 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	November 8, 2007   

SUBJECT:	Flonicamid Chronic Aggregate Dietary (Food and Drinking Water)
Exposure and Risk Assessments for an IR-4 Section 3 Registration Action
on Root Vegetables (Except Sugar Beet; Subgroup 1B), Tuberous and Corm
Vegetables (Subgroup 1C), Leafy Brassica Greens (Subgroup 5B), Radish
Tops, Turnip Greens, Hops, Dried Cones, and Okra.  PP# 6E7081.

PC Code:		128016			Decision Number: 368509

DP Number:		343466

Petition Number:	6E7081

REVIEWER:	Amelia M. Acierto, Chemist 

Registration Action Branch 3/HED (7509P)

THROUGH:   Sheila Piper, Chemist

		Douglas Dotson, Chemist

Dietary Exposure Science Advisory Council (DESAC)

Health Effects Division (7509P)

Paula Deschamp, Chief

Registration Action Branch 3

Health Effects Division (7509P)

TO:		Sheila Piper, Risk Assessor

Chemistry & Exposure Branch 

Health Effects Division (7509P)

Executive Summary

Chronic aggregate dietary (food and drinking water) exposure and risk
assessments were conducted using the Dietary Exposure Evaluation Model
(DEEM-FCID(, Version 2.03), which uses food consumption data from the
USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII) from
1994-1996 and 1998.  In addition to residues in/on food items, the
assessment also addresses potential residues in drinking water.  In this
analysis the chronic dietary exposure and risk estimates resulting from
food and water intake were determined for the general U.S. population
and various population subgroups.  Flonicamid has no acute endpoint and
has been determined to be “not a carcinogen;” therefore only a
chronic analysis was performed to support a petition for tolerances in
conjunction with an IR-4 petition for a Section 3 registration for the
new uses of flonicamid in/on vegetable, root crop (except sugar beet,
subgroup 1B), radish, tops, tuberous and corm vegetable (subgroup 1C),
Brassica, leafy greens 

(subgroup 5B), turnip (greens), hop, dried cones, and okra.  Tolerances
have already been established under 40 CFR 180.613 on cotton, cucurbit
vegetables, fruiting vegetables, leafy vegetables (group 4 except
Brassica, except spinach), spinach, pome fruit (group 11), potato, stone
fruit (group 12), head and stem Brassica (subgroup 5A) and mustard
greens.

Chronic Dietary Exposure Results and Characterization

A chronic dietary (food and drinking water) exposure assessment was
conducted for the proposed commodities, registered commodities and
drinking water.  Except for water, a conservative unrefined assessment
was conducted.  The residue levels used in the assessment were the
tolerance levels recommended by HED for the new commodities, the
tolerance levels established under 40 CFR.§180.613 for registered crops
(head and stem Brassica, cotton, cucurbit vegetable, fruiting vegetable,
leafy vegetable, mustard greens, potato, pome fruit, spinach and stone
fruit),  and revised tolerance levels for livestock commodities.  

Estimated concentrations of 1.5 ppb (1.5 x 10-3 ppm) for the 1 in 10
year annual mean concentration of flonicamid in drinking water from the
proposed uses were provided by EFED and incorporated directly into the
chronic assessment.  A Tier II drinking water assessment for the
proposed uses was performed using PRZM/EXAMS modeling with index
reservoir (IR) scenarios and percent crop area (PCA) adjustment factors.


The chronic dietary (food and drinking water) exposure to flonicamid is
below HED’s level of concern for the general U.S. population and all
population subgroups.  The chronic dietary exposure estimates are 10%
cPAD for the general U.S. population, 15% cPAD for all infants (<1 year
old), and 23% cPAD for children 1-2 years old, the most highly exposed
population subgroup.

Acute Dietary Exposure Results and Characterization

An acute dietary risk assessment was not performed as flonicamid has no
acute toxicological endpoint.

Cancer Dietary Exposure Results and Characterization

A cancer dietary assessment was not conducted as flonicamid has been
determined to be “not a carcinogen.” 

 

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For acute and chronic assessments, the risk is
expressed as a percentage of a maximum acceptable dose (i.e., the dose
which HED has concluded will result in no unreasonable adverse health
effects).  This dose is referred to as the population adjusted dose
(PAD).  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL,
e.g.) divided by the required uncertainty or safety factors.

For non-cancer chronic exposures, HED is concerned when estimated
dietary risk exceeds 100% of the PAD.  HED is generally concerned when
estimated cancer risk exceeds one in one million. References which
discuss the acute and chronic risk assessments in more detail are
available on the EPA/pesticides web site:  “Available Information on
Assessing Exposure from Pesticides, A User’s Guide,” 21-JUN-2000,
web link:      HYPERLINK
"http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf" 
http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf  ; or see
SOP 99.6 (20-AUG-1999).

