Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

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### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

OFFICE OF
CHEMICAL SAFETY AND
POLLUTION PREVENTION



### MEMORANDUM

Date: 07/14/2010

Subject: Bifenazate (000586); Chronic Dietary Exposure and Risk Assessment. Harmonization of Tolerances for Residues in/on Grapes and Small Vine Climbing Fruit (Subgroup 13-07F) with Canadian Maximum Residue Limits (MRLs).

PC Code: 000586 DP Barcode: D380060
Decision No.: 423556 Registration No .: 400-514
Petition No.: 9E7642 Regulatory Action: Amended Section 3 Risk Assessment Type: Dietary Assessment Case No.: 7609
TXR No.: NA CAS No.: 149877-41-8
MRID No .: None 40 CFR: §180.572



### Reviewer: William D. Wassell, Chemist Risk Assessment Branch 1 (RAB1) Health Effects Division (HED, 7509P)

Through: David Soderberg, Chemist Nancy Dodd, Chemist Dietary Exposure Science Advisory Council (DESAC) Health Effects Division (7509P)
and George F. Kramer, Ph.D., Branch Senior Chemist RAB1/HED (7509P)

To: William D. Wassell, Risk Assessor RAB1/HED (7509P)
And Barbara Madden, RM 05 Registration Division (RD; 7505P)

Executive Summary

Registration Division has requested HED to harm onize tolerances for residues of bifenazate on grapes with Canadian MRLs. As part of the current action, HED recommended for the establishment of the following tolerances for the combined residues of bifenazate and D3598:Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

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### Fruit, Small, Vine Climbing, Subgroup 13-07F, Except Fuzzy Kiwifruit.................................................1.0 ppm Note: grapes are the representative commodity for Subgroup 13-07F.

A chronic dietary (food plus drinking water) ri sk assessment was conducted using the Dietary Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCID TM , ver. 2.03).

DEEM- FCID TM incorporates the food consumption data from the United States Department of Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by Individuals (CSFII; 1994-1996 and 1998). The chronic analyses incorporated tolerance-level residues for all commodities excluding squash, peach, and tomato (average field-trial residues were assumed) and milk (the tolerance level was adjusted upward to account for all of the residues of concern for risk assessment). The chronic analyses incorporated average percent crop-treated information provided by the Biological Economic Anal ysis Division (BEAD; 09/18/2008). DEEM TM (ver. 7.81) default processing factors were assumed for all commodities excluding apple juice, grape juice, wine/sherry, tomato paste, and tomato puree. The processing factors for these commodities were reduced to 0.23, 0.17, 0.17, 1, and 1, respectively, based on data from processing studies. The analyses also included the chronic surface water point estimate generated using the Food Quality Protection Ac t (FQPA) Index Reservoir Screening Tool (FIRST) and the dry bean application scenario (2 x 0.75 lb ai/acre; 14-day retreatment interval (RTI); highest registered/proposed rate). The chronic exposure estimate is 30% chronic population-adjusted dose (cPAD) for the U.S. population. The most highly-exposed population subgroup was children 1 to 2 years old which utilized 81% of the cPAD. Thus, chronic dietary exposure to bifenazate is not of concern. Based on a critical-commodity contribution analysis
conducted in DEEM-FCID TM , the major contributors to the risk for children 1 to 2 years old were Crop Group 6 commodities (legume vegetables, succulent or dried), Crop Subgroup 6A commodities (edible-podded legume vegetables) and other commodities (denoted with group “O” in the residue files; includes water, tropical fruits, grape, and cranberry).

An acute dietary exposure assessment is not required for bifenazate since an acute dietary endpoint was not selected. This is based on the ab sence of an appropriate endpoint attributed to a single dose. Additionally, bifenazate is classifi ed as "not likely" to be a human carcinogen; therefore, a cancer dietary exposure assessment was not performed for bifenazate.

I. Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide. For chronic assessments, the risks are expressed as a percentage of a maximum acceptable dose. A cPAD was established based upon the one-year oral toxicity study in dogs. The PAD is equivalent to the point of departure (POD, NOA EL, LOAEL) divided by the required uncertainty or safety factors. Dietary risk is expressed as a percentage of the PAD. HED is concerned when estimated dietary risk exceeds 100% of the PAD. References which discuss the chronic risk assessment in more detail are available on the EPA/pesticides web site: “Available Information on Assessing Exposure from Pesticides, A User’s Guide,” 6/21/2000, web link: http://www.epa.gov/fedrgstr/EPA-PEST/2000/July /Day-12/6061.pdf; or see SOP 99.6 (8/20/99). The most recent (previous) dietary exposure assessment for bifenazate was performed on 05/25/2010 (D371941, W.D. Wassell).Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

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### II. Residue Information

Residues of Concern in Plants, Livestock, and Drinking Water: Table 1 is a summary of the HED Metabolism Assessment Review Committee (MARC) decisions concerning the residues ofconcern in plants, livestock, rotational crops, and drinking water (D276801, T. Bloem, 16-Aug2001; D290053, T. Bloem, 29-May-2003).

