Document ID: EPA-HQ-OPP-2006-0347-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-09-22T04:00Z

Page
1
of
55
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
August
15,
2006
SUBJECT:
Propiconazole:
FQPA
Human
Health
Risk
Assessment
for
New
Uses
on
Various
Crops.
PP#
2F6371,
6E4788,
7E4860,
and
8E4931.
PC
Code:
122101.
DP
Barcode
D319598,
313963,
313965,
313967,
325817,
234716.

FROM:
Yan
Donovan,
Chemist
and
Risk
Assessor
Reregistration
Branch
4
Health
Effects
Division
(
7509C)

And
Abdallah
Khasawinah,
Toxicologist
James
Miller,
Environmental
Scientist
Reregistration
Branch
4
Health
Effects
Division
(
7509C))

THROUGH:
Susan
Hummel,
Senior
Scientist,
Reregistration
Branch
4
Richard
Loranger,
Senior
Scientist,
Registration
Branch
2
Health
Effects
Division
(
7509C)

TO:
Mary
Waller/
Cynthia
Giles­
Parker
Fungicide
Branch
Registration
Division
Attached
is
the
Health
Effect
Division's
(
HED's)
human
health
risk
assessment
for
propiconazole
new
and
revised
uses.
Propiconazole
is
among
the
group
of
chemicals,
which
generate
common
metabolite,
called
1,2,4­
triazole
and
its
conjugates
triazole
alanine
and
triazole
acetic
acid.
A
separate
document
is
available
to
address
the
common
metabolite
risk
issue
(
HED
memo
of
M.
Doherty,
2/
7/
06,
D322215).
1,2,4­
triazole
and
its
conjugates
will
not
be
further
discussed
in
this
document
other
than
the
data
needs
in
Section
10.
There
are
antimicrobial
uses
for
propiconazole
as
well.
Antimicrobial
Division
(
AD)
has
conducted
a
risk
assessment
for
all
existing
and
potential
antimicrobial
uses.
The
present
aggregate
risk
assessment
includes
the
Page
2
of
55
risks
from
antimicrobial
uses
in
mushroom
houses
(
dietary)
and
in
treated
wood
in
play
sets
and
residential
decks
(
residential
post­
application
exposure).

The
Team
Reviewers
who
contributed
to
the
disciplinary
chapters
and
the
references
are
listed
below.

1)
Propiconazole:
Phase
4,
HED
Chapter
of
the
Re­
registration
Eligibility
Decision
Document
(
RED),
Yan
Donovan,
6/
28/
06,
D329668;

2)
Residue
Chemistry
Summary
Document;
Yan
Donovan
(
D238458,
7/
31/
2006);

3)
Occupational
and
Residential
Exposure
Assessment;
James
Miller,
Environmental
Scientist
(
D325817,
6/
15/
06);

4)
Revised
Occupational
and
Residential
Exposure
Assessment
of
the
Antimicrobial
Uses;
Tim
Leighton
(
D324052,
02/
01/
06);

5)
Amendment
to
the
Propiconazole
RED
for
Children's
Post­
application
Exposure
from
Treated
Structures;
Tim
Leighton
(
D330159,
06/
20/
06);

6)
Dietary
Exposure
and
Risk
Assessment
for
New
uses;
Yan
Donovan
(
D312278,
8/
15/
06);

7)
Drinking
Water
Assessment;
James
Lin
from
EFED
(
D325821,
07
/
07/
06).
Page
3
of
55
TABLE
OF
CONTENTS
1.0
Executive
Summary............................................................................................
5
2.0
Ingredient
Profile
................................................................................................
8
2.1.
Summary
of
Registered/
Proposed
Uses
................................................................................................
8
2.2
Structure
and
Nomenclature
...............................................................................................................
11
2.3
Physical
and
Chemical
Properties.......................................................................................................
12
3.0
Metabolism
Assessment
..................................................................................
13
3.1
Comparative
Metabolic
Profile...........................................................................................................
13
3.2
Nature
of
the
Residue
in
Foods...........................................................................................................
14
3.2.1.
Description
of
Primary
Crop
Metabolism
..................................................................................
14
3.2.2
Description
of
Livestock
Metabolism..........................................................................................
14
3.2.3
Description
of
Rotational
Crop
Metabolism,
including
identification
of
major
metabolites
and
specific
routes
of
biotransformation.
.........................................................................................
15
3.3
Environmental
Degradation................................................................................................................
15
3.4
Tabular
Summary
of
Metabolites
and
Degradates
...............................................................................
15
3.5
Toxicity
Profile
of
Major
Metabolites
and
Degradates
........................................................................
20
3.6
Summary
of
Residues
for
Tolerance
Expression
and
Risk
Assessment
................................................
20
3.6.1
Tabular
Summary
.......................................................................................................................
20
3.6.2
Rationale
for
Inclusion
of
Metabolites
and
Degradates..............................................................
20
4.0
Hazard
Characterization/
Assessment.............................................................
21
4.1
Hazard
Characterization.....................................................................................................................
21
4.2
FQPA
Hazard
Considerations.............................................................................................................
22
4.3
Hazard
Identification
and
Toxicity
Endpoint
Selection........................................................................
22
4.4
Special
FQPA
Safety
Factor
...............................................................................................................
25
4.5
Endocrine
Disruption
.........................................................................................................................
25
5.0
PUBLIC
HEALTH
DATA....................................................................................
26
5.1
Incident
Reports.................................................................................................................................
26
6.0
Exposure
Characterization/
Assessment
............................................................
26
Page
4
of
55
6.1
Dietary
Exposure/
Risk
Pathway
.........................................................................................................
26
6.1.1
Residue
Profile.............................................................................................................................
26
6.1.2
Acute
and
Chronic
Dietary
Exposure
and
Risk..........................................................................
30
6.2
Water
Exposure/
Risk
Pathway
...........................................................................................................
31
6.3
Residential
(
Non­
Occupational)
Exposure/
Risk
Pathway
....................................................................
32
7.0
Aggregate
Risk
Assessments
and
Risk
Characterization.............................
34
7.1
Acute
Aggregate
Risk
........................................................................................................................
35
7.2
Short­
Term
Aggregate
Risk................................................................................................................
35
7.3
Intermediate­
Term
Aggregate
Risk.....................................................................................................
37
7.4
Long­
Term
Aggregate
Risk................................................................................................................
38
7.5
Cancer
Risk
.......................................................................................................................................
38
8.0
Cumulative
Risk
Characterization/
Assessment
.............................................
38
9.0
Occupational
Exposure/
Risk
Pathway............................................................
39
9.1
Short/
Intermediate/
Long­
Term
Handler
Risk......................................................................................
39
9.2
Short/
Intermediate/
Long­
Term
Postapplication
Risk...........................................................................
42
10.0
Data
Needs
and
Label
Requirements..............................................................
44
10.1
Residue
Chemistry
Data
Needs
..........................................................................................................
45
10.2
ORE
Data
Needs................................................................................................................................
46
10.3
Toxicology
Data
Needs
.....................................................................................................................
46
Page
5
of
55
1.0
EXECUTIVE
SUMMARY
Syngenta
Crop
Protection
(
Syngenta)
and
Interregional
Research
Project
No.
4
(
IR­
4)
have
submitted
several
petitions
supporting
new
or
amended
uses
on
various
crops
for
propiconazole,
formulated
as
a
3.6
lb/
gal
emulsifiable
concentrate
(
EC)
or
a
45%
wettable
powder
(
WP).
The
proposed
uses
are
for
broadcast
foliar
applications
using
ground
or
aerial
equipment
at
rates
ranging
from
0.11
to
0.28
lb
ai/
A/
application.
For
tree
nuts,
the
proposed
use
is
for
up
to
four
foliar
applications
at
0.225
lb
ai/
A,
for
a
total
of
0.90
lb
ai/
A,
with
a
60­
day
preharvest
interval
(
PHI).
For
bush
and
cane
berries
and
cranberries,
the
proposed
uses
are
for
4
or
5
foliar
applications
at
0.17
lb
ai/
A,
for
totals
of
0.68­
0.84
lb
ai/
A,
with
PHIs
of
30
or
45
days.
For
carrots,
leaf
petiole
vegetables,
dry
peas
and
beans,
sugar
beets
and
strawberries,
the
proposed
uses
are
for
3
or
4
broadcast
foliar
applications
at
0.11
lb
ai/
A,
for
totals
of
0.34
or
0.45
lb
ai/
A,
with
PHIs
of
0
to
21
days.
For
mint,
the
proposed
use
is
for
two
broadcast
foliar
applications
at
0.113
lb
ai/
A,
for
a
total
of
0.225
ai/
A,
with
a
PHI
of
30
days.
For
soybeans,
the
proposed
use
is
for
two
broadcast
foliar
applications
at
0.169
lb
ai/
A
at
up
to
growth
stage
R6,
for
a
total
of
0.338
ai/
A,
with
a
PHI
of
30
days.
For
rice,
the
proposed
use
is
for
a
single
application
or
split
applications
at
heading
totaling
~
0.30
lb
ai/
A,
with
a
PHI
of
35
days.
For
other
cereal
grains,
the
proposed
uses
are
for
2
to
4
broadcast
foliar
applications
at
0.113
lb
ai/
A
up
to
heading
or
grain
development,
for
totals
of
0.22
or
0.45
ai/
A,
with
PHIs
of
14­
45
days.
In
conjunction
with
these
uses,
Syngenta
and
IR­
4
are
proposing
permanent
tolerances
for
propiconazole
residues
in/
on
various
plant
commodities
at
levels
ranging
from
0.1
ppm
on
alfalfa
to
32
ppm
on
soybean
hay.

Propiconazole
is
a
member
of
the
class
of
the
ergosterol
biosynthesis
inhibiting
fungicides.
The
mode
of
antifungal
action
of
propiconazole
is
attributed
to
the
inhibition
of
CYP51
(
lanosterol­
14­
a­
demethylase).
Propiconazole
has
low
to
moderate
toxicity
in
experimental
animals
by
the
oral,
dermal
and
inhalation
routes,
is
moderately
irritating
to
the
eyes,
and
minimally
irritating
to
the
skin,
and
it
is
a
dermal
sensitizer.
The
primary
target
organ
for
propiconazole
toxicity
in
animals
is
the
liver.
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.
For
the
scenarios
associated
with
the
new
uses,
HED
concludes
that
the
endpoints
selected
by
HIARC
are
still
appropriate.

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
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.
There
fore,
the
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
(
female
age
13­
49)
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
Page
6
of
55
the
Agency
and
was
reviewed.
The
study
confirms
that
neurotoxic
signs
are
observed
at
high
doses,
but
without
neuropathological
or
neurobehavioral
effects.
Accordingly,
the
propiconazole
risk
assessment
team
determined
that
a
developmental
neurotoxicity
study
was
not
necessary
and
the
3X
database
uncertainty
factor
for
acute
(
female
13­
49)
and
short­
term
scenarios
was
removed.