The most recent dietary risk assessment for flonicamid was conducted by
Amelia Acierto 

(26-April-2005, DP Number 315611).

II.	Residue Information    

 

Flonicamid Use:

Flonicamid is a Group 9C insecticide (selective feeding blocker)
registered for the control of a variety of aphid pests and the
suppression of a variety of non-aphid pests.  Tolerances for registered
commodities can be found in 40 CFR.§180.613.  The tolerances that are
currently being recommended are listed in Table 1, below.    The residue
of concern for plants are parent flonicamid and its major metabolites
TFNA-AM, TFNA and TFNG; in ruminants are parent and its metabolites
TFNA-AM and TFNA. 

Residue Data used for Chronic Assessments:

The residue levels used in the chronic assessment were the established
tolerance levels for plant commodities established under 40 CFR
§180.613 and the tolerance levels based on the crop trials for the
proposed crops.  Most of the livestock commodity tolerances are being
increased because all regulated residues are going to be included in the
tolerances.  See Table 1, below for the increased livestock commodity
tolerances. 

Estimated concentrations of flonicamid in drinking water from the
proposed uses were provided by EFED and incorporated directly into the
chronic assessment.  

The assessments used 100% crop treated.

Table 1. 	Tolerance Summary for Flonicamid

Commodity or Subgroup	Proposed Tolerance (ppm)	Established Tolerance
(ppm)	Recommended Tolerance (ppm)	Comments; Correct Commodity Definition

Tolerances for combined residues of flonicamid and its metabolites TFNA,
TFNA-AM, and TFNG

[40 CFR 180.613(a)(1)]:

Brassica, leafy greens, subgroup 5B	16	--	16

	Hop, dried cones	7.0	--	7.0

	Mustard greens	--	11	16	Residues in/on mustard greens will be covered
by the tolerance for leafy Brassica green, subgroup 5B.

Okra	0.4	--	0.40

	Potato

0.20	0.20	Residues in/on potato will be covered by the tolerance for
tuberous and corm vegetables, subgroup 1C.

Radish, tops	16	--	16	Residues will be covered by the tolerance for
leafy Brassica green, subgroup 5B.

Turnip, greens	16	--	16

	Vegetable, root, except sugar beet, subgroup 1B	0.45	--	0.60
Recommended tolerance based on crop field trial data

Vegetable, tuberous and corm, subgroup 1C	0.2	--	0.20

	Tolerances for combined residues of flonicamid and its metabolites
TFNA-AM and TFNA in/on livestock commodities [40 CFR 180.613(a)(2)]:

Cattle, fat	--	0.02	0.03	Increased tolerances are needed to reflect
combined limits of quantitation for all regulated residues.

Cattle, meat	--	0.05	0.08

	Cattle, meat byproducts	--	0.08	0.08	No change needed.

Egg	--	0.03	0.04	An increased tolerance is needed to account for all
regulated residues.

Goat, fat	--	0.02	0.03	Increased tolerances are needed to reflect
combined limits of quantitation for all regulated residues.

Goat, meat	--	0.05	0.08

	Goat, meat byproducts	--	0.08	0.08	No change needed.

Horse, fat	--	0.02	0.03	Increased tolerances are needed to reflect
combined limits of quantitation for all regulated residues.

Horse, meat	--	0.05	0.08

	Horse, meat byproducts	--	0.08	0.08	No change needed.

Milk	--	0.02	0.03	Increased tolerances are needed to reflect combined
limits of quantitation for all regulated residues.

Poultry, fat	--	0.02	0.03

	Poultry, meat	--	0.02	0.03

	Poultry, meat byproducts	--	0.02	0.03

	Sheep, fat	--	0.02	0.03

	Sheep, meat	--	0.05	0.08

	Sheep, meat byproducts	--	0.08	0.08	No change needed.



Processing Factors:

Separate tolerances were established for dried potatoes, tomato paste,
and tomato puree based on processing studies.  The adjustment factor #1
was set to 1.0 for these commodities; the DEEM default processing
factors were used for the other processed commodities for which default
processing factors are available. 

III.  Drinking Water

The drinking water residues used in the dietary risk assessment were
provided by the Environmental Fate and Effects Division (EFED) in the
following memorandum: “Drinking Water  Assessment for  the IR-4 New
Uses of Flonicamid on Brassica, Hops, Tubulars, and Okra. Including The
Flonicamid Degradation Products (TFNG, TFNA, TFNA-OH, TFNA-AM and
TFNG-AM).”   Water residues were incorporated in the DEEM-FCID into
the food categories “water, direct, all sources” and “water,
indirect, all sources.” 

