Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
1
of
20
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
June
15,
2006
SUBJECT:
Propiconazole
Revised
Acute
and
Chronic
Dietary
Exposure
Assessments
for
Reregistration
Evaluation
Decision
(
RED)­
Phase
4.

PC
Code:
122101
DP
:
329667
REVIEWER:
Yan
Donovan,
Chemist
Reregistration
Branch
4/
Health
Effects
Division
(
7505C)

THROUGH:
William
Cutchin,
Chemist
Thurston
Morton,
Chemist
Dietary
Exposure
Science
Advisory
Council
(
DESAC)
Health
Effects
Division
(
7509C)

TO:
Yan
Donavon,
Risk
Assessor
Reregistration
Branch
4/
Health
Effects
Division
(
7505C)

Executive
Summary
Revised
acute
and
chronic
dietary
risk
assessments
were
conducted
incorporating
comments
from
phase
2
comments
period
for
propiconazole
RED.
As
a
result
of
the
phase
2
comments,
drinking
water
numbers
have
been
revised.
New
tolerance
on
rice
bran
was
proposed
based
on
the
Agency's
review
of
the
rice
processing
study.
New
acute
dietary
endpoints
and
aPADs
were
selected
based
on
the
review
of
the
recently
submitted
acute
neurotoxicity
study.

The
acute
and
chronic
dietary
assessment
used
the
Dietary
Exposure
Evaluation
Model
(
DEEMFCIDTM
Version
2.03)
which
uses
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
The
analyses
were
performed
to
support
the
RED
for
the
use
of
propiconazole.
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
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Acute
Dietary
Exposure
Results
and
Characterization
An
acute
dietary
analysis
for
propiconazole
was
conducted
using
tolerance
levels
and
100
%
CT
for
all
existing
and
proposed
uses.
The
acute
PAD
is
0.3
mg/
kg/
day
for
all
population
subgroups
(
includes
females
13­
49
years).
The
results
of
the
analysis
indicate
that
acute
risk
from
the
dietary
exposure
(
food
and
water)
to
propiconazole
from
the
requested
uses
did
not
exceed
HED's
level
of
concern
for
the
U.
S.
population
or
any
population
subgroup.
The
exposure
to
the
U.
S.
population
is
3%
aPAD,
the
highest
exposure
is
to
all
infants
<
1
yrs
old,
at
8%
aPAD.

Chronic
Dietary
Exposure
Results
and
Characterization
A
chronic
dietary
analysis
for
propiconazole
was
conducted
using
tolerance
levels
and
100
%
CT
for
all
existing
and
proposed
uses.
The
results
of
the
analysis
indicate
that
chronic
risk
from
the
dietary
exposure
(
food
and
water)
to
propiconazole
from
the
requested
use
did
not
exceed
HED's
level
of
concern
for
the
U.
S.
population
or
any
population
subgroup.
The
exposure
to
the
U.
S.
population
was
3%
cPAD
and
the
most
highly
exposed
subgroup,
Children
1­
2
yrs
old,
at
8%
cPAD.

Cancer
Dietary
Exposure
Results
and
Characterization
The
HIARC
classified
propiconazole
as
a
Group
C
­
possible
human
carcinogen,
non­
quantifiable,
and,
therefore,
quantification
of
human
cancer
risk
is
not
required.

Water
Contribution
The
highest
estimates
from
surface
water
(
acute,
86.4
ppb
and
chronic,
37.5
ppb)
were
used
in
the
DEEM
analysis.

I.
Introduction
Dietary
risk
assessment
incorporates
both
exposure
and
toxicity
of
a
given
pesticide.
For
acute
and
chronic
assessments,
the
risk
is
expressed
as
a
percentage
of
a
maximum
acceptable
dose
(
i.
e.,
the
dose
which
HED
has
concluded
will
result
in
no
unreasonable
adverse
health
effects).
This
dose
is
referred
to
as
the
population
adjusted
dose
(
PAD).
The
PAD
is
equivalent
to
the
Reference
Dose
(
RfD)
divided
by
the
special
FQPA
Safety
Factor.

For
acute
and
non­
cancer
chronic
exposures,
HED
is
concerned
when
estimated
dietary
risk
exceeds
100%
of
the
PAD.
HED
is
generally
concerned
when
estimated
cancer
risk
exceeds
one
in
one
million
(
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:
AAvailable
Information
on
Assessing
Exposure
from
Pesticides,
A
User's
Guide,
6/
21/
2000,
web
link:
http://
www.
epa.
gov/
fedrgstr/
EPA­
PEST/
2000/
July/
Day­
12/
6061.
pdf
;
or
see
SOP
99.6
(
8/
20/
99).
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
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20
The
most
recent
dietary
risk
assessment
for
propiconazole
was
conducted
by
D.
Hrdy
supporting
the
primary
human
health
risk
assessment
for
propiconazole
(
HED
memo
of
D.
Hrdy,
D318269,
08/
18/
05).

II.
Residue
Information
Dietary
Exposure
These
acute
and
chronic
assessments
were
based
on
the
assumption
of
tolerance­
level
residues
for
all
commodities
with
existing
and
proposed
tolerances
and
100%
crop
treated
(%
CT)
for
all
commodities.
The
existing
tolerances
are
listed
in
40
CFR
§
180.434.
This
dietary
analysis
included
all
reassessed
and
proposed
tolerances
outlined
in
Table
1
below,
which
is
from
the
revised
residue
chemistry
summary
chapter
for
propiconazole
by
Y.
Donovan,
06/
15/
06,
D329394.

DEEM
default
processing
factors
from
DEEM
(
Version
7.81)
were
used
for
all
processed
commodities
that
do
not
have
individual
tolerances.

Table
1.
Tolerance
Reassessment
Summary
for
Propiconazole.

Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Tolerances
Established
Under
40
CFR
§
180.434(
a)

Bananas
0.2
0.2
[
Banana]

Barley,
grain
0.1
0.3
Translated
from
wheat
data.
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.

Barley,
straw
1.5
15.0
Translated
from
wheat
data.
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.

Cattle,
fat
0.1
0.1
0.08
ppm
combined
residues
in
fat
were
expected
from
MTDB.

Cattle,
kidney
2.0
2.0
1.01
ppm
combined
residues
in
kidney
were
expected
from
MTDB.
However,
several
new
uses
are
pending
which
may
increase
the
MTDB.
Propiconazole
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Table
1.
Tolerance
Reassessment
Summary
for
Propiconazole.

Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Cattle,
liver
2.0
2.0
1.33
ppm
combined
residues
in
liver
were
expected
from
MTDB.
However,
several
new
uses
are
pending
which
may
increase
the
MTDB.

Cattle,
meat
byproducts,
except
kidney
and
liver
0.1
0.1
(
see
comments
above
in
fat)

Cattle,
meat
0.1
0.1
0.04
ppm
combined
residues
in
meat
were
expected
from
MTDB.
However,
several
new
uses
are
pending
which
may
increase
the
MTDB.

Celery
5.0
5.0
Corn,
field,
stover
12
12
Expiration
date
11/
30/
08
[
Corn,
field,
stover]

Corn,
field,
forage
12
12
Expiration
date
11/
30/
08
[
Corn,
field,
forage]

Corn,
field,
grain
0.1
0.1
Expiration
date
11/
30/
08
[
Corn,
field,
grain]

Corn,
sweet,
kernels
plus
cobs
with
husks
removed
0.1
0.1
Expiration
date
11/
30/
08
[
Corn,
sweet,
kernels
plus
cobs
with
husks
removed]

Eggs
0.1
Revoke
Feeding
study
data
indicate
that
tolerances
for
poultry
commodities
are
not
necessary.