Table 1. Residues for Tolerance Expression and Risk Assessment.

Matrix Residues included in Risk Assessment Residues included in Tolerance Expression
Plants bifenazate, D3598 (expressed as pare nt) bifenazate, D3598 (expressed as parent)

Livestock (excluding fat) bifenazate, D3598 (expressed as parent), A1530, A1530-sulfate (expressed as A1530) bifenazate, D3598 (expressed as parent), A1530, A1530-sulfate (expressed as A1530)
Livestock – fat bifenazate, D3598 (expressed as parent) bifenazate, D3598 (expressed as parent)
Rotational Crops could not be determined 1 could not be determined 1

Drinking Water D1989 Not applicable

1 Based on the results of the confined rotational crop study conducte d at 0.5 lb ai/acre (the application rate for the registere d crops which are likely to be rotated), HED concluded that resi dues in rotated crops were unlikely and that tolerances were

unnecessary.



### Established/Recommended Tolerances: Bifenazate is currently registered for application to various commodities with tolerances ranging from 0.1 to 35 ppm (40 CFR 180.572(a)(1)). Section 18 registrations have also been established for application of bifenazate to cherry, soybean, tomato, potato, and timothy with tolerances ranging from 0.05 to 150 ppm (40 CFR 180.572(b)). Tolerances, as a result of secondary residues, are established in milk, ruminant meat, ruminant fat, and ruminant meat byproducts at 0.02 to 0.10 ppm (40 CFR 180.572(a)(1) and (a)(2)). As part of the current action, HED recommended for the establishment of the following tolerances for the combined residues of bifenazate and D3598:

Fruit, Small, Vine Climbing, Subgroup 13-07F, Except Fuzzy Kiwifruit.................................................1.0 ppm

Plant/Livestock Residues Used in the Chronic Risk Assessments: The chronic analyses incorporated established/recommended tolerance-level residues for all registered/proposed crops excluding milk (see discussion below), squash, peach, tomato, soybean, and soybean oil. For squash, peach, and tomato, the following average field trial residues were assumed: squash - 0.09 ppm (D290053, T. Bloem, 29-May-2003; D286170, 20-Apr-2004), peach - 0.37 ppm (D313261, T. Bloem, 12-Jul-2006), tomato - 0.19 ppm (45772005.der.wpd).

For soybean commodities, the tolerance level (1.5 ppm) for residues established in conjunction with a Section 18 request was used. The tolerances established in conjunction with the Section 18 expired on 12/31/2009. A Section 3 registration for use on soybean has been established in conjunction with a tolerance for residues of bifenazate at 0.70 ppm. Using the tolerance level established in conjunction with the Section 18 is a conservative assumption.

DEEM TM (ver. 7.81) default processing factors were assumed for all commodities excluding apple juice, grape juice, wine/sherry, tomato past e, and tomato puree. The processing factors for these commodities were reduced to 0.23, 0.17, 0.17, 1.0, and 1.0, respectively, based on data from processing studies (apple and grape - D277089, T. Bloem, 16-Aug-2001; tomato - 45772006.der2.wpd). HED notes that the Section 18 tolerance for residues on tart cherry at 5.0 ppm is based on data translations (D317316, T. Bloem et al. , 5-May-2005) and is greater thanBifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

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### the established tolerances for residues in/on stone fruit (group 12). Since the Section 18 cherry application scenario is identical to the Section 3 registration, the tolerance for residues in/on stone fruit was used for cherry.

The ruminant metabolism study indicated that the major residue in milk, originally identified as A1530-sulfate but now thought to be D9569, occupi ed 41% of the total radioactive residues (TRRs) and combined residues of bifenazate and D3598 occupied 9% of the TRRs. Therefore, the ratio of the major residue in milk to combined residues of bifenazate/D3598 is 4.6. The ruminant feeding study resulted in combined residues of bifenazate/D3598 in/on milk of <0.01 ppm (<LOQ) at a 10-ppm dietary burden (A1530 was included as a residue of concern only because the analytical method did not differen tiate between A1530-sulfate and A1530). Based on the current maximum theoretical dietary burden of 1.9 ppm and 4.6 ratio from the ruminant metabolism study and assuming a combined bifenazate/D3598 residue of 0.01 ppm, a milk residue of 0.011 ppm is calculated ((0.01 + (0.01 x 4.6)) x (1.9 ÷ 10) = 0.011). Residues in milk fat were set to 0.275 ppm (milk residue (0.011 ppm) x 25 = 0.275 ppm) based on the maximum theoretical concentration factor of 25x for milk fat and the ruminant feeding study which resulted in higher residues in fat than in meat and meat byproducts.