No monitoring data of flonicamid were available to the Environmental
Fate and Effects Division (EFED).  The estimated drinking water
concentrations from surface water sources were calculated using the Tier
II PRZM (Pesticide Root Zone Model) and EXAMS (Exposure Analysis
Modeling System).  PRIZM is used to simulate pesticide transport as a
result of runoff and erosion from an agricultural field and EXAMS
estimates environmental fate and transport of pesticides in surface
water.  The values generated by the models for drinking water were
multiplied by a national crop area factor (PCA), which accounts for the
fact that it is unlikely for any basin to be completely planted to
agricultural crops.  Ground water concentrations were estimated using
the Tier I SCI-GROW Model.  Flonicamid may be applied by aerial or
ground as per the labels for this product.   This memo only addresses
the estimations of parent flonicamid and its major metabolites, TFNG,
TFNA, TFNA-OH, TFNA-AM and TFNG-AM.  

Based on modeling results, the estimated drinking water (surface water)
concentrations of combined residues of flonicamid and its degradation
products (based on three aerial applications at the rate of 0.089 lb
ai/acre and the values adjusted with PCA factor of 0.87) are:

  

9.8 µg /L for the 1 in 10 year annual peak concentration (acute) - 
Based on the Florida carrot scenario.  

1.5 µg /L for the 1 in 10 year annual mean concentration (non-cancer
chronic)- Based on the California lettuce and Maine potato scenario.   

0.97µg /L for the 30 year annual mean concentration (cancer chronic) - 
Based on the Idaho potato scenario.   

Both the acute and chronic estimated concentrations for flonicamid in
ground water using the SCIGROW (version 2.3) Model are 1.32 x 10-3 µg/L
(ppb) for the combined residues. 

In general, the linked PRZM/EXAMS  Model produces estimated aquatic
concentrations that are expected to be exceeded once within a 10-year
period.

The model and its description are available at the EPA internet site:  
HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .  

	

	

IV.	DEEM-FCID™ Program and Consumption Information

Flonicamid chronic dietary exposure assessment wase conducted using the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database DEEM-FCID™,Version 2.03 which incorporates consumption
data from USDA’s Continuing Surveys of Food Intakes by Individuals
(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, but for acute exposure assessment are retained as
individual consumption events.  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.

V.	Toxicological Information

Toxicological Endpoints and Doses for Chronic Dietary Risk Assessment

The toxicity database for flonicamid was evaluated by HED's Registration
Action Branch III's Toxicology Team on 9/30/2004.  The Toxicology Team
at that meeting selected endpoints and evaluated for FQPA concerns the
potential hazard and exposure data for flonicamid and determined that
there was no need for an additional safety factor for the protection of
infants and children.  The Cancer Assessment Review Committee met on
1/5/2005.  The findings of those meetings, as related to dietary
exposure, are summarized in Table 2.  Flonicamid is classified to be
category “Suggestive Evidence of Carcinogenicity, but Not Sufficient
to Assess Human Carcinogenic Potential,” according to the EPA Draft
Guidelines for Carcinogen Risk Assessment dated July, 1999; therefore, a
cancer assessment is not necessary.



Table 2.  Summary of Dose and Toxicological Endpoint Selection Relative
to Use in Dietary Human Health Risk Assessment for Flonicamid



Exposure

Scenario	

Dose (mg/kg/day) 

UF	

FQPA Safety Factor and Level of Concern for Risk Assessment	

Endpoint for Risk Assessment



Acute Dietary

general population including infants and children	

N/A

	

N/A	

N/A.



Chronic Dietary

(All populations)	

NOAEL= 4.0 mg/kg/day  

UF = 100 

cPAD = 0.04 mg/kg/day	

FQPA SF = 1x

cPAD = Chronic RfD 

               FQPA SF

           = 0.04 mg/kg/day	

2-Gen reproduction study in the rat.  Parental LOAEL = 22 mg/kg/day
based on increased kidney weights, kidney hyaline deposition, increased
blood serum LH (F1 females). 



Cancer (oral, dermal, inhalation)	

Classified as "Suggestive Evidence of Carcinogenicity, but Not
Sufficient to Assess Human Carcinogenic Potential"	

N/A	

N/A

UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOEL = no
observed adverse effect level, LOAEL = lowest observed adverse effect
level, cPAD = chronic populatio, adjusted dose, Rfd = reference dose,
N/A = not applicable.

