry Growers Association, 2001 ).

### 88 i.e.
, d w 

### = water column depth = 0.305 m

In order to model degradation prior to the flood at harvest, the application rates for n number of pre-harvest applications were independently degraded over the interim until flooding and then summed (Equation 4).

Equation 4: Degradation in a Dry Bog.


# ¦

 

## u n t k

n ai ai n 

## e m m

1 2 

## ' ' (4)

where,

m ai 

### ' = mass per unit area at flood [kg/ha]

m ai 

### ' n 

### = mass applied per unit area on the n th 

### application [kg/ha] k 2 

### = upper 90 th 

### percentile degradation rate constant on dry bog [1/d]
t n 

### = interval from the n th 

### application to harvest [d] n = number of pre-harvest applications

These four equations and parameter sets constitute the Provisional Cranberry Model (Equations 1-4).

Equations 2, 4, and 5: Provisional Cranberry Model.


# ¦

 

## u n t k

n ai ai n 

## e m m

1 2 

## ' ' (4)

where,

m ai 

### ' = mass per unit area at flood [kg/ha]

m ai 

### ' n 

### = mass applied per unit area on the n th 

### application [kg/ha] k 2 

### = upper 90 th 

### percentile degradation rate constant on dry bog [1/d]
t n 

### = interval from the n th 

### application to harvest [d] n = number of pre-harvest applications

followed by:

d b sed sed w kt ai

w 

## K d d e m C U T 3 2



## 10 ' 10

 



##   (5)

and, if appropriate:

OC d 

### K K 01

. 0 (2)

### 89 where, C w 

### = water concentration [ μ g/L] t = interval since flood [d] k = upper 90 th 

### percentile degradation rate constant [1/d] K d 

### = water-sediment partitioning coefficient [L/kg] K OC 

### = organic carbon partitioning coefficient [L/kg] d w 

### = water column depth = 0.305 m d sed 

### = sediment depth = 0.01 m ș sed 

### = porosity of sediment = 0.509
ȡ b 

### = bulk density of sediment = 1300 kg/m 3

### 90 Appendix C. Surface Water Modeling (SWCC) Output Files


# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (bushberries & caneberries, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the ORberriesOP field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 1.3% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (94.4% of the total transport), followed by runoff (5.57%) and erosion (0.04%). In the water body, pesticide dissipates with an effective water column half-life of 1272.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1348 days) followed by volatilization (22846 days). In the benthic region, pesticide dissipation is negligible (1308.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1308.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 37.2 4-day Avg (1-in-10 yr) 37.1 21-day Avg (1-in-10 yr) 36.8 60-day Avg (1-in-10 yr) 36.2 365-day Avg (1-in-10 yr) 33.1

Entire Simulation Mean 26.8

Table 2. Summary of Model Inputs for tebufenozide.

Scenario ORberriesOP Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

### 91 Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .95 .125
5/25 Foliar 0.28 .95 .125
6/4 Foliar 0.28 .95 .125
6/14 Foliar 0.28 .95 .125

Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (bushberries & caneberries, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the ORberriesOP field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 0.7% of tebufenozide applied to the field eventually reaches the

### 92 water body. The main mechanism of transport from the field to the water body is by spray drift (88.9% of the total transport), followed by runoff (11%) and erosion (0.08%). In the water body, pesticide dissipates with an effective water column half-life of 1272.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1348 days) followed by volatilization (22846 days). In the benthic region, pesticide dissipation is negligible (1308.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1308.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 20.5 4-day Avg (1-in-10 yr) 20.4 21-day Avg (1-in-10 yr) 20.3 60-day Avg (1-in-10 yr) 20.0 365-day Avg (1-in-10 yr) 18.1

Entire Simulation Mean 14.1

Table 2. Summary of Model Inputs for tebufenozide.

Scenario ORberriesOP Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

### 93 Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .99 .062
5/25 Foliar 0.28 .99 .062
6/4 Foliar 0.28 .99 .062
6/14 Foliar 0.28 .99 .062

Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (canola, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the NDcanolaSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 1.7% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (72.1% of the total transport), followed by runoff (27.6%) and erosion (0.27%). In the water body, pesticide dissipates with an effective water column half-life of 1513.0 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1617.9 days) followed by volatilization (23340.5 days). In the benthic region, pesticide dissipation is negligible (1570.5 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1570.5 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

### 94 Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 58.6 4-day Avg (1-in-10 yr) 58.4 21-day Avg (1-in-10 yr) 57.9 60-day Avg (1-in-10 yr) 56.8 365-day Avg (1-in-10 yr) 51.5

Entire Simulation Mean 39.6

Table 2. Summary of Model Inputs for tebufenozide.

Scenario NDcanolaSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .95 .125
5/25 Foliar 0.28 .95 .125
6/4 Foliar 0.28 .95 .125
6/14 Foliar 0.28 .95 .125

Figure 1. Yearly Peak Concentrations

### 95 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (canola, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the NDcanolaSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 1.1% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (55.2% of the total transport), followed by runoff (44.4%) and erosion (0.44%). In the water body, pesticide dissipates with an effective water column half-life of 1513.0 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1617.9 days) followed by volatilization (23340.5 days). In the benthic region, pesticide dissipation is negligible (1570.5 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1570.5 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 40.1 4-day Avg (1-in-10 yr) 40.0 21-day Avg (1-in-10 yr) 39.6 60-day Avg (1-in-10 yr) 38.7 365-day Avg (1-in-10 yr) 34.7

### 96 Entire Simulation Mean 25.7

Table 2. Summary of Model Inputs for tebufenozide.

