Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

PC Code: 024875 

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

 

MEMORANDUM

DATE: 09-JUN-2010 

SUBJECT: Spiromesifen: Chronic Aggregate Dietary (Food and Drinking Water) Exposure 

and Risk Assessment for the Proposed Uses on Leaf Petioles Subgroup 4B; Pea, 

Dry, Seed; Spearmint, Tops; and Peppermint, Tops. 

PC Code: 024875 DP Barcodes: D369098; D373923 

Decision Nos.: 418426; 426584 Registration Nos.: 264-719 and 264-850 

Petition Nos.: 9F7602; 0E7684 Regulatory Action: Section 3 

Risk Assessment Type: Dietary Case No.: NA 

TXR No.: NA CAS No.: 283594-90-1

MRID No.: NA 40 CFR: §180.607

REVIEWER: Julie L. Van Alstine, Environmental Health Scientist

Risk Assessment Branch 1 (RAB1) 

Health Effects Division (HED; 7509P) 

THROUGH: Thurston G. Morton, Chemist 

 Breann Hanson, Biologist 

Dietary Exposure Science Advisory Council (DESAC)/HED (7509P) 

and 

George F. Kramer, Ph.D., Senior Chemist 

RAB1/HED (7509P) 

TO: Julie L. Van Alstine, Environmental Health Scientist 

 RAB1/HED (7509P) 

and 

 John Hebert (RM 07)/Jennifer Gaines 

 Barbara Madden (RM05)/Andrew Ertman 

 Registration Division (RD; 7505P) 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

PC Code: 024875 

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Executive Summary

A chronic aggregate dietary (food and drinking water) exposure and risk assessment was 

conducted using the Dietary Exposure Evaluation Model (DEEM-FCIDTM, Version 2.03) which 

uses food consumption data from the U.S. Department of Agriculture’s (USDA’s) Continuing 

Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. The analysis was 

performed to support the Section 3 requests for use of spiromesifen [Oberon® 2SC 

Insecticide/Miticide (EPA Reg. No. 264-719) and Oberon® 4SC Insecticide/Miticide (EPA Reg. 

No. 264-850)] on the following commodities: leaf petioles subgroup 4B; pea, dry, seed; 

spearmint, tops; and peppermint, tops. 

Acute Dietary (Food and Drinking Water) Exposure Results and Characterization

No toxic effects attributable to a single exposure to spiromesifen have been identified; therefore, 

an acute reference dose (aRfD) has not been established for spiromesifen and an acute dietary 

exposure assessment was not conducted. 

Chronic Dietary (Food and Drinking Water) Exposure Results and Characterization 

An unrefined, chronic dietary exposure assessment was conducted assuming tolerance-level 

residues [except for the leafy-green and leafy-Brassica vegetable subgroups (4A, 4B, and 5B) 

and spearmint and peppermint tops and oil – see Section II for more details], DEEMTM 7.81 

default processing factors, and 100% crop treated (%CT). Drinking water was incorporated 

directly into the dietary assessment using the chronic concentration for surface water generated 

by the Provisional Cranberry Model. The chronic dietary risk assessment shows that for all 

included commodities, the chronic dietary risk estimates are not of concern to HED [i.e., 

<100% chronic population-adjusted dose (cPAD)]. For the general U.S. population the 

exposure for food and water utilized 51% of the cPAD. The chronic dietary risk estimate for the 

highest reported exposed population subgroup, all infants (<1 year old), is 78% of the cPAD. 

Cancer Dietary (Food and Drinking Water) Exposure Results and Characterization

A cancer dietary assessment was not conducted because spiromesifen is classified as “not likely 

to be carcinogenic to humans.” 

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For acute 

and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose 

(i.e., the dose which HED has concluded will result in no unreasonable adverse health effects). 

This dose is referred to as the population-adjusted dose (PAD). The PAD is equivalent to point 

of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty or safety factors. 

For acute and non-cancer chronic exposures, HED is concerned when estimated dietary risk 

exceeds 100% of the PAD. HED is generally concerned when estimated cancer risk exceeds one 

in one million. References which discuss the acute and chronic risk assessments in more detail 

are available on the EPA/pesticides web site: “Available Information on Assessing Exposure 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

PC Code: 024875 

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from Pesticides, A User’s Guide,” 21-JUN-2000, web link: http://www.epa.gov/fedrgstr/EPAPEST/2000/July/Day-12/6061.pdf; or see SOP 99.6 (20-AUG-1999). 

The most recent dietary exposure risk assessment for spiromesifen was conducted in support of a 

request to reduce rotational crop plantback interval (PBIs) for bulb vegetables (crop group 3) 

(Memo, S. Levy, 04-NOV-2009; D370550). 