Percent Crop Treated Information: Average percent crop treated information, provided by BEAD, were used for numerous registered crops. The percent crop-treated information used in the dietary analysis was as follows: pepper, tomato, watermelon, cucumber, apricot, cherry, pecan, pistachio, and walnut utilized 1% crop- treated; apple, nectarine, plum, almond, and grapes utilized 5% crop-treated; pear and peach utilized 10% crop-treated; and strawberry utilized 30% crop-treated (see Attachment 1).

Drinking Water Residues Used in the Chronic Risk Assessments: Surface and ground water estimated drinking water concentrations (EDWCs) were generated using the FIRST and screening concentration in ground water (SCI-GROW) models, respectively. Both models were run using the dry bean application scenario (2 x 0.75 lb ai/acre; 14-day RTI; highest registered/proposed rate). The resulting chronic EDWCs in ground and surface water were 0.044 ppb and 11.2 ppb, respectively (EFED Memo; A. Al-Mudallal, 9/30/08, D349290). Since the surface water concentration was the highest, the chronic dietary run was conducted assuming a residue of 0.0112 ppm for all water sources (direct and indirect). EFED has completed a more recent estimate of EDWCs (EFED Memo, 1/28/2010, M. Corbin, et al ., D371784); however, the EDWCs of this assessment are lower than the 2008 assessment. Thus, the EDWCs from the 2008 assessment were used in this analysis.

III. Program and Consumption Information

Chronic dietary exposure assessments were conducted using DEEM-FCIDTM (ver. 2.03), which incorporates consumption data from USDA’s CSFII 1994-1996 and 1998. The 1994-96, 98 dataare based on the reported consumption of more than 20,000 individuals over two nonconsecutive survey days. Foods “as consumed” (e.g., apple pie) are linked to EPA-defined food commodities (e.g. apples, peeled fruit - cooked; fr esh 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. Based on analysis of the 1994-96, 98 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: theBifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

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### general U.S. population, all infants (<1 year old), children 1-2 years old, children 3-5 years old, children 6-12 years old, youth 13-19 years old, a dults 20-49 years old, females 13-49 years old, 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.

IV. Toxicological Information

A summary of the toxicological doses and endpoint s selected for dietary exposure assessment is provided in Table 2.

Table 2. Toxicological Endpoints for Dietary Analysis.

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) An acute dietary endpoint was not selected based on the ab sence of an appropriate endpoint attributed to a single
dose.

Chronic Dietary;
(all populations) NOAEL= 1.0 mg/kg/day
UF = 100 cRfD = 0.01 mg/kg/day FQPA SF = 1X cPAD = 0.01 mg/kg/day LOAEL = 8.9/10.4 mg/kg/day [M/F] based on changes in hematological and clinical chemistry parameters, and histopathology in bone marrow, liver, and kidney in the one-year dog feeding study.

Cancer Bifenazate is classified as " not likely" to be a human carcinogen.

1 UF = uncertainty factor, FQPA SF = FQPA safety factor , NOAEL = no-observed-adverse-effect-level, LOAEL = lowestobserved-adverse-effect-level, cPAD = chronic popul ation-adjusted dose, RfD = reference-dose.



### V. Results/Discussion

The chronic exposure estimates are ≤ 81% cPAD and are, therefore, less than HED’s level of concern. The most highly-exposed population subgroup was children 1 to 2 years old. Based on a critical-commodity contribution analysis conducted in DEEM-FCID TM , the major contributors to the risk for children 1 to 2 years old were Crop Group 6 commodities (legume vegetables, succulent or dried), Crop Subgroup 6A commodities (edible-podded legume vegetables) and other commodities (denoted with group “O” in the residue files; includes water, tropical fruits, grape, and cranberry). The results of the current DEEM-FCID run are summarized in Table 3.Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

Page 6 of 13 Table 3. Summary of Chronic Dietary Exposure and Risk for Bifenazate (Drinking Water Exposure Included).