Scenario NDcanolaSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .99 .062
5/25 Foliar 0.28 .99 .062
6/4 Foliar 0.28 .99 .062
6/14 Foliar 0.28 .99 .062

Figure 1. Yearly Peak Concentrations

### 97 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (citrus, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for theUSEPA standard pond with the FLcitrusSTD field scenario. A graphical presentation of the yearto-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 3.3% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (61.3% of the total transport), followed by spray drift (38.5%) and erosion (0.25%). In the water body, pesticide dissipates with an effective water column half-life of 575.5 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 595.1 days) followed by volatilization (17534.8 days). In the benthic region, pesticide dissipates very slowly (577.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 577.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 60.4 4-day Avg (1-in-10 yr) 60.2 21-day Avg (1-in-10 yr) 59.2 60-day Avg (1-in-10 yr) 58.1

### 98 365-day Avg (1-in-10 yr) 48.9

Entire Simulation Mean 41.2

Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLcitrusSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.291 .95 .125
5/28 Foliar 0.291 .95 .125
6/12 Foliar 0.291 .95 .125
6/26 Foliar 0.291 .95 .125
7/10 Foliar 0.235 .95 .125

Figure 1. Yearly Peak Concentrations

### 99 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (citrus, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for theUSEPA standard pond with the FLcitrusSTD field scenario. A graphical presentation of the yearto-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2.7% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (76.8% of the total transport), followed by spray drift (22.9%) and erosion (0.32%). In the water body, pesticide dissipates with an effective water column half-life of 575.5 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 595.1 days) followed by volatilization (17534.8 days). In the benthic region, pesticide dissipates very slowly (577.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 577.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 51.6 4-day Avg (1-in-10 yr) 51.4 21-day Avg (1-in-10 yr) 50.8 60-day Avg (1-in-10 yr) 49.7

### 100 365-day Avg (1-in-10 yr) 41.5

Entire Simulation Mean 34.3

Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLcitrusSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.291 .99 .062
5/28 Foliar 0.291 .99 .062
6/12 Foliar 0.291 .99 .062
6/26 Foliar 0.291 .99 .062
7/10 Foliar 0.235 .99 .062

Figure 1. Yearly Peak Concentrations

### 101 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (brassica, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the FLcabbageSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 3.4% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (62.8% of the total transport), followed by spray drift (37.2%) and erosion (0.05%). In the water body, pesticide dissipates with an effective water column half-life of 630.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 650.7 days) followed by volatilization (20703.4 days). In the benthic region, pesticide dissipates very slowly (631.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 631.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 90.8 4-day Avg (1-in-10 yr) 90.4 21-day Avg (1-in-10 yr) 89.4 60-day Avg (1-in-10 yr) 86.8 365-day Avg (1-in-10 yr) 82.5

Entire Simulation Mean 67.8

### 102 Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLcabbageSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
2/15 Foliar 0.135 .95 .125
2/25 Foliar 0.135 .95 .125
3/7 Foliar 0.135 .95 .125
3/17 Foliar 0.135 .95 .125
3/27 Foliar 0.135 .95 .125
5/15 Foliar 0.135 .95 .125
5/25 Foliar 0.135 .95 .125
6/4 Foliar 0.135 .95 .125
6/14 Foliar 0.135 .95 .125
6/24 Foliar 0.135 .95 .125
8/15 Foliar 0.135 .95 .125
8/25 Foliar 0.135 .95 .125
9/4 Foliar 0.135 .95 .125
9/14 Foliar 0.135 .95 .125
9/24 Foliar 0.135 .95 .125

### 103 Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (brassica, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the FLcabbageSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2.8% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (78% of the total transport), followed by spray drift (22%) and erosion (0.06%). In the water body, pesticide dissipates with an effective water column half-life of 630.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 650.7 days) followed by volatilization (20703.4 days). In the benthic region, pesticide dissipates very slowly (631.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 631.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 78.8 4-day Avg (1-in-10 yr) 78.5 21-day Avg (1-in-10 yr) 77.4 60-day Avg (1-in-10 yr) 75.1

### 104 365-day Avg (1-in-10 yr) 70.9

Entire Simulation Mean 56.9

Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLcabbageSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
2/15 Foliar 0.135 .99 .062
2/25 Foliar 0.135 .99 .062
3/7 Foliar 0.135 .99 .062
3/17 Foliar 0.135 .99 .062
3/27 Foliar 0.135 .99 .062
5/15 Foliar 0.135 .99 .062
5/25 Foliar 0.135 .99 .062
6/4 Foliar 0.135 .99 .062
6/14 Foliar 0.135 .99 .062
6/24 Foliar 0.135 .99 .062
8/15 Foliar 0.135 .99 .062
8/25 Foliar 0.135 .99 .062
9/4 Foliar 0.135 .99 .062

### 105 9/14 Foliar 0.135 .99 .062
9/24 Foliar 0.135 .99 .062

Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (cotton, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the MScottonSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2.6% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (50% of the total transport), followed by spray drift (48.6%) and erosion (1.41%). In the water body, pesticide dissipates with an effective water column half-life of 786.1 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 813.7 days) followed by volatilization (23106.5 days). In the benthic region, pesticide dissipates very slowly (789.9 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 789.9 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 59.6

### 106 4-day Avg (1-in-10 yr) 59.4 21-day Avg (1-in-10 yr) 58.8 60-day Avg (1-in-10 yr) 56.8 365-day Avg (1-in-10 yr) 47.3

Entire Simulation Mean 33.8

Table 2. Summary of Model Inputs for tebufenozide.

