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## 1.0 CONCLUSIONS

Dietary exposure and risk estimates resulting from current methoxyfenozide uses, along with the proposed Section 18 use on rice, are not of concern to HED. Aggregate exposure and risk estimates, resulting from residues in food and drinking water combined with an existing residential use on ornamentals, are not of concern. Occupational risks, in terms of margins of exposure (MOEs), fro m the proposed use on rice in CA are all estimated to be greater than 100 with baseline clothing, and are therefore not of concern to HED.

The most recent Section 3 human health risk assessment involving methoxyfenozide was

conducted for the new use o n chives (D422208; E. Holman; 8 September 2015), and to support registration review. Additional details can be found in this document, with only summary information regarding methoxyfenozide hazard characterization and toxicity endpoints included

below in support of the current Section 18 request. Generally, information and/or conclusions which remain unchanged from the previous risk assessment are not reiterated; instead, a reference to the previous document is provided.

The California Rice Commissi on (CRC) has submitted 3 residue field trials (from a metabolism study report) with methoxyfenozide on rice in Manteca, CA. Summarized results of this study have been submitted by California’s Department of Pesticide Regulation (DPR) in support of CRC’s p etition for a Section 18 exemption. HED has no objection to the establishment of a

time

- limited tolerance for methoxyfenozide residues in or on rice grain, as listed below; in addition, HED has determined that a tolerance for residues in rice bran is also needed.

Note to RD: RD should ensure that the Section 18 label for use on rice in CA has the same personal protective equipment (PPE) as is currently listed on the Section 3 registered label for Intrepid 2F (EPA Registration #62719

- 442).

TABLE 1.0 Tolerance Summary for Methoxyfenozide (40CFR §180.544).
Proposed Commodity Proposed Tolerance (ppm) Recommended Tolerance (ppm) Correct Commodity Definition ; Comments

40CFR §180.544[b]

Rice, grain 0.5 0.50 Based on the submitted metabolism study data.

Rice, bran None 4.0 Based on the proposed tolerance in rice grain,

and the theoretical concentration factor from OCSPP 860.1520, Table 3 (7.7X).



## Environmental Justice Considerations

Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with US Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low

- I ncome Populations

, ( http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf )

.

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## As a part of every pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well

- established procedures. In line with OPP policy, HED estimates risks to population subg roups from pesticide exposures that are based on patterns of that subgroup’s food and water consumption, and activities in and around the home that involve pesticide use in a residential setting. Extensive data on food consumption patterns are compiled by the US Department of Agriculture (USDA) under the National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). These food consumption patterns are used in pesticide risk assessments for all registered food uses of a pesticide . These data are analyzed and categorized by subgroups based on age, season of the year, ethnic group, and region of the country. Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups, and exposure assessments are perform ed when conditions or circumstances warrant. Whenever appropriate, non

- dietary exposures based on home use of pesticide products and associated risks for adult applicators and for children, youths and adults entering or playing on treated areas post

- appli cation are evaluated. Further considerations are currently in development as OPP has committed resources and expertise to the development of specialized software and models that consider exposure to bystanders and farm workers, as well as lifestyle and tr aditional dietary patterns among specific subgroups.

Review of Human Research

This risk assessment relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical. These data, which include studies from the Pesticide Handlers Exposure Database Version 1.1 (PHED 1.1), the Agricultural Handler Exposure Task Force (AHETF) database, and the Outdoor Residential Exposure Task Force (ORETF) database, are subject to ethics review pursuant to 40CFR §26, have received that review, and are compliant with applicable ethics requiremen ts. For certain studies, that review may have included review by the Human Studies Review Board. Descriptions of data sources, as well as guidance on their use, can be found at http://www.epa.gov/pesticides/science/handler exposure

- data.html and http://www.epa.gov/pesticides/science/post

- app

- exposure

- data.html

.

2.0 ACTION REQUESTED

California’s DPR has requested a Section 18 emergency exemption for the use of the diacylhydrazine insecticide, methoxyfenozide (with CAS name 3

- methoxy

- 2

- methylbenzoic acid

2

- (3,5

- dimethylbenzoyl)

- 2

- (1,1

- dimethylethyl)

- hydrazide), on rice in the State of CA. It is

formulated as the end

- use product (EP) Intrepid 2F (EPA Registration #62719

- 442), and is intended to control armyworms and Western yellow striped armyworms. Intrepid 2F is an aqueous suspension (AS) formulation containing 2 pounds of active in gredient per gallon (lb ai/gal), equivalent to 22.6% ai by weight. The counties of CA affected by this crisis exemption include Butte, Glenn, Sacramento, Yolo and Yuba. Human health exposures and risks addressed

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### Page 5 of 35 

## in this document include chronic dietary r isk (exposure to methoxyfenozide residues in food and water), aggregate risk, and exposure and risk to workers.

3.0 BACKGROUND

Overview

Intrepid 2F will be applied up to two times per year via aerial equipment at a rate of 0.12

- 0.16 lb

ai/acr e (lb ai/A), resulting in a maximum total seasonal application rate of 0.32 lb ai/A. The proposed Section 18 label stipulates a minimum re

- treatment interval (RTI) of 10 days, and a minimum pre

- harvest interval (PHI) of 14 days. Applications should begin when armyworm

numbers reach the treatment threshold. To determine if the treatment threshold has been reached, users should grab rice plants with two hands at the base, and slide up to the top of the plant. Approximately 6 to 8 armyworms in each hand is the threshold to treat. All applicable directions, restrictions and precautions on both the USEPA Section 3 registered label and the proposed Section 18 label for Intrepid 2F must be followed. Based on the Section 3 label

directions for the uses on corn and sorghum, aerial applications are to be made in a minimum of 10 gallons per acre (GPA) of water. An example of the proposed Section 18 label for Intrepid 2F was provided, and the proposed use directions are summarized in Table 3.1.

TABLE 3.1 Summ ary of Proposed Section 18 Use Directions for Methoxyfenozide on Rice.
Application Type; Equipment 1 

### Single Use Rate (lb

ai/A) Max.

Uses Per

Season Max. Seasonal Use Rate (lb ai/A) 2 

### PHI 3


### (Days) Use Directions, Application Timing, and Limitations

Foliar; aerial equipment. 0.12

- 0.16 2 0.32 14 Minimum RTI 4 

### of 10 days.

1. For aerial application, apply in a minimum of 10 GPA (from the Section 3 registered label directions for the uses

on corn and sorghum).

2. Equal to the maximum annual use rate (there is only one growing season per year for rice in CA).

3. PHI = Pre

- Harvest Interval.

4. RTI = Re

- Treatment Interval.



## Permanent t olerances have been established for residues of methoxyfenozide in or on a wide variety of crops, at levels of 0.02 to 400 ppm, in 40CFR §180.544[a][1], [a][2], [d][1] and [d][2]. The residue of concern in primary crops, for purposes of both risk assessme nt and tolerance expression, is parent methoxyfenozide only. The chemical structure and nomenclature of methoxyfenozide, and its physicochemical properties are presented in Appendix C.

Regarding international maximum residue limits (MRLs) for methoxyfenozide, harmonization of the proposed tolerance in rice is not an issue, as there are no established Canadian or Codex MRLs for methoxyfenozide residues in rice commodities.

Occupation al assessments were previously conducted for both handler and post

- application exposures from the use on chives. Exposure inputs are the same for rice as those used in the

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### Page 6 of 35 

## chives assessment (D426658; Z. Figueroa; 9 September 2015). An MOE of 100 or more is sufficient to protect workers from handler and post

- application occupational exposures to methoxyfenozide. Occupational handler and post

- application risk estimates (in terms of MOEs) from the proposed use are all above 100, and therefore are not of con cern.

In accordance with the FQPA, in evaluating human health risks from exposure to pesticides, HED aggregates exposure from various routes (residential exposure is added to dietary exposure from food and drinking water). While there are no new resi dential uses of methoxyfenozide associated with this Section 18 action, there is an existing use on ornamentals that may result in residential handler exposure for adult populations. The residential handler exposure resulting from applying methoxyfenozide to ornamentals, using a backpack sprayer, was combined with the chronic dietary exposure from the most highly exposed adult population subgroup (general US adult population) to determine aggregate exposure and risk. The calculated exposure resulted

in an aggregate MOE of 540; this risk estimate is not of concern, since it is significantly higher than the level of concern (LOC) of <100.

Hazard Characterization and Assessment

For detailed information, please refer to the recent human health risk ass essment conducted for methoxyfenozide’s use on chives (D422208; E. Holman; 8 September 2015), and to support registration review. No additional toxicity data have been submitted since the previous risk assessment. Toxicity profile tables, summarizing the findings of the available toxicity studies, are provided in Appendix A.

The toxicological database is considered complete for methoxyfenozide. The following studies, which use exposure routes (oral and dermal) consistent with potential human exposu re scenarios, have been submitted: Primary acute toxicity, irritation and dermal sensitization; subchronic oral toxicity in the rat, mouse and dog; rat 28

- day dermal toxicity; rat chronic oral toxicity/carcinogenicity; dog chronic oral toxicity; mouse ora l carcinogenicity; rat and rabbit oral toxicity; rat oral two

- generation reproductive toxicity; genotoxicity battery; rat acute and subchronic neurotoxicity; rat general metabolism; rat dermal penetration (on formulation); and rat immunotoxicity. HED ha s determined that a 28

- day inhalation toxicity study is not needed for methoxyfenozide, based on a weight of evidence (WOE) approach that considered all of the available hazard and exposure information, including physicochemical properties (TXRs

#0053782 a nd 0055054), and the use of a highly conservative oral point of departure (POD). With the exception of a single occupational exposure MOE of 450, all residential and occupational exposure MOEs for risk via the inhalation route were well above 1000.

Many of the available short

- term or subchronic toxicity studies on methoxyfenozide showed little or no toxicity. The main target organs were the liver, thyroid and red blood cells. Mild anemia (decreases in RBC count, hematocrit and hemoglobin) was obser ved in the rat and dog following chronic dietary exposure, along with methemoglobinemia and RBC structural abnormalities.

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### Page 7 of 35 

## Increased platelets were also observed. An increase in the cellularity of rib and sternum bone marrow, along with macrophage pigment ation in the liver and spleen, were reported in the dog. No significant hematological changes were seen in the dog or rat subchronic studies, or the rat two week range

- finding studies; however, hematological effects were observed in the dog two week range

- finding study, along with increased spleen weight. The data suggest that a compensatory mechanism for the RBC effects may occur over time, based on the effects observed at two weeks in the dog range

- finding studies that were not observed in the subchroni c study, and on more pronounced changes in hematological parameters at Week 14 in the rat and dog chronic studies than were observed at evaluations conducted at later times in those studies. No hematological effects were reported in the mouse.