Fruit,
Stone,
group
12
1.0
1.0
[
Fruit,
stone,
group
12]

Goat,
fat
0.1
0.1
(
see
comments
in
cattle)

Goat,
kidney
2.0
2.0
(
see
comments
in
cattle)

Goat,
liver
2.0
2.0
(
see
comments
in
cattle)

Goat,
meat
byproducts,
except
kidney
and
liver
0.1
0.1
(
see
comments
in
cattle)
Propiconazole
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Table
1.
Tolerance
Reassessment
Summary
for
Propiconazole.

Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Goat,
meat
0.1
0.1
(
see
comments
in
cattle)

Grass,
forage
0.5
0.5
Grass,
hay
(
straw)
40
40
[
Grass,
hay]

Grass,
straw
40
40
[
Grass,
straw]

Hog,
fat
0.1
0.1
(
see
comments
in
cattle)

Hog,
kidney
2.0
2.0
(
see
comments
in
cattle)

Hog,
liver
2.0
2.0
(
see
comments
in
cattle)

Hog,
meat
byproducts,
except
kidney
and
liver
0.1
0.1
(
see
comments
in
cattle)

Hog,
meat
0.1
0.1
(
see
comments
in
cattle)

Horse,
fat
0.1
0.1
(
see
comments
in
cattle)

Horse,
kidney
2.0
2.0
(
see
comments
in
cattle)

Horse,
liver
2.0
2.0
(
see
comments
in
cattle)

Horse,
mbyp
(
except
kidney
and
liver)
0.1
0.1
[
Horse,
meat
byproducts,
except
kidney
and
liver](
see
comments
in
cattle)

Horse,
meat
0.1
0.1
(
see
comments
in
cattle)

Milk
0.05
0.05
0.03
ppm
combined
residues
in
milk
were
expected
from
26.5ppm
MTDB.

Mushroom
0.1
0.1
Use
of
propiconazole
on
mushrooms
is
being
supported
by
IR­
4.
Currently
there
are
no
registered
uses
of
propiconazole
on
mushrooms.
[
Mushroom]

Oat,
forage
10.0
10.0
[
Oat,
forage]

Oat,
grain
0.1
0.1
[
Oat,
grain]

Oat,
hay
30.0
2.0
Translated
from
wheat
hay.
[
Oat,
hay]

Oat,
straw
1.0
1.0
[
Oat,
straw]
Propiconazole
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Table
1.
Tolerance
Reassessment
Summary
for
Propiconazole.

Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Peanut
0.2
0.2
Expiration
date
11/
30/
08
[
Peanut].
Parent
accounted
30%
of
the
TRR
based
on
peanut
metabolism
(
MARC
memo
of
4/
4/
02,
D279299).

Peanut,
hay
20.0
20.0
Expiration
date
11/
30/
08
[
Peanut,
hay]

Pecans
0.1
0.1
Syngenta
has
proposed
removal
of
the
established
tolerance
for
pecans
on
establishment
of
the
proposed
tree
nut
crop
group
tolerance
(
pending
tolerance
petition
PP#
9F3470).

Pineapple
0.1
0.1
Expiration
date
11/
30/
08
Pineapple,
fodder
0.1
Revoke
Expiration
date
11/
30/
08;
no
longer
considered
a
significant
livestock
feed
item.

Plum,
prune,
fresh
1.0
Revoke
This
tolerance
has
been
replaced
by
the
stone
fruits
group
tolerance.

Rice,
grain
0.1
0.3
The
available
data,
reflecting
the
maximum
registered
use
pattern,
indicate
that
the
maximum
combined
residues
of
propiconazole
and
its
metabolites
determined
as
2,4­
DCBA
were
0.28
ppm
in/
on
rice
grain.
(
HED
memo
of
02/
23/
05,
T.
Morton,
D240856).

Rice,
straw
3.0
3.0
(
HED
memo
of
02/
23/
05,
T.
Morton,
D240856).

Rye,
grain
0.1
0.3
Translated
from
wheat
data.
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.

Rye,
straw
1.5
15.0
Translated
from
data
for
wheat
straw.

Sheep,
fat
0.1
0.1
(
see
comments
in
cattle)

Sheep,
kidney
2.0
2.0
(
see
comments
in
cattle)

Sheep,
liver
2.0
2.0
(
see
comments
in
cattle)
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Table
1.
Tolerance
Reassessment
Summary
for
Propiconazole.

Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Sheep,
mbyp
(
except
kidney
and
liver)
0.1
0.1
(
see
comments
in
cattle)

Sheep,
meat
0.1
0.1
(
see
comments
in
cattle)

Wheat,
grain
0.1
0.30
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.

Wheat,
straw
1.5
15.0
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.

Tolerances
To
Be
Proposed
Under
40
CFR
§
180.434(
a)

Aspirated
grain
fractions
20
(
sorghum)
1
5.0
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.
[
Grain,
aspirated
fraction]

Barley,
hay
None
established
2.0
Translate
from
wheat
hay
Corn,
pop,
grain
None
established
0.1
Translate
from
field
corn
Corn,
pop,
stover
None
established
12
Translate
from
field
corn
Corn,
sweet,
forage
None
established
12
Translate
from
field
corn
Corn,
sweet,
stover
None
established
12
Translate
from
field
corn
Rice,
bran
None
established
1.0
Concentration
factor
for
rice
bran
is
2.9x.
(
MRID45080811.
DER2)

Rice,
hulls
None
established
1.2
Concentration
factor
for
rice
hulls
is
3.8x.
(
MRID45080811.
DER2)

Rye,
forage
None
established
2.0
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.

Wheat
forage
None
established
2.0
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.
[
wheat,
forage]

Wheat
hay
None
established
2.0
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.
[
Wheat,
hay]

Wheat
Bran
None
established
1.0
Memo
of
02/
02/
05,
Y.
Donovan,
D271790.
[
Wheat,
bran]

Tolerances
Established
Under
40
CFR
§
180.434(
b)
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Table
1.
Tolerance
Reassessment
Summary
for
Propiconazole.

Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Blueberry
1.0
N/
A
Expiration
date
11/
31/
07.
Recommended
in
Agency
memo
of
02/
22/
05,
D.
Rate,
D313289.
[
Blueberry]

Cranberry
1.0
N/
A
Expiration
date
12/
31/
05
[
Cranberry]

Dry
bean
forage
8.0
N/
A
Expiration
date
12/
31/
05
[
Bean,
dry,
forage]

Dry
bean
hay
8.0
N/
A
Expiration
date
12/
31/
05
[
Bean,
dry,
hay]

Dry
bean
0.5
N/
A
Expiration
date
12/
31/
05
[
Bean,
dry]

Sorghum,
aspirated
grain
fractions
20
N/
A
Expiration
date
06/
30/
05
Sorghum,
grain,
grain
0.2
N/
A
Expiration
date
06/
30/
05
[
Sorghum,
,
grain,
grain]

Sorghum,
grain,
stover
1.5
N/
A
Expiration
date
06/
30/
05
Soybean,
bean
0.5
(
pending)
N/
A
Agency
memo
of
04/
14/
04,
J.
R.
Tomerlin,
D262299.

Soybean,
forage
8.0
(
pending)
N/
A
Agency
memo
of
04/
14/
04,
J.
R.
Tomerlin,
D262299.

Soybean,
hay
25.0
(
pending)
N/
A
Agency
memo
of
04/
14/
04,
J.
R.
Tomerlin,
D262299.

Tolerances
Established
Under
40
CFR
§
180.434(
c)

Sunflower
None
established
TBD
2
Peppermint,
tops;
[
Spearmint,
tops
0.3
0.3
Regional
registration
for
use
west
of
the
Cascade
Mountains
only.
[
Peppermint,
tops]
[
Spearmint,
tops]

Rice,
wild
0.5
0.5
MN
[
Rice,
wild]
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1
The
20­
ppm
tolerance
for
sorghum
aspirated
grain
fractions
is
a
time­
limited
tolerance
to
support
a
Section
18
Exemption.