Scenario MScottonSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .95 .125
5/25 Foliar 0.28 .95 .125
6/4 Foliar 0.28 .95 .125
6/14 Foliar 0.28 .95 .125

Figure 1. Yearly Peak Concentrations

### 107 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (cotton, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the MScottonSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (67.1% of the total transport), followed by spray drift (31%) and erosion (1.89%). In the water body, pesticide dissipates with an effective water column half-life of 786.1 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 813.7 days) followed by volatilization (23106.5 days). In the benthic region, pesticide dissipates very slowly (789.9 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 789.9 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 49.9 4-day Avg (1-in-10 yr) 49.8 21-day Avg (1-in-10 yr) 49.5 60-day Avg (1-in-10 yr) 47.8 365-day Avg (1-in-10 yr) 39.2

Entire Simulation Mean 26.1

### 108 Table 2. Summary of Model Inputs for tebufenozide.

Scenario MScottonSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .99 .062
5/25 Foliar 0.28 .99 .062
6/4 Foliar 0.28 .99 .062
6/14 Foliar 0.28 .99 .062

Figure 1. Yearly Peak Concentrations

### 109 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (cranberry, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the ORberriesOP field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 1.3% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (94.7% of the total transport), followed by runoff (5.28%) and erosion (0.04%). In the water body, pesticide dissipates with an effective water column half-life of 1272.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1348 days) followed by volatilization (22846 days). In the benthic region, pesticide dissipation is negligible (1308.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1308.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 37.4 4-day Avg (1-in-10 yr) 37.3 21-day Avg (1-in-10 yr) 37.0 60-day Avg (1-in-10 yr) 36.5 365-day Avg (1-in-10 yr) 33.3

Entire Simulation Mean 26.7

### 110 Table 2. Summary of Model Inputs for tebufenozide.

Scenario ORberriesOP Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .95 .125
5/22 Foliar 0.28 .95 .125
5/29 Foliar 0.28 .95 .125
6/5 Foliar 0.28 .95 .125

Figure 1. Yearly Peak Concentrations

### 111 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (cranberry, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the ORberriesOP field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 0.69% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (89.5% of the total transport), followed by runoff (10.5%) and erosion (0.08%). In the water body, pesticide dissipates with an effective water column half-life of 1272.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1348 days) followed by volatilization (22846 days). In the benthic region, pesticide dissipation is negligible (1308.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1308.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 20.5 4-day Avg (1-in-10 yr) 20.5 21-day Avg (1-in-10 yr) 20.3 60-day Avg (1-in-10 yr) 20.0 365-day Avg (1-in-10 yr) 18.4

Entire Simulation Mean 14.0

### 112 Table 2. Summary of Model Inputs for tebufenozide.

Scenario ORberriesOP Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .99 .062
5/22 Foliar 0.28 .99 .062
5/29 Foliar 0.28 .99 .062
6/5 Foliar 0.28 .99 .062

Figure 1. Yearly Peak Concentrations

### 113 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (fruiting vegetables, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the FLpeppersSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 3.7% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (66.2% of the total transport), followed by spray drift (33.7%) and erosion (0.05%). In the water body, pesticide dissipates with an effective water column half-life of 575.5 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 595.1 days) followed by volatilization (17534.8 days). In the benthic region, pesticide dissipates very slowly (577.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 577.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 112. 4-day Avg (1-in-10 yr) 111. 21-day Avg (1-in-10 yr) 111. 60-day Avg (1-in-10 yr) 108. 365-day Avg (1-in-10 yr) 93.4

Entire Simulation Mean 76.0

### 114 Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLpeppersSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .95 .125
5/25 Foliar 0.28 .95 .125
6/4 Foliar 0.28 .95 .125
6/14 Foliar 0.28 .95 .125
7/15 Foliar 0.28 .95 .125
7/25 Foliar 0.28 .95 .125
8/4 Foliar 0.28 .95 .125
8/14 Foliar 0.28 .95 .125

Figure 1. Yearly Peak Concentrations

### 115 Image: SWCC output for fruiting vegetables with benthic (pore water and sediment) EECs.

### 116 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (fruiting vegetables, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the FLpeppersSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 3.2% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (80.4% of the total transport), followed by spray drift (19.5%) and erosion (0.07%). In the water body, pesticide dissipates with an effective water column half-life of 575.5 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 595.1 days) followed by volatilization (17534.8 days). In the benthic region, pesticide dissipates very slowly (577.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 577.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 99.4 4-day Avg (1-in-10 yr) 99.0 21-day Avg (1-in-10 yr) 98.1 60-day Avg (1-in-10 yr) 95.8 365-day Avg (1-in-10 yr) 82.1

Entire Simulation Mean 65.3

Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLpeppersSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0

### 117 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .99 .062
5/25 Foliar 0.28 .99 .062
6/4 Foliar 0.28 .99 .062
6/14 Foliar 0.28 .99 .062
7/15 Foliar 0.28 .99 .062
7/25 Foliar 0.28 .99 .062
8/4 Foliar 0.28 .99 .062
8/14 Foliar 0.28 .99 .062

Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (mint, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for theUSEPA standard pond with the ORmintSTD field scenario. A graphical presentation of the yearto-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are

### 118 summarized in Tables 2 and 3. This model estimates that about 1.4% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (91.7% of the total transport) followed by runoff (8.31%). In the water body, pesticide dissipates with an effective water column half-life of 1272.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1348 days) followed by volatilization (22846 days). In the benthic region, pesticide dissipation is negligible (1308.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1308.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 73.0 4-day Avg (1-in-10 yr) 72.9 21-day Avg (1-in-10 yr) 72.2 60-day Avg (1-in-10 yr) 71.4 365-day Avg (1-in-10 yr) 67.8

Entire Simulation Mean 55.6

Table 2. Summary of Model Inputs for tebufenozide.

Scenario ORmintSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

### 119 Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .95 .125
5/25 Foliar 0.28 .95 .125
6/4 Foliar 0.28 .95 .125
6/14 Foliar 0.28 .95 .125
7/15 Foliar 0.28 .95 .125
7/25 Foliar 0.28 .95 .125
8/4 Foliar 0.28 .95 .125
8/14 Foliar 0.28 .95 .125

Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (mint, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for theUSEPA standard pond with the ORmintSTD field scenario. A graphical presentation of the yearto-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 0.74% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (84% of the total transport), followed by runoff (16%) and erosion (0.01%). In the water body, pesticide dissipates with an effective water column half-life of 1272.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of

### 120 dissipation in the water column is metabolism (effective average half-life = 1348 days) followed by volatilization (22846 days). In the benthic region, pesticide dissipation is negligible (1308.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1308.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 40.4 4-day Avg (1-in-10 yr) 40.3 21-day Avg (1-in-10 yr) 39.9 60-day Avg (1-in-10 yr) 39.5 365-day Avg (1-in-10 yr) 37.6

Entire Simulation Mean 30.2

Table 2. Summary of Model Inputs for tebufenozide.