Incr eased liver weight and periportal hypertrophy were observed in the rat and dog. These findings were observed in the rat following two

- week, subchronic or chronic dietary exposure, and in the dietary reproductive toxicity study, and in the dog following ch ronic exposure. In the

rat two

- week study, increased adrenal gland weight and hypertrophy of the zona fasciculata, and increased thyroid follicular cell hypertrophy/hyperplasia were also observed; however, these findings were not seen with subchronic expo sure. Thyroid hypertrophy and altered colloid and increased adrenal weights were observed in the rat chronic oral study, and the incidence and severity of chronic progressive glomerulonephropathy was increased. Thyroid weights were increased in the dog f ollowing chronic exposure, but there was no accompanying histopathology.

In the mouse, effects were limited to decreased body weights and weight gain in the subchronic study; however, no effects were seen with long

- term exposure at dietary concentrati ons exceeding the limit dose. No body weight effects were observed in the rat or dog. Dermal effects were not observed in the rat following a 28

- day exposure. This finding is consistent with the relatively low dermal absorption of 2% of the applied dose , observed in an in vivo dermal absorption study in rats treated with an 80% wettable powder (WP) formulation.

Acute and subchronic oral neurotoxicity studies in the rat did not show evidence of potential neurotoxicity. In the acute study, decreased hindlimb grip strength on Day 0 was reported in males, but only at the limit dose; it was not observed in the subchronic neurotoxicity study, and was therefore not considered evidence of neurotoxicity. No clinical signs of neurotoxicity or neurohistopatho logy were observed in other guideline studies.

No maternal or developmental effects were observed in rat or rabbit oral developmental toxicity

studies. In the rat two

- generation reproductive toxicity study, parental effects were limited to

increased liver weight, and microscopic periportal hypertrophy. No offspring or reproductive toxicity was observed. In a 28

- day dietary immunotoxicity study in the rat, no immunotoxicity was observed. The only observed effect was increased liver weight.

Ther e was no evidence of carcinogenicity in the rat dietary 24

- month chronic toxicity/carcinogenicity study or the mouse dietary 18

- month carcinogenicity study. No

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### Page 8 of 35 

## mutagenic or clastogenic potential was observed in the battery of genotoxicity studies. Based on these findings, methoxyfenozide is classified as “not likely to be carcinogenic to humans” (2005 Agency revised carcinogenicity assessment guidelines).

Long

- term occupational exposure is not expected from the proposed use. Residential exposure is also not expected from the proposed Section 18 use on rice; however there is the potential for residential handler exposure associated with the existing use on ornamentals. The toxicological doses and endpoints selected for use in dietary and non

- occupati onal human health risk assessments are summarized in Table 3.2, while those for use in occupational human health risk assessments are summarized in Table 3.3; the tables are shown on the following 2 pages. The acute toxicity and subchronic/chronic toxicit y profiles for methoxyfenozide are provided in Appendix A.

FQPA Safety Factor Considerations

The required 10X FQPA safety factor for methoxyfenozide was reduced to 1X, based on the following considerations: 1) The toxicity database for methoxyfenozide is complete, including studies addressing potential pre

- and post

- natal susceptibility, neurotoxicity and immunotoxicity; 2) there is no evidence that methoxyfenozide is neurotoxic, and a developmental neurotoxicity study is not required; 3) there is no residual uncertainty, and no evidence of increased quantitative or qualitative susceptibility in the developing or young animal; and 4) the dietary exposure assessments do not underestimate potential exposure from food and drinking water, and the use pattern indicates a low potential for residential

exposure.

Summary of Toxicological Endpoints

TABLE 3.2 Methoxyfenozide Toxicological Doses and Endpoints for Use in Dietary and Non

Occupational Human Health R isk Assessments.
Exposure Scenario Point of Departure

(POD) Uncertainty and FQPA Safety Factors RfD, PAD,

LOC for Risk

Assessment Study and Toxicological Effects

Acute dietary (all populations, including infants

and children and

females 13

- 49 years of age) No toxicity (no hazard) was identified for a single oral exposure.

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### Page 9 of 35 Chronic dietary (all populations) NOAEL = 10.2 mg/kg/day UF A 

### = 10X

UF H 

### = 10X FQPA SF = 1 Chronic RfD = 0.10 mg/kg/day

cPAD = 0.10 mg/kg/day Co

- critical studies: Combined oral chronic toxicity/carcinogenicity

– rat. LOAEL = 411/491 mg/kg/day (M/F), based on hematological changes (decreased RBC parameters), periportal liver hypertrophy, thyroid hypertrophy and altered colloid, and possibly increas ed adrenal weight.

Chronic oral toxicity

– dog. NOAEL = 9.8/12.6 mg/kg/day[M/F] LOAEL = 106.1/110.6 mg/kg/day, based on hematological changes (decreased RBC parameters, slight methemoglobinemia) and increased

serum bilirubin.

Incidental oral

short

- term (1

- 30 days) NOAEL = 16.8 mg/kg/day UF A 

### = 10X

UF H 

### = 10X Residential

LOC for MOE

< 100 Two

- week oral range

- finding study

– dog.

LOAEL = 90.8 mg/kg/day, based on hematological changes (decreased RBC parameters, increased Heinz body count, reticulocyte counts, erythrocyte morphology and methemoglobinemia) and increased spleen weights.

Dermal short

- term (1

- 30 days) or

intermediate

- term (1

- 6 months) No toxicity (no hazard) was identified for dermal exposure.

TABLE 3.2 Methoxyfenozide Toxicological Doses and Endpoints for Use in Dietary and Non

Occupational Human Health Risk Assessments.
Exposure Scenario Point of Departure

(POD) Uncertainty and FQPA Safety Factors RfD, PAD,

LOC for Risk

Assessment Study and Toxicological Effects

Inhalation shortterm (1

- 30 days) and intermediateterm (1

- 6 months) NOAEL = 16.8 mg/kg/day ( inhalation toxicity

considered equivalent to oral toxicity.) UF A 

### = 10X

UF H 

### = 10X Residential

LOC for MOE

< 100 Two

- week oral range

- finding study

– dog.

LOAEL = 90.8 mg/kg/day, based on hematological changes (decreased RBC parameters, increased Heinz body count, reticulocyte counts, erythrocyte morphology and methemoglobinemia) and increased spleen weights.
Cancer (oral, dermal, inhalation) Classification: Not likely to be carcinogenic to humans.

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### Page 10 of 35 Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty fac tor. UF A 

### = extrapolation from animal to human (interspecies). UF H 

### = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (c = chronic). RfD = reference do se. MOE = margin of exposure. LOC = level of

concern.

TABLE 3.3 Methoxyfenozide Toxicological Doses and Endpoints for Use in Occupational Human

Health Risk Assessments.
Exposure Scenario Point of Departure

(POD) Uncertainty

Factors LOC for

Risk

Assessment Study and Toxicological Effects

Dermal short

- term (1

- 30 days) or

intermediate

- term (16 months) No toxicity (no hazard) was identified for dermal exposure.

Inhalation short

- term (1

- 30 days) and

intermediate

- term (16 months) NOAEL =

16.8 mg/kg/day (Inhalation toxicity

considered equivalent to oral toxicity.) UF A 

### = 10X

UF H 

### = 10X Occupational

LOC for

MOE < 100 Two

- week oral range

- finding study

– dog.

LOAEL = 90.8 mg/kg/day, based on hematological changes (decreased RBC parameters, increased Heinz body count, reticulocyte counts, erythrocyte morphology and methemoglobinemia) and increased spleen weights.

Cancer (oral, dermal, inhalation) Classificati on: Not likely to be carcinogenic to humans.

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty fac tor. UF A 

### = extrapolation from animal to human (interspecies). UF H 

### = potential variation in sensitivity among members of the human population (intraspecies). MOE = margin of exposure. LOC = level of

concern.



## Residue Chemistry and Tolerance Assessment

Further details on the methoxyfenozide residue chemistry database can be found in the recently completed risk assessment (D422208; E. Holman; 8 September 2015), or in the residue chemistry summary documents ass ociated with review of the proposed use on chives (D425285; W.T. Drew; 31 March 2015 and D429009; W.T. Drew; 8 September 2015).

The proposed Section 18 use on rice in CA will not significantly affect livestock dietary burdens. Rice grain and bran ar e significant feed items in cattle, poultry and swine production, fed at 10 to 20% of the diet. However, they would only be fed in the area of the five CA counties specified for this Section 18 use. Additionally, any rice grain or bran fed to livestock w ould most likely replace sorghum grain (fed at 40

- 80% of the diet), in which there is an existing tolerance of 6.0

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## ppm. Since the recommended tolerance in rice grain is 0.50 ppm, and the recommended tolerance in rice bran is 4.0 ppm, any substitution of s orghum grain by rice grain or bran in livestock diets would not increase the dietary burden. Therefore, as part of this Section 18 use, no revisions to the existing livestock tolerances are required.

Regarding international MRLs for methoxyfenozide, harmonization of the proposed tolerance in rice is not an issue, as there are no established Canadian or Codex MRLs for methoxyfenozide

residues in rice commodities.

Nature of the Residue

Based on previously submitted plant metabolism studies, the residue of concern in rice (as a primary crop), for both tolerance setting and risk assessment purposes, is the parent compound, methoxyfenozide.

Residue Analytical Methods

The FDA multiresidue methods are not suitable for analysis of methoxyfenozide or its regulated metabolites. However, adequate single methods are available for enforcing the current tolerances for methoxyfenozide in primary crops and animal commodities. Depending on the plant commodity, the limits of quantitation (LOQs) for methoxyfenozide in primary crop

commodities are 0.010

- 0.050 ppm. The tolerance enforcement methods include use of high performance liquid chromatography (HPLC), with either tandem mass spectrometric detection (LC/MS/M S), or ultraviolet detection (HPLC/UV). It is also noted that the European Food Safety Authority (EFSA) has concluded that the multiresidue QuEChERS method, combined with HPLC/MS/MS, is adequate for tolerance enforcement in plant and animal commodities (E FSA, 2014).

Crop Field Trials

Field trials with methoxyfenozide on rice were not conducted. Results of a rice metabolism study were submitted in support of the proposed Section 18 exemption. The metabolism trials

were conducted at an outdoor se cured research area at the Plant Sciences, Incorporated, Field Research Facility in Manteca, CA (Report #34

- 98

- 156; D.H. Carpenter; 1999). Four confined rice plots were established inside separate screen

- house enclosures (3 treated plots, and an

untreated control plot). The paddy rice crops were grown according to appropriate agronomic practices, including proper rice paddy preparation, fertilization, weeding and flood irrigation. No pesticides of similar structure to the test substance had ever been use d on the soil in the past.

The test substances comprised radiolabeled methoxyfenozide (3 different label locations, 1 for each treated plot), formulated as a 10% ai (by weight) emulsifiable concentrate (EC). These were applied as 2 foliar spray appli cations at a total rate of 0.93 or 1.1 lb ai/acre per year. The spray volumes used were approximately 100 gallons per acre (GPA). The treated rice plant

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### Page 12 of 35 

## samples were harvested at a PHI of 62 days after the second treatment, and 98 days after the first

ap plication (RTI of 36 days). The proposed Section 18 use pattern entails up to two applications per growing season (with one growing season per year), via aerial equipment (minimum spray volume of 10 GPA), at a rate of 0.12

- 0.16 lb ai/A, resulting in a max imum total seasonal application rate of 0.32 lb ai/A. The proposed minimum RTI is 10 days, and the minimum PHI is 14 days.