II. Residue Information

Residues of Concern: The nature of the residue in plants and livestock is adequately understood 

based on acceptable metabolism studies conducted on lactating goats, laying hens, lettuce, 

cotton, tomato, and confined rotational crops. Based on these studies, the residues of concern in 

plants (primary and rotational) and livestock commodities are as follows (Memo, K. Martin, et 

al., 17-FEB-2005; D300469): 

Primary crops: spiromesifen and its enol metabolite. BSN 2060-4-hydroxymethyl (free and conjugated) is a 

residue of concern in leafy vegetables (risk assessment only) 

Rotational crops: spiromesifen, its enol metabolite, and its metabolites containing the 4-hydroxymethyl moiety 

Livestock: spiromesifen and its metabolites containing the enol and 4-hydroxymethyl moieties 

Established Tolerances: Tolerances have been established under 40 CFR §180.607(a)(1) for the 

combined residues of spiromesifen and its enol metabolite, calculated as the parent compound 

equivalents, in/on primary crop commodities several raw agricultural commodities (RACs). 

Tolerances have been established under 40 CFR §180.607(a)(2) for the combined residues of 

spiromesifen and its metabolites containing the enol and 4-hydroxymethyl (4-hydroxy-3-[4-

(hydroxymethyl)-2,6-dimethylphenyl]-1-oxaspiro[4.4]non-3-en-2-one) moieties, expressed as 

parent equivalents, in/on livestock commodities. Under 40 CFR §180.607(d), tolerances for the 

inadvertent or indirect combined residues of spiromesifen, its enol metabolite, and its metabolites 

containing the 4-hydroxymethyl moiety, calculated as the parent compound equivalents, have 

been established for rotational crops alfalfa, barley, sugar beet, oat, and wheat commodities. 

Recommended Tolerances: Pending submission of revised Sections B and F, the deuterated 

spiromesifen-enol standard, and storage stability data for celery, the available residue chemistry 

database supports the HED-recommended tolerances for residues of the insecticide/miticide 

spiromesifen, including its metabolites and degradates, in or on the commodities listed below. 

Compliance with the tolerance levels specified below is to be determined by measuring only the 

sum of spiromesifen [2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-

dimethylbutanoate], its enol metabolite (4-hydroxy-3-(2,4,6-trimethylphenyl)-1-

oxaspiro[4.4]non-3-en-2-one), calculated as the stoichiometric equivalent of spiromesifen, in or 

on the following RACs: 

Leaf petioles subgroup 4B ....................................... 6.0 ppm 

Pea, dry, seed ......................................................... 0.20 ppm 

Spearmint, tops ......................................................... 45 ppm 

Peppermint, tops ....................................................... 45 ppm 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

PC Code: 024875 

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Residue Data Used for Chronic Assessment: The chronic assessment was based on the 

assumption of tolerance-level residues for all commodities, except for the leafy-green and leafyBrassica vegetable subgroups (4A, 4B, and 5B) and spearmint and peppermint tops and oil. An 

additional metabolite, BSN 2060-4-hydroxymethyl, was observed in the metabolism studies of 

lettuce only, comprising 21% of the total radioactive residues. Since this metabolite’s toxicity is 

expected to be comparable to the parent compound, it was included in the risk assessment for 

leafy crops (including subgroups 4A, 4B, and 5B and spearmint and peppermint tops and oil), 

but not in the tolerance expression. To account for this additional toxicity exposure, the 

recommended tolerance level was multiplied by a correction factor of 1.3x, where 1.3 = 

(Metabolite in Risk Assessment)/(Metabolite in Tolerance Expression). Therefore, in the 

chronic assessment, a residue of 15.6 ppm was used for leafy-green and leafy-Brassica vegetable 

subgroups (4A and 5B), a residue of 7.8 was used for leaf petioles subgroup 4B, and a residue of 

58.5 were used for spearmint and peppermint tops and oil (see Table 1). 

Table 1. Corrected Residues Used in the Chronic Assessment. 

Crop Group and/or Commodity Tolerance (ppm) Corrected Residue Used in Chronic Assessment1 

Brassica, leafy greens, subgroup 5B 12 15.6 

Leafy greens subgroup 4A 12 15.6 

Leaf petioles subgroup 4B 6.02 7.8 

Spearmint tops 452 58.5 

Spearmint oil 452 58.5 

Peppermint tops 452 58.5 

Peppermint oil 452 58.5 1

 Tolerance level residues were corrected to account for potential additional toxicity exposure due to the BSN 2060-4-

hydroxymethyl metabolite which was observed in the metabolism studies of lettuce only. The recommended tolerance level was 

multiplied by a correction factor of 1.3x, where 1.3 = (Metabolite in Risk Assessment)/(Metabolite in Tolerance Expression). 

2

 These are HED-proposed tolerances based on the current petition.

%CT Information: The chronic assessment was based on the assumption of 100% CT for all 

commodities. 

Processing Factors: DEEMTM 7.81 default processing factors were used for all processed 

commodities (where provided). 

III. Drinking Water Data 

The drinking water residues used in the dietary risk assessment were provided by EFED in the 

following memorandum: “Drinking Water Exposure Assessment for Proposed New Uses of 

Spiromesifen on Wheat, Sorghum, Dry Peas, Mint, and the Leafy Petioles Crop Subgroup (4B)” 

(Memo, G. Orrick, 25-MAR-2010; D368558) and incorporated directly into this dietary 

assessment. Water residues were incorporated in the DEEM-FCIDTM into the food categories 

“water, direct, all sources” and “water, indirect, all sources.” 

