Document ID: EPA-HQ-OPP-2007-0536-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-12-23T05:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

								OFFICE OF

 PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

Date:  		July 23, 2009

SUBJECT:	Fenarimol.  Chronic Dietary (Food and Drinking Water) Exposure
Assessment for the Petition Proposing Tolerances for Residues of
Fenarimol on Hops.

PC Code:  	206600	DP Number:	331895

Decision No.:	367682	Registration No.:	10163-273

Petition No.:	6E7074	Regulatory Action:	Section 3 

Assessment Type:	Dietary	Registration Case No.:	None

TXR No.:	None	CAS No.:	60168-88-9

MRID No.:	None	40 CFR:	§180.421

FROM:	Breann Hanson, Biologist 

Alternative Risk Integration and Assessment (ARIA) Team

Risk Integration Minor Use and Emergency Response Branch 				
(RIMUERB)/Registration Division (RD; 7505P)

THROUGH:   William Cutchin, Acting Senior Branch Scientist

		ARIA Team

RIMERB/RD (7505P)

AND

Thurston Morton, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (HED; 7509P)

TO:		Breann Hanson, Biologist

ARIA Team

RIMUERB/RD (7505P)

	Daniel Rosenblatt /Barbara Madden/Susan Stanton

	RIMUERB/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a chronic
dietary (food + drinking water) exposure analysis for the fungicide
fenarimol, alpha-(2
chlorophenyl)-alpha-(4-chlorophenyl)-5-pyrimidinemethanol, on hops. 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. 

A chronic dietary risk assessment was 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. 
This analysis was performed to support an Interregional Research Project
No. 4 (IR-4) petition (PP#: 6E7074) proposing the use of Rubigan™ EC
(EPA Reg. No. 10163-273), a 12 % emulsifiable concentrate liquid which
contains 1.0 lb active ingredient (ai) per gallon, for control of
powdery mildew on hops.  

Additionally, in order to harmonize with a Codex Maximum Residue Limit
(MRL) of 0.3 ppm for apples, EPA has proposed increasing the tolerance
for residues of apples from 0.1 ppm to 0.3 ppm.  The Agency has
determined that the increased tolerance is safe, i.e., there is a
reasonable certainty that no harm will result from aggregate exposure
(FR Notice: Volume 72, Number 108, 6/6/2007). 

In calculating dietary risk estimates, ARIA has compared the chronic
population-adjusted dose (cPAD) to the respective estimated dietary
exposures.  Typically, ARIA has concerns regarding dietary risk when the
estimates exceed 100% of the cPAD.  

Drinking Water Contribution

The Environmental Fate and Effects Division (EFED) provided a drinking
water assessment for fenarimol.  The assessment evaluated the maximum
use patterns of the current uses on turf and ornamentals as they appear
on the proposed labels.  Additionally, exposure was estimated for
fenarimol use on turf that is restricted to professional stadia and golf
course tees, greens, and fairways at the currently proposed application
rates.  The resulting estimated drinking water concentrations (EDWCs)
are noted in Table 2, below.  With the currently proposed use patterns,
the 1-in-10-year annual mean EDWC is 226 ppb.  With the revised use
patterns proposed by EFED, the exposure estimate is significantly
reduced, resulting in a 1-in-10-year annual mean EDWC of 66 ppb.

 Acute Dietary (Food + Drinking Water) Exposure Results and
Characterization

HED previously determined the doses and endpoints for use in human
health risk assessments for fenarimol.  There was no appropriate
endpoint for assessing acute dietary exposure; therefore, no acute
dietary risk assessment was performed.

Chronic Dietary (Food + Drinking Water) Exposure Results and
Characterization

The chronic dietary exposure assessment for fenarimol is highly refined
using anticipated residues based on Food and Drug Administration (FDA)
monitoring data for apples, bananas, cherries, grapes and pears.  Field
trial residue data were used for pecans.  Percent crop treated (%CT)
information and processing factors, where available, were used in the
assessment. There were no PDP monitoring data available for fenarimol.
The only registered uses of fenarimol in/on food/feed crops are apples,
pears, cherries, pecans, hazelnuts and grapes.  Bananas were included in
the assessment to account for imported bananas.  