Scenario ORmintSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .99 .062
5/25 Foliar 0.28 .99 .062

### 121 6/4 Foliar 0.28 .99 .062
6/14 Foliar 0.28 .99 .062
7/15 Foliar 0.28 .99 .062
7/25 Foliar 0.28 .99 .062
8/4 Foliar 0.28 .99 .062
8/14 Foliar 0.28 .99 .062

Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (ornamentals, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the FLnurserySTD_V2 field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2.8% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (55.9% of the total transport), followed by spray drift (44%) and erosion (0.15%). In the water body, pesticide dissipates with an effective water column half-life of 552.2 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 569.6 days) followed by volatilization (18091 days). In the benthic region, pesticide dissipates very slowly (552.9 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 552.9 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

### 122 Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 84.9 4-day Avg (1-in-10 yr) 84.5 21-day Avg (1-in-10 yr) 83.4 60-day Avg (1-in-10 yr) 81.8 365-day Avg (1-in-10 yr) 70.3

Entire Simulation Mean 55.8

Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLnurserySTD_V2 Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .95 .125
5/25 Foliar 0.28 .95 .125
6/4 Foliar 0.28 .95 .125
6/14 Foliar 0.28 .95 .125
6/24 Foliar 0.28 .95 .125
7/4 Foliar 0.28 .95 .125
7/14 Foliar 0.28 .95 .125
7/24 Foliar 0.28 .95 .125

### 123 Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (ornamentals, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the FLnurserySTD_V2 field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2.3% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (72.6% of the total transport), followed by spray drift (27.2%) and erosion (0.2%). In the water body, pesticide dissipates with an effective water column half-life of 552.2 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 569.6 days) followed by volatilization (18091 days). In the benthic region, pesticide dissipates very slowly (552.9 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 552.9 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 70.9 4-day Avg (1-in-10 yr) 70.6 21-day Avg (1-in-10 yr) 69.7 60-day Avg (1-in-10 yr) 68.3

### 124 365-day Avg (1-in-10 yr) 58.8

Entire Simulation Mean 44.7

Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLnurserySTD_V2 Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .99 .062
5/25 Foliar 0.28 .99 .062
6/4 Foliar 0.28 .99 .062
6/14 Foliar 0.28 .99 .062
6/24 Foliar 0.28 .99 .062
7/4 Foliar 0.28 .99 .062
7/14 Foliar 0.28 .99 .062
7/24 Foliar 0.28 .99 .062

Figure 1. Yearly Peak Concentrations

### 125 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (pome, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the NCappleSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2.2% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (57.9% of the total transport), followed by runoff (42%) and erosion (0.16%). In the water body, pesticide dissipates with an effective water column half-life of 1100.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1159.4 days) followed by volatilization (21824.1 days). In the benthic region, pesticide dissipation is negligible (1125.4 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1125.4 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 96.4 4-day Avg (1-in-10 yr) 96.1 21-day Avg (1-in-10 yr) 95.2 60-day Avg (1-in-10 yr) 93.5 365-day Avg (1-in-10 yr) 84.4

Entire Simulation Mean 70.5

### 126 Table 2. Summary of Model Inputs for tebufenozide.

Scenario NCappleSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.347 .95 .125
5/25 Foliar 0.347 .95 .125
6/4 Foliar 0.347 .95 .125
6/14 Foliar 0.347 .95 .125
6/24 Foliar 0.347 .95 .125
7/4 Foliar 0.347 .95 .125
7/14 Foliar 0.017 .95 .125

Figure 1. Yearly Peak Concentrations

### 127 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (pome, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the NCappleSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 1.6% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (60.3% of the total transport), followed by spray drift (39.5%) and erosion (0.23%). In the water body, pesticide dissipates with an effective water column half-life of 1100.9 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 1159.4 days) followed by volatilization (21824.1 days). In the benthic region, pesticide dissipation is negligible (1125.4 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 1125.4 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 72.2 4-day Avg (1-in-10 yr) 72.0 21-day Avg (1-in-10 yr) 71.6 60-day Avg (1-in-10 yr) 70.0 365-day Avg (1-in-10 yr) 62.7

Entire Simulation Mean 51.2

### 128 Table 2. Summary of Model Inputs for tebufenozide.

Scenario NCappleSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.347 .99 .062
5/25 Foliar 0.347 .99 .062
6/4 Foliar 0.347 .99 .062
6/14 Foliar 0.347 .99 .062
6/24 Foliar 0.347 .99 .062
7/4 Foliar 0.347 .99 .062
7/14 Foliar 0.017 .99 .062

Figure 1. Yearly Peak Concentrations

### 129 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (sugarcane, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the LAsugarcaneSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 4.3% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (68.8% of the total transport), followed by spray drift (28.9%) and erosion (2.3%). In the water body, pesticide dissipates with an effective water column half-life of 724.8 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 749.1 days) followed by volatilization (22381 days). In the benthic region, pesticide dissipates very slowly (727.2 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 727.2 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 86.7 4-day Avg (1-in-10 yr) 86.4 21-day Avg (1-in-10 yr) 85.7 60-day Avg (1-in-10 yr) 84.3 365-day Avg (1-in-10 yr) 72.6

Entire Simulation Mean 52.3

### 130 Table 2. Summary of Model Inputs for tebufenozide.

Scenario LAsugarcaneSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .95 .125
5/25 Foliar 0.28 .95 .125
6/4 Foliar 0.28 .95 .125
6/14 Foliar 0.28 .95 .125

