Document ID: EPA-HQ-OPP-2009-0032-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-05-12T04:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

  SEQ CHAPTER \h \r 1 MEMORANDUM

Date:  3/15/2010

SUBJECT:	Fluazinam  Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessments for the Section 3
Registration Action on Apples, Carrots, Head Lettuce, Leaf Lettuce, and
the Bulb Onion Subgroup (3-07A)

PC Code:  129098	DP Barcodes:  D374522

Decision No.:  404254	Registration No.: 71512-1

Petitions:  8E7506, 9E7570, and 9F7571	Regulatory Action:  Section 3
Registration

Risk Assessment Type:  NA	Case No.:  NA

TXR No.:  NA	CAS No.:    SEQ CHAPTER \h \r 1 79622-59-6

MRID Nos.:  NA	40 CFR:  §180.574

		              									

FROM:  	Douglas Dotson, Ph.D., Chemist

		Risk Assessment Branch II

		Health Effects Division (7509P)	  SEQ CHAPTER \h \r 1 

		

THROUGH:	Toiya Goodlow, Chemist

		Debra Rate, Ph.D., Biologist

		Dietary Exposure Science Advisory Council

		

TO:		Laura Nollen/Barbara Madden, RM Team 5, RIMUERB

		John Bazuin/Tony Kish, PM Team 22, Fungicide Branch

		Registration Division (7505P)		  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h
\r 1 

		

Executive Summary

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 U.S. Department of Agriculture’s Continuing
Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998. 
The analyses were conducted as part of a human health risk assessment
for the requested uses of fluazinam on apples, carrots, head lettuce,
leaf lettuce, and the Bulb onion subgroup (3-07A).

The acute analysis is based on tolerance-level residues for all
commodities and uses high-end residue estimates for the metabolite AMGT.
 In addition, the acute assessment assumes 100% crop treated and
incorporates modeled estimated drinking water concentrations (EDWCs)
that account for both parent fluazinam and its transformation products. 
Therefore, the resulting exposure and risk estimates are considered to
be very conservative.  The acute risk estimates are below HED’s level
of concern for all population subgroups, including those comprised of
infants and children.  Generally, HED is concerned when risk estimates
exceed 100% of the population-adjusted dose (PAD).  The acute risk
estimate for the general U.S. population is 4.1% of the acute PAD
(aPAD).  The most highly exposed population subgroup is Females 13-49,
which uses 20% of the aPAD.

The chronic analysis is based on tolerance-level residues for all
commodities except apples.  For apples, the average field trial value
was used.  As with the acute assessment, it assumes high-end estimates
for AMGT, 100% crop treated, and incorporates modeled EDWCs that account
for both parent and transformation products.  Again, the resulting
exposure and risk estimates are considered to be conservative.  Chronic
risk estimates are also below HED’s level of concern for all
population subgroups.  The risk estimate for the general U.S. population
is 14% of the chronic PAD (cPAD).  The most highly exposed population
subgroup is All Infants (<1 year old), which uses 40% of the cPAD.

Fluazinam is classified as having “suggestive evidence of
carcinogenicity, but not sufficient to assess human carcinogenic
potential.”  The CARC determined that quantification using a linear
low dose approach was not required and the cRfD is protective of cancer
effects.  As a result, a separate cancer dietary exposure analysis was
not performed.

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 acute and non-cancer chronic exposures, HED is concerned when
estimated dietary risk exceeds 100% of the PAD.  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 fluazinam was conducted by
M. Doherty (Memo, D340854, 8/1/2007).



II.   Residue Information

Fluazinam is currently registered in the U.S. for use on ginseng,
peanuts, potatoes, turnip greens, Crop Group 5 (Brassica leafy
vegetables), Subgroup 6A (except pea), Subgroup 6B (except pea),
Subgroup 6C (except pea), the Bushberry subgroup (13B), and other
bushberries that are included in Subgroup 13-07B but not 13B. 
Tolerances range from 0.01 ppm for the Brassica leafy vegetables and
turnip greens to 7.0 ppm for the Bushberry subgroup and other
bushberries.  In addition, there is a tolerance of 3.0 ppm for residues
in/on wine grapes (no U.S. registration).  These tolerances are listed
in 40 CFR 180.574.  These commodities were all included in the most
recent dietary exposure assessment that was performed for fluazinam
(memo, D340854, M. Doherty, 8/1/2007).

The current tolerance petitions include apples, carrots, head lettuce,
leaf lettuce, and the Bulb onion subgroup (3-07B).  In addition, the 7.0
ppm tolerance for the Bushberry subgroup (13B) is being replaced by a
7.0 ppm tolerance for the updated Bushberry subgroup (13-07B).  As a
result, the individual tolerances for the various bushberry crops that
were not a part of subgroup 13-B are being revoked.