The chronic dietary risk assessment for fenarimol at the EDWC of 226 ppb
showed that chronic dietary risk estimates are above ARIA’s level of
concern (i.e. >100% chronic population adjusted doses (cPAD)) for
infants (<1 year old), the highest exposed population subgroup (260% of
the cPAD), as well as for children 1-2 years old (120% of the cPAD) and
children 3-5 years old (110% of the cPAD).

At the EDWC of 66 ppb as a result of EFED’s proposed changes in the
use pattern, the chronic dietary risk estimates are below ARIA’s level
of concern (i.e. <100% chronic population adjusted doses (cPAD)) for
infants (<1 year old), the highest exposed population subgroup (76% of
the cPAD), as well as for the general US population (23% of the cPAD).

  

Cancer Exposure Results and Characterization

HED classified fenarimol as a “not likely to be carcinogenic to
humans” based on the absence of significant tumor increases in two
adequate rodent carcinogenicity studies; therefore, quantification of
human cancer risk is not required.

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 ARIA 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, ARIA is concerned when
estimated dietary risk exceeds 100% of the PAD.  ARIA is generally
concerned when estimated cancer risk exceeds one in one million (i.e.,
the risk exceeds 1 x 10-6).  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,” 6/21/2000, 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 (8/20/99).

The most recent dietary risk assessment for fenarimol was conducted by
HED (DP#: 278898, D. Drew, 11/19/2001), in conjunction with an
anticipated residue analysis, to determine the chronic dietary risks
associated with the re-registration of fenarimol.  

II.	Residue Information

Tolerances:  Permanent tolerances are established for residues of
fenarimol in/on a variety of commodities at levels ranging from 0.01 ppm
in/on livestock meat, fat and kidneys to 1.0 ppm in/on cherries [40 CFR
§180.421(a)].  

Residue of Concern:  HED previously concluded that the residue of
concern for both plants and livestock is fenarimol.  Although HED
previously suggested that field trial studies on new crops include data
for parent and metabolites (B &C), the registrant submitted data for
only fenarimol-only on hops.  

Recommended Tolerances:  As part of the current petition (PP#: 6E7074),
ARIA recommends (DP#: 331894, D. Rate, 11/15/2006) for the tolerance,
noted below, for residues of fenarimol under 40 CFR 180.421(a):

Hops	1.2 ppm

Residue Data Used for Chronic Assessment:  The DEEM-FCID( chronic
analysis was performed using ARs from field trial data, processing
factors and updated %CT information.  

Anticipated Residues and Processing Factors:  

Table 1.  Processing Factors Used in the Chronic Dietary Analysis for
Fenarimol

Commodity	Data Used	Anticipated Residue (PPM)	Processing Factor

Apples

   juice

   dried	1996-1999 FDA Data for Apples	0.0015	1x

0.05x

8x

Bananas

   dried	1996-1999 FDA Data for Bananas	0.0045	1x

3.9x

Cherries

   juice

   dried	1996-1999 FDA Data for Cherries	0.0034	1x

1.5x

4x

Filberts	Field Trial Data

(MRID 43758901)	0.01	1x

Grapes

   juice

   raisin

   wine	1996-1999 FDA Data for Grapes	0.0060	1x

1.2x

1.6

1x

Pears

   juice

   dried	1996-1999 FDA Data for Pears	0.0015	1x

0.05x

6.25x

Pecans	Field Trial Data

(MRID 00145943)	0.0037	1x

Meat-lean (fat/free) w/o bones	

Ruminant Feeding Study

(MRID 40098605)	0.00009	1x

Meat-fat w/o bones

0.0001	1x

Dried meat*

0.00009	1.92x

Meat byproducts*

0.0003	1x

Other organ meats*

0.0003	1x

Kidney*

0.0001	1x

* includes beef, sheep, goat and horse

The DEEM default processing factors were used for all food forms except
apple juice, pear juice, grape juice, and raisins, for which the
aforementioned factors derived from the processing studies were used. 
Since the previous DEEM, tolerances on liver have been revoked since it
is considered to be included in the meat byproducts tolerance.

