Document ID: EPA-HQ-OPP-2008-0478-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-07-08T04:00Z

SEQ CHAPTER \h \r 1 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF              

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES 

MEMORANDUM

DATE:  	26-FEB-2009  

SUBJECT:	Pyrimethanil: Acute and Chronic Aggregate Dietary (Food and
Drinking Water) Exposure and Risk Assessment for the Section 3
Registration on New Postharvest Uses on Stone Fruits Crop Group 12 and a
Preharvest Use on Lemon (Citrus Fruits Crop Group 10) (PP#8E7353). 

PC Code:  288201	DP Barcode:  D362715

Decision No.:  393117	Registration No.:  642719-375

Petition No.:  8E7353 	Regulatory Action:  Section 3

Risk Assessment Type: Dietary	Case No.:  NA

TXR No.:   NA	CAS No.:  53112-28-0

MRID No.:  NA	40 CFR:  §180.518

REVIEWER:	Wesley C. Carr, Jr., Associate Toxicologist

Medical Toxicology Branch

California Department of Pesticide Regulation

THROUGH:	Joyce Gee, Ph.D., Senior Toxicologist

Medical Toxicology Branch

		California Department of Pesticide Regulation

And

		William Cutchin, Acting Senior Branch Scientist

Debra Rate, Ph.D., Biologist

ARIA Team

Risk Integration Minor Use, Inerts, Emergency Response Branch (RIMUERB)

Registration Division (RD; 7505P)

TO:		John Redden, Team Leader

ARIA Team

RIMUERB/RD (7505P)

and

Debra Rate, Ph.D., Biologist

ARIA Team

RIMUERB/RD (7505P)

Executive Summary

Aggregate (food + water) acute and chronic dietary exposure and risk
assessments were conducted for the general U.S. population and various
population subgroups using the Dietary Exposure Evaluation Model - Food
Consumption Intake Database (DEEM-FCID(, ver. 2.03) model.  This model
uses food consumption data from the United States Department of
Agriculture’s (USDA’s) Continuing Surveys of Food Intakes by
Individuals (CSFII; 1994-1996 and 1998).  The analyses were performed to
support an amended Section 3 registration for use of the fungicide
pyrimethanil [4,6-dimethyl-N-phenyl-2-pyrimidinamine] in/on stone fruits
and citrus fruits.  

Acute Dietary Exposure Results and Characterization

The unrefined acute assessment assumed that pyrimethanil residues are
present in all commodities at tolerance levels and that 100% of all
crops are treated.  DEEM™ Version 7.81 default processing factors were
used to estimate residues in dried fruit (apricot, peach, prune and
raisin) and fruit juices (cherry, grape and prune).  Drinking water was
incorporated directly into the dietary assessment using the estimated
drinking water concentration (EDWC) generated by the Pesticide Root Zone
Model (PRZM)/ and Exposure Analysis Modeling System (EXAMS) and
Screening Concentration in Ground Water (SCI-GROW) water models.

The resulting acute dietary exposure estimates for food and water
combined are well below ARIA’s level of concern (i.e., <100% of the
acute population-adjusted dose (aPAD) of 1.0 mg/kg bw/day) for the
general U.S. population and all population subgroups except females
13-49 years of age.  Additionally, the acute dietary exposure estimates
for food and water combined are below ARIA’s level of concern (i.e.,
<100% of the aPAD of 0.45 mg/kg bw/day) for the females 13-49 years of
age population subgroup.  Using the DEEM-FCID software, dietary exposure
is estimated at 0.097656 mg/kg/day for the general U.S. population (ca.
10% of the aPAD), 0.349407 mg/kg/day (ca. 35% of the aPAD) for all
infants <1 years old, the population subgroup with the highest estimated
acute dietary exposure to pyrimethanil and 0.057646 mg/kg/day for the
females 13-49 years of age population (ca. 13% of the aPAD).  Therefore,
the acute dietary risk assessment shows that for all included
commodities plus drinking water, the acute dietary risk estimates are
below ARIA’s level of concern for the general population subgroups and
females 13-49 years of age (i.e. <100% aPAD).

Chronic Dietary Exposure Results and Characterization

The unrefined acute and chronic assessments assumed that pyrimethanil
residues are present in all commodities at tolerance levels and that
100% of all crops are treated.  DEEM™ Version 7.81 default processing
factors were used to estimate residues in dried fruit (apricot, peach,
prune and raisin) and fruit juices (cherry, grape and prune).  As in the
acute scenario, drinking water was incorporated directly into the
chronic dietary assessment using the EDWC values generated by the
PRZM/EXAMS and SCI-GROW ground water models.

The resulting chronic dietary exposure estimates for food and water
combined are well below ARIA’s level of concern (i.e., <100% of the
chronic population-adjusted dose (cPAD) of 0.2 mg/kg bw/day) for the
overall U.S. population and all population subgroups.  Using the
DEEM-FCID software, dietary exposure is estimated at 0.022477 mg/kg/day
for the general U.S. population (13% of the cPAD) and 0.106869 mg/kg/day
(ca. 63% of the cPAD) for children 1 to 2 years old, the population
subgroup with the highest estimated chronic dietary exposure to
pyrimethanil.  The chronic dietary risk assessment shows that for all
included commodities plus drinking water, the chronic dietary risk
estimates are below ARIA’s level of concern (i.e. <100% cPAD).

Cancer

A separate cancer dietary assessment was not conducted for pyrimethanil
as the chronic assessment is considered protective for carcinogenic
effects.  The margin of exposure (MOE) for the cancer assessment is 760
which is below the level of concern to ARIA/HED (MOE >100).

Generally, for threshold cancer effects where the mode of action is well
understood, like thyroid carcinogens such as pyrimethanil, the MOE that
indicates a reasonable certainty of no harm would be 100 (representing 2
factors of 10x for inter-species and intra-species extrapolation).  

The most recent previous dietary risk assessment for pyrimethanil was
conducted by W. Wassell (6/03/2008, DP# 352813).

I.  Introduction

Dietary risk assessment incorporates both exposure and toxicity of a
given pesticide.  For acute and chronic (non-cancer) 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, NOAEL).  This dose is referred
to as the PAD.  The PAD is equivalent to the point of departure (POD,
NOAEL, LOAEL) divided by the required uncertainty factors (UFs).

For acute and chronic (cancer and non-cancer) exposures, ARIA/HED is
concerned when estimated dietary risk exceeds 100% of the PAD for acute
and non-cancer chronic assessment and MOEs of less than 100 for cancer
assessment.  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).

Generally, for threshold cancer effects where the mode of action is well
understood, like thyroid carcinogens such as pyrimethanil, the MOE that
indicates a reasonable certainty of no harm would be 100 (representing 2
factors of 10x for inter-species and intra-species extrapolation).  

The most recent previous dietary risk assessment for pyrimethanil was
conducted by W. Wassell (6/03/2008, DP# 352813).  Additionally, there
was an earlier pyrimethanil dietary risk assessment conducted by T.
Bloem (3/25/2004, DP# 300631).

