Document ID: EPA-HQ-OPP-2007-0302-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-03-05T05:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

Date:  			12/14/2007

Subject:		PP#6E7167; Bifenazate (000586); Chronic Dietary Exposure and
Risk Assessment.  Petition for Establishment of Tolerances for Uses on
Caneberry (Crop Subgroup Group 13A); Wild Raspberry; Edible-podded
Legume Vegetable (Crop Subgroup 6A); Succulent-shelled Pea and Bean
(Crop Subgroup 6B); Soybean, Succulent-shelled; and Various Tropical
Fruits Including Papaya, Star Apple, Black Sapote, Mango, Sapodilla,
Canistel, Mamey Sapote, Lychee, Longan, Spanish Lime, Rambutan, Pulasan,
Guava, Feijoa, Jaboticaba, Wax Jambu, Starfruit, Passionfruit, and
Acerola.  

DP No.:	347496	Decision No.:	373262

PC Code:	000586	MRID No.:	None

40 CFR §180.	572

Chemical Class:	Miticide/Insecticide

Reviewer:	William D. Wassell, Chemist

		Registration Action Branch 1 (RAB1)

		Health Effects Division (HED, 7509P)

Through:	Christina Swartz, Chemist

		Toiya Goodlow, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

and

				George Kramer, Ph.D., Branch Senior Chemist

RAB1/HED (7509C)

To:		Daniel Rosenblatt, RM 05

	Registration Division (7505P) 

Executive Summary

Chronic dietary risk assessments were conducted using the Dietary
Exposure Evaluation Model - Food Consumption Intake Database
(DEEM-FCID(, ver. 2.03).  DEEM- FCID( 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; J. Carter,
13-Jul-2006).  DEEM( (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 FQPA Index
Reservoir Screening Tool (FIRST) and the strawberry application scenario
(2 x 0.50 lb ai/acre; 21-day retreatment interval (RTI); highest
registered/proposed rate).  The chronic exposure estimates are (47% cPAD
and are, therefore, not of concern to HED.   The most highly-exposed
population subgroup was children 1 to 2 years old.  Based on a
critical-commodity analysis conducted in DEEM-FCID(, the major
contributors to the risk for children 1 to 2 years old were
succulent-shelled peas and beans, succulent or dried-legume vegetables,
milk, and edible-pod legume vegetables.

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  SEQ CHAPTER \h \r 1  cPAD
was established based upon the one-year oral toxicity study in dogs. 
The PAD is the reference dose (RfD) divided by the Food Quality
Protection Act (FQPA) Safety Factor.  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 dietary exposure assessment for
bifenazate was performed on 19-July-2006 (DP# 330587, T. Bloem).

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-Aug-2001;
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)2	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.

2	Subsequent to the decision indicated above, the petitioner submitted
radiovalidation data for the livestock enforcement method
(46691301.der.wpd; D313261, T. Bloem, 5-July-2006).  These data
indicated that, contrary to what was presented in the ruminant
metabolism study, the major residue in milk is D9569 not A1530-sulfate. 
HED requested data clarifying this discrepancy.

Established/Recommended Tolerances:  Bifenazate is currently registered
for application to pome fruit, fruiting vegetable, cucurbit vegetable,
tree nut, nectarine, peach, plum, grape, strawberry, cotton, hops, okra,
peppermint, and spearmint with tolerances ranging from 0.1 - 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 0.05-150 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 0.02-0.10
ppm (40 CFR 180.572(a)(1) and (a)(2)).  

As part of the current reviews, HED recommended for the establishment of
the following tolerances for the combined residues of bifenazate and
D3598:  

Papaya	7.0 ppm

Star apple	7.0 ppm

Black sapote	7.0 ppm

Mango	7.0 ppm

Sapodilla	7.0 ppm

Canistel	7.0 ppm

Mamey sapote	7.0 ppm

Lychee	5.0 ppm

Longan	5.0 ppm

Spanish lime	5.0 ppm

Rambutan	5.0 ppm

Pulasan	5.0 ppm

Guava	0.90 ppm

Feijoa	0.90 ppm

Jaboticaba	0.90 ppm

Wax jambu	0.90 ppm

Starfruit	0.90 ppm

Passionfruit	0.90 ppm

Acerola	0.90 ppm

Caneberry subgroup 13A	5.0 ppm

Wild raspberry	5.0 ppm

Vegetable, legume, edible-podded, subgroup 6A	6.0 ppm

Pea and bean, succulent-shelled, subgroup 6B	0.70 ppm

Soybean, succulent-shelled	0.70 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 next
paragraph), squash, peach, tomato, soybean, and soybean oil.  For
squash, peach, tomato, soybean, and soybean oil, 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
soybeans, the tolerance level (1.5 ppm) for residues established in
conjunction with a Section 18 request was used.  DEEM( (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 tart cherry tolerance
of 5.0 ppm, which was based on data translations (D317316, T. Bloem et
al., 5-May-2005), is greater than the HED recommended tolerances for
residues in/on peach and nectarines.  Since the Section 18 cherry
application scenario is identical to the Section 3 registration, the
HED-recommended tolerance for residues in/on peach and nectarine 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 (attachment 1; J. Carter,
13-Jul-2006).