Percent Crop Treated:  A Screening Level Usage Analysis (SLUA) for
fenarinol was provided by BEAD based on data years 2001-2007 (DP#:
366920, A. Grube, 7/15/2009). The maximum percent crop treated (%CT) was
used for estimating chronic dietary exposure.  Of the currently
registered uses of fenarimol, wet apple pomace is the only commodity
that is considered a livestock feed item; therefore, the maximum %CT for
apples was used for livestock commodities.

Table 2. SLUA %CT Information

Crop	Max. %CT

Apples	20

Cabbage	< 2.5

Cherries	15

Grapes	25

Peaches	< 2.5

Pears	10

III.	Drinking Water Data

The drinking water residues used in the dietary risk assessment were
provided by EFED (DP#: 363249, G. Orrick, 6/30/2009) and incorporated
directly into this dietary assessment.  Water residues were incorporated
in the DEEM-FCID into the food categories “water, direct, all
sources” and “water, indirect, all sources.”   Because a previous
dietary assessment run resulted in dietary risk exceedances, revisions
to the current labels were submitted to the Agency.   The revised
assessment evaluated the maximum use patterns of the current uses on
turf and ornamentals as they appear on the proposed labels. 
Additionally, exposure was estimated for fenarimol use on turf that is
restricted to professional stadia and golf course tees, greens, and
fairways at the currently proposed application rates.  Exposure
estimates reflect total residues of concern that include fenarimol and
its degradates of risk concern.

The Pesticide Root Zone Model (PRZM v3.12.2) and Exposure Analysis
Modeling System (EXAMS v2.98.4.6) simulation models coupled with the
input shell PE (v5.0) was used to generate EDWCs of fenarimol residues
that may occur in surface water used as drinking water.  Screening
Concentration in Ground Water (SCI-GROW v2.3) is a regression model used
as a screening tool to estimate pesticide concentrations found in ground
water used as drinking water.

The surface water EDWCs for the currently proposed use patterns are
similar to those in the previous drinking water assessment (DP#: 330715;
G. Orrick, 9/13/2007), as the maximum use pattern for turf has not
changed with the exception that application is currently limited to
ground equipment.   If turf uses of fenarimol are limited to
professional stadia and golf course tees and greens at 11 lbs ai/A and
to golf course fairways at 8.1 lbs ai/A, exposure estimates are reduced,
resulting in a 1-in-10-year annual mean EDWC of 66 µg/L.  See Table 3,
below.

Table 3.  Tier II Total Residue EDWCs in Surface Water and Ground Water
from Currently and Potentially Proposed Labels for Current and Proposed
Fenarimol Uses.

Source	Use (modeled rate)	1-in-10-year Peak Exposure (ppb)	1-in-10-year
Annual Mean Exposure (ppb)	30-year Mean Exposure (ppb)

Current Use Pattern

Surface water	Turf (11 lbs ai/A/year)	283	226	154

Ground water

19	19	<19

EFED Proposed Use Pattern

Surface water

	Professional stadia, golf course tees and greens (at 11 lbs ai/A/year)
and golf course fairways (at 8.1 lbs ai/A/year)	80	66	44

Ground water

19	19	<19

IV.	DEEM-FCID™ Program and Consumption Information

The fenarimol chronic dietary exposure assessment was 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, 1998 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, 1998 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

HED previously determined the doses and endpoints for use in human
health risk assessments for fenarimol.  HED recently revised the FQPA
safety factor (DP#: 331611, C. Swartz, 3/22/2007); the FQPA safety
factor for fenarimol has been reduced to 1x for chronic dietary
assessment.  