II.  Residue Information

Residues of Concern in Plants and Livestock:  Table 1 is a summary of
the HED Metabolism Assessment Review Committee (MARC) decisions
concerning the residues of concern in plants, ruminants, and milk for
tolerance expression and risk assessment purposes (Memo, 1/12/2004, J.
Morales, et al., DP# 248001).

Table 1. Residues of Concern in Plants and Ruminants.

Matrix	

Residues of Concern

	

For Risk Assessment	

For Tolerance Expression

Plants	

Parent Only	

Parent Only

Ruminant	

Parent + AEC614276	

Parent + AEC614276

Milk	

Parent + AEC614277	

Parent + AEC614277

Pyrimethanil tolerances are published in 40 CFR §180.518.  Tolerances
are established (40 CFR §180.518(a)(1)) for residues of pyrimethanil in
or on the following raw agricultural commodities (RACs):

Table 2.  Existing Tolerances (40 CFR §180.518(a)(1)) for Residues of
Pyrimethanil.

Commodity	Establish Tolerance level (ppm)

Almond	0.20

Almond, hulls	12

Apple, wet pomace	40

Banana	0.10

Citrus oil	150

Citrus Fruit (group 10)	10

Pome Fruit (group 11)	14.0

Stone Fruit (group 12)	3.0

Grape	5.0

Grape, raisin	8.0

Onion, bulb	0.10

Onion, green	2.0

Pistachio	0.20

Strawberry	3.0

Tomato	0.50

Tuberous and Corm Vegetables (subgroup 1C)	0.05

Tolerances are established (40 CFR §180.518(a)(2)) for residues of
pyrimethanil and its metabolite AEC614276
[4-{4,6-dimethyl-2-pyrimidinyl)amino]phenol] in or on the RACs:

Table 3.  Existing Tolerances (40 CFR §180.518(a)(2)) for Residues of 

Pyrimethanil and Its Metabolite AEC614276

Commodity	Establish Tolerance level (ppm)

Fat1	0.01

Kidney1	2.5

Meat1	0.01

Meat byproduct (except kidney)1	0.01

1 of cattle, goats, horse, and sheep

Finally, tolerances are established (40 CFR §180.518(a)(3)) for
residues of pyrimethanil and its metabolite AEC614277
[4,6-dimethyl-2-(phenylamino)-pyrimidinol] in or on milk at 0.05 ppm. 

Recommended Tolerances:   The current petition recommends the tolerances
for residues on citrus fruits group 10 should be increased from 10 ppm
to 11 ppm; and stone fruits group 12 should be increased from 3.0 to 10
ppm. 

IR-4 has proposed new / modified tolerances for residues of pyrimethanil
in or on the following commodities: citrus fruit, group 10; and stone
fruits group 12.  The California Department of Pesticide Regulation and
ARIA have reviewed residue data submitted (Table 4) to support these
tolerances and concluded that the following tolerances are appropriate
[DP# 361301, D. Rate, in process].

Table 4.  Summary of Recommended Tolerances for Pyrimethanil 

Crop Commodity	

Recommended Tolerance (ppm)

Citrus Fruit, Group 10 	11.0

Stone Fruit, Group 12	10.0

Food Residues and processing factors used in the Acute and Chronic
Analysis:  The acute and chronic analyses assumed DEEM( (ver. 7.81)
default processing factors (as necessary), empirical processing factors
for orange and apple juice, tolerance-level residues, and 100%
crop-treated (CT) for all commodities.  The empirical processing factors
for orange juice and apple juice can be found in DP# 248001 (Memo,
1/12/2004, J. Morales, et al., PP No. 2F06439 & PP No. 2F06480).

  Drinking Water Data

The Environment Fate and Effects Division (EFED) reassessed pyrimethanil
for the proposed new uses presented in this memo.  None of the new
proposed use scenarios exceeded the estimated drinking water
concentrations presented in the memo “Pyrimethanil.  Application for
Amended Section 3 Registration of Xedathane A for Postharvest Use on
Pome Fruits by Thermafog Application; Acute and Chronic Dietary Exposure
and Risk Assessment” (DP# 352813, W. Wassell; 6/03/2008).  EFED
studies indicated that pyrimethanil is expected to be moderately
persistent in the environment.  Aerobic metabolism is expected to be the
major route of degradation for pyrimethanil in the environment.  The
only major degradate is 2-amino-4,6-dimethylpyrimidine (degradate 1). 
Although it may be less toxic than the parent, degradate 1 is expected
to be more mobile and more persistent in the environment than the
parent.  MARC recommended that parent and degradate 1 are the residues
of concern for drinking water.

EFED provided Tier 1 EDWCs for ground water (SCI-GROW), and Tier 2 EDWCs
for surface water (PRZM/EXAMS) for pyrimethanil and its major metabolite
(2-amino-4,6-dimethylpyrimidine), for use in the human-health risk
assessment.  The models and their descriptions are available at the EPA
internet site:   HYPERLINK "http://www.epa.gov/oppefed1/models/water/" 
http://www.epa.gov/oppefed1/models/water/ .  Table 5 shows the highest
combined residues of pyrimethanil and its major metabolite based on the
registered seasonal application rate of 2.1 lb ai/A on strawberry in
Florida.  

Table 5.  Estimated Drinking Water Concentrations for Combined Total
Residues, Parent (Pyrimethanil) Plus Major Degradate
(2-amino-4,6-dimethylpyrimidine).

Chemical	Acute (peak) Surface Water Concentration (ppb)	Annual Average
Surface Water Concentration (ppb)	Ground Water Concentration (ppb)

Pyrimethanil plus 

2-amino-4,6-dimethylpyrimidine.	37.8	5.1	4.8

In this assessment, the annual average surface water concentration (5.1
ppb) and the acute peak surface water concentrations (37.8 ppb) were
used for chronic and acute dietary exposure assessments, respectively.

IV.  DEEM-FCID( Program and Consumption Information

Pyrimethanil acute and chronic dietary exposure assessments were
conducted using the DEEM-FCID( (ver. 2.03), which incorporates
consumption data from USDA’s CSFII (1994-1996 and 1998).  The 1994-96
and 98 data are based on the reported consumption of more than 20,000
individuals over two non-consecutive survey days.  Foods “as
consumed” (i.e., apple pie) are linked to EPA-defined food commodities
(i.e., 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 years old, children 3-5 years old, children 6-12 years old,
youth 13-19 years old, adults 20-49 years old, females 13-49 years old,
and adults 50+ years old.

For the chronic dietary exposure assessment, an estimate of the residue
level in each food or food-form (i.e., orange or orange juice) on the
food commodity residue list is multiplied by the average daily
consumption estimate for that food/food form.  The resulting residue
consumption estimate for each food/food form is summed with the residue
consumption 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., 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 levels (tiers) of analysis.  However, for unrefined and
partially refined assessments (Tiers 1 and 2), significant differences
in user vs. per capita exposure and risk are identified and noted in the
risk assessment.