Drinking Water Residues Used in the Chronic Risk Assessments:  Surface
and ground water estimated drinking water concentrations (EDWCs) were
generated using the FIRST (87% cropped area) and screening concentration
in ground water (SCI-GROW) models, respectively.  Both models were run
using the strawberry application scenario (2 x 0.50 lb ai/acre; 21-day
RTI; highest registered/proposed rate).  The resulting chronic EDWCs in
ground and surface water were <0.001 ppb and 6.38 ppb, respectively
(EFED Memo; D286171, T. Nguyen, 10-Oct-2003). Since the surface water
concentration was the highest, the chronic dietary run was conducted
assuming a residue of 0.00638 ppm for all water sources (direct and
indirect). 

III.  Program and Consumption Information

DEEM-FCID™ (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
non-consecutive survey days.  Foods “as consumed” (e.g., apple pie)
are linked to EPA-defined food commodities (e.g. apples, peeled fruit -
cooked; fresh or N/S; baked; or wheat flour - cooked; fresh or N/S,
baked) using publicly available recipe translation files developed
jointly by USDA/ARS and EPA.  For chronic exposure assessment,
consumption data are averaged for the entire U.S. population and within
population subgroups.  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 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 food-form (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 = lowest-
observed-adverse-effect-level, cPAD = chronic population-adjusted dose,
RfD = reference-dose.

V.  Results/Discussion

The chronic exposure estimates are (47% 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
analysis conducted in DEEM-FCID(, the major contributors to the risk for
children 1 to 2 years old were succulent-shelled peas and beans, 
succulent or dried-legume vegetables, milk, and edible-pod legume
vegetables.

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	0.01	0.0019	19%

All Infants (< 1 year old)

0.0041	41%

Children 1-2 years old

0.0047	47%

Children 3-5 years old

0.0040	40%

Children 6-12 years old

0.0026	26%

Youth 13-19 years old

0.0016	16%

Adults 20-49 years old

0.0013	13%

Adults 50+ years old

0.0016	16%

Females 13-49 years old

0.0015	15%

VI.  Characterization of Inputs/Outputs

The chronic analyses were refined through the use of average field trial
residues, experimentally- determined processing factors, and average
percent crop-treated information.  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 (5%), 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 tolerance-level 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 estimate incorporated into the analysis was generated
with the assumption that 87% of the basin was cropped and 100% of the
cropped area was treated.  

Based on a critical-commodity analysis conducted in DEEM-FCID(, the
major contributors to the risk for children 1 to 2 years old were
succulent-shelled peas and beans, succulent or dried-legume vegetables,
milk, and edible-pod legume vegetables.

VII.  Conclusions

The chronic exposure estimates are (47% cPAD and are not of concern to
HED.   The most highly-exposed 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( chronic residue file	

Attachment 3:	DEEM-FCID( chronic exposure estimates 

RDI:  DE SAC Reviewers:  11/26/2007. 

7509P: RAB1: PY-2: Room 10316: 305-6135: Bifenazate

Attachment 1:	BEAD Average Percent Crop Treated Information



Attachment 2:	DEEM-FCID( chronic residue file

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for BIFENAZATE                        
1994-98 data