No appropriate endpoint was available in the toxicological data base to
estimate risk to the general population or for females (ages 13 to 50)
from a single dose administration of fenarimol.  Therefore, an acute
dietary exposure assessment need not be performed.  For chronic dietary
exposure, the NOAEL is 0.6 mg/kg/day based on decreased litter size at
1.2 mg/kg/day (LOAEL) as determined from a 2-generation rat reproduction
toxicity study.  HED classified fenarimol as “not likely to be
carcinogenic to humans.” As such, a cancer dietary risk assessment is
not warranted.

The doses relevant to dietary exposure are summarized in Table 4, below.

Table 4.  Summary of Toxicological Doses and Endpoints for Fenarimol 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 (All Populations)	N/A	N/A	N/A	No appropriate hazard was
identified for single dose risk assessment.

Chronic Dietary (All Populations)	NOAEL= 0.6

mg/kg/day	UFA=10X

UFH=10X

FQPA SF=1X

	Chronic RfD =0.006

mg/kg/day

cPAD =0.006

mg/kg/day	Rat reproduction

LOAEL = 1.2 mg/kg/day Based on decreased liveborn litter size.

Cancer (oral, dermal, inhalation)	Classification:  “Not likely to be
Carcinogenic to Humans” based on the absence of significant tumor
increases in two adequate rodent carcinogenicity studies.

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.  

VI.	Results/Discussion 

As stated above, for chronic dietary assessments, ARIA is concerned when
dietary risk exceeds 100% of the cPAD.  The DEEM-FCID( analyses estimate
the dietary exposure of the US population and various population
subgroups.  The results reported in Table 3 (below) are for the general
US population (total), all infants <1, children 1-2, children 3-5,
children 6-12, youths 13-19, females 13-49, adults 20-49, and adults 50+
years old for chronic exposure.  

Results of Chronic Dietary Exposure Analysis:  The chronic dietary risk
assessment for fenarimol at the EDWC of 226 ppb showed that chronic
dietary risk estimates are above ARIA’s level of concern (i.e. >100%
chronic population adjusted doses (cPAD)) for infants (<1 year old), the
highest exposed population subgroup (260% of the cPAD), as well as for
children 1-2 years old (120% of the cPAD) and children 3-5 years old
(110% of the cPAD).

At the EDWC of 66 ppb as a result of EFED’s proposed changes in the
use pattern, the chronic dietary risk estimates are below ARIA’s level
of concern (i.e. <100% chronic population adjusted doses (cPAD)) for
infants (<1 year old), the highest exposed population subgroup (76% of
the cPAD), as well as for the general US population (23% of the cPAD).

The results of the chronic dietary exposure analyses are reported in the
Summary Tables (Tables 5 and 6, below).

Table 5.  Summary of Dietary Exposure and Risk for Fenarimol with an
EDWC of 226 ppb.  

Population Subgroup1	DEEM Acute Dietary Analysis,

95th Percentile	DEEM Chronic Dietary Analysis

	Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% cPAD

General U.S. Population	

NA 2

	0.004775	80

All Infants (< 1 year old)

0.015626	260

Children 1-2 years old

0.007088	120

Children 3-5 years old

0.006630	110

Children 6-12 years old

0.004571	76

Youth 13-19 years old

0.003448	58

Adults 20-49 years old

0.004464	74

Adults 50+ years old

0.004687	78

Females 13-49 years old

0.004436	74

1 Values for the population with the highest risk for each type of risk
assessment are bolded.  

2 NA = Not Applicable; no acute dietary endpoint was identified for
these population subgroups.

Table 6.  Summary of Dietary Exposure and Risk for Fenarimol with an
EDWC of 66 ppb.  