Figure 1. Yearly Peak Concentrations

### 131 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (sugarcane, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the LAsugarcaneSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 3.8% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (81.1% of the total transport), followed by spray drift (16.2%) and erosion (2.71%). In the water body, pesticide dissipates with an effective water column half-life of 724.8 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 749.1 days) followed by volatilization (22381 days). In the benthic region, pesticide dissipates very slowly (727.2 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 727.2 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 79.6 4-day Avg (1-in-10 yr) 79.3 21-day Avg (1-in-10 yr) 78.6 60-day Avg (1-in-10 yr) 76.9 365-day Avg (1-in-10 yr) 66.5

Entire Simulation Mean 46.0

### 132 Table 2. Summary of Model Inputs for tebufenozide.

Scenario LAsugarcaneSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.28 .99 .062
5/25 Foliar 0.28 .99 .062
6/4 Foliar 0.28 .99 .062
6/14 Foliar 0.28 .99 .062

Figure 1. Yearly Peak Concentrations

### 133 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (almonds etc., aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the CAalmond_WirrigSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 1.5% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (82% of the total transport), followed by runoff (18%) and erosion (0.01%). In the water body, pesticide dissipates with an effective water column half-life of 954.3 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 997.3 days) followed by volatilization (22091.5 days). In the benthic region, pesticide dissipates very slowly (968.1 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 968.1 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 59.6 4-day Avg (1-in-10 yr) 59.4 21-day Avg (1-in-10 yr) 58.9 60-day Avg (1-in-10 yr) 57.6 365-day Avg (1-in-10 yr) 51.7

Entire Simulation Mean 45.9

### 134 Table 2. Summary of Model Inputs for tebufenozide.

Scenario CAalmond_WirrigSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.527 .95 .125
5/25 Foliar 0.527 .95 .125
6/4 Foliar 0.527 .95 .125
6/14 Foliar 0.527 .95 .125
6/24 Foliar 0.023 .95 .125

Figure 1. Yearly Peak Concentrations

### 135 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (almonds etc., ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the CAalmond_WirrigSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 0.91% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (68.4% of the total transport), followed by runoff (31.6%) and erosion (0.02%). In the water body, pesticide dissipates with an effective water column half-life of 954.3 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 997.3 days) followed by volatilization (22091.5 days). In the benthic region, pesticide dissipates very slowly (968.1 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 968.1 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 35.2 4-day Avg (1-in-10 yr) 35.1 21-day Avg (1-in-10 yr) 34.9 60-day Avg (1-in-10 yr) 34.1 365-day Avg (1-in-10 yr) 30.4

Entire Simulation Mean 27.2

### 136 Table 2. Summary of Model Inputs for tebufenozide.

Scenario CAalmond_WirrigSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.527 .99 .062
5/25 Foliar 0.527 .99 .062
6/4 Foliar 0.527 .99 .062
6/14 Foliar 0.527 .99 .062
6/24 Foliar 0.023 .99 .062

Figure 1. Yearly Peak Concentrations

### 137 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (pecans, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the GAPecansSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by spray drift (61.9% of the total transport), followed by runoff (38%) and erosion (0.14%). In the water body, pesticide dissipates with an effective water column half-life of 742.1 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 761.9 days) followed by volatilization (28482.4 days). In the benthic region, pesticide dissipates very slowly (739.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 739.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 69.9 4-day Avg (1-in-10 yr) 69.6 21-day Avg (1-in-10 yr) 69.0 60-day Avg (1-in-10 yr) 67.6 365-day Avg (1-in-10 yr) 56.9

Entire Simulation Mean 48.8

### 138 Table 2. Summary of Model Inputs for tebufenozide.

Scenario GAPecansSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.291 .95 .125
5/23 Foliar 0.291 .95 .125
5/31 Foliar 0.291 .95 .125
6/8 Foliar 0.291 .95 .125
6/16 Foliar 0.291 .95 .125
6/24 Foliar 0.291 .95 .125
7/2 Foliar 0.291 .95 .125
7/10 Foliar 0.090 .95 .125

Figure 1. Yearly Peak Concentrations

### 139 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (pecans, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the GAPecansSTD field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 1.4% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (56.2% of the total transport), followed by spray drift (43.6%) and erosion (0.2%). In the water body, pesticide dissipates with an effective water column half-life of 742.1 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 761.9 days) followed by volatilization (28482.4 days). In the benthic region, pesticide dissipates very slowly (739.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 739.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 52.0 4-day Avg (1-in-10 yr) 51.8 21-day Avg (1-in-10 yr) 51.3 60-day Avg (1-in-10 yr) 50.2 365-day Avg (1-in-10 yr) 43.3

Entire Simulation Mean 34.4

### 140 Table 2. Summary of Model Inputs for tebufenozide.

Scenario GAPecansSTD Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.291 .99 .062
5/23 Foliar 0.291 .99 .062
5/31 Foliar 0.291 .99 .062
6/8 Foliar 0.291 .99 .062
6/16 Foliar 0.291 .99 .062
6/24 Foliar 0.291 .99 .062
7/2 Foliar 0.291 .99 .062
7/10 Foliar 0.090 .99 .062

Figure 1. Yearly Peak Concentrations

### 141 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (trees, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the FLnurserySTD_V2 field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2.9% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (56.6% of the total transport), followed by spray drift (43.3%) and erosion (0.12%). In the water body, pesticide dissipates with an effective water column half-life of 552.2 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 569.6 days) followed by volatilization (18091 days). In the benthic region, pesticide dissipates very slowly (552.9 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 552.9 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 12.4 4-day Avg (1-in-10 yr) 12.3 21-day Avg (1-in-10 yr) 12.1 60-day Avg (1-in-10 yr) 11.7 365-day Avg (1-in-10 yr) 9.88

Entire Simulation Mean 7.10

### 142 Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLnurserySTD_V2 Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.14 .95 .125
5/20 Foliar 0.14 .95 .125

Figure 1. Yearly Peak Concentrations

### 143 

# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (trees, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for the USEPA standard pond with the FLnurserySTD_V2 field scenario. A graphical presentation of the year-to-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 2.3% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (73.2% of the total transport), followed by spray drift (26.7%) and erosion (0.16%). In the water body, pesticide dissipates with an effective water column half-life of 552.2 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 569.6 days) followed by volatilization (18091 days). In the benthic region, pesticide dissipates very slowly (552.9 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 552.9 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 10.6 4-day Avg (1-in-10 yr) 10.5 21-day Avg (1-in-10 yr) 10.3 60-day Avg (1-in-10 yr) 10.0 365-day Avg (1-in-10 yr) 8.51

Entire Simulation Mean 5.73

Table 2. Summary of Model Inputs for tebufenozide.