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.

Tolerances
are
established
for
residues
of
propiconazole
and
its
metabolites
determined
as
2,4­
dichlorobenzoic
acid,
all
expressed
as
parent
compound
in/
on
various
plant
and
animal
commodities
[
40
CFR
§
180.434].
The
reassessed
tolerances
as
recommended
in
the
HED
RED
will
be
expressed
as
propiconazole
per
se.
As
a
result,
in
some
cases
the
tolerance
levels
will
be
over
estimated,
due
to
the
fact
that
the
analytical
method
for
data
collection
is
a
comment
moiety
method
that
detects
all
residues
convertible
to
2,4­
dichlorobenzoic
acid
(
DCBA),
and
the
field
data
were
reported
as
propiconazole
and
all
its
metabolites
containing
2,4­
DCBA.
As
a
result,
HED
is
unable
to
separate
out
the
parent
residue
from
the
metabolites
at
this
time.
HED
recommends
that
the
registrant
analyze
parent
and
metabolites
separately
in
all
future
field
trials,
so
that
more
realistic
tolerances
can
be
set
in
the
future.

Provided
that
minor
changes
are
made
to
the
proposed
use
directions,
the
available
field
trial
data
on
almonds,
bush
and
cane
berries,
carrots,
celery,
corn,
cranberries,
mint,
onions,
pecans,
rice,
sorghum,
soybeans,
strawberries
and
wheat
are
adequate
and
support
the
proposed
use
patterns
for
propiconazole
(
EC
or
WP)
on
these
crops.
The
number
and
geographic
distribution
of
the
field
trials
are
adequate,
and
the
appropriate
samples
were
collected.
Samples
were
analyzed
using
adequate
analytical
methods
and
the
sample
storage
intervals
are
supported
by
the
available
storage
stability
data.
Side­
by­
side
field
trials
were
conducted
on
almond,
celery,
field
corn,
and
sugar
beets
to
compare
residues
from
the
EC
and
WP
formulation.
These
data
show
residues
are
comparable
from
the
two
products,
with
the
exception
of
sugar
beet
tops
at
the
requested
PHI.
A
conditional
registration
can
be
established
on
sugar
beet
tops.
For
dry
peas
and
beans,
however,
there
are
no
sufficient
field
trial
data
to
support
the
proposed
use.
HED
recommends
against
the
establishment
of
permanent
tolerance
on
crop
subgroup
6C
until
additional
field
trial
data
are
submitted.
The
Agency's
Guidance
for
Setting
Pesticide
Tolerances
Based
on
Field
Trial
Data
(
tolerance
spread
sheet)
was
utilized
for
determining
appropriate
tolerance
levels
on
plant
commodities.

The
estimated
drinking
water
concentrations
from
surface
water
sources
were
calculated
using
Tier
II
PRZM
(
Pesticide
Root
Zone
Model)
and
EXAMS
(
Exposure
Analysis
Modeling
System).
For
each
specific
use,
the
maximum
allowable
label
rate
was
input
to
PE4V01.
The
output
concentrations
were
without
percent
crop
area
(
PCA)
consideration.
The
final
estimated
drinking
water
concentrations
were
then
adjusted
with
the
proper
PCA.
Except
the
uses
of
soybean
(
0.41)
and
wheat
(
0.56),
other
uses
assume
the
default
PCA
of
0.87.
Among
these
modeling
results,
turf
use
gives
the
highest
acute
concentration
of
55.78
ug/
l.
For
the
chronic
exposure,
turf
use
also
gives
the
highest
concentration
of
21.61
ug/
L.
Page
7
of
55
The
estimated
environmental
concentrations
in
ground
water
were
calculated
using
the
Tier
I
SCI­
GROW
(
Screening
Concentration
In
Ground
Water)
model.
SCI­
GROW
is
neither
scenario­
nor
crop­
specific.
The
only
input
requirements
are
application
rate,
number
of
applications,
Koc,
and
aerobic
soil
metabolism
half­
life.
The
higher
estimated
concentrations
are
associated
with
the
higher
rate.
Turf
use
gives
the
highest
concentration
of
0.64
µ
g/
L
(
ppb).

Acute
and
chronic
dietary
analyses
for
propiconazole
were
conducted
using
tolerance
levels
and
100
%
CT
for
all
proposed
new
uses,
revised
uses,
and
existing
uses.
The
results
of
the
analyses
indicate
that
acute
and
chronic
risks
from
the
dietary
exposure
(
food
and
water)
to
propiconazole
do
not
exceed
HED's
level
of
concern
for
the
United
States
population
or
any
population
subgroup.

Although
no
new
residential
use
was
requested
associated
with
the
subject
petitions,
there
are
existing
residential
uses
for
propiconazole.
The
registered
residential
use
patterns
result
in
post
application
dermal
exposures
to
adults,
and
dermal
and
oral
exposures
to
infants
and
children.
These
exposures
are
considered
short
term
only
and
were
previously
assessed
in
HED's
phase
4
RED.
In
addition
to
using
HED's
SOP
for
residential
assessment,
the
turf
transferable
residue
(
TTR)
was
used
in
the
calculation.
The
dermal
and
incidental
oral
exposure
to
infants
and
children
were
combined,
and
all
MOEs
do
not
exceed
HED's
level
of
concern.
Risk
to
children
playing
on
propiconazole­
treated
structures
(
from
antimicrobial
use)
was
also
assessed
using
a
screening
level
assessment.
This
risk
assessment,
based
on
high­
end
screening­
level
assumptions,
indicates
no
risk
of
concern.
Confirmatory
data
for
the
surface
residues
are
needed
to
verify
this
screening­
level
assessment.

Aggregate
risk
assessments
were
conducted
for
acute,
chronic,
short
and
intermediate
term
exposure
duration.
The
risks
do
not
exceed
HED's
level
of
concern.
Acute
aggregate
risk
included
food
and
water
only;
chronic
aggregate
risk
also
included
food
and
water
because
no
chronic
exposure
from
residential
uses
is
expected.
Short­
term
aggregate
risk
included
food,
water,
and
residential/
antimicrobial
exposures.
Intermediate
term
aggregate
risk
included
food,
water,
and
residential
exposure
to
Children
1­
2
years
old
from
treated
wood
used
in
deck
and
play
structures.

The
short­
and
intermediate­
term
occupational
handler
non­
cancer
risk
assessment
for
propiconazole
indicates
that
for
all
commercial/
agricultural
handler
scenarios,
risks
do
not
exceed
HED's
level
of
concern
(
i.
e.,
MOEs
>
100)
with
use
of
chemical­
resistant
gloves.
For
occupational
post­
application
exposures
and
risks,
data
from
propiconazole­
specific
studies
were
used
along
with
crop­
specific
transfer
coefficients.
The
non­
cancer
occupational
postapplication
worker
risk
assessment
indicates
that
risks
do
not
exceed
HED's
level
of
concern
(
i.
e.,
MOEs
>
100)
on
the
day
of
the
treatment
(
day
after
treatment
(
DAT)
=
0).

As
a
conazole
pesticide,
all
propiconazole
new
registrations
should
be
conditional
until
issues
related
to
common
metabolite
risk
are
resolved.
Pending
the
submission
of
label
changes
outlined
in
Section
10.1
under
data
gaps,
HED
recommends
the
establishment
of
permanent
tolerances
for
propiconazole
residues
at
the
levels
recommended
in
the
Table
11.
Registrations
Page
8
of
55
should
be
granted
on
a
conditional
basis
until
the
data
outlined
in
Section
10.0
plus
the
sugar
beet
top
data
in
Section
10.1
are
submitted.

2.0
INGREDIENT
PROFILE
Propiconazole
is
a
systemic
broad­
spectrum
fungicide
registered
for
treatment
of
disease
in
a
variety
of
crops.
It
is
a
member
of
the
class
of
the
ergosterol
biosynthesis
inhibiting
fungicides.
The
mode
of
antifungal
action
of
conazoles
is
attributed
to
the
inhibition
of
CYP51
(
lanosterol­
14­
a­
demethylase).
Propiconazole
end­
use
products
are
marketed
in
the
United
States
under
the
trade
names
Tilt
®
,
Alamo
®
,
Banner
®
,
Orbit
®
,
and
Quilt
TM.
The
amount
of
active
ingredients
in
the
various
formulations
range
from
11.4%
to
45%.
Recently,
propiconazole
is
also
registered
for
use
on
a
variety
of
crops
under
the
trade
names
of
Stratego
 
Twin­
Pak
 
and
Stratego
 
,
which
are
end­
use
products
containing
a
mixture
of
trifloxystrobin
and
propiconazole.
The
propiconazole
formulations
registered
for
food/
feed
uses
include
emulsifiable
concentrate
(
EC)
and
flowable
concentrate
(
FlC)
formulations.

2.1.
Summary
of
Registered/
Proposed
Uses
Table
2.1
summarized
the
new
proposed
agricultural
uses.
Uses
are
based
on
an
example
labels
provided
for
the
EC
formulations
(
1/
14/
05)
and
the
approved
labels
for
the
WP
(
accepted
12/
11/
03)
and
EC
MAI
(
accepted
3/
8/
06).

Table
2.1.
Summary
of
Directions
for
Proposed
Uses
of
Propiconazole.

Application
Timing,
Type
and
Equipment
Formulation
[
EPA
Reg.
No.]
Single
rate
(
Lb
ai/
A)
Max.
#
of
Apps.
per
Season
Max.
Seasonal
Rate
(
lb
ai/
A)
PHI
(
days)
Use
Directions
and
Limitations
1
Almond
Foliar
applications
beginning
at
bud­
break
Ground
or
aerial
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.225
4
0.90
NS
Apply
in
a
minimum
of
20
or
50
gal/
A
using
aerial
and
ground
equipment,
respectively.
Minimum
RTI
is
7
days
Do
not
graze
livestock
in
treated
areas
or
cut
treated
cover
crop
for
feed
Berries
(
Bush
and
Cane
berries)
and
Cranberry
Foliar
applications
beginning
at
bud­
break
or
for
cane
berries
beginning
as
a
delayed
dormant
application
Ground
or
aerial
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.169
5
0.84
30
Apply
in
a
minimum
of
5­
10
or
20­
50
gal/
A
using
aerial
and
ground
equipment,
respectively.
The
minimum
RTI
is
7­
28
days
depending
on
the
disease.

Cranberry
(
For
use
Only
in
Wisconsin
and
the
Pacific
Northwest)
Broadcast
foliar
applications
from
bud
break
to
fruit
set
3.6
lb/
gal
EC
[
100­
702]
0.169
4
0.68
45
Minimum
RTI
is
10
days
Carrots
Broadcast
foliar
applications
when
conditions
favor
disease
development
Ground
or
aerial
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.113
4
0.45
14
Apply
in
a
minimum
of
5
or
15
gal/
A
using
aerial
and
ground
equipment,
respectively.
Minimum
RTI
is
7
days
Application
may
include
spreader­
sticker
Page
9
of
55
Table
2.1.
Summary
of
Directions
for
Proposed
Uses
of
Propiconazole.