The proposed use patterns [adjusted by the national default percent-cropped area (PCA) factor 

(87%) for surface water assessment] are less than those from the previously assessed use patterns 

[including the provisional surface water exposure estimates for use on cranberries that were 

adjusted by regional default PCA factors (14-77%)]. Therefore, the exposure estimates from the 

use patterns of maximum exposure in the previous water-exposure assessment (Memo, G. 

Orrick, 01-OCT-2008; D351035) remain the maximum exposure estimates for use in dietary risk 

assessment. 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

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Because monitoring data are unavailable, estimates for spiromesifen concentrations were made 

only with mathematical models. Surface water and ground water estimated drinking water 

concentrations (EDWCs) were modeled with the Provisional Cranberry Model and Screening 

Concentration in Ground Water (SCI-GROW) Model, respectively. EDWCs were generated for 

the total toxic residue which includes spiromesifen, the -enol and -carboxy metabolites, and 

unextracted material. The surface water estimate was the value used in this assessment. 

Table 2. Total Residue EDWCs in Surface Water and Ground Water for the Proposed Spiromesifen Uses on Leaf Petioles 

Subgroup 4B; Pea, Dry, Seed; Spearmint, Tops; and Peppermint, Tops, Based on the Maximum Use Patterns for 

Cranberries and Ornamentals.

Source Use (maximum rate) 1-in-10-year Peak 

Exposure (ppb)

1-in-10-year Annual Mean 

Exposure (ppb)

30-year Mean 

Exposure (ppb) 

Surface water Cranberries (0.75 lbs a.i./A/year) 199 188 <188 

Ground water Ornamentals (3.0 lbs a.i./A/year) 86 86 <86 

IV. DEEM-FCIDTM Program and Consumption Information

The spiromesifen chronic dietary exposure assessment was conducted using DEEM-FCIDTM

(Version 2.03) which incorporates consumption data from USDA’s CSFII, 1994-1996 and 1998. 

The 1994-96 and 1998 data are based on the reported consumption of more than 20,000 

individuals over two non-consecutive survey days. Foods “as consumed” (e.g., apple pie) are 

linked to EPA-defined food commodities (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; 

or wheat flour - cooked; fresh or N/S, baked) using publicly available recipe translation files 

developed jointly by USDA/ARS and EPA. For chronic exposure assessment, consumption data 

are averaged for the entire U.S. population and within population subgroups, but for acute 

exposure assessment are retained as individual consumption events. Based on analysis of the 

1994-96, and 1998 CSFII consumption data, which took into account dietary patterns and survey 

respondents, HED concluded that it is most appropriate to report risk for the following 

population subgroups: the general U.S. population, all infants (<1 year old), children 1-2, 

children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old. 

For chronic dietary exposure assessment, an estimate of the residue level in each food or foodform (e.g., orange or orange juice) on the food commodity residue list is multiplied by the 

average daily consumption estimate for that food/food form to produce a residue intake estimate. 

The resulting residue intake estimate for each food/food form is summed with the residue intake 

estimates for all other food/food forms on the commodity residue list to arrive at the total 

average estimated exposure. Exposure is expressed in mg/kg body weight/day and as a percent 

of the cPAD. This procedure is performed for each population subgroup. 

V. Toxicological Information 

The RAB1 toxicologists have reevaluated the spiromesifen database and reaffirmed the previous 

toxicology conclusions. The endpoints in Table 3 have been confirmed by the risk assessment 

team as appropriate for the current risk assessment. 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

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Table 3. Summary of Toxicological Endpoints for Use in Human-Health Risk Assessment1.

Exposure 

Scenario

Dose Used in Risk Assessment,

UF

FQPA SF and Level 

of Concern for Risk 

Assessment 

Study and Toxicological Effects

Acute Dietary 

All populations

Not applicable None An endpoint of concern attributable to a single 

dose was not identified. An acute RfD was not 

established. 

Chronic Dietary 

all populations

NOAEL = 2.2 mg/kg/day 

UF = 100X 

Chronic RfD = 0.022 mg/kg/day 

cPAD = 0.022 mg/kg/day 

FQPA SF = 1X Two-generation reproduction rats. 

The parental systemic LOAEL (M/F)=13.2/91.0 

mg/kg bw/day based on decreased body weight 

and spleen weight in males; and decreased body 

weight, spleen weight, atrophy of adrenal zona 

glomerulosa, and thyroid follicular cell 

hypertrophy in F1 females. 

Cancer (oral, 

dermal, inhalation) Classification: Not likely to be carcinogenic to humans. 

1

 UF = uncertainty factor; NOAEL = no-observed adverse-effect level; LOAEL = lowest-observed adverse-effect 

level; PAD = population-adjusted dose (a = acute, c = chronic); FQPA SF = FQPA Safety Factor; RfD = reference 

dose. 

VI. Results/Discussion 

For chronic assessments, HED is concerned when dietary risk exceeds 100% of the PAD. The 

DEEM-FCIDTM analyses estimate the dietary exposure of the U.S. population and various 

population subgroups. The results reported in Table 4 are for the general U.S. population, all 

infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, 

adults 20-49, and adults 50+ years. 