The results of the rice metabolism field trials indicate that the total residues of methoxyfenozide

and its metabolites were be tween 0.524 to 0.712 ppm in rice grain. Because of the large differences in the use patterns between the metabolism trials and the proposed Section 18 use directions, a conservative tolerance level of 0.5 ppm was proposed by CalDPR in its Pesticide

Evalua tion Report (Documents #52791

- 0212 and

- 0213; S. Zuberi, PhD; 21 August 2015), and is also recommended by HED (as 0.50 ppm). The HED recommended tolerance includes an additional significant figure (0.50 ppm instead of the proposed tolerance of 0.5 ppm). This is in order to avoid the situation where rounding of a residue result to the level of precision of the tolerance expression would be considered non

- violative (such as 1.4 ppm being rounded to 1 ppm).

Because of the potential for methoxyfenozide r esidues to concentrate in the processed commodity rice bran, HED recommends that a tolerance of 4.0 ppm be established in that commodity. This tolerance is based on the theoretical concentration factor from OCSPP Residue Chemistry Test Guideline 860.1520, Table 3 (7.7X), and the recommended tolerance in rice grain of 0.50 ppm (7.7 x 0.50 ppm = 3.85 ppm, rounded up to 4.0 ppm).

HED has no objection to the establishment (associated with Section 18 registration) of timelimited tolerances for methoxyfenoz ide residues at 0.50 ppm in rice grain, and at 4.0 ppm in

rice bran.

TABLE 3.4 Tolerance Summary for Methoxyfenozide (40CFR §180.544).
Proposed Commodity Proposed Tolerance (ppm) Recommended Tolerance (ppm) Correct Commodity Definition ; Comments

40CFR §180.544[b]

Rice, grain 0.5 0.50 Based on the submitted metabolism study data.

Rice, bran None 4.0 Based on the proposed tolerance in rice grain,

and the theoretical concentration factor from OCSPP 860.1520, Table 3 (7.7X).



## Dietary Exposure and Risk from Food and Drinking Water

There was no appropriate endpoint identified for assessing acute dietary exposure; therefore, no acute dietary risk assessment was performed.

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### Page 13 of 35 

## A chronic aggregate dietary (food and drinking water) exposure and risk assessment was conducted using the Dietary Exposure Evaluation Model software (Version 3.16) with the Food Commodity Intake Database (DEEM

- FCID). This software uses 2003

- 2008 food consumption

data from t he US Department of Agriculture’s (USDA’s) National Health and Nutrition Examination Survey, What We Eat in America , (NHANES/WWEIA). All current and proposed uses of methoxyfenozide, were included in this assessment. The dietary input and output files

ar e provided in Appendix B.

Tolerances have been established for methoxyfenozide residues (40CFR §180.544) in multiple crop commodities, subgroups and groups. These values were incorporated into the dietary assessment, along with the recommended tolera nce of 0.50 ppm for residues in white rice (and white rice babyfood) and brown rice (and brown rice babyfood), along with the recommended tolerance of 4.0 ppm for residues in rice bran and rice bran babyfood. The chronic dietary

assessment assumes 100% cr op treated (PCT). DEEM (Version 7.81) default processing factors were used for most processed commodities that do not have individual tolerances; the only exception was a processing factor of 0.2X for orange juice from a processing study (D358341; D.

Rate ; 10 June 2009). The chronic dietary assessment is highly conservative, and therefore provides an upper

- bound estimate of dietary exposure and risk.

Modeled drinking water residue estimates used in the dietary risk assessment were provided by EFED (D 429160; K. Milians; 22 September 2015), and incorporated directly into the dietary analysis. Water residues were incorporated in DEEM

- FCID via entry into the food categories “water, direct, all sources” and “water, indirect, all sources.” The estimated drinking water concentration (EDWC) recommended by EFED for use in the chronic dietary assessment was 0.214 ppm (post

- breakthrough, long

- term mean), as generated by the Pesticide Root Zone Model

– Ground Water (PRZM

- GW).

Based on these highly conserva tive assumptions, chronic dietary risk estimates are less than 84% of the chronic population

- adjusted dose (cPAD) for all population subgroups. As summarized in Table 3.5, children 1 to 2 years of age are the most highly

- exposed subgroup, utilizing 84% of the cPAD, while the general US population utilizes 31% of the cPAD. Generally, HED is concerned when risk estimates exceed 100% of the PAD; therefore, all chronic dietary risk

estimates are below HED’s LOC.

TABLE 3.5 Summary of Chronic Dietary Expo sure and Risk Estimates for Methoxyfenozide.

Population Subgroup* [Years of Age] cPAD (mg/kg/day) Dietary Exposure Estimate (mg/kg/day) % cPAD

General US Population 0.102 0.031087 31

All Infants [< 1] 0.102 0.046764 46

Children [1

- 2] 0.102 0.085467 84

Children [3

- 5] 0.102 0.065000 64

Children [6

- 12] 0.102 0.036028 35

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### Page 14 of 35 Youth [13

- 19] 0.102 0.023580 23

Adults [20

- 49] 0.102 0.027214 27

Adults [50+] 0.102 0.026998 27

Females [13

- 49] 0.102 0.027788 27

* Values for the population subgroup with the highest risk are in bold type.



## Methoxyfenozide has been classified by the Cancer Assessment Review Committee (CARC) as not likely to be carcinogenic to humans; therefore, cancer risk is not of concern.

Residential Exposure and Risk

Methoxyfenozide is not intended for use in public or residential settings. At this time, there are no uses for methoxyfenozide related to this action that would result in direct non

- dietary exposure in a residential or recreational setting. However, there are existing residential ornamental uses that were previously reassessed to reflect updates to HED’s 2012 Residential SOPs (available at http://www.epa.gov/pesticides/science/residential

- exposure

- sop.html ) , along with policy changes for body weight assumptions (D389739; M. Collantes; 27 February 12). Handler inhalation exposure scenarios resulted in MOEs greater than 100, ranging from 76,000 to greater than 3 million, and these risk estimates are not of concern. Although a POD from an oral study was used to assess the handler inhalation risks, the calculated MOEs are all > 76,000, thus providing an ample margin of safety to account for any uncertainties in the route

- to

- rou te extrapolation.

Spray Drift

Since methoxyfenozide can be applied to agricultural crops via ground or aerial equipment, the potential for indirect exposure to methoxyfenozide related to spray drift was assessed in the most

recent risk assessmen t (D422208; E. Holman; 8 September 2015), in support of Registration Review. The spray drift assessment was based on incidental oral exposures only due to the lack of a dermal endpoint for methoxyfenozide. The highest exposure, resulting from drift follo wing methoxyfenozide applications using aerial equipment, was for children 1 to 2 years old (MOEs ≥ 11,000, with an LOC < 100). There were no risks of concern at the field’s edge (assuming a residential lawn is directly adjacent to a field where agricultu ral crops are grown and treated with aerial, groundboom or airblast equipment).

Exposure inputs related to spray drift are the same for rice as those used in the previous assessment. Therefore, the previous spray drift assessment is applicable to the e xposures expected in conjunction with the proposed Section 18 use, and are not of concern.

Aggregate Exposure and Risk

In accordance with the FQPA, HED must consider and aggregate pesticide exposures and risks from three major sources: food, drink ing water, and residential exposures. In an aggregate

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### Page 15 of 35 

## assessment, exposures from dietary and residential sources are added together. There are no uses for methoxyfenozide related to this action that would result in direct non

- dietary exposure in a

reside ntial or recreational setting. However, there is an existing use on ornamentals that may result in residential handler exposure. As part of the most recent risk assessment (D422208; E. Holman; 8 September 2015), the residential handler exposure resulting from applying methoxyfenozide to ornamentals, using a backpack sprayer, was combined with the chronic dietary exposure from the most highly exposed adult population subgroup (general US adult population) to determine aggregate exposure and risk. The calc ulated exposure resulted in an aggregate MOE of 540; this risk estimate is not of concern, since it is significantly higher than the LOC of <100. With the addition of this Section 18 use on rice, there is minimal impact on the chronic dietary exposure. T he aggregate MOE of 540 remains unchanged from the previous aggregate risk assessment, and is not of concern.

Cumulative Exposure and Risk

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a

common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to methoxyfenozide and any other substances, and methoxyfenozide does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, E PA has not assumed that methoxyfenozide has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity, and to evaluate the cumulative effects of such chem icals, see the policy statements released by EPA’s Office of Pesticide Programs (OPP) concerning common mechanism determinations and procedures for cumulating effects from substances found to have

a common mechanism on EPA’s website at http://www.epa.gov/pesticides/cumulative/

.

Occupational Exposure and Risk

Under the specific Section 18 exemption requested, the durations of exposure for the use on rice to control armyworms in the state of CA are expected to be short

- term (1

- 30 days) and

intermediate

- term (1

- 6 months). Long

- term exposures (greater than 6 months) are not anticipated.

Occupational exposure and risk estimates from the use of methoxyfenozide on chives (including additional crop group expansions) were included in the most recent risk assessment (D422208; E. Holman; 8 September 2015), with MOEs not of concern, ranging from 450 to 570,000 for

inh alation exposure (level of concern for inhalation is MOE < 100). Exposure inputs are the same for rice as those used in the previous occupational assessment (D426658; Z. Figueroa; 9 September 2015). Therefore, the previous occupational handler and post

- a pplication assessments are applicable to the occupational exposures expected in conjunction with the proposed Section 18 use, and are not of concern.

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### Page 16 of 35 

## Note to RD: RD should ensure that the Section 18 label for use on rice in CA has the same PPE

as is currently listed on the Section 3 registered label for Intrepid 2F (EPA Registration #62719442).

Restricted Entry Interval (REI)

The Section 18 label should have the same REI as the Intrepid 2F label. The 4

- hour REI on registered labels is appro priate.

4.0 REFERENCES

Risk Assessment Memorandum

Methoxyfenozide. Human Health Draft Risk Assessment for Registration Review and New Use Risk Assessment to Support the Registration of Proposed Use on Chives, and Crop Group Expansions for Stone Fruit and Tree Nuts. ; D422208; E. Holman; 8 September 2015.

Occupational and Residential Exposure Assessment Memorandum

Methoxyfenozide. Occupational and Residential Exposure/Risk Assessment for Registration Review and to Support the Regis tration of Proposed Use on Chives and Crop Group Expansions. ; D426658; Z. Figueroa; 9 September 2015.

Residue Chemistry Documents

RH

- 112485 Nature of Residues in Rice ; Report #34

- 98

- 156; D.H. Carpenter; 9 February 1999.

Pesticide Evaluation Report Chemistry ; Documents #52791

- 0212 and

- 0213; S. Zuberi, PhD; 21 August 2015.

Methoxyfenozide. Petition to Establish Permanent Tolerances, and Associated Section 3 Registration, for Residues Resulting from Use of the Insect icide on Chives; and to Convert Stone Fruit Group 12 (Except Fresh Prune Plums) to Stone Fruit Group 12

- 12 (Except Fresh Prune Plums), and Tree Nut Group 14 to Tree Nut Group 14

- 12. Summary of Analytical Chemistry and

Residue Data. ; D425285; W.T. Drew; 31 March 2015.