V.  Toxicological Information

The HIARC met on April 24, 2003 to determine endpoint selection for
pyrimethanil.  At this meeting, the HIARC also evaluated the potential
for increased susceptibility of infants and children from exposure to
pyrimethanil as required by the Food Quality Protection Act (FQPA) of
1996 (TXR No. 0052257, 12/2/03).  The Cancer Peer Review Committee
(CPRC) evaluated the data on pyrimethanil on 5/29/96 and concluded that
pyrimethanil should be classified as Group C - possible human carcinogen
- and recommended that MOE methodology be used for the estimation of
human risk (TXR # 0050189, 2/11/97; an acceptable MOE was not defined by
CPRC or HIARC).  However, for threshold cancer effects where the mode of
action is well understood, like thyroid carcinogens such as
pyrimethanil, the general margin of exposure that indicates a reasonable
certainty of no harm would be 100 (representing 2 factors of 10 for
inter-species and intra-species extrapolation).  Table 6 is a summary of
the decisions made by the HIARC and the CPRC concerning dietary exposure
assessment.  

Based on toxicological considerations (evaluated by HIARC) and the
residue assumptions used in the dietary analyses (evaluated by the risk
assessment team; RAB1/HED), it was concluded that the FQPA Safety Factor
should be reduced to 1x when assessing dietary exposure to pyrimethanil.

Table 6  Summary of Toxicological Doses and Endpoints for Pyrimethanil
for Use in Dietary Exposure Risk Assessments.

Exposure/

Scenario	Point of Departure	Uncertainty/FQPA Safety Factors	RfD, PAD,
Level of Concern 	Study and Toxicological Effects

Acute Dietary

(Females 13-49 years of age)	NOAEL= 45 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Acute RfD = 0.45 mg/kg/day

aPAD =0.45 mg/kg/day	Developmental Toxicity - Rabbit:

LOAEL = 300 mg/kg/day based on increases in fetuses with 13 thoracic
vertebrae and 13 pairs of ribs.

Acute Dietary (General Population, including Infants and Children) 
NOAEL = 100 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Acute RfD = 1 mg/kg/day	Acute Neurotoxicity- Rat:  LOAEL = 1000
mg/kg/day based on decreased motor activity, ataxia, decreased body
temperature, hind limb grip strength, and dilated pupils.

Chronic Dietary (All Populations)	NOAEL= 17 mg/kg/day	UFA= 10x

UFH= 10x

FQPA SF= 1x

	Chronic RfD = 0.17 mg/kg/day

cPAD = 0.17 mg/kg/day	Chronic Toxicity - Rat: 

LOAEL = 221 mg/kg/day based on decreased body weight gains; increased
serum cholesterol and GGT, increased relative liver/body weight ratios,
necropsy and histopathological findings in the liver and thyroid.

Cancer (oral, dermal, inhalation)   	Pyrimethanil was classified as a
Group C carcinogen based on thyroid follicular cell tumors in both sexes
of the 2-year rat study (NOAEL = 17 mg/kg/day); the CPRC recommended the
MOE approach (i.e. threshold consideration; MOE = NOAEL ( chronic
exposure) when assessing risk because there appeared to be sufficient
evidence for relating thyroid tumors in the rat to a disruption of the
thryroid-putitary status (see TXR No. 0052257 for full discussion);
acceptable MOE was not defined by the HIARC or CPRC.  However, for
threshold cancer effects where the mode of action is well understood,
like thyroid carcinogens such as pyrimethanil, the general margin of
exposure that indicates a reasonable certainty of no harm would be 100
(representing 2 factors of 10 for inter-species and intra-species 
extrapolation).  

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 (intraspecies).  UFH =
potential variation in sensitivity among members of the human population
(interspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use
of a short-term study for long-term risk assessment.  UFDB = to account
for the absence of key data (i.e., lack of a critical study).  FQPA SF =
FQPA Safety Factor.  PAD = population adjusted dose (a = acute, c =
chronic).  RfD = reference dose.  MOE = margin of exposure.  LOC = level
of concern.  N/A = not applicable.

VI.   Results/Discussion

As stated above, for acute and chronic assessments, ARIA/HED is
concerned when dietary risk exceeds 100% of the aPAD or cPAD,
respectively.  The following paragraphs are summaries of the DEEM-FCID(
(ver. 2.03) acute and chronic exposure analyses.

Acute and chronic aggregate (food + water) analyses were performed using
DEEM-FCID( estimating the dietary exposure of the U.S. population and
various population subgroups.  The results are summarized in Tables 7
and 8 below for acute and chronic analyses respectively.  

The resulting acute food exposure estimates are not of concern to ARIA
(<100% aPAD) at the 95th percentile of the exposure distribution for the
US general population (ca. 10% aPAD), and all population subgroups; the
most highly exposed population subgroup is all infants <1 year old with
ca. 35% aPAD.  The resulting chronic food exposure estimates are not of
concern to ARIA (<100% cPAD) for U.S. general population (ca. 13% cPAD)
and all population subgroups; the most highly exposed population
subgroup is children 1-2 years old with 63% cPAD.  A separate cancer
dietary assessment was not conducted for pyrimethanil as the chronic
assessment is considered protective for carcinogenic effects.  The MOE
for cancer assessment is 760 which is below the level of concern to HED
(MOE <100).

Table 7.  Summary of Acute Dietary Exposure & Risk for Pyrimethanil at
the 95th Percentile.

Population Subgroup	aPAD (mg/kg/day)	Exposure (mg/kg/day)	

%aPAD

General U.S. Population	1.0	0.097656	10

All Infants (< 1 year old)

0.349407	35

Children 1-2 years old

0.336523	34

Children 3-5 years old

0.245654	25

Children 6-12 years old

0.128346	13

Youth 13-19 years old

0.060097	6

Adults 20-49 years old

0.053444	5

Adults 50+ years old

0.064689	7

Females 13-49 years old	0.45	0.057646	13

*Population subgroup with the highest exposure and risk is in bold type.



Table 8.  Summary of Chronic Dietary Exposure and Risk for Pyrimethanil.

Population Subgroup	cPAD (mg/kg/day)	Exposure (mg/kg/day)	%cPAD

General U.S. Population	0.17	0.022477	13

All Infants (< 1 year old)

0.090130	53

Children 1-2 years old

0.106869	63

Children 3-5 years old

0.073678	43

Children 6-12 years old

0.033439	20

Youth 13-19 years old

0.013225	8

Adults 20-49 years old

0.011950	7

Adults 50+ years old

0.016453	10

Females 13-49 years old

0.013112	8

*Population subgroup with the highest exposure and risk is in bold type.