2
Tolerance
can
not
be
established
until
field
data
are
submitted.
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Water
Exposure
(
EFED
memo
of
Jim
Lin,
07/
07/
06,
D361358)

With
the
exception
of
rice
use,
estimated
drinking
water
concentrations
from
surface
water
sources
were
calculated
using
Tier
II
PRZM
(
Pesticide
Root
Zone
Model)
and
EXAMS
(
Exposure
Analysis
Modeling
System).
PRZM
is
used
to
simulate
pesticide
transport
as
a
result
of
runoff,
erosion,
and
off­
target
spray
drift
from
an
agricultural
field
and
EXAMS
estimates
environmental
fate
and
transport
of
pesticides
in
surface
water.
These
models
are
run
using
the
linkage
program
shell,
PE4V01,
which
incorporates
the
standard
scenarios
developed
by
EFED.

Linked
crop­
specific
scenarios
and
meteorological
data
were
used
to
estimate
exposure
as
a
result
of
uses
on
various
field
crops
and
vegetables.
Simulations
were
done
using
the
Index
Reservoir
scenario
in
EXAMS,
which
is
designed
after
an
actual
reservoir
for
a
drinking
water
source
drawn
from
surface
water.
Weather
and
agricultural
practices
are
simulated
over
30
years
so
that
the
1­
in10
year
exceedence
probability
at
the
site
can
be
estimated.
The
values
generated
by
the
models
for
drinking
water
were
multiplied
by
a
crop
area
factor
(
PCA),
which
represents
the
maximum
extent
to
which
HUC­
8
watersheds
in
the
continental
US
are
planted
to
agricultural
crops.

For
Rice
Use,
the
Policy
for
Estimating
Aqueous
Concentrations
from
Pesticides
Labeled
for
Use
on
Rice,
dated
October
29,
2002,
was
followed
in
estimating
drinking
water
concentrations
from
rice
use.
The
estimated
environmental
concentration
(
EEC
in
ug/
L)
represents
the
dissolved
concentration
occurring
in
the
water
column
and
the
concentration
in
water
released
from
the
paddy.
Movement
of
pesticide
on
suspended
sediment
is
not
considered
Based
on
the
PRZM­
EXAMS
and
SCI­
GROW
models,
for
surface
water,
the
highest
estimated
environmental
concentrations
(
EECs)
of
propiconazole
for
acute
exposure
is
86.4
parts
per
billion
(
ppb)
(
rice
use),
and
for
chronic
exposure
is
37.5
ppb
(
turf
use).
For
ground
water,
the
highest
EEC
for
acute
and
chronic
exposure
is
0.7
ppb.
The
highest
estimates
from
surface
water
(
acute,
86.4
ppb
and
chronic
exposure,
37.5
ppb)
were
used
in
the
DEEM
analysis.

Table
2
 
Estimated
Drinking
Water
Concentrations
from
Surface
Water
Sources
Pre
PAC
Adjustment
Post
PCA
Adjustment
Use
Scenario
1­
in­
10
probability
peak
(
Acute)
1­
in­
10
probability
yearly
(
Chronic)
1­
in­
10
probability
peak
(
Acute)
1­
in­
10
probability
yearly
(
Chronic)

Wheat
/
ND
5.92
(
ug/
L)
2.81
(
ug/
L)
3.32
(
ug/
L)
1.57
(
ug/
L)
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Grass
Seed
/
OR
4.23
2.07
3.68
1.80
Rice
peak
conc:
86.40
ug/
L
and
annual
mean
conc.:
2.92
ug/
L
Pecans
/
GA
19.56
4.84
17.02
4.21
Peaches
/
GA
6.59
2.44
5.73
2.12
Sweet
Corn
/
FL
19.26
3.24
8.86
1.49
Sweet
Corn
/
OR
4.23
2.07
1.95
0.95
Dry
Beans
/
MI
8.21
4.37
7.14
3.80
Peanuts
/
NC
10.34
3.43
9.00
2.98
Barley
(
use
ND
Wheat
Sceanrio)
3.14
1.36
2.73
1.18
Celery
(
use
FL
Carrots
Scenario)
13.64
2.66
11.87
2.31
Turf
/
PA
87.89
43.13
76.46
37.52
Turf
/
FL
75.03
30.50
65.28
26.54
III.
DEEM­
FCIDJ
Program
and
Consumption
Information
Propiconazole
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMFCIDJ
Version
2.03),
which
incorporates
consumption
data
from
USDA=
s
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
The
1994­
96,
98
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
non­
consecutive
survey
days.
Foods
Aas
consumed@
(
e.
g.,
apple
pie)
are
linked
to
EPA­
defined
food
commodities
(
e.
g.
apples,
peeled
fruit
­
cooked;
fresh
or
N/
S;
baked;
or
wheat
flour
­
cooked;
fresh
or
N/
S,
baked)
using
publicly
available
recipe
translation
files
developed
jointly
by
USDA/
ARS
and
EPA.
For
chronic
exposure
assessment,
consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups,
but
for
acute
exposure
assessment
are
retained
as
individual
consumption
events.
Based
on
analysis
of
the
1994­
96,
98
CSFII
consumption
data,
which
took
into
account
dietary
patterns
and
survey
respondents,
HED
concluded
that
it
is
most
appropriate
to
report
risk
for
the
following
population
subgroups:
the
general
U.
S.
population,
all
infants
(<
1
year
old),
children
1­
2,
children
3­
5,
children
6­
12,
youth
13­
19,
adults
20­
49,
females
13­
49,
and
adults
50+
years
old.

For
chronic
dietary
exposure
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food
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form
(
e.
g.,
orange
or
orange
juice)
on
the
food
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form
to
produce
a
residue
intake
estimate.
The
resulting
residue
intake
estimate
for
each
food/
food
form
is
summed
with
the
residue
intake
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
average
estimated
exposure.
Exposure
is
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD.
This
procedure
is
performed
for
each
population
subgroup.

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

IV.
Toxicological
Information
HED's
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
concluded
that
the
toxicology
database
for
propiconazole
is
complete
for
FQPA
assessment.
Endpoints
and
dose
response
have
been
selected
for
acute,
chronic
dietary,
short
and
intermediate­
term
dermal,
inhalation,
and
incidental
oral,
and
long
term
dermal
and
inhalation
exposures.

The
HIARC
also
concluded
that
the
database
was
adequate
to
characterize
any
potential
for
prenatal
or
postnatal
risk
for
infants
and
children.
There
is
low
concern
for
pre­
and/
or
postnatal
toxicity
resulting
from
exposure
to
propiconazole,
and
no
residual
uncertainties
were
identified.
The
Special
FQPA
factor
is
thus
1X.
The
HIARC
had
previously
determined
that
an
acute
neurotoxicity
(
ACN)
study
was
required
based
on
neurotoxic
signs
in
pregnant
rats
administered
high
propiconazole
doses
(
360
mg/
kg/
day)
during
gestation.
HIARC
had
determined
that
for
acute
(
single
dose)
and
short­
term
exposure
scenarios
a
3X
database
uncertainty
factor
(
UFDB)
was
adequate
to
account
for
the
lack
of
the
ACN.
In
September,
2005
the
ACN
was
submitted
to
the
Agency
and
reviewed.
The
study
confirms
that
neurotoxic
signs
are
observed
at
high
doses,
but
there
was
no
neuropathology
and
there
were
no
effects
on
neurobehavioral
parameters.
Accordingly,
the
propiconazole
risk
assessment
team
determined
that
a
developmental
neurotoxicity
study
was
not
necessary
and
the
database
uncertainty
factor
for
acute
and
shortterm
scenarios
was
removed.
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The
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
classified
propiconazole
as
Group
C
­
possible
human
carcinogen
and
recommended
that
for
the
purpose
of
risk
characterization
the
reference
Dose
(
RfD)
approach
should
be
used
and
would
be
protective.