Application
Timing,
Type
and
Equipment
Formulation
[
EPA
Reg.
No.]
Single
rate
(
Lb
ai/
A)
Max.
#
of
Apps.
per
Season
Max.
Seasonal
Rate
(
lb
ai/
A)
PHI
(
days)
Use
Directions
and
Limitations
1
Celery
(
Leaf
Petiole
Vegetables,
subgroup
4B)
Broadcast
foliar
applications
when
conditions
favor
disease
development
Ground
or
aerial
equipment
3.6
lb/
gal
EC
[
100­
617]
1.04
lb/
gal
EC
[
100­
1178]
45%
WP
[
100­
780]
0.113
4
0.45
14
Minimum
RTI
is
7
days
Application
may
include
spreader­
sticker
Cereals
(
wheat,
barley,
rye,
triticale
and
oats)
3.6
lb/
gal
EC
[
100­
617]
0.113
2
0.225
30/
35/
45
Do
not
apply
after
Feekes
Stage
10.5
Minimum
RTI
is
14
days.
30­
and
45­
day
PHIs
are
specified
for
forage
and
hay,
respectively,
following
an
application
at
Feekes
Stage
5.
A
general
35­
day
PHI
is
also
specified
for
grazing
or
harvest
of
forage,
hay
and
mature
wheat.
Broadcast
foliar
applications
up
to
Flowering
(
Feekes
Stage
10.5)
Aerial
or
ground
equipment,
including
chemigation
1.04
lb/
gal
EC
[
100­
1178]
0.113
2
0.167
45
Do
not
harvest
wheat
for
forage
and
do
not
graze
or
feed
livestock
treated
forage
or
cut
green
crop
of
hay
or
silage
Broadcast
foliar
applications
up
to
Feekes
Stage
8
Aerial
or
ground
equipment,
including
chemigation
45%
WP
[
100­
780]
0.113
1
0.113
40
Do
not
apply
after
Feekes
Stage
8
Do
not
apply
to
oats
with
40
days
of
harvest.
Except
for
oat
forage
and
hay,
do
not
graze
or
feed
livestock
treated
forage
or
cut
the
green
crop
for
hay
or
silage
Corn
(
field,
seed,
pop
and
sweet)
Broadcast
foliar
applications
when
conditions
favor
disease
development
Aerial
or
ground
equipment,
including
chemigation
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.113
4
0.45
14/
30
Minimum
RTI
is
7
days.
A
14­
day
PHI
is
specified
for
sweet
corn
forage
and
ears,
and
a
30­
day
PHI
is
specified
for
forage,
grain
and
stover
of
field,
pop,
and
seed
corn.

Dry
Beans
and
Peas
Broadcast
foliar
applications
when
conditions
favor
disease
development
Aerial
or
ground
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.113
3
0.338
14
Do
not
apply
to
succulent
bean
varieties
Apply
in
a
minimum
of
5
or
15
gal/
A
using
aerial
and
ground
equipment,
respectively.
Minimum
RTI
is
14
days
Filberts
(
Hazelnuts)
Foliar
applications
beginning
at
bud
break
Aerial
or
ground
equipment
3.6
lb/
gal
EC
[
100­
617]
0.225
4
0.90
NS
For
aerial
applications,
minimum
volumes
of
5­
10
or
20
gal/
A
are
recommended.
For
ground
applications,
minimum
volumes
of
10­
50
or
100
gal/
A
are
recommended.
Minimum
RTI
is
14
days
Do
not
graze
livestock
in
treated
areas
or
cut
treated
cover
crop
for
feed
Onions
(
green,
dry
bulb,
or
seed
crop)
2
Broadcast
foliar
applications
when
conditions
favor
disease
development
Aerial
or
ground
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.225
2
0.45
0
3/
14
Apply
in
a
minimum
of
5
or
15
gal/
A
using
aerial
and
ground
equipment,
respectively.
Minimum
RTI
is
7
days
Page
10
of
55
Table
2.1.
Summary
of
Directions
for
Proposed
Uses
of
Propiconazole.

Application
Timing,
Type
and
Equipment
Formulation
[
EPA
Reg.
No.]
Single
rate
(
Lb
ai/
A)
Max.
#
of
Apps.
per
Season
Max.
Seasonal
Rate
(
lb
ai/
A)
PHI
(
days)
Use
Directions
and
Limitations
1
PHIs
are
0
for
green
onions
and
14
days
for
dry
bulb
onions
Peppermint
and
Spearmint
Broadcast
foliar
applications
beginning
when
plants
are
2­
4
inches
in
height
Equipment
not
specified
3.6
lb/
gal
EC
[
100­
617]
0.113
2
0.225
30
Apply
in
a
minimum
of
20
gal/
A
Minimum
RTI
is
10
days
Pecans
Foliar
applications
beginning
at
emergence
of
green
leaves
Aerial
or
ground
equipment
3.6
lb/
gal
EC
[
100­
617]
[
100­
702]
1.04
lb/
gal
EC
[
100­
1178]
45%
WP
[
100­
780]
0.225
4
0.90
NS
Apply
in
a
minimum
of
20
gal/
A
for
aerial
applications
Minimum
RTI
is
14
days,
Do
not
apply
after
shuck
split
The
label
for
100­
1178
also
specifies
a
45­
day
PHI
Do
not
graze
livestock
in
treated
areas
or
cut
treated
cover
crop
for
feed
Pistachios
Foliar
applications
beginning
at
emergence
of
green
leaves
Aerial
or
ground
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.225
4
0.90
NS
Apply
in
a
minimum
of
20
gal/
A
for
aerial
applications
and
50­
100
gal/
A
for
ground
applications
Minimum
RTI
is
14
days
Do
not
graze
livestock
in
treated
areas
or
cut
treated
cover
crop
for
feed
Rice
(
Do
not
use
in
CA)

0.28
1
Broadcast
foliar
application(
s)
after
tillering
Ground
or
aerial
equipment
3.6
lb/
gal
EC
[
100­
617]
1.04
lb/
gal
EC
[
100­
1178]
45%
WP
[
100­
780]

0.169
2
0.338
35
Apply
aerially
in
a
minimum
of
5­
20
gal/
A.
Minimum
RTI
is
10
days
The
label
for
the
1.04
lb/
gal
EC
prohibits
applications
after
head
emergence.
Do
not
apply
to
stubble
or
ratoon
crop.
Do
not
use
in
rice
fields
where
crayfish
farming
will
be
practiced
or
drain
water
from
treated
fields
into
ponds
used
for
crayfish
farming.
Do
not
use
water
drained
from
treated
fields
to
irrigate
other
crops
water
Sorghum
Broadcast
foliar
applications
beginning
at
or
just
prior
to
flowering
Aerial
or
ground
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.113
4
0.45
21/
30
Apply
in
a
minimum
of
5
or
15
gal/
A
using
aerial
and
ground
equipment,
respectively.
PHIs
are
30
days
for
forage
and
21
days
for
grain
and
stover
Minimum
RTI
is
5
days
Soybeans
Broadcast
foliar
applications
beginning
at
first
appearance
of
disease
until
to
pod
fill
(
Stage
R5)
Ground
and
aerial
equipment
3.6
lb/
gal
EC
[
100­
617]
1.04
lb/
gal
EC
[
100­
1178]
45%
WP
[
100­
780]
0.169
2
0.338
30
Apply
in
a
minimum
of
5
and
15
gal/
A
using
aerial
and
ground
equipment,
respectively.
Minimum
RTI
is
14
days
Do
not
graze
or
feed
soybean
forage
or
hay
Page
11
of
55
Table
2.1.
Summary
of
Directions
for
Proposed
Uses
of
Propiconazole.

Application
Timing,
Type
and
Equipment
Formulation
[
EPA
Reg.
No.]
Single
rate
(
Lb
ai/
A)
Max.
#
of
Apps.
per
Season
Max.
Seasonal
Rate
(
lb
ai/
A)
PHI
(
days)
Use
Directions
and
Limitations
1
Strawberries
Broadcast
foliar
applications
before
disease
levels
reach
5%
Aerial
or
ground
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.113
4
0.45
0
Apply
in
a
minimum
of
5
or
15
gal/
A
using
aerial
and
ground
equipment,
respectively.
Minimum
RTI
is
7
days
Sugar
beets
Broadcast
foliar
applications
beginning
at
first
appearance
of
disease
Equipment
not
specified
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.113
3
0.338
21
Minimum
RTI
is
10
days
Tree
Nut
Crops
Foliar
application
at
unspecified
timing
Ground
and
aerial
equipment
3.6
lb/
gal
EC
[
100­
617]
45%
WP
[
100­
780]
0.225
4
0.90
60
Apply
in
a
minimum
of
20
for
aerial
applications,
or
50­
100
gal/
A
for
ground
applications.
Minimum
RTI
is
not
specified.

2.2
Structures
and
Nomenclature
All
pertinent
product
chemistry
data
requirements
have
been
satisfied
for
the
Novartis
95%
T/
TGAI,
except
that
additional
data
are
required
concerning
stability
and
UV/
visible
absorption
(
OPPTS
830.6313
and
7050).
Product
chemistry
refers
to
HED
memo
of
Yan
Donovan,
08/
17/
05,
D318480.
Page
12
of
55
TABLE
2.2.
Test
Compound
Nomenclature
Chemical
Structure
Cl
Cl
O
O
N
N
N
CH
3
Empirical
Formula
C15H17Cl2N3O2
Common
name
Propiconazole
Company
experimental
name
CGA­
64250
IUPAC
name
1­((
2­(
2,4­
Dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl)
methyl)­
1H­
1,2,4­
triazole
CAS
name
1H­
1,2,4­
Triazole,
1­((
2­(
2,4­
dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl)
methyl)­

CAS
Registry
Number
60207­
90­
1
End­
use
product/
EP
Tilt
®
,
Alamo
®
,
Banner
®
,
and
Orbit
®
,
Quilt,
Stratego
 
Twin­
Pak
 
and
Stratego
 
.