VII.	Characterization of Inputs/Outputs

These chronic dietary exposure and risk estimates are conservative since
they assume that 100% of crops are treated with pyrimethanil and that
residues are present at tolerance levels.  In addition, drinking water
exposure estimates were based on screening level estimates generated by
the PRZM/EXAMS and SCI-GROW ground water models.  Dietary exposure
estimates could be refined through the use of anticipated residues and
percent crop treated data, as well as refined estimated drinking water
concentrations.  However, since estimated exposures and risks using
conservative assumptions are well below ARIA’s level of concern, such
refinement is not warranted.

VIII.	Conclusions

The unrefined dietary exposure assessment using DEEM-FCID™ indicates
that both acute and chronic dietary (food + drinking water) exposures to
pyrimethanil are below ARIA’s level of concern for this pesticide. 
Estimated acute dietary exposures are less than or equal to ca. 35% of
the aPAD for the general U.S. population subgroups (aPAD = 1.0
mg/kg/day).  The most highly acutely exposed population subgroup is all
infants <1 year old.  For the females 13-49 years of age population
subgroup, the estimated acute dietary exposure is ca. 13% of the aPAD
(aPAD = 0.45 mg/kg/day).  Finally, the estimated chronic dietary
exposures are less than or equal to ca. 63% of the cPAD for children 1-2
years of age and all population subgroups.

IX.		List of Attachments

Attachment 1:  Acute Food plus Water Residue Input File 

Attachment 2:  Acute Results File

Attachment 3:  Chronic Food plus Water Residue Input File 

Attachment 4:  Chronic Results File

**   SEQ CHAPTER \h \r 1 This assessment was developed as part of a
cooperative work-share program between the California Department of
Pesticide Regulation (CDPR) and the U.S. Environmental Protection Agency
(USEPA).  The toxicity studies/endpoints, No Observable Effects Levels
(NOELs), exposure assumptions and consumption databases used in this
document were selected by the U.S. EPA. 

			Attachment 1:  DEEM-FCID( Acute Residue File

U.S. Environmental Protection Agency                                
Ver. 2.10

DEEM-FCID Acute analysis for PYRIMETHANIL

Residue file name: D:\DEEM_FCID residue files\res\IR4\Pyrimethanil EPA
FY09 DPR work share ACUTE with H2O Tier 1.R98

Analysis Date 02-25-2009             Residue file dated:
01-20-2009/13:50:02/14

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: FQPA SF of 1x for all endpoints; aPAD above for general
populations; aPAD females 13-50 = 0.45 mg/kg/day

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

14000030 14   Almond                             0.200000   1.000  1.000
         

14000031 14   Almond-babyfood                    0.200000   1.000  1.000
         

14000040 14   Almond, oil                        0.200000   1.000  1.000
         

14000041 14   Almond, oil-babyfood               0.200000   1.000  1.000
         

11000070 11   Apple, fruit with peel            14.000000   1.000  1.000
          

11000080 11   Apple, peeled fruit               14.000000   1.000  1.000
          

11000081 11   Apple, peeled fruit-babyfood      14.000000   1.000  1.000
          

11000090 11   Apple, dried                      14.000000   8.000  1.000
          

11000091 11   Apple, dried-babyfood             14.000000   8.000  1.000
          

11000100 11   Apple, juice                      14.000000   0.350  1.000
          

11000101 11   Apple, juice-babyfood             14.000000   0.350  1.000
          

11000110 11   Apple, sauce                      14.000000   1.000  1.000
          

11000111 11   Apple, sauce-babyfood             14.000000   1.000  1.000
          

12000120 12   Apricot                           10.000000   1.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

12000121 12   Apricot-babyfood                  10.000000   1.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

12000130 12   Apricot, dried                    10.000000   6.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

12000140 12   Apricot, juice                    10.000000   1.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

12000141 12   Apricot, juice-babyfood           10.000000   1.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

01030150 1CD  Arrowroot, flour                   0.050000   1.000  1.000
         

01030151 1CD  Arrowroot, flour-babyfood          0.050000   1.000  1.000
         

01030170 1CD  Artichoke, Jerusalem               0.050000   1.000  1.000
         

95000230 O    Banana                             0.100000   1.000  1.000

95000231 O    Banana-babyfood                    0.100000   1.000  1.000

95000240 O    Banana, dried                      0.100000   3.900  1.000

95000241 O    Banana, dried-babyfood             0.100000   3.900  1.000

21000440 M    Beef, meat                         0.010000   1.000  1.000

          Full comment: D284001

21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000

          Full comment: D284001

21000450 M    Beef, meat, dried                  0.010000   1.920  1.000

          Full comment: D284001

21000460 M    Beef, meat byproducts              0.010000   1.000  1.000

          Full comment: D284001

21000461 M    Beef, meat byproducts-babyfood     0.010000   1.000  1.000

          Full comment: D284001

21000470 M    Beef, fat                          0.010000   1.000  1.000

          Full comment: D284001

21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000

          Full comment: D284001

21000480 M    Beef, kidney                       2.500000   1.000  1.000

          Full comment: DP# 347248

21000490 M    Beef, liver                        0.010000   1.000  1.000

          Full comment: D284001

21000491 M    Beef, liver-babyfood               0.010000   1.000  1.000

          Full comment: D284001

01030820 1CD  Cassava                            0.050000   1.000  1.000

          Full comment: D284001

01030821 1CD  Cassava-babyfood                   0.050000   1.000  1.000

          Full comment: D284001

12000900 12   Cherry                            10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000901 12   Cherry-babyfood                   10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000910 12   Cherry, juice                     10.000000   1.500  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000911 12   Cherry, juice-babyfood            10.000000   1.500  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10001060 10   Citrus citron                     11.000000   1.000  1.000

          Full comment: D284001

10001070 10   Citrus hybrids                    11.000000   1.000  1.000

          Full comment: D284001

10001080 10   Citrus, oil                      150.000000   1.000  1.000

          Full comment: D284001

11001290 11   Crabapple                         14.000000   1.000  1.000

          Full comment: DP# 347248 

01031390 1CD  Dasheen, corm                      0.050000   1.000  1.000

          Full comment: D284001

01031660 1CD  Ginger                             0.050000   1.000  1.000

          Full comment: D284001

01031661 1CD  Ginger-babyfood                    0.050000   1.000  1.000

          Full comment: D284001

01031670 1CD  Ginger, dried                      0.050000   1.000  1.000

          Full comment: D284001

23001690 M    Goat, meat                         0.010000   1.000  1.000

          Full comment: D284001

23001700 M    Goat, meat byproducts              0.010000   1.000  1.000

          Full comment: D284001

23001710 M    Goat, fat                          0.010000   1.000  1.000

          Full comment: D284001

23001720 M    Goat, kidney                       2.500000   1.000  1.000

          Full comment: DP# 347248

23001730 M    Goat, liver                        0.010000   1.000  1.000

          Full comment: D284001

95001750 O    Grape                              5.000000   1.000  1.000

          Full comment: D284001

95001760 O    Grape, juice                       5.000000   1.200  1.000

          Full comment: D284001

95001761 O    Grape, juice-babyfood              5.000000   1.200  1.000

          Full comment: D284001

95001770 O    Grape, leaves                      5.000000   1.000  1.000

          Full comment: D284001

95001780 O    Grape, raisin                      8.000000   1.000  1.000

          Full comment: D284001

95001790 O    Grape, wine and sherry             5.000000   1.000  1.000

          Full comment: D284001

10001800 10   Grapefruit                        11.000000   1.000  1.000

          Full comment: D284001

10001810 10   Grapefruit, juice                 11.000000   2.100  1.000

          Full comment: D284001

24001890 M    Horse, meat                        0.010000   1.000  1.000

          Full comment: D284001

10001970 10   Kumquat                           11.000000   1.000  1.000

          Full comment: D284001

10001990 10   Lemon                             11.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002000 10   Lemon, juice                      11.000000   2.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002001 10   Lemon, juice-babyfood             11.000000   2.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002010 10   Lemon, peel                       11.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002060 10   Lime                              11.000000   1.000  1.000