Table
3.
Summary
of
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13­
49)
Dev.
NOAEL
=
30
mg
ai/
kg/
day
UF
=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD
FQPA
SF
=
0.3
mg/
kg/
day
Developmental
Toxicity
Study
­
Rats.
Developmental
toxicity:
increased
incidence
of
rudimentary
ribs,
cleft
palate
malformations
(
0.3%)
unossified
sternebrae,
as
well
as
increased
incidence
of
shortened
and
absent
renal
papillae.

Acute
Dietary
(
General
Population
including
infants
and
children)
NOAEL
=
30
mg
kg/
day
UF
=
100
Acute
RfD
=
0.3
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD
FQPA
SF
=
0.3
mg/
kg/
day
Acute
Neurotoxicity
Study
 
Rats.

Clinical
signs
(
piloerection,
diarrhea,
tiptoe
gait).

Chronic
Dietary
(
All
populations)
NOAEL
=
10
mg
ai/
kg/
day
UF
=
100
Chronic
RfD
=
0.1
mg/
kg/
day
1X
cPAD
=
chronic
RfD
FQPA
SF
=
0.1
mg/
kg/
day
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)

Cancer
(
Oral,
dermal,
inhalation)
Group
C,
possible
human
carcinogen,
RfD
approach
for
risk
characterization.

UF
=
uncertainty
factor,
FQPA
SF
=
Special
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern,
NA
=
Not
Applicable
NOTE:
The
Special
FQPA
Safety
Factor
recommended
by
the
HIARC
assumes
that
the
exposure
databases
(
dietary
food,
drinking
water,
and
residential)
are
complete
and
that
the
risk
assessment
for
each
potential
exposure
scenario
includes
all
metabolites
and/
or
degradates
of
concern
and
does
not
underestimate
the
potential
risk
for
infants
and
children.
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V.
Results/
Discussion
As
stated
above,
for
acute
and
chronic
dietary
assessments,
HED
is
concerned
when
dietary
risk
exceeds
100%
of
the
PAD.
The
DEEM­
FCID
TM
analyses
estimate
the
dietary
exposure
of
the
U.
S.
population
and
various
population
subgroups.
The
exposure
results
reported
in
Tables
4
and
5
are
for
the
general
U.
S.
Population,
all
infants
(<
1
year
old),
children
1­
2,
children
3­
5,
children
6­
12,
youth
13­
19,
females
13­
49,
adults
20­
49,
and
adults
50+
years.
The
acute
exposure
results
reported
in
Table
4
include
at
the
95th
percentile
the
general
US
population
at
3
%
aPAD
and
the
most
highly
exposed
subgroup,
all
infants
<
1
yrs
old,
at
8%
aPAD.
The
chronic
dietary
risk
estimates
in
Table
5
include
general
US
population
at
3%
cPAD
and
the
most
highly
exposed
subgroup,
Children
1­
2
yrs
old,
at
8%
cPAD.
All
the
dietary
risk
estimates
are
below
100%
of
the
PADs.
A
determination
of
cancer
dietary
risk
was
not
required.
These
analyses
are
highly
conservative,
Tier
1
dietary
exposure
assessments.
Further
refinement
to
the
analyses
could
be
made
through
the
use
of
anticipated
residues,
incorporation
of
percentages
of
crops
treated
with
propiconazole,
and/
or
monitoring
data
that
better
reflect
residues
at
the
time
of
consumption.
Since
risk
estimates
are
well
below
HED's
level
of
concern,
a
more
highly
refined
analysis
is
not
needed
at
this
time.
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Table
4.
Results
of
Acute
Dietary
Exposure
Analysis
for
FOOD
and
Water
95th
Percentile
99th
Percentile
99.9th
Percentile
Population
Subgroup
aPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.3
0.00965
3.2
0.01595
5.3
0.02798
9.3
All
Infants
(<
1
year
old)
0.3
0.02352
7.8
0.03109
10
0.04693
15
Children
1­
2
years
old
0.3
0.01843
6.1
0.02936
9.8
0.05908
20
Children
3­
5
years
old
0.3
0.01556
5.2
0.02209
7.4
0.03597
12.

Children
6­
12
years
old
0.3
0.01074
3.6
0.01678
5.6
0.02691
9.0
Youth
13­
19
years
old
0.3
0.00700
2.3
0.01107
3.7
0.01793
6.0
Adults
20­
49
years
old
0.3
0.00730
2.4
0.01090
3.6
0.01792
6.0
Adults
50+
years
old
0.3
0.00700
2.3
0.01029
3.4
0.01605
5.4
Females
13­
49
years
old
0.3
0.00725
2.4
0.01076
3.6
0.01597
5.3
Table
5.
Results
of
Chronic
Dietary
Exposure
Analysis
for
FOOD
and
Water
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.1
0.003113
3.1
All
Infants
(<
1
year
old)
0.1
0.006597
6.6
Children
1­
2
years
old
0.1
0.007753
7.8
Children
3­
5
years
old
0.1
0.006464
6.5
Children
6­
12
years
old
0.1
0.004314
4.3
Youth
13­
19
years
old
0.1
0.002627
2.6
Adults
20­
49
years
old
0.1
0.002510
2.5
Adults
50+
years
old
0.1
0.002490
2.5
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
16
of
20
Table
5.
Results
of
Chronic
Dietary
Exposure
Analysis
for
FOOD
and
Water
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
Females
13­
49
years
old
0.1
0.002434
2.4
VI.
Conclusions
These
Tier
1
analyses
demonstrate
that
the
requested
uses
for
propiconazole
will
not
result
in
dietary
risk
estimates
that
exceed
HED's
level
of
concern
for
any
of
the
regulated
population
subgroups,
including
those
comprised
of
infants
and
children.

A
summary
of
the
dietary
exposure
analyses
is
given
in
Table
6.
Propiconazole
does
not
possess
cancer
dietary
endpoints;
therefore,
the
results
of
only
the
acute
and
chronic
analyses
are
given
in
the
table.

Table
6.
Summary
of
Dietary
Exposure
and
Risk
for
Propiconazole
FOOD
PLUS
WATER.

Acute
Dietary
(
95th
Percentile)
Chronic
Dietary
Cancer
Population
Subgroup*
Dietary
Exposure
(
mg/
kg/
day)
%
aPAD
Dietary
Exposure
(
mg/
kg/
day)
%
cPAD
Dietary
Exposure
(
mg/
kg/
day)
Risk
General
U.
S.
Population
0.00965
3.2
0.003113
3.1
All
Infants
(<
1
year
old)
0.02352
7.8
0.006597
6.6
Children
1­
2
years
old
0.01843
6.1
0.007753
7.8
Children
3­
5
years
old
0.01556
5.2
0.006464
6.5
Children
6­
12
years
old
0.01074
3.6
0.004314
4.3
Youth
13­
19
years
old
0.00700
2.3
0.002627
2.6
Adults
20­
49
years
old
0.00730
2.4
0.002510
2.5
Adults
50+
years
old
0.00700
2.3
0.002490
2.5
Females
13­
49
years
old
0.00725
2.4
0.002434
2.4
N/
A
VII.
List
of
Attachments
Attachment
1.
Acute
Food
plus
Water
Residue
Input
file.
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
17
of
20
Attachment
2.
Acute
Results
file.
Attachment
3.
Chronic
Food
plus
Water
Residue
Input
file.
Attachment
4.
Chronic
Results
file.
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
18
of
20
Attachment
1.
Acute
Food
plus
Water
Residue
Input
file.