Chronic Population Subgroup cPAD (mg/kg/day) Exposure (mg/kg/day) %cPAD General U.S. Population 0.003036 30 All Infants (<1 year old) 0.006661 67 Children 1-2 years old 0.008094 81 Children 3-5 years old 0.006120 61 Children 6-12 years old 0.003749 37 Youth 13-19 years old 0.002164 22 Adults 20-49 years old 0.002523 25 Adults 50+ years old 0.002591 26 Females 13-49 years old 0.01

0.002382 24



### VI. Characterization of Inputs/Outputs

The chronic analyses were refined with average field trial residues, experimentally determined processing factors, and average percent crop-treated information for some commodities. HED notes that registration for application to cherry tomato was approved without the submission of cherry tomato field trial data (D297604, T. Bloem, 12-July-2006) and that the current analysis incorporated average tomato field trial residues. Since the analysis assumed the average tomato residue of 0.19 ppm (from greenhouse trials, whereas the average residue from field trials was 0.11 ppm) and since the analysis incorporated percent crop-treated information for tomato (1%), HED concludes that the lack of cherry tomato residue data will not significantly affect the analysis. HED concludes that the exposure estimates provided in this document are unlikely tounderestimate actual exposure for the following reasons: (1) the analysis incorporated tolerancelevel residues or made use of average residues derived from crop field trial studies (maximum application rate and minimum pre-harvest interval); and (2) the surface drinking water estimates were unrefined and based on the maximum rate use pattern.

Based on a critical-commodity contribution analysis conducted in DEEM-FCID TM , the major contributors to the risk for children 1 to 2 years old were Crop Group 6 commodities (legume vegetables, succulent or dried), Crop Subgroup 6A commodities (edible-podded legume vegetables) and other commodities (denoted with group “O” in the residue files; includes water, tropical fruits, grape, and cranberry).

VII. Conclusions

The chronic exposure estimates are ≤ 81 cPAD and are not of concern to HED. The most highlyexposed population subgroup was children 1 to 2 years old.

VIII. List of Attachments

Attachment 1: BEAD Average Percent Crop-Treated Information
Attachment 2: DEEM-FCID TM Chronic Residue File
Attachment 3: DEEM-FCID TM Chronic Exposure Estimates



### RDI: DE SAC Reviewers: 06/25/2010
7509P: RAB1: PY-2: Room 10597: 305-6135: BifenazateBifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

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### Attachment 1: BEAD Average Percent Crop Treated InformationBifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

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

Filename: P:\Work Files\$ Bifenazate\New DEEM\Harmonization_2010_wdw000586c.R98
Chemical: bifenazate RfD(Chronic): .01 mg/kg bw/day NOEL(Chronic): 0 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 07-15-2010/11:59:30/8 Program ver. 2.03 Comment: no acute endpoint identified; FQPA SF of 1x

------------------------------------------------------------------------------ EPA Crop Def Res Adj.Factors

Comment Code Grp Commodity Name (ppm) #1 #2

-------- --------------------------------- ---------- ------ ------ ------- 95000010 O Acerola 0.900000 1.000 1.000
95000200 O Avocado 7.000000 1.000 1.000 95000740 O Canistel 7.000000 1.000 1.000 95000890 O Cherimoya 1.600000 1.000 1.000 95001280 O Cottonseed, oil 0.750000 1.000 1.000 95001281 O Cottonseed, oil-babyfood 0.750000 1.000 1.000 95001300 O Cranberry 1.500000 1.000 1.000 95001301 O Cranberry-babyfood 1.500000 1.000 1.000 95001310 O Cranberry, dried 1.500000 1.000 1.000 95001320 O Cranberry, juice 1.500000 1.100 1.000 95001321 O Cranberry, juice-babyfood 1.500000 1.100 1.000 95001510 O Feijoa 0.900000 1.000 1.000 95001750 O Grape 1.000000 1.000 0.050 95001760 O Grape, juice 1.000000 0.170 0.050 95001761 O Grape, juice-babyfood 1.000000 0.170 0.050 95001770 O Grape, leaves 1.000000 1.000 0.050 95001780 O Grape, raisin 1.200000 1.000 0.050 95001790 O Grape, wine and sherry 1.000000 0.170 0.050
95001830 O Guava 0.900000 1.000 1.000 95001831 O Guava-babyfood 0.900000 1.000 1.000 95001880 O Hop 15.000000 1.000 1.000 95001920 O Jaboticaba 0.900000 1.000 1.000 95001950 O Kiwifruit 1.000000 1.000 1.000 95002090 O Longan 5.000000 1.000 1.000 95002110 O Lychee 5.000000 1.000 1.000 95002120 O Lychee, dried 5.000000 1.850 1.000 95002140 O Mamey apple 7.000000 1.000 1.000 95002150 O Mango 7.000000 1.000 1.000 95002151 O Mango-babyfood 7.000000 1.000 1.000 95002160 O Mango, dried 7.000000 1.000 1.000 95002170 O Mango, juice 7.000000 1.000 1.000 95002171 O Mango, juice-babyfood 7.000000 1.000 1.000 95002450 O Papaya 7.000000 1.000 1.000 95002451 O Papaya-babyfood 7.000000 1.000 1.000 95002460 O Papaya, dried 7.000000 1.800 1.000 95002470 O Papaya, juice 7.000000 1.500 1.000 95002520 O Passionfruit 0.900000 1.000 1.000 95002521 O Passionfruit-babyfood 0.900000 1.000 1.000 95002530 O Passionfruit, juice 0.900000 1.000 1.000 95002531 O Passionfruit, juice-babyfood 0.900000 1.000 1.000 95002750 O Peppermint 25.000000 1.000 1.000 95002760 O Peppermint, oil 25.000000 1.000 1.000 95003330 O Sapote, Mamey 7.000000 1.000 1.000 95003460 O Soursop 1.600000 1.000 1.000 95003510 O Spanish lime 5.000000 1.000 1.000 95003520 O Spearmint 25.000000 1.000 1.000 95003530 O Spearmint, oil 25.000000 1.000 1.000 95003580 O Starfruit 0.900000 1.000 1.000 95003590 O Strawberry 1.500000 1.000 0.300Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