Methoxyfenozide. Petition to Establish Permanent Tolerances, and Associated Section 3 Registration, for Residues Resulting from Use of the Insecticide on Chives; and to Convert Stone Fruit Group 12 (Except Fresh Prune Plums) to Stone Fruit Group 12

- 12 (Except Fresh Prune Plums), and Tree Nut Group 14 to Tree Nut Group 14

- 12. ADDENDUM to Summary of Analytical Chemistry and Residue Data. ; D429009; W.T. Drew; 8 September 2015.

Drinking Water Assessment Memorandum

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### Page 17 of 35 

## Drinking Wate r Assessment and Ecological Risk Summary for the Crisis Exemption Petition for the Use of Methoxyfenozide on Rice in California. ; D429160; K. Milians; 22 September 2015.

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### Page 18 of 35 

## APPENDIX A: TOXICOLOGY ASSESSMENT

Toxicology Data Requirements

The requirements (40CFR §158.340) for food use of methoxyfenozide. Use of new guideline numbers in Table A.1, below, does not imply that the new (1998) guideline protocols were used.

TABLE A.1 Toxicology Data Requirements for Methoxyfenozide (Technic al).

Study Required Satisfied

870.1100 Acute Oral Toxicity 870.1200 Acute Dermal Toxicity 870.1300 Acute Inhalation Toxicity 870.2400 Primary Eye Irritation 870.2500 Primary Dermal Irritation

870.2600 Dermal Sensitization yes

yes

yes

yes

yes

yes yes

yes

yes

yes

yes

yes
870.3100 Oral Subchronic (rodent) 870.3150 Oral Subchronic (nonrodent)

870.3200 21

- Day Dermal

870.3250 90

- Day Dermal

870.3465 28

- or 90

- Day Inhalation yes

yes

yes

no
no* yes

yes

yes

-

no

870.3700a Developmental Toxicity (rodent) 870.3700b Developmental Toxicity (nonrodent) 870.3800 Reproduction yes

yes

yes yes

yes

yes

870.4100a Chronic Toxicity (rodent) 870.4100b Chronic Toxicity (nonrodent) 870.4200a Oncogenicity (rat) 870.4200b Oncogenicity (mouse) 870.4300 Chronic/Oncogenicity yes

yes

yes

yes

yes yes

yes

yes

yes

yes
870.5100 Mutagenicity

— Gene Mutation

- bacterial 870.5300 Mutagenicity

— Gene Mutation

- mammalian 870.5xxx Mutagenicity

— Structural Chromosomal Aberrations 870.5xxx Mutagenicity

— Other Genotoxic Effects yes

yes

yes

yes yes

yes

yes

yes 870.6100a Acute Delayed Neurotoxicity (hen)

870.6100b 90

- Day Neurotoxicity (hen) 870.6200a Acute Neurotoxicity Screening Battery (rat)

870.6200b 90

- Day Neurotoxicity Screening Battery (rat) 870.6300 Develop. Neurotoxicity no

no

yes

yes

no -

-
yes

yes

-

870.7485 General Metabolism

870.7600 Dermal Penetration 870.7800 Immunotoxicity yes

yes

yes yes

yes

yes

Special Studies for Ocular Effects. Acute Oral (rat) Subchronic Oral (rat)

Six

- month Oral (dog) no

no

no -

-

-

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### Page 19 of 35 * The required repeated dose inhalation toxicity study has been waived. 

## Toxicity Profiles

TABLE A.2 Acute Toxicity Profile

– Methoxyfenozide (Technical).

Guideline # Study Type MRID Results Toxicity Category

870.1100 Acute oral [rat] 44144415 LD 50 

### >5000 mg/kg, both sexes IV

870.1100 Acute oral [mouse] 44144416 LD 50 

### >5000 mg/kg, both sexes IV

870.1200 Acute dermal [rat] 44144418 LD 50 

### >2000 mg/kg, both sexes III

870.1300 Acute inhalation [rat] 44144420 LC 50 

### >4.3 mg/L, both sexes IV

870.2400 Acute eye irritation [rabbit] 44144422 Very mild irritant IV

870.2500 Acute dermal irritation [rabbit] 44144424 Not an irritant IV

870.2600 Skin sensitization [Guinea pig] 44144426 Not a sensitizer N/A

TABLE A.3 Subchronic, Chronic and Other Toxicity Profile

– Methoxyfenozide (Technical)

Guideline # Study Type MRID # (Year)/

Classification /Doses Results

Nonguideline 2

- week oral

range

- finding (rat) 44617722 (1995)

Acceptable/nonguideline
0, 50, 250, 1000, 5000, 20,000 ppm in the diet [note: mg/kg/day equivalents not calculated;

see 90

- day oral rat for mg/kg/day] NOAEL = 250 ppm (approximately 17.0/19.1 mg/kg/day M/F based on main study doses) LOAEL = 1000 ppm (approximately 69.3/72.4 mg/kg/day M/F based on main study doses), based on thyroid gland hypertrophy/hyperplasia in males and females, and increased adrenal hypertrophy of zona fasciculata in females.

At ≥5000 ppm, increased abs/rel live r and adrenal weights, hepatocellular hypertrophy

870.3100 90

- Day oral toxicity (rat) 44617722 (1995) Acceptable/guideline

0, 50, 250, 1000, 5000, 20,000 ppm in the diet

M: 0, 3.4, 17.0, 69.3, 353.4, 1368.8 mg/kg/day
F: 0, 3.7, 19.1,72.4, 379.3, 1531.2 mg/kg/day NOAEL = 69.3/72.4 mg/kg/day [M/F] LOAEL = 353.4 mg/kg/day [M/F] based on periportal hepatocellular hypertrophy and increased liver weight.
At 1368.8/1531.2 mg/kg/day: decreased RBC and Hg in females.

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### Page 20 of 35 TABLE A.3 Subchronic, Chronic and Other Toxicity Profile

– Methoxyfenozide (Technical)

Guideline # Study Type MRID # (Year)/

Classification /Doses Results

870.3100 90

- Day oral toxicity (mouse) 44617723 (1995)

Acceptable/guideline 0,

70, 700, 2500, 7000
ppm in the diet

M: 0, 11.9, 112.5, 428.2, 1149.3 mg/kg/day;

F: 0, 17.4, 165.1, 589.4, 1742.1 mg/kg/day NOAEL = 428.2/589.4 mg/kg/day [M/F]

LOAEL = 1149.3/1742.1 mg/kg/day [M/F] based on decreased body weight gain.

Nonguideline 2

- week rangefinding (dog) 44617724 (1995)

Acceptable/nonguideline

0, 300, 3500, 15,000 or 30,000 ppm in the diet (2 animals/sex/dose)

M: 0, 11.7

- 14.7, 141.6167.6, 264.7

- 370.4, 571.4631.7, 1113.7

- 1337.0 mg/kg/day;

F: 0, 13.3

- 16.8, 90.8 184.8,

285.9

- 336.8, 582.3630.9,

1092.6

- 1169.1 mg/kg/day NOAEL = 11.7

- 14.7/13.3

- 16.8 mg/kg/day [M/F]

LOAEL = 141.6

- 167.6/90.8

- 184.8 mg/kg/day [M/F], based on hematological changes (decreased RBC parameters, increased Heinz body count, reticulocyte counts , erythrocyte morphology and methemoglobinemia) and increased spleen weights.

At ≥264.7 mg/kg/day, bilirubinemia

870.3150 90

- Day oral toxicity (dog) 44617724 (1995)

Acceptable/guideline

0, 15, 50, 500 or 5000 ppm

in the diet

M: 0, 0.6, 2.0, 21.4, 197.5 mg/kg/day;

F: 0, 0.6, 1.9, 20.4, 208.8 mg/kg/day NOAEL = 197.5/208.8 mg/kg/day [M/F] LOAEL >197.5/208.8 mg/kg/day [M/F](HDT).

870.3200 28

- Day dermal toxicity (rat) 44517725 (1998)

Acceptable/guideline

0, 75, 300, 1000 mg/kg/day Systemic NOAEL = 1000 mg/kg/day Systemic LOAEL > 1000 mg/kg/day (HDT)

Local dermal NOAEL = 1000 mg/kg/day Local dermal LOAEL > 1000 mg/kg/day (HDT)

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### Page 21 of 35 TABLE A.3 Subchronic, Chronic and Other Toxicity Profile

– Methoxyfenozide (Technical)

Guideline # Study Type MRID # (Year)/

Classification /Doses Results

870.3700a Prenatal developmental in (rat) 44638201 (1994)

Acceptable/guideline

0, 100, 300, 1000 mg/kg/day (gavage) Maternal NOAEL = 1000 mg/kg/day LOAEL >1000 mg/kg/day (HDT) Developmental NOAEL = 1000 mg/kg/day LOAEL >1000 mg/kg/day (HDT)

870.3700b Prenatal developmental in (rabbit) 44617726 (1997)

Acceptable/guideline

0, 100, 300, 1000 mg/kg/day (gavage) Materna l NOAEL = 1000 mg/kg/day LOAEL > 1000 mg/kg/day (HDT) Developmenta l NOAEL = 1000 mg/kg/day LOAEL > 1000 mg/kg/day (HDT)

870.3800 Reproduction and fertility effects (rat) 44617727 (1997)

Acceptable/guideline

0, 200, 2000 or 20,000 ppm in diet

P1 males: 0, 15.4, 153.4 or 1551.9 mg/kg/day;

P1 females: 0, 17.9, 180.7, 1820.7 mg/kg/day Parental/Systemic NOAEL = 153.4/180.7 mg/kg/day [M/F];

LOAEL = 1551.9/1820.7 mg/kg/day [M/F]

based on increased absolute and relative liver weights and microscopic midzonal to periportal hepatocellular hypertrophy. Reproductive NOAEL = 1551.9/1820.7 mg/kg/day [M/F]; LOAEL > 1551.9/1820.7 mg/kg/day [M/F](HDT) Offspring NOAEL = mg/kg/day LOAEL > 1551.9/1820.7 mg/kg/day [M/F](HDT)

870.4100a Chronic toxicity (rat) See 870.4300

870.4100b Chronic toxicity (dog) 44617728 (1997)

Acceptable/guideline

0, 60, 300, 3000 or 30,000 ppm in diet

M: 0, 2.2, 9.8, 106.1, 1152.4 mg/kg/day

F: 0, 2.2, 12.6, 110.6, 1199.2 mg/kg/day NOAEL = 9.8/12.6 mg/kg/day [M/F] LOAEL = 106.1/110.6 mg/kg/day [M/F] based on mild hematological changes (decreased RBC parameters, slight methemoglobinemia) and

increas ed serum bilirubin. Hematological

effects first observed at week 14.
At 1152.4/1199.2 mg/kg/day: bilirubinemia in males, increased abs/rel liver and thyroid weights, increased cellularity of sternum and rib marrow, increased pigmented macrophages in

liv er and spleen.