Scenario FLnurserySTD_V2 Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1

### 144 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.14 .99 .062
5/20 Foliar 0.14 .99 .062

Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (pasture, aerial) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for theUSEPA standard pond with the RangeBSS field scenario. A graphical presentation of the yearto-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 3.5% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (64.7% of the total transport), followed by spray drift (35.3%) and erosion (0.02%). In the water body, pesticide dissipates with an effective water column half-life of 687.4 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 713.5 days) followed by volatilization (18759.6 days).

### 145 In the benthic region, pesticide dissipates very slowly (692.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 692.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 30.6 4-day Avg (1-in-10 yr) 30.5 21-day Avg (1-in-10 yr) 30.2 60-day Avg (1-in-10 yr) 29.6 365-day Avg (1-in-10 yr) 26.2

Entire Simulation Mean 21.2

Table 2. Summary of Model Inputs for tebufenozide.

Scenario RangeBSS Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.14 .95 .125
5/25 Foliar 0.14 .95 .125
6/4 Foliar 0.14 .95 .125
6/14 Foliar 0.14 .95 .125

### 146 Figure 1. Yearly Peak Concentrations



# Summary of Water Modeling of tebufenozide and the USEPA Standard Pond (pasture, ground) Estimated Environmental Concentrations for tebufenozide are presented in Table 1 for theUSEPA standard pond with the RangeBSS field scenario. A graphical presentation of the yearto-year peaks is presented in Figure 1. These values were generated with the Surface Water Concentration Calculator (SWCC Version 1.106). Critical input values for the model are summarized in Tables 2 and 3. This model estimates that about 3% of tebufenozide applied to the field eventually reaches the water body. The main mechanism of transport from the field to the water body is by runoff (79.4% of the total transport), followed by spray drift (20.6%) and erosion (0.03%). In the water body, pesticide dissipates with an effective water column half-life of 687.4 days. (This value does not include dissipation by transport to the benthic region; it includes only processes that result in removal of pesticide from the complete system.) The main source of dissipation in the water column is metabolism (effective average half-life = 713.5 days) followed by volatilization (18759.6 days). In the benthic region, pesticide dissipates very slowly (692.6 days). The main source of dissipation in the benthic region is metabolism (effective average half-life = 692.6 days). The vast majority of the pesticide in the benthic region (91.9%) is sorbed to sediment rather than in the pore water.

Table 1. Estimated Environmental Concentrations (ppb) for tebufenozide.

Peak (1-in-10 yr) 26.5 4-day Avg (1-in-10 yr) 26.4 21-day Avg (1-in-10 yr) 26.3 60-day Avg (1-in-10 yr) 25.8

### 147 365-day Avg (1-in-10 yr) 22.8

Entire Simulation Mean 18.1

Table 2. Summary of Model Inputs for tebufenozide.

Scenario RangeBSS Cropped Area Fraction 1 Koc (ml/g) 105 Water Half-Life (days) @ 25 °C 553.2 Benthic Half-Life (days) @ 25 °C 537 Photolysis Half-Life (days) @ 40 °Lat 0

Hydrolysis Half-Life (days) 0 Soil Half-Life (days) @ 25 °C 93.1 Foliar Half-Life (days) 0

Molecular Wt 352 Vapor Pressure (torr) 2.25e-8 Solubility (mg/l) .83

Table 3. Application Schedule for tebufenozide.

Date (Mon/Day) Type Amount (kg/ha) Eff. Drift
5/15 Foliar 0.14 .99 .062
5/25 Foliar 0.14 .99 .062
6/4 Foliar 0.14 .99 .062
6/14 Foliar 0.14 .99 .062

Figure 1. Yearly Peak Concentrations

### 148

### 149 Appendix D. Example T-REX (v. 1.5.2) Input and Output for Tebufenozide

What body weight range is assessed (grams)? Birds Mammals

Small 20 15

Medium 100 35

Large 1000 1000 Assessed Species Inputs (optional, use defaults for RQs for national level assessments)

### 150 EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

100 343.51 3.44 157.44 1.57 193.23 1.93 21.47 0.21 134.54 1.35 Broadleaf Plants Fruits/Pods/Seeds

Size class not used for dietary risk quotients Short Grass

NOAEC (ppm) Tall Grass Arthropods Table X. Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients

EECs and RQs

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 10989.15 327.51 0.03 150.11 0.01 184.23 0.02 20.47 0.00 128.2761503 0.011672979 4.5488 0.000413935 35 8891.40 226.36 0.03 103.75 0.01 127.33 0.01 14.15 0.00 88.65598092 0.009970984 3.1438 0.000353581 1000 3845.80 52.48 0.01 24.05 0.01 29.52 0.01 3.28 0.00 20.5552 0.00534484 0.7289 0.000189533 Table X. Upper Bound Kenaga, Acute Mammalian Dose-Based Risk Quotients

Granivore Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods Size Class (grams) Adjusted LD50 Short Grass EECs and RQs

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 200 343.51 1.72 157.44 0.79 193.23 0.97 21.47 0.11 134.54 0.67 Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Table X. Upper Bound Kenaga, Chronic Mammalian Dietary Based Risk Quotients EECs and RQs Arthropods

Size class not used for dietary risk quotients NOAEC (ppm)

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ 15 27.69 327.51 11.83 150.11 5.42 184.23 6.65 20.47 0.74 128.28 4.63 4.55 0.16 35 22.41 226.36 10.10 103.75 4.63 127.33 5.68 14.15 0.63 88.66 3.96 3.14 0.14 1000 9.69 52.48 5.42 24.05 2.48 29.52 3.05 3.28 0.34 20.56 2.12 0.73 0.08 Granivore Table X. Upper Bound Kenaga, Chronic Mammalian Dose-Based Risk Quotients EECs and RQs

Size Class (grams) Adjusted NOAEL Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Arthropods

### 151 Appendix E. Example Terrplant (v. 1.2.2) Input and Output for Tebufenozide

TerrPlant v. 1.2.2 Green values signify user inputs (Tables 1, 2 and 4). Input and output guidance is in popups indicated by red arrows.