Chemical
Class
Triazole
Known
Impurities
of
Concern
None
2.3
Physical
and
Chemical
Properties
Page
13
of
55
TABLE
2.3.
Physicochemical
Properties
Parameter
Value
Reference
Molecular
Weight
342.23
MRID
No.:
40583701
Boiling
point/
range
>
250
°
C
at
101.325
kPa,
120
°
C
at
1.9
Pa
MRID
No.:
43698701
pH
4.9
@
25
°
C
(
1%
aqueous
dispersion)
MRID
No.:
43698701
Density
1.289
g/
cm3
typical
@
20
°
C
MRID
No.:
43698701
Water
solubility
(
20
°
C)
0.10
g/
L
at
20
°
C
MRID
No.:
41720301
Solvent
solubility
(
temperature
not
specified)
Completely
miscible
in
ethanol,

acetone,
toluene
and
n­
octanol.

n­
hexane
=
47
g/
L
MRID
No.:
42030201
Vapor
pressure
(
25
°
C)
4.2
x
10­
7
mmHg
@
25
°
C
MRID
No.:
41720301
Dissociation
constant,
pKa
pKa
1.09
MRID
No.:
43698701
Octanol/
water
partition
coefficient,
Log
(
KOW)
(
25
°
C)
3.72
@
pH
6.6
MRID
No.:
43698701
UV/
visible
absorption
spectrum
(
8max,
nm)
Not
available
MRID
No.:
40583703
3.0
METABOLISM
ASSESSMENT
3.1
Rat
Metabolic
Profile
The
Rat
metabolism
study
labeled
with
14C
at
the
triazole­[
3,5]
position
indicated
that
parent
compound
was
extensively
metabolized;
a
group
of
metabolites
(
peak
U8,
11%)
appearing
in
the
urine.
Another
study
labeled
with
(
U­
14C)­
Phenyl
found
several
metabolites,
including
CGA
118245
(
61.8%
in
males,
2.4%
in
females),
CGA
217495
(
8.9%
in
males,
58.3%
in
females),
CGA
91304
(
2.3%
in
males
only),
and
CGA
118244
(
3.6%
in
females
only)
after
intravenous
dosing.
These
metabolites
were
also
detected
to
varying
degrees
in
the
urine
of
the
orally
dosed
groups.
In
the
feces,
no
parent
material
was
detected
in
the
iv
group,
but
detected
in
the
other
groups
(
6.8­
17.6%
of
the
fecal
radioactivity
in
males
and
females).
Radiolabeled
materials
cochromatographing
with
standards
CGA
91305,
CGA
118245
and
CGA
177291
were
reported
ranging
from
0.5%
­
10.9%
of
the
fecal
radioactivity
in
males
and
females
or
in
one
sex
alone.
Most
of
the
fecal
radioactivity
was
not
characterized.
Metabolites
CGA
217495
and
CGA
177291
are
not
found
in
plant
or
livestock
metabolism
(
see
Appendix
for
structures).
In
two
other
(
U­
14C)­
phenyl
and
14C­
triazole
ring
labeled
propiconazole
studies,
the
percentages
of
fecal
metabolites
extracted
and
distributed
at
various
pH's
were
not
substantially
different
between
the
triazole
and
phenyl
labeled
samples,
which
suggest
that
the
bridge
between
the
phenyl
ring
and
the
triazole
ring
remained
intact.
The
proposed
metabolic
pathway
appears
to
involve
the
cleavage
of
the
dioxolane
ring
through
the
oxidation
of
the
propyl
side
chain,
with
Page
14
of
55
subsequent
dechlorination
and
conjugation.
In
a
(
U­
14C)­
phenyl
labeled
propiconazole
metabolism
study
in
mice,
it
was
concluded
that
the
major
metabolic
pathway
in
mice
proceeds
via
elimination
of
the
dioxolane
ring
leading
to
ketone
formation
(
CGA
91304)
and
reduction
to
yield
the
corresponding
alcohol
(
CGA
91305).
Both
CGA
91304
and
CGA
91305
are
found
in
plants
and
livestock.

3.2
Nature
of
the
Residue
in
Foods
3.2.1.
Description
of
Primary
Crop
Metabolism
Available
plant
metabolism
data
(
primary
and
rotated
crops)
show
that
plants
absorb,
metabolize
and
translocate
propiconazole
throughout
the
plant.
A
major
metabolic
pathway
in
plants
appears
to
be
hydroxylation
(
primarily
of
the
beta­
carbon)
of
the
n­
propyl
group
on
the
dioxolane
ring
of
the
cis/
trans
isomers
of
propiconazole.
These
metabolites
appear
to
readily
form
sugar
conjugates.
The
majority
of
TRR
was
found
in
the
stalks,
such
as
peanut
stalk,
wheat
forage
and
straw,
grape
leaves,
and
celery
stalks
(
See
Table
3.4
for
TRRs).
A
possible
alternative
pathway
involves
reductive
deketalization
of
the
dioxolane
ring
and
sugar
conjugation
of
the
resulting
metabolite.
The
alkyl
bridge
between
the
phenyl
and
triazole
rings
is
metabolized
and
free
triazole,
as
1H­
1,2,4­
triazole,
is
released.
The
free
triazole
is
readily
conjugated
with
the
amino
acid,
serine/
alanine,
forming
triazole
alanine,
which
is
further
metabolized
to
triazole
acetic
acid
possibly
through
the
intermediate
formation
of
triazole
lactic
acid.
As
mentioned
earlier,
the
triazole
issue
will
be
addressed
separately.

3.2.2
Description
of
Livestock
Metabolism
For
one
ruminant
study,
three
lactating
goats
received
[
phenyl­
14C]
propiconazole
at
67­
92
ppm
for
four
consecutive
days
in
feed.
The
parent
(
1.7­
13.9%
TRR),
and
metabolites
CGA­
118244
(
9.4­
34%
TRR),
and
CGA­
91305
(
15.9­
31.3%
TRR)
were
identified
in
the
organic
extract
of
tissues;
metabolites
CGA­
118244
(
23%
TRR)
and
CGA­
91305
(
24%
TRR)
were
also
identified
in
milk.
In
addition,
an
unknown
was
quantitated
(
6.2­
31.1%
TRR)
in
goat
tissues.
In
a
second
ruminant
study,
a
single
goat
was
fed
[
triazole­
14C]
propiconazole
at
4.53
ppm
(
0.2x)
for
10
days.
The
TRR
in
tissues
and
milk
ranged
from
0.01
ppm
in
muscle
to
0.96
ppm
in
liver;
TRR
in
milk
were
0.015
ppm.
On
further
analysis
of
subsamples
of
milk
and
liver,
sulfate
and
glucuronide
conjugates
were
found
in
milk,
and
conjugation
with
amino
acids
was
suggested
in
liver;
propiconazole
per
se
was
not
identified
in
milk
or
liver.

For
the
poultry
study,
four
laying
hens
received
[
phenyl­
14C]
propiconazole
at
67
ppm
for
eight
consecutive
days
in
feed.
The
dosing
level
corresponds
to
560x
the
maximum
theoretical
dietary
burden
to
poultry.
The
parent
(
1.4­
39.0%
TRR),
and
metabolites
CGA­
118244
(
1.5­
50.0%
TRR),
and
CGA­
91305
(
17.7­
78.6%
TRR)
were
identified
in
the
organic
extracts
of
tissues
and
eggs.
Page
15
of
55
3.2.
Description
of
Rotational
Crop
Metabolism,
including
identification
of
major
metabolites
and
specific
routes
of
biotransformation.

The
nature
of
the
residue
in
confined
rotational
crops
is
understood,
and
no
additional
confined
rotational
crop
data
are
required
for
the
purpose
of
reregistration.
Based
on
acceptable
studies
reviewed
by
EFED,
the
metabolism
of
propiconazole
in
rotational
crops
is
similar
to
that
in
primary
crops.
In
a
rotational
crop
study,
metabolites
in
peanut
kernels
were
identified
as
triazole
acetic
acid
(
3.8%
TRR)
and
triazole
alanine
(
67.9%
TRR).
Metabolites
identified
in
the
rotational
crop
samples
included
triazole
acetic
acid
(
2.4%­
68.7%
TRR),
triazole
alanine
(
6.7%­
79.4%
TRR),
triazole
lactic
acid
(
4.9%­
35.8%
TRR)
and
polar
metabolites
E,
F,
G,
H
(
1.0%­
7.0%
TRR).

3.3
Environmental
Degradation
Acceptable
and
supplemental
environmental
fate
data
indicate
that
propiconazole
is
persistent
in
most
soil
and
aqueous
environments.
Propiconazole
is
stable
to
hydrolysis
and
photodegradation
in
water.
It
has
an
aerobic
soil
metabolism
half­
life
of
69
days
and
is
persistent
in
aquatic
environments
(
t
½
=
426
days).
Aqueous
photolysis
may
occur
in
the
presence
of
sensitizers
(
t
½
=
<
1
day).
Its
principal
route
of
dissipation
in
terrestrial
environments
appears
to
be
adsorption
to
soil;
adsorption
increases
with
soil
organic
matter
content
(
Kd
values=
1.2
on
sand
to
9.34
on
silty
clay
loam
soils).
Terrestrial
field
dissipation
half­
lives
of
about
100
days
was
reported
in
four
soils.
In
supplemental
aquatic
dissipation
studies
in
rice
fields,
propiconazole
dissipated
rapidly
(
t
½
=
<
5
days)
although
the
route
of
dissipation
was
not
apparent.

Propiconazole
is
moderately
mobile
to
relatively
immobile
in
most
soil
and
aqueous
environments.
Propiconazole
is
not
volatile
(
vapor
pressure
is
1.3
x
10­
6
Torr
at
200
C).
Propiconazole
adsorbs
to
soil
with
adsorption
increasing
with
soil
organic
matter
content
(
Kd
values
=
1.2
on
sand
to
9.34
on
silty
clay
loam
soils).

Propiconazole
is
broken
down
through
hydroxylation
of
the
propyl
side
chain
and
the
dioxolane
ring
to
give
1,2,4­
triazole
and
other
products,
including
particle­
bound
material
and
carbon
dioxide.

CGA­
136735,
CGA­
118245
and
CGA­
71019
were
identified
as
major
degradates
(>
10%
of
applied)
in
environmental
fate
studies.

Minor
degradates
include
CGA­
91304
and
CGA­
91305.