          Full comment: D284001

10002070 10   Lime, juice                       11.000000   2.000  1.000

          Full comment: D284001

10002071 10   Lime, juice-babyfood              11.000000   2.000  1.000

          Full comment: D284001

11002100 11   Loquat                            14.000000   1.000  1.000

          Full comment: DP# 347248 

27002220 D    Milk, fat                          0.050000   1.000  1.000

          Full comment: DP# 347248

27002221 D    Milk, fat - baby food/infant for   0.050000   1.000  1.000

          Full comment: DP# 347248

27012230 D    Milk, nonfat solids                0.050000   1.000  1.000

          Full comment: DP# 347248

27012231 D    Milk, nonfat solids-baby food/in   0.050000   1.000  1.000

          Full comment: DP# 347248

27022240 D    Milk, water                        0.050000   1.000  1.000

          Full comment: DP# 347248

27022241 D    Milk, water-babyfood/infant form   0.050000   1.000  1.000

          Full comment: DP# 347248

27032251 D    Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000

          Full comment: DP# 347248

12002300 12   Nectarine                         10.000000   1.000  1.000

          Full comment: D284001

03002370 3    Onion, dry bulb                    0.100000   1.000  1.000

          Full comment: D284001

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000  1.000

          Full comment: D284001

03002380 3    Onion, dry bulb, dried             0.100000   9.000  1.000

          Full comment: D284001

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000  1.000

          Full comment: D284001

03002390 3    Onion, green                       2.000000   1.000  1.000

          Full comment: D284001

10002400 10   Orange                            11.000000   1.000  1.000

          Full comment: D284001

10002410 10   Orange, juice                     11.000000   0.007  1.000

          Full comment: D284001

10002411 10   Orange, juice-babyfood            11.000000   0.007  1.000

          Full comment: D284001

10002420 10   Orange, peel                      11.000000   1.000  1.000

          Full comment: D284001

12002600 12   Peach                             10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002601 12   Peach-babyfood                    10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002610 12   Peach, dried                      10.000000   7.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002611 12   Peach, dried-babyfood             10.000000   7.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002620 12   Peach, juice                      10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002621 12   Peach, juice-babyfood             10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

11002660 11   Pear                              14.000000   1.000  1.000

          Full comment: DP# 347248 

11002661 11   Pear-babyfood                     14.000000   1.000  1.000
         

   Full comment: DP# 347248 

11002670 11   Pear, dried                       14.000000   6.250  1.000

          Full comment: DP# 347248 

11002680 11   Pear, juice                       14.000000   1.000  1.000

          Full comment: DP# 347248 

11002681 11   Pear, juice-babyfood              14.000000   1.000  1.000

          Full comment: DP# 347248 

95002830 O    Plantain                           0.100000   1.000  1.000

95002840 O    Plantain, dried                    0.100000   3.900  1.000

12002850 12   Plum                              10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002851 12   Plum-babyfood                     10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002860 12   Plum, prune, fresh                10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002861 12   Plum, prune, fresh-babyfood       10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002870 12   Plum, prune, dried                10.000000   5.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002871 12   Plum, prune, dried-babyfood       10.000000   5.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002880 12   Plum, prune, juice                10.000000   1.400  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002881 12   Plum, prune, juice-babyfood       10.000000   1.400  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

01032960 1C   Potato, chips                      0.050000   1.000  1.000

          Full comment: D284001

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500  1.000

          Full comment: D284001

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500  1.000

          Full comment: D284001

01032980 1C   Potato, flour                      0.050000   1.000  1.000

          Full comment: D284001

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000

          Full comment: D284001

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000

          Full comment: D284001

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000

          Full comment: D284001

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000

          Full comment: D284001

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000
         

   Full comment: D284001

10003070 10   Pummelo                           11.000000   1.000  1.000
         

   Full comment: D284001

11003100 11   Quince                            14.000000   1.000  1.000
         

   Full comment: DP# 347248 

26003390 M    Sheep, meat                        0.010000   1.000  1.000
         

   Full comment: D284001

26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000
         

   Full comment: D284001

26003400 M    Sheep, meat byproducts             0.010000   1.000  1.000
         

   Full comment: D284001

26003410 M    Sheep, fat                         0.010000   1.000  1.000

          Full comment: D284001

26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000

          Full comment: D284001

26003420 M    Sheep, kidney                      2.500000   1.000  1.000

          Full comment: DP# 347248

26003430 M    Sheep, liver                       0.010000   1.000  1.000

          Full comment: D284001

95003590 O    Strawberry                         3.000000   1.000  1.000

          Full comment: D284001

95003591 O    Strawberry-babyfood                3.000000   1.000  1.000

          Full comment: D284001

95003600 O    Strawberry, juice                  3.000000   1.000  1.000

          Full comment: D284001

95003601 O    Strawberry, juice-babyfood         3.000000   1.000  1.000

          Full comment: D284001

01033660 1CD  Sweet potato                       0.050000   1.000  1.000

          Full comment: D284001

01033661 1CD  Sweet potato-babyfood              0.050000   1.000  1.000

          Full comment: D284001

10003690 10   Tangerine                         11.000000   1.000  1.000

          Full comment: D284001

10003700 10   Tangerine, juice                  11.000000   2.300  1.000

          Full comment: D284001

01033710 1CD  Tanier, corm                       0.050000   1.000  1.000

          Full comment: D284001

08003750 8    Tomato                             0.500000   1.000  1.000

          Full comment: D284001

08003751 8    Tomato-babyfood                    0.500000   1.000  1.000

          Full comment: D284001

08003760 8    Tomato, paste                      0.500000   5.400  1.000

          Full comment: D284001

08003761 8    Tomato, paste-babyfood             0.500000   5.400  1.000

          Full comment: D284001

08003770 8    Tomato, puree                      0.500000   3.300  1.000

          Full comment: D284001

08003771 8    Tomato, puree-babyfood             0.500000   3.300  1.000

          Full comment: D284001

08003780 8    Tomato, dried                      0.500000  14.300  1.000

          Full comment: D284001

08003781 8    Tomato, dried-babyfood             0.500000  14.300  1.000

          Full comment: D284001

08003790 8    Tomato, juice                      0.500000   1.500  1.000

          Full comment: D284001

01033870 1CD  Turmeric                           0.050000   1.000  1.000

          Full comment: D284001

86010000 O    Water, direct, all sources         0.037800   1.000  1.000

   Full comment: EPA EFED Memo 01-09-2009

86020000 O    Water, indirect, all sources       0.037800   1.000  1.000

   	   Full comment: EPA EFED Memo 01-09-2009

01034060 1CD  Yam, true                          0.050000   1.000  1.000

          Full comment: D284001

01034070 1CD  Yam bean                           0.050000   1.000  1.000

          Full comment: D284001

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

Attachment 2:  DEEM-FCID( Acute Exposure Estimates

U.S. Environmental Protection Agency                                 
Ver. 2.02

DEEM-FCID ACUTE Analysis for PYRIMETHANIL                       
(1994-98 data)