HED is recommending in favor of tolerances for lettuce and onions. 
However, because of major data deficiencies, HED is not recommending in
favor of tolerances for apples and carrots.  Apples and carrots are
being included in the assessments, however, because HED is anticipating
that the registrant will resolve the data deficiencies and pursue the
tolerances for apples and carrots.  As a result, the acute and chronic
dietary exposure analyses include residue values for these commodities
as well.  Tolerances are currently in effect for potatoes and peanuts. 
These commodities have animal feed items associated with them (processed
potato waste and peanut meal).  Apples and carrots also have animal feed
items associated with them (wet apple pomace and carrot culls).  Because
of these animal feed items, HED is including meat byproducts and fat of
cattle, goat, horse, and sheep in the acute and chronic dietary exposure
analyses. 

The residue of concern for risk assessment in root and tuber vegetables
and bulb vegetables is parent fluazinam.  For all other plant
commodities, the residues of concern in plants for risk assessment are
fluazinam and its metabolite AMGT.  Field trial data reflecting AMGT
residues were provided for apples, but not for head or leaf lettuce. 
Data for AMGT are not needed for carrots and bulb onions because these
crops are either root or bulb vegetables.

For carrots and the commodities of the Bulb onion subgroup (3-07B), the
recommended tolerance was used in both the acute and chronic
assessments.  For head and leaf lettuce, an upper-bound ratio of 0.35:1
(AMGT:fluazinam) was used to estimate the AMGT residue.  This factor is
the maximum AMGT:fluazinam ratio in grapes in the grape metabolism
study.  The values obtained using this ratio were used in both the acute
and chronic assessments.  In the apple field trials, both fluazinam and
AMGT were measured.  The fluazinam tolerance is 2.0 ppm and the highest
combined (fluazinam + AMGT) residue is 1.69 ppm.  The tolerance was used
in the acute assessment and the average combined (fluazinam + AMGT)
residue value of 0.215 ppm was used in the chronic assessment.  For an
explanation of the factors used for previously registered plant
commodities, see the last dietary exposure assessment that was performed
for fluazinam (Memo, D340854, M. Doherty, 8/1/2007).  

In animal commodities, the residues of concern for risk assessment are
parent fluazinam and its metabolites AMPA and DAPA.  A residue value of
0.02 ppm is being used for meat byproducts and fat of cattle, goats,
horses, and sheep (Memo, D360840, D. Dotson, x/x/2010).  This value is a
very conservative one that accounts for all residues of concern in meat
byproducts and fat.

The assessments were based on DEEM 7.81 default processing factors for
processed commodities.  A full listing of the residue inputs used in the
analyses is included as Attachments 1 and 3.

Table 1.  Summary of New-Use Food Crop Residue Levels Used in the Acute
and Chronic

               Dietary Exposure Analyses

Crop/Crop Group	Tolerance Level

(ppm)	Residue Level for Dietary Exposure Assessment

(ppm)

Apples (Acute Assessment)	2.0	2.0 (tolerance)

Apples (Chronic Assessment)	2.0	0.215 (avg combined (fluazinam + AMGT)
residue)

Carrots	0.70	0.7* (tolerance)

Bulb Onions (Subgroup 3-07A)	0.20	0.20* (tolerance)

Head Lettuce	0.02	0.027 (0.02 tolerance x 1.35)

Leaf Lettuce	2.0	2.7 (2.0 tolerance x 1.35)

*AMGT is not a significant residue in root and tuber crops or in bulb
vegetables, so no correction is necessary for risk assessment

III.   Percent Crop Treated Information

The acute and chronic assessments were both based on the assumption that
100% of all commodities with fluazinam tolerances will be treated.

IV.   Drinking Water Data

The drinking water residue used in the dietary risk assessment was
provided by the Environmental Fate and Effects Division (EFED; D360713,
J. Meléndez, 2/24/2010) and incorporated directly into this dietary
assessment into the food categories “water, direct, all sources” and
“water, indirect, all sources.”  The residues of concern in drinking
water for risk assessment are parent fluazinam and its transformation
products, including DCPA, CAPA, DAPA and HYPA.  The estimated acute and
chronic drinking water concentrations (EDWC) are based on ground
application of fluazinam to apples.  The values are provided in Table 2,
below.  The groundwater value was generated using the Screening
Concentration in Groundwater (SCI-GROW) Model and the surface water
values were generated using the FQPA Index Reservoir Screening Tool
(FIRST) Model.  The surface water estimates were used for both the acute
and chronic assessments because they were higher than the groundwater
value.  For the acute assessment, a value of 117 ppb was used.  This
value includes both parent and degradates.  For the chronic assessment,
a value of 19.8 ppb was used.  This value also includes both parent and
degradates.  For more information about EFED’s drinking water models,
see   HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ ).