Page 9 of 13 95003591 O Strawberry-babyfood 1.500000 1.000 0.300 95003600 O Strawberry, juice 1.500000 1.000 0.300 95003601 O Strawberry, juice-babyfood 1.500000 1.000 0.300 95003610 O Sugar apple 1.600000 1.000 1.000 86010000 O Water, direct, all sources 0.011200 1.000 1.000 86020000 O Water, indirect, all sources 0.011200 1.000 1.000 21000440 M Beef, meat 0.020000 1.000 1.000 21000441 M Beef, meat-babyfood 0.020000 1.000 1.000 21000450 M Beef, meat, dried 0.020000 1.920 1.000 21000460 M Beef, meat byproducts 0.020000 1.000 1.000 21000461 M Beef, meat byproducts-babyfood 0.020000 1.000 1.000 21000470 M Beef, fat 0.100000 1.000 1.000 21000471 M Beef,fat-babyfood 0.100000 1.000 1.000 21000480 M Beef, kidney 0.020000 1.000 1.000 21000490 M Beef, liver 0.020000 1.000 1.000 21000491 M Beef, liver-babyfood 0.020000 1.000 1.000 23001690 M Goat, meat 0.020000 1.000 1.000 23001700 M Goat, meat byproducts 0.020000 1.000 1.000 23001710 M Goat, fat 0.100000 1.000 1.000 23001720 M Goat, kidney 0.020000 1.000 1.000 23001730 M Goat, liver 0.020000 1.000 1.000 24001890 M Horse, meat 0.020000 1.000 1.000 28002210 M Meat, game 0.020000 1.000 1.000 25002900 M Pork, meat 0.020000 1.000 1.000 25002901 M Pork, meat-babyfood 0.020000 1.000 1.000 25002910 M Pork, skin 0.100000 1.000 1.000 25002920 M Pork, meat byproducts 0.020000 1.000 1.000 25002921 M Pork, meat byproducts-babyfood 0.020000 1.000 1.000 25002930 M Pork, fat 0.100000 1.000 1.000 25002931 M Pork, fat-babyfood 0.100000 1.000 1.000 25002940 M Pork, kidney 0.020000 1.000 1.000 25002950 M Pork, liver 0.020000 1.000 1.000 29003120 M Rabbit, meat 0.020000 1.000 1.000 26003390 M Sheep, meat 0.020000 1.000 1.000 26003391 M Sheep, meat-babyfood 0.020000 1.000 1.000 26003400 M Sheep, meat byproducts 0.020000 1.000 1.000 26003410 M Sheep, fat 0.100000 1.000 1.000 26003411 M Sheep, fat-babyfood 0.100000 1.000 1.000 26003420 M Sheep, kidney 0.020000 1.000 1.000 26003430 M Sheep, liver 0.020000 1.000 1.000 27002220 D Milk, fat 0.275000 1.000 1.000 27002221 D Milk, fat - baby food/infant for 0.275000 1.000 1.000 27012230 D Milk, nonfat solids 0.011000 1.000 1.000 27012231 D Milk, nonfat solids-baby food/in 0.011000 1.000 1.000 27022240 D Milk, water 0.011000 1.000 1.000 27022241 D Milk, water-babyfood/infant form 0.011000 1.000 1.000 27032251 D Milk, sugar (lactose)-baby food/ 0.011000 1.000 1.000 01030150 1CD Arrowroot, flour 0.100000 1.000 1.000 01030151 1CD Arrowroot, flour-babyfood 0.100000 1.000 1.000 01030170 1CD Artichoke, Jerusalem 0.100000 1.000 1.000
01030820 1CD Cassava 0.100000 1.000 1.000 01030821 1CD Cassava-babyfood 0.100000 1.000 1.000 01031390 1CD Dasheen, corm 0.100000 1.000 1.000 01031660 1CD Ginger 0.100000 1.000 1.000 01031661 1CD Ginger-babyfood 0.100000 1.000 1.000 01031670 1CD Ginger, dried 0.100000 1.000 1.000 01032960 1C Potato, chips 0.100000 1.000 1.000 01032970 1C Potato, dry (granules/ flakes) 0.100000 6.500 1.000 01032971 1C Potato, dry (granules/ flakes)-b 0.100000 6.500 1.000 01032980 1C Potato, flour 0.100000 6.500 1.000 01032981 1C Potato, flour-babyfood 0.100000 6.500 1.000 01032990 1C Potato, tuber, w/peel 0.100000 1.000 1.000 01032991 1C Potato, tuber, w/peel-babyfood 0.100000 1.000 1.000 01033000 1C Potato, tuber, w/o peel 0.100000 1.000 1.000Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