VI.	Results/Discussion

 is concerned when dietary risk exceeds 100% of the PAD.  The
DEEM-FCID™ analyses estimate the dietary exposure of the U.S.
population and various population subgroups.  The results reported in
Table 3 below are for the general U.S. Population, all infants (<1 year
old), children 1-2, children 3-5, children 6-12, youth 13-19, females
13-49, adults 20-49, and adults 50+ years.  

Results of Chronic Dietary (Food and Drinking Water) Exposure Analysis		
		

The results of the chronic dietary (food and drinking water) exposure
analysis are reported in Table 3 below.      

The chronic dietary (food and drinking water) exposure to flonicamid is
below HED’s level of concern for the general U.S. population and all
population subgroups.  The chronic dietary exposure estimates are 10%
cPAD for the general U.S. population and 15% cPAD for all infants (<1
year old), and 23% cPAD for children 1-2 years old, the most highly
exposed population subgroup.

Table 3.   Summary of Dietary (Food and Drinking Water) Exposure and
Risk for Flonicamid



Population Subgroup	

cPAD (mg/kg/day)	

Exposure (mg/kg/day)	

% cPAD





DEEM-FCID	

DEEM-FCID



General U.S. Population	

0.04	

0.004095	10



All Infants (< 1 year old)	

0.04	

0.006087	15



Children 1-2 years old	

0.04	

0.009070	23



Children 3-5 years old	

0.04	

0.007205	18



Children 6-12 years old	

0.04	

0.004483	11



Youth 13-19 years old	

0.04	

0.003280	8



Adults 20-49 years old	

0.04	

0.003513	9



Females 13-49 years old	

0.04	

0.003504	9



Adults 50+ years old	

0.04	

0.003978	10



VII.	Characterization of Inputs/Outputs

The chronic dietary exposure analysis is a conservative one.  As a
result, HED is confident that exposure is not underestimated to the U.S.
population or any population subgroup.  Further refinements could be
made; however, they are not necessary at the present time.

VIII.	 Conclusions

The chronic dietary exposure assessment was conducted for the proposed
uses on root vegetables (except sugar beet; subgroup 1B), tuberous and
corm vegetables (subgroup 1C), leafy Brassica greens (subgroup 5B),
turnip greens, hops, dried cones, and okra and drinking water.  A
conservative assessment was conducted.  Estimated concentrations of
flonicamid in drinking water from the proposed uses were provided by
EFED and incorporated directly into the chronic assessments.  

The chronic dietary (food and drinking water) exposure to flonicamid is
below HED’s level of concern for the general U.S. population and all
population subgroups.  The chronic dietary exposure estimates are 10%
cPAD for the general U.S. population and 15% cPAD for all infants (<1
year old), and 23% cPAD for children 1-2 years old, the most highly
exposed population subgroup.

IX.		List of Attachments

#1: DEEM(-FCID Chronic Residue Input File.

#2: DEEM(-FCID Chronic Results.

Attachment 1.  DEEM(-FCID Chronic Residue Input File.

Filename: C:\Documents and
Settings\aacierto\Desktop\Flonicamid.DEEMr\FLONICAMID.R98