Table 2.  Maximum Tier I Estimated Drinking Water Concentrations 

Drinking Water Source (Model Used) 	USE (Rate Modeled)	Maximum Estimated
Drinking Water Concentration  (EDWC; ppb) 

Groundwater

(SCI-GROW) Total Residues of Fluazinam (including parent)	Apples

(4.5 lb a.i./A/season)	Acute and Chronic	0.216

Surface Water

DEEM-FCID™ Program and Consumption Information

Fluazinam acute and chronic dietary exposure assessments were 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.

For acute exposure assessments, individual one-day food consumption data
are used on an individual-by-individual basis.  The reported consumption
amounts of each food item can be multiplied by a residue point estimate
and summed to obtain a total daily pesticide exposure for a
deterministic exposure assessment, or “matched” in multiple random
pairings with residue values and then summed in a probabilistic
assessment.  The resulting distribution of exposures is expressed as a
percentage of the aPAD on both a user (i.e., only those who reported
eating relevant commodities/food forms) and a per-capita (i.e., those
who reported eating the relevant commodities as well as those who did
not) basis.  In accordance with HED policy, per capita exposure and risk
are reported for all tiers of analysis.  However, for tiers 1 and 2, any
significant differences in user vs. per capita exposure and risk are
specifically identified and noted in the risk assessment.

VI.   Toxicological Information

Adequate toxicological data have been submitted to permit assessment of
fluazinam.  The data show that the primary target organ for chronic
exposure to fluazinam is the liver.  Acute neurotoxicity was seen in
rats and developmental toxicity was seen in rabbits.  As a result, both
acute and chronic dietary assessments are appropriate.  The data also
support reducing the FQPA Safety Factor to 1x.  Based on the available
information, a dietary assessment of cancer risk is not necessary. 
Detailed toxicological considerations can be found in the human health
risk assessment for fluazinam (Memo, D371444, D. Dotson, 3/x/2010).  The
fluazinam doses and endpoints for dietary exposure assessments are
summarized in Table 3.

Table 3.  Toxicological Doses and Endpoints for Fluazinam for Use in
Dietary Risk Assessments

Exposure/

Scenario	Point of Departure	Uncertainty/

FQPA Safety Factors	RfD, PAD, Level of Concern for Risk Assessment	Study
and Toxicological Effects

Acute Dietary (General population)	NOAEL= 50 mg/kg/day

	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	Acute RfD =0.5 mg/kg/day

aPAD

= 0.5mg/kg/day	Acute Neurotoxicity-Rats.

LOAEL = 1000 mg/kg/day based on decreased motor activity and soft stools
on day of dosing. 

Acute Dietary

(Females 13-49 years of age)	NOAEL (developmental) = 7 mg/kg/day	UFA=
10x

UFH=10x

FQPA SF=1x

Total UF=100x	Acute RfD =0.07 mg/kg/day

aPAD

= 0.07mg/kg/day	Developmental Toxicity- Rabbits.

Developmental LOAEL = 12  mg/kg/day based on increased incidence of
total litter resorptions and possible increased incidence of fetal
skeletal abnormalities.

Chronic Dietary (All Populations)	NOAEL= 1.1 mg/kg/day

	UFA= 10x

UFH=10x

FQPA SF=1x

Total UF=100x	Chronic RfD =0.011 mg/kg/day

cPAD

= 0.011mg/kg/day	Carcinogenicity-Mice.

LOAEL = 10.7 mg/kg/day based on liver histopathology and increased liver
weight.  

Cancer (oral, dermal, inhalation)	Classification: “Suggestive evidence
of carcinogenicity, but not sufficient to assess human carcinogenic
potential.”  The cRfD is protective of cancer effects.

Point of Departure (PoD) = A data point or an estimated point that is
derived from observed dose-response data and  used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures.  NOAEL = no observed adverse effect level. 
LOAEL = lowest observed adverse effect level.  UF = uncertainty factor. 
UFA = extrapolation from animal to human (interspecies).  UFH =
potential variation in sensitivity among members of the human population
(intraspecies). FQPA SF = FQPA Safety Factor.  PAD = population adjusted
dose (a = acute, c = chronic).  RfD = reference dose. N/A = not
applicable.

  TC \l3 "3.5.10	Classification of Carcinogenic Potential 



VII.   Results/Discussion 

As stated above, for acute and chronic assessments, HED 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 4 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.  Risk estimates are below HED’s level of concern
for all population subgroups in both the acute and chronic analyses. 
The acute risk estimate for the general U.S. population is 4.1% of the
acute PAD (aPAD).  The most highly exposed population subgroup is
Females 13-49, which uses 20% of the aPAD.  The chronic risk estimate
for the general U.S. population is 14% of the chronic PAD (cPAD).  The
most highly exposed population subgroup is All Infants (<1 year old),
which uses 40% of the cPAD.