Page 10 of 13 01033001 1C Potato, tuber, w/o peel-babyfood 0.100000 1.000 1.000 01033660 1CD Sweet potato 0.100000 1.000 1.000 01033661 1CD Sweet potato-babyfood 0.100000 1.000 1.000 01033710 1CD Tanier, corm 0.100000 1.000 1.000 01033870 1CD Turmeric 0.100000 1.000 1.000 01034060 1CD Yam, true 0.100000 1.000 1.000
01034070 1CD Yam bean 0.100000 1.000 1.000 06030320 6C Bean, broad, seed 0.600000 1.000 1.000 06020330 6B Bean, cowpea, succulent 0.700000 1.000 1.000 06030340 6C Bean, cowpea, seed 0.600000 1.000 1.000 06030350 6C Bean, great northern, seed 0.600000 1.000 1.000 06030360 6C Bean, kidney, seed 0.600000 1.000 1.000 06020370 6B Bean, lima, succulent 0.700000 1.000 1.000 06030380 6C Bean, lima, seed 0.700000 1.000 1.000 06030390 6C Bean, mung, seed 0.600000 1.000 1.000 06030400 6C Bean, navy, seed 0.600000 1.000 1.000 06030410 6C Bean, pink, seed 0.600000 1.000 1.000 06030420 6C Bean, pinto, seed 0.600000 1.000 1.000 06010430 6A Bean, snap, succulent 6.000000 1.000 1.000 06010431 6A Bean, snap, succulent-babyfood 6.000000 1.000 1.000 06030980 6C Chickpea, seed 0.600000 1.000 1.000 06030981 6C Chickpea, seed-babyfood 0.600000 1.000 1.000 06030990 6C Chickpea, flour 0.600000 1.000 1.000 06022550 6B Pea, succulent 0.700000 1.000 1.000 06022551 6B Pea, succulent-babyfood 0.700000 1.000 1.000 06032560 6C Pea, dry 0.600000 1.000 1.000 06032561 6C Pea, dry-babyfood 0.600000 1.000 1.000 06012570 6A Pea, edible podded, succulent 6.000000 1.000 1.000 06032580 6C Pea, pigeon, seed 0.600000 1.000 1.000 06022590 6B Pea, pigeon, succulent 0.700000 1.000 1.000 06003470 6 Soybean, seed 1.500000 1.000 1.000 06003480 6 Soybean, flour 1.500000 1.000 1.000 06003481 6 Soybean, flour-babyfood 1.500000 1.000 1.000 06003490 6 Soybean, soy milk 1.500000 1.000 1.000 06003491 6 Soybean, soy milk-babyfood or in 1.500000 1.000 1.000 06003500 6 Soybean, oil 1.500000 1.000 1.000 06003501 6 Soybean, oil-babyfood 1.500000 1.000 1.000 08001480 8 Eggplant 2.000000 1.000 1.000
08002340 8 Okra 2.000000 1.000 1.000 08002700 8 Pepper, bell 2.000000 1.000 0.010 08002701 8 Pepper, bell-babyfood 2.000000 1.000 0.010 08002710 8 Pepper, bell, dried 2.000000 1.000 0.010 08002711 8 Pepper, bell, dried-babyfood 2.000000 1.000 0.010 08002720 8 Pepper, nonbell 2.000000 1.000 0.010 08002721 8 Pepper, nonbell-babyfood 2.000000 1.000 0.010 08002730 8 Pepper, nonbell, dried 2.000000 1.000 0.010
08003740 8 Tomatillo 2.000000 1.000 1.000
08003750 8 Tomato 0.190000 1.000 0.010 08003751 8 Tomato-babyfood 0.190000 1.000 0.010 08003760 8 Tomato, paste 0.190000 1.000 0.010 08003761 8 Tomato, paste-babyfood 0.190000 1.000 0.010 08003770 8 Tomato, puree 0.190000 1.000 0.010 08003771 8 Tomato, puree-babyfood 0.190000 1.000 0.010 08003780 8 Tomato, dried 0.190000 14.300 0.010 08003781 8 Tomato, dried-babyfood 0.190000 14.300 0.010 08003790 8 Tomato, juice 0.190000 1.500 0.010 09020210 9B Balsam pear 0.750000 1.000 1.000 09010750 9A Cantaloupe 0.750000 1.000 1.000
09010800 9A Casaba 0.750000 1.000 1.000 09020880 9B Chayote, fruit 0.750000 1.000 1.000 09021020 9B Chinese waxgourd 0.750000 1.000 1.000
09021350 9B Cucumber 0.750000 1.000 0.010 09011870 9A Honeydew melon 0.750000 1.000 1.000 09023080 9B Pumpkin 0.750000 1.000 1.000Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

