![](media/image1.wmf)**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY**

**WASHINGTON, D.C. 20460**

**OFFICE OF**

**PREVENTION, PESTICIDES**

**AND TOXIC SUBSTANCES**

**[MEMORANDUM]{.underline}**

Date: 19-July-2006

Subject: **Bifenazate - Chronic Dietary Exposure and Risk Assessment.**
Application of Bifenazate to succulent Pea, Tuberous and Corm Vegetables
(subgroup 1c), and Stone Fruit. PC Code: 000586. DP No.: 330587. PP No.:
5E6992. Decision No.: 360901.

Reviewer/To: Tom Bloem, Chemist

Registration Action Branch 1/Health Effects Division (RAB1/HED; 7509C)

Through: Toiya Goodlow, Chemist, Reregistration Branch 1 (RRB1)

Christina Swartz, Branch Chief RAB2

Dietary Exposure Science Advisory Committee (DESAC)

George Kramer, Ph.D., Senior Chemist

RAB1/HED (7509C)

**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
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, tomato, and
soybean (average field-trial residues were assumed) and milk
(anticipated residue was assumed). 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, 5.0, and 5.0, respectively, based on data from
processing studies. The analyses also included the chronic surface water
point estimate generated using the Tier 1 model 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 94% cPAD and are, therefore, less than HED's level of concern
(children 1-2 years old were the most highly exposed population). Based
on a critical-commodity analysis conducted in DEEM-FCID, the major
contributor to the risk was soybean oil (16-55% of the cPAD).

**I. Introduction**

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide. For chronic assessments, the risk is expressed as a
percentage of a maximum acceptable dose. This is the PAD, which HED has
concluded will result in no unreasonable adverse health effects. The PAD
is the 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 26-April-2005 (D315873, 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).

Subsequent to these decisions, the petitioner submitted a
radiovalidation study 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. HED notes that the ruminant feeding study
did not monitor for D9569 (monitored for residues of bifenazate, D3598,
A1530, and A1530-sulfate).

  -----------------------------------------------------------------------
  **Table 1.                                   
  Residues for                                 
  Tolerance                                    
  Expression and                               
  Risk Assessment**                            
  ----------------- -------------------------- --------------------------
  Matrix            Residues included in Risk  Residues included in
                    Assessment                 Tolerance Expression

  Plants            bifenazate, D3598          bifenazate, D3598
                    (expressed as parent)      (expressed as parent)

  Livestock         bifenazate, D3598          bifenazate, D3598
  (excluding        (expressed as parent),     (expressed as parent),
  fat)^2^           A1530, A1530-sulfate       A1530, A1530-sulfate
                    (expressed as A1530)       (expressed as A1530)

  Livestock - fat   bifenazate, D3598          bifenazate, D3598
                    (expressed as parent)      (expressed as parent)

  Rotational Crops  could not be determined^1^ could not be determined^1^

  Drinking Water    D1989                      D1989
  -----------------------------------------------------------------------

^1^ Based on the results of the confined rotational crop study conducted
0.5 lb ai/acre and 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, tomato, soybean, 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 (succulent pea and tuberous and corm vegetables - D324430, T.
Bloem, 5-July-2006; stone fruit, plum, and fat (cattle, goat, hog,
horse, sheep) - D313261, T. Bloem, 5-July-2006):

pea, garden, succulent 0.20 ppm

pea, edible podded, succulent 4.0 ppm

vegetable, tuberous and corm, subgroup 1c 0.10 ppm

fruit, stone, group 12 (except
plum)\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...\...
2.5 ppm

plum 0.20 ppm

fat (cattle, goat, hog, horse, sheep) 0.10 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), soybean - 0.49 ppm
(D308822, J. Tyler, 29-Oct-2004), and soybean oil - 5.9 ppm (0.49 ppm x
theoretical processing factor of 12.0 = 5.9 ppm; D308822, J. Tyler,
29-Oct-2004). 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, 5.0, and 5.0,
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 stone fruit tolerance. Since the Section 18
cherry application scenario is identical to the Section 3 registration,
the HED-recommended stone fruit tolerance indicated above was used for
cherry.