Residue file: M:\Work Files\$ Bifenazate\DEEM\wdw000586c.R98   Adjust.
#2 used

Analysis Date 11-26-2007             Residue file dated:
11-26-2007/11:47:59/8

Reference dose (RfD) = 0.01 mg/kg bw/day

Comment:no acute endpoint identified; FQPA SF of 1x

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

95000010 O    Acerola                            0.900000   1.000     
1.000   

14000030 14   Almond                             0.200000   1.000     
0.010  

14000031 14   Almond-babyfood                    0.200000   1.000     
0.010  

14000040 14   Almond, oil                        0.200000   1.000     
0.010  

14000041 14   Almond, oil-babyfood               0.200000   1.000     
0.010  

11000070 11   Apple, fruit with peel             0.750000   1.000     
0.010  

11000080 11   Apple, peeled fruit                0.750000   1.000     
0.010  

11000081 11   Apple, peeled fruit-babyfood       0.750000   1.000     
0.010  

11000090 11   Apple, dried                       0.750000   8.000     
0.010  

11000091 11   Apple, dried-babyfood              0.750000   8.000     
0.010  

11000100 11   Apple, juice                       0.750000   0.230     
0.010  

11000101 11   Apple, juice-babyfood              0.750000   0.230     
0.010  

11000110 11   Apple, sauce                       0.750000   1.000     
0.010  

11000111 11   Apple, sauce-babyfood              0.750000   1.000     
0.010  

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  

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  

09020210 9B   Balsam pear                        0.750000   1.000     
1.000  

06020330 6B   Bean, cowpea, succulent            0.700000   1.000     
1.000  

06010430 6A   Bean, snap, succulent              0.700000   1.000     
1.000  

06010431 6A   Bean, snap, succulent-babyfood     0.700000   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  

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  

13010580 13A  Boysenberry                        5.000000   1.000     
1.000  

14000590 14   Brazil nut                         0.200000   1.000     
1.000  

14000680 14   Butternut                          0.200000   1.000     
1.000  

95000740 O    Canistel                           7.000000   1.000     
1.000  

09010750 9A   Cantaloupe                         0.750000   1.000     
1.000  

09010800 9A   Casaba                             0.750000   1.000     
1.000  

14000810 14   Cashew                             0.200000   1.000     
1.000  

01030820 1CD  Cassava                            0.100000   1.000     
1.000  

01030821 1CD  Cassava-babyfood                   0.100000   1.000     
1.000  

09020880 9B   Chayote, fruit                     0.750000   1.000     
1.000  

12000900 12   Cherry                             2.500000   1.000     
1.000  

12000901 12   Cherry-babyfood                    2.500000   1.000     
1.000  

12000910 12   Cherry, juice                      2.500000   1.500     
1.000  

12000911 12   Cherry, juice-babyfood             2.500000   1.500     
1.000  

14000920 14   Chestnut                           0.200000   1.000     
1.000  

06030980 6C   Chickpea, seed                     0.200000   1.000     
1.000  

06030981 6C   Chickpea, seed-babyfood            0.200000   1.000     
1.000  

06030990 6C   Chickpea, flour                    0.200000   1.000     
1.000  

09021020 9B   Chinese waxgourd                   0.750000   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  

11001290 11   Crabapple                          0.750000   1.000     
1.000  

09021350 9B   Cucumber                           0.750000   1.000     
0.010  

01031390 1CD  Dasheen, corm                      0.100000   1.000     
1.000  

13011420 13A  Dewberry                           5.000000   1.000     
1.000  

08001480 8    Eggplant                           2.000000   1.000     
1.000  

95001510 O    Feijoa                             0.900000   1.000     
1.000  

14001550 14   Filbert                            0.200000   1.000     
1.000  

14001560 14   Filbert, oil                       0.200000   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  

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  

95001750 O    Grape                              0.750000   1.000     
0.050  

95001760 O    Grape, juice                       0.750000   0.170     
0.050  

95001761 O    Grape, juice-babyfood              0.750000   0.170     
0.050  

95001770 O    Grape, leaves                      0.750000   1.000     
0.050  

95001780 O    Grape, raisin                      1.200000   1.000     
0.050  

95001790 O    Grape, wine and sherry             0.750000   0.170     
0.050  

95001830 O    Guava                              0.900000   1.000     
1.000  

95001831 O    Guava-babyfood                     0.900000   1.000     
1.000  

14001850 14   Hickory nut                        0.200000   1.000     
1.000  

09011870 9A   Honeydew melon                     0.750000   1.000     
1.000  

95001880 O    Hop                               15.000000   1.000     
1.000  

24001890 M    Horse, meat                        0.020000   1.000     
1.000  

13012080 13A  Loganberry                         5.000000   1.000     
1.000  95002090 O    Longan                             5.000000   1.000
     1.000  

11002100 11   Loquat                             0.750000   1.000     
1.000  

95002110 O    Lychee                             5.000000   1.000     
1.000  

95002120 O    Lychee, dried                      5.000000   1.000     
1.000  

14002130 14   Macadamia nut                      0.200000   1.000     
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  

28002210 M    Meat, game                         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  

12002300 12   Nectarine                          2.500000   1.000     
0.050  

08002340 8    Okra                               2.000000   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   1.000     
1.000  

95002470 O    Papaya, juice                      7.000000   1.000     
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  

