OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460

PC Code: 121027
DP Barcodes: 412827
Date: May 6, 2014

MEMORANDUM

SUBJECT: Environmental Fate and Ecological Risk Assessment for Proposed Use of Methoxyfenozide on Pineapple.

TO: Olga Odiott, Risk Manager Mark Suarez, Product Manager
Insecticide Branch Registration Division (Mail Code 7505P)

FROM: Mary Clock-Rust, Biologist Karen Milians, Ph.D., Chemist Ideliz Negrón-Encarnación, Ph.D., Chemist
Environmental Risk Branch IV Environmental Fate and Effects Division (7507P )

REVIEWED
BY: Thomas Steeger, Ph.D., Senior Science Advisor Jim Carleton, Ph.D., Environmental Scientist
Environmental Risk Branch IV Environmental Fate and Effects Division (7507P )

APPROVED
BY: Sarah Winfield, Acting Branch Chief
Environmental Risk Branch IV Environmental Fate and Effects Division (7507P )

The Environmental Fate and Effects Division (EFE D) has completed a revi ew of the proposed use of the insecticide methoxyfenozide [Intrepid ® 

### 2F, EPA Reg. No. 62719-442 (22.6 % active ingredient)] on pineapple.

Conclusions on the Proposed Use on Pineapple EFED’s analysis determined that there is potential for direct adverse effects to Federally listed threatened and endangered species (hereafter referred to as “listed”) species of freshwater aquatic invertebrates from the proposed use of methoxyfe nozide on pineapple. Sp ecifically, the proposed use has the potential for direct effects to listed freshwater in vertebrates following acute exposure-Page 2 of 36- 

### and direct effects to listed and non-listed freshwater invert ebrate species following chronic exposure. The likelihood of direct adverse effects to birds, mamm als, fish, and terrestrial and aquatic plants and estuarine/mari ne invertebrates from exposure to methoxyfenozide as a result of the proposed use on pineappl es is expected to be lo w. However, the extent to which other taxa that may depend on freshwater aquatic invertebrate specie s may be indirectly aff ected is uncertain. The potential for direct adverse e ffects to adult honey bees ( Apis mellifera ) is considered low as a preliminary review of recently submitted data do not indicate that hone y bee brood (larvae/pupae) are adversely affected by exposure to the compound. Because of methoxyfenozide’s mode of action as an ecdysone agonist, there is uncertainty as to the extent to which larval stages of other insects (excluding honey bees) may be affected since the compound is intended to induce premature molts thereby resulting in the death of the target organism.

Methoxyfenozide is persistent and moderately mobile ( Table 2 ), which, combined with the fact that this compound acts through pathways which ar e common to a broad range of organisms which rely on the molting horm one ecdysone, makes it plausible th at methoxyfenozide may pose greater long-term ecological risk than what is suggested by this screening- level assessment. No data are available to assess the potential ri sks of methoxyfenozide exposure to terrestrial plants or to aquatic vascular plants; however, given the mode of ac tion of methoxyfenozide as an insect growth regulator, there is uncer tainty whether the compound would have any effects on plants. The data available for aquatic non-vascular plants did not i ndicate any adverse effects from exposure up to the solubility limit of the compound (3.3 mg/L). Further, no reports of plant damage resulting from exposure to methoxyfenozide have been reco rded in EFED’s incident databases.

EFED notes that the maximum application rate a nd the annual application rate may be misstated on Intrepid ® 

### labels. The maximum single appli cation rate is stated as 7 fl oz/A (label states this as 0.10 lb a.i./A) and the maximum annual application rate is stated as 28 fl oz/A (label states 0.44 lb a.i./A). At 2 lb a.i./gal, that is 0.015 lb a.i./fl oz or 0.109375 lb a.i./7 oz. Based on these calculations, EFED used 0.11 lb a.i./A as the maxi mum single application rate to assess potential
risk.

Ecological Effects Data Methoxyfenozide is very highly toxic to freshwater invertebrates and moderately toxic to other aquatic organisms on an acute exposure basis. Methoxyfenozide is practically non-toxic to the Northern bobwhite quail ( Colinus virginianus ), rat, and adult honey bees ( Apis mellifera ). More recently submitted data are under review since the last risk assessment action for methoxyfenozide (USEPA, 2013). The studies are summarized below. There are no outstanding data gaps for ecological effects data for which data have not been submitted.

The registrant has submitted data (MRID 489387- 01) examining the eff ects of methoxyfenozide on the development of amphibians, using the African clawed frogs ( Xenopus laevis ), in response to uncertainties regardi ng potential impacts on the hypothalami c-pituitary-thyroi d axis (HPT). This amphibian study is currently under review in EFED.

Also, the registrant has submitted additio nal studies (MRIDs 489622-01, 489622-02, 489622-03) on honey bee larvae/pupae (brood) and on methoxyfenozide residue s in bee colonies from almonds treated with methoxyfenozide. Th ese studies were submitted to a ddress uncertainty regarding the-Page 3 of 36- 

### potential of methoxyfenozide to affect honey be e molting. While EFED has not yet completed the review process for these studies, preliminary results indicate that methoxyfe nozide does not result in adverse effects to honey bee larvae and pupae development, nor does it affect colony overwintering survival, although uncertainties have been identified in these studies.

Finally, the registrant submitted data on red swamp crayfish ( Procambarus clarkia ) to address uncertainty whether other aquatic organisms that molt may be sensitive to methoxyfenozide. In this study, exposure of crayfish to methoxyfenozid e did not affect survival, growth (length or weight), total number of molts or number of molts per females in crayfish (EC 50 

### : >190 μ g a.i./L;
NOAEC: 190 μ g a.i./L; MRID 457027-02). The study is scientifically sound and classified as supplemental because it is a non-guideline study (MRID 457027-02).

The Ecological Incident Information System (E IIS) database contains five incidents for methoxyfenozide. All five incide nts reported bee kills in which methoxyfenozide was mentioned. Four reported incidents took place in Ca lifornia, and one in New York State

. For all of these incidents, more than one pesticide was named along with methoxyfenozide. Since methoxyfenozide alone is not acutely toxic to adult bees on an acute contact or oral exposure basis
and since these beekill incidents involved th e loss of adult bees, it is uncertain that methoxyfenozide was the cause of these losses. EPA does not have toxi city data nor does it
conduct risk assessments for tank mixes of different chemicals or combinations of active ingredients. It is ther efore unknown whether the toxi city of methoxyfenozide to bees is enhanced or otherwise affected by other chemicals that may be tank mixed with it or sprayed concurrently.

Environmental Fate Data One of the outstanding data requirements for me thoxyfenozide was identi fied in the initial Section 3 registration ( i.e., Three years after use, obt aining approval for and conducting monitoring of surface water and sediment in a representative sample of high use areas in proximity to surface water ).

The main purpose of this data re quirement was to address EPA’s concern that multiple years of Intrepid ® 

### use may result in accumulation of methoxyfenoz ide residues in water and/or sediment. DAS (Dow Agricultural Science) submitted an in terim report regarding a monitoring study on lotic (flowing) ( e.g. rivers) and lentic water bodies ( e.g. ponds) and associated benthic sediment being conducted in each of the following states: California, Mississippi, and Michigan. More details about the report are provided in subsequent sections. The final monitoring report was submitted by DAS on April 18, 2014 and it is currently under review.-Page 4 of 36- OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION 

### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460



# Environmental Fate and Ecological Risk Assessment for the Proposed Use of Methoxyfenozide on Pineapple.

Methoxyfenozide

CAS Registry No: 161050-58-4 PC Code: 121027

P

repared b y : Mary Clock-Rust, Biologist Karen Milians, Ph.D., Chemist Ideliz Negrón-Encarnación, Ph.D., Chemist U.S. Environmental Protection Agency Office of Pesticide Programs
Environmental Fate and Effects Division
Environmental Risk Branch IV 1200 Pennsylvania Ave., NW
Mail Code 7507P Washington, DC 20460 R eviewed b y : Sarah Winfield, Acting Branch Chief Thomas Steeger, Ph.D., Senior Science Advisor Jim Carleton, Ph.D., Senior Scientist

May 6, 2014

### 5 Executive Summary

Methoxyfenozide is a registered in secticide (insect growth regulato r) for a variety of agricultural as well as non-agricultural uses . The chemical acts as an ecdysone agonist that induces a precocious incomplete molt in invertebrates, partic ularly lepidopterans. Af ter ingestion of toxic doses, sensitive larvae stop feeding and the molti ng process initiates prematurely leading to desiccation and ultimately, death.

Methoxyfenozide is proposed for us e to control lepidopterous larvae pests in pineapple in Hawaii. Intrepid ® 

### would be applied as a foliar sp ray at a rate of 4 to 7 fl. oz /Acre or 0.06 to 0.10 lb a.i./acre, with a minimum retreatment interval of 7 days. The proposed yearly maximum application rate is 0.44 lb a.i./acre/year.

Methoxyfenozide is persistent and moderately mobile; once introduced in to the environment, methoxyfenozide could travel to key aquatic environmental compar tments and persist for extended periods of time, impacting a broad range of a quatic species particular ly in sandy soils where surface and groundwater can be confluent.

Based on the maximum application rate for the propos ed use, there is potential for direct adverse effects to Federally-listed threatened/endangered (hereafter referred to as “listed”) freshwater aquatic invertebrates.