Chemical Name PC code Use Application Method

Application Form Solubilit y in Water ( ppm )

Input Parameter Symbol Value Units Application Rate A 0.47 lbs a.i./A

Incorporation I 1 none Runoff Fraction R 0.01 none

Drift Fraction D 0.05 none

Equation EEC

(A/I)*R 0.0047 (A/I)*R*10 0.047 A*D 0.0235 ((A/I)*R)+(A*D) 0.0282 ((A/I)*R*10)+(A*D) 0.0705 0.83 129026

Description

Total for semi-aquatic areas Table 3. EECs for Tebufenozide. Units in lbs a.i./A.

Runoff to dry areas Runoff to semi-aquatic areas Spray drift Total for dry areas Table 1. Chemical Identity.
Tebufenozide

Tree nuts

Table 2. Input parameters used to derive EECs. Airblast Liquid

### 152 Appendix F. STIR Input Parameters and Results


# Input

Application and Chemical Information
Enter Chemical Name Tebufenozide Enter Chemical Use Tree nuts, etc. Is the Application a Spray? (enter y or n) y If Spray What Type (enter ground or air) air Enter Chemical Molecular Weight (g/mole) 352.26 Enter Chemical Vapor Pressure (mmHg) 2.30E-08 Enter Application Rate (lb a.i./acre) 0.47

Toxicity Properties

Bird Enter Lowest Bird Oral LD 50 (mg/kg bw) 2150 Enter Mineau Scaling Factor 1.15 Enter Tested Bird Weight (kg) 0.178 Mammal Enter Lowest Rat Oral LD 50 (mg/kg bw) 5000 Enter Lowest Rat Inhalation LC 50 (mg/L) 1.33 Duration of Rat Inhalation Study (hrs) 4 Enter Rat Weight (kg) 0.271



## Output Results Avian (0.020 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 4.36E-04 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 5.48E-05 Adjusted Inhalation LD 50 4.12E+00 Ratio of Vapor Dose to Adjusted Inhalation LD 50 1.33E-05 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 4.52E-02 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 1.10E-02 Exposure not Likely Significant



### Results Mammalian (0.015 kg ) Maximum Vapor Concentration in Air at Saturation (mg/m 3 ) 4.36E-04 Maximum 1-hour Vapor Inhalation Dose (mg/kg) 6.89E-05 Adjusted Inhalation LD 50 9.59E+01 Ratio of Vapor Dose to Adjusted Inhalation LD 50 7.18E-07 Exposure not Likely Significant Maximum Post-treatment Spray Inhalation Dose (mg/kg) 5.68E-02 Ratio of Droplet Inhalation Dose to Adjusted Inhalation LD 50 5.92E-04 Exposure not Likely Significant

### 153 Appendix G. SIP Input Parameters and Results

Table 2. Mammalian Results Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 0.1428 0.1428 Adjusted toxicity value (mg/kg-bw) 3845.8028 9.6914 Ratio of exposure to toxicity 0.0000 0.0147

Conclusion* Drinking water exposure alone is NOT a potential

concern for mammals Drinking water exposure alone is NOT a potential

concern for mammals Table 1. Inputs Parameter Value Chemical name Tebufenozide Solubility (in water at 25 o C; mg/L) 0.83

Mammalian LD 50 (mg/kg-bw) 5000 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species Mammalian NOAEL (mg/kg-bw) 12.6 Mammalian test species laboratory rat Body weight (g) of "other" mammalian species

Avian LD 50 (mg/kg-bw) 2150 Avian test species northern bobwhite quail Body weight (g) of "other" avian species Mineau scaling factor 1.15 Mallard NOAEC (mg/kg-diet) 980 Bobwhite quail NOAEC (mg/kg-diet) 100 NOAEC (mg/kg-diet) for other bird species 0 Body weight (g) of other avian species NOAEC (mg/kg-diet) for 2nd other bird species Body weight (g) of 2nd other avian species

Table 3. Avian Results Parameter Acute Chronic Upper bound exposure (mg/kg-bw) 0.6723 0.6723 Adjusted toxicity value (mg/kg-bw) 1548.9235 10.6298 Ratio of exposure to acute toxicity 0.0004 0.0632

Conclusion* Drinking water exposure alone is NOT a potential concern for birds Drinking water exposure alone is NOT a potential concern for birds

*Conclusion is for drinking water exposure alone. This does not combine all routes of exposure. Therefore, when aggregated with other routes ( i.e ., diet, inhalation, dermal), pesticide exposure through drinking water may contribute to a total exposure that has potential for effects to non-target animals.

### 154 Appendix H. Classifications of Environmental Fate Studies Submitted for Tebufenozide

Table H.1. Available environmental fate da ta for tebufenozide an d remaining data gaps

158 Guideline (OCSPP) Description MRID Classification Data Gap? Comments

161-1 (835.2120) Hydrolysis 424362-04 Acceptable No

161-2 (835.2240) Photodegradation in water 424362-05 Supplemental No The study was conducted in pond water, not in buffered systems as required. However, based on the UV absorbance spectrum, aqueous photolysis is not expected.

161-3 (835.2410) Photodegradation on soil 429915-12 Acceptable No

161-4 (835.2370) Photodegradation in air NA Waived. No Based on low vapor pressure and Henry’s Law Constant, limited volatility is assumed.