The CARC determined that the cRfD is protective of cancer effects.  As
the %cPAD for the general population (14%) is less than 100%, cancer
risk is also not of concern.

Full listings of exposure and risk estimates are included in Attachments
2 (acute analysis) and 4 (chronic analysis).

Table 4.  Summary of Acute and Chronic Exposure and Risk Estimates for
Fluazinam

Population Subgroup	Acute Assessment (95th Percentile)	Chronic
Assessment

	aPAD, mg/day	Exposure Estimate, mg/day	% aPad	cPAD, mg/day	Exposure
Estimate, mg/day	% cPad

U.S. Population	0.5	0.020332	4.1	0.011	0.001530	14

All infants	0.5	0.086600	17	0.011	0.004411	40

Children 1-2 yrs	0.5	0.098940	20	0.011	0.004064	37

Children 3-5 yrs	0.5	0.063647	13	0.011	0.002789	25

Children 6-12 yrs	0.5	0.022625	4.5	0.011	0.001374	13

Youth 13-19 yrs	0.5	0.013076	2.6	0.011	0.000813	7.4

Adults 20-49 yrs	0.5	0.012952	2.6	0.011	0.001346	12

Adults 50+ yrs	0.5	0.012761	2.6	0.011	0.001488	14

Females 13-49 yrs	0.07	0.014124	20	0.011	0.001394	13

VIII.   Characterization of Inputs/Outputs

HED considers both the acute and chronic assessments to be very
conservative.  The acute assessment is based on tolerance-level residues
for all commodities, with worst-case assumptions being made concerning
residue levels of the metabolite AMGT.  In addition, it was assumed that
100% of all crops with registered or requested uses of fluazinam will be
treated.  The EDWCs include parent fluazinam and its transformation
products.  These same assumptions and inputs were used for the chronic
assessment, except that an average field trial value was used for
apples.  These assumptions result in highly conservative,
health-protective estimates of exposure and risk.

 

IX.   Conclusions

The exposure estimates generated by the dietary exposure model that was
used are likely to be overestimates of actual dietary exposures that
might occur.  The aggregate (food + water) dietary risk estimates are
below HED’s level of concern for all population subgroups for both the
acute and chronic exposure scenarios.

X.   List of Attachments

Attachment 1.  Acute Dietary Residue Input File for Fluazinam.

Attachment 2.  Results of Acute Dietary Exposure Assessment

Attachment 3.  Chronic Dietary Residue Input File for Fluazinam

Attachment 4.  Results of Chronic Dietary Exposure Assessment

cc:  D. Dotson



Attachment 1:  Acute Dietary Residue Input File for Fluazinam

DEEM FCID Version 2.03

Acute NOAEL for general population including infants and children:  50
mg/kg bw/day

Acute PAD for general population including infants and children:  0.5
mg/kg bw/day