EFED’s analysis determined that the proposed use has the potential for direct effects to listed freshwater invertebrates following acute expos ure and to listed and non-listed freshwater invertebrates following chronic exposure. The lik elihood of direct advers e effects to birds, mammals, fish, and terrestrial and aquatic plants and es tuarine/marine invert ebrates from exposure to methoxyfenozide as a result of the proposed use on pineapples is expected to be low. However, the extent to which other taxa that may depend on freshwater aquatic invertebrate species may be indirectly affected is uncertain. The potential for direct adverse effects to adult honey bees is considered low and a preliminary review of recen tly submitted data do not indicate that honey bee brood (larvae/pupae) are adversely affected by exposure to the compound. Because of methoxyfenozide’s mode of action as an ecdysone agoni st, there is uncertainty as to the extent to which larval stages of other insects may be affected sinc e the compound is intended to induce premature molts thereby re sulting in the death.

Introduction

This assessment evaluates potential risks to non- target species resultin g from the proposed new uses of Intrepid ® 

### 2F insecticide (22.6 % active ingredient) on pineap ple. This use has been proposed by the technical registra nt, Dow AgroSciences (DAS).

In 2013, EFED completed an ecological risk assessment (USEPA 2004) for methoxyfenozide on a variety of uses, including herb subgroup 19A (ex cept chives), dates, sorghum, fruiting vegetable group 8-10, pome fruit group 11-10, berry subgroups 13-07 A, F & G, and tropical tree fruits (sugar apple, cherimoya, atemoya, custard appl e, ilama, soursop, and biriba) (USEPA, 2013).

### 6 Recently, EFED completed the pr eliminary problem formulation for the environmental fate, ecological risk, endangered species, and drinking water exposure assessments to be conducted as part of the Registration Review of methoxyfenozide (USEPA, 2013b).

Mode of Action

Methoxyfenozide belongs to the diacylhydrazine cla ss of insecticides that interfere with the binding of the endogenous steroidal molting hormone 20-hydroxyecdysone with its nuclear receptor protein complex and, as such, is referred to as an ecdysteroid agonist (Dhadilla et al . 1998;
Shimizu et al . 1997). This non-steroidal ecdysone agonist induces a precocious incomplete molt in invertebrates, particularly lepidopterans ( e.g ., moths). After ingestion of toxic doses, sensitive larvae stop feeding and the molting process initi ates prematurely leading to desiccation and ultimately, death.

Use Characterization

Based on the submitted labels, the maximum proposed single application rate for pineapples is 0.10 lb a.i./acre, and the proposed maximu m yearly rate is 0.44 lb a.i./A ( Table 1 ). Intrepid ® 

### 2F contains 22.6% a.i. and could be applied to pin eapples by ground or aerial application equipment. The maximum number of applications allowed per year is four. The minimum application interval on the proposed label is seven days (Refer to Table 1 below).

Table 1. Summary use information for methoxyfen ozide proposed new use on pineapple, based on Intrepid ® 

### 2F supplemental label (EPA Reg. No. 62719-442).

Use Max. Single Application
Rate (lbs. a.i./A) 1 Max. No. of Applications Max. Yearly Application

Rate (lbs.

a.i./A) Min. Application

Interval

(days) Application Method

Pineapple 0.10 4 0.44 7 Ground spray (foliar)/Aerial

1 To be consistent with the maximum yearly application ra te (0.44 lb a.i./Acr e), EFED used 0.11 lbs ai/A as the maximum single application rate. T he maximum single application rate is stated on labels as 7 fl oz/A (the label states this as 0.10 lb a.i./A) and the maximum annual rate is stated as 28 fl oz/A (the label states 0.44 lb a.i./A). At 2 lb a.i./gal, that is 0.015 lb a.i./fl oz or 0.109375 lb a.i. /7 oz, which rounds off to 0.11 lb a.i./A. Based on these calculations, EFED decided to use 0. 11 lb a.i./Acre for risk assessmen t as the maximum application rate.



### Exposure Characterization

Environmental Fate and Transport Characterization

Methoxyfenozide is persistent (t 1/2 

### = 1 to 3 years in soil and water; Goring et al. 1975) and moderately mobile (K oc 

### = 219 – 922 L/kg oc 

### in various soils; FAO scal e, 2000). It is stable to photolysis and hydrolysis (at all pH levels), is not significantly volatile, a nd degrades very slowly by microbial activity. Degradates are predom inantly RH-117236 (3,5-dimethylbenzoic acid Ntert-butyl-N’-(3-hydroxy-2-m ethylbenzoyl)hydrazide) and RH -131154 (3-[N-tert-butyl-N’-(3-

### 7 methoxy-2-methylbenzoyl)-hydrazino carbonyl]-5-methylbenzoic acid), although present only in low relative amounts ( i.e. equivalent to less than 10% of a pplied radioactivity). Because of its resistance to degradation and its moderate mobility, methoxyfenozide has the potential to move off the site of application by leaching and/or eros ion/runoff, and to accumulate in aquatic systems.
Table 2 summarizes the physical-chemical properties of methoxyfenozide. For further details on the environmental fate and transport of methox yfenozide, please refer to DP Barcode D249466, USEPA (2001 a ).

Table 2. General Chemical Properties a nd Environmental Fate Parameters of Methoxyfenozide.

Chemical/Fate Parameter Value Source Comment

Chemical name n-tert-butyl-N’-[2-methyl-3- methoxybenzoyl]-3,5- dimethylbenzohydrazide D249466 Product chemistry data

Molecular mass 368 g/mol D249466 Product chemistry data

Vapor pressure (25  C) 2.0 x 10 -8 torr D249466 Product chemistry data

Solubility (25  C) 3.3 mg/L D249466

Octanol-water partition coefficient (K
ow ) 5,248 (log K
ow =3.72) D249466

Organic carbon partitioning coefficient (K
oc ) 267, 922, 678, 219, 365 L/kg
oc MRID 441444-33

Hydrolysis half-life (pH 5, 7, 9) Stable MRID 441444-30 Default

Aqueous photolysis half-life Stable MRID 446178-05 Default

Soil photolysis half-life Stable MRID 446178-06 Default

Aerobic soil metabolism half-life 573, 1100, 772, 336 d MRIDs 446178-08, 446178-07, 441444-32

Aerobic aqueous metabolism halflife 387, 962 d MRID 446178-09

Anaerobic aqueous metabolism
half-life 654 d MRID 446178-10

Terrestrial field dissipation half-life 237, 139, 151, 92 d MRID 446178-12,
446178-11



### Measures of Aquatic Exposure

The estimated environmental con centrations (EECs) in surface water from the proposed use on pineapples were generated using EFED’s Ti er I aquatic models: The GENeric Estimated Environmental Concentration (G ENEEC version 2.0, August 2001) m odel is a Tier 1 computer program which uses the soil/water partition coeffici ent and degradation kinetic data for a pesticide
to estimate runoff from a 10-hectare field into a 1-hectare by 2-meter deep “standard” pond. This model is designed as a coarse screen and estimates conservative pesticide concentrations in surface

### 8 water to determine which ones potentially pose suffi cient risk to warrant higher-level modeling. GENEEC estimates acute, as well as longer-term EEC values and is designed to mimic a Pesticide Root Zone Model/Exposure Analysis Model Sy stem (PRZM-EXAMS) simulation. The GENEEC model considers reduction in dissolved pesticide concentration due to adsorption of pesticide to soil or sediment, incorporation, degradation in soil before wash-off to a water body, direct deposition of spray drift into the water body, and degrad ation of the pesticid e within the water body. An effort was also made to refine aqua tic EECs using the Surface Water Concentration Calculator (SWCC) tool a nd is discussed below.

Input parameters for GE NEEC are listed in Table 3 . The method of application was obtained from the proposed supplemental label (Intrepid ® 

### 2F), as well the application rate, retreatment interval
and buffer zone. The retreatment interval re presents the minimum amount of time required between applications of the pest icide. Pineapple was modeled us ing aerial and ground application. Spray drift buffer zones of 25 and 150 feet (specifi ed on the proposed label) were used for ground and aerial applicati ons, respectively.

Chemical property model input values were chos en in accordance with EFED’s current input parameter guidance (USEPA 2009). The upper 90% confidence limit on the mean half-life (960 d) was selected to represent aerobic soil metabolism and both hydrolysis and photolysis were modeled as stable. The upper 90% confidence limit on the mean ha lf-life (1,562 d) was selected to represent aerobic aquatic metabolism. In add ition, the mean organic carbon partition coefficient (K oc 

### ) of 490 L/kg oc 

### and aqueous solubility of 3.3 mg/L we re incorporated for GENEEC modeling.

Table 3. GENEEC Chemical-Specific I nput Parameters for Methoxyfenozide.

Table 3. GENEEC (v2.0) input parameter values for methoxyfenozide use on pineapple 1



### .
PARAMETER (units) VALUE(S) SOURCE COMMENT

Application Rate (lb a.i. /A) 0.11 Proposed label

Number of Applications 4 Proposed label

Interval between Applications (days) 7 Proposed label

Method of Application Ground/Aerial

spray Proposed label

Organic Carbon Soil Partition Coefficient, K OC (L/kg OC ) 490 MRID: 44144433 Represents the average value among four values ranging from 219 to 922 L/kg.

Aerobic Soil Metabolism Half-life (days) 960 MRIDs 44617808, 44617807,
4414432 Represents the 90 percent upper
confidence limit on the mean of four half-life values (695 days).

Wetted in? No Proposed label

Depth of Incorporation (inches) 0 Proposed label

### 9 Table 3. GENEEC (v2.0) input parameter values for methoxyfenozide use on pineapple 1



### .
PARAMETER (units) VALUE(S) SOURCE COMMENT

Spray Drift Buffer Zone (ft) 25 (ground)

150 (aerial) Proposed label

Solubility in Water @ 25 O C, unbuffered (mg/L or ppm) 3.3 D249466 –

Aerobic Aquatic Metabolism Half-life (days) 1562 MRID: 44617809 Represents the 90 percent upper
confidence limit on the mean of three half-life values (674.5 days).