3.4
Tabular
Summary
of
Metabolites
and
Degradates
(
The
highest
%
TRR
is
chosen
when
both
[
14C]
triazole­
labeled
propiconazole
or
[
14C]
phenyllabeled
studies
were
conducted).
Page
16
of
55
Table
3.4.
Tabular
Summary
of
Metabolites
and
Degradates
Percent
TRR
(
PPM)
1
Chemical
Name
(
other
names
in
parenthesis)
Commodity
Matrices
­
Major
Residue
(>
10%
TRR)
Matrices
­
Minor
Residue
(<
10%
TRR)
Structure
Wheat
grain
(
0.1
lbs
ai/
A)
0.4
Wheat
forage
(
0.1
lbs
ai/
A)
7.3
Wheat
straw
(
0.1
lbs
ai/
A)
3.9
Wheat
grain
(
0.5
lbs
ai/
A)
0.8
Wheat
forage
(
0.5
lbs
ai/
A
17.2
Wheat
straw
(
0.5
lbs
ai/
A)
9.0
Celery,
stalk
85.3
Grape,
fruit
14.6
Grape,
juice
2.0
Peanut,
kernel
(
field)
­­

Peanut,
stalk
(
field)
54
Peanut,
shell
(
field)
­­

Peanut,
kernel
(
green
house)
N/
A
Peanut,
stalk
(
green
house)
89
Peanut,
shell
(
green
house)
N/
A
Rotational
Crops
Peanut,
stalk
5
Peanut,
shell
­­

Peanut,
kernel
­­

Wheat,
grain
­­

Wheat,
mature
stalk
­­

Wheat,
immature
stalk
0.7
Parent
Lettuce,
head
­­
Cl
Cl
O
O
N
N
N
CH
3
Page
17
of
55
Table
3.4.
Tabular
Summary
of
Metabolites
and
Degradates
Percent
TRR
(
PPM)
1
Chemical
Name
(
other
names
in
parenthesis)
Commodity
Matrices
­
Major
Residue
(>
10%
TRR)
Matrices
­
Minor
Residue
(<
10%
TRR)
Structure
Carrot
­­

Corn,
kernel
­­

Corn,
cob
­­

Corn,
immature
stalk
­­

corn,
mature
stalk
­­

Ruminant
1.7­
13.9
Poultry
1.4­
39
Rat
­­

Water
­­

Wheat
grain
(
0.1
lbs
ai/
A)
0.1
Wheat
forage
(
0.1
lbs
ai/
A)
0.3
Wheat
straw
(
0.1
lbs
ai/
A)
1.2
Wheat
grain
(
0.5
lbs
ai/
A)
0.3
Wheat
forage
(
0.5
lbs
ai/
A
0.3
Wheat
straw
(
0.5
lbs
ai/
A)
1.5
Celery,
stalk
1.1
Grape,
fruit
32.6
Grape,
juice
31.4
Rotational
Crops
­­

Ruminant
­­

Poultry
­­

Rat
2
­
3.6
CGA­
91304
Water
<
10%
Cl
Cl
O
N
N
N
Wheat
grain
(
0.1
lbs
ai/
A)
0.1
Wheat
forage
(
0.1
lbs
ai/
A)
0.3
CGA­
91305
Wheat
straw
(
0.1
lbs
ai/
A)
0.1
Page
18
of
55
Table
3.4.
Tabular
Summary
of
Metabolites
and
Degradates
Percent
TRR
(
PPM)
1
Chemical
Name
(
other
names
in
parenthesis)
Commodity
Matrices
­
Major
Residue
(>
10%
TRR)
Matrices
­
Minor
Residue
(<
10%
TRR)
Structure
Wheat
grain
(
0.5
lbs
ai/
A)
0.1
Wheat
forage
(
0.5
lbs
ai/
A
0.3
Wheat
straw
(
0.5
lbs
ai/
A)
0.1
Celery,
stalk
1.9
Grape,
fruit
4.9
Grape,
juice
2.9
Peanut,
kernel
(
field)
­­

Peanut,
stalk
(
field)
3
Peanut,
shell
(
field)
­­

Peanut,
kernel
(
green
house)
8
Peanut,
stalk
(
green
house)
­­

Peanut,
shell
(
green
house)
­­

Rotational
Crops
Peanut,
stalk
2
Peanut,
shell
­­

Peanut,
kernel
­­

Wheat,
grain
­­

Wheat,
mature
stalk
­­

Wheat,
immature
stalk
2.1
Lettuce,
head
­­

Carrot
­­

Ruminant
15.9­
31.3
­­

Poultry
17.7­
78.6
­­

Rat
­­
CGA­
91305
Water
<
10%
Cl
Cl
OH
N
N
N
Page
19
of
55
Table
3.4.
Tabular
Summary
of
Metabolites
and
Degradates
Percent
TRR
(
PPM)
1
Chemical
Name
(
other
names
in
parenthesis)
Commodity
Matrices
­
Major
Residue
(>
10%
TRR)
Matrices
­
Minor
Residue
(<
10%
TRR)
Structure
Wheat
grain
(
0.1
lbs
ai/
A)
0.4
Wheat
forage
(
0.1
lbs
ai/
A)
0.4
Wheat
straw
(
0.1
lbs
ai/
A)
1.0
Wheat
grain
(
0.5
lbs
ai/
A)
0.2
Wheat
forage
(
0.5
lbs
ai/
A
0.4
Wheat
straw
(
0.5
lbs
ai/
A)
1.1
Celery,
stalk
1.4
Rotational
Crops
­­

Ruminant
9.4­
34
­­

Poultry
2­
50
­­

Rat
3.6
CGA­
118244
Water
­­
Cl
Cl
O
O
N
N
N
CH
3
OH
Wheat
grain
(
0.1
lbs
ai/
A)
0.4
Wheat
forage
(
0.1
lbs
ai/
A)
0.2
Wheat
straw
(
0.1
lbs
ai/
A)
0.4
Wheat
grain
(
0.5
lbs
ai/
A)
0.1
Wheat
forage
(
0.5
lbs
ai/
A
0.1
Wheat
straw
(
0.5
lbs
ai/
A)
0.3
Celery,
stalk
­­
CGA­
118245
Rat
61.8
Cl
Cl
O
O
N
N
N
OH
Page
20
of
55
Wheat
grain
(
0.1
lbs
ai/
A)
­­

Wheat
forage
(
0.1
lbs
ai/
A)
ND
Wheat
straw
(
0.1
lbs
ai/
A)
0.1
Wheat
grain
(
0.5
lbs
ai/
A)
ND
Wheat
forage
(
0.5
lbs
ai/
0.1
Wheat
straw
(
0.5
lbs
ai/
A)
0.8
Celery,
stalk
­­
CGA­
136735
Rat
­­
Cl
Cl
O
O
N
N
N
CH
3
O
H
3.5
Toxicity
Profile
of
Major
Metabolites
and
Degradates
See
Section
3.6.2
3.6
Summary
of
Residues
for
Tolerance
Expression
and
Risk
Assessment
3.6.1
Tabular
Summary
Table
3.6.
HED
MARC
Meeting
Summary
Chart
:
Propiconazole
Date:
18­
Dec­
2001,
and
08­
Jan­
2002
Residues
of
Concern
Matrix
For
Risk
Assessment
i
For
Tolerance
Expression
Plants
Parent
plus
all
metabolites
convertible
to
2,4­
DCBA
Parent
only
Rotational
crop
Parent
plus
all
metabolites
convertible
to
2,4­
DCBA
Parent
only
Livestock:
Parent
plus
all
metabolites
convertible
to
2,4­
DCBA
Parent
only
Water
Parent
only
N/
A
i
Triazole
is
also
a
residue
of
concern,
but
it
will
be
addressed
separately.

3.6.2
Rationale
for
Inclusion
of
Metabolites
and
Degradates
Page
21
of
55
Plant:
The
analytical
method
is
a
single
moiety
method,
which
detects
all
residues
convertible
to
2,4­
dichlorobenzoic
acid
(
DCBA);
therefore,
MARC
concluded
that
for
risk
assessment,
parent
and
all
metabolites
convertible
to
2,4­
DCBA
are
residues
of
concern.
The
metabolites
that
have
the
basic
structure
of
propiconazole
(
e.
g.
alkanol,
beta­
hydroxy
and
conjugates)
would
likely
exhibit
some
of
the
same
toxicity
as
the
parent
compound,
but
would
not
likely
be
more
toxic
than
the
parent
compound.
For
the
purposes
of
risk
assessment
HED
would
assume
these
metabolites
would
have
equal
toxicity
as
the
parent
compound.
(
The
conjugates
are
included
because
of
the
possibility
they
could
be
hydrolyzed
in
the
stomach
to
the
unconjugated
form).
For
tolerance
expression,
MARC
recommended
parent
only
for
the
following
reasons:
1)
To
harmonize
with
the
Codex
MRL
which
is
parent
only;
2)
There
are
a
number
of
pesticides
that
have
2,4­
DCBA
as
common
metabolite;
and
3)
FDA
multiresidue
method
detects
parent
only,
and
that
FDA
monitoring
pattern
likely
only
detects
parent.

Rotational
crop:
As
with
primary
crops,
parent
and
all
metabolites
convertible
to
2,4­
DCBA
are
residue
of
concern
for
risk
assessment
since
the
analytical
method
is
a
single
moiety
method
which
detects
all
residues
convertible
to
2,4­
dichlorobenzoic
acid
(
DCBA).
Although
these
metabolites
are
detected
at
very
low
levels,
they
are
of
toxicological
concern
and
cannot
be
excluded
from
risk
assessment.
For
tolerance
expression,
MARC
recommended
parent
only.
The
most
blatent
misuse
of
propiconazole
would
be
application
to
unlabeled
crops.
If
rotational
crop
tolerances
were
expressed
in
terms
of
parent,
then
any
residues
of
propiconazole
on
rotated
crops
would
likely
be
due
to
direct
application
to
these
crops.
While
triazole
acetic
acid
is
the
major
metabolite
in
rotational
crop
study,
triazole
and
its
conjugates
are
common
metabolites
from
a
number
of
other
pesticides
and
have
been
addressed
separately.

Animals:
MARC
recommended
that
parent
and
all
metabolites
convertible
to
2,4­
DCBA
are
residues
of
concern
for
risk
assessment
since
the
analytical
method
detects
all
residues
convertible
to
2,4­
dichlorobenzoic
acid
(
DCBA).
Tolerance
expression
will
be
parent
only.
If
only
propiconazole
per
se
is
regulated,
there
will
not
likely
be
a
need
for
meat
and
milk
tolerances;
only
meat
by­
products
would
likely
require
a
tolerance.
Should
there
be
detectable
residues
of
the
parent
compound
in
meat
and
milk,
it
would
most
certainly
be
as
a
result
of
a
misuse.

Water:
MARC
recommended
that
parent
only
is
needed
to
be
included
in
the
risk
assessment
since
the
parent
is
persistent
and
immobile.
There
are
several
minor
degradates
(<
10%
TRR)
but
none
of
them
are
expected
to
be
significantly
more
toxic
than
the
parent.
Triazole
is
not
a
major
degradate
in
water
and
therefore
was
not
included
in
the
water
modeling;
the
potential
for
exposure
to
triazole
in
drinking
water
has
been
addressed
in
a
separate
document.

4.0
HAZARD
CHARACTERIZATION/
ASSESSMENT
4.1
Hazard
Characterization
For
detailed
discussion
on
propiconazole
toxicity
profile,
refer
to
HED's
phase
4
reregistration
eligibility
document
(
HED
memo
of
6/
28/
06,
Yan
Donovan,
D329668).
Page
22
of
55
Propiconazole
has
low
to
moderate
toxicity
in
experimental
animals
by
the
oral
(
Category
III),
dermal
(
Category
III)
and
inhalation
routes
(
Category
IV).
It
is
moderately
irritating
to
the
eyes
(
Category
III),
and
minimally
irritating
to
the
skin
(
Category
IV).
It
is
a
dermal
sensitizer.
Propiconazole
is
readily
absorbed
by
the
rat
skin
with
a
40%
absorption
within
10
hours
of
dermal
application.