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis: The chronic dietary 

exposure for food and drinking water utilized 51% of the cPAD for the general U.S. population. 

The chronic dietary exposure for the highest reported exposed population subgroup, all infants 

(<1 year old) was 78% of the cPAD. The results of the chronic dietary exposure analyses are 

reported in Table 4.

Table 4. Summary of Dietary (Food and Drinking Water) Exposure Risk for Spiromesifen. 

Acute Dietary (95th Percentile) Chronic Dietary 

Population Subgroup Dietary Exposure 

(mg/kg/day) 

% 

aPAD 

Dietary Exposure 

(mg/kg/day) 

% 

cPAD 

General U.S. Population 0.011172 51 

All Infants (<1 year old) 0.017078 78 

Children 1-2 years old 0.015659 71 

Children 3-5 years old 0.015154 69 

Children 6-12 years old 0.011299 51 

Youth 13-19 years old 0.009059 41 

Adults 20-49 years old 0.010825 49 

Adults 50+ years old 0.010938 50 

Females 13-49 years old 

NA 

0.010942 50 

*The values for the highest exposed population for each type of risk assessment are bolded. 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

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VII. Characterization of Inputs/Outputs

These analyses are considered to be very conservative dietary exposure assessments. Residues in 

foods were assumed to be equivalent to the tolerance levels except for the leafy-green and leafyBrassica vegetable subgroups (4A, 4B, and 5B) and spearmint and peppermint tops and oil. 

Tolerance-level residues should always exceed the residue levels found on food commodities at 

the time of consumption. When field trials are performed, the maximum allowable application 

rate is used and crops are harvested at the minimum PHI. Samples are stored frozen until 

analysis to ensure minimal degradation of residues. In actual practice, however, growers will not 

usually use the maximum application rates for economic reasons. In addition, most crops are not 

harvested and immediately stored frozen. Also, 100% CT was assumed. For these reasons, 

HED is confident that this analysis does not underestimate risk to the general U.S. population or 

any population subgroup. Further refinement to the analyses could be made through the use of 

anticipated residues, empirical processing factors, and incorporation of percentages of crops 

treated with spiromesifen. Since risk estimates are not of concern to HED, a more highly refined 

analysis is not needed at this time. 

VIII. Conclusions

A chronic dietary exposure and risk assessments was conducted for the proposed food uses and 

permanent tolerances of spiromesifen, including potential exposure from drinking water. The 

chronic dietary (food and drinking water) exposure to spiromesifen is not of concern to HED for 

the general U.S. population and all population subgroups. The chronic dietary exposure utilized 

51% cPAD for the general U.S. population, and 78% of the cPAD for all infants (<1 year old), 

the most highly exposed population subgroup. 

IX. List of Attachments 

Attachment 1: DEEM-FCIDTM Chronic Residue Input File. 

Attachment 2: DEEM-FCIDTM Chronic Results File. 

cc: J. Van Alstine 

RDI: T. Morton (5/18/10), B. Hanson (5/18/10); G. Kramer (5/17/10) 

J. Van Alstine: S-10954: Potomac Yard 1 (PY1): (703) 603-8866: 7509P: RAB1 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

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Attachment 1: DEEM-FCIDTM Chronic Residue Input File 

Filename: C:\Documents and Settings\jlangsda\My Documents\Chemicals\Spiromesifen\Crop Group 