Residue file: D:\DEEM_FCID residue files\res\IR4\Pyrimethanil EPA FY09
DPR work share ACUTE with H2O Tier 1.R98               				Adjustment
factor #2 NOT used.

Analysis Date 02-25-2009             Residue file dated:
01-20-2009/13:50:02/14

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: FQPA SF of 1x for all endpoints; aPAD above for general
populations; aPAD females 13-50

 = 0.45 mg/kg/day

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

Summary calculations (per capita):

      95th Percentile             99th Percentile             99.9th
Percentile

Exposure  % aRfD     MOE    Exposure  % aRfD     MOE    Exposure  % aRfD
  MOE 

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

U.S. Population:

0.097656    9.77    1024    0.231700   23.17     431    0.488398   48.84
   204 

Western Region:

0.106980   10.70     934    0.246545   24.65     405    0.470198   47.02
   212 

Hispanic:

0.115883   11.59     862    0.258320   25.83     387    0.529939   52.99
   188 

Non-hispanic whites:

0.094061    9.41    1063    0.224955   22.50     444    0.461494   46.15
   216 

Non-hispanic blacks:

0.097571    9.76    1024    0.247562   24.76     403    0.541702   54.17
   184 

Non-hispanic/non-white/non-black:

0.120505   12.05     829    0.235195   23.52     425    0.471533   47.15
   212 

All infants:

0.349407   34.94     286    0.612770   61.28     163    1.604463  160.45
    62 

Nursing infants (<1 yr old):

0.270798   27.08     369    0.461882   46.19     216    0.682371   68.24
   146 

Non-nursing infants (<1 yr old):

0.376210   37.62     265    0.635830   63.58     197    1.607565  160.76
    62 

Children 1-2 yrs:

0.336523   33.65     297    0.533496   53.35     187    0.837497   83.75
   119 

Children 3-5 yrs:

0.245654   24.57     407    0.375091   37.51     266    0.607399   60.74
   164 

Children 6-12 yrs:

0.128346   12.83     779    0.221907   22.19     450    0.376680   37.67
   265 

Youth 13-19 yrs:

0.060097    6.01    1663    0.117560   11.76     850    0.232181   23.22
   430 

Adults 20-49 yrs:

0.053444    5.34    1871    0.092643    9.26    1079    0.190359   19.04
   525 

Adults 50+ yrs:

0.064689    6.47    1545    0.113840   11.38     878    0.220998   22.10
   452

Females 13-49 yrs1:

0.057646    12.81    1734   0.101242   22.50     987    0.179366   39.86
   557 

1 The percent aPAD (or percent aRfD) and MOEs for the subgroup Females
13–49 years were recalculated as the toxicological doses (NOAEL = 45
mg/kg/day) and endpoints (aPAD = aRfd = 0.45 mg/kg/day) for this
subgroup are different than that of all other subgroups.

Attachment 3:  DEEM-FCID( Chronic Residue File

U.S. Environmental Protection Agency                                
Ver. 2.10

DEEM-FCID Acute analysis for PYRIMETHANIL

Residue file name: D:\DEEM_FCID residue files\res\IR4\Pyrimethanil EPA
FY09 DPR work share CHRONIC with H2O Tier 1.R98

Analysis Date 02-25-2009             Residue file dated:
01-20-2009/13:53:20/14

Reference dose: (RfD, Chronic) = 0.17 mg/kg bw/day  NOEL = 17 mg/kg
bw/day

Comment: FQPA SF of 1x for all endpoints; cPAD for all populations is
0.17 mg/kg/day

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

  EPA    Crop                                   Def Res     Adj.Factors 
 Comment

  Code    Grp  Food Name                         (ppm)       #1    #2   

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

14000030 14   Almond                             0.200000   1.000  1.000
         

14000031 14   Almond-babyfood                    0.200000   1.000  1.000
         

14000040 14   Almond, oil                        0.200000   1.000  1.000
         

14000041 14   Almond, oil-babyfood               0.200000   1.000  1.000
         

11000070 11   Apple, fruit with peel            14.000000   1.000  1.000
          

11000080 11   Apple, peeled fruit               14.000000   1.000  1.000
          

11000081 11   Apple, peeled fruit-babyfood      14.000000   1.000  1.000
          

11000090 11   Apple, dried                      14.000000   8.000  1.000
          

11000091 11   Apple, dried-babyfood             14.000000   8.000  1.000
          

11000100 11   Apple, juice                      14.000000   0.350  1.000
          

11000101 11   Apple, juice-babyfood             14.000000   0.350  1.000
          

11000110 11   Apple, sauce                      14.000000   1.000  1.000
          

11000111 11   Apple, sauce-babyfood             14.000000   1.000  1.000
          

12000120 12   Apricot                           10.000000   1.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

12000121 12   Apricot-babyfood                  10.000000   1.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

12000130 12   Apricot, dried                    10.000000   6.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

12000140 12   Apricot, juice                    10.000000   1.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