Acute NOAEL for Females 13-49:  7 mg/kg bw/day

Acute PAD for Females 13-49:  0.07 mg/kg bw/day

Filename: C:\Documents and Settings\ddotson\My
Documents\Deemfcid\Fluazinam\

                 FluazinamAcuteRev3.R98

Date created/last modified: 03-15-2010/13:48:15/8

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

01010780 1AB  Carrot                             0.700000   1.000  1.000
 

01010781 1AB  Carrot-babyfood                    0.700000   1.000  1.000
 

01010790 1AB  Carrot, juice                      0.700000   1.000  1.000
 

01011680 1AB  Ginseng, dried                     4.500000   1.000  1.000
 

01032960 1C   Potato, chips                      0.020000   1.000  1.000
 

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500  1.000
 

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500  1.000
 

01032980 1C   Potato, flour                      0.020000   6.500  1.000
 

01032981 1C   Potato, flour-babyfood             0.020000   6.500  1.000
 

01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000
 

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000
 

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000
 

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000
 

03001640 3    Garlic                             0.200000   1.000  1.000
 

03001650 3    Garlic, dried                      0.200000   1.000  1.000
 

03001651 3    Garlic, dried-babyfood             0.200000   1.000  1.000
 

03002370 3    Onion, dry bulb                    0.200000   1.000  1.000
 

03002371 3    Onion, dry bulb-babyfood           0.200000   1.000  1.000
 

03002380 3    Onion, dry bulb, dried             0.200000   9.000  1.000
 

03002381 3    Onion, dry bulb, dried-babyfood    0.200000   9.000  1.000
 

03003380 3    Shallot                            0.200000   1.000  1.000
 

04012040 4A   Lettuce, head                      0.027000   1.000  1.000
 

04012050 4A   Lettuce, leaf                      2.700000   1.000  1.000
 

05010610 5A   Broccoli                           0.013500   1.000  1.000
 

05010611 5A   Broccoli-babyfood                  0.013500   1.000  1.000
 

05010620 5A   Broccoli, Chinese                  0.013500   1.000  1.000
 

05010640 5A   Brussels sprouts                   0.013500   1.000  1.000
 

05010690 5A   Cabbage                            0.013500   1.000  1.000
 

05010710 5A   Cabbage, Chinese, napa             0.013500   1.000  1.000
 

05010720 5A   Cabbage, Chinese, mustard          0.013500   1.000  1.000
 

05010830 5A   Cauliflower                        0.013500   1.000  1.000
 

05011960 5A   Kohlrabi                           0.013500   1.000  1.000
 

05020630 5B   Broccoli raab                      0.013500   1.000  1.000
 

05020700 5B   Cabbage, Chinese, bok choy         0.013500   1.000  1.000
 

05021170 5B   Collards                           0.013500   1.000  1.000
 

05021940 5B   Kale                               0.013500   1.000  1.000
 

05022290 5B   Mustard greens                     0.013500   1.000  1.000
 

05023180 5B   Rape greens                        0.013500   1.000  1.000
 

05023890 5B   Turnip, greens                     0.013500   1.000  1.000
 

06010430 6A   Bean, snap, succulent              0.135000   1.000  1.000
 

06010431 6A   Bean, snap, succulent-babyfood     0.135000   1.000  1.000
 

06012570 6A   Pea, edible podded, succulent      0.135000   1.000  1.000
 

06020310 6B   Bean, broad, succulent             0.054000   1.000  1.000
 

06020330 6B   Bean, cowpea, succulent            0.054000   1.000  1.000
 

06020370 6B   Bean, lima, succulent              0.054000   1.000  1.000
 

06022550 6B   Pea, succulent                     0.054000   1.000  1.000
 

06022551 6B   Pea, succulent-babyfood            0.054000   1.000  1.000
 

06022590 6B   Pea, pigeon, succulent             0.054000   1.000  1.000
 

06030300 6C   Bean, black, seed                  0.027000   1.000  1.000
 

06030320 6C   Bean, broad, seed                  0.027000   1.000  1.000
 

06030340 6C   Bean, cowpea, seed                 0.027000   1.000  1.000
 

06030350 6C   Bean,  great northern, seed        0.027000   1.000  1.000
 

06030360 6C   Bean, kidney, seed                 0.027000   1.000  1.000
 

06030380 6C   Bean, lima, seed                   0.027000   1.000  1.000
 

06030390 6C   Bean, mung, seed                   0.027000   1.000  1.000
 

06030400 6C   Bean, navy, seed                   0.027000   1.000  1.000
 

06030410 6C   Bean, pink, seed                   0.027000   1.000  1.000
 

06030420 6C   Bean, pinto, seed                  0.027000   1.000  1.000
 

06030980 6C   Chickpea, seed                     0.027000   1.000  1.000
 

06030981 6C   Chickpea, seed-babyfood            0.027000   1.000  1.000
 

06030990 6C   Chickpea, flour                    0.027000   1.000  1.000
 

06031820 6C   Guar, seed                         0.027000   1.000  1.000
 

06031821 6C   Guar, seed-babyfood                0.027000   1.000  1.000
 

06032030 6C   Lentil, seed                       0.027000   1.000  1.000
 

06032560 6C   Pea, dry                           0.027000   1.000  1.000
 

06032561 6C   Pea, dry-babyfood                  0.027000   1.000  1.000
 

06032580 6C   Pea, pigeon, seed                  0.027000   1.000  1.000
 

11000070 11   Apple, fruit with peel             2.000000   1.000  1.000
 

11000080 11   Apple, peeled fruit                2.000000   1.000  1.000
 

11000081 11   Apple, peeled fruit-babyfood       2.000000   1.000  1.000
 

11000090 11   Apple, dried                       2.000000   8.000  1.000
 

11000091 11   Apple, dried-babyfood              2.000000   8.000  1.000
 

11000100 11   Apple, juice                       2.000000   1.300  1.000
 

11000101 11   Apple, juice-babyfood              2.000000   1.300  1.000
 

11000110 11   Apple, sauce                       2.000000   1.000  1.000
 

11000111 11   Apple, sauce-babyfood              2.000000   1.000  1.000
 

13020570 13B  Blueberry                          7.800000   1.000  1.000
 

13020571 13B  Blueberry-babyfood                 7.800000   1.000  1.000
 

13021360 13B  Currant                            7.800000   1.000  1.000
 

13021370 13B  Currant, dried                     7.800000   1.000  1.000
 

13021490 13B  Elderberry                         7.800000   1.000  1.000
 

13021740 13B  Gooseberry                         7.800000   1.000  1.000
 

13021910 13B  Huckleberry                        7.800000   1.000  1.000
 

21000460 M    Beef, meat byproducts              0.050000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000
 

21000470 M    Beef, fat                          0.050000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.050000   1.000  1.000
 