Hydrolysis Half-life @ pH 7 (days) 0 MRID: 44144430 Stable.

Aquatic Photolysis Half-life @ pH 7 (days) 0 MRID: 44617805 Stable

1 Parameters are selected as per Guidance for Selecting Input Parameters in Modeling the Environmental Fate and Transport of Pesticides; Version 2.1, October 22, 2009.



### Modeling Results

The EECs for the proposed use on pineapple are listed below in Table 4 . Model input/output data
for these estimates are attached in Appendix A

.

Table 4. Surface Water EECs Based on Methoxyf enozide Use on Proposed New Use on Pineapple.

USE SCENARIO 

### Estimated Environmental Concentrations (EECs, ppb) Application

Method Peak 4-day 21-day 60-day 90-day

Pineapple (GENEEC; rate modeled in kg a.i./ha); 0.11 x 4 applic. @ 7-d interval Ground 13.5 13.4 13.2 12.7 12.4

Aerial 13.2 13.2 13.0 12.5 12.2

Bolded numbers represent the highest EECs among each crop from the uses/scenarios modeled.



### A refined assessment using the SWCC was obtained for comparison and characterization purposes. The SWCC estimates pesticide concentrations in surface water that result from pesticide applications to land. This model is designed to simulate the environmental concentration of pesticide in the water column and sediment for us e in regulatory applications by the USEPA Office of Pesticides (OPP). The SWCC uses PRZM ve rsion 5.0+ (PRZM5) and the Variable Volume Water Body Model (VVWM), replacing the older PRZM/EXAMS shell (PE5 shell; last updated November 2006), which used PRZM 3 (Carsel et al ., 2005) and EXAMS (Bur ns, 2003). In this refinement, the Puerto Rico (PR) coffee scenario wa s used due to the lack of a specific scenario for pineapples grown in Hawaii. The PR coffee scen ario was run with different weather files (first PR weather, and then two Hawaii weather files were used: Oahu and Maui) to obtain a range of EECs. In addition to varying weather files, the curve numbers (CN) were also varied to reflect varying levels of runoff and leach ing associated with pineapple pr oduction (owing primarily to the use of plastic mulch). Although pi neapple crops are usua lly associated with soils that leach ( i.e.

, they are typically cultivated in sandy soils), wh ich are represented by a CN of 70, they may be ‘mulched’ with polyethene plastic sheets, which increases runoff and decreases leaching – this is

### 10 represented by a CN of 90. Although the SWCC is considered a Tier 2 model, used for refining EECs initially derived from GENEEC, the SWCC -generated EECs overlapped with and/or exceeded those generated through GENEEC. The re sults of this analysis can be found in Appendix
A . Although an effort was made to refine EECs, th e exposure estimates did not differ substantially from those provided through GENEEC ; therefore, the GENEEC values serve as the foundation for
the risk assessment.

Aquatic Exposure Monitoring

Methoxyfenozide was not analyzed in monitori ng conducted by the U. S. Geological Survey (USGS) National Water Quality Assessment (N AWQA) program and is not included in the California Department of Pes ticide Regulation (CDPR) Surf ace Water Database (CDPR 2003). OPP is not currently aware of ot her monitoring programs in which methoxyfenozide is an analyte.

One of the outstanding data requirements for met hoxyfenozide was identified in the ini tial Section 3 registration:

Three years after use, obtain ing approval for and conducting monitoring of surface water and sediment in a representative sample of high use areas in proximity to surface water.

DAS (Dow Agricultural Science) has agreed to sample for methoxyfenozide over a two-year period in lotic (flowing) water bodies ( e.g. rivers) and lentic water bodies ( e.g. ponds) and
associated sediment in each of the following states: California, Mississippi, and Michigan, with the Agency’s guidance (USEPA 2011). A summary of interim sampling results from this effort is provided in Table 5 . For more information refer to USEPA, 2013a. The final monitoring report was submitted by DAD on April 18, 2014 and it is cu rrently under review. Based on the interim results, in flowing water (lotic environments), methoxyfenozide was not detected in any of the benthic sediments and in static (lentic) pond e nvironments, the compound was only detected once in benthic sediments. In lotic systems, the comp ound was frequently detected in samples collected in California and Mississippi; however, the majority of samples were at or below the limit of quantification. For lentic systems, the compound was frequently detected in the water columns of samples collected in Michigan a nd Mississippi; however, again, the majority of samples were at or below the limit of quantification (LOQ). Peak residue level in lotic systems ranged as high as 1 μg/L while in lentic syst ems, the peak was 0.85 μg/L.

Table 5. Summary of Interim Sampling Result s for Methoxyfenozide in Lotic and Lentic
Water Column and Associated Benthic Sediments

State Parameters Lotic Lentic

Water ( μ g/L) Sediment ( μ g/kg) Water ( μ g/L) Sediment ( μ g/kg)

CA Detects/Samples Range
Mean/Median 72/72
0.018 – 1.0
0.14/0.061 0/4

-

- 1/10
0.017

- 0/10

-

-

MI Detects/Samples Range 0/14

- 0/2

- 8/11
0.025 – 0.85 1/11
3.4

### 11 Mean/Median - - 0.19/0.06 -

MS Detects/Samples Range
Mean/Median 38/48
0.016 – 0.181
0.036 /0.025 0/4

-

- 8/10
0.019 – 0.233

0.056/0.024 0/10

-

- For water, the limit of detection (LOD) was 0.015 μg/L and the limit of quantitation (LOQ) was 0.05 μg/L. Values between the LOQ and LOD are in italic. For sediment, th e LOD was 3 μg/kg and the LOQ was 10 μg/kg.



### Measures of Terrestrial Exposure

T-REX 1 

### (Version 1.3.1) is used to calculate dietar y EECs for estimating exposure to birds and mammals resulting from the proposed use of me thoxyfenozide. Upper-bound Kenega nomogram values are used to derive EECs for methoxyfenoz ide exposures to birds based on dietary-based exposure. A one year time period is simulated. The default foliar half-life of 35 days was used for modeling the proposed uses. An example printo ut from the T-REX model is provided in Appendix
C . Risks to terrestrial pl ants were not assessed.

Ecological Effects Characterization

Appendix B provides a full listing of the ecological effect data that have been submitted for methoxyfenozide.

Aquatic Effects Characterization

Based on the most sensitive toxic ity endpoints, methoxyfenozide is cl assified as moderately toxic to freshwater fish (and to aquatic-phase amphibians, for which freshwater fish serve as surrogates),
estuarine/marine invertebrates and estuarine/marine fish, and as very highl y toxic to freshwater
invertebrates on an acu te exposure basis ( Table 7 ). In some cases the ac ute toxicity endpoint is non-definitive and suggests that the potential acute toxicity of methoxyfenozide to these species may be limited by the chemical’s solubility (3.3 mg/L at 25 o 

### C). Toxicity data show effects on survival in freshwater fish exposed to methoxyf enozide on a chronic exposure basis. The midge ( Chironomus riparius ), a freshwater benthic invertebrate, wa s the most sensitive species tested on a chronic exposure basis, and resulted in delaye d emergence and development of the species (at the LOAEC of 0.013 mg a.i./L, only 45% of the mi dges emerged, and these de veloped slower than controls). Chronic toxicity data in fish indicate that freshwat er fish [fathead minnow Pimephales promelas , NOAEC=0.53 mg a.i./L (based on survival)] are more sens itive than marine/estuarine fish [sheepshead minnow, Cyprinodon variegatus , NOAEC=1.5 mg a.i./L (based on growth)] to methoxyfenozide. No acute toxicity data are available for midge larvae; therefore, an acute-tochronic ratio (ACR) was used to calculate an ac ute freshwater invertebra te endpoint using acute and chronic toxicity data from another aquatic invertebrate, i.e ., the freshwater waterflea ( Daphnia magnia ) 2 

### . This results in an estimated EC 50 

### of 0.06 mg a.i./L for the midge 3



### .

1 USEPA. 2014. T-REX Version 1.5.2 (Terrestrial Residue Exposure). http://www.epa.gov/oppefed1/models/terrestrial/#trex (last accessed 03.25/14)

2 The most sensitive acute and chronic endpoints available for daphnids are an EC 50 of 3.7 mg a.i./L (MRID 441444- 11) and a NOAEC of 0.20 mg a.i./L (MRID 446177-14), respectively.

3 [(3.7 mg a.i./L)/(0.20 mg a.i./L) = (0.06 mg a.i./L)/(0.0031 mg a.i./L)]

### 12 The registrant has submitted data (MRID 489387- 01) examining the effects of chronic exposure to methoxyfenozide on the development of African clawed frogs ( Xenopus laevis ) in response to uncertainties regarding potential impacts on the hypothalamic-pituitary-thyroid axis (HPT) based on chronic mammalian toxicity data. EFED has not yet completed the review process for the amphibian study, but preliminary results indicate that methoxyfenozide has effects on thyroid histology at 0.0747 mg a.i./L under flow-through conditions.

The freshwater green algae ( Pseudokirchnerie lla subcapitata ) was the most se nsitive aquatic nonvascular plant tested, but the endpoint was non-definitive, i.e ., the effect concentration for 50% mortality of the algae exceeded the highest concentration tested (EC 50 

### >3.4 mg a.i./L), suggesting that the chemical’s solubility may limit its im pacts on aquatic non-vascular plants. Data on the effects of methoxyfenozide on vascul ar plants are not available.

For estuarine/marine invertebrates, chronic toxi city data are available for the mysid shrimp ( Americamysis bahia ). In this study, reduced growth (length) occurred, with a NOAEC of 0.025 mg a.i./L.

The registrant submitted data on red swamp crayfish ( Procambarus clarkia ) to address uncertainty whether other aquatic organisms that molt may be sensitive to methoxyfenozide. Exposure of crayfish to methoxyfenozide did no t affect survival, growth (lengt h or weight), total number of molts or number of molts pe r females in crayfish (EC 50 

### : >0.190 mg a.i./L; NOAEC: 0.190 mg a.i./L; MRID 457027-02). The study is scientific ally sound; however, it is classified as supplemental because it is a non-guideline study.

Terrestrial Effects Characterization

Methoxyfenozide is classified as practically non-toxic to birds (as well as reptiles and terrestrialphase amphibians, for which birds serve as surrogat es) on both an acute oral and subacute dietary exposure basis; the compound is pr actically non-toxic to mammals on an acute oral exposure basis. In a reproductive toxicity study in bobwhite quail ( Colinus virginianus ; MRID 446177-11), methoxyfenozide caused a statistica lly significant difference in eggshell thickness compared to untreated controls. Across the dietary treatment levels of methoxyfenozid e tested, declines in eggshell thickness were accompanie d with increases in the number of eggs cracked, although the increase in the number of eggs cracked was not statis tically significant. Th e endpoint of eggshell thinning observed at the LOAEC (780 mg/kg-diet) was used to ca lculate chronic risk to birds (NOAEC=520 mg/kg-diet). No other effects were observed in chronic toxicity studies with birds.

In mammals, chronic exposure to rats adversel y affected survival at the 20,000 ppm dose level (LOAEC, highest dose tested) in a 2-year combin ed chronic toxicity/car cinogenicity study (MRID 446177-31). The NOAEC from this study is 8,000 ppm.

Methoxyfenozide is classified as “pract ically non-toxic” to adult honey bees ( Apis mellifera ; Table
8 ), but has been shown to be hi ghly toxic to target lepidopteran pests on an acute dietary exposure basis (European corn borer, Ostrinia nubilalis : LC 50 

### =0.009 ppm; Trisyono and Chippendale 1997).

### 13 Although methoxyfenozide is intended to target lepidopterans, ther e is uncertainty regarding the extent to which other species of insects and taxa dependent on ecdysone may be affected. Because of methoxyfenozide’s mode of act ion, larval insects, including larval honey bees, may be more sensitive to methoxyfenozide than are adult insects. To address this uncertainty honey bee larval toxicity data were required by EPA. In a 21-day honey bee brood study (MRID 450655-01) with formulated product (RH 2485 SC 240), there were no significant effect s on brood development following exposure of the bee colony to a formul ation of methoxyfenozide (101 mg formulated product/L) via spiked sugar solution. The regi strant has submitted additional studies on honey bee brood development and on methoxyfenozide residues in bee colonies from almonds treated with methoxyfenozide at bloom to further addre ss this uncertainty (MRIDs 489622-01, 489622-02, 489622-03). While EFED has not yet completed the re view process for these studies, preliminary results indicate that exposure to methoxyfenozid e did not result in adverse effects to honey bee larvae and pupae development, or to colony overwintering surviv al, although uncertainties have
been identified in these studies.

No data are available to assess the effects of methoxyfenozide on te rrestrial plants. However, given the mode of action of the compound (insect growth re gulator) and the lack of toxicity observed in non-vascular aquatic plants, as well as a lack of reported plant incidents for methoxyfenozide, toxicity data for terrestr ial plants are not needed.

Table 7. Summary of the Most Sensitive En dpoints from Aquatic Toxicity Studies for Methoxyfenozide

Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in

terms of
measured active

ingredient) Acute Toxicity
Classification Source (MRID) Study
Classification

Freshwater
Fish 96-Hour
Acute Toxicity Rainbow trout Oncorhynchus mykiss LC 50 >4.2 mg
a.i./L (No mortality at

the highest
treatment level tested) Moderately
Toxic 441444-10 Acceptable

Full Life Cycle Toxicity Fathead minnow Pimephales promelas NOAEC=0.53 mg
a.i./L LOAEC=1.0 mg a.i./L (survival) N/A 446177-16 Acceptable

Freshwater
Invertebrates Estimate
based on
Acute-toChronic
Ratio 1 Midge
Chironomus

riparius EC 50 = 0.06 1 mg a.i./L (mortality) Very highly
toxic N/A 1 N/A

Chronic
Effects on Midge

Larvae NOAEC=0.0031 mg a.i./L

LOAEC=0.0063 mg a.i./L

(Delayed emergence and development) N/A 450328-01 Supplemental

### 14 Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in

terms of
measured active

ingredient) Acute Toxicity
Classification Source (MRID) Study
Classification

Estuarine/
Marine Fish 96-Hour
Acute Toxicity Sheepshead minnow

Cyprinodon variegatus 96-hr LC 50 >2.8 mg a.i./L Moderately
Toxic 441444-12 Acceptable

Early Life Stage Toxicity NOAEC = 1.5 mg
a.i./L

LOAEC = 2.6 mg
a.i./L

(growth) N/A 446177-12 Acceptable

Estuarine/
Marine
Invertebrates 96-Hour
Shell Deposition Eastern oyster

Crassostrea

virginica 96-hr EC 50 = 1.2 mg a.i./L Moderately
Toxic 441444-13 Acceptable

Invertebrate Life Cycle Toxicity Mysid

Americamysis bahia ( formerly Mysidopsis bahia) NOAEC = 0.025 mg a.i./L
LOAEC = 0.051 mg a.i./L (Reduced growth/length) N/A 446177-15 Acceptable

NonVascular Aquatic
Plants 5-Day Toxicity

Test Freshwater alga

Pseudokirchneriella subcapitata

( formerly
Selenastrum capricornutum) EC 50 >3.4 mg
a.i./L

NOAEC= 3.4 mg
a.i./L

No effects at the highest treatment
level tested N/A 446177-18 Acceptable

1 Acute-to-Chronic Ratio (ACR) was used to estimate the acute toxi city for the midge using the ratio of acute to chronic data p oints from studies
with Daphnia and the chronic NOAEC from the midge lifecycle test. [(3.7 mg a.i./L)/(0.20 mg a.i./L) = (0.06 mg a.i./L)/(0.0031 mg a.i./L)]



### Table 8: Summary of the Most Sensitive Endp oints from Terrestrial Toxicity Studies for Methoxyfenozide

### 15 Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in

terms of
measured active

ingredient) Acute Toxicity
Classification Source (MRID) Study
Classification

Birds Acute Oral Toxicity Northern bobwhite quail
Colinus virginianus LD 50 >2,250 mg a.i./kg-bw

No effects at highest treatment
level tested Practically
Non-Toxic 441444-06 Acceptable

Subacute Dietary Toxicity Northern bobwhite quail
Colinus virginianus LC 50 >5,870 mg a.i./kg-diet

No effects at highest treatment
level tested Practically
Non-Toxic 441444-07 Acceptable

Avian Reproductiv e Toxicity Northern bobwhite quail
Colinus virginianus NOAEC=520 mg a.i./kg-diet

(Reduction in

eggshell thickness) N/A 446177-11 Acceptable

Mammals Acute oral Toxicity Rat

Rattus norvegicus LD 50 >5,000 mg a.i./kg-bw Acute Toxicity Category 4 441444-15 Acceptable

Chronic Dietary Toxicity Rat

Rattus norvegicus NOAEC =8,000 ppm diet

(survival) N/A 446177-31 Acceptable

Terrestrial
Invertebrates Acute
Contact Toxicity Honey bee

Apis mellifera LD 50 >100 μg
a.i./bee Practically
Non-Toxic 441444-29 Acceptable

Oral Toxicity LC 50 > 100 μg
a.i./bee Practically
Non-Toxic 446177-17 Supplemental

### 16 Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in

terms of
measured active

ingredient) Acute Toxicity
Classification Source (MRID) Study
Classification

Brood NOAEL=101 mg
a.i./L N/A 450655-01 Supplemental

1 Birds represent surrogates for terrest rial-phase amphibians and reptiles.



## 4.3. Ecological Incidents

The ecological incident information system (EIIS ) is a database maintained by the Office of Pesticide Programs; the database contains ecological in cidents that have been reported to the Agency. When available, EIIS includes date an d location of an incident, type and magnitude of effects observed in various species, use(s) of pesticides known or suspected of cont ributing to the incident, and results of any chemical residue anal ysis or other analyses conducted during incident investigation. EIIS incidents are categorized according to the certainty that the incident resulted from pesticide exposure. The Avian Incident Monitoring System (AIMS) 4 

### is a database administered by the American Bird Conservancy th at contains publicly av ailable data on reported avian incidents involving pesticides. Many of the in cidents listed in this database are also in the
EIIS. Because of uncertainties re garding the extent to which inci dents are reported to EPA, the absence of incident report s cannot be construed as th e absence of incidents.

EIIS contains five incidents for methoxyfenozide. All five incidents reported bee kills in which methoxyfenozide was mentioned. Four reported in cidents took place in California, and one in
New York State

. For all of these incidents, more than one pesticide was named along with methoxyfenozide. Since methoxyfenozide alone is not acutely toxic to a dult bees on an acute contact or oral exposure ba sis and since these beekill incidents i nvolved the loss of adult bees, it is uncertain that methoxyfenozide was the cause of these losses. Also, preliminary analysis of available toxicity data on th e chronic effects of methoxyf enozide on honey bee brood do not indicate adverse effects on developing bees at th e exposure concentrations tested. EPA does not have toxicity data nor does it conduct risk as sessments for tank mixes of different chemicals or combinations of active ingredients. It is therefore unknown whether methoxyfenozide’s potential toxicity to bees is enhanced or otherwise affect ed by other chemicals that may be tank mixed with it or sprayed concurrently.

In the Office of Pesticide Programs’ Aggregate Inci dent Reports, there were no incidents attributed to methoxyfenozide. AIMS was also searched on March 11, 2014 and revealed no incidents to
birds associated with methoxyfenozide.

Table 9. Summary of Methoxyfenozide Incidents

4 American Bird Conservancy. 2014. Avian Incident Monitoring System. http://www.abcbirds.org/abcprograms/policy/toxins/aims/aims/login.cfm

### 17 Chemical

Name (Product Name) Crop Incident
Data System
Number Date Certainty Location Affected Taxa Application
Method

Methoxyfenozide (Intrepid ® 2F) Pistachios I023107-
019 July
2011 Unlikely California Honey bees (92 colonies) Ground

Almonds I024029-
001 February
2012 Unlikely California Honey bees (464 colonies) Unknown

Orchard/

Corn Planting I024270-
001 May
2012 Unlikely New York Honey bees (48 colonies) Corn planted with air planter

Almonds I025162-
001 February
2013 Unlikely California Honey bees (464 colonies) Unknown

Almonds I026240-
001 February
2014 Possible California Honey bees (7,800 colonies) Ground



### Risk Characterization

Risk Estimation

Aquatic Organisms

In the acute freshwater fish, acu te estuarine/marine fish, and non- vascular aquatic plant toxicity studies submitted, there were no mortality or sub-lethal effects at the highest treatment levels tested ( i.e ., LC 50, 

### endpoints are ‘greater than’ valu es); therefore, these endpoints are not used to calculate risk quotient (RQ) values. However, the information in these studies was used to help characterize potential risk in the Risk Description section of this assessment.

The RQs for freshwater invertebrates exceed the Agency’s levels of concern (LOCs) for listed species based on acute exposure (LOC=0.05) and fo r listed and non-listed species based on chronic exposure (LOC=1) for the proposed use ( Table 10 ). For estuarine/marine invertebrates, RQs for the proposed pineapple use do not exceed the Agency’s acute or chronic risk LOCs for either listed or non-listed species.

Table 10. Acute and Chronic RQ Values for Freshwater and Estuarine/Marine Invertebrates from the Proposed Us e of Methoxyfenozide on Pineapples.

Use Site (Scenario) Exposure Type EEC ( μg a.i./L) Freshwater Invertebrate RQ 1 Estuarine/Marine Invertebrate RQ 2 Pineapple (ground application) Acute 13.5 (peak) 0.24* 0.011 Chronic 13.2 (21-day) 4.3 0.53 Pineapple (aerial application) Acute 13.2 (peak) 0.23* 0.011 Chronic 13.0 (21-day) 4.2 0.52

1 Based on an ACR-calculated LC 50 of 0.06 mg a.i./L (57 μg a.i./L) (midge, Chironomus riparus ) and a NOAEC of 0.0031 mg a.i./L (3.1μg a.i./L ) (midge, Chironomus riparus ).

2 Based on an EC 50 of 1.2 mg a.i./L (1200 μg a.i./L) (Eastern oyster, Crassostrea virginica ) and a NOAEC of 0.025 mg a.i./L (25 μg a.i./L) (mysid, Americamysis bahia ).
Bolded numbers exceed the Agency ’s LOC for non-listed ( i.e , RQ ≥ 0.5) and listed species ( i.e ., RQ ≥ 0.05); bolded
with * exceeds Agency’s LOC for listed species only.

### 18 As stated above, acute risk to either freshwater fish or estuarine/marine fish from methoxyfenozide
was not assessed since the 96-hr LC 50 

### value exceeded the highest concentration tested, and no mortality was observed at the highest concentratio n. Chronic risk for freshwater fish was assessed using the most sensitive NOAEC of 530 μg a.i./L (based on reduced survival) for the fathead minnow, and chronic risk for marine/estuarine fi sh was assessed using the most sensitive NOAEC of 1500 μg a.i./L (growth) for the sheepshead minnow. None of the chronic RQs for fish (freshwater or marine/estuarine) exceed the Agency’s chronic risk LOC (RQ ≥ 1.0) for the proposed uses ( Table 11 ).

Table 11. Chronic RQ Values for Marine/E stuarine and Freshwater Fish from the Proposed Use of Methoxyfenozide on Pineapple

Use Site (Scenario) EEC ( μg a.i./L) Freshwater Fish RQ 1 Marine/Estuarine Fish RQ 2 Pineapple (ground application) 12.7 (60-day) 0.024 0.008

Pineapple (aerial application) 12.5 (60-day) 0.024 0.008

1. Based on a NOAEC of 530 μg a.i./L (fathead minnow, Pimephalas promelus ).
2. Based on a NOAEC of 1500 μg a.i./L (sheepshead minnow, Cyprinodon variegatus ).



### Terrestrial Organisms

In the avian acute and sub-acute toxicity studies submitted, there were no mortality or sub-lethal effects at the highest treatment levels tested ( i.e ., the acute oral LD 50 

### and sub-acute dietary LC 50 

### values are ‘greater than (>)’ valu es); therefore, these endpoints are not used to calculate RQ values. However, the information in these studies was used to help characterize risk in the ‘Risk Description’ section of this assessment. For chroni c risk, RQs for birds in several forage categories are all below the Agency’s chronic risk LOC (RQ ≥ 1.0) for the proposed use (RQs range from 0.17 to 0.01) ( Table 12 ).

Table 12. Dietary-based Upper-Bound Avian Ch ronic EEC and RQ Values for Proposed Methoxyfenozide Use on Pineapple

.

Application

Method Dietary-Based EECs and RQs 1

Short Grass Tall Grass Broadleaf Plants/
Small Insects Fruits/Pods/
Seeds/ Large Insects

EEC 2 RQ EEC RQ EEC RQ EEC RQ

Use Site/Crop Group (Max. Single Application Rate)

Pineapple (0.11 lb a.i./A)

Ground/Aerial 86.81 0.17 39.79 0.08 48.83 0.09 5.43 0.01

1 Based on a NOAEC of 520 mg a.i./kg-diet (Northern bobwhite quail, Colinus virginianus ).

2 From T-REX, Version 1.5.2. See Appendix C for details.



### In the available mammalian acute toxicity studies, there were no mortality or sublethal effects at the highest treatment levels tested ( i.e ., the acute oral LD 50 

### is a ‘greater than (>)’ value); therefore,

### 19 these endpoints are not used to calculate RQ values. However, information from the studies was used to help characterize risk in the ‘Risk Description’ section of this assessment.

In mammals, chronic exposure to rats decreased survival at the 20,000 ppm dose level (LOAEC, highest dose tested) in a 2-year combined toxicity/carcinogenicity study (MRID 446177-31). The NOAEC from this study is 8,000 ppm. Chronic RQ s for mammals were calculated by comparing the NOAEC (8,000 mg a.i./kg-diet) to upper-bound e xposure values from T- REX. Dietary-based chronic RQs for mammals are all below the LOC (1.0) for chronic mammalian risk ( Table 13 ). Dose-based RQs for mammals are also below th e chronic risk LOC for mammals (ranging from <0.01 to 0.02) ( Table 14 ). See Appendix C for details.

Table 13. Dietary-based Upper-Bound Mamma lian Chronic EEC and RQ Values for Proposed Methoxyfenozide Use on Pineapple

.

Application

Method Dietary-Based EECs and RQs 1

Short Grass Tall Grass Broadleaf Plants/
Small Insects Fruits/Pods/
Seeds/ Large Insects

EEC 2 RQ EEC RQ EEC RQ EEC RQ

Use Site/Crop Group (Max. Single Application Rate)

Pineapple (0.11 lb a.i./A)

Ground/Aerial 86.81 <0.01 39.79 <0.01 48.83 <0.01 5.43 <0.01

1 Based on a NOAEC of 8,000 mg a.i./kg-diet (rat).

2 From T-REX, Version 1.5.2. See Appendix C for details.

### 20 Table 14. Dose-based Upper-Bound Mammalian Chronic EEC and RQ Values for Proposed Methoxyfenozide Use on Pineapple

.

Application

Method:
Ground/Aerial Dose-Based EECs and RQs 1

Short Grass Tall Grass Broadleaf Plants/
Small Insects Fruits/Pods/
Seeds/ Large Insects Seeds

EEC 2 RQ EEC RQ EEC RQ EEC RQ EEC RQ

Use Site/Crop Group (Max. Single Application Rate)

Pineapple (0.11 lb a.i./A)

Mammalian
Size Class
15 g 82.76 0.02 37.93 0.01 46.55 0.01 5.17 <0.01 1.15 <0.01

35 g 57.20 0.02 26.22 0.01 32.18 0.01 3.58 <0.01 0.79 <0.01

1000 g 13.26 0.01 6.08 0.01 7.46 0.01 0.83 <0.01 0.18 <0.01

1 Based on adjusted NOAELs, that were in turn based on a NOAEC of 8,000 mg a.i./kg-diet (rat).

2 From T-REX, Version 1.5.2. See Appendix C for details.



### EFED does not currently estimate RQs for non-listed terrestrial non-target i nvertebrates. As noted previously, methoxyfenozide is classified as ‘pr actically non-toxic’ to adult honey bees but has been shown to be very toxic to target lepidopteran species such as the European corn borer (which is a common lepidopteran pest of corn) on an acute dietary exposure basis (Trisyono and Chippendale 1997). Screening-level ri sk assessments do not typically evaluate risks to terrestrial invertebrates; however, toxicity information for bene ficial insects is used to develop precautionary label language where necessary. Based on the available data from adult honey bees, precautionary label language for bees does not ap pear necessary and current labe ls do not have a bee warning. As stated earlier, the registrant has submitted additional studies on honey bee brood development and on methoxyfenozide residues in bee colonies from almonds treated with methoxyfenozide at bloom (MRIDs 489622-01, 489622-02, 489622-03). While EFED has not yet completed the review process for these studies, preliminary re sults indicate that exposure to methoxyfenozide does not result in adverse effects to honey bee larvae and pupae development, or to colony overwintering survival, although unc ertainties have been identifie d in the submitted studies.

Risk Description

Methoxyfenozide is characterized as persistent and moderately mob ile and is expected to move into surface water through run-off and spray drif t following application. The results of this screening-level risk assessment indicate that the proposed new use of methoxyfenozide on pineapples has the potential for direct adve rse effects on listed an d non-listed freshwater invertebrates. The RQs for freshwater invertebrate s exceed the Agency’s LOCs for acute risk to listed species and LOCs for chroni c risk to listed and non-listed species for the proposed use on pineapple. These results are based on EECs deri ved for maximum-labeled spray application rates for the proposed use. The like lihood of direct adverse effect s to birds, mammals, fish, and terrestrial and aquatic plants a nd estuarine/marine invertebrates from exposure to methoxyfenozide

### 21 as a result of the proposed use on pi neapples is expected to be low. However, the extent to which other taxa that may depend on fres hwater aquatic invertebrate spec ies may be indirectly affected
is uncertain.

Risks to Aquatic Organisms

Methoxyfenozide is characterized as moderately toxic to freshw ater fish, estuarine/marine
invertebrates and estuarine/marine fish and highly toxic to fres hwater invertebrates on an acute exposure basis. Acute toxicity risk estimates were non-definitive ( i.e ., the EC or LC 50 

### values exceeded the highest concentration tested) for fres hwater and estuarine/marine fish and aquatic nonvascular plants and suggest that the toxicity of the compound to these taxa may be limited by its solubility

Aquatic exposure estimates are based on EECs obtained by GENEEC m odeling. GENEEC EECs are typically regarded as repres enting conservative estimates of exposure because the input value for the application rate is the labeled maximum, the entire watershed is assumed to be cropped and treated, runoff is assumed to be from a 6-inch rainfall over a 24-hour period, and the geographic location of use is regarded as representative of high-end potential for pesticide runoff and is not necessarily representative of runoff conditions for the labeled use. However, when a refined assessment using SWCC was obtained for comparison purposes (See Appendix A ), the refined EECs overlapped and/or exceeded those generate d using GENEEC and did not substantially change risk estimates.

For freshwater invertebrates, RQ values (usi ng GENEEC EECs) exceed th e Agency’s acute listed species LOC (0.05), when conservative runoff assumptions (CN=90) are used in the SWCC modeling runs, the LOC is exceeded for both listed and non-listed fo r freshwater aquatic invertebrates species. That said , there is some uncertainty in the acute risk to invertebrates since
the EC 50 

### was calculated using an ACR (to represent the more sensitive midge) based on the ratio of acute-to-chronic toxicity fo r the freshwater invertebrate D. magna . For comparison, if RQs for freshwater invertebrates are calculated using the D. magna EC 50 

### of 3.7 mg a.i./L and the NOAEC of 0.20 mg a.i./L for D. magna , LOCs are not exceeded (acute RQ=0.004, chronic RQ=0.07) using the conservative EECs derived using GENEEC. Risk estimates for marine/estuarine invertebrates
do not exceed acute or chronic risk LOCs for listed or non-listed species.

Because there were no mortalities or sub-lethal effects at the highest treatment levels tested in the
freshwater fish and estuarine/marine fish acute toxicity studies, RQ va lues for acute exposures
were not calculated in the Risk Estimation section of this assessment. In order to gain a better understanding of how the EECs for the maximum propos ed application rate re late to the toxicity data currently available for these taxa, RQs were calculated using the conservative assumption that the highest concentrations tested in th e toxicity studies represent endpoints [ i.e ., LC 50 

### = 4.2 mg a.i./L (freshwater fish); LC 50 

### = 2.8 mg a.i./L (estuarine/marine fish)]. A similar assumption was made for aquatic plants (EC 50 

### = 3.4 mg a.i./L for freshwater alg ae). As stated earlier, in some
cases the non-definitive acute t oxicity endpoint suggests that th e potential acute toxicity of methoxyfenozide may be limited by the chem ical’s solubility (3.3 mg/L at 25 o 

### C). Using the peak

### 22 aquatic EEC for ground applicat ion (0.0135 mg a.i./L), all of these acute RQs are below the Agency's acute risk LOCs (freshwater fish RQ = 0.003; estuarine/ma rine fish RQ = 0.005; freshwater algae RQ = 0.004). The actual RQs woul d be lower because no effects were observed at the highest treatment levels tested. Additionally, base d on the results of EFED’s risk assessment (using the GENEEC EECs) for the proposed use, the chronic RQ va lues for fish (freshwater and estuarine/marine) do not exceed the Agency’s LOCs for listed or non-listed species.

Therefore, the likelihood of direct adverse effects to fish and aquatic plants and estuarine/marine invertebrates from exposure to methoxyfenozide as a result of the proposed use on pineapples is expected to be low. However, the extent to whic h other taxa that may depend on freshwater aquatic invertebrate species may be indi rectly affected is uncertain.

No data are available to assess th e potential risks of me thoxyfenozide exposure to aquatic vascular plants; however, given the mode of action of methoxyfenozide as an insect growth regulator and that toxicity data for nonvascular aquatic plants did not demonstrate adverse effects up to the solubility limit (3.3 mg/L) of the compound, the current information does not suggest that there would be adverse effects on plan ts. Finally, there are no reporte d plant incidents in EFED’s
incident databases.

Risks to Terrestrial Organisms

On an acute exposure basis, methoxyfenozide is cl assified as practically non-toxic to birds, mammals and adult honey bees.

Because no mortality or sub-lethal effects were observed at the hi ghest treatment levels tested in
the avian acute oral and sub-acute dietary studies, standard RQ va lues were not calculated in the
Risk Estimation section of this assessment. In order to gain a better understa nding of how the EECs for the maximum proposed methoxyfenozide application rates relate to the t oxicity data currently available for birds, the T-REX model was used to calculate RQs using the conservative assumption that the highest values tested in the avian studies re present endpoints [ i.e ., acute oral LD 50 

### = 2,250 mg/kg-bw (bobwhite quail) and sub-acute dietary LC 50 

### = 5,870 mg/kg diet ( bobwhite quail)]. In this analysis, none of the RQs exceeds the Agency ’s acute risk LOC for listed (LOC=0.1) or nonlisted species (LOC = 0.5). The actual RQs would be lower than these because no effects were observed at the highest treatme nt levels tested. And as discussed previously in the Risk Estimation section, for chronic risk, RQs for birds in severa l forage categories are all below the Agency’s chronic risk LOC ( Table 12 ).

Therefore, the potential for advers e effects to birds from acute, s ub-acute, or chr onic exposure to methoxyfenozide from the proposed new uses is c onsidered low. However, the extent to which birds that depend on freshwater aquatic invertebrate species may be indirectly affected is uncertain.

For mammals, because there was no mo rtality or sub-lethal effects at the highest treatment levels tested in the acute oral toxicity study with ra ts, the standard acute and RQ values were not
calculated in the Risk Estimation section of this assessment. Calculating RQs using the conservative assumption that the highest value test ed in the acute toxici ty study represents the

### 23 endpoint ( i.e ., acute oral LD 50 

### =5,000 mg/kg-bw), results in acute RQs <0.01 for the proposed use on pineapple. Therefore, the acute RQs in this analysis do not exceed the Agency’s acute risk LOCs for mammals. The actual RQs would be lower than these since no acute mortality effects were actually identified at the highest treatment levels tested.

In mammals, chronic exposure to rats adversel y affected survival at the 20,000 ppm dose level (LOAEC, highest dose tested) in a 2-year combin ed chronic toxicity/car cinogenicity study (MRID 446177-31). The NOAEC from this study is 8,000 ppm.

Chronic risk to mammals can be estimated by comparing the NOAEC (8,000 mg a.i./kg-diet) to upper-bound exposure values from T-REX. Assu ming exposure to mammals from the proposed use on pineapple, which results in the highest (m ost conservative) EECs, the highest RQ is 0.09, which does not exceed the chronic risk LOC (1.0). See Appendix C for details.

Therefore, the likelihood of direct adverse effects to mammals from acute exposure to methoxyfenozide from the proposed new use is c onsidered low. Additionally, the likelihood of
adverse effects on mammals from chroni c exposure is considered low.

No data are available to assess th e potential risks of me thoxyfenozide exposure to terrestrial plants; however, given the mode of action of methoxyfenoz ide as an insect growth regulator, there is uncertainty whether the compound may have any e ffects on plants. Also, there are no reports of plant damage resulting from exposure to methoxyf enozide in EFED’s in cident data bases.

Terrestrial Invertebrates

EFED does not currently estimate RQs for non-listed terrestrial non-target i nvertebrates. Based on the acute contact and acute oral toxicity studies with young adult honey bees, the LD 50 

### for methoxyfenozide is >100 μg/bee. Therefore, the potential for di rect adverse effects to adult honey
bees is considered low. Alt hough larval insects are expected to be more sensitive to methoxyfenozide than adults based on the mode of action of the compound, available data on the effects of methoxyfenozide on honey bee brood devel opment do not indicate any significant effects up to 101 mg a.i./L based on a 21-day feeding st udy examining larval development through adult emergence (MRID 489622-01). A preliminary review of data on the toxicity of methoxyfenozide to honey bee colonies does not i ndicate that the com pound adversely affects ove rwintering survival
of bees.

Federally Threatened and Endang ered (Listed) Species Concerns

Based on this screening-level assessment, there are potential acute risks to the listed freshwater invertebrates from the proposed new use of methoxyfenozide on pineapple at the maximum application rate ( Table 16 ). According to EFED’s LOCATEs data base 5 

### for endangered and threatened species, two of the invertebrate specie s in Hawaii/pineapple area are listed as aquatic: the Kauai cave amphipod and Newcomb’s snail. Additionally, five listed species of damselfly

5 LOCATES=Locations of Crops and Endangered and Threatened Species, Version 2.3.

### 24 insects have aquatic larval stages that would be of concern (see Appendix D for LOCATES report).

Because of the potential risk from direct effects to th e listed invertebrates described above, should exposure occur, it is uncertain whether listed speci es of all taxa may potentially be affected indirectly due to alterations in their habitat ( e.g ., food sources, shelter, and areas to reproduce).

Table 16

. Listed Species Risks Associated with Potent ial Direct or Indirect Effects Due to the Proposed Use of Methoxyfenozide on Pineapple.

LISTED TAXON DIRECT EFFECTS*

Terrestrial and semi-aquatic plants - monocots Not assessed

Terrestrial and semi-aquatic plants - dicots Not assessed

Aquatic Insects Yes (acute)

Birds No

Terrestrial-phase amphibians No

Reptiles No

Mammals No

Aquatic plants No

Freshwater fish No

Aquatic-phase amphibians No

Freshwater crustaceans Yes (acute)

Mollusks No

Marine/estuarine fish No

Marine/estuarine crustaceans No

*The acute risk to listed species LOC was exceeded for freshwa ter invertebrates. Therefore, the potential for indirect adverse effects to those species that rely on a specific animal species (s pecifically freshwater invertebrates, estuarine/marine invertebrates, and/or terrestrial invertebrates) or multiple animal species (specifically freshwater invertebrates, estuarine/marine invertebrates, and/or terre strial invertebrates) are un certain. Indirect effects may include general habitat modification, host plant loss, and food supply disruption.

### 25 Conclusions for Proposed New Use

In this action, methoxyfenozide is proposed to be used as a foliar spray on pineapples.

Based on the maximum application rate for the proposed use, methoxyfenoz ide has the potential
for direct effects to listed freshw ater invertebrate speci es after acute exposure and direct effects to
listed and non-listed freshwater invertebra te species following chronic exposure.

The likelihood of direct adverse e ffects to birds, mammals, fish, a nd terrestrial and aquatic plants and estuarine/marine invertebrates from exposure to methoxyfenozide as a result of the proposed use on pineapples is expected to be low. However, the extent to which othe r taxa that may depend on freshwater aquatic invertebrate species may be indirectly affected is uncertain.

As identified in previous assessments, methoxyfenoz ide is persistent and moderately mobile which combined with the fact that this compound acts through pathways which are common to a broad range of organisms that rely on ecdysone and undergo molting makes it plausible that methoxyfenozide may pose a greate r long-term ecological risk th an what is suggested by the screening-level assessment.

Literature Cited

Burns, Lawrence (2003). Exposure Analysis Mode ling System (EXAMS): User Manual and System Documentation. Ecosystem Research Division, National Exposure Research Laboratory. U. S. Environmental Protection Agency, Athens, GA.

California Department of Pesticide Regulation (CDPR) (2003). Methoxyfenozide. Public Report 2003-3. Tracking ID Numbers 195668 and 196546.

Carsel, R.F., J.C. Imhoff, P.R. Humel, J.M. Cheplick, and A.S. Donigian, Jr. (2005).

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

.

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

PRZM 3, A Model for Predicting Pesticide and Nitroge n Fate in the Crop Root and Unsaturated Zones: User’s Manual for Release 3.12.2. National Exposure Research Laboratory, Office of Research and Development, U. S. Environmental Protection Agency, Athens, GA.

### 26 Shimizu, B., Y. Nakagawa, K. Hattori, K. Nishimur a, N. Kurihara, and T. Ueno (1997). Molting hormonal and larvicidal activities of aliphatic acyl analogs of dibenzoylhydrazine insecticides. Steroids 62 (10): 638
- 642.

Trisyono, A., and G. M. Chippendale (1997). Effect of the non-steroidal ecdysone agonists, methoxyfenozide and tebufenozide, on the European corn borer (Lepidoptera; Pyralidae). J. Econ.
Entomol ., 90: 1486-1492. (ECOTOX No.: 64128).

USEPA (2004). Overview of the Ecological Risk Ass essment Process in the Office of Pesticide Programs. U.S. Environmental Protection Agency, Endangered and Threatened Species Effects Determinations, Office of Prevention, Pesticides and Toxic Substances Office of Pesticide Programs, Washington, D.C. 100 pgs. January 23.

USEPA. 2009. Guidance for Selecting Input Parame ters in Modeling the En vironmental Fate and Transport of Pesticides. U.S. Environmental Protecti on Agency, Office Fate and Effects Division, Oct. 22, 2009. Online at: http://www.epa.gov/oppefed1/models/water/input_parameter_guidance.htm

USEPA. (2011). Review of Addendum to Site Selection Report w ith Recommended Alternate Sampling Sites for Lentic Water Bodies in California (MRID 47809904) (MRID: 478099-04). From C. Peck (EFED) and M. Echeverria (EFED) to C. Myers (RD) and R. Gebken (PRD). DP barcode 394308. October 12, 2011.

USEPA (2013). Environmental Fate and Ecological Risk Assessment for Proposed Use of Methoxyfenozide on Herb Subgroup 19A (except chives), Dates, Sorghum, Fruiting Vegetable GFroup 8-10, Pome Fruit Group 11-10, Berry Subgroups 13-07 A, F & G, Tropical Tree Fruits AN D Section 18 Emergency Exemption Petition for Use of Methoxyfenozide to Control Carob Moth on Dates. 

### From Environmental Fate and Effects Division (EFED) to Registration Division (RD). 

### DP Barcodes: 407284, 407808, 410683. June 13, 2013.

USEPA. 2013a. Methoxyfenozide: Review of Interim Report on Surface Water and Sediment Monitoring (MRID 49050001). Office of Chemical Safety and Pollu tion Prevention, Office of Pesticide Programs, From Environmental Fate and Effects Division (EFED) to Registration Division (R D); from C. Peck to M. Suarez. March 26, 2013.

USEPA. 2013b. Registration Review: Preliminary Pr oblem Formulation for Environmental Fate, Ecological Risk, Endangered Species, and Human Health Drinking Water Exposure Assessments for Methoxyfenoxide. DP Barcode: D404482. Date: April 25, 2013.

### 27 Appendix A: GENNEC Input/Output Files for Methoxyfenozide

Pineapples (Ground)

RUN No. 1 FOR Methoxyfenozide ON Pineapple * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP ONE(MULT)
INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- .110(.437) 4 7 490.0 3.3 GRHIME (.8) 25.0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 960.00 2 N/A .00- .00 ****** 1562.00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 13.46 13.42 13.20 12.73 12.39



### Pineapple (Aerial)

RUN No. 2 FOR Methoxyfenozide ON Pineapple * INPUT VALUES *

-------------------------------------------------------------------- RATE (#/AC) No.APPS & SOIL SOLUBIL APPL TYPE NO-SPRAY INCORP
ONE(MULT) INTERVAL Koc (PPM ) (%DRIFT) (FT) (IN)

-------------------------------------------------------------------- .110(.437) 4 7 490.0 3.3 AERL_C (1.9) 150.0 .0

FIELD AND STANDARD POND HALFLIFE VALUES (DAYS)

-------------------------------------------------------------------- METABOLIC DAYS UNTIL HYDROLYSIS PHOTOLYSIS METABOLIC COMBINED (FIELD) RAIN/RUNOFF (POND) (POND-EFF) (POND) (POND)

-------------------------------------------------------------------- 960.00 2 N/A .00- .00 ****** 1562.00

GENERIC EECs (IN MICROGRAMS/LITER (PPB)) Version 2.0 Aug 1, 2001

-------------------------------------------------------------------- PEAK MAX 4 DAY MAX 21 DAY MAX 60 DAY MAX 90 DAY

GEEC AVG GEEC AVG GEEC AVG GEEC AVG GEEC

-------------------------------------------------------------------- 13.22 13.18 12.97 12.50 12.17

### 28 SWCC Estimated Environmental Concentrations (ppb) for Methoxyfenozide and the USEPA
Standard Pond.

Table 1. PR Coffee scenario modeled with Puerto Rico Coffee weather file.

Peak (1-in-10 yr) 35.1

4-day Avg (1-in-10 yr) 35.0

21-day Avg (1-in-10 yr) 34.7

60-day Avg (1-in-10 yr) 34.1

365-day Avg (1-in-10 yr) 31.7

Entire Simulation Mean 18.4

Table 2. PR Coffee scenario modeled with Oahu weather file (w22521) without modification to the Curve Number (85).

Peak (1-in-10 yr) 41.0

4-day Avg (1-in-10 yr) 41.1

21-day Avg (1-in-10 yr) 40.9

60-day Avg (1-in-10 yr) 39.0

365-day Avg (1-in-10 yr) 35.0

Entire Simulation Mean 24.9

Table 3. PR Coffee scenario modeled with Oahu weather file (w22521) with Curve Number of 70.

Peak (1-in-10 yr) 16.7

4-day Avg (1-in-10 yr) 16.8

21-day Avg (1-in-10 yr) 16.9

60-day Avg (1-in-10 yr) 16.1

365-day Avg (1-in-10 yr) 14.5

Entire Simulation Mean 9.64

Table 4. PR Coffee scenario modeled with Oahu weather file (w22521) with Curve Number of 90.

Peak (1-in-10 yr) 63.8

4-day Avg (1-in-10 yr) 63.8

21-day Avg (1-in-10 yr) 63.2

60-day Avg (1-in-10 yr) 60.8

365-day Avg (1-in-10 yr) 55.0

Entire Simulation Mean 40.2

### 29 Table 5. PR Coffee scenario modeled with Maui weather file (w22516) without modification to the Curve Number (85).

Peak (1-in-10 yr) 33.9

4-day Avg (1-in-10 yr) 33.9

21-day Avg (1-in-10 yr) 34.0

60-day Avg (1-in-10 yr) 31.3

365-day Avg (1-in-10 yr) 26.1

Entire Simulation Mean 20.8

Table 6. PR Coffee scenario modeled with Maui weather file (w22516) with Curve Number of 70.

Peak (1-in-10 yr) 13.1

4-day Avg (1-in-10 yr) 13.1

21-day Avg (1-in-10 yr) 13.0

60-day Avg (1-in-10 yr) 12.3

365-day Avg (1-in-10 yr) 10.3

Entire Simulation Mean 7.85

Table 7. PR Coffee scenario modeled with Maui weather file (w22516) with Curve Number of 90.

Peak (1-in-10 yr) 55.0

4-day Avg (1-in-10 yr) 54.9

21-day Avg (1-in-10 yr) 54.9

60-day Avg (1-in-10 yr) 50.2

365-day Avg (1-in-10 yr) 43.6

Entire Simulation Mean 34.5



### Table 2. Summary of Model Inputs for Methoxyfenozide-Pineapple.

Scenario PRcoffeeSTD

Koc (ml/g) 490

Water Half Life (days) @ 25 °C 1559

Benthic Half Life (days) @ 25 °C 1962

Photolysis Half Life (days) @ 40
°Lat 0

Hydrolysis Half Life (days) 0

### 30 Soil Half Life (days) @ 25 °C 960

Foliar Half Life (days) 0

Molecular Wt 368

Vapor Pressure (torr) 2e-8

Solubility (mg/l) 3.3

### 31 APPENDIX B: Summary of the Available Toxicity Data for Methoxyfenozide.

TABLE B.1. Summary of Submitted Toxicity Data for Methoxyfenozide and Aquatic
Animals.

Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in

terms of
measured active

ingredient) Acute Toxicity
Classification Source (MRID) Study
Classification

Freshwater
Fish 96-Hour
Acute Toxicity Rainbow trout Oncorhynchus mykiss LC 50 >4.2 mg/L (No mortality at the highest
treatment level tested) Moderately
Toxic 441444-10 Acceptable

Full Life

Cycle Toxicity Fathead minnow Pimephales promelas NOAEC = 0.53 mg a.i./L
LOAEC = 1.0

(survival) N/A 446177-16 Acceptable

Freshwater
Invertebrates 48-hour
Acute Toxicity Waterflea

Daphnia magna EC 50 = 3.7 mg
a.i./L Moderately
Toxic 441444-11 Acceptable

Estimate
based on
Acute-toChronic
Ratio 1 Midge
Chironomus

riparius EC 50 = 0.05 1 mg a.i./L (mortality) Very highly
toxic N/A 1 N/A

Chronic Toxicity Waterflea

Daphnia magna NOAEC = 0.20 mg a.i./L

LOAEC = 0.39 mg a.i./L (survival) N/A 446177-14 Acceptable

Chronic
Effects on

Midge

Larvae Midge
Chironomus

riparius NOAEC=0.0063 mg a.i./L

LOAEC=0.013 mg a.i./L

(Delayed emergence and development) N/A 450328-01 Supplemental

Estuarine/
Marine Fish 96-Hour
Acute Toxicity Sheepshead
minnow

Cyprinodon variegatus 96-hr LC 50 >2.8 mg a.i./L Moderately
Toxic 441444-12 Acceptable

Early Life

Stage Toxicity Sheepshead
minnow Cyprinodon variegatus N/A N/A 446177-12 Currently under
review in EFED

### 32 Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in

terms of
measured active

ingredient) Acute Toxicity
Classification Source (MRID) Study
Classification

Estuarine/

Marine
Invertebrates 96-Hour
Shell Depositio

n Eastern oyster

Crassostrea

virginica 96-hr EC 50 = 1.2 mg a.i./L Moderately
Toxic 441444-13 Acceptable

Invertebra

te Life Cycle Toxicity Mysid

Americamysis bahia ( formerly

Mysidopsis

bahia) NOAEC = 0.025 mg a.i./L
LOAEC = 0.051 mg a.i./L (Reduced growth/length) N/A 446177-15 Acceptable

Non-Vascular Aquatic Plants 5-Day Toxicity

Test Freshwater alga

Pseudokirchneri ella subcapitata ( formerly
Selenastrum capricornutum) EC 50 >3.4 mg
a.i./L

NOAEC= 3.4 mg
a.i./L

No effects at the highest treatment
level tested N/A 446177-18 Acceptable

1 This endpoint is based on an acute to chronic ratio using acute and chronic data from daphnids and chronic data from midges.

### 33 TABLE B.2. Summary of Available Toxicity Data for Methoxyfenozide and Terrestrial
Animals.

Taxonomic

Group Study Type Surrogate Species Toxicity Value (all units in

terms of
measured active

ingredient) Acute Toxicity
Classification Source (MRID) Study
Classification

Birds Acute
Oral Toxicity Northern bobwhite quail
Colinus virginianus LD 50 >2,250 mg a.i./kg-bw

No effects at highest treatment
level tested Practically
Non-Toxic 441444-06 Acceptable

Subacute Dietary Toxicity Northern bobwhite quail
Colinus virginianus LC 50 >5,870 mg a.i./kg-diet

No effects at highest treatment
level tested Practically
Non-Toxic 441444-07 Acceptable

Avian Reproduct
ive Toxicity Northern bobwhite quail
Colinus virginianus NOAEC=520 mg a.i./kg-diet N/A 446177-11 Acceptable

Mammals Acute oral Toxicity Rat

Rattus norvegicus LD 50 >5,000 mg a.i./kg-bw Acute Toxicity Category 4 441444-15 Acceptable

Chronic Dietary Toxicity Rat

Rattus norvegicus NOAEC = 8,000 ppm diet (Survival) N/A 446177-31 Acceptable

Terrestrial
Invertebrates Acute
Contact Toxicity Honey bee

Apis mellifera LD 50 >100 μg/bee Practically
Non-Toxic 441444-29 Acceptable

Dietary Toxicity Honey bee

Apis mellifera LC 50 > 100 μg/bee Practically
Non-Toxic 446177-17 Supplemental

### 34 Appendix C. T-REX Example Summary of Chronic Risk Quot ient Calculations Based on Upper Bound Kenaga EECs for Pineapple for Birds and Mammals

Upper Bound Kenaga, Acute Avian Dose

‐ Based Risk Quotients

Size

Class (grams) Adjusted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods /Seeds Arthropods Granivore

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

20 1620.97 98.87 0.06 45.31 0.03 55.61 0.03 6.18 0.00 38.72 0.02 1.37 0.00

100 2063.57 56.38 0.03 25.84 0.01 31.71 0.02 3.52 0.00 22.08 0.01 0.78 0.00

1000 2914.87 25.24 0.01 11.57 0.00 14.20 0.00 1.58 0.00 9.89 0.00 0.35 0.00

Upper Bound Kenaga, Subacute Avian Dietary Based Risk Quotients

LC50 EECs and RQs

Short Grass Tall Grass Broadleaf

Plants Fruits/Pods/Seeds

EEC RQ EEC RQ EEC RQ EEC RQ

5870 86.81 0.01 39.79 0.01 48.83 0.01 5.43 0.00

Size class not used for dietary risk quotients

Upper Bound Kenaga, Chronic Avian Dietary Based Risk Quotients

NOAEC (ppm) EECs and RQs

Short Grass Tall Grass Broadleaf

Plants Fruits/Pods/Seeds

EEC RQ EEC RQ EEC RQ EEC RQ

520 86.81 0.17 39.79 0.08 48.83 0.09 5.43 0.01

Size class not used for dietary risk quotients

### 35 Upper Bound Kenaga, Acute Mammalian Dose

‐ Based Risk Quotients

Size

Class (gra ms) Adjus

ted

LD50 EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/Seeds Granivore

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 1098

9.15 82.76 0.0

1 37.93 0.00 46.55 0.00 5.17 0.00 1.1495 0.0001

35 8891.

40 57.20 0.0

1 26.22 0.00 32.18 0.00 3.58 0.00 0.7945 9E

‐ 05

1000 3845.

80 13.26 0.0

0 6.08 0.00 7.46 0.00 0.83 0.00 0.1842 5E

‐ 05

Upper Bound Kenaga, Chronic Mammalian Dietary Based Risk Quotients

NOAEC (ppm) EECs and RQs

Short Grass Tall Grass Broadleaf

Plants Fruits/Pods/Seeds/Large Insects

EEC RQ EEC RQ EEC RQ EEC RQ

8000 86.81 0.01 39.7

9 0.00 48.83 0.01 5.43 0.00

Size class not used for dietary risk quotients

Upper Bound Kenaga, Chronic Mammalian Dose

‐ Based Risk Quotients

Size

Class (grams) Adjusted

NOAEL EECs and RQs

Short Grass Tall Grass Broadleaf Plants Fruits/Pods/

Seeds Granivore

EEC RQ EEC RQ EEC RQ EEC RQ EEC RQ

15 879.13 82.76 0.09 37.93 0.04 46.55 0.05 5.17 0.01 1.15 0.00

35 711.31 57.20 0.08 26.22 0.04 32.18 0.05 3.58 0.01 0.79 0.00

1000 307.66 13.26 0.04 6.08 0.02 7.46 0.02 0.83 0.00 0.18 0.00

### 36 Appendix D. LOCATES Report