Page 11 of 13 09023090 9B Pumpkin, seed 0.750000 1.000 1.000 09023560 9B Squash, summer 0.090000 1.000 1.000 09023561 9B Squash, summer-babyfood 0.090000 1.000 1.000 09023570 9B Squash, winter 0.090000 1.000 1.000 09023571 9B Squash, winter-babyfood 0.090000 1.000 1.000
09013990 9A Watermelon 0.750000 1.000 0.010 09014000 9A Watermelon, juice 0.750000 1.000 0.010 11000070 11 Apple, fruit with peel 0.750000 1.000 0.050 11000080 11 Apple, peeled fruit 0.750000 1.000 0.050 11000081 11 Apple, peeled fruit-babyfood 0.750000 1.000 0.050 11000090 11 Apple, dried 0.750000 8.000 0.050 11000091 11 Apple, dried-babyfood 0.750000 8.000 0.050 11000100 11 Apple, juice 0.750000 0.230 0.050 11000101 11 Apple, juice-babyfood 0.750000 0.230 0.050 11000110 11 Apple, sauce 0.750000 1.000 0.050 11000111 11 Apple, sauce-babyfood 0.750000 1.000 0.050 11001290 11 Crabapple 0.750000 1.000 1.000 11002100 11 Loquat 0.750000 1.000 1.000
11002660 11 Pear 0.750000 1.000 0.100 11002661 11 Pear-babyfood 0.750000 1.000 0.100 11002670 11 Pear, dried 0.750000 6.250 0.100 11002680 11 Pear, juice 0.750000 1.000 0.100 11002681 11 Pear, juice-babyfood 0.750000 1.000 0.100 11003100 11 Quince 0.750000 1.000 1.000 12000120 12 Apricot 2.500000 1.000 0.010 12000121 12 Apricot-babyfood 2.500000 1.000 0.010 12000130 12 Apricot, dried 2.500000 6.000 0.010 12000140 12 Apricot, juice 2.500000 1.000 0.010 12000141 12 Apricot, juice-babyfood 2.500000 1.000 0.010 12000900 12 Cherry 2.500000 1.000 0.010 12000901 12 Cherry-babyfood 2.500000 1.000 0.010 12000910 12 Cherry, juice 2.500000 1.500 0.010 12000911 12 Cherry, juice-babyfood 2.500000 1.500 0.010
12002300 12 Nectarine 2.500000 1.000 0.050
12002600 12 Peach 0.370000 1.000 0.100 12002601 12 Peach-babyfood 0.370000 1.000 0.100 12002610 12 Peach, dried 0.370000 7.000 0.100 12002611 12 Peach, dried-babyfood 0.370000 7.000 0.100 12002620 12 Peach, juice 0.370000 1.000 0.100 12002621 12 Peach, juice-babyfood 0.370000 1.000 0.100
12002850 12 Plum 0.200000 1.000 0.050 12002851 12 Plum-babyfood 0.200000 1.000 0.050 12002860 12 Plum, prune, fresh 0.200000 1.000 0.050 12002861 12 Plum, prune, fresh-babyfood 0.200000 1.000 0.050 12002870 12 Plum, prune, dried 0.200000 5.000 0.050 12002871 12 Plum, prune, dried-babyfood 0.200000 5.000 0.050 12002880 12 Plum, prune, juice 0.200000 1.400 0.050 12002881 12 Plum, prune, juice-babyfood 0.200000 1.400 0.050 13010550 13A Blackberry 5.000000 1.000 1.000 13010560 13A Blackberry, juice 5.000000 1.000 1.000 13010561 13A Blackberry, juice-babyfood 5.000000 1.000 1.000 13020570 13B Blueberry 1.500000 1.000 1.000 13020571 13B Blueberry-babyfood 1.500000 1.000 1.000 13010580 13A Boysenberry 5.000000 1.000 1.000 13011420 13A Dewberry 5.000000 1.000 1.000 13021740 13B Gooseberry 1.000000 1.000 1.000 13012080 13A Loganberry 5.000000 1.000 1.000 13013200 13A Raspberry 5.000000 1.000 1.000 13013201 13A Raspberry-babyfood 5.000000 1.000 1.000 13013210 13A Raspberry, juice 5.000000 1.000 1.000 13013211 13A Raspberry, juice-babyfood 5.000000 1.000 1.000
14000030 14 Almond 0.200000 1.000 0.050 14000031 14 Almond-babyfood 0.200000 1.000 0.050 14000040 14 Almond, oil 0.200000 1.000 0.050Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