Table
4.1a
:
Acute
Toxicity
Profile
­
Propiconazole
Guideline
No.
Study
Type
MRID
#
Results
Toxicity
Category
870.1100
Acute
Oral
­
rat
00058591
LD50
=
1517
mg/
kg
III
870.1200
Acute
Dermal­
rabbit
00058596
LD50
=
>
4000
mg/
kg
III
870.1300
Acute
Inhalation
­
rat
41594801
LC50
=
>
5.84
mg/
L
IV
870.2400
Primary
Eye
Irritation
00058597
Corneal
opacity
reversed
in
72
hours
III
870.2500
Primary
Skin
Irritation
00058598
No
irritation
IV
870.2600
Dermal
Sensitization
44949501
Sensitizer
­

4.2
FQPA
Hazard
Considerations
HIARC
(
February
13,
2003)
concluded
that
the
toxicology
database
for
propiconazole
is
complete
for
FQPA
assessment.
The
HIARC
concluded
that
there
is
low
concern
for
pre­
and/
or
postnatal
toxicity
resulting
from
exposure
to
propiconazole.
In
the
developmental
toxicity
study
in
rats,
the
HIARC
considered
the
fetal
effects
observed
in
this
study
at
a
dose
lower
than
that
evoking
maternal
toxicity
to
be
quantitative
evidence
of
increased
susceptibility
of
fetuses
to
in
utero
exposure
to
propiconazole.
In
the
developmental
toxicity
study
in
rabbits,
the
HIARC
determined
that
neither
quantitative
nor
qualitative
evidence
of
increased
susceptibility
of
fetuses
to
in
utero
exposure
to
propiconazole
was
observed
in
this
study.
In
the
2­
generation
reproduction
study
in
rats,
the
HIARC
determined
that
neither
quantitative
nor
qualitative
evidence
of
increased
susceptibility
of
neonates
(
as
compared
to
adults)
to
pre­
and/
or
postnatal
exposure
to
propiconazole
was
observed
in
this
study.
Since
there
was
quantitative
evidence
of
increased
susceptibility
of
the
young
following
exposure
to
propiconazole
in
the
developmental
rat
study,
HIARC
performed
a
Degree
of
Concern
Analysis
and
concluded
that
the
degree
of
concern
for
the
effects
observed
in
this
study
was
low
and
no
residual
uncertainties
were
identified.
The
FQPA
factor
is
thus
1X.

HIARC
(
February
13,
2003)
concluded
that
the
toxicology
database
for
propiconazole
is
complete
for
FQPA
assessment.
The
database
was
adequate
to
characterize
any
potential
for
prenatal
or
postnatal
risk
for
infants
and
children.

4.3
Hazard
Identification
and
Toxicity
Endpoint
Selection
Page
23
of
55
4.3.1
Margins
of
Exposure
Summary
of
target
Margins
of
Exposure
(
MOEs)
for
risk
assessment
as
recommended
by
HIARC.

Route
Duration
Short­
Term
(
1­
30
Days)
Intermediate­
Term
(
1
­
6
Months)
Long­
Term
(>
6
Months)

Occupational
(
Worker)
Exposure
Dermal
100
100
100
Inhalation
100
100
100
Residential
(
Non­
Dietary)
Exposure
Oral
100
100
NA
Dermal
100
100
100
Inhalation
100
100
100
4.3.2
Recommendation
for
Aggregate
Exposure
Risk
Assessments
As
per
FQPA,
1996,
when
there
are
potential
residential
exposures
to
the
pesticide,
aggregate
risk
assessment
must
consider
exposures
from
three
major
sources:
oral,
dermal
and
inhalation
exposures.
The
toxicity
endpoints
selected
for
these
routes
of
exposure
may
be
aggregated
as
follows.
°
For
the
General
Population,
including
infants
and
children,
the
short
term
oral
exposure
can
be
aggregated
with
the
short­
term
dermal
and
inhalation
due
to
a
common
toxicological
endpoint
(
clinical
signs
in
the
ACN
study).
°
A
common
toxicological
endpoint
was
identified
for
intermediate­
and
long­
term
oral,
dermal
(
oral
equivalent)
and
inhalation
(
oral
equivalent)
routes.
These
routes
can
be
aggregated
for
these
scenarios
for
the
appropriate
population.

Table
4.3.
Summary
of
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
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.
Page
24
of
55
Table
4.3.
Summary
of
Toxicological
Doses
and
Endpoints
for
Propiconazole
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
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)).

Short­
Term
(
1­
30
days)
Incidental
Oral
NOAEL
=
30
mg
kg/
day
Residential
MOE
=
100
Occupational
=
NA
Acute
Neurotoxicity
Study
 
Rats.

Clinical
signs
(
piloerection,
diarrhea,
tiptoe
gait).

Intermediate­
Term
(
1
­
6
months)
Incidental
Oral
NOAEL=
10
mg
ai/
kg/
day
Residential
MOE
=
100
Occupational
=
NA
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)).

Short­
Term
(
1
­
30
days)
Dermal
NOAEL=
30
mg
ai/
kg/
day
Dermal
absorption
rate
=
40%
Residential
MOE
=
100
Occupational
MOE
=
100
Acute
Neurotoxicity
Study
 
Rats.

Clinical
signs
(
piloerection,
diarrhea,
tiptoe
gait).
Page
25
of
55
Intermediate­
Term
dermal
(
1
­
6
months)
and
Long­
Term
dermal
(>
6
months)
Oral
NOAEL=
10
mg
ai/
kg/
day
(
Dermal
absorption
rate
=
40%)
Residential
MOE
=
100
Occupational
MOE
=
100
24
Month
Oncogenicity
Study
­
Mice.
Liver
toxicity
(
increased
liver
weight
in
males
and
increase
in
liver
lesions)
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)

Short­
Term
(
1
­
30
days)
Inhalation
NOAEL=
30
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)
Residential
MOE
=
100
Occupational
MOE
=
100
Acute
Neurotoxicity
Study
 
Rats.

Clinical
signs
(
piloerection,
diarrhea,
tiptoe
gait).

Intermediate­
Term
(
1
­
6
months)
and
Long­
Term
Inhalation
(>
6
months)
Oral
NOAEL=
10
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)
Residential
MOE
=
100
Occupational
MOE
=
100
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,
and
RfD
approach
for
risk
characterization.

UF
=
uncertainty
factor,
FQPA
SF
=
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.

4.4
FQPA
Safety
Factor
Based
upon
the
above­
described
data,
no
FQPA
safety
factor
is
needed
(
i.
e.
1X)
since
there
are
no
residual
uncertainties
for
pre
and/
or
post
natal
toxicity.
The
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.

4.5
Endocrine
Disruption
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
Page
26
of
55
recommendations
of
its
Endocrine
Disruptor
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
a
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

In
the
available
toxicity
studies
on
propiconazole,
there
was
no
estrogen,
androgen,
and/
or
thyroid
mediated
toxicity.

When
additional
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
has
been
developed,
propiconazole
may
be
subjected
to
further
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

5.0
Public
Health
Data
5.1
Incident
Reports
(
HED
memo
of
J.
Blondell,
D319239,
07/
26/
05)

From
the
review
of
the
Incident
Data
System,
it
appears
that
a
majority
of
cases
involved
skin
symptoms
such
as
rash,
itching,
and
skin
irritation
and
respiratory
effects
such
as
difficulty
breathing.
Poison
Control
Center
data
would
tend
to
support
the
Incident
Data
System
results;
dermal
irritation,
erythema,
and
difficulty
breathing
were
among
the
most
common
effects
reported.

Measures
to
limit
skin
and
respiratory
exposure
are
recommended
for
this
pesticide.
Appropriate
personal
protective
equipment
to
protect
the
skin
is
also
recommended
for
both
handlers
and
field
workers
who
are
likely
to
have
substantial
contact
with
propiconazole.

6.0
EXPOSURE
CHARACTERIZATION/
ASSESSMENT
Residue
Chemistry
Summary
Document;
Yan
Donovan
(
D238458,
7/
31/
2006)

6.1
Dietary
Exposure/
Risk
Pathway
6.1.1
Residue
Profile
Propiconazole
[
1­[[
2­(
2,4­
dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl]
methyl]­
1H­
1,2,4­
triazole]
is
a
systemic
broad­
spectrum
fungicide
registered
for
treatment
of
disease
in/
on
a
variety
of
crops.
Propiconazole
end­
use
products
are
marketed
in
the
United
States
under
the
trade
names
Tilt
®
,
Alamo
®
,
Banner
®
,
and
Orbit
®
.
Recently,
propiconazole
is
also
registered
for
use
on
a
variety
of
crops
under
the
trade
names
of
Stratego
 
Twin­
Pak
 
and
Stratego
 
,
which
are
end­
use
products
containing
a
mixture
of
trifloxystrobin
and
propiconazole.
The
amount
of
active
ingredient
range
from
11.4%
to
45%.
The
propiconazole
formulations
Page
27
of
55
registered
for
food/
feed
uses
include
emulsifiable
concentrate
(
EC)
and
flowable
concentrate
(
FlC)
formulations.

Syngenta
Crop
Protection
(
Syngenta)
and
Interregional
Research
Project
No.
4
(
IR­
4)
have
submitted
several
petitions
supporting
new
or
amended
uses
on
various
crops
for
propiconazole,
formulated
as
a
3.6
lb/
gal
emulsifiable
concentrate
(
EC)
or
a
45%
wettable
powder
(
WP).
The
proposed
uses
are
for
broadcast
foliar
applications
using
ground
or
aerial
equipment
at
rates
ranging
from
0.11
to
0.28
lb
ai/
A/
application.
For
tree
nuts,
the
proposed
use
is
for
up
to
four
foliar
applications
at
0.225
lb
ai/
A,
for
a
total
of
0.90
lb
ai/
A,
with
a
60­
day
preharvest
interval
(
PHI).
For
bush
and
cane
berries
and
cranberries,
the
proposed
uses
are
for
4
or
5
foliar
applications
at
0.17
lb
ai/
A,
for
totals
of
0.68­
0.84
lb
ai/
A,
with
PHIs
of
30
or
45
days.
For
carrots,
leaf
petiole
vegetables,
dry
peas
and
beans,
sugar
beets
and
strawberries,
the
proposed
uses
are
for
3
or
4
broadcast
foliar
applications
at
0.11
lb
ai/
A,
for
totals
of
0.34
or
0.45
lb
ai/
A,
with
PHIs
of
0
to
21
days.
For
mint,
the
proposed
use
is
for
two
broadcast
foliar
applications
at
0.113
lb
ai/
A,
for
a
total
of
0.225
ai/
A,
with
a
PHI
of
30
days.
For
soybeans,
the
proposed
use
is
for
two
broadcast
foliar
applications
at
0.169
lb
ai/
A
at
up
to
growth
stage
R6,
for
a
total
of
0.338
ai/
A,
with
a
PHI
of
30
days.
For
rice,
the
proposed
use
is
for
a
single
application
or
split
applications
at
heading
totaling
~
0.30
lb
ai/
A,
with
a
PHI
of
35
days.
For
other
cereal
grains,
the
proposed
uses
are
for
2
to
4
broadcast
foliar
applications
at
0.113
lb
ai/
A
up
to
heading
or
grain
development,
for
totals
of
0.22
or
0.45
ai/
A,
with
PHIs
of
14­
45
days.
In
conjunction
with
these
uses,
Syngenta
and
IR­
4
are
proposing
permanent
tolerances
for
propiconazole
residues
in/
on
various
plant
commodities
at
levels
ranging
from
0.1
ppm
on
alfalfa
to
32
ppm
on
soybean
hay.