21000480 M    Beef, kidney                       0.050000   1.000  1.000
 

21000490 M    Beef, liver                        0.050000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.050000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.050000   1.000  1.000
 

23001710 M    Goat, fat                          0.050000   1.000  1.000
 

23001720 M    Goat, kidney                       0.050000   1.000  1.000
 

23001730 M    Goat, liver                        0.050000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000
 

26003410 M    Sheep, fat                         0.050000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.050000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.050000   1.000  1.000
 

26003430 M    Sheep, liver                       0.050000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.117000   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.117000   1.000  1.000
 

95001790 O    Grape, wine and sherry             3.000000   1.000  1.000
 

95002630 O    Peanut                             0.020000   1.000  1.000
 

95002640 O    Peanut, butter                     0.020000   1.890  1.000
 

95002650 O    Peanut, oil                        0.020000   1.000  1.000
 



Attachment 2:  Results of Acute Dietary Exposure Assessment

Residue file: FluazinamAcuteRev2.R98

Analysis Date: 03-15-2010/13:48:15 (13:50:15 for Females 13-49)

Residue file dated: 03-15-2010/13:48:15/8

Daily totals for food and food form consumption used.

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

Summary calculations (per capita):

                    95th Percentile      99th Percentile      99.9th
Percentile

                   Exposure   % aRfD    Exposure   % aRfD    Exposure  
% aRfD 

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

U.S. Population:

                    0.020332     4.07    0.056560    11.31    0.137350  
 27.47 

All infants:

                    0.086600    17.32    0.138084    27.62    0.428363  
 85.67 

Children 1-2 yrs:

                    0.098940    19.79    0.166177    33.24    0.312424  
 62.48 

Children 3-5 yrs:

                    0.063647    12.73    0.114181    22.84    0.193539  
 38.71 

Children 6-12 yrs:

                    0.022625     4.53    0.054452    10.89    0.085714  
 17.14 

Youth 13-19 yrs:

                    0.013076     2.62    0.029793     5.96    0.052066  
 10.41 

Adults 20-49 yrs:

                    0.012952     2.59    0.024926     4.99    0.042089  
  8.42 

Adults 50+ yrs:

                    0.012761     2.55    0.022255     4.45    0.040379  
  8.08 

Females 13-49 yrs:

                    0.014124    20.18    0.027763    39.66    0.051897  
 74.14 

 

Attachment 3:  Chronic Dietary Residue Input File for Fluazinam

DEEM FCID Version 2.03

Chronic NOAEL:  1.1 mg/kg bw/day

Chronic PAD:  0.011 mg/kg bw/day

Filename: C:\Documents and Settings\ddotson\My
Documents\Deemfcid\Fluazinam\

                 FluazinamChronicRev3.R98

Date created/last modified: 03-15-2010/13:41:58/8

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Commodity Name                    (ppm)       #1    #2   