Chemical: FLONICAMID

RfD(Chronic): .04 mg/kg bw/day  NOEL(Chronic): 4 mg/kg bw/day

RfD(Acute): 0 mg/kg bw/day  NOEL(Acute):  0 mg/kg bw/day

Date created/last modified: 11-16-2007/14:10:38/8          Program ver.
2.03

Comment: CHRONIC ONLY

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

04010050 4A   Amaranth, leafy                    4.000000   1.000  1.000
 

11000070 11   Apple, fruit with peel             0.200000   1.000  1.000
 

11000080 11   Apple, peeled fruit                0.200000   1.000  1.000
 

11000081 11   Apple, peeled fruit-babyfood       0.200000   1.000  1.000
 

11000090 11   Apple, dried                       0.200000   8.000  1.000
 

11000091 11   Apple, dried-babyfood              0.200000   8.000  1.000
 

11000100 11   Apple, juice                       0.200000   1.300  1.000
 

11000101 11   Apple, juice-babyfood              0.200000   1.300  1.000
 

11000110 11   Apple, sauce                       0.200000   1.000  1.000
 

11000111 11   Apple, sauce-babyfood              0.200000   1.000  1.000
 

12000120 12   Apricot                            0.600000   1.000  1.000
 

12000121 12   Apricot-babyfood                   0.600000   1.000  1.000
 

12000130 12   Apricot, dried                     0.600000   6.000  1.000
 

12000140 12   Apricot, juice                     0.600000   1.000  1.000
 

12000141 12   Apricot, juice-babyfood            0.600000   1.000  1.000
 

01030150 1CD  Arrowroot, flour                   0.200000   1.000  1.000
 

01030151 1CD  Arrowroot, flour-babyfood          0.200000   1.000  1.000
 

01030170 1CD  Artichoke, Jerusalem               0.200000   1.000  1.000
 

04010180 4A   Arugula                            4.000000   1.000  1.000
 

09020210 9B   Balsam pear                        0.400000   1.000  1.000
 

21000440 M    Beef, meat                         0.080000   1.000  1.000
 

21000441 M    Beef, meat-babyfood                0.080000   1.000  1.000
 

21000450 M    Beef, meat, dried                  0.080000   1.920  1.000
 

21000460 M    Beef, meat byproducts              0.080000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.080000   1.000  1.000
 

21000470 M    Beef, fat                          0.030000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.030000   1.000  1.000
 

21000480 M    Beef, kidney                       0.080000   1.000  1.000
 

21000490 M    Beef, liver                        0.080000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.080000   1.000  1.000
 