4B--Celery; Dried Pea; Mint\DEEM\Spiromesifen_024875_Chronic__17-MAY-2010.R98 

Chemical: Spiromesifen 

RfD(Chronic): .022 mg/kg bw/day NOEL(Chronic): 2.2 mg/kg bw/day 

RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day 

Date created/last modified: 05-17-2010/13:44:41/8 Program ver. 2.03 

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

 EPA Crop Def Res Adj.Factors Comment 

 Code Grp Commodity Name (ppm) #1 #2 

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

01010520 1A Beet, sugar 0.030000 1.000 1.000 3F6537 

01010521 1A Beet, sugar-babyfood 0.030000 1.000 1.000 3F6537 

01010530 1A Beet, sugar, molasses 0.030000 1.000 1.000 3F6537 

01010531 1A Beet, sugar, molasses-babyfood 0.030000 1.000 1.000 3F6537 

01030150 1CD Arrowroot, flour 0.020000 1.000 1.000 3F6537 

01030151 1CD Arrowroot, flour-babyfood 0.020000 1.000 1.000 3F6537 

01030170 1CD Artichoke, Jerusalem 0.020000 1.000 1.000 3F6537 

01030820 1CD Cassava 0.020000 1.000 1.000 3F6537 

01030821 1CD Cassava-babyfood 0.020000 1.000 1.000 3F6537 

01031390 1CD Dasheen, corm 0.020000 1.000 1.000 3F6537 

01031660 1CD Ginger 0.020000 1.000 1.000 3F6537 

01031661 1CD Ginger-babyfood 0.020000 1.000 1.000 3F6537 

01031670 1CD Ginger, dried 0.020000 1.000 1.000 3F6537 

01032960 1C Potato, chips 0.020000 1.000 1.000 3F6537 

01032970 1C Potato, dry (granules/ flakes) 0.020000 6.500 1.000 3F6537 

01032971 1C Potato, dry (granules/ flakes)-b 0.020000 6.500 1.000 3F6537 

01032980 1C Potato, flour 0.020000 6.500 1.000 3F6537 

01032981 1C Potato, flour-babyfood 0.020000 6.500 1.000 3F6537 

01032990 1C Potato, tuber, w/peel 0.020000 1.000 1.000 3F6537 

01032991 1C Potato, tuber, w/peel-babyfood 0.020000 1.000 1.000 3F6537 

01033000 1C Potato, tuber, w/o peel 0.020000 1.000 1.000 3F6537 

01033001 1C Potato, tuber, w/o peel-babyfood 0.020000 1.000 1.000 3F6537 

01033660 1CD Sweet potato 0.020000 1.000 1.000 3F6537 

01033661 1CD Sweet potato-babyfood 0.020000 1.000 1.000 3F6537 

01033710 1CD Tanier, corm 0.020000 1.000 1.000 3F6537 

01033870 1CD Turmeric 0.020000 1.000 1.000 3F6537 

01034060 1CD Yam, true 0.020000 1.000 1.000 3F6537 

01034070 1CD Yam bean 0.020000 1.000 1.000 3F6537 

03001640 3 Garlic 0.090000 1.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03001650 3 Garlic, dried 0.090000 1.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03001651 3 Garlic, dried-babyfood 0.090000 1.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03001980 3 Leek 0.090000 1.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03002370 3 Onion, dry bulb 0.090000 1.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03002371 3 Onion, dry bulb-babyfood 0.090000 1.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03002380 3 Onion, dry bulb, dried 0.090000 9.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03002381 3 Onion, dry bulb, dried-babyfood 0.090000 9.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03002390 3 Onion, green 0.090000 1.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

03003380 3 Shallot 0.090000 1.000 1.000 New to 

 Full comment: New tol. level, inadvertent residues, 8F7398 

04010050 4A Amaranth, leafy 15.600000 1.000 1.000 3F6537 

04010180 4A Arugula 15.600000 1.000 1.000 3F6537 

04011040 4A Chrysanthemum, garland 15.600000 1.000 1.000 3F6537 

04011330 4A Cress, garden 15.600000 1.000 1.000 3F6537 

04011340 4A Cress, upland 15.600000 1.000 1.000 3F6537 

04011380 4A Dandelion, leaves 15.600000 1.000 1.000 3F6537 

04011500 4A Endive 15.600000 1.000 1.000 3F6537 
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04012040 4A Lettuce, head 15.600000 1.000 1.000 3F6537 