Population Subgroup1	DEEM Acute Dietary Analysis,

95th Percentile	DEEM Chronic Dietary Analysis

	Exposure (mg/kg/day)	% aPAD	Exposure (mg/kg/day)	% cPAD

General U.S. Population	

NA 2

	0.001402	23

All Infants (< 1 year old)

0.004570	76

Children 1-2 years old

0.002080	35

Children 3-5 years old

0.001942	32

Children 6-12 years old

0.001337	22

Youth 13-19 years old

0.001010	17

Adults 20-49 years old

0.001315	22

Adults 50+ years old

0.001374	23

Females 13-49 years old

0.001300	22

1 Values for the population with the highest risk for each type of risk
assessment are bolded.  

2 NA = Not Applicable; no acute dietary endpoint was identified for
these population subgroups.

VII.	Characterization of Inputs/Outputs

The chronic dietary exposure assessment for fenarimol is highly refined
using anticipated residues based on FDA monitoring data for apples,
bananas, cherries, grapes and pears.  Field trial residue data were used
for pecans.  %CT information and processing factors, where available,
were also used in the assessment. There were no PDP monitoring data
available for fenarimol.  Bananas were included in the assessment to
account for imported bananas.  

VII.	Conclusions

As noted above, dietary risk estimates for fenarimol exceed ARIA’s
level of concern at an EDWC of 226 ppb.  At an EDWC of 66 ppb, dietary
risk estimates for fenarimol are below ARIA’s level of concern for all
population subgroups, including those comprised of infants and children.
 The highest exposed population subgroup, all infants (<1 year old),
results in a cPAD of 76%.  

VIII.	List of Attachments

Attachment 1:  Chronic Food plus Water Residue Input File at the EDWC of
226 ppb

Attachment 2:  Chronic Results File at the EDWC of 226 ppb

Attachment 3:  Chronic Food plus Water Residue Input File at the EDWC of
66 ppb

Attachment 4:  Chronic Results File at the EDWC of 66 ppb

cc:  T. Gibson/M. Waller RM 21

Attachment 1:  Chronic Food plus Water Residue Input File at the EDWC of
226 ppb

   

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FENARIMOL                         
1994-98 data

Residue file: C:\Documents and Settings\bhanson\My Documents\Breann's
Work\Aria\Fenarimol\Finals\FINALS\206600c.R98