12000141 12   Apricot, juice-babyfood           10.000000   1.000  1.000
         

          Full comment: 8E7353 Proposed Tolerance 2009

01030150 1CD  Arrowroot, flour                   0.050000   1.000  1.000
         

01030151 1CD  Arrowroot, flour-babyfood          0.050000   1.000  1.000
         

01030170 1CD  Artichoke, Jerusalem               0.050000   1.000  1.000
         

95000230 O    Banana                             0.100000   1.000  1.000

95000231 O    Banana-babyfood                    0.100000   1.000  1.000

95000240 O    Banana, dried                      0.100000   3.900  1.000

95000241 O    Banana, dried-babyfood             0.100000   3.900  1.000

21000440 M    Beef, meat                         0.010000   1.000  1.000

          Full comment: D284001

21000441 M    Beef, meat-babyfood                0.010000   1.000  1.000

          Full comment: D284001

21000450 M    Beef, meat, dried                  0.010000   1.920  1.000

          Full comment: D284001

21000460 M    Beef, meat byproducts              0.010000   1.000  1.000

          Full comment: D284001

21000461 M    Beef, meat byproducts-babyfood     0.010000   1.000  1.000

          Full comment: D284001

21000470 M    Beef, fat                          0.010000   1.000  1.000

          Full comment: D284001

21000471 M    Beef,fat-babyfood                  0.010000   1.000  1.000

          Full comment: D284001

21000480 M    Beef, kidney                       2.500000   1.000  1.000

          Full comment: DP# 347248

21000490 M    Beef, liver                        0.010000   1.000  1.000

          Full comment: D284001

21000491 M    Beef, liver-babyfood               0.010000   1.000  1.000

          Full comment: D284001

01030820 1CD  Cassava                            0.050000   1.000  1.000

          Full comment: D284001

01030821 1CD  Cassava-babyfood                   0.050000   1.000  1.000

          Full comment: D284001

12000900 12   Cherry                            10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000901 12   Cherry-babyfood                   10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000910 12   Cherry, juice                     10.000000   1.500  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12000911 12   Cherry, juice-babyfood            10.000000   1.500  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10001060 10   Citrus citron                     11.000000   1.000  1.000

          Full comment: D284001

10001070 10   Citrus hybrids                    11.000000   1.000  1.000

          Full comment: D284001

10001080 10   Citrus, oil                      150.000000   1.000  1.000

          Full comment: D284001

11001290 11   Crabapple                         14.000000   1.000  1.000

          Full comment: DP# 347248 

01031390 1CD  Dasheen, corm                      0.050000   1.000  1.000

          Full comment: D284001

01031660 1CD  Ginger                             0.050000   1.000  1.000

          Full comment: D284001

01031661 1CD  Ginger-babyfood                    0.050000   1.000  1.000

          Full comment: D284001

01031670 1CD  Ginger, dried                      0.050000   1.000  1.000

          Full comment: D284001

23001690 M    Goat, meat                         0.010000   1.000  1.000

          Full comment: D284001

23001700 M    Goat, meat byproducts              0.010000   1.000  1.000

          Full comment: D284001

23001710 M    Goat, fat                          0.010000   1.000  1.000

          Full comment: D284001

23001720 M    Goat, kidney                       2.500000   1.000  1.000

          Full comment: DP# 347248

23001730 M    Goat, liver                        0.010000   1.000  1.000

          Full comment: D284001

95001750 O    Grape                              5.000000   1.000  1.000

          Full comment: D284001

95001760 O    Grape, juice                       5.000000   1.200  1.000

          Full comment: D284001

95001761 O    Grape, juice-babyfood              5.000000   1.200  1.000

          Full comment: D284001

95001770 O    Grape, leaves                      5.000000   1.000  1.000

          Full comment: D284001

95001780 O    Grape, raisin                      8.000000   1.000  1.000

          Full comment: D284001

95001790 O    Grape, wine and sherry             5.000000   1.000  1.000

          Full comment: D284001

10001800 10   Grapefruit                        11.000000   1.000  1.000

          Full comment: D284001

10001810 10   Grapefruit, juice                 11.000000   2.100  1.000

          Full comment: D284001

24001890 M    Horse, meat                        0.010000   1.000  1.000

          Full comment: D284001

10001970 10   Kumquat                           11.000000   1.000  1.000

          Full comment: D284001

10001990 10   Lemon                             11.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002000 10   Lemon, juice                      11.000000   2.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002001 10   Lemon, juice-babyfood             11.000000   2.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002010 10   Lemon, peel                       11.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

10002060 10   Lime                              11.000000   1.000  1.000

          Full comment: D284001

10002070 10   Lime, juice                       11.000000   2.000  1.000

          Full comment: D284001

10002071 10   Lime, juice-babyfood              11.000000   2.000  1.000

          Full comment: D284001

11002100 11   Loquat                            14.000000   1.000  1.000

          Full comment: DP# 347248 

27002220 D    Milk, fat                          0.050000   1.000  1.000

          Full comment: DP# 347248

27002221 D    Milk, fat - baby food/infant for   0.050000   1.000  1.000

          Full comment: DP# 347248

27012230 D    Milk, nonfat solids                0.050000   1.000  1.000

          Full comment: DP# 347248

27012231 D    Milk, nonfat solids-baby food/in   0.050000   1.000  1.000

          Full comment: DP# 347248

27022240 D    Milk, water                        0.050000   1.000  1.000

          Full comment: DP# 347248

27022241 D    Milk, water-babyfood/infant form   0.050000   1.000  1.000

          Full comment: DP# 347248

27032251 D    Milk, sugar (lactose)-baby food/   0.050000   1.000  1.000

          Full comment: DP# 347248

12002300 12   Nectarine                         10.000000   1.000  1.000

          Full comment: D284001

03002370 3    Onion, dry bulb                    0.100000   1.000  1.000

          Full comment: D284001

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000  1.000

          Full comment: D284001

03002380 3    Onion, dry bulb, dried             0.100000   9.000  1.000

          Full comment: D284001

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000  1.000

          Full comment: D284001

03002390 3    Onion, green                       2.000000   1.000  1.000

          Full comment: D284001

10002400 10   Orange                            11.000000   1.000  1.000

          Full comment: D284001

10002410 10   Orange, juice                     11.000000   0.007  1.000

          Full comment: D284001

10002411 10   Orange, juice-babyfood            11.000000   0.007  1.000

          Full comment: D284001

10002420 10   Orange, peel                      11.000000   1.000  1.000

          Full comment: D284001

12002600 12   Peach                             10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002601 12   Peach-babyfood                    10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002610 12   Peach, dried                      10.000000   7.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002611 12   Peach, dried-babyfood             10.000000   7.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002620 12   Peach, juice                      10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002621 12   Peach, juice-babyfood             10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

11002660 11   Pear                              14.000000   1.000  1.000

          Full comment: DP# 347248 

11002661 11   Pear-babyfood                     14.000000   1.000  1.000
         

   Full comment: DP# 347248 

11002670 11   Pear, dried                       14.000000   6.250  1.000

          Full comment: DP# 347248 

11002680 11   Pear, juice                       14.000000   1.000  1.000

          Full comment: DP# 347248 

11002681 11   Pear, juice-babyfood              14.000000   1.000  1.000

          Full comment: DP# 347248 

95002830 O    Plantain                           0.100000   1.000  1.000

95002840 O    Plantain, dried                    0.100000   3.900  1.000

12002850 12   Plum                              10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002851 12   Plum-babyfood                     10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002860 12   Plum, prune, fresh                10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002861 12   Plum, prune, fresh-babyfood       10.000000   1.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002870 12   Plum, prune, dried                10.000000   5.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002871 12   Plum, prune, dried-babyfood       10.000000   5.000  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002880 12   Plum, prune, juice                10.000000   1.400  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