04012050 4A Lettuce, leaf 15.600000 1.000 1.000 3F6537 

04012480 4A Parsley, leaves 15.600000 1.000 1.000 3F6537 

04013130 4A Radicchio 15.600000 1.000 1.000 3F6537 

04013550 4A Spinach 15.600000 1.000 1.000 3F6537 

04013551 4A Spinach-babyfood 15.600000 1.000 1.000 3F6537 

04020760 4B Cardoon 7.800000 1.000 1.000 

04020850 4B Celery 7.800000 1.000 1.000 

04020851 4B Celery-babyfood 7.800000 1.000 1.000 

04020860 4B Celery, juice 7.800000 1.000 1.000 

04020870 4B Celtuce 7.800000 1.000 1.000 

04021520 4B Fennel, Florence 7.800000 1.000 1.000 

04023220 4B Rhubarb 7.800000 1.000 1.000 

04023670 4B Swiss chard 7.800000 1.000 1.000 

05010610 5A Broccoli 2.000000 1.000 1.000 3F6537 

05010611 5A Broccoli-babyfood 2.000000 1.000 1.000 3F6537 

05010620 5A Broccoli, Chinese 2.000000 1.000 1.000 3F6537 

05010640 5A Brussels sprouts 2.000000 1.000 1.000 3F6537 

05010690 5A Cabbage 2.000000 1.000 1.000 3F6537 

05010710 5A Cabbage, Chinese, napa 2.000000 1.000 1.000 3F6537 

05010720 5A Cabbage, Chinese, mustard 2.000000 1.000 1.000 3F6537 

05010830 5A Cauliflower 2.000000 1.000 1.000 3F6537 

05011960 5A Kohlrabi 2.000000 1.000 1.000 3F6537 

05020630 5B Broccoli raab 15.600000 1.000 1.000 3F6537 

05020700 5B Cabbage, Chinese, bok choy 15.600000 1.000 1.000 3F6537 

05021170 5B Collards 15.600000 1.000 1.000 3F6537 

05021940 5B Kale 15.600000 1.000 1.000 3F6537 

05022290 5B Mustard greens 15.600000 1.000 1.000 3F6537 

05023180 5B Rape greens 15.600000 1.000 1.000 3F6537 

06003470 6 Soybean, seed 0.020000 1.000 1.000 08DE03 

06003480 6 Soybean, flour 0.020000 1.000 1.000 08DE03 

06003481 6 Soybean, flour-babyfood 0.020000 1.000 1.000 08DE03 

06003490 6 Soybean, soy milk 0.020000 1.000 1.000 08DE03 

06003491 6 Soybean, soy milk-babyfood or in 0.020000 1.000 1.000 08DE03 

06003500 6 Soybean, oil 0.020000 1.000 1.000 08DE03 

06003501 6 Soybean, oil-babyfood 0.020000 1.000 1.000 08DE03 

06010430 6A Bean, snap, succulent 0.800000 1.000 1.000 7E7195 

06010431 6A Bean, snap, succulent-babyfood 0.800000 1.000 1.000 7E7195 

06020310 6B Bean, broad, succulent 0.100000 1.000 1.000 7E7195 

06020330 6B Bean, cowpea, succulent 0.100000 1.000 1.000 7E7195 

06020370 6B Bean, lima, succulent 0.100000 1.000 1.000 7E7195 

06030300 6C Bean, black, seed 0.020000 1.000 1.000 7E7195 

06030320 6C Bean, broad, seed 0.020000 1.000 1.000 7E7195 

06030340 6C Bean, cowpea, seed 0.020000 1.000 1.000 7E7195 

06030350 6C Bean, great northern, seed 0.020000 1.000 1.000 7E7195 

06030360 6C Bean, kidney, seed 0.020000 1.000 1.000 7E7195 

06030380 6C Bean, lima, seed 0.020000 1.000 1.000 7E7195 

06030390 6C Bean, mung, seed 0.020000 1.000 1.000 7E7195 

06030400 6C Bean, navy, seed 0.020000 1.000 1.000 7E7195 

06030410 6C Bean, pink, seed 0.020000 1.000 1.000 7E7195 

06030420 6C Bean, pinto, seed 0.020000 1.000 1.000 7E7195 

06030980 6C Chickpea, seed 0.200000 1.000 1.000 7E7195 

06030981 6C Chickpea, seed-babyfood 0.200000 1.000 1.000 7E7195 

06030990 6C Chickpea, flour 0.200000 1.000 1.000 7E7195 

06031820 6C Guar, seed 0.020000 1.000 1.000 7E7195 

06031821 6C Guar, seed-babyfood 0.020000 1.000 1.000 7E7195 

06032030 6C Lentil, seed 0.200000 1.000 1.000 7E7195 

06032560 6C Pea, dry 0.200000 1.000 1.000 7E7195 

06032561 6C Pea, dry-babyfood 0.200000 1.000 1.000 7E7195 

06032580 6C Pea, pigeon, seed 0.200000 1.000 1.000 7E7195 

08001480 8 Eggplant 0.450000 1.000 1.000 3F6537 

08002340 8 Okra 0.450000 1.000 1.000 

08002700 8 Pepper, bell 0.450000 1.000 1.000 3F6537 

08002701 8 Pepper, bell-babyfood 0.450000 1.000 1.000 3F6537 

08002710 8 Pepper, bell, dried 0.450000 1.000 1.000 3F6537 

08002711 8 Pepper, bell, dried-babyfood 0.450000 1.000 1.000 3F6537 

08002720 8 Pepper, nonbell 0.450000 1.000 1.000 3F6537 

08002721 8 Pepper, nonbell-babyfood 0.450000 1.000 1.000 3F6537 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