                                                               Adjust.
#2 used

Analysis Date 07-21-2009             Residue file dated:
07-21-2009/13:27:11/8

Reference dose (RfD) = 0.006 mg/kg bw/day

Comment:6E7074

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

11000070 11   Apple, fruit with peel             0.001500   1.000     
0.200   

11000080 11   Apple, peeled fruit                0.001500   1.000     
0.200   

11000081 11   Apple, peeled fruit-babyfood       0.001500   1.000     
0.200   

11000090 11   Apple, dried                       0.001500   8.000     
0.200   

11000091 11   Apple, dried-babyfood              0.001500   8.000     
0.200   

11000100 11   Apple, juice                       0.001500   0.050     
0.200   

11000101 11   Apple, juice-babyfood              0.001500   0.050     
0.200   

11000110 11   Apple, sauce                       0.001500   1.000     
0.200   

11000111 11   Apple, sauce-babyfood              0.001500   1.000     
0.200   

95000230 O    Banana                             0.004500   1.000     
1.000   

95000231 O    Banana-babyfood                    0.004500   1.000     
1.000   

95000240 O    Banana, dried                      0.004500   3.900     
1.000   

95000241 O    Banana, dried-babyfood             0.004500   3.900     
1.000   

21000440 M    Beef, meat                         0.000090   1.000     
0.200   

21000441 M    Beef, meat-babyfood                0.000090   1.000     
0.200   

21000450 M    Beef, meat, dried                  0.000090   1.920     
0.200   

21000460 M    Beef, meat byproducts              0.000300   1.000     
0.200   

21000461 M    Beef, meat byproducts-babyfood     0.000300   1.000     
0.200   

21000470 M    Beef, fat                          0.000100   1.000     
0.200   

21000471 M    Beef,fat-babyfood                  0.000100   1.000     
0.200   

21000480 M    Beef, kidney                       0.000100   1.000     
0.200   

12000900 12   Cherry                             0.003400   1.000     
0.150   

12000901 12   Cherry-babyfood                    0.003400   1.000     
0.150   

12000910 12   Cherry, juice                      0.003400   1.500     
0.150   

12000911 12   Cherry, juice-babyfood             0.003400   1.500     
0.150   

14001550 14   Filbert                            0.010000   1.000     
1.000   

14001560 14   Filbert, oil                       0.010000   1.000     
1.000   

23001690 M    Goat, meat                         0.000090   1.000     
0.200   

23001700 M    Goat, meat byproducts              0.000300   1.000     
0.200   

23001710 M    Goat, fat                          0.000100   1.000     
0.200   

23001720 M    Goat, kidney                       0.000100   1.000     
0.200   

95001750 O    Grape                              0.006000   1.000     
0.250   

95001760 O    Grape, juice                       0.006000   1.200     
0.250   

95001761 O    Grape, juice-babyfood              0.006000   1.200     
0.250   

95001770 O    Grape, leaves                      0.006000   1.000     
0.250   

95001780 O    Grape, raisin                      0.006000   1.600     
0.250   

95001790 O    Grape, wine and sherry             0.006000   1.000     
0.250   

95001880 O    Hop                                1.200000   1.000     
1.000   

24001890 M    Horse, meat                        0.000090   1.000     
0.200   

11002660 11   Pear                               0.001500   1.000     
0.100   

11002661 11   Pear-babyfood                      0.001500   1.000     
0.100   

11002670 11   Pear, dried                        0.001500   6.250     
0.100   

11002680 11   Pear, juice                        0.001500   0.050     
0.100   

11002681 11   Pear, juice-babyfood               0.001500   0.050     
0.100   

14002690 14   Pecan                              0.003700   1.000     
1.000   

95002830 O    Plantain                           0.004500   1.000     
1.000   

95002840 O    Plantain, dried                    0.004500   3.900     
1.000   

26003390 M    Sheep, meat                        0.000090   1.000     
0.200   

26003391 M    Sheep, meat-babyfood               0.000090   1.000     
0.200   

26003400 M    Sheep, meat byproducts             0.000300   1.000     
0.200   

26003410 M    Sheep, fat                         0.000100   1.000     
0.200   

26003411 M    Sheep, fat-babyfood                0.000100   1.000     
0.200   

26003420 M    Sheep, kidney                      0.000100   1.000     
0.200   

86010000 O    Water, direct, all sources         0.226000   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.226000   1.000     
1.000   

Attachment 2:  Chronic Results File at the EDWC of 226 ppb

 

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\bhanson\My
Documents\Breann's Work\Aria\Fenarimol\Finals\FINALS\206600c.R98

                                                     Adjustment factor
#2 used.

Analysis Date 07-21-2009/13:29:34     Residue file dated:
07-21-2009/13:27:11/8

Reference dose (RfD, Chronic) = .006 mg/kg bw/day

COMMENT 1: 6E7074

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.004775               
79.6%