TABLE A.3 Subchronic, Chronic and Other Toxicity Profile

– Methoxyfenozide (Technical)

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### Page 22 of 35 Guideline # Study Type MRID # (Year)/

Classification /Doses Results

870.4200 Carcinogenicity (rat) 44617731 (1998)

Acceptable/guideline

0, 200, 8000 or 20,000 ppm in diet

M: 0, 10.2, 411 or 1045 mg/kg/day

F: 0, 11.9, 491 or 1248 mg/kg/day NOAEL = 10.2/11.9 mg/kg/day [M/F] LOAEL = 411/491 mg/kg/day [M/F] based on hematological changes (decreased RBC parameters), periportal liver hyper trophy, thyroid hypertrophy and altered colloid; possibly increased adrenal weight.

At 1045/1248 mg/kg/day: decreased survival in males, decreased body weight in females, increased abs/rel liver weight, chronic progressive glomerulonephropathy, tissue

mineralization.

no evidence of carcinogenicity

870.4300 Carcinogenicity (mouse) 44617729 (1998)

Acceptable/guideline

0, 70, 2800, 7000 ppm

M: 0, 10.0, 40.5 or 1020 mg/kg/day

F: 0, 12.8, 529 or 1354 mg/kg/day NOAEL = 1020/1354 mg/kg/day [M/F] LOAEL >1020/1354 mg/kg/day [M/F](HDT)

no evidence of carcinogenicity

Gene Mutation

870. 5100 Bacterial reverse gene mutation

- Salmonella 44144428 (1995)

Acceptable/guideline

0, 50, 200, 500, 2000, 5000 μg/plate, initial assay; 0,
160, 300, 500, 900, 1600 μg/plate, repeat assay No evidence of mutagenicity with or without S9 activation up to solubility limit (precipitation observed at ≥900 μg/plate).

Gene Mutation

870.5100 Bacterial reverse gene mutation

- Salmonella 44617733 (1998)

Acceptable/guideline
0, 50, 200, 500, 2000, 5000 μg/plate, test

material: RH

- 117,236 (Metabolite M

- B) No evidence of mutagenicity with or without S9 activation up to solubility limit (prec ipitation observed at 2000 and 5000 μg/plate)

TABLE A.3 Subchronic, Chronic and Other Toxicity Profile

– Methoxyfenozide (Technical)

Guideline # Study Type MRID # (Year)/

Classification /Doses Results

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### Page 23 of 35 In Vitro

Mammalian

Gene Mutation

870.5300 HGPRT forward gene mutation assay (Chinese hamster ovary, or CHO, cells) 44617734 (1994)

Acceptable/guideline

0, 0.1, 0.5, 1.0, 5.0, 10, 50,
100, 500, 1000, 1250 μg/mL (range

- finding study);

0.5, 1.0, 5.0, 10, 50, 100 μg/mL (definitive study) No evidence of mutagenicity with or without S9 activation up to solubility limit (precipitation observed at ≥100 μg/mL).

In Vitro Cytogenetics

870.5375 Chromosomal
aberration, CHO

cells 44617735 (1994)

Acceptable/guideline

0, 0.21, 0.63, 2.1, 6.3, 21, 63, 108, 625, 1250 μg/mL (range

- finding study);

0, 13, 125, 100, 150 μg/mL (definitive study) No evidence of increased frequency of chromosomal aberration in the presence or

absence of S9 activation u p doses causing reduced mitotic indices (≥50 μg/mL).

Other Effects

870.5395 In vivo mouse micronucleus

assay 44617801 (1995)

Acceptable/nonguideline

0, 500, 2500, 5000 mg/kg single IP dose No evidence of increased frequency of

micronucleus formation in treated CD

- 1mice in bone marrow at 24 or 48 hrs postdosing; tested up to the limit dose for this assay.

870.6200a Acute neurotoxicity screening battery (rat) 44617802 (1996)

Acceptable/guideline

0, 1000, 2000 mg/kg by

gavage NOAEL = 1000 mg/kg (males); 2000 mg/kg (females; HDT) LOAEL = 2000 mg/kg (males) based on decreased hindlimb grip strength on Day 0; >2000 mg/kg females (HDT)

870.6200b Subchronic neurotoxicity screening battery (rat) 44617803 (1996)

Acceptable/guideline

0, 200, 2000 or 20,000 ppm in diet

Males 0, 13, 130, 1318 mg/kg/day

Females 0, 16, 159, 1577 mg/kg/day NOAEL = 1318/1577 mg/kg/day [M/F]; LOAEL > 1318/1577 mg/kg/day [M/F] (HDT)

TABLE A.3 Subchronic, Chronic and Other Toxicity Profile

– Methoxyfenozide (Technical)

Guideline # Study Type MRID # (Year)/

Classification /Doses Results

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### Page 24 of 35 870.7485 Metabolism and pharmacokinetics (rat) 44617804 (1998)

Acceptable/guideline

Single gavage doses of 10 mg/kg and 1000 mg/kg; 5day repeated gavage doses of 10 mg/kg Absorption and excretion were rapid (<48 hrs postdosing). Tissue distribution was extensive but bioaccumulation was not observed. Major

route of excretion was via fec es (86

- 97%) and to a lesser extent, the urine (5

- 13%). Enterohepatic circulation was observed. The primary routes of metabolism were Odemethylation and oxidative hydroxylation followed by conjugation with glucuronic acid.

870.7600 Dermal penetration (rat) 44638202 (1998)

Acceptable/guideline Mean dermal absorption at 10 and 24 hrs was 2% using an 80WP formulation.

870.7800 Immunotoxicity (female rat) 48592601 (2011)

Acceptable/guideline

0, 76.9, 324 or 1076 mg/kg/day in the diet (ppm not indicated) Immunotoxicity NOAEL = 1076 mg/kg/day

Immunotoxicity LOAEL = not established

Systemic toxicity NOAEL = = 76.9 mg/kg/day
Systemic toxicity LOAEL = 324 mg/kg/day,

based on increased liver wei ghts.



## APPENDIX B: Dietary Assessment Input and Output Files

Input Listing for the Chronic Dietary Assessment of Methoxyfenozide

Filename: C: \ Users \ wdrew \ Documents \ MethoxyfenozideDEEM122215ChronicInput.R08 Chemical: Methoxyfenozide RfD(Chronic): .102 mg/kg bw/day NOEL(Chronic): 10.2 mg/kg bw/day
RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day
Date created/last modified: 12

- 22

- 2015/08:48:38 Program ver. 3.16, 03

- 08

- d

------------------------------------------------- ---------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 9500001000 O Acerola 0.400000 1.000 1.000

1400003000 14 Almond 0.100000 1.000 1.000

1400004000 14 Almond, oil 0.100000 1.000 1.000

1400004001 14 Al mond, oil

- babyfood 0.100000 1.000 1.000

1400003001 14 Almond

- babyfood 0.100000 1.000 1.000
0401005000 4A Amaranth, leafy 30.000000 1.000 1.000 PP#: 9

Full comment: PP#: 9F0 6062, 0F06201, 0F06213, 1F06259

1100009000 11 Apple, dried 2.000000 8.000 1.000

1100009001 11 Apple, dried

- babyfood 2.000000 8.000 1.000 1100007000 11 Apple, fruit with peel 2.000000 1.000 1.000

1100010000 11 Apple, juice 2.000000 1.300 1.000

1100010001 11 Apple, juice

- babyfood 2.000000 1.300 1.000

1100008000 11 Apple, peeled fruit 2.000000 1.000 1.000

1100008001 11 Apple, peeled fruit

- babyfood 2.000000 1.000 1.000

1100011000 11 Apple, sauce 2.000000 1.000 1.000

1100011001 11 Apple, sauce

- babyfood 2.000000 1.000 1.000

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### Page 25 of 35 1202012000 12B Apricot 3.000000 1.000 1.000 1202013000 12B Apricot, dried 3.000000 6.000 1.000

1202014000 12B Apricot, juice 3.000000 1.000 1.000

1202014001 12B Apricot, juice

- babyfood 3.000000 1.000 1.000 1202012001 12B Apricot

- babyfood 3.000000 1.000 1.000
0103015000 1CD Arrowroot, flour 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0103015001 1CD Arrowroot, flour

- babyfood 0.020000 1.000 1.0 00 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0103017000 1CD Artichoke, Jerusalem 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
9500016000 O Artichoke, globe 3.000000 1.000 1.000
0401018000 4A Arugula 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
9500019500 O Atemoya 0.6 00000 1.000 1.000

9500020000 O Avocado 0.600000 1.000 1.000
0902021000 9B Balsam pear 0.300000 1.000 1.000

1901029000 19A Basil, dried leaves 400.000000 1.000 1.000

1901029001 19A Basi l, dried leaves

- babyfood 400.000000 1.000 1.000

1901028000 19A Basil, fresh leaves 400.000000 1.000 1.000

1901028001 19A Basil, fresh leaves

- babyfood 400.000000 1.000 1.000
0603035000 6C Bean, great northern, seed 0.500000 1.000 1.000
0603030000 6C Bean, black, seed 0.500000 1.000 1.000
0603032000 6C Bean, broad, seed 0.500000 1.000 1.000
0602031000 6B Bean, broad, succulent 0.300000 1.000 1.000
0603034000 6C Bean, cowpea, seed 4.000000 1.000 1.000
0602033000 6B Bean, cowpea, succulent 4.000000 1.000 1.000
0603036000 6C Bean, kidney, seed 0.500000 1.000 1.000
0603038000 6C Bean, lima, seed 0.500000 1.000 1.000
0602037000 6B Bean, lima, succulent 0.300000 1.000 1.000
0603039000 6C Bean, mung, seed 0.500000 1.000 1.000
0603040000 6C Bean, navy, seed 0.500000 1.000 1.000 0603041000 6C Bean, pink, seed 0.500000 1.000 1.000 0603042000 6C Bean, pinto, seed 0.500000 1.000 1.000
0601043000 6A Bean, snap, succulent 2.000000 1.000 1.000
0601043001 6A Bean, snap, succulent

- babyfood 2.000000 1.000 1.000
3100047000 31 Beef, fat 0.500000 1.000 1.000

3100047001 31 Beef, fat

- babyfood 0.500000 1.000 1.000 3100048000 31 Beef, kidney 0.100000 1.000 1.000
3100049000 31 Beef, liver 0.400000 1.000 1.000
3100049001 31 Beef, liver

- babyfoo d 0.400000 1.000 1.000
3100044000 31 Beef, meat 0.020000 1.000 1.000
3100046000 31 Beef, meat byproducts 0.100000 1.000 1.000
3100046001 31 Beef, meat byproducts

- babyfood 0.1000 00 1.000 1.000
3100045000 31 Beef, meat, dried 0.020000 1.920 1.000

3100044001 31 Beef, meat

- babyfood 0.020000 1.000 1.000
0101050000 1AB Beet, garden, roots 0.900000 1.000 1.000

0 101050001 1AB Beet, garden, roots

- babyfood 0.900000 1.000 1.000
0200051000 2 Beet, garden, tops 30.000000 1.000 1.000
0101052000 1A Beet, sugar 0.500000 1.000 1.000
0101053000 1A Beet, s ugar, molasses 0.500000 1.000 1.000
0101053001 1A Beet, sugar, molasses