PC Code: 024875 

______________________________________________________________________________________

Page 10 of 12 

08002730 8 Pepper, nonbell, dried 0.450000 1.000 1.000 3F6537 

08003740 8 Tomatillo 0.450000 1.000 1.000 3F6537 

08003750 8 Tomato 0.450000 1.000 1.000 3F6537 

08003751 8 Tomato-babyfood 0.450000 1.000 1.000 3F6537 

08003760 8 Tomato, paste 0.800000 1.000 1.000 8E7340 

08003761 8 Tomato, paste-babyfood 0.800000 1.000 1.000 8E7340 

08003770 8 Tomato, puree 0.450000 3.300 1.000 3F6537 

08003771 8 Tomato, puree-babyfood 0.450000 3.300 1.000 3F6537 

08003780 8 Tomato, dried 0.450000 14.300 1.000 3F6537 

08003781 8 Tomato, dried-babyfood 0.450000 14.300 1.000 3F6537 

08003790 8 Tomato, juice 0.450000 1.500 1.000 3F6537 

09010750 9A Cantaloupe 0.100000 1.000 1.000 3F6537 

09010800 9A Casaba 0.100000 1.000 1.000 3F6537 

09011870 9A Honeydew melon 0.100000 1.000 1.000 3F6537 

09013990 9A Watermelon 0.100000 1.000 1.000 3F6537 

09014000 9A Watermelon, juice 0.100000 1.000 1.000 3F6537 

09020210 9B Balsam pear 0.100000 1.000 1.000 3F6537 

09020880 9B Chayote, fruit 0.100000 1.000 1.000 3F6537 

09021020 9B Chinese waxgourd 0.100000 1.000 1.000 3F6537 

09021350 9B Cucumber 0.100000 1.000 1.000 3F6537 

09023080 9B Pumpkin 0.100000 1.000 1.000 3F6537 

09023090 9B Pumpkin, seed 0.100000 1.000 1.000 3F6537 

09023560 9B Squash, summer 0.100000 1.000 1.000 3F6537 

09023561 9B Squash, summer-babyfood 0.100000 1.000 1.000 3F6537 

09023570 9B Squash, winter 0.100000 1.000 1.000 3F6537 

09023571 9B Squash, winter-babyfood 0.100000 1.000 1.000 3F6537 

13020570 13B Blueberry 2.000000 1.000 1.000 8E7340 

13020571 13B Blueberry-babyfood 2.000000 1.000 1.000 8E7340 

15000250 15 Barley, pearled barley 0.030000 1.000 1.000 3F6537 

15000251 15 Barley, pearled barley-babyfood 0.030000 1.000 1.000 3F6537 

15000260 15 Barley, flour 0.030000 1.000 1.000 3F6537 

15000261 15 Barley, flour-babyfood 0.030000 1.000 1.000 3F6537 

15000270 15 Barley, bran 0.030000 1.000 1.000 3F6537 

15001200 15 Corn, field, flour 0.020000 1.000 1.000 3F6537 

15001201 15 Corn, field, flour-babyfood 0.020000 1.000 1.000 3F6537 

15001210 15 Corn, field, meal 0.020000 1.000 1.000 3F6537 

15001211 15 Corn, field, meal-babyfood 0.020000 1.000 1.000 3F6537 

15001220 15 Corn, field, bran 0.020000 1.000 1.000 3F6537 

15001230 15 Corn, field, starch 0.020000 1.000 1.000 3F6537 

15001231 15 Corn, field, starch-babyfood 0.020000 1.000 1.000 3F6537 

15001240 15 Corn, field, syrup 0.020000 1.500 1.000 3F6537 

15001241 15 Corn, field, syrup-babyfood 0.020000 1.500 1.000 3F6537 

15001250 15 Corn, field, oil 0.020000 1.000 1.000 3F6537 

15001251 15 Corn, field, oil-babyfood 0.020000 1.000 1.000 3F6537 

15001260 15 Corn, pop 0.020000 1.000 1.000 8F7338 

15001270 15 Corn, sweet 0.020000 1.000 1.000 8E7340 

15001271 15 Corn, sweet-babyfood 0.020000 1.000 1.000 8E7340 

15002310 15 Oat, bran 0.030000 1.000 1.000 

15002320 15 Oat, flour 0.030000 1.000 1.000 

15002321 15 Oat, flour-babyfood 0.030000 1.000 1.000 

15002330 15 Oat, groats/rolled oats 0.030000 1.000 1.000 

15002331 15 Oat, groats/rolled oats-babyfood 0.030000 1.000 1.000 

15004010 15 Wheat, grain 0.030000 1.000 1.000 3F6537 

15004011 15 Wheat, grain-babyfood 0.030000 1.000 1.000 3F6537 

15004020 15 Wheat, flour 0.030000 1.000 1.000 3F6537 

15004021 15 Wheat, flour-babyfood 0.030000 1.000 1.000 3F6537 

15004030 15 Wheat, germ 0.030000 1.000 1.000 3F6537 

15004040 15 Wheat, bran 0.030000 1.000 1.000 3F6537 

21000440 M Beef, meat 0.020000 1.000 1.000 7E7195 

21000441 M Beef, meat-babyfood 0.020000 1.000 1.000 7E7195 

21000450 M Beef, meat, dried 0.020000 1.920 1.000 7E7195 

21000460 M Beef, meat byproducts 0.200000 1.000 1.000 8E7340 

21000461 M Beef, meat byproducts-babyfood 0.200000 1.000 1.000 8E7340 

21000470 M Beef, fat 0.100000 1.000 1.000 7E7195 

21000471 M Beef,fat-babyfood 0.100000 1.000 1.000 7E7195 

21000480 M Beef, kidney 0.200000 1.000 1.000 8E7340 

21000490 M Beef, liver 0.200000 1.000 1.000 8E7340 

21000491 M Beef, liver-babyfood 0.200000 1.000 1.000 8E7340 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

PC Code: 024875 

______________________________________________________________________________________

Page 11 of 12 

23001690 M Goat, meat 0.020000 1.000 1.000 7E7195 

23001700 M Goat, meat byproducts 0.200000 1.000 1.000 8E7340 