Filename:
C:\
Documents
and
Settings\
ydonovan\
DEEM
Files\
122101RevisedWaterNumbers\
acute122101RevH2Onumbers.
R98
Chemical:
Propiconazole
RfD(
Chronic):
.1
mg/
kg
bw/
day
NOEL(
Chronic):
0
mg/
kg
bw/
day
RfD(
Acute):
.3
mg/
kg
bw/
day
NOEL(
Acute):
0
mg/
kg
bw/
day
Date
created/
last
modified:
06­
19­
2006/
12:
51:
15/
8
Program
ver.
2.03
Comment:
Acute
for
general
popn
­
0.3
(
including
females
now)
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
EPA
Crop
Def
Res
Adj.
Factors
Comment
Code
Grp
Commodity
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
12000120
12
Apricot
1.000000
1.000
1.000
12000121
12
Apricot­
babyfood
1.000000
1.000
1.000
12000130
12
Apricot,
dried
1.000000
6.000
1.000
12000140
12
Apricot,
juice
1.000000
1.000
1.000
12000141
12
Apricot,
juice­
babyfood
1.000000
1.000
1.000
95000230
O
Banana
0.200000
1.000
1.000
95000231
O
Banana­
babyfood
0.200000
1.000
1.000
95000240
O
Banana,
dried
0.200000
3.900
1.000
95000241
O
Banana,
dried­
babyfood
0.200000
3.900
1.000
15000250
15
Barley,
pearled
barley
0.300000
1.000
1.000
15000251
15
Barley,
pearled
barley­
babyfood
0.300000
1.000
1.000
15000260
15
Barley,
flour
0.300000
1.000
1.000
15000261
15
Barley,
flour­
babyfood
0.300000
1.000
1.000
15000270
15
Barley,
bran
0.300000
1.000
1.000
06030300
6C
Bean,
black,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030320
6C
Bean,
broad,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030340
6C
Bean,
cowpea,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030350
6C
Bean,
great
northern,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030360
6C
Bean,
kidney,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030380
6C
Bean,
lima,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030390
6C
Bean,
mung,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030400
6C
Bean,
navy,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030410
6C
Bean,
pink,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030420
6C
Bean,
pinto,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
21000440
M
Beef,
meat
0.100000
1.000
1.000
21000441
M
Beef,
meat­
babyfood
0.100000
1.000
1.000
21000450
M
Beef,
meat,
dried
0.100000
1.920
1.000
21000460
M
Beef,
meat
byproducts
0.100000
1.000
1.000
21000461
M
Beef,
meat
byproducts­
babyfood
0.100000
1.000
1.000
21000470
M
Beef,
fat
0.100000
1.000
1.000
21000471
M
Beef,
fat­
babyfood
0.100000
1.000
1.000
21000480
M
Beef,
kidney
2.000000
1.000
1.000
21000490
M
Beef,
liver
2.000000
1.000
1.000
21000491
M
Beef,
liver­
babyfood
2.000000
1.000
1.000
13020570
13B
Blueberry
1.000000
1.000
1.000
13020571
13B
Blueberry­
babyfood
1.000000
1.000
1.000
04020850
4B
Celery
5.000000
1.000
1.000
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
19
of
20
04020851
4B
Celery­
babyfood
5.000000
1.000
1.000
04020860
4B
Celery,
juice
5.000000
1.000
1.000
12000900
12
Cherry
1.000000
1.000
1.000
12000901
12
Cherry­
babyfood
1.000000
1.000
1.000
12000910
12
Cherry,
juice
1.000000
1.500
1.000
12000911
12
Cherry,
juice­
babyfood
1.000000
1.500
1.000
06030980
6C
Chickpea,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030981
6C
Chickpea,
seed­
babyfood
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030990
6C
Chickpea,
flour
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
15001200
15
Corn,
field,
flour
0.100000
1.000
1.000
15001201
15
Corn,
field,
flour­
babyfood
0.100000
1.000
1.000
15001210
15
Corn,
field,
meal
0.100000
1.000
1.000
15001211
15
Corn,
field,
meal­
babyfood
0.100000
1.000
1.000
15001220
15
Corn,
field,
bran
0.100000
1.000
1.000
15001230
15
Corn,
field,
starch
0.100000
1.000
1.000
15001231
15
Corn,
field,
starch­
babyfood
0.100000
1.000
1.000
15001240
15
Corn,
field,
syrup
0.100000
1.500
1.000
15001241
15
Corn,
field,
syrup­
babyfood
0.100000
1.500
1.000
15001250
15
Corn,
field,
oil
0.100000
1.000
1.000
15001251
15
Corn,
field,
oil­
babyfood
0.100000
1.000
1.000
15001260
15
Corn,
pop
0.100000
1.000
1.000
15001270
15
Corn,
sweet
0.100000
1.000
1.000
15001271
15
Corn,
sweet­
babyfood
0.100000
1.000
1.000
95001300
O
Cranberry
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
95001301
O
Cranberry­
babyfood
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
95001310
O
Cranberry,
dried
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
95001320
O
Cranberry,
juice
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
95001321
O
Cranberry,
juice­
babyfood
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
23001690
M
Goat,
meat
0.100000
1.000
1.000
23001700
M
Goat,
meat
byproducts
0.100000
1.000
1.000
23001710
M
Goat,
fat
0.100000
1.000
1.000
23001720
M
Goat,
kidney
2.000000
1.000
1.000
23001730
M
Goat,
liver
2.000000
1.000
1.000
06031820
6C
Guar,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06031821
6C
Guar,
seed­
babyfood
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
24001890
M
Horse,
meat
0.100000
1.000
1.000
06032030
6C
Lentil,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
27002220
D
Milk,
fat
0.050000
1.000
1.000
27002221
D
Milk,
fat
­
baby
food/
infant
for
0.050000
1.000
1.000
27012230
D
Milk,
nonfat
solids
0.050000
1.000
1.000
27012231
D
Milk,
nonfat
solids­
baby
food/
in
0.050000
1.000
1.000
27022240
D
Milk,
water
0.050000
1.000
1.000
27022241
D
Milk,
water­
babyfood/
infant
form
0.050000
1.000
1.000
27032251
D
Milk,
sugar
(
lactose)­
baby
food/
0.050000
1.000
1.000
95002280
O
Mushroom
0.100000
1.000
1.000
12002300
12
Nectarine
1.000000
1.000
1.000
15002310
15
Oat,
bran
0.100000
1.000
1.000
15002320
15
Oat,
flour
0.100000
1.000
1.000
15002321
15
Oat,
flour­
babyfood
0.100000
1.000
1.000
15002330
15
Oat,
groats/
rolled
oats
0.100000
1.000
1.000
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
20
of
20
15002331
15
Oat,
groats/
rolled
oats­
babyfood
0.100000
1.000
1.000
12002600
12
Peach
1.000000
1.000
1.000
12002601
12
Peach­
babyfood
1.000000
1.000
1.000
12002610
12
Peach,
dried
1.000000
7.000
1.000
12002611
12
Peach,
dried­
babyfood
1.000000
7.000
1.000
12002620
12
Peach,
juice
1.000000
1.000
1.000
12002621
12
Peach,
juice­
babyfood
1.000000
1.000
1.000
95002630
O
Peanut
0.200000
1.000
1.000
95002640
O
Peanut,
butter
0.200000
1.890
1.000
95002650
O
Peanut,
oil
0.200000
1.000
1.000
14002690
14
Pecan
0.100000
1.000
1.000
95002750
O
Peppermint
0.300000
1.000
1.000
95002760
O
Peppermint,
oil
0.300000
1.000
1.000
95002790
O
Pineapple
0.100000
1.000
1.000
95002791
O
Pineapple­
babyfood
0.100000
1.000
1.000
95002800
O
Pineapple,
dried
0.100000
5.000
1.000
95002810
O
Pineapple,
juice
0.100000
1.700
1.000
95002811
O
Pineapple,
juice­
babyfood
0.100000
1.700
1.000
95002830
O
Plantain
0.200000
1.000
1.000
95002840
O
Plantain,
dried
0.200000
3.900
1.000
12002850
12
Plum
1.000000
1.000
1.000
12002851
12
Plum­
babyfood
1.000000
1.000
1.000
12002860
12
Plum,
prune,
fresh
1.000000
1.000
1.000
12002861
12
Plum,
prune,
fresh­
babyfood
1.000000
1.000
1.000
12002870
12
Plum,
prune,
dried
1.000000
5.000
1.000
12002871
12
Plum,
prune,
dried­
babyfood
1.000000
5.000
1.000
12002880
12
Plum,
prune,
juice
1.000000
1.400
1.000
12002881
12
Plum,
prune,
juice­
babyfood
1.000000
1.400
1.000
25002900
M
Pork,
meat
0.100000
1.000
1.000
25002901
M
Pork,
meat­
babyfood
0.100000
1.000
1.000
25002910
M
Pork,
skin
0.100000
1.000
1.000
25002920
M
Pork,
meat
byproducts
0.100000
1.000
1.000
25002921
M
Pork,
meat
byproducts­
babyfood
0.100000
1.000
1.000
25002930
M
Pork,
fat
0.100000
1.000
1.000
25002931
M
Pork,
fat­
babyfood
0.100000
1.000
1.000
25002940
M
Pork,
kidney
2.000000
1.000
1.000
25002950
M
Pork,
liver
2.000000
1.000
1.000
15003230
15
Rice,
white
0.300000
1.000
1.000
15003231
15
Rice,
white­
babyfood
0.300000
1.000
1.000
15003240
15
Rice,
brown
0.300000
1.000
1.000
15003241
15
Rice,
brown­
babyfood
0.300000
1.000
1.000
15003250
15
Rice,
flour
0.300000
1.000
1.000
15003251
15
Rice,
flour­
babyfood
0.300000
1.000
1.000
15003260
15
Rice,
bran
1.000000
1.000
1.000
New
To
Full
comment:
New
Tolerance/
Rice
Processing
Study
15003261
15
Rice,
bran­
babyfood
1.000000
1.000
1.000
New
To
Full
comment:
New
Tolerance/
Rice
Processing
Study
15003280
15
Rye,
grain
0.300000
1.000
1.000
15003290
15
Rye,
flour
0.300000
1.000
1.000
26003390
M
Sheep,
meat
0.100000
1.000
1.000
26003391
M
Sheep,
meat­
babyfood
0.100000
1.000
1.000
26003400
M
Sheep,
meat
byproducts
0.100000
1.000
1.000
26003410
M
Sheep,
fat
0.100000
1.000
1.000
26003411
M
Sheep,
fat­
babyfood
0.100000
1.000
1.000
26003420
M
Sheep,
kidney
2.000000
1.000
1.000
26003430
M
Sheep,
liver
2.000000
1.000
1.000
15003440
15
Sorghum,
grain
0.200000
1.000
1.000
Exp
6/
Full
comment:
Exp
6/
30/
05
15003450
15
Sorghum,
syrup
0.200000
1.000
1.000
Exp
6/
Full
comment:
Exp
6/
30/
05
06003470
6
Soybean,
seed
0.500000
1.000
1.000
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
21
of
20
06003480
6
Soybean,
flour
0.500000
1.000
1.000
06003481
6
Soybean,
flour­
babyfood
0.500000
1.000
1.000
06003490
6
Soybean,
soy
milk
0.500000
1.000
1.000
06003491
6
Soybean,
soy
milk­
babyfood
or
in
0.500000
1.000
1.000
06003500
6
Soybean,
oil
0.500000
1.000
1.000
06003501
6
Soybean,
oil­
babyfood
0.500000
1.000
1.000
95003520
O
Spearmint
0.300000
1.000
1.000
95003530
O
Spearmint,
oil
0.300000
1.000
1.000
86010000
O
Water,
direct,
all
sources
0.086400
1.000
1.000
Per
Ja
Full
comment:
Per
James
Lin
email
of
6/
6/
06
86020000
O
Water,
indirect,
all
sources
0.086400
1.000
1.000
Per
Ja
Full
comment:
Per
James
Lin
email
of
6/
6/
06
15004010
15
Wheat,
grain
0.300000
1.000
1.000
15004011
15
Wheat,
grain­
babyfood
0.300000
1.000
1.000
15004020
15
Wheat,
flour
0.300000
1.000
1.000
15004021
15
Wheat,
flour­
babyfood
0.300000
1.000
1.000
15004030
15
Wheat,
germ
0.300000
1.000
1.000
15004040
15
Wheat,
bran
1.000000
1.000
1.000
15004050
15
Wild
rice
0.500000
1.000
1.000
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
22
of
20
Attachment
2.
Acute
Results
file.