- babyfood 0.500000 1.000 1.000
0101052001 1A Beet, sugar

- babyfood 0.500000 1.000 1.000
1301055000 13A Blackberry 6.000000 1.000 1.000

1301056000 13A Blackberry, juice 6.000000 1.000 1.000

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 26 of 35 1301056001 13A Blackberry, juice

- babyfood 6.000000 1.000 1.000

1302057000 13B Blueberry 4.00 0000 1.000 1.000

1302057001 13B Blueberry

- babyfood 4.000000 1.000 1.000
1301058000 13A Boysenberry 6.000000 1.000 1.000

1400059000 14 Brazil nut 0.100000 1.000 1.000

0501061000 5A Broccoli 7.000000 1.000 1.000

0502063000 5B Broccoli raab 30.000000 1.000 1.000
0501062000 5A Broccoli, Chinese 7.000000 1.000 1.000

0501061001 5A Broccoli

- babyfoo d 7.000000 1.000 1.000
0501064000 5A Brussels sprouts 7.000000 1.000 1.000

0101067000 1AB Burdock 0.900000 1.000 1.000

1400068000 14 Butternut 0.1 00000 1.000 1.000
0501069000 5A Cabbage 7.000000 1.000 1.000 0502070000 5B Cabbage, Chinese, bok choy 30.000000 1.000 1.000 0501072000 5A Cabbage, Chinese, mustard 7.000000 1.000 1.000 0501071000 5A Cabbage, Chinese, napa 7.000000 1.000 1.000

9500074000 O Canistel 0.600000 1.000 1.000
0901075000 9A Cantaloupe 0.300000 1.000 1.000

0402076000 4B Cardoon 25.000000 1.000 1.000

0101078000 1AB Carrot 0.900000 1.000 1.000 0101079000 1AB Carrot, juice 0.900000 1.000 1.000

0101078001 1AB Carrot

- babyfood 0.900000 1.000 1.000

1400081000 14 Cashew 0.100000 1.000 1.000

0103082000 1CD Cassava 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

0103082001 1CD Cassava

- babyfood 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

0501083000 5A Cauliflower 7.000000 1.000 1.000

0101084000 1AB Celeriac 0.900000 1.000 1.000
0402085000 4B Celery 25.000000 1.000 1.000 0402086000 4B Celery, juice 25.000000 1.000 1.000 0402085001
4B Celery

- babyfood 25.000000 1.000 1.000 0402087000 4B

Celtuce 25.000000 1.000 1.000 0902088000 9B Chayote, fruit 0.300000 1.000 1.000 9500089000 O Cherimoya 0.600000 1.000 1.000 1201090000 12A Cherry 3.000000 1.000 1.000 1201091000 12A Cherry, juice 3.000000 1.500 1.000 1201091001 12A Cherry, juice

- babyfood 3.000000 1.500 1.000

1 201090001 12A Cherry

- babyfood 3.000000 1.000 1.000

1400092000 14 Chestnut 0.100000 1.000 1.000
4000096000 40 Chicken, fat 0.020000 1.000 1.000
4000096001 40 Chicken, fat

- babyfood 0.020000 1.000 1.000
4000094000 40 Chicken, liver 0.100000 1.000 1.000
4000093000 40 Chicken, meat 0.020000 1.000 1.000 4000095000 40 Chicken, meat byproducts 0.020000 1.000 1.000 4000095001 40 Chicken, meat byproducts

- babyfoo 0.020000 1.000 1.000
4000093001 40 Chicken, meat

- babyfood 0.020000 1.000 1.000
4000097000 40 Chicken, skin 0.020000 1.000 1.000
4000097001 40 Chicken, skin

- babyfood 0.020000 1.000 1.000 0603099000 6C Chickpea, flour 0.500000 1.000 1.000 0603098000 6C Chickpea, seed 0.500000 1.000 1.000

0603098001 6 C Chickpea, seed

- babyfood 0.500000 1.000 1.000 0101100000 1AB Chicory, roots 0.900000 1.000 1.000 0200101000 2 Chicory, tops 30.000000 1.000 1.000 0902102000 9B Chinese waxgourd 0.300000 1.000 1.000

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 27 of 35 1901102500 19A Chive, dried leaves 400.000000 1.000 1.000
0302103000 3B Chive, fresh leaves 30.000000 1.000 1.000
0401104000 4A Chrysa nthemum, garland 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

1901118000 19A Cilantro, leaves 400.000000 1.000 1.000

1901118001 19A Cilantro, leaves

- babyfood 400.000000 1.000 1. 000

1902105000 19B Cinnamon 4.500000 1.000 1.000

1902105001 19B Cinnamon

- babyfood 4.500000 1.000 1.000
1001106000 10A Citron 3.000000 1.000 1.000 PP# 1E

Full comment: PP# 1 E7842 1001107000 10A Citrus hybrids 3.000000 1.000 1.000 PP# 1E

Full comment: PP# 1E7842
1001108000 10A Citrus, oil 100.000000 1.000 1.000 PP# 1E

Full comment: PP# 1E7842

050211 7000 5B Collards 30.000000 1.000 1.000

1902119000 19B Coriander, seed 4.500000 1.000 1.000

1902119001 19B Coriander, seed

- babyfood 4.500000 1.000 1.000
1500122000 15 Corn, field, bran 0.050000 1.000 1.000

1500125000 15 Corn, field, oil 0.200000 1.000 1.000

1500125001 15 Corn, field, oil

- babyfood 0.200000 1.000 1.000

1500123000 15 Corn, field, starch 0.050000 1.000 1.000

1500123001 15 Corn, field, starch

- babyfood 0.050000 1.000 1.000

1500124000 15 Corn, field, syrup 0.050000 1.500 1.000

1500124001 15 Corn, field, syrup

- babyfood 0.050000 1.500 1.000
1500126000 15 Corn, pop 0.050000 1.000 1.000 PP# 8E

Full comment: PP# 8E7447

1500127000 15 Corn, sweet 0.050000 1.000 1.000

1500127001 15 Corn, sweet

- babyfood 0.050000 1.000 1.000

2003128000 20C Cottonseed, oil 2.000000 1.000 1.000

2003128001 20C Cottonse ed, oil

- babyfood 2.000000 1.000 1.000
1100129000 11 Crabapple 2.000000 1.000 1.000
1307130000 13G Cranberry 0.500000 1.000 1.000 1307131000 13G Cranberry, dried 0.500000 1.000 1.000 1307132000 13G Cranberry, juice 0.500000 1.100 1.000 1307132001 13G Cranberry, juice

- babyfood 0.500000 1.100 1.000
1307130001 13G Cranberry

- babyfood 0.500000 1.000 1. 000
0401133000 4A Cress, garden 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0401134000 4A Cress, upland 30.000000 1.000 1.000 PP#: 9

Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

0902135000 9B Cucumber 0.300000 1.000 1.000

1302136000 13B Currant 4.000000 1.000 1.000
1302137000 13B Currant, dried 4.000000 1.000 1.000
0401138000 4A Dandelion, leaves 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0103139000 1CD Dasheen, corm 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0200140000 2 Dasheen, leaves 30.000000 1.000 1.000

9500141000 O Date 8.000000 1.000 1.000
1902143000 19B Dill, seed 4.500000 1.000 1.000

1901144000 19A Dillweed 400.000000 1.000 1.000 7000146000 70 Egg, white 0.020000 1.000 1.000 7000146001 70 Egg, white (solids)

- babyfood 0.020000 1.000 1.000
7000145000 70 Egg, whole 0.020000 1.000 1.000
7000145001 70 Egg, whole

- babyfood 0.020000 1.000 1. 000

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 28 of 35 7000147000 70 Egg, yolk 0.020000 1.000 1.000
7000147001 70 Egg, yolk

- babyfood 0.020000 1.000 1.000
0802148000 8BC Eggplant 2.000000 1.000 1.000

1302149000 13B Elderberry 4.000000 1.000 1.000
0401150000 4A Endive 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259 9500151000 O Feijoa 0.400000 1.000 1.000
0402152000 4B Fennel, Florence 25.000000 1.000 1.000
2001163000 20A Flax seed, oil 1.000000 1.000 1.000
0301165000 3A Garlic, bulb 0.100000 1. 000 1.000
0301165001 3A Garlic, bulb

- babyfood 0.100000 1.000 1.000 0103166000 1CD Ginger 0.020000 1.000 1.000 PP#: 9

Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

0103167000 1C D Ginger, dried 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259 0103166001 1CD Ginger

- babyfood 0.020000 1.000 1.000 PP#: 9

Full comment: PP#: 9F06 062, 0F06201, 0F06213, 1F06259 0101168000 1AB Ginseng, dried 0.900000 1.000 1.000

3200171000 32 Goat, fat 0.500000 1.000 1.000

3200172000 32 Goat, kidney 0.100000 1.000 1.000
3200173000 32 Goat, liver 0.400000 1.000 1.000

3200169000 32 Goat, meat 0.020000 1.000 1.000
3200170000 32 Goat, meat byproducts 0.100000 1.000 1.000 1100173500 11 Goji berry 2.000000 1.000 1.000 Goji i Full comment: Goji is in Crop Group 8

- 10
1302174000 13B Gooseberry 4.000000 1.000 1.000
1304175000 13D Grape 1.000000 1.000 1.000

1304176000 13D Grape, juice 1.000000 1.200 1.000

1304176001 13D Grape, juice

- babyfood 1.000000 1.200 1.000
9500177000 O Grape, leaves 1.000000 1.000 1.000 9500178000 O Grape, raisin 1.500000 1.000 1.000 1304179000 13D Grape, wine and sherry 1.000000 1.000 1.000 1003180000 10C Grapefruit 3.000000 1.00 0 1.000 PP# 1E

Full comment: PP# 1E7842 1003181000 10C Grapefruit, juice 3.000000 2.100 1.000 PP# 1E

Full comment: PP# 1E7842
0603182000 6C Guar, seed 0.500000 1.000 1.000 060 3182001
6C Guar, seed

- babyfood 0.500000 1.000 1.000 9500183000 O Guava

0.400000 1.000 1.000 9500183001 O Guava

- babyfood 0.400000

1.000 1.000 1400155000 14 Hazelnut 0.100000 1.000

1.000
1400156000 14 Hazelnut, oil 0.100000 1.000 1.000 1901184000
19A Herbs, other 400.000000 1.000 1.000
1901184001 19A Herbs, other

- babyfood 400.0000 00 1.000 1.000 1400185000 14 Hickory nut 0.100000 1.000 1.000
0901187000 9A Honeydew melon 0.300000 1.000 1.000

3300189000 33 Horse, meat 0.020000 1.000 1.000

0101 190000 1AB Horseradish 0.900000 1.000 1.000
1302191000 13B Huckleberry 4.000000 1.000 1.000

0502194000 5B Kale 30.000000 1.000 1.000

0501196000 5A Kohlrabi 7.000000 1.000 1.000
1002197000 10B Kumquat 3.000000 1.000 1.000 PP# 1E