06022550 6B   Pea, succulent                     0.700000   1.000     
1.000  

06022551 6B   Pea, succulent-babyfood            0.700000   1.000     
1.000  

06012570 6A   Pea, edible-podded, succulent      6.000000   1.000     
1.000  

06022590 6B   Pea, pigeon, succulent             0.700000   1.000     
1.000  

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  

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  

14002690 14   Pecan                              0.200000   1.000     
0.010  

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  

95002750 O    Peppermint                        25.000000   1.000     
1.000  

95002760 O    Peppermint, oil                   25.000000   1.000     
1.000  

14002820 14   Pistachio                          0.200000   1.000     
1.000  

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  

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  

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  

01033001 1C   Potato, tuber, w/o peel-babyfood   0.100000   1.000     
1.000  

09023080 9B   Pumpkin                            0.750000   1.000     
1.000  

09023090 9B   Pumpkin, seed                      0.750000   1.000     
1.000  

11003100 11   Quince                             0.750000   1.000     
1.000  

29003120 M    Rabbit, meat                       0.020000   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  

95003330 O    Sapote, Mamey                      7.000000   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  

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  

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  

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  

95003580 O    Starfruit                          0.900000   1.000     
1.000  

95003590 O    Strawberry                         1.500000   1.000     
0.250  

95003591 O    Strawberry-babyfood                1.500000   1.000     
0.250  

95003600 O    Strawberry, juice                  1.500000   1.000     
0.250  

95003601 O    Strawberry, juice-babyfood         1.500000   1.000     
0.250  

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  

08003740 8    Tomatillo                          2.000000   1.000     
1.000  

08003750 8    Tomato                             0.190000   1.000     
0.050  

08003751 8    Tomato-babyfood                    0.190000   1.000     
0.050  

08003760 8    Tomato, paste                      0.190000   1.000     
0.050  

08003761 8    Tomato, paste-babyfood             0.190000   1.000     
0.050  

08003770 8    Tomato, puree                      0.190000   1.000     
0.050  

08003771 8    Tomato, puree-babyfood             0.190000   1.000     
0.050  

08003780 8    Tomato, dried                      0.190000  14.300     
0.050  

08003781 8    Tomato, dried-babyfood             0.190000  14.300     
0.050  

08003790 8    Tomato, juice                      0.190000   1.500     
0.050  

01033870 1CD  Turmeric                           0.100000   1.000     
1.000  

14003910 14   Walnut                             0.200000   1.000     
0.010  

86010000 O    Water, direct, all sources         0.006380   1.000     
1.000  

86020000 O    Water, indirect, all sources       0.006380   1.000     
1.000  

09013990 9A   Watermelon                         0.750000   1.000     
0.010  

09014000 9A   Watermelon, juice                  0.750000   1.000     
0.010  

01034060 1CD  Yam, true                          0.100000   1.000     
1.000  

Attachment 3:	DEEM-FCID( chronic exposure estimates

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: M:\Work Files\$ Bifenazate\DEEM\wdw000586c.R98

                                                     Adjustment factor
#2 used.

Analysis Date 12-03-2007/15:17:32     Residue file dated:
12-03-2007/15:10:19/8

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)                     0.001920               
19.2%

U.S. Population (spring season)             0.001970               
19.7%

U.S. Population (summer season)             0.002108               
21.1%

U.S. Population (autumn season)             0.001787               
17.9%

U.S. Population (winter season)             0.001816               
18.2%

Northeast region                            0.001817               
18.2%

Midwest region                              0.001906               
19.1%

Southern region                             0.001792               
17.9%

Western region                              0.002230               
22.3%

Hispanics                                   0.002156               
21.6%

Non-hispanic whites                         0.001857               
18.6%

Non-hispanic blacks                         0.001806               
18.1%

Non-hisp/non-white/non-black                0.002724               
27.2%

All infants (< 1 year)                      0.004028               
40.3%

Nursing infants                             0.001666               
16.7%

Non-nursing infants                         0.004924               
49.2%

Children 1-6  yrs                           0.004139               
41.4%

Children 7-12 yrs                           0.002410               
24.1%

Females 13-19 (not preg or nursing)         0.001364               
13.6%

Females 20+ (not preg or nursing)           0.001441               
14.4%

Females 13-50 yrs                           0.001607               
16.1%

Females 13+ (preg/not nursing)              0.003506               
35.1%

Females 13+ (nursing)                       0.001853               
18.5%

Males 13-19 yrs                             0.001752               
17.5%

Males 20+ yrs                               0.001663               
16.6%

Seniors 55+                                 0.001450               
14.5%

Children 1-2 yrs                            0.004687               
46.9%

Children 3-5
yr⁳†††††††††††††〠〮㌰㤹″††††
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㤱礠獲††††††††††††††〠〮㄰㘵′††
†††††ㄠ⸵┶

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ᜀAdults 20-49 yrs                            0.001623               
16.2%

Adults 50+ yrs                              0.001475               
14.7%

Females 13-49 yrs                           0.001495               
15.0%

page   PAGE  1  of   NUMPAGES  14