Spiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 1 of 12 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 Us es 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 Advi sory 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 an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 2 of 12 Executive Summary

A chronic aggregate dietary (food and drinki ng water) exposure and risk assessment was conducted using the Dietary Exposur e Evaluation Model (DEEM-FCID TM 

### , Version 2.03) which uses food consumption data from the U.S. Depa rtment of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (C SFII) from 1994-1996 and 1998. The analysis was performed to support the Section 3 reque sts 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) Ex posure 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 esta blished for spiromesifen and an acute dietary exposure assessment was not conducted.

Chronic Dietary (Food and Dr inking Water) Exposure Resu lts and Characterization

An unrefined, chronic dietary exposure assessm ent 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], DEEM TM 

### 7.81 default processing factors, and 100% crop treat ed (%CT). Drinking water was incorporated directly into the dietary asse ssment using the chronic concentr ation for surface water generated by the Provisional Cranberry Model. The chroni c 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 cP AD. The chronic dietary risk estimate for the highest reported exposed populat ion 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 incorporat es both exposure and toxicity of a given pesticide. For acute and chronic assessments, the risk is expresse d 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 co ncerned 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 ExposureSpiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 3 of 12 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 interv al (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 conducte d on lactating goats, laying hens, lettuce, cotton, tomato, and confined rotational crops. Ba sed 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 vege tables (risk assessment only)

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

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



### Established Tolerances: Tolerances have been establ ished under 40 CFR §180.607(a)(1) for the combined residues of spiromesifen and its en ol metabolite, calculated as the parent compound equivalents, in/on primary crop commodities se veral raw agricultural commodities (RACs). Tolerances have been establ ished 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 commoditie s. 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 degrad ates, in or on the commodities listed below. Compliance with the tolerance levels specified be low 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 metabolit e (4-hydroxy-3-(2,4,6-trimethylphenyl)-1- oxaspiro[4.4]non-3-en-2-one), calcul ated as the stoichiometric equi valent 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 ppmSpiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 4 of 12 Residue Data Used for Chronic Assessment: The chronic assessment was based on the assumption of tolerance-level residues for all co mmodities, except for the leafy-green and leafyBrassica vegetable subgroups (4A, 4B, and 5B) and sp earmint and peppermint tops and oil. An additional metabolite, BSN 2060-4-hydroxymethyl, wa s observed in the metabolism studies of lettuce only, comprising 21% of the total radioactiv e residues. Since this metabolite’s toxicity is expected to be comparable to the parent co mpound, it was included in th e risk assessment for leafy crops (including subgroups 4A, 4B, and 5B and spearmint and peppermint tops and oil), but not in the tolerance expre ssion. To account for this addi tional 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 pp m 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 Assessment 1

Brassica , leafy greens, subgroup 5B 12 15.6 Leafy greens subgroup 4A 12 15.6 Leaf petioles subgroup 4B 6.0 2 7.8 Spearmint tops 45 2 58.5 Spearmint oil 45 2 58.5 Peppermint tops 45 2 58.5 Peppermint oil 45 2 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 observe d 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 toleran ces based on the current petition.



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

Processing Factors: DEEM TM 

### 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 Exposur e Assessment for Proposed New Uses of Spiromesifen on Wheat, Sorghum, Dry Peas, Mi nt, and the Leafy Petioles Crop Subgroup (4B)” (Memo, G. Orrick, 25-MAR-2010; D368558) and inco rporated directly into this dietary assessment. Water residues were incorporated in the DEEM-FCID TM 

### into the food categories “water, direct, all sources” and “w ater, indirect, all sources.”

The proposed use patterns [adjusted by the nati onal default percent-cr opped 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 f actors (14-77%)]. Therefore, the exposure estimates from the use patterns of maximum exposure in the pr evious water-exposure assessment (Memo, G. Orrick, 01-OCT-2008; D351035) remain the maximum exposure estimates for use in dietary risk

assessment.Spiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 5 of 12 Because monitoring data are unavailable, estimates for spiromesifen concentrations were made only with mathematical models. Surface wa ter and ground water estimated drinking water concentrations (EDWCs) were modeled with the Provisional Cranberry Model and Screening Concentration in Ground Water (SCI-GROW) Mode l, respectively. EDWC s were generated for the total toxic residue which includes spiromes ifen, the -enol and -carboxy metabolites, and unextracted material. The surface water estima te was the value used in this assessment.

Table 2. Total Residue EDWCs in Surface Water and Ground Wat er for the Proposed Spiromesifen Uses on Leaf Petioles Subgroup 4B; Pea, Dry, Seed; Spearmint, Tops; and Pepp ermint, 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-FCID TM 

### Program and Consumption Information

The spiromesifen chronic dietary exposure assessment was conducted using DEEM-FCID TM 

### (Version 2.03) which incorporates consump tion 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-consecu tive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commoditi es (e.g., apples, peeled fruit - cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S, baked) using publicly avai lable recipe translation files developed jointly by USDA/ARS and EPA. For ch ronic 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 co nsumption 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 re port 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, yout h 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an esti mate of the residue level in each food or foodform (e.g., orange or orange juice) on the f ood commodity residue list is multiplied by the average daily consumption estimate for that food/f ood form to produce a residue intake estimate. The resulting residue intake estimate for each f ood/food form is summed w ith the residue intake estimates for all other food/food forms on the comm odity residue list to arrive at the total average estimated exposure. Exposure is expres sed 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 spir omesifen database and reaffirmed the previous toxicology conclusions. The endpoi nts in Table 3 have been confirmed by the risk assessment team as appropriate for the current risk assessment.Spiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 6 of 12 Table 3. Summary of Toxicological Endpoints for Use in Human-Health Risk Assessment 1

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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 concer n 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 thyr oid follicular cell hypertrophy in F 1 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 = chro nic); 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-FCID TM 

### analyses estimate the dietary exposu re of the U.S. population and various population subgroups. The results reported in Ta ble 4 are for the general U.S. population, all infants (<1 year old), children 1-2, childre n 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 populat ion subgroup, all infants (<1 year old) was 78% of the cPAD. The result s of the chronic dietary exposure analyses are reported in Table 4.

Table 4. Summary of Dietary (Food and Dri nking Water) Exposure Risk for Spiromesifen. Acute Dietary (95 th 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 an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 7 of 12 VII. Characterization of Inputs/Outputs

These analyses are considered to be very cons ervative dietary exposure assessments. Residues in foods were assumed to be equivalent to the tole rance 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 th e residue levels found on food commodities at the time of consumption. When field trials are performed, the maximu m 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. Al so, 100% CT was assumed. For these reasons, HED is confident that this analysis does not unde restimate risk to the general U.S. population or any population subgroup. Further refinement to th e analyses could be made through the use of anticipated residues, empirical processing factor s, 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 spirom esifen, including potential expos ure 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 dietar y 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-FCID TM 

### Chronic Residue Input File.
Attachment 2: DEEM-FCID TM 

### 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: RAB1Spiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 8 of 12 Attachment 1: DEEM-FCID TM 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 3F6537Spiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 9 of 12 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 3F6537Spiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### 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 8E7340Spiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### 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 3F6537Spiromesifen Dietary Exposure an d Risk Assessment DP# 369098 PC Code: 024875

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### Page 12 of 12 Attachment 3: DEEM-FCID TM 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

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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%**

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