12002881 12   Plum, prune, juice-babyfood       10.000000   1.400  1.000

          Full comment: 8E7353 Proposed Tolerance 2009

01032960 1C   Potato, chips                      0.050000   1.000  1.000

          Full comment: D284001

01032970 1C   Potato, dry (granules/ flakes)     0.050000   6.500  1.000

          Full comment: D284001

01032971 1C   Potato, dry (granules/ flakes)-b   0.050000   6.500  1.000

          Full comment: D284001

01032980 1C   Potato, flour                      0.050000   1.000  1.000

          Full comment: D284001

01032981 1C   Potato, flour-babyfood             0.050000   1.000  1.000

          Full comment: D284001

01032990 1C   Potato, tuber, w/peel              0.050000   1.000  1.000

          Full comment: D284001

01032991 1C   Potato, tuber, w/peel-babyfood     0.050000   1.000  1.000

          Full comment: D284001

01033000 1C   Potato, tuber, w/o peel            0.050000   1.000  1.000

          Full comment: D284001

01033001 1C   Potato, tuber, w/o peel-babyfood   0.050000   1.000  1.000
         

   Full comment: D284001

10003070 10   Pummelo                           11.000000   1.000  1.000
         

   Full comment: D284001

11003100 11   Quince                            14.000000   1.000  1.000
         

   Full comment: DP# 347248 

26003390 M    Sheep, meat                        0.010000   1.000  1.000
         

   Full comment: D284001

26003391 M    Sheep, meat-babyfood               0.010000   1.000  1.000
         

   Full comment: D284001

26003400 M    Sheep, meat byproducts             0.010000   1.000  1.000
         

   Full comment: D284001

26003410 M    Sheep, fat                         0.010000   1.000  1.000

          Full comment: D284001

26003411 M    Sheep, fat-babyfood                0.010000   1.000  1.000

          Full comment: D284001

26003420 M    Sheep, kidney                      2.500000   1.000  1.000

          Full comment: DP# 347248

26003430 M    Sheep, liver                       0.010000   1.000  1.000

          Full comment: D284001

95003590 O    Strawberry                         3.000000   1.000  1.000

          Full comment: D284001

95003591 O    Strawberry-babyfood                3.000000   1.000  1.000

          Full comment: D284001

95003600 O    Strawberry, juice                  3.000000   1.000  1.000

          Full comment: D284001

95003601 O    Strawberry, juice-babyfood         3.000000   1.000  1.000

          Full comment: D284001

01033660 1CD  Sweet potato                       0.050000   1.000  1.000

          Full comment: D284001

01033661 1CD  Sweet potato-babyfood              0.050000   1.000  1.000

          Full comment: D284001

10003690 10   Tangerine                         11.000000   1.000  1.000

          Full comment: D284001

10003700 10   Tangerine, juice                  11.000000   2.300  1.000

          Full comment: D284001

01033710 1CD  Tanier, corm                       0.050000   1.000  1.000

          Full comment: D284001

08003750 8    Tomato                             0.500000   1.000  1.000

          Full comment: D284001

08003751 8    Tomato-babyfood                    0.500000   1.000  1.000

          Full comment: D284001

08003760 8    Tomato, paste                      0.500000   5.400  1.000

          Full comment: D284001

08003761 8    Tomato, paste-babyfood             0.500000   5.400  1.000

          Full comment: D284001

08003770 8    Tomato, puree                      0.500000   3.300  1.000

          Full comment: D284001

08003771 8    Tomato, puree-babyfood             0.500000   3.300  1.000

          Full comment: D284001

08003780 8    Tomato, dried                      0.500000  14.300  1.000

          Full comment: D284001

08003781 8    Tomato, dried-babyfood             0.500000  14.300  1.000

          Full comment: D284001

08003790 8    Tomato, juice                      0.500000   1.500  1.000

          Full comment: D284001

01033870 1CD  Turmeric                           0.050000   1.000  1.000

          Full comment: D284001

86010000 O    Water, direct, all sources         0.005100   1.000  1.000

   Full comment: EPA EFED Memo 01-09-2009

86020000 O    Water, indirect, all sources       0.005100   1.000  1.000

   	   Full comment: EPA EFED Memo 01-09-2009

01034060 1CD  Yam, true                          0.050000   1.000  1.000

          Full comment: D284001

01034070 1CD  Yam bean                           0.050000   1.000  1.000

          Full comment: D284001

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

Attachment 4:	DEEM-FCID( Chronic Exposure Estimates

U.S. Environmental Protection Agency                                
Ver. 2.10

DEEM-FCID Acute analysis for PYRIMETHANIL

Residue file name: D:\DEEM_FCID residue files\res\IR4\Pyrimethanil EPA
FY09 DPR work share CHRONIC with H2O Tier 1.R98

Analysis Date 02-25-2009             Residue file dated:
01-20-2009/13:53:20/14

Reference dose: aRfD = 1 mg/kg bw/day  NOEL = 100 mg/kg bw/day

Comment: FQPA SF of 1x for all endpoints; cPAD for all populations is
0.17 mg/kg/day

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

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg             Percent
of   

           Subgroup                       body wt/day             Rfd   
   

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

U.S. Population (total)                     0.022477               
13.2%

U.S. Population (spring season)             0.023104               
13.6%

U.S. Population (summer season)             0.020720               
12.2%

U.S. Population (autumn season)             0.022512               
13.2%

U.S. Population (winter season)             0.023673               
13.9%

Northeast region                            0.025252               
14.9%

Midwest region                              0.022483               
13.2%

Southern region                             0.018923               
11.1%

Western region                              0.025624               
15.1%

Hispanics                                   0.025656               
15.1%

Non-hispanic whites                         0.022150               
13.0%

Non-hispanic blacks                         0.020510               
12.1%

Non-hisp/non-white/non-black                0.025838               
15.2%

All infants (< 1 year)                      0.090130               
53.0%

Nursing infants                             0.053341               
31.4%

Non-nursing infants                         0.104097               
61.2%

Children 1-6  yrs                           0.080645               
47.4%

Children 7-12 yrs                           0.030614               
18.0%

Females 13-19 (not preg or nursing)         0.013972                
8.2%

Females 20+ (not preg or nursing)           0.014455                
8.5%

Females 13-50 yrs                           0.015246                
9.0%

Females 13+ (preg/not nursing)              0.019072               
11.2%

Females 13+ (nursing)                       0.019571               
11.5%

Males 13-19 yrs                             0.012512                
7.4%

 

 

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RMales 20+ yrs                               0.012468                
7.3%

Seniors 55+                                 0.017084               
10.0%

Children 1-2 yrs                            0.106869               
62.9%

Children 3-5 yrs                            0.073678               
43.3%

Children 6-12 yrs                           0.033439               
19.7%

Youth 13-19 yrs                             0.013225                
7.8%

Adults 20-49 yrs                            0.011950                
7.0%

Adults 50+ yrs                              0.016453                
9.7%

Females 13-49 yrs                           0.013112                
7.7%

Pyrimethanil          Dietary Exposure and Risk Assessment         DP
Number: 362715        PC Code:  288201

________________________________________________________________________
______________	

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