U.
S.
Environmental
Protection
Agency
Ver.
2.02
DEEM­
FCID
ACUTE
Analysis
for
PROPICONAZOLE
(
1994­
98
data)
Residue
file:
acute122101RevH2Onumbers.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date:
06­
19­
2006/
11:
50:
19
Residue
file
dated:
06­
19­
2006/
11:
39:
20/
8
Daily
totals
for
food
and
foodform
consumption
used.
Run
Comment:
"
Acute
for
general
popn
­
0.3
(
including
females
now)"
===============================================================================

Summary
calculations
(
per
capita):

95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
%
aRfD
Exposure
%
aRfD
Exposure
%
aRfD
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
­­­­­­­­­­
­­­­­­­­
U.
S.
Population:
0.009652
3.22
0.015946
5.32
0.027984
9.33
Hispanics:
0.011998
4.00
0.019577
6.53
0.033612
11.20
Non­
hispanic
whites:
0.009094
3.03
0.014873
4.96
0.025933
8.64
Non­
hispanic
blacks:
0.010270
3.42
0.016660
5.55
0.030254
10.08
Non­
hisp/
non­
white/
non­
black:
0.011084
3.69
0.017377
5.79
0.045799
15.27
All
infants:
0.023517
7.84
0.031089
10.36
0.046934
15.64
Nursing
infants
(<
1
yr
old):
0.016513
5.50
0.027602
9.20
0.034885
11.63
Females
13+
(
preg/
not
nursing):
0.007523
2.51
0.010287
3.43
0.011465
3.82
Females
13+
(
nursing):
0.008392
2.80
0.010126
3.38
0.010737
3.58
Children
1­
2
yrs:
0.018429
6.14
0.029355
9.79
0.059078
19.69
Children
3­
5
yrs:
0.015561
5.19
0.022094
7.36
0.035971
11.99
Children
6­
12
yrs:
0.010740
3.58
0.016779
5.59
0.026908
8.97
Youth
13­
19
yrs:
0.007004
2.33
0.011073
3.69
0.017934
5.98
Adults
20­
49
yrs:
0.007303
2.43
0.010901
3.63
0.017921
5.97
Adults
50+
yrs:
0.007000
2.33
0.010294
3.43
0.016047
5.35
Females
13­
49
yrs:
0.007250
2.42
0.010761
3.59
0.015968
5.32
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
23
of
20
Attachment
3.
Chronic
Food
plus
Water
Residue
Input
file.

