Bifenazate (000586) Dietary Exposure 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 harmonize 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 Exposure 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) risk assessment was conducted using the Dietary 

Exposure Evaluation Model - Food Consumption Intake Database (DEEM-FCIDTM, ver. 2.03). 

DEEM- FCIDTM 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 Analysis Division (BEAD; 09/18/2008). DEEMTM (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 Act (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-FCIDTM, 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 absence of an appropriate endpoint attributed to 

a single dose. Additionally, bifenazate is classified 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, NOAEL, 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 Exposure 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 of 

concern 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 parent) 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 determined1 could not be determined1

Drinking Water D1989 Not applicable 

1

 Based on the results of the confined rotational crop study conducted at 0.5 lb ai/acre (the application rate for the registered 

crops which are likely to be rotated), HED concluded that residues 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. 

DEEMTM (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, 1.0, 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 than 
Bifenazate (000586) Dietary Exposure 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, occupied 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 differentiate 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 data 

are 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; 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. 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: the 
Bifenazate (000586) Dietary Exposure 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, adults 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 endpoints 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 absence 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 population-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-FCIDTM, 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 Exposure and Risk Assessment DP# 380060

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

Population Subgroup cPAD (mg/kg/day) Chronic 

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 to 

underestimate 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-FCIDTM, 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-FCIDTM Chronic Residue File 

Attachment 3: DEEM-FCIDTM Chronic Exposure Estimates 

RDI: DE SAC Reviewers: 06/25/2010 

7509P: RAB1: PY-2: Room 10597: 305-6135: Bifenazate 
Bifenazate (000586) Dietary Exposure and Risk Assessment DP# 380060

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Attachment 1: BEAD Average Percent Crop Treated Information 
Bifenazate (000586) Dietary Exposure and Risk Assessment DP# 380060

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Attachment 2: DEEM-FCIDTM 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 0.300 
Bifenazate (000586) Dietary Exposure and Risk Assessment DP# 380060

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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 1.000 
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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 1.000 
Bifenazate (000586) Dietary Exposure 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 0.050 
Bifenazate (000586) Dietary Exposure 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 0.010 
Bifenazate (000586) Dietary Exposure and Risk Assessment DP# 380060

Page 13 of 13 

Attachment 3: DEEM-FCIDTM 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% 

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