The
nature
of
propiconazole
residues
in
plants
and
animals
is
adequately
understood
based
on
the
available
peanut,
wheat,
grape,
rice,
celery,
carrot,
goat,
and
poultry
metabolism
studies.
A
major
metabolic
pathway
in
plants
appears
to
be
hydroxylation
(
primarily
of
the
beta­
carbon)
of
the
n­
propyl
group
on
the
dioxolane
ring
of
the
cis/
trans
isomers
of
propiconazole.
These
metabolites
appear
to
readily
form
sugar
conjugates.
The
majority
of
TRR
was
found
in
the
stalks,
such
as
peanut
stalk,
wheat
forage
and
straw,
grape
leaves,
and
celery
stalks.
The
HED
MARC
concluded
that
for
plants
and
animals,
residues
of
propiconazole
and
all
its
metabolites
containing
the
2,4­
dichlorophenyl
moiety
(
2,4­
DCBA),
including
conjugates,
are
of
concern
and
should
be
included
in
the
dietary
(
food)
risk
assessments,
and
that
propiconazole
per
se
should
be
included
in
the
dietary
(
water)
risk
assessments.
For
tolerance
expression,
MARC
concluded
that
the
current
tolerance
expression
for
propiconazole
should
be
amended
to
include
residues
of
propiconazole
per
se
only.
This
allows
for
harmonization
with
the
residue
definition
for
Codex.

The
free
triazole,
triazole
alanine,
and
triazole
acetic
acid
are
also
residues
of
concern.
Since
these
are
common
metabolites
from
several
triazole
containing
pesticides,
the
risk
from
these
metabolites
has
been
assessed
separately
(
HED
memo
of
2/
7/
06,
M.
Doherty,
D322215).
The
cited
assessment
included
all
the
proposed
propiconazole
new
uses
in
the
subject
petitions.

For
enforcing
the
revised
tolerances,
a
GC
method
using
flame
ionization
detection
(
Method
AG­
354)
is
also
available
for
determining
residues
of
propiconazole
per
se
in/
on
plant
Page
28
of
55
commodities,
and
has
an
LOQ
of
0.05
ppm.
In
addition,
Multiresidue
Methods
Section
302
can
also
be
used
to
determine
parent
propiconazole
in
both
plant
and
animal
matrices.

Samples
from
the
various
field
trials
and
processing
studies
supporting
the
current
petitions
were
analyzed
for
combined
residues
of
propiconazole
and
its
2,4­
DCBA
containing
metabolites
using
GC/
ECD
Methods
AG­
454B
and
AG­
626,
which
are
more
recent
versions
of
AG­
454A.
With
the
exception
of
almond
hulls,
which
had
a
LOQ
of
0.1
ppm,
the
validated
LOQ
for
combined
residues
was
0.05
ppm
in
all
raw
and
processed
commodities.
Each
of
the
methods
was
validated
in
conjunction
with
the
field
trials
and
processing
studies.
In
addition,
samples
from
one
of
the
wheat
field
trials
and
processing
studies
were
also
analyzed
for
residues
of
propiconazole,
per
se,
using
a
multiresidue
method
from
the
Pesticide
Analytical
Manual
(
PAM,
Vol.
I,
Section
302).

Adequate
storage
stability
data
are
available
indicating
that
residues
of
propiconazole
are
stable
at
 ­
15
º
C
for
up
to
36
months
in
peaches,
bananas,
corn
meal,
wheat
grain,
celery,
corn
oil,
and
peanut
nutmeat,
hay,
and
hulls;
10
months
in
carrots;
and
4­
6
months
in
soybean
seed
and
fodder.
Weathered
residues
of
propiconazole
and
its
metabolites
were
also
found
to
be
stable
under
frozen
storage
conditions
in
grass
forage,
straw,
and
seed
for
up
to
39
months
at
­
20
º
C;
wild
rice
and
stone
fruits
for
up
to
25
months;
and
peanut
hulls
and
fodder
for
25
months
at
­
15
º
C.
These
data
support
most
of
the
samples
storage
intervals
and
conditions
in
the
field
trials
and
processing
studies
submitted
with
the
current
petitions.
In
cases
where
existing
storage
stability
data
are
not
available,
concurrent
storage
stability
data
were
submitted
along
with
field
trials.

Provided
that
minor
changes
are
made
to
the
proposed
use
directions,
the
available
field
trial
data
on
almonds,
bush
and
cane
berries,
carrots,
celery,
corn,
cranberries,
mint,
onions,
pecans,
rice,
sorghum,
strawberries
and
wheat
are
adequate
and
support
the
proposed
use
patterns
for
propiconazole
(
EC
or
WP)
on
these
crops.
The
number
and
geographic
distribution
of
the
field
trials
are
adequate,
and
the
appropriate
samples
were
collected.
Samples
were
analyzed
using
adequate
analytical
methods
and
the
sample
storage
intervals
are
supported
by
the
available
storage
stability
data.
Side­
by­
side
field
trials
were
conducted
on
almond,
celery,
field
corn,
and
sugar
beets
to
compare
residues
from
the
EC
and
WP
formulation.
These
data
show
residues
are
comparable
from
the
two
products,
with
the
exception
of
sugar
beet
tops
at
the
requested
PHI.

Adequate
field
trial
data
are
also
available
to
support
the
use
of
the
45%
WP
formulation
on
sugar
beets.
However,
based
on
the
results
of
the
side­
by­
side
tests
with
the
WP
and
EC
formulations,
residues
in/
on
tops
at
the
proposed
21­
day
PHI
are
likely
to
be
higher
for
the
EC
formulation
than
the
WP
formulation.
Therefore,
a
complete
set
of
field
trial
data
is
required
for
sugar
beet
tops
reflecting
the
use
of
the
EC
formulation.
A
conditional
registration
can
be
established
on
sugar
beet
tops.

For
soybeans,
after
considering
all
the
available
soybean
field
trial
data,
HED
concluded
that
sufficient
residue
data
are
available
to
support
tolerances
on
soybean
forage
and
hay
harvested
30
days
following
the
second
of
two
applications
totaling
0.33
lb
ai/
A
(
1x
rate).
Although
the
petitioner
has
requested
tolerances
for
soybean
forage
and
hay,
the
Agency
notes
that
the
Page
29
of
55
currently
proposed
use
directions
for
soybean
prohibit
the
feeding
or
grazing
for
forage
or
hay.
HED
also
considers
sufficient
residue
data
are
available
to
support
tolerances
on
soybean
seed,
even
though
the
PHIs
of
the
soybean
seed
data
vary
from
30
to
90
days.
Since
soybean
mature
at
different
times
depending
on
the
growing
regions,
PHI
in
days
can
vary
from
region
to
region;
therefore,
provided
the
label
has
such
language
as
"
do
not
apply
later
than
the
R5
growth
stage'
or
`
apply
up
to
Stage
R6",
no
additional
field
trials
are
required
for
soybean
seeds.

For
dry
peas
and
beans,
however,
there
are
no
sufficient
field
trial
data
to
support
the
proposed
use
as
only
six
dry
bean
field
trials
are
available
and
no
dry
pea
field
trials
were
conducted.
For
a
subgroup
crop
tolerance
on
6C,
a
total
of
12
dry
bean
field
trials
and
5
dry
pea
field
trials
are
required.
In
addition,
the
available
dry
bean
field
trials
support
a
PHI
of
28
days
rather
than
the
14­
day
PHI
on
the
proposed
label.
HED
recommends
against
the
establishment
of
permanent
tolerance
on
subgroup
crop
6C
until
additional
field
trial
data
are
submitted.

The
Agency's
Guidance
for
Setting
Pesticide
Tolerances
Based
on
Field
Trial
Data
(
tolerance
spread
sheet)
was
utilized
for
determining
appropriate
tolerance
levels
on
plant
commodities.
While
these
tolerance/
residue
levels
are
suitable
for
Tier
I
dietary
risk
assessment,
they
are
considered
conservative
for
tolerances
in
that
the
field
trial
data
were
reported
as
parent
plus
all
metabolites
containing
2,4­
DCBA,
while
the
tolerance
expression
is
parent
only.
HED
recommends
that
the
registrant
analyze
parent
and
metabolites
separately
in
all
future
field
trials,
so
that
more
realistic
tolerances
can
be
set
in
the
future.

Adequate
processing
studies
are
available
for
alfalfa
(
rotational
crop),
field
corn,
mint,
rice,
sorghum,
soybean,
sugar
beet,
and
wheat.
These
studies
indicate
that,
with
the
exception
of
aspirated
grain
fractions
(
AGF),
combined
propiconazole
residues
did
not
concentrate
in
processed
commodities
derived
from
alfalfa,
field
corn,
mint,
sorghum,
and
soybeans,
or
in
polished
rice,
sugar
beet
refined
sugar,
or
wheat
germ,
shorts,
middlings
and
flour.
However,
combined
residues
were
shown
to
concentrate
in
rice
hulls
(
3.8x)
and
bran
(
2.9x),
sugar
beet
molasses
(
7.4x)
and
dried
pulp
(
4.9x),
and
wheat
bran
(
3.2x).
Considering
the
highest
average
field
trial
(
HAFT)
residues
in
the
various
RACs
and
the
above
processing
factors,
appropriate
tolerances
for
combined
propiconazole
residues
are
20
and
15
ppm
for
rice
hulls
and
bran,
1.5
and
1.0
ppm
for
sugar
beet
molasses
and
dried
pulp,
and
0.6
ppm
for
wheat
bran.
The
recommended
tolerance
for
wheat
bran
will
be
translated
to
bran
of
barley
and
rye.
With
regards
to
AGF,
combined
residues
were
also
shown
to
concentrate
by
various
degrees
in
AGF
derived
from
field
corn
(
12.8x),
sorghum
(
5.2x),
soybeans
(
32x),
and
wheat
(
13x)
following
late
season
applications.
Considering
these
AGF
concentration
factors
and
the
HAFT
residues
in
the
respective
RACs,
the
maximum
expected
residues
in
AGF
are
1.28
ppm
for
corn,
10.9
ppm
for
sorghum,
30
ppm
for
soybean,
and
4.14
ppm
for
wheat.
Therefore,
the
recommended
tolerance
for
propiconazole
residues
in
AGF
is
30
ppm
based
on
the
soybean
data.