Filename:
C:\
Documents
and
Settings\
ydonovan\
DEEM
Files\
122101RevisedWaterNumbers\
chronic122101RevH2Onumbers.
R98
Chemical:
Propiconazole
RfD(
Chronic):
.1
mg/
kg
bw/
day
NOEL(
Chronic):
0
mg/
kg
bw/
day
RfD(
Acute):
.3
mg/
kg
bw/
day
NOEL(
Acute):
0
mg/
kg
bw/
day
Date
created/
last
modified:
06­
19­
2006/
13:
49:
04/
8
Program
ver.
2.03
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
EPA
Crop
Def
Res
Adj.
Factors
Comment
Code
Grp
Commodity
Name
(
ppm)
#
1
#
2
­­­­­­­­
­­­­
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­
­­­­­­
­­­­­­­
12000120
12
Apricot
1.000000
1.000
1.000
12000121
12
Apricot­
babyfood
1.000000
1.000
1.000
12000130
12
Apricot,
dried
1.000000
6.000
1.000
12000140
12
Apricot,
juice
1.000000
1.000
1.000
12000141
12
Apricot,
juice­
babyfood
1.000000
1.000
1.000
95000230
O
Banana
0.200000
1.000
1.000
95000231
O
Banana­
babyfood
0.200000
1.000
1.000
95000240
O
Banana,
dried
0.200000
3.900
1.000
95000241
O
Banana,
dried­
babyfood
0.200000
3.900
1.000
15000250
15
Barley,
pearled
barley
0.300000
1.000
1.000
15000251
15
Barley,
pearled
barley­
babyfood
0.300000
1.000
1.000
15000260
15
Barley,
flour
0.300000
1.000
1.000
15000261
15
Barley,
flour­
babyfood
0.300000
1.000
1.000
15000270
15
Barley,
bran
0.300000
1.000
1.000
06030300
6C
Bean,
black,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030320
6C
Bean,
broad,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030340
6C
Bean,
cowpea,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030350
6C
Bean,
great
northern,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030360
6C
Bean,
kidney,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030380
6C
Bean,
lima,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030390
6C
Bean,
mung,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030400
6C
Bean,
navy,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030410
6C
Bean,
pink,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030420
6C
Bean,
pinto,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
21000440
M
Beef,
meat
0.100000
1.000
1.000
21000441
M
Beef,
meat­
babyfood
0.100000
1.000
1.000
21000450
M
Beef,
meat,
dried
0.100000
1.920
1.000
21000460
M
Beef,
meat
byproducts
0.100000
1.000
1.000
21000461
M
Beef,
meat
byproducts­
babyfood
0.100000
1.000
1.000
21000470
M
Beef,
fat
0.100000
1.000
1.000
21000471
M
Beef,
fat­
babyfood
0.100000
1.000
1.000
21000480
M
Beef,
kidney
2.000000
1.000
1.000
21000490
M
Beef,
liver
2.000000
1.000
1.000
21000491
M
Beef,
liver­
babyfood
2.000000
1.000
1.000
13020570
13B
Blueberry
1.000000
1.000
1.000
13020571
13B
Blueberry­
babyfood
1.000000
1.000
1.000
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
24
of
20
04020850
4B
Celery
5.000000
1.000
1.000
04020851
4B
Celery­
babyfood
5.000000
1.000
1.000
04020860
4B
Celery,
juice
5.000000
1.000
1.000
12000900
12
Cherry
1.000000
1.000
1.000
12000901
12
Cherry­
babyfood
1.000000
1.000
1.000
12000910
12
Cherry,
juice
1.000000
1.500
1.000
12000911
12
Cherry,
juice­
babyfood
1.000000
1.500
1.000
06030980
6C
Chickpea,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030981
6C
Chickpea,
seed­
babyfood
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06030990
6C
Chickpea,
flour
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
15001200
15
Corn,
field,
flour
0.100000
1.000
1.000
15001201
15
Corn,
field,
flour­
babyfood
0.100000
1.000
1.000
15001210
15
Corn,
field,
meal
0.100000
1.000
1.000
15001211
15
Corn,
field,
meal­
babyfood
0.100000
1.000
1.000
15001220
15
Corn,
field,
bran
0.100000
1.000
1.000
15001230
15
Corn,
field,
starch
0.100000
1.000
1.000
15001231
15
Corn,
field,
starch­
babyfood
0.100000
1.000
1.000
15001240
15
Corn,
field,
syrup
0.100000
1.500
1.000
15001241
15
Corn,
field,
syrup­
babyfood
0.100000
1.500
1.000
15001250
15
Corn,
field,
oil
0.100000
1.000
1.000
15001251
15
Corn,
field,
oil­
babyfood
0.100000
1.000
1.000
15001260
15
Corn,
pop
0.100000
1.000
1.000
15001270
15
Corn,
sweet
0.100000
1.000
1.000
15001271
15
Corn,
sweet­
babyfood
0.100000
1.000
1.000
95001300
O
Cranberry
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
95001301
O
Cranberry­
babyfood
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
95001310
O
Cranberry,
dried
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
95001320
O
Cranberry,
juice
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
95001321
O
Cranberry,
juice­
babyfood
1.000000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
23001690
M
Goat,
meat
0.100000
1.000
1.000
23001700
M
Goat,
meat
byproducts
0.100000
1.000
1.000
23001710
M
Goat,
fat
0.100000
1.000
1.000
23001720
M
Goat,
kidney
2.000000
1.000
1.000
23001730
M
Goat,
liver
2.000000
1.000
1.000
06031820
6C
Guar,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
06031821
6C
Guar,
seed­
babyfood
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
24001890
M
Horse,
meat
0.100000
1.000
1.000
06032030
6C
Lentil,
seed
0.500000
1.000
1.000
Exp
12
Full
comment:
Exp
12/
31/
05
27002220
D
Milk,
fat
0.050000
1.000
1.000
27002221
D
Milk,
fat
­
baby
food/
infant
for
0.050000
1.000
1.000
27012230
D
Milk,
nonfat
solids
0.050000
1.000
1.000
27012231
D
Milk,
nonfat
solids­
baby
food/
in
0.050000
1.000
1.000
27022240
D
Milk,
water
0.050000
1.000
1.000
27022241
D
Milk,
water­
babyfood/
infant
form
0.050000
1.000
1.000
27032251
D
Milk,
sugar
(
lactose)­
baby
food/
0.050000
1.000
1.000
95002280
O
Mushroom
0.100000
1.000
1.000
12002300
12
Nectarine
1.000000
1.000
1.000
15002310
15
Oat,
bran
0.100000
1.000
1.000
15002320
15
Oat,
flour
0.100000
1.000
1.000
15002321
15
Oat,
flour­
babyfood
0.100000
1.000
1.000
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
25
of
20
15002330
15
Oat,
groats/
rolled
oats
0.100000
1.000
1.000
15002331
15
Oat,
groats/
rolled
oats­
babyfood
0.100000
1.000
1.000
12002600
12
Peach
1.000000
1.000
1.000
12002601
12
Peach­
babyfood
1.000000
1.000
1.000
12002610
12
Peach,
dried
1.000000
7.000
1.000
12002611
12
Peach,
dried­
babyfood
1.000000
7.000
1.000
12002620
12
Peach,
juice
1.000000
1.000
1.000
12002621
12
Peach,
juice­
babyfood
1.000000
1.000
1.000
95002630
O
Peanut
0.200000
1.000
1.000
95002640
O
Peanut,
butter
0.200000
1.890
1.000
95002650
O
Peanut,
oil
0.200000
1.000
1.000
14002690
14
Pecan
0.100000
1.000
1.000
95002750
O
Peppermint
0.300000
1.000
1.000
95002760
O
Peppermint,
oil
0.300000
1.000
1.000
95002790
O
Pineapple
0.100000
1.000
1.000
95002791
O
Pineapple­
babyfood
0.100000
1.000
1.000
95002800
O
Pineapple,
dried
0.100000
5.000
1.000
95002810
O
Pineapple,
juice
0.100000
1.700
1.000
95002811
O
Pineapple,
juice­
babyfood
0.100000
1.700
1.000
95002830
O
Plantain
0.200000
1.000
1.000
95002840
O
Plantain,
dried
0.200000
3.900
1.000
12002850
12
Plum
1.000000
1.000
1.000
12002851
12
Plum­
babyfood
1.000000
1.000
1.000
12002860
12
Plum,
prune,
fresh
1.000000
1.000
1.000
12002861
12
Plum,
prune,
fresh­
babyfood
1.000000
1.000
1.000
12002870
12
Plum,
prune,
dried
1.000000
5.000
1.000
12002871
12
Plum,
prune,
dried­
babyfood
1.000000
5.000
1.000
12002880
12
Plum,
prune,
juice
1.000000
1.400
1.000
12002881
12
Plum,
prune,
juice­
babyfood
1.000000
1.400
1.000
25002900
M
Pork,
meat
0.100000
1.000
1.000
25002901
M
Pork,
meat­
babyfood
0.100000
1.000
1.000
25002910
M
Pork,
skin
0.100000
1.000
1.000
25002920
M
Pork,
meat
byproducts
0.100000
1.000
1.000
25002921
M
Pork,
meat
byproducts­
babyfood
0.100000
1.000
1.000
25002930
M
Pork,
fat
0.100000
1.000
1.000
25002931
M
Pork,
fat­
babyfood
0.100000
1.000
1.000
25002940
M
Pork,
kidney
2.000000
1.000
1.000
25002950
M
Pork,
liver
2.000000
1.000
1.000
15003230
15
Rice,
white
0.300000
1.000
1.000
15003231
15
Rice,
white­
babyfood
0.300000
1.000
1.000
15003240
15
Rice,
brown
0.300000
1.000
1.000
15003241
15
Rice,
brown­
babyfood
0.300000
1.000
1.000
15003250
15
Rice,
flour
0.300000
1.000
1.000
15003251
15
Rice,
flour­
babyfood
0.300000
1.000
1.000
15003260
15
Rice,
bran
1.000000
1.000
1.000
New
To
Full
comment:
New
Tolerance/
Rice
Processing
Study
15003261
15
Rice,
bran­
babyfood
1.000000
1.000
1.000
New
To
Full
comment:
New
Tolerance/
Rice
Processing
Study
15003280
15
Rye,
grain
0.300000
1.000
1.000
15003290
15
Rye,
flour
0.300000
1.000
1.000
26003390
M
Sheep,
meat
0.100000
1.000
1.000
26003391
M
Sheep,
meat­
babyfood
0.100000
1.000
1.000
26003400
M
Sheep,
meat
byproducts
0.100000
1.000
1.000
26003410
M
Sheep,
fat
0.100000
1.000
1.000
26003411
M
Sheep,
fat­
babyfood
0.100000
1.000
1.000
26003420
M
Sheep,
kidney
2.000000
1.000
1.000
26003430
M
Sheep,
liver
2.000000
1.000
1.000
15003440
15
Sorghum,
grain
0.200000
1.000
1.000
Exp
6/
Full
comment:
Exp
6/
30/
05
15003450
15
Sorghum,
syrup
0.200000
1.000
1.000
Exp
6/
Full
comment:
Exp
6/
30/
05
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
26
of
20
06003470
6
Soybean,
seed
0.500000
1.000
1.000
06003480
6
Soybean,
flour
0.500000
1.000
1.000
06003481
6
Soybean,
flour­
babyfood
0.500000
1.000
1.000
06003490
6
Soybean,
soy
milk
0.500000
1.000
1.000
06003491
6
Soybean,
soy
milk­
babyfood
or
in
0.500000
1.000
1.000
06003500
6
Soybean,
oil
0.500000
1.000
1.000
06003501
6
Soybean,
oil­
babyfood
0.500000
1.000
1.000
95003520
O
Spearmint
0.300000
1.000
1.000
95003530
O
Spearmint,
oil
0.300000
1.000
1.000
86010000
O
Water,
direct,
all
sources
0.037520
1.000
1.000
Per
Ja
Full
comment:
Per
James
Lin
email
6/
6/
06
Turf
in
PA
86020000
O
Water,
indirect,
all
sources
0.037520
1.000
1.000
Per
Ja
Full
comment:
Per
James
Lin
email
6/
6/
06
Turf
in
PA
15004010
15
Wheat,
grain
0.300000
1.000
1.000
15004011
15
Wheat,
grain­
babyfood
0.300000
1.000
1.000
15004020
15
Wheat,
flour
0.300000
1.000
1.000
15004021
15
Wheat,
flour­
babyfood
0.300000
1.000
1.000
15004030
15
Wheat,
germ
0.300000
1.000
1.000
15004040
15
Wheat,
bran
1.000000
1.000
1.000
15004050
15
Wild
rice
0.500000
1.000
1.000
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
27
of
20
Attachment
4.
Chronic
Results
file.