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

01010780 1AB  Carrot                             0.700000   1.000  1.000
 

01010781 1AB  Carrot-babyfood                    0.700000   1.000  1.000
 

01010790 1AB  Carrot, juice                      0.700000   1.000  1.000
 

01011680 1AB  Ginseng, dried                     4.500000   1.000  1.000
 

01032960 1C   Potato, chips                      0.020000   1.000  1.000
 

01032970 1C   Potato, dry (granules/ flakes)     0.020000   6.500  1.000
 

01032971 1C   Potato, dry (granules/ flakes)-b   0.020000   6.500  1.000
 

01032980 1C   Potato, flour                      0.020000   6.500  1.000
 

01032981 1C   Potato, flour-babyfood             0.020000   6.500  1.000
 

01032990 1C   Potato, tuber, w/peel              0.020000   1.000  1.000
 

01032991 1C   Potato, tuber, w/peel-babyfood     0.020000   1.000  1.000
 

01033000 1C   Potato, tuber, w/o peel            0.020000   1.000  1.000
 

01033001 1C   Potato, tuber, w/o peel-babyfood   0.020000   1.000  1.000
 

03001640 3    Garlic                             0.200000   1.000  1.000
 

03001650 3    Garlic, dried                      0.200000   1.000  1.000
 

03001651 3    Garlic, dried-babyfood             0.200000   1.000  1.000
 

03002370 3    Onion, dry bulb                    0.200000   1.000  1.000
 

03002371 3    Onion, dry bulb-babyfood           0.200000   1.000  1.000
 

03002380 3    Onion, dry bulb, dried             0.200000   9.000  1.000
 

03002381 3    Onion, dry bulb, dried-babyfood    0.200000   9.000  1.000
 

03003380 3    Shallot                            0.200000   1.000  1.000
 

04012040 4A   Lettuce, head                      0.027000   1.000  1.000
 

04012050 4A   Lettuce, leaf                      2.700000   1.000  1.000
 

05010610 5A   Broccoli                           0.013500   1.000  1.000
 

05010611 5A   Broccoli-babyfood                  0.013500   1.000  1.000
 

05010620 5A   Broccoli, Chinese                  0.013500   1.000  1.000
 

05010640 5A   Brussels sprouts                   0.013500   1.000  1.000
 

05010690 5A   Cabbage                            0.013500   1.000  1.000
 

05010710 5A   Cabbage, Chinese, napa             0.013500   1.000  1.000
 

05010720 5A   Cabbage, Chinese, mustard          0.013500   1.000  1.000
 

05010830 5A   Cauliflower                        0.013500   1.000  1.000
 

05011960 5A   Kohlrabi                           0.013500   1.000  1.000
 

05020630 5B   Broccoli raab                      0.013500   1.000  1.000
 

05020700 5B   Cabbage, Chinese, bok choy         0.013500   1.000  1.000
 

05021170 5B   Collards                           0.013500   1.000  1.000
 

05021940 5B   Kale                               0.013500   1.000  1.000
 

05022290 5B   Mustard greens                     0.013500   1.000  1.000
 

05023180 5B   Rape greens                        0.013500   1.000  1.000
 

05023890 5B   Turnip, greens                     0.013500   1.000  1.000
 

06010430 6A   Bean, snap, succulent              0.135000   1.000  1.000
 

06010431 6A   Bean, snap, succulent-babyfood     0.135000   1.000  1.000
 

06012570 6A   Pea, edible podded, succulent      0.135000   1.000  1.000
 

06020310 6B   Bean, broad, succulent             0.054000   1.000  1.000
 

06020330 6B   Bean, cowpea, succulent            0.054000   1.000  1.000
 

06020370 6B   Bean, lima, succulent              0.054000   1.000  1.000
 

06022550 6B   Pea, succulent                     0.054000   1.000  1.000
 

06022551 6B   Pea, succulent-babyfood            0.054000   1.000  1.000
 

06022590 6B   Pea, pigeon, succulent             0.054000   1.000  1.000
 

06030300 6C   Bean, black, seed                  0.027000   1.000  1.000
 

06030320 6C   Bean, broad, seed                  0.027000   1.000  1.000
 

06030340 6C   Bean, cowpea, seed                 0.027000   1.000  1.000
 

06030350 6C   Bean,  great northern, seed        0.027000   1.000  1.000
 

06030360 6C   Bean, kidney, seed                 0.027000   1.000  1.000
 

06030380 6C   Bean, lima, seed                   0.027000   1.000  1.000
 

06030390 6C   Bean, mung, seed                   0.027000   1.000  1.000
 

06030400 6C   Bean, navy, seed                   0.027000   1.000  1.000
 

06030410 6C   Bean, pink, seed                   0.027000   1.000  1.000
 

06030420 6C   Bean, pinto, seed                  0.027000   1.000  1.000
 

06030980 6C   Chickpea, seed                     0.027000   1.000  1.000
 

06030981 6C   Chickpea, seed-babyfood            0.027000   1.000  1.000
 

06030990 6C   Chickpea, flour                    0.027000   1.000  1.000
 

06031820 6C   Guar, seed                         0.027000   1.000  1.000
 

06031821 6C   Guar, seed-babyfood                0.027000   1.000  1.000
 

06032030 6C   Lentil, seed                       0.027000   1.000  1.000
 

06032560 6C   Pea, dry                           0.027000   1.000  1.000
 

06032561 6C   Pea, dry-babyfood                  0.027000   1.000  1.000
 

06032580 6C   Pea, pigeon, seed                  0.027000   1.000  1.000
 

11000070 11   Apple, fruit with peel             0.215000   1.000  1.000
 

11000080 11   Apple, peeled fruit                0.215000   1.000  1.000
 

11000081 11   Apple, peeled fruit-babyfood       0.215000   1.000  1.000
 

11000090 11   Apple, dried                       0.215000   8.000  1.000
 

11000091 11   Apple, dried-babyfood              0.215000   8.000  1.000
 

11000100 11   Apple, juice                       0.215000   1.300  1.000
 

11000101 11   Apple, juice-babyfood              0.215000   1.300  1.000
 