As indicated above, the petitioner submitted data which indicates that
the major residue in milk is D9569 and not A1530-sulfate as previously
indicated. HED requested that the petitioner submit data confirming the
identity of the major residues in milk (D313261, T. Bloem,
12-July-2006). The ruminant metabolism study indicated that major
residue in milk, originally identified as A1530-sulfate but now thought
to be D9569, occupied 41% of the total radioactive residue (TRR) and
combined residues of bifenazate and D3598 occupied 9% of the TRR.
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 analtical method did not differentiate between
A1530-sulfate and A1530). Based on the current maximum theoretical
dietary burden of 6.99 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 0.0391 ppm is calculated ((0.01 + (0.01 x 4.6)) x (6.99
÷ 10) = 0.0391). Residues in milk fat were set to 0.98 ppm (milk residue
(0.0391 ppm) x 25 = 0.98 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 environmental concentrations (EECs) were
generated using the FIRST (87% cropped area) and SCI-GROW models,
respectively. Both models were ran using the strawberry application
scenario (2 x 0.50 lb ai/acre; 21-day RTI; highest registered/proposed
rate). The resulting chronic EECs 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**

Chronic dietary exposure assessments were conducted using 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, children 3-5, children 6-12, youth 13-19, adults 20-49,
females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue
level in each food or 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**

The HED Hazard Identification Assessment Review Committee (HIARC) met on
four occasions to examine the toxicology database for bifenazate and to
determine the appropriate toxicological endpoints for dietary and
occupational/residential exposure assessment (meeting dates -
21-Aug-2001 (TXR No. 0014658), 24-Apr-2001 (TXR No. 0014576), 13-
Apr-1999 (TXR No. 0013335), and 4-Feb-1999 (TXR No. 0013277)). The HED
Food Quality Protection Act Safety Factor Committee (FQPA SFC) met on
27-August-2001 to evaluate the bifenazate toxicological database in
reference to the potential for enhanced sensitivity to infants and
children (TXR No. 0014661). Based on the conclusions made by the HIARC
and FQPA SFC, the complete residue chemistry and environmental fate
databases, and the conservative assumptions used when generating the
dietary exposure estimates, HED concludes that the FQPA SF should be
reduced to 1x. A summary of the toxicological doses and endpoints
selected for dietary exposure assessment is provided in Table 2.

+----------+-------------+-------------+------------------------------+
| **Table  |             |             |                              |
| 2.       |             |             |                              |
| Toxic    |             |             |                              |
| ological |             |             |                              |
| E        |             |             |                              |
| ndpoints |             |             |                              |
| for      |             |             |                              |
| Dietary  |             |             |                              |
| An       |             |             |                              |
| alysis** |             |             |                              |
+==========+=============+=============+==============================+
| **Ex     | **Dose Used | **FQPA SF   | **Study and Toxicological    |
| posure** | in Risk     | and Level   | Effects**                    |
|          | As          | of Concern  |                              |
| **Sc     | sessment,** | for Risk    |                              |
| enario** |             | A           |                              |
|          | **UF**      | ssessment** |                              |
+----------+-------------+-------------+------------------------------+
| Acute    | An acute    |             |                              |
| Dietary; | dietary     |             |                              |
|          | endpoint    |             |                              |
| all      | was not     |             |                              |
| pop      | selected    |             |                              |
| ulations | based on    |             |                              |
|          | the absence |             |                              |
|          | of an       |             |                              |
|          | appropriate |             |                              |
|          | endpoint    |             |                              |
|          | attributed  |             |                              |
|          | to a single |             |                              |
|          | dose.       |             |                              |
+----------+-------------+-------------+------------------------------+
| Chronic  | NOAEL= 1.0  | FQPA SF =   | LOAEL = 8.9/10.4 mg/kg/day   |
| Dietary; | mg/kg/day   | 1X          | \[M/F\] based on changes in  |
|          |             |             | hematological and clinical   |
| all      | UF = 100    | cPAD = 0.01 | chemistry parameters, and    |
| pop      |             | mg/kg/day   | histopathology in bone       |
| ulations | cRfD = 0.01 |             | marrow, liver, and kidney in |
|          | mg/kg/day   |             | 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 dietary risk estimates are 94% cPAD and are, therefore, less
than HED's level of concern (children 1-2 years old were the most highly
exposed population).