Page 12 of 13 14000041 14 Almond, oil-babyfood 0.200000 1.000 0.050
14000590 14 Brazil nut 0.200000 1.000 1.000
14000680 14 Butternut 0.200000 1.000 1.000
14000810 14 Cashew 0.200000 1.000 1.000
14000920 14 Chestnut 0.200000 1.000 1.000 14001550 14 Filbert 0.200000 1.000 1.000 14001560 14 Filbert, oil 0.200000 1.000 1.000 14001850 14 Hickory nut 0.200000 1.000 1.000
14002130 14 Macadamia nut 0.200000 1.000 1.000
14002690 14 Pecan 0.200000 1.000 0.010 14002820 14 Pistachio 0.200000 1.000 0.010
14003910 14 Walnut 0.200000 1.000 0.010Bifenazate (000586) Dietary Exposur e and Risk Assessment DP# 380060

Page 13 of 13 

### Attachment 3: DEEM-FCID TM Chronic Exposure Estimates

U.S. Environmental Protection Agency Ver. 2.00 DEEM-FCID Chronic analysis for BIFENAZATE (1994-98 data) Residue file name: P:\Work Files\$ Bifenazate\New DEEM\Harmonization_2010_wdw000586c.R98 Adjustment factor #2
used. Analysis Date 07-15-2010/12:01:06 Residue file dated: 07-15- 2010/11:59:30/8 Reference dose (RfD, Chronic) = .01 mg/kg bw/day COMMENT 1: no acute endpoint identified; FQPA SF of 1x

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

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

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- ------------- --------------- U.S. Population (total) 0.003036 30.4%

U.S. Population (spring season) 0.003016 30.2% U.S. Population (summer season) 0.003284 32.8% U.S. Population (autumn season) 0.002949 29.5% U.S. Population (winter season) 0.002888 28.9% Northeast region 0.002766 27.7% Midwest region 0.003039 30.4% Southern region 0.003079 30.8% Western region 0.003205 32.0% Hispanics 0.003156 31.6% Non-hispanic whites 0.002959 29.6% Non-hispanic blacks 0.003052 30.5% Non-hisp/non-white/non-black 0.003963 39.6%

All infants (< 1 year) 0.006661 66.6%

Nursing infants 0.003721 37.2% Non-nursing infants 0.007778 77.8% Children 1-6 yrs 0.006640 66.4% Children 7-12 yrs 0.003471 34.7% Females 13-19 (not preg or nursing) 0.001980 19.8% Females 20+ (not preg or nursing) 0.002459 24.6% Females 13-50 yrs 0.002518 25.2% Females 13+ (preg/not nursing) 0.004091 40.9% Females 13+ (nursing) 0.002971 29.7% Males 13-19 yrs 0.002343 23.4% Males 20+ yrs 0.002604 26.0% Seniors 55+ 0.002590 25.9%

Children 1-2 yrs 0.008094 80.9% Children 3-5 yrs 0.006120 61.2% Children 6-12 yrs 0.003749 37.5% Youth 13-19 yrs 0.002164 21.6% Adults 20-49 yrs 0.002523 25.2% Adults 50+ yrs 0.002591 25.9% Females 13-49 yrs 0.002382 23.8%

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