U.S. Population (spring season)             0.004735               
78.9%

U.S. Population (summer season)             0.005129               
85.5%

U.S. Population (autumn season)             0.004614               
76.9%

U.S. Population (winter season)             0.004615               
76.9%

Northeast region                            0.004355               
72.6%

Midwest region                              0.004828               
80.5%

Southern region                             0.004538               
75.6%

Western region                              0.005471               
91.2%

Hispanics                                   0.005417               
90.3%

Non-hispanic whites                         0.004659               
77.7%

Non-hispanic blacks                         0.004530               
75.5%

Non-hisp/non-white/non-black                0.005848               
97.5%

All infants (< 1 year)                      0.015626              
260.4%

Nursing infants                             0.005798               
96.6%

Non-nursing infants                         0.019356              
322.6%

Children 1-6  yrs                           0.006665              
111.1%

Children 7-12 yrs                           0.004330               
72.2%

Females 13-19 (not preg or nursing)         0.003354               
55.9%

Females 20+ (not preg or nursing)           0.004762               
79.4%

Females 13-50 yrs                           0.004616               
76.9%

Females 13+ (preg/not nursing)              0.004634               
77.2%

Females 13+ (nursing)                       0.006603              
110.1%

Males 13-19 yrs                             0.003511               
58.5%

Males 20+ yrs                               0.004289               
71.5%

Seniors 55+                                 0.004683               
78.1%

Children 1-2 yrs                            0.007088              
118.1%

Children 3-5 yrs                            0.006630              
110.5%

Children 6-12 yrs                           0.004571               
76.2%

Youth 13-19 yrs                             0.003448               
57.5%

Adults 20-49 yrs                            0.004464               
74.4%

Adults 50+ yrs                              0.004687               
78.1%

Females 13-49 yrs                           0.004436               
73.9%

Attachment 3:  Chronic Food plus Water Residue Input File at the EDWC of
66 ppb

U.S. Environmental Protection Agency                                
Ver. 2.00

DEEM-FCID Chronic analysis for FENARIMOL                         
1994-98 data

Residue file: C:\Documents and Settings\bhanson\My Documents\Breann's
Work\Aria\Fenarimol\Finals\FINALS\206600c(water66).R98

                                                               Adjust.
#2 used

Analysis Date 07-21-2009             Residue file dated:
07-21-2009/13:28:50/8

Reference dose (RfD) = 0.006 mg/kg bw/day

Comment:6E7074

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

Food Crop                                       Residue      
Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)       

