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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), from 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 on 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 Commission (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 petition 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-Income 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 subgroups 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 performed 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-application 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 traditional 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 requirements. 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/handlerexposure-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 ingredient 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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in this document include chronic dietary risk (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/acre (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 Summary of Proposed Section 18 Use Directions for Methoxyfenozide on Rice. 

Application Type; 

Equipment1 

Single Use 

Rate (lb 

ai/A) 

Max. 

Uses Per 

Season

Max. Seasonal 

Use Rate (lb 

ai/A)2 

PHI3

(Days) 

Use Directions, Application 

Timing, and Limitations

Foliar; aerial equipment. 0.12-0.16 2 0.32 14 Minimum RTI4 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 tolerances 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 assessment 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. 

Occupational 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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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 concern. 

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 residential 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 assessment 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 exposure 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 oral 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 has 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 and 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 observed in the rat and dog following 

chronic dietary exposure, along with methemoglobinemia and RBC structural abnormalities. 
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Increased platelets were also observed. An increase in the cellularity of rib and sternum bone 

marrow, along with macrophage pigmentation 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 subchronic 

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. 

 

Increased 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 chronic 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 exposure. 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 following 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 concentrations 

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 

neurohistopathology 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. 

There 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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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-occupational 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 toxicity 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 NonOccupational 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

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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Chronic dietary (all 

populations) 

NOAEL = 10.2 

mg/kg/day 

UFA = 10X 

UFH = 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 increased 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 

UFA = 10X 

UFH = 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 NonOccupational 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.) 

UFA = 10X 

UFH = 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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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 factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = 

population adjusted dose (c = chronic). RfD = reference dose. 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.) 

UFA = 10X 

UFH = 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) 

Classification: 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 factor. UFA = extrapolation from animal to human (interspecies). UFH = 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 associated 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 are 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 would 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 sorghum 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/MS), 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 

(EFSA, 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 secured 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 used 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 applications 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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samples were harvested at a PHI of 62 days after the second treatment, and 98 days after the first 

application (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 maximum 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 between 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 

Evaluation 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 residues 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 methoxyfenozide 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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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 the 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 

are 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 tolerance 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% crop 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 (D429160; 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 conservative 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 Exposure 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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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-route 

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 assessment (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 following 

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 agricultural 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 exposures 

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, drinking water, and residential exposures. In an aggregate 
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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 

residential 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 calculated 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. The 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, EPA 

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 chemicals, 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 

inhalation 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-application 

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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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 appropriate. 

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 Registration 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 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. 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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Drinking Water 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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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 (Technical). 

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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* 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 LD50 >5000 mg/kg, both sexes IV 

870.1100 Acute oral [mouse] 44144416 LD50 >5000 mg/kg, both sexes IV 

870.1200 Acute dermal [rat] 44144418 LD50 >2000 mg/kg, both sexes III 

870.1300 Acute inhalation [rat] 44144420 LC50 >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 liver 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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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, 90.8184.8, 

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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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) 

Maternal NOAEL = 1000 mg/kg/day 

LOAEL > 1000 mg/kg/day (HDT) 

Developmental NOAEL = 1000 mg/kg/day 

LOAEL > 1000 mg/kg/day (HDT) 

870.3800 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 

increased 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 

liver and spleen. 

TABLE A.3 Subchronic, Chronic and Other Toxicity Profile – Methoxyfenozide (Technical)
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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 hypertrophy, 

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 (precipitation 

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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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 up 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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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 feces (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 weights. 

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 Almond, 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#: 9F06062, 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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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 1.000 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 0.600000 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 Basil, 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-babyfood 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 0.100000 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 

0101050001 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, sugar, 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 
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Page 26 of 35

1301056001 13A Blackberry, juice-babyfood 6.000000 1.000 1.000 

1302057000 13B Blueberry 4.000000 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-babyfood 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 0.100000 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 

1201090001 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 6C 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 Chrysanthemum, 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# 1E7842 

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 

0502117000 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 Cottonseed, 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 1CD 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#: 9F06062, 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 1.000 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 0603182001 

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 400.000000 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 

0101190000 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-babyfood 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 comment: 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 Loganberry 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 Onion, 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 1.000 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 

9500253000 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 1.000 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 4.500000 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 

9500275000 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 0.700000 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 35

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 1.000 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 0.020000 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 1.000 

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 1.000 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, roots 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 
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1301321001 13A Raspberry, 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 Squash, 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 
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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 3.000000 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 14.300 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 

0801376001 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-babyfood 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 Watermelon 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 

US EPA Ver. 3.16, 03-08-d 
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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% 

Children 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 

CH3

O

N

H

N

O

CH3

CH3

H3C CH3

H3C O

CH3
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Common name Methoxyfenozide 

Company experimental name RH-2485 

Molecular formula C22H28N2O3

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-

(1,1dimethylethyl)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/cm3) 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, pKa None 

Octanol/water partition coefficient 

(Log [KOW]) 

3.72 ± 0.04 

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