  ------------------------------------------------------------------------
  **Table 3: Summary                                     
  of Chronic Dietary                                     
  Exposure and Risk                                      
  for Bifenazate                                         
  (drinking water                                        
  included)**                                            
  -------------------- -------------- ------------------ -----------------
  Population Subgroup  cPAD           Chronic            
                       (mg/kg/day)                       

                                      Exposure           %cPAD
                                      (mg/kg/day)        

  General U.S.         0.01           0.003835           38
  Population                                             

  All Infants (\< 1                   0.007938           79
  year old)                                              

  Children 1-2 years                  0.009386           94
  old                                                    

  Children 3-5 years                  0.008595           86
  old                                                    

  Children 6-12 years                 0.005942           59
  old                                                    

  Youth 13-19 years                   0.003712           37
  old                                                    

  Adults 20-49 years                  0.003084           31
  old                                                    

  Adults 50+ years old                0.002554           26

  Females 13-49 years                 0.002864           29
  old                                                    
  ------------------------------------------------------------------------

**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 greenhouse
residue of 0.19 ppm (average field tomato residue 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 preharvest interval); **(2)** incorporated maximum
theoretical processing factors for several commodities including a12x
processing factor for soybean oil (D305565, J. Tyler, 29-Oct-2004); and
**(3)** 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 treated.

Based on a critical-commodity analysis conducted in DEEM-FCID, the major
contributor to the risk was soybean oil (16-55% of the cPAD).

**VII. Conclusions**

The chronic dietary risk estimates are 94% cPAD and are therefore less
than HED's level of concern (children 1-2 years old were the most highly
exposed population).

**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

cc Daniel Rosenblatt/Sidney Jackson (RM 05) and Daniel Kenny/Rita Kumar
(RM 01)

T. Bloem:S10945:Potomac Yard:(703)605-0217:7509P

Attachment 1: BEAD Average Percent Crop Treated Information

![](media/image2.wmf){width="6.489583333333333in"
height="8.408333333333333in"}

![](media/image3.wmf){width="6.489583333333333in"
height="8.408333333333333in"}

![](media/image4.wmf){width="6.489583333333333in"
height="8.408333333333333in"}

Attachment 2: DEEM-FCID chronic residue file

Filename: C:\\Documents and Settings\\tbloem\\bifenazate\\tuberous and
corm vegetables and succulent pea\\000586c.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: 07-14-2006/13:36:39/8 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

\-\-\-\-\-\-\-- \-\-\--
\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--
\-\-\-\-\-\-\-\-\-- \-\-\-\-\-- \-\-\-\-\-- \-\-\-\-\-\--

95001280 O Cottonseed, oil 0.750000 1.000 1.000

95001281 O Cottonseed, oil-babyfood 0.750000 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

95001880 O Hop 15.000000 1.000 1.000

95002750 O Peppermint 25.000000 1.000 1.000

95002760 O Peppermint, oil 25.000000 1.000 1.000

95003520 O Spearmint 25.000000 1.000 1.000

95003530 O Spearmint, oil 25.000000 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

86010000 O Water, direct, all sources 0.006380 1.000 1.000

86020000 O Water, indirect, all sources 0.006380 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 0.980000 1.000 1.000