162-1 (835.4100) Aerobic soil metabolism 424362-06 478811-02 Supplemental Supplemental No Acceptable data available for one U.S. (CA loam) and four German soils. Data for one additional U.S. (NJ sandy loam) soil were judged not valid due to anomalous degradation profile and absence of microbial biomass measurements.

162-2 835.4200 Anaerobic soil metabolism NA NA No Data not needed since an acceptable anaerobic aquatic metabolism study has been submitted.

162-4 (835.4300) Aerobic Aquatic Metabolism 424362-07 Acceptable No

162-3 (835.4400) Anaerobic Aquatic Metabolism 429312-16 Acceptable No

163-1 (835.1230) (835.1240) Leaching and adsorption/ desorption 424362-08 Acceptable No 429312-18 Acceptable The study was upgraded to acceptable by the submission of additional information (DP211383). 429312-19 Supplemental Data are supplemental because they are for a degradate. The study is valid and meets guidelines.

163-2 (835.1410) Laboratory Volatility NA Waived No

164-1 (835.6100) Terrestrial Field Dissipation 429915-14 Acceptable No Upgraded to acceptable in DP211383. Two CA bareground studies. 437977-03 Supplemental Bareground studies in NY and WA. Supplemental since incomplete data reported on water balance and soil taxonomic classification.

164-2 (835.6200) Aquatic Field Dissipation NA Not typically required for terrestrial applications No

164-3 Forestry Field Dissipation 439356-05 439356-10 Not Acceptable In Reserve Submitted study is not acceptable. Data were too variable to determine the dissipation rate. Parent and degradates were not stable in frozen storage.

439356-04 Not Acceptable Submitted study is not acceptable. Data were too variable to determine the dissipation rate. Parent and degradates were not stable in frozen storage. 165-4 Bioaccumulation in Fish 424362-09 Acceptable No Was upgraded to acceptable following submission of metabolite identification data. 429312-24 Acceptable

### 155 Appendix I. Classifications of Ecological Effects Studies Cited in the Risk Assessment for Tebufenozide

Table I.1. Available ecological effects data for terrestrial animals exposed to tebufenozide.

158 Guideline (OPPTS) Description MRID/ Accession Classification Comments

71-1 (850.2100) Avian oral toxicity 42436234 Acceptable

*Close proximity to non-study (untreated) foraging areas. 71-2 (850.2200) Avian dietary toxicity 42436235 Acceptable
42436237 Acceptable

71-4 (850.2300) Avian reproduction 42991501 Acceptable

141-1 (850.3020) Honeybee acute contact toxicity 42436244 Acceptable

141-5 (850.3040) Field testing for pollinators 47929605 Supplemental*

47929606 Supplemental** **Poor performance relative to bee development.

Nonguideline Semi-field testing for pollinators 47929602 Supplemental*** ***Limited difference between positive and negative controls.

47929603 Supplemental  ** **Potential cross-over in foraging activity across treatment groups.

47929604 Invalid***** *****High control mortality.

### 156 Table I.2. Available ecological effects data for aquatic animals exposed to tebufenozide.

Guideline Description MRID/ Accession Classification Comments

72-1 (850.1075) Freshwater fish – Acute toxicity 42436240 Acceptable

**Mysid life cycle test failed to establish a NOAEC.

***Fathead minnow full lifecycle failed to establish NOAEC 42436239 Acceptable

47926502 (degradate) Supplemental

47926503 (degradate) Supplemental

47926504 (degradate) Supplemental

47926509 (degradate) Supplemental

72-3 (850.1075) Saltwater fish – Acute toxicity 42991504 Acceptable

72-2 (850.1010) Freshwater invertebrates – Acute toxicity 42436241 Acceptable

43699701

(TEP) Acceptable

47926501 (degradate) Supplemental

47926505 (degradate) Supplemental

47926507 (degradate) Supplemental

72-3 (850.1025) (850.1035) Saltwater invertebrates – Acute toxicity 42807701 Acceptable
42991505 Acceptable

72-4 (850.1300) Freshwater invertebrate – life cycle test 44198301 Acceptable 42436243 Acceptable

43699702

(TEP) Supplemental

72-4 (850.1350) Saltwater invertebrates – life cycle test 44414301 Acceptable 42991505 Supplemental

72-4 (850.1400) Freshwater fish – early life stage test 42436242 Acceptable

72-4 (850.1400) Saltwater fish – early life stage test 44080901 Supplemental

72-5 (850.1500) Fish – life cycle test 44221901 Supplemental

OECD 229 (890.1350) Fish short term reproduction 48702201 Acceptable ****Submitted by registrant in response to data call-in for fish full life cycle toxicity.

### 157 Table I-3. Available ecological effects data for plants exposed to tebufenozide.

Guideline Description MRID Classification Comments

122-1 (850.4100) Terrestrial Plant toxicity: Tier I seedling emergence 48533001 Acceptable* *Consistent with Tier 1 toxicity guideline but did not establish a NOAEL for dicots.

**Phytotoxic effects in controls. 123-1 (850.4225) Terrestrial Plant toxicity: Tier 2 seedling emergence NA Not submitted

122-1 (850.4150) Terrestrial Plant toxicity: Tier I vegetative vigor 48533002 Acceptable*

123-1 (850.4150) Terrestrial Plant toxicity: Tier 2 vegetative vigor NA Not submitted

122-2 (850.4400) Aquatic Plant Growth: algae 42436245 Supplemental** 42629501 Supplemental

47926506 (degradate) Supplemental

47926508 (degradate) Supplemental

47926510 (degradate) Supplemental

122-2 (850.4400) Aquatic Plant Growth: vascular plants 48533003 Acceptable

### 158 Attachments (Separate Electronic Files)

Attachment I. Bibliography of ECOTOX Open Literature (June 2014 Refresh) Attachment II. ECOTOX Data Table (June 2014 Refresh)