01010500 1AB  Beet, garden, roots                0.600000   1.000  1.000
 

01010501 1AB  Beet, garden, roots-babyfood       0.600000   1.000  1.000
 

05010610 5A   Broccoli                           1.500000   1.000  1.000
 

05010611 5A   Broccoli-babyfood                  1.500000   1.000  1.000
 

05010620 5A   Broccoli, Chinese                  1.500000   1.000  1.000
 

05020630 5B   Broccoli raab                     16.000000   1.000  1.000
 

05010640 5A   Brussels sprouts                   1.500000   1.000  1.000
 

01010670 1AB  Burdock                            0.600000   1.000  1.000
 

05010690 5A   Cabbage                            1.500000   1.000  1.000
 

05020700 5B   Cabbage, Chinese, bok choy        16.000000   1.000  1.000
 

05010710 5A   Cabbage, Chinese, napa             1.500000   1.000  1.000
 

05010720 5A   Cabbage, Chinese, mustard          1.500000   1.000  1.000
 

09010750 9A   Cantaloupe                         0.400000   1.000  1.000
 

04020760 4B   Cardoon                            4.000000   1.000  1.000
 

01010780 1AB  Carrot                             0.600000   1.000  1.000
 

01010781 1AB  Carrot-babyfood                    0.600000   1.000  1.000
 

01010790 1AB  Carrot, juice                      0.600000   1.000  1.000
 

09010800 9A   Casaba                             0.400000   1.000  1.000
 

01030820 1CD  Cassava                            0.200000   1.000  1.000
 

01030821 1CD  Cassava-babyfood                   0.200000   1.000  1.000
 

05010830 5A   Cauliflower                        1.500000   1.000  1.000
 

01010840 1AB  Celeriac                           0.600000   1.000  1.000
 

04020850 4B   Celery                             4.000000   1.000  1.000
 

04020851 4B   Celery-babyfood                    4.000000   1.000  1.000
 

04020860 4B   Celery, juice                      4.000000   1.000  1.000
 

04020870 4B   Celtuce                            4.000000   1.000  1.000
 

09020880 9B   Chayote, fruit                     0.400000   1.000  1.000
 

12000900 12   Cherry                             0.600000   1.000  1.000
 

12000901 12   Cherry-babyfood                    0.600000   1.000  1.000
 

12000910 12   Cherry, juice                      0.600000   1.500  1.000
 

12000911 12   Cherry, juice-babyfood             0.600000   1.500  1.000
 

40000930 P    Chicken, meat                      0.030000   1.000  1.000
 

40000931 P    Chicken, meat-babyfood             0.030000   1.000  1.000
 

40000940 P    Chicken, liver                     0.030000   1.000  1.000
 

40000950 P    Chicken, meat byproducts           0.030000   1.000  1.000
 

40000951 P    Chicken, meat byproducts-babyfoo   0.030000   1.000  1.000
 

40000960 P    Chicken, fat                       0.030000   1.000  1.000
 

40000961 P    Chicken, fat-babyfood              0.030000   1.000  1.000
 

40000970 P    Chicken, skin                      0.030000   1.000  1.000
 

40000971 P    Chicken, skin-babyfood             0.030000   1.000  1.000
 

01011000 1AB  Chicory, roots                     0.600000   1.000  1.000
 

09021020 9B   Chinese waxgourd                   0.400000   1.000  1.000
 

04011040 4A   Chrysanthemum, garland             4.000000   1.000  1.000
 

05021170 5B   Collards                          16.000000   1.000  1.000
 

95001280 O    Cottonseed, oil                    0.500000   1.000  1.000
 

95001281 O    Cottonseed, oil-babyfood           0.500000   1.000  1.000
 

11001290 11   Crabapple                          0.200000   1.000  1.000
 

04011330 4A   Cress, garden                      4.000000   1.000  1.000
 

04011340 4A   Cress, upland                      4.000000   1.000  1.000
 

09021350 9B   Cucumber                           0.400000   1.000  1.000
 

04011380 4A   Dandelion, leaves                  4.000000   1.000  1.000
 

01031390 1CD  Dasheen, corm                      0.200000   1.000  1.000
 

70001450 P    Egg, whole                         0.040000   1.000  1.000
 

70001451 P    Egg, whole-babyfood                0.040000   1.000  1.000
 

70001460 P    Egg, white                         0.040000   1.000  1.000
 

70001461 P    Egg, white (solids)-babyfood       0.040000   1.000  1.000
 

70001470 P    Egg, yolk                          0.040000   1.000  1.000
 

70001471 P    Egg, yolk-babyfood                 0.040000   1.000  1.000
 

08001480 8    Eggplant                           0.400000   1.000  1.000
 

04011500 4A   Endive                             4.000000   1.000  1.000
 

04021520 4B   Fennel, Florence                   4.000000   1.000  1.000
 

01031660 1CD  Ginger                             0.200000   1.000  1.000
 

01031661 1CD  Ginger-babyfood                    0.200000   1.000  1.000
 

01031670 1CD  Ginger, dried                      0.200000   1.000  1.000
 

01011680 1AB  Ginseng, dried                     0.600000   1.000  1.000
 

23001690 M    Goat, meat                         0.080000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.080000   1.000  1.000
 