11000110 11   Apple, sauce                       0.215000   1.000  1.000
 

11000111 11   Apple, sauce-babyfood              0.215000   1.000  1.000
 

13020570 13B  Blueberry                          7.800000   1.000  1.000
 

13020571 13B  Blueberry-babyfood                 7.800000   1.000  1.000
 

13021360 13B  Currant                            7.800000   1.000  1.000
 

13021370 13B  Currant, dried                     7.800000   1.000  1.000
 

13021490 13B  Elderberry                         7.800000   1.000  1.000
 

13021740 13B  Gooseberry                         7.800000   1.000  1.000
 

13021910 13B  Huckleberry                        7.800000   1.000  1.000
 

21000460 M    Beef, meat byproducts              0.050000   1.000  1.000
 

21000461 M    Beef, meat byproducts-babyfood     0.050000   1.000  1.000
 

21000470 M    Beef, fat                          0.050000   1.000  1.000
 

21000471 M    Beef,fat-babyfood                  0.050000   1.000  1.000
 

21000480 M    Beef, kidney                       0.050000   1.000  1.000
 

21000490 M    Beef, liver                        0.050000   1.000  1.000
 

21000491 M    Beef, liver-babyfood               0.050000   1.000  1.000
 

23001700 M    Goat, meat byproducts              0.050000   1.000  1.000
 

23001710 M    Goat, fat                          0.050000   1.000  1.000
 

23001720 M    Goat, kidney                       0.050000   1.000  1.000
 

23001730 M    Goat, liver                        0.050000   1.000  1.000
 

26003400 M    Sheep, meat byproducts             0.050000   1.000  1.000
 

26003410 M    Sheep, fat                         0.050000   1.000  1.000
 

26003411 M    Sheep, fat-babyfood                0.050000   1.000  1.000
 

26003420 M    Sheep, kidney                      0.050000   1.000  1.000
 

26003430 M    Sheep, liver                       0.050000   1.000  1.000
 

86010000 O    Water, direct, all sources         0.019800   1.000  1.000
 

86020000 O    Water, indirect, all sources       0.019800   1.000  1.000
 

95001790 O    Grape, wine and sherry             3.000000   1.000  1.000
 

95002630 O    Peanut                             0.020000   1.000  1.000
 

95002640 O    Peanut, butter                     0.020000   1.890  1.000
 

95002650 O    Peanut, oil                        0.020000   1.000  1.000
 



Attachment 4:  Results of Chronic Dietary Exposure Assessment

Residue file name: C:\Documents and Settings\ddotson\My
Documents\Deemfcid\Fluazinam\

                               FluazinamChronicRev3.R98

Residue file dated: 03-15-2010/13:41:58/8

Analysis Date 03-15-2010/13:51:29

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.001530               
13.9%

U.S. Population (spring season)             0.001483               
13.5%

U.S. Population (summer season)             0.001563               
14.2%

U.S. Population (autumn season)             0.001553               
14.1%

U.S. Population (winter season)             0.001518               
13.8%

Northeast region                            0.001699               
15.4%

Midwest region                              0.001413               
12.8%

Southern region                             0.001306               
11.9%

Western region                              0.001859               
16.9%

Hispanics                                   0.001378               
12.5%

Non-hispanic whites                         0.001636               
14.9%

Non-hispanic blacks                         0.001048                
9.5%

Non-hisp/non-white/non-black                0.001532               
13.9%

All infants (< 1 year)                      0.004411               
40.1%

Nursing infants                             0.002420               
22.0%

Non-nursing infants                         0.005167               
47.0%

Children 1-6  yrs                           0.003082               
28.0%

Children 7-12 yrs                           0.001261               
11.5%

Females 13-19 (not preg or nursing)         0.000812                
7.4%

Females 20+ (not preg or nursing)           0.001544               
14.0%

Females 13-50 yrs                           0.001415               
12.9%

Females 13+ (preg/not nursing)              0.001169               
10.6%

Females 13+ (nursing)                       0.001183               
10.8%

Males 13-19 yrs                             0.000808                
7.3%

Males 20+ yrs                               0.001250               
11.4%

Seniors 55+                                 0.001512               
13.7%

Children 1-2 yrs                            0.004064               
36.9%

 

 

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Children 3-5 yrs                            0.002789               
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Children 6-12 yrs                           0.001374               
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Adults 20-49 yrs                            0.001346               
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Adults 50+ yrs                              0.001488               
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Females 13-49 yrs                           0.001394               
12.7%

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

Fluazinam 	Dietary Exposure and Risk Assessment	DP Number:  D374522

PC Code:  129098

 PAGE   

Page   PAGE  2  of   NUMPAGES  16 

DRAFT – Confidential, Internal, and Deliberative Material

[Chemical Name]	Dietary Exposure and Risk Assessment	DP Number:
[xxxxxxx]

PC Code:  [xxxxxx]