The
maximum
theoretical
dietary
burdens
(
MTDB)
for
combined
propiconazole
residues
were
calculated
to
be
28.0
ppm
for
beef
and
18.5ppm
for
dairy
cattle,
2.3
ppm
for
swine
and
2.0
ppm
for
poultry.
To
estimate
maximum
combined
residues
in
cattle
and
swine
commodities,
the
residue
levels
for
the
75­
ppm
feeding
level
at
21
days
were
selected,
as
these
residue
levels
were
the
highest
for
the
75­
ppm
group.
This
feeding
level
represents
a
2.7x
the
MTDBs
for
beef
Page
30
of
55
cattle,
4.2x
for
dairy
cattle,
and
a
32.6x
for
swine.
Maximum
combined
residues
were
estimated
by
dividing
the
residue
values
for
milk
and
tissues
at
the
75­
ppm
dose
level
by
2.7
for
cattle,
4.2
for
milk,
and
32.6
for
swine.
For
beef
cattle,
estimated
combined
residues
at
a
1x
feeding
level
are
1.7
ppm
for
kidney,
1.6
ppm
for
liver,
0.03
ppm
for
muscle,
0.05
ppm
for
fat,
and
0.03
pm
for
milk.
For
swine,
estimated
combined
residues
at
a
1x
feeding
level
are
0.14ppm
for
kidney,
0.13
ppm
for
liver
and
<
0.005
ppm
for
muscle
and
fat.
HED
recommends
that
the
following
tolerance
levels
be
established:
For
cattle,
goat,
horses
and
sheep,
kidney
and
liver
at
2.0
ppm;
meat
and
meat
byproduct
(
except
kidney
and
liver)
and
fat
at
0.05
ppm,
milk
at
0.05
ppm.
For
hog,
kidney
and
liver
at
0.20
ppm,
no
tolerances
are
needed
for
meat,
fat,
and
meat
byproduct.

For
poultry
tissues
and
eggs,
estimated
combined
residues
and
parent
residues
were
calculated
in
the
same
manner
as
for
cattle
and
swine.
The
maximum
combined
residues
in
tissues
and
eggs
from
the
7.5­
ppm
dose
group
in
the
poultry
feeding
study
were
used
to
estimate
residues
at
the
1x
feeding
level.
The
estimated
combined
residues
at
the
1x
feeding
level
are
all
<
LOQ.
Therefore,
tolerances
for
poultry
tissues
and
eggs
are
not
required
as
quantifiable
levels
of
propiconazole
are
unlikely
to
occur
in
these
commodities
[
40
CFR
180.6(
a)
(
3)].

Adequate
confined
rotational
crop
studies
are
available
indicating
that
the
residues
in
rotational
crops
are
similar
to
the
primary
crops.
The
confined
studies
also
support
the
105­
day
plant­
back
interval
(
PBI)
currently
listed
on
product
labels
for
crops
without
direct
uses.
Under
the
current
petition,
Syngenta
has
submitted
extensive
rotational
crop
field
trial
data
on
alfalfa
planted
following
propiconazole­
treated
wheat
and
proposed
a
0.1
ppm
tolerance
for
inadvertent
residues
in/
on
alfalfa.
The
available
alfalfa
rotational
crop
field
trials
are
adequate
and
will
support
a
75­
day
PBI
for
alfalfa
following
propiconazole
application(
s)
to
primary
crops
at
up
to
0.22
lb
ai/
A/
season.

6.1.2
Acute
and
Chronic
Dietary
Exposure
and
Risk
(
Food
and
Water)

(
HED
memo
of
08/
15/
06,
Yan
Donovan,
D312278)

Acute
and
chronic
dietary
risk
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FCIDJ,
Version
2.02)
which
uses
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.

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.
At
the
95th
percentile,
the
exposure
to
the
U.
S.
population
is
at
6
%
aPAD;
the
highest
exposed
subgroup
(
all
infants
<
1
yrs
old)
is
at
14%
aPAD.
Page
31
of
55
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
is
at
6
%
cPAD,
and
the
most
highly
exposed
subgroup,
Children
1­
2
years
old,
is
at
14
%
cPAD.

Cancer
Dietary
Exposure
Results
and
Characterization
The
HIARC
classified
propiconazole
as
a
Group
C
­
possible
human
carcinogen,
nonquantifiable
For
the
purpose
of
risk
characterization
the
reference
Dose
(
RfD)
approach
should
be
used
and
would
be
protective.

Water
Contribution
The
Agency
used
PRZM­
EXAMS
and
SCI­
GROW
screening
models
to
determine
the
EECs
of
propiconazole
in
surface
and
ground
water,
respectively.
Based
on
the
PRZM­
EXAMS
and
SCIGROW
models,
for
surface
water,
the
highest
estimated
environmental
concentration
(
EEC)
of
propiconazole
for
acute
exposure
is
55.8
parts
per
billion
(
ppb)
(
Turf
use),
and
for
chronic
exposure
is
21.6
ppb
(
turf
use).
For
ground
water,
the
highest
EEC
for
acute
and
chronic
exposure
is
0.64
ppb.
The
highest
estimates
from
surface
water
(
acute,
55.8
ppb
and
chronic,
21.6
ppb)
were
used
in
the
DEEM
analysis.

6.2
Water
Exposure/
Risk
Pathway
Drinking
Water
Assessment;
James
Lin
(
D325821,
07/
07/
06)

Propiconazole
appears
to
be
persistent
and
moderately
mobile
to
relative
immobile
in
most
soil
environment.
In
the
aquatic
environment,
propiconazole
degradation
appears
to
be
dependent
solely
on
aqueous
photolysis
in
the
presence
of
photo
sensitizers.
In
soil
environment,
propiconazole
dissipation
appears
to
depend
on
incorporation
or
binding
to
soil
organic
matter
content.

Laboratory
and
terrestrial
field
dissipation
data
indicate
that
propiconazole
is
stable
in
soil
and
aqueous
environments.
However,
in
supplemental
aquatic
dissipation
data
using
basin­
irrigation
and
flow
through
irrigation
systems
in
rice
fields,
propiconazole
was
found
to
be
dissipated
rapidly
(
t
½
<
5
days).
Aqueous
photolysis
studies
using
sensitizers
indicated
rapid
degradation
(
t
½
<
1
days)
of
propiconazole,
which
appears
to
be
the
case
in
rice
fields.
Furthermore,
aquatic
metabolism
and
dissipation
studies
indicate
propiconazole
dissipates
by
incorporation
or
binding
into
the
organic
matter
content
of
soil/
sediment.

Propiconazole
mobility
in
soil
appears
to
be
dependent
on
the
soil's
organic
matter
content.
In
general,
propiconazole
appears
to
be
moderately
mobile
(
Kd
<
5)
in
soils
with
a
low
organic
Page
32
of
55
matter
content
(<
1%).
However,
in
soils
with
higher
organic
matter
content
(>
1%),
propiconazole
appears
to
be
relatively
immobile
(
Kd
>
5).
Therefore,
propiconazole
may
reach
ground
water
in
soils
with
low
organic
contents.
Propiconazole
may
also
contaminate
surface
water
through
off­
site
runoff
and
spray
drift.

A
registrant
submitted
drinking
water
monitoring
study
showed
a
very
few
detections
among
a
total
of
thirty­
eight
selected
CWSs
in
twelve
states.
EFED
concluded
that
the
sampling
scheduling
of
this
monitoring
study
is
not
rigorous
enough
to
be
used
for
water
assessment.
Since
the
monitoring
studies
did
not
provide
good
quality
data,
this
drinking
water
assessment
is
based
on
the
model
predicted
drinking
water
concentrations
Drinking
Water
Estimates
from
Surface
Water
Sources
The
estimated
drinking
water
concentrations
from
surface
water
sources
were
calculated
using
Tier
II
PRZM
(
Pesticide
Root
Zone
Model)
and
EXAMS
(
Exposure
Analysis
Modeling
System).
For
each
specific
use,
the
maximum
allowable
label
rate
was
input
to
PE4V01.
The
output
concentrations
were
without
PCA
consideration.
The
final
estimated
drinking
water
concentrations
were
then
adjusted
with
the
proper
PCA.
Except
the
uses
of
soybean
(
0.41)
and
wheat
(
0.56),
other
uses
assume
the
default
PCA
of
0.87.
Among
these
modeling
results,
turf
use
gives
the
highest
acute
concentration
of
55.78
ug/
l.
For
the
chronic
exposure,
turf
use
has
the
highest
concentration
of
21.61
ug/
L,

Drinking
Water
Estimates
from
Ground
Water
Sources
The
estimated
environmental
concentrations
in
ground
water
were
calculated
using
the
Tier
I
SCI­
GROW
(
Screening
Concentration
In
Ground
Water)
model.
SCI­
GROW
is
neither
scenario­
nor
crop­
specific.
The
only
input
requirements
are
application
rate,
number
of
applications,
Koc,
and
aerobic
soil
metabolism
half­
life.
The
higher
estimated
concentrations
are
associated
with
the
higher
rate.
Turf
use
has
the
highest
concentration
of
0.64
µ
g/
L
(
ppb).

Table
6.2.
Summary
of
Estimated
Surface
and
Ground
Water
Concentrations
for
Chemical.
Propiconazole
parent
compound
Exposure
Duration
Surface
water
(
ppb)
Ground
water
(
ppb)
Acute
55.8
0.64
Chronic
(
non­
cancer)
21.6
0.64
Chronic
(
cancer)
N/
A
N/
A
6.3
Residential
(
Non­
Occupational)
Exposure/
Risk
Pathway
Propiconazole:
Occupational
and
Residential
Exposure
Assessment;
James
Miller,
Environmental
Scientist
(
D325817,
6/
15/
06)
Propiconazole
Occupational
and
Residential
Exposure
Assessment
of
the
Antimicrobial
Uses;
Timothy
Leighton
(
D326306,
2/
1/
2006)
Amendment
to
the
Propiconazole
RED
for
Children's
Post­
application
Exposure
from
Treated
Structures;
Tim
Leighton
(
D330159,
06/
20/
06)
Page
33
of
55
Residential
Post­
application
Exposures
and
Risks
The
existing
residential
use
patterns
result
in
post
application
dermal
exposures
to
adults,
and
dermal
and
oral
exposures
to
infants
and
children.
These
exposures
are
considered
short
term
only,
due
to
the
fact
that:
1)
Post­
application
exposures
were
calculated
using
Propiconazole
as
the
parent
compound;
2)
Compound
specific
TTR
data
indicates
that
at
the
Indiana,
California,
and
Pennsylvania
test
sites,
average
total
propiconazole
residues
declined
to
below