23001710 M    Goat, fat                          0.030000   1.000  1.000
 

23001720 M    Goat, kidney                       0.080000   1.000  1.000
 

23001730 M    Goat, liver                        0.080000   1.000  1.000
 

09011870 9A   Honeydew melon                     0.400000   1.000  1.000
 

95001880 O    Hop                                7.000000   1.000  1.000
 

24001890 M    Horse, meat                        0.080000   1.000  1.000
 

01011900 1AB  Horseradish                        0.600000   1.000  1.000
 

05021940 5B   Kale                              16.000000   1.000  1.000
 

05011960 5A   Kohlrabi                           1.500000   1.000  1.000
 

04012040 4A   Lettuce, head                      4.000000   1.000  1.000
 

04012050 4A   Lettuce, leaf                      4.000000   1.000  1.000
 

11002100 11   Loquat                             0.200000   1.000  1.000
 

27002220 D    Milk, fat                          0.030000   1.000  1.000
 

27002221 D    Milk, fat - baby food/infant for   0.030000   1.000  1.000
 

27012230 D    Milk, nonfat solids                0.030000   1.000  1.000
 

27012231 D    Milk, nonfat solids-baby food/in   0.030000   1.000  1.000
 

27022240 D    Milk, water                        0.030000   1.000  1.000
 

27022241 D    Milk, water-babyfood/infant form   0.030000   1.000  1.000
 

27032251 D    Milk, sugar (lactose)-baby food/   0.030000   1.000  1.000
 

05022290 5B   Mustard greens                    16.000000   1.000  1.000
 

12002300 12   Nectarine                          0.600000   1.000  1.000
 

08002340 8    Okra                               0.400000   1.000  1.000
 

04012480 4A   Parsley, leaves                    4.000000   1.000  1.000
 

01012500 1AB  Parsley, turnip rooted             0.600000   1.000  1.000
 

01012510 1AB  Parsnip                            0.600000   1.000  1.000
 

01012511 1AB  Parsnip-babyfood                   0.600000   1.000  1.000
 

12002600 12   Peach                              0.600000   1.000  1.000
 

12002601 12   Peach-babyfood                     0.600000   1.000  1.000
 

12002610 12   Peach, dried                       0.600000   7.000  1.000
 

12002611 12   Peach, dried-babyfood              0.600000   7.000  1.000
 

12002620 12   Peach, juice                       0.600000   1.000  1.000
 

12002621 12   Peach, juice-babyfood              0.600000   1.000  1.000
 

11002660 11   Pear                               0.200000   1.000  1.000
 

11002661 11   Pear-babyfood                      0.200000   1.000  1.000
 

11002670 11   Pear, dried                        0.200000   6.250  1.000
 

11002680 11   Pear, juice                        0.200000   1.000  1.000
 

11002681 11   Pear, juice-babyfood               0.200000   1.000  1.000
 

08002700 8    Pepper, bell                       0.400000   1.000  1.000
 

08002701 8    Pepper, bell-babyfood              0.400000   1.000  1.000
 

08002710 8    Pepper, bell, dried                0.400000   1.000  1.000
 

08002711 8    Pepper, bell, dried-babyfood       0.400000   1.000  1.000
 

08002720 8    Pepper, nonbell                    0.400000   1.000  1.000
 

08002721 8    Pepper, nonbell-babyfood           0.400000   1.000  1.000
 

08002730 8    Pepper, nonbell, dried             0.400000   1.000  1.000
 

12002850 12   Plum                               0.600000   1.000  1.000
 

12002851 12   Plum-babyfood                      0.600000   1.000  1.000
 

12002860 12   Plum, prune, fresh                 0.600000   1.000  1.000
 

12002861 12   Plum, prune, fresh-babyfood        0.600000   1.000  1.000
 

12002870 12   Plum, prune, dried                 0.600000   5.000  1.000
 

12002871 12   Plum, prune, dried-babyfood        0.600000   5.000  1.000
 

12002880 12   Plum, prune, juice                 0.600000   1.400  1.000
 

12002881 12   Plum, prune, juice-babyfood        0.600000   1.400  1.000
 

01032960 1C   Potato, chips                      0.200000   1.000  1.000
 

01032970 1C   Potato, dry (granules/ flakes)     0.400000   1.000  1.000
 

01032971 1C   Potato, dry (granules/ flakes)-b   0.400000   1.000  1.000
 

01032980 1C   Potato, flour                      0.200000   6.500  1.000
 

01032981 1C   Potato, flour-babyfood             0.200000   6.500  1.000
 

01032990 1C   Potato, tuber, w/peel              0.200000   1.000  1.000
 

01032991 1C   Potato, tuber, w/peel-babyfood     0.200000   1.000  1.000
 

01033000 1C   Potato, tuber, w/o peel            0.200000   1.000  1.000
 

01033001 1C   Potato, tuber, w/o peel-babyfood   0.200000   1.000  1.000
 

60003010 P    Poultry, other, meat               0.030000   1.000  1.000
 

60003020 P    Poultry, other, liver              0.030000   1.000  1.000
 

60003030 P    Poultry, other, meat byproducts    0.030000   1.000  1.000
 

60003040 P    Poultry, other, fat                0.030000   1.000  1.000
 

60003050 P    Poultry, other, skin               0.030000   1.000  1.000
 

09023080 9B   Pumpkin                            0.400000   1.000  1.000
 

09023090 9B   Pumpkin, seed                      0.400000   1.000  1.000
 

11003100 11   Quince                             0.200000   1.000  1.000
 

04013130 4A   Radicchio                          4.000000   1.000  1.000
 

01013140 1AB  Radish, roots                      0.600000   1.000  1.000
 

02003150 2    Radish, tops                      16.000000   1.000  1.000
 

01013160 1AB  Radish, Oriental, roots            0.600000   1.000  1.000
 

05023180 5B   Rape greens                       16.000000   1.000  1.000
 

04023220 4B   Rhubarb                            4.000000   1.000  1.000
 

01013270 1AB  Rutabaga                           0.600000   1.000  1.000
 

01013310 1AB  Salsify, roots                     0.600000   1.000  1.000
 

26003390 M    Sheep, meat                        0.080000   1.000  1.000
 

26003391 M    Sheep, meat-babyfood               0.080000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.080000   1.000  1.000
 

26003410 M    Sheep, fat                         0.030000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.030000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.080000   1.000  1.000
 