27002221 D Milk, fat - baby food/infant for 0.980000 1.000 1.000

27012230 D Milk, nonfat solids 0.039100 1.000 1.000

27012231 D Milk, nonfat solids-baby food/in 0.039100 1.000 1.000

27022240 D Milk, water 0.039100 1.000 1.000

27022241 D Milk, water-babyfood/infant form 0.039100 1.000 1.000

27032251 D Milk, sugar (lactose)-baby food/ 0.039100 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

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

06020330 6B Bean, cowpea, succulent 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

06022550 6B Pea, succulent 0.200000 1.000 1.000

06022551 6B Pea, succulent-babyfood 0.200000 1.000 1.000

06012570 6A Pea, edible podded, succulent 4.000000 1.000 1.000

06022590 6B Pea, pigeon, succulent 0.200000 1.000 1.000

06003470 6 Soybean, seed 0.490000 1.000 1.000

06003480 6 Soybean, flour 0.490000 1.000 1.000

06003481 6 Soybean, flour-babyfood 0.490000 1.000 1.000

06003490 6 Soybean, soy milk 0.490000 1.000 1.000

06003491 6 Soybean, soy milk-babyfood or in 0.490000 1.000 1.000

06003500 6 Soybean, oil 5.900000 1.000 1.000

06003501 6 Soybean, oil-babyfood 5.900000 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 0.050

08003751 8 Tomato-babyfood 0.190000 1.000 0.050

08003760 8 Tomato, paste 0.190000 5.000 0.050

08003761 8 Tomato, paste-babyfood 0.190000 5.000 0.050

08003770 8 Tomato, puree 0.190000 5.000 0.050

08003771 8 Tomato, puree-babyfood 0.190000 5.000 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

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

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 0.010

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

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 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

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

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

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 1.000

14003910 14 Walnut 0.200000 1.000 0.010

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: C:\\Documents and
Settings\\tbloem\\bifenazate\\tuberous and corm vegetables and succulent
pea\\000586c.R98

Adjustment factor #2 used.

Analysis Date 07-27-2006/09:58:15 Residue file dated:
07-14-2006/13:36:39/8

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) 0.003835 38.3%

U.S. Population (spring season) 0.003900 39.0%

U.S. Population (summer season) 0.003864 38.6%

U.S. Population (autumn season) 0.003764 37.6%

U.S. Population (winter season) 0.003815 38.2%

Northeast region 0.003689 36.9%

Midwest region 0.004040 40.4%

Southern region 0.003717 37.2%

Western region 0.003933 39.3%

Hispanics 0.003999 40.0%

Non-hispanic whites 0.003795 37.9%

Non-hispanic blacks 0.003885 38.9%

Non-hisp/non-white/non-black 0.003956 39.6%

All infants (\< 1 year) 0.007938 79.4%

Nursing infants 0.002697 27.0%

Non-nursing infants 0.009927 99.3%

Children 1-6 yrs 0.008684 86.8%

Children 7-12 yrs 0.005654 56.5%

Females 13-19 (not preg or nursing) 0.003211 32.1%

Females 20+ (not preg or nursing) 0.002622 26.2%

Females 13-50 yrs 0.003078 30.8%

Females 13+ (preg/not nursing) 0.003447 34.5%

Females 13+ (nursing) 0.003636 36.4%

Males 13-19 yrs 0.004181 41.8%

Males 20+ yrs 0.003160 31.6%

Seniors 55+ 0.002521 25.2%

Children 1-2 yrs 0.009386 93.9%

Children 3-5 yrs 0.008595 85.9%

Children 6-12 yrs 0.005942 59.4%

Youth 13-19 yrs 0.003712 37.1%

Adults 20-49 yrs 0.003084 30.8%

Adults 50+ yrs 0.002554 25.5%

Females 13-49 yrs 0.002864 28.6%

\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\-\--