                                                             #1        
#2 

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

11000070 11   Apple, fruit with peel             0.001500   1.000     
0.200   

11000080 11   Apple, peeled fruit                0.001500   1.000     
0.200   

11000081 11   Apple, peeled fruit-babyfood       0.001500   1.000     
0.200   

11000090 11   Apple, dried                       0.001500   8.000     
0.200   

11000091 11   Apple, dried-babyfood              0.001500   8.000     
0.200   

11000100 11   Apple, juice                       0.001500   0.050     
0.200   

11000101 11   Apple, juice-babyfood              0.001500   0.050     
0.200   

11000110 11   Apple, sauce                       0.001500   1.000     
0.200   

11000111 11   Apple, sauce-babyfood              0.001500   1.000     
0.200   

95000230 O    Banana                             0.004500   1.000     
1.000   

95000231 O    Banana-babyfood                    0.004500   1.000     
1.000   

95000240 O    Banana, dried                      0.004500   3.900     
1.000   

95000241 O    Banana, dried-babyfood             0.004500   3.900     
1.000   

21000440 M    Beef, meat                         0.000090   1.000     
0.200   

21000441 M    Beef, meat-babyfood                0.000090   1.000     
0.200   

21000450 M    Beef, meat, dried                  0.000090   1.920     
0.200   

21000460 M    Beef, meat byproducts              0.000300   1.000     
0.200   

21000461 M    Beef, meat byproducts-babyfood     0.000300   1.000     
0.200   

21000470 M    Beef, fat                          0.000100   1.000     
0.200   

21000471 M    Beef,fat-babyfood                  0.000100   1.000     
0.200   

21000480 M    Beef, kidney                       0.000100   1.000     
0.200   

12000900 12   Cherry                             0.003400   1.000     
0.150   

12000901 12   Cherry-babyfood                    0.003400   1.000     
0.150   

12000910 12   Cherry, juice                      0.003400   1.500     
0.150   

12000911 12   Cherry, juice-babyfood             0.003400   1.500     
0.150   

14001550 14   Filbert                            0.010000   1.000     
1.000   

14001560 14   Filbert, oil                       0.010000   1.000     
1.000   

23001690 M    Goat, meat                         0.000090   1.000     
0.200   

23001700 M    Goat, meat byproducts              0.000300   1.000     
0.200   

23001710 M    Goat, fat                          0.000100   1.000     
0.200   

23001720 M    Goat, kidney                       0.000100   1.000     
0.200   

95001750 O    Grape                              0.006000   1.000     
0.250   

95001760 O    Grape, juice                       0.006000   1.200     
0.250   

95001761 O    Grape, juice-babyfood              0.006000   1.200     
0.250   

95001770 O    Grape, leaves                      0.006000   1.000     
0.250   

95001780 O    Grape, raisin                      0.006000   1.600     
0.250   

95001790 O    Grape, wine and sherry             0.006000   1.000     
0.250   

95001880 O    Hop                                1.200000   1.000     
1.000   

24001890 M    Horse, meat                        0.000090   1.000     
0.200   

11002660 11   Pear                               0.001500   1.000     
0.100   

11002661 11   Pear-babyfood                      0.001500   1.000     
0.100   

11002670 11   Pear, dried                        0.001500   6.250     
0.100   

11002680 11   Pear, juice                        0.001500   0.050     
0.100   

11002681 11   Pear, juice-babyfood               0.001500   0.050     
0.100   

14002690 14   Pecan                              0.003700   1.000     
1.000   

95002830 O    Plantain                           0.004500   1.000     
1.000   

95002840 O    Plantain, dried                    0.004500   3.900     
1.000   

26003390 M    Sheep, meat                        0.000090   1.000     
0.200   

26003391 M    Sheep, meat-babyfood               0.000090   1.000     
0.200   

26003400 M    Sheep, meat byproducts             0.000300   1.000     
0.200   

26003410 M    Sheep, fat                         0.000100   1.000     
0.200   

26003411 M    Sheep, fat-babyfood                0.000100   1.000     
0.200   

26003420 M    Sheep, kidney                      0.000100   1.000     
0.200   

86010000 O    Water, direct, all sources         0.066000   1.000     
1.000   

86020000 O    Water, indirect, all sources       0.066000   1.000     
1.000 

Attachment 4:  Chronic Results File at the EDWC of 66 ppb.

U.S. Environmental Protection Agency                                
Ver. 2.00

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

Residue file name: C:\Documents and Settings\bhanson\My
Documents\Breann's
Work\Aria\Fenarimol\Finals\FINALS\206600c(water66).R98

                                                     Adjustment factor
#2 used.

Analysis Date 07-21-2009/13:31:06     Residue file dated:
07-21-2009/13:28:50/8

Reference dose (RfD, Chronic) = .006 mg/kg bw/day

COMMENT 1: 6E7074

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.001402               
23.4%

U.S. Population (spring season)             0.001392               
23.2%

U.S. Population (summer season)             0.001506               
25.1%

U.S. Population (autumn season)             0.001354               
22.6%

U.S. Population (winter season)             0.001355               
22.6%

Northeast region                            0.001279               
21.3%

Midwest region                              0.001419               
23.6%

Southern region                             0.001332               
22.2%

Western region                              0.001607               
26.8%

Hispanics                                   0.001589               
26.5%

Non-hispanic whites                         0.001369               
22.8%

Non-hispanic blacks                         0.001328               
22.1%

Non-hisp/non-white/non-black                0.001714               
28.6%

All infants (< 1 year)                      0.004570               
76.2%

Nursing infants                             0.001697               
28.3%

Non-nursing infants                         0.005660               
94.3%

Children 1-6  yrs                           0.001953               
32.6%

Children 7-12 yrs                           0.001267               
21.1%

Females 13-19 (not preg or nursing)         0.000981               
16.3%

Females 20+ (not preg or nursing)           0.001395               
23.3%

Females 13-50 yrs                           0.001353               
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摧挻bᬀMales 20+ yrs                               0.001267          
     21.1%

Seniors 55+                                 0.001373               
22.9%

Children 1-2 yrs                            0.002080               
34.7%

Children 3-5 yrs                            0.001942               
32.4%

Children 6-12 yrs                           0.001337               
22.3%

Youth 13-19 yrs                             0.001010               
16.8%

Adults 20-49 yrs                            0.001315               
21.9%

Adults 50+ yrs                              0.001374               
22.9%

Females 13-49 yrs                           0.001300               
21.7%

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Fenarimol	Dietary Exposure Assessment	DP#: 331895			

PC Code: 206600

		

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