23001710 M Goat, fat 0.100000 1.000 1.000 7E7195 

23001720 M Goat, kidney 0.200000 1.000 1.000 8E7340 

23001730 M Goat, liver 0.200000 1.000 1.000 8E7340 

24001890 M Horse, meat 0.020000 1.000 1.000 7E7195 

26003390 M Sheep, meat 0.020000 1.000 1.000 7E7195 

26003391 M Sheep, meat-babyfood 0.020000 1.000 1.000 7E7195 

26003400 M Sheep, meat byproducts 0.200000 1.000 1.000 8E7340 

26003410 M Sheep, fat 0.100000 1.000 1.000 7E7195 

26003411 M Sheep, fat-babyfood 0.100000 1.000 1.000 7E7195 

26003420 M Sheep, kidney 0.200000 1.000 1.000 8E7340 

26003430 M Sheep, liver 0.200000 1.000 1.000 8E7340 

27002220 D Milk, fat 0.250000 1.000 1.000 8E7340 

27002221 D Milk, fat - baby food/infant for 0.250000 1.000 1.000 8E7340 

27012230 D Milk, nonfat solids 0.010000 1.000 1.000 7E7195 

27012231 D Milk, nonfat solids-baby food/in 0.010000 1.000 1.000 7E7195 

27022240 D Milk, water 0.010000 1.000 1.000 7E7195 

27022241 D Milk, water-babyfood/infant form 0.010000 1.000 1.000 7E7195 

27032251 D Milk, sugar (lactose)-baby food/ 0.010000 1.000 1.000 7E7195 

86010000 O Water, direct, all sources 0.188000 1.000 1.000 

86020000 O Water, indirect, all sources 0.188000 1.000 1.000 

95001280 O Cottonseed, oil 0.500000 1.000 1.000 3F6537 

95001281 O Cottonseed, oil-babyfood 0.500000 1.000 1.000 3F6537 

95001300 O Cranberry 2.000000 1.000 1.000 8E7340 

95001301 O Cranberry-babyfood 2.000000 1.000 1.000 8E7340 

95001310 O Cranberry, dried 2.000000 1.000 1.000 8E7340 

95001320 O Cranberry, juice 2.000000 1.100 1.000 8E7340 

95001321 O Cranberry, juice-babyfood 2.000000 1.100 1.000 8E7340 

95002750 O Peppermint 58.500000 1.000 1.000 

95002760 O Peppermint, oil 58.500000 1.000 1.000 

95003520 O Spearmint 58.500000 1.000 1.000 

95003530 O Spearmint, oil 58.500000 1.000 1.000 

95003590 O Strawberry 2.000000 1.000 1.000 3F6537 

95003591 O Strawberry-babyfood 2.000000 1.000 1.000 3F6537 

95003600 O Strawberry, juice 2.000000 1.000 1.000 3F6537 

95003601 O Strawberry, juice-babyfood 2.000000 1.000 1.000 3F6537 
Spiromesifen Dietary Exposure and Risk Assessment DP# 369098 

PC Code: 024875 

______________________________________________________________________________________

Page 12 of 12 

Attachment 3: DEEM-FCIDTM Chronic Results File

U.S. Environmental Protection Agency Ver. 2.00 

DEEM-FCID Chronic analysis for SPIROMESIFEN (1994-98 data) 

Residue file name: C:\Documents and Settings\jlangsda\My 

Documents\Chemicals\Spiromesifen\Crop Group 4B--Celery; Dried Pea; 

Mint\DEEM\Spiromesifen_024875_Chronic__17-MAY-2010.R98 

 Adjustment factor #2 used. 

Analysis Date 05-17-2010/13:45:21 Residue file dated: 05-17-2010/13:44:41/8 

Reference dose (RfD, Chronic) = .022 mg/kg bw/day 

=============================================================================== 

 Total exposure by population subgroup 

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

 Total Exposure 

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

 Population mg/kg Percent of 

 Subgroup body wt/day Rfd 

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

U.S. Population (total) 0.011172 50.8% 

U.S. Population (spring season) 0.011414 51.9% 

U.S. Population (summer season) 0.011284 51.3% 

U.S. Population (autumn season) 0.010969 49.9% 

U.S. Population (winter season) 0.011026 50.1% 

Northeast region 0.011222 51.0% 

Midwest region 0.011144 50.7% 

Southern region 0.010252 46.6% 

Western region 0.012616 57.3% 

Hispanics 0.011451 52.0% 

Non-hispanic whites 0.010990 50.0% 

Non-hispanic blacks 0.010592 48.1% 

Non-hisp/non-white/non-black 0.015149 68.9% 

All infants (< 1 year) 0.017078 77.6% 

Nursing infants 0.006669 30.3% 

Non-nursing infants 0.021028 95.6% 

Children 1-6 yrs 0.015039 68.4% 

Children 7-12 yrs 0.010914 49.6% 

Females 13-19 (not preg or nursing) 0.008830 40.1% 

Females 20+ (not preg or nursing) 0.011458 52.1% 

Females 13-50 yrs 0.011048 50.2% 

Females 13+ (preg/not nursing) 0.010137 46.1% 

Females 13+ (nursing) 0.013373 60.8% 

Males 13-19 yrs 0.009206 41.8% 

Males 20+ yrs 0.010231 46.5% 

Seniors 55+ 0.010799 49.1% 

Children 1-2 yrs 0.015659 71.2% 

Children 3-5 yrs 0.015154 68.9% 

Children 6-12 yrs 0.011299 51.4% 

Youth 13-19 yrs 0.009059 41.2% 

Adults 20-49 yrs 0.010825 49.2% 

Adults 50+ yrs 0.010938 49.7% 

Females 13-49 yrs 0.010942 49.7% 

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