Full comment: PP# 1E7842

0302198000 3B Leek 5.000000 1.000 1.000

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 29 of 35 1002199000 10B Lemon 3.000000 1.000 1.000 PP# 1E

Full comment: PP# 1E7842

1002200000 10B Lemon, juice 3.000000 2.000 1.000 PP# 1E

Full comment: PP# 1E7842

1002200001 10B Lemon, juice

- babyfoo d 3.000000 2.000 1.000 PP# 1E
Full comment: PP# 1E7842
1002201000 10B Lemon, peel 3.000000 1.000 1.000 PP# 1E

Full comment: PP# 1E7842
1901202000 19A Lemongrass 400.000000 1.000 1.000
0603203000 6C Lentil, seed 0.500000 1.000 1.000

0401204000 4A Lettuce, head 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0401205000 4A Lettuce, leaf 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
1002206000 10B Lime 3.000000 1.000 1.000 PP# 1E

Full comme nt: PP# 1E7842

1002207000 10B Lime, juice 3.000000 2.000 1.000 PP# 1E

Full comment: PP# 1E7842

1002207001 10B Lime, juice

- babyfood 3.000000 2.000 1.000 PP# 1E

Full comment: PP# 1E7842
1301208000 13A Log anberry 6.000000 1.000 1.000
9500209000 O Longan 2.000000 1.000 1.000
1100210000 11 Loquat 2.000000 1.000 1.000
9500211000 O Lychee 2.000000 1.000 1.000 9500212000 O Lychee, dried 2.000000 1.850 1.000

1400213000 14 Macadamia nut 0.100000 1.000 1.000
9500215000 O Mango 0.600000 1 .000 1.000 9500216000 O Mango, dried 0.600000 1.000 1.000 9500217000 O Mango, juice 0.600000 1.000 1.000 9500217001 O Mango, juice

- babyfood 0.600000 1.000 1.000
9500215001 O Mango

- babyfood 0.600000 1.000 1.000

1901220000 19A Marjoram 400.000000 1.000 1.000

1901220001 19A Marjoram

- babyfood 400.000000 1.000 1.000
3600222000 36 Milk, fat 0.100000 1.000 1.000
3600222001 36 Milk, fat

- baby food/infant formu 0.100000 1.000 1.000
3600223000 36 Milk, nonfat solids 0.100000 1.000 1.000
3600223001 36 Milk, nonfat solids

- baby food/in 0.100000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.100000 1.000 1.000
3600224000 36 Milk, water 0.100000 1.000 1.000
3600224001 36 Milk, water

- babyfood/infant form 0.100000 1.000 1.000
0502229000 5B Mustard greens 30.000000 1.000 1.000 1202230000

12B Nectarine 3.000000 1.000 1.000

0802234000 8BC Okra 2.000000 1.000 1.000
0301237000 3A Onion, bulb 0.100000 1.000 1.000
0301238000 3A Onion, bulb, dried 0.100000 9.000 1.000 0301238001
3A Onion, bulb, dried

- babyfood 0.100000 9.000 1.000

0301237001 3A On ion, bulb

- babyfood 0.100000 1.000 1.000 0302239000 3B Onion, green 5.000000 1.000 1.000
1001240000 10A Orange 3.000000 1.000 1.000 PP# 1E

Full comment: PP# 1E7842

1001241000 10A Orange, juice 3.000000 0.200 1.000 PP# 1E

Full comment: PP# 1E7842

1001241001 10A Orange, juice

- babyfood 3.000000 0.200 1.000 PP# 1E
Full comment: PP# 1E7842
1001242000 10A Orange, peel 3.000000 1.000 1.000 PP# 1E

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 30 of 35 Full comment: PP# 1E7842
9500245000 O Papaya 0.600000 1.000 1.000 9500246000 O Papaya, dried 0.600000 1.800 1.000

9500247000 O Papaya, juice 0.600000 1.500 1.000
9500245001 O Papaya

- babyfood 0.600000 1.000 1.000

1901249000 19A Parsley, dried leaves 400.000000 1.000 1.000

1901249001 19A Parsley, dried leaves

- babyfood 400.000000 1.000 1.000
0401248000 4A Parsley, leaves 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259 0101250000 1AB Parsley, turnip rooted 0.900000 1.0 00 1.000 0101251000 1AB Parsnip 0.900000 1.000 1.000 0101251001 1AB Parsnip

- babyfood 0.900000 1.000 1.000

9500252000 O Passionfruit 0.400000 1.000 1.000

950025300 0 O Passionfruit, juice 0.400000 1.000 1.000 9500253001 O Passionfruit, juice

- babyfood 0.400000 1.000 1.000

9500252001 O Passionfruit

- babyfood 0.400000 1.000 1.000
0603256000 6C Pea, dry 0.500000 1.000 1.000
0603256001 6C Pea, dry

- babyfood 0.500000 1.000 1.000 0601257000 6A Pea, edible podded, succulent 2.000000 1.000 1.000 0603258000 6C Pea, pigeon, seed 0. 500000 1.000 1.000 0602259000 6B Pea, pigeon, succulent 0.300000 1.000 1.000

0602255000 6B Pea, succulent 0.300000 1.000 1.000
0602255001 6B Pea, succulent

- babyfood 0.300000 1.000 1.000

1202260000 12B Peach 3.000000 1.000 1.000

1202261000 12B Peach, dried 3.000000 7.000 1.000

1202261001 12B Peach, dried

- babyfood 3.000000 7.000 1.000

1202262000 12B Peach, juice 3 .000000 1.000 1.000

1202262001 12B Peach, juice

- babyfood 3.000000 1.000 1.000

1202260001 12B Peach

- babyfood 3.000000 1.000 1.000

9500263000 O Peanut 0.020000 1.000 1.000
9500264000 O Peanut, butter 0.020000 1.890 1.000
9500265000 O Peanut, oil 0.040000 1.000 1.000

1100266000 11 Pear 2.000000 1.000 1.000
1100267000 11 Pear, dried 2.000000 6.250 1.000

1100268000 11 Pear, juice 2.000000 1.000 1.000

1100268001 11 Pear, juice

- babyfood 2.000000 1.000 1.000

1100266001 11 Pear

- babyfood 2.000000 1.00 0 1.000

1400269000 14 Pecan 0.100000 1.000 1.000
0802270000 8B Pepper, bell 2.000000 1.000 1.000 0802271000 8B Pepper, bell, dried 2.000000 1.000 1.000

0802271001 8B Pepper, bell, dried

- babyfood 2.000000 1.000 1.000
0802270001 8B Pepper, bell

- babyfood 2.000000 1.000 1.000

1902274000 19B Pepper, black and white 4.500000 1.000 1.000

1902274001 19B Pepper, black and white

- babyfood 4.5 00000 1.000 1.000
0802272000 8BC Pepper, nonbell 2.000000 1.000 1.000 0802273000 8BC Pepper, nonbell, dried 2.000000 1.000 1.000 0802272001
8BC Pepper, nonbell

- babyfood 2.000000 1.000 1.000

9500 275000 O Peppermint 7.000000 1.000 1.000 9500276000 O Peppermint, oil 7.000000 1.000 1.000

1400278000 14 Pine nut 0.100000 1.000 1.000 9500279000 O Pineapple 0.700000 1.000 1.000 9500280000 O Pineapple, dried 0.700000 5.000 1.000 9500281000 O Pineapple, juice 0.700000 1.700 1.000 9500281001 O Pineapple, juice

- babyfood 0.700 000 1.700 1.000 9500279001 O Pineapple

- babyfood 0.700000 1.000 1.000

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 31 of 3 5 1400282000 14 Pistachio 0.100000 1.000 1.000

1203285000 12C Plum 3.000000 1.000 1.000

1203287000 12C Plum, prune, dried 0.300000 5.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

1203287001 12C Plum, prune, dried

- babyfood 0.300000 5.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

1203286000 12C Plum, prune, fresh 0.300000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

1203286001 12C Plum, prune, fresh

- babyfood 0.300000 1.000 1.00 0 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

1203288000 12C Plum, prune, juice 0.300000 1.400 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

1203288001 12C Plum, prune, juice

- babyfood 0.300000 1.400 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

1203285001 12C Plum

- babyfood 3.000000 1.000 1.000
9500289000 O Pomegranate 0.600000 1.000 1.000 PP # 8E

Full comment: PP# 8E7447
3400293000 34 Pork, fat 0.100000 1.000 1.000
3400293001 34 Pork, fat

- babyfood 0.100000 1.000 1.000 3400294000 34 Pork, kidney 0.020 000 1.000 1.000
3400295000 34 Pork, liver 0.100000 1.000 1.000
3400290000 34 Pork, meat 0.020000 1.000 1.000
3400292000 34 Pork, meat byproducts 0.020000 1.000 1.000
3400292001 34 Pork, meat byproducts

- babyfood 0.020000 1.000 1.000
3400290001 34 Pork, meat

- babyfood 0.020000 1.000 1.000
3400291000 34 Pork, skin 0.020000 1.000 1.000

0103296000 1C Potato , chips 0.020000 1.000 1.000
0103297000 1C Potato, dry (granules/ flakes) 0.020000 6.500 1.000
0103297001 1C Potato, dry (granules/ flakes)

- b 0.020000 6.500 1.000
0103298000 1C Potato, flour 0.020000 6.500 1.000
0103298001 1C Potato, flour

- babyfood 0.020000 6.500 1.000
0103300000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000
0103300001 1C Potato, tuber, w/o peel

- babyfood 0.020000 1.000 1.000
0103299000 1C Potato, tuber, w/peel 0.020000 1.000 1.000
0103299001 1C Potato, tuber, w/peel

- babyfood 0.020000 1.000 1.000
6000304000 60 Poultry, other, fat 0.020000 1.000 1.000 6000302000 60 Poultry, other, liver 0.100000 1.000 1.000
6000301000 60 Poultry, other, meat 0.020000 1.000 1.000
6000303000 60 Poultry, other, meat byproducts 0.020000 1.000 1.00 0 6000305000 60 Poultry, other, skin 0.020000 1.000 1.000

1003307000 10C Pummelo 3.000000 1.000 1.000 PP# 1E

Full comment: PP# 1E7842 0902308000 9B Pumpkin 0.300000 1.000 1.000 0902309000 9B Pumpkin, seed 0.300000 1.000 1.000
1100310000 11 Quince 2.000000 1.000 1.000

0401313000 4A Radicchio 30.000000 1.000 1.00 0 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0101316000 1AB Radish, Oriental, roots 0.900000 1.000 1.000 0200317000 2 Radish, Oriental, tops 30.000000 1.000 1.000 0101314000 1AB Radish, r oots 0.900000 1.000 1.000 0200315000 2 Radish, tops 30.000000 1.000 1.000
0502318000 5B Rape greens 30.000000 1.000 1.000 2001319000 20A Rapeseed, oil 1 .000000 1.000 1.000 2001319001 20A Rapeseed, oil

- babyfood 1.000000 1.000 1.000 1301320000 13A Raspberry 6.000000 1.000 1.000

1301321000 13A Raspberry, juice 6.000000 1.000 1.000

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 32 of 35 1301321001 13A Raspber ry, juice