26003430 M    Sheep, liver                       0.080000   1.000  1.000
 

04013550 4A   Spinach                            9.000000   1.000  1.000
 

04013551 4A   Spinach-babyfood                   9.000000   1.000  1.000
 

09023560 9B   Squash, summer                     0.400000   1.000  1.000
 

09023561 9B   Squash, summer-babyfood            0.400000   1.000  1.000
 

09023570 9B   Squash, winter                     0.400000   1.000  1.000
 

09023571 9B   Squash, winter-babyfood            0.400000   1.000  1.000
 

01033660 1CD  Sweet potato                       0.200000   1.000  1.000
 

01033661 1CD  Sweet potato-babyfood              0.200000   1.000  1.000
 

04023670 4B   Swiss chard                        4.000000   1.000  1.000
 

01033710 1CD  Tanier, corm                       0.200000   1.000  1.000
 

08003740 8    Tomatillo                          0.400000   1.000  1.000
 

08003750 8    Tomato                             0.400000   1.000  1.000
 

08003751 8    Tomato-babyfood                    0.400000   1.000  1.000
 

08003760 8    Tomato, paste                      2.000000   1.000  1.000
 

08003761 8    Tomato, paste-babyfood             2.000000   1.000  1.000
 

08003770 8    Tomato, puree                      0.500000   1.000  1.000
 

08003771 8    Tomato, puree-babyfood             0.500000   1.000  1.000
 

08003780 8    Tomato, dried                      0.400000  14.300  1.000
 

08003781 8    Tomato, dried-babyfood             0.400000  14.300  1.000
 

08003790 8    Tomato, juice                      0.400000   1.500  1.000
 

50003820 P    Turkey, meat                       0.030000   1.000  1.000
 

50003821 P    Turkey, meat-babyfood              0.030000   1.000  1.000
 

50003830 P    Turkey, liver                      0.030000   1.000  1.000
 

50003831 P    Turkey, liver-babyfood             0.030000   1.000  1.000
 

50003840 P    Turkey, meat byproducts            0.030000   1.000  1.000
 

50003841 P    Turkey, meat byproducts-babyfood   0.030000   1.000  1.000
 

50003850 P    Turkey, fat                        0.030000   1.000  1.000
 

50003851 P    Turkey, fat-babyfood               0.030000   1.000  1.000
 

50003860 P    Turkey, skin                       0.030000   1.000  1.000
 

50003861 P    Turkey, skin-babyfood              0.030000   1.000  1.000
 

01033870 1CD  Turmeric                           0.200000   1.000  1.000
 

05023890 5B   Turnip, greens                    16.000000   1.000  1.000
 

01013880 1AB  Turnip, roots                      0.600000   1.000  1.000
 

86010000 O    Water, direct, all sources

                 110-Uncooked; Fresh or N/S; Cook Meth N/S

                                                 0.001500   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.001500   1.000  1.000
 

09013990 9A   Watermelon                         0.400000   1.000  1.000
 

09014000 9A   Watermelon, juice                  0.400000   1.000  1.000
 

01034060 1CD  Yam, true                          0.200000   1.000  1.000
 

01034070 1CD  Yam bean                           0.200000   1.000  1.000
 

Attachment 2:  DEEM(-FCID Chronic Results

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and
Settings\aacierto\Desktop\Flonicamid.DEEMr\FLONICAMID.R98

                                                 Adjustment factor #2
NOT used.

Analysis Date 11-16-2007/14:18:07     Residue file dated:
11-16-2007/14:10:38/8

Reference dose (RfD, Chronic) = .04 mg/kg bw/day

NOEL (Chronic) = 4 mg/kg bw/day

COMMENT 1: CHRONIC ONLY

========================================================================
======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of  
Percent 

           Subgroup                       body wt/day   Exposure 1/  of
RfD 

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

U.S. Population (total)                     0.004095          977      
10.2%

U.S. Population (spring season)             0.004096          976      
10.2%

U.S. Population (summer season)             0.004141          966      
10.4%

U.S. Population (autumn season)             0.004133          968      
10.3%

U.S. Population (winter season)             0.004001        1,000      
10.0%

Northeast region                            0.004258          939      
10.6%

Midwest region                              0.003893        1,028       
9.7%

Southern region                             0.003940        1,015       
9.8%

Western region                              0.004410          907      
11.0%

Hispanics                                   0.003861        1,036       
9.7%

Non-hispanic whites                         0.003770        1,061       
9.4%

Non-hispanic blacks                         0.005283          757      
13.2%

Non-hisp/non-white/non-black                0.006604          606      
16.5%

All infants (< 1 year)                      0.006087          657      
15.2%

Nursing infants                             0.003118        1,283       
7.8%

Non-nursing infants                         0.007214          554      
18.0%

Children 1-6  yrs                           0.007597          527      
19.0%

Children 7-12 yrs                           0.004241          943      
10.6%

Females 13-19 (not preg or nursing)         0.003055        1,309       
7.6%

Females 20+ (not preg or nursing)           0.003819        1,047       
9.5%

Females 13-50 yrs                           0.003587        1,115       
9.0%

Females 13+ (preg/not nursing)              0.003024        1,323       
7.6%

Females 13+ (nursing)                       0.003991        1,002      
10.0%

Males 13-19 yrs                             0.003486        1,148       
8.7%

Males 20+ yrs                               0.003546        1,128       
8.9%

Seniors 55+                                 0.004002          999      
10.0%

Children 1-2 yrs                            0.009070          441      
22.7%

Children 3-5 yrs                            0.007205          555      
18.0%

Children
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Adults 50+ yrs                              0.003978        1,005       
9.9%

Females 13-49 yrs                           0.003504        1,142       
8.8%

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

Flonicamid				Dietary Exposure Assessment		DP Barcode: D343466

PC Code:						

Page( PAGE  1 (of(( NUMPAGES  17 