U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
PROPICONAZOLE
(
1994­
98
data)
Residue
file
name:
C:\
Documents
and
Settings\
ydonovan\
DEEM
Files\
122101RevisedWaterNumbers\
chronic122101RevH2Onumbers.
R98
Adjustment
factor
#
2
NOT
used.
Analysis
Date
06­
19­
2006/
13:
52:
27
Residue
file
dated:
06­
19­
2006/
13:
49:
04/
8
Reference
dose
(
RfD,
Chronic)
=
.1
mg/
kg
bw/
day
NOEL
(
Chronic)
=
10
mg/
kg
bw/
day
===============================================================================
Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Population
mg/
kg
Margin
of
Percent
Subgroup
body
wt/
day
Exposure
1/
of
RfD
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­
­­­­­­­­­
U.
S.
Population
(
total)
0.003113
3,212
3.1%

U.
S.
Population
(
spring
season)
0.003106
3,220
3.1%
U.
S.
Population
(
summer
season)
0.003241
3,085
3.2%
U.
S.
Population
(
autumn
season)
0.003047
3,282
3.0%
U.
S.
Population
(
winter
season)
0.003058
3,270
3.1%

Northeast
region
0.003091
3,235
3.1%
Midwest
region
0.003205
3,121
3.2%
Southern
region
0.002855
3,502
2.9%
Western
region
0.003444
2,904
3.4%

Hispanics
0.003550
2,817
3.5%
Non­
hispanic
whites
0.003048
3,280
3.0%
Non­
hispanic
blacks
0.002891
3,459
2.9%
Non­
hisp/
non­
white/
non­
black
0.003766
2,655
3.8%

All
infants
(<
1
year)
0.006597
1,516
6.6%
Nursing
infants
0.002927
3,417
2.9%
Non­
nursing
infants
0.007990
1,252
8.0%
Children
1­
6
yrs
0.006751
1,481
6.8%
Children
7­
12
yrs
0.004082
2,450
4.1%

Females
13­
19
(
not
preg
or
nursing)
0.002394
4,178
2.4%
Females
20+
(
not
preg
or
nursing)
0.002442
4,095
2.4%
Females
13­
50
yrs
0.002615
3,825
2.6%
Females
13+
(
preg/
not
nursing)
0.002854
3,504
2.9%
Females
13+
(
nursing)
0.003111
3,215
3.1%

Males
13­
19
yrs
0.002845
3,515
2.8%
Males
20+
yrs
0.002553
3,917
2.6%
Seniors
55+
0.002503
3,994
2.5%

Children
1­
2
yrs
0.007753
1,290
7.8%
Children
3­
5
yrs
0.006464
1,547
6.5%
Children
6­
12
yrs
0.004314
2,318
4.3%
Youth
13­
19
yrs
0.002627
3,807
2.6%
Adults
20­
49
yrs
0.002510
3,983
2.5%
Adults
50+
yrs
0.002490
4,016
2.5%
Propiconazole
Dietary
Exposure
Assessment
DP
Barcode:
D329667
PC
Code:
122101
Page:
28
of
20
Females
13­
49
yrs
0.002434
4,108
2.4%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