- babyfood 6.000000 1.000 1.000
1301320001 13A Raspberry

- babyfood 6.000000 1.000 1.000

0402322000 4B Rhubarb 25.000000 1.000 1.000

1500326000 15 Rice, bran 4.000000 1.000 1.000

1500326001 15 Rice, bran

- babyfood 4.000000 1.000 1.000

1500324000 15 Rice, brown 0.500000 1.000 1.000

1500324001 15 Rice, brown

- babyfood 0.500000 1.000 1.000

1500323000 15 Rice, white 0.500000 1.000 1.000

1500323001 15 Rice, white

- babyfood 0.500000 1.000 1.000
0101327000 1AB Rutabaga 0.900000 1.000 1.000

2002330000 20B Safflower, oil 1.000000 1.000 1.000

2002330001 20B Safflower, oil

- babyfood 1.000000 1.000 1.000 0101331000 1AB Salsify, roots 0.900000 1.000 1.000 0200332000 2 Salsify, tops 30.000000 1.000 1.000
9500333000 O Sapote, Mamey 0.600000 1.000 1.000
1901334000 19A Savory 400.000000 1.000 1.000

2001337000 20A Sesame, oil 1.000000 1.000 1.000

2001337001 20A Sesame, oil

- babyfood 1.000000 1.000 1.000

2001336000 20A Sesame, seed 1.000000 1.000 1.000

2001336001 20A Sesame, seed

- babyfood 1.000000 1.000 1.000
0301338000 3A Shallot, bulb 0.100000 1.000 1.000
0302338500 3B Shallot, fresh leaves 5.000000 1.000 1.000
3500341000 35 Sheep, fat 0.500000 1.000 1.000
3500341001 35 Sheep, fat

- babyfood 0.500000 1.000 1.000 3500342000 35 Sheep, kidney 0.100000 1.000 1.000 3500343000 35 Sheep, liver 0.400000 1.000 1.000
3500339000 35 Sheep, meat 0.020000 1.000 1.000
3500340000 35 Sheep, meat byproducts 0.100000 1.000 1.000
3500339001 35 Sheep, meat

- babyfood 0.020000 1.000 1.000 1500344000 15 Sorghum, grain 6.000000 1.000 1.000
1500345000 15 Sorghum, syrup 6.000000 1.000 1.000
9500346000 O Soursop 0.600000 1.000 1.000
0603348000 6C Soybean, flour 1.000000 1.000 1.000
0603348001 6C Soybean, flour

- babyfood 1.000000 1.000 1.000 0600350000 6 Soybean, oil 1.000000 1.000 1.000 0600350001 6 Soybean, oil

- babyfood 1.000000 1.000 1.000
0600347000 6 Soybean, seed 1. 000000 1.000 1.000 0600349000 6 Soybean, soy milk 1.000000 1.000 1.000 0600349001 6 Soybean, soy milk

- babyfood or in 1.000000 1.000 1.000 9500351000 O Spanish lime 2.000000 1.000 1.000 9500352000 O Spearmint 7.000000 1.000 1.000 9500353000 O Spearmint, oil 7.000000 1.000 1.000

1902354000 19B Spices, other 4.500000 1.000 1.000

1902354001 19B Spices, other

- babyfood 4.500000 1.000 1.000 0401355000 4A Spinach 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259 0401355001 4A Spinach

- babyfood 30.000000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0902356000 9B Squash, summer 0.300000 1.000 1.000
0902356001 9B Squash, summer

- babyfood 0.300000 1.000 1.000 0902357000
9B Squas h, winter 0.300000 1.000 1.000 0902357001 9B Squash, winter

- babyfood 0.300000 1.000 1.000 9500358000 O Starfruit
0.400000 1.000 1.000 1307359000 13G Strawberry 2.000000 1.000 1.000 1307360000 13G Strawberry, juice 2.000000 1.000

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 33 of 35 1.000 1307360001 13G Strawberry, juice

- babyfood 2.000000 1.000 1.000
1307359001 13G Strawberry

- babyfood 2.000000 1.000 1.000

2002365000 20B Sunflower, oil 1.000000 1.000 1.000

2002365001 20B Sunflower, oil

- babyfood 1.000000 1.000 1.000
2002364000 20B Sunflower, seed 1.000000 1.000 1.000
0103366000 1CD Sweet potato 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0103366001 1CD Sweet potato

- babyfood 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

0402367000 4B Swiss chard 25.000000 1.000 1.000 1001369000 10A Tangerine 3.000000 1.000 1.000 PP# 1E

Full comment: PP# 1E7842 1001370000 10A Tangerine, juice 3.000 000 2.300 1.000 PP# 1E
Full comment: PP# 1E7842
0103371000 1CD Tanier, corm 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259

0801374000 8A Tomatillo 2.000000 1.000 1.000

0801375000 8A Tomato 2.000000 1.000 1.000
0801380000 8A Tomato, Tree 2.000000 1.000 1.000
0801378000 8A Tomato, dried 2.000000 1 4.300 1.000
0801378001 8A Tomato, dried

- babyfood 2.000000 14.300 1.000 0801379000 8A Tomato, juice 2.000000 1.500 1.000
0801376000 8A Tomato, paste 2.000000 5.400 1.000

080137 6001 8A Tomato, paste

- babyfood 2.000000 5.400 1.000
0801377000 8A Tomato, puree 2.000000 3.300 1.000
0801377001 8A Tomato, puree

- babyfood 2.000000 3.300 1.000

0801375001 8A Tomato

- babyf ood 2.000000 1.000 1.000
5000385000 50 Turkey, fat 0.020000 1.000 1.000
5000385001 50 Turkey, fat

- babyfood 0.020000 1.000 1.000 5000383000 50 Turkey, liver 0.100000 1.000 1.000 5000383001 50 Turkey, liver

- babyfood 0.100000 1.000 1.000
5000382000 50 Turkey, meat 0.020000 1.000 1.000
5000384000 50 Turkey, meat byproducts 0.020000 1.000 1.000
5000384001 50 Turkey, meat byproducts

- babyfood 0.020000 1.000 1.000
5000382001 50 Turkey, meat

- babyfood 0.020000 1.000 1.000
5000386000 50 Turkey , skin 0.020000 1.000 1.000 5000386001 50 Turkey, skin

- babyfood 0.020000 1.000 1.000
0103387000 1CD Turmeric 0.020000 1.000 1.000 PP#: 9

Full comment: PP#: 9F06062 , 0F06201, 0F06213, 1F06259 0502389000 5B Turnip, greens 30.000000 1.000 1.000 0101388000 1AB Turnip, roots 0.900000 1.000 1.000

1400391000 14 Walnut 0.100000 1.000 1.000
8601000000 86A Water, direct, all sources 0.214000 1.000 1.000
8602000000 86B Water, indirect, all sources 0.214000 1.000 1.000

0901399000 9A Waterm elon 0.300000 1.000 1.000 0901400000 9A Watermelon, juice 0.300000 1.000 1.000

0103407000 1CD Yam bean 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259
0103406000 1CD Yam, true 0.020000 1.000 1.000 PP#: 9
Full comment: PP#: 9F06062, 0F06201, 0F06213, 1F06259



## Output Listing for the Chronic Dietary Assessment of Methoxyfenozide

U S EPA Ver. 3.16, 03

- 08

- d

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 34 of 35 DEEM

- FCID Chronic analysis for METHOXYFENOZIDE NHANES 2003

- 2008 2

- day

Residue file name: C: \ Users \ wdrew \ Documents \ MethoxyfenozideDEEM122215ChronicInput.R08 Adjustment factor #2 NOT used. Analysis Date 12

- 22

- 2015/10:47:46 Residue file dated: 12

- 22

- 2015/08:48:38 Reference dose (RfD, Chronic) = .102 mg/kg bw/day

=============================================================================== Total exposure by population subgroup

------------------------------------------------------------------------------- Total Exposure

----------------------------------- Population mg/kg Percent of

Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Population 0.031087 30.5% Hispanic 0.032568 31.9%

Non

- Hisp

- White 0.030854 30.2%

Non

- Hisp

- Black 0.029108 28.5%

Non

- Hisp

- Other 0.035111 34.4% Nursing Infants 0. 025096 24.6%

Non

- Nursing Infants 0.056443 55.3%

Female 13+ PREG 0.029328 28.8%

Children 1

- 6 0.070039 68.7%

Ch ildren 7

- 12 0.033291 32.6%

Male 13

- 19 0.023051 22.6%

Female 13

- 19/NP 0.024085 23.6%

Male 20+ 0.025261 24.8%

Female 20+/NP 0.028746 28.2%

Seniors 55+ 0.026677 26.2%

All Infants 0.046765 45.8%

Female 13

- 50 0.027777 27.2%

Children 1

- 2 0.085467 83.8%

Children 3

- 5 0.065000 63.7%

Children 6

- 12 0.036028 35.3%

Youth 13

- 19 0.023580 23.1%

Adults 20

- 49 0.027215 26.7%

Adults 50

- 99 0.026998 26.5%

Female 13

- 49 0.027789 27.2%

-------------------------------------------------------------------------------



## APPENDIX C: Nomenclature and Physicochemical Characteristics of Methoxyfenozide.

Nomenclature

TABLE C.1 Methoxyfenozide Nomenclature

.
Chemical structure

C H 3 

### O N H N

O C H 3



### C H 3 

### C H

3 

### C H 3



### O C H

3 

### C H 3

### Methoxyfenozide Human Health Risk Assessment DP Barcode D429147



### Page 35 of 35 Common name Methoxyfenozide

Company experimental name RH

- 2485

Molecular formula C 22 

### H 28 

### N 2 

### O 3 

### Molecular weight 368.47

IUPAC name N

- tert

- butyl

- N′

- (3

- methoxy

- o

- toluoyl)

- 3,5

- xylohydrazide

CAS name 3

- methoxy

- 2

- methylbenzoic acid 2

- (3,5

- dimethylbenzoyl)

- 2

- (1,1 dimethylethyl)hydrazide

CAS registry number 161050

- 58

- 4

End

- use product (EP) 2 lb ai/gal (240 g ai/L) flowable concentrate (FlC) formulation (Intrepid 2F; EPA Registration #62719

- 442).



## Physicochemical Characteristics

TABLE C.2 Physicochemical Properties of Methoxyfenozide.

Parameter Value Reference

Melting point/range (oC) 206.1

- 208 D231303, H. Podall, 19 May 1997 pH 7.0

Density (g/cm 3 

### ) 0.740 ± 0.0081

Water solubility (mg/L at 20oC) 3.3

Solvent solubility (g/L at 20oC) N

- heptane 1.87 Xylene 3.38

1,2

- dichloroethane 36.72

Methanol 192.92

2

- Propanol 50.22

Vapor pressure (Pa at 25oC) 1.33 x 10

- 5



### Dissociation constant, pK
a 

### None

Octanol/water partition coefficient (Log [K OW 

### ]) 3.72 ± 0.04

UV/visible absorption spectrum No absorption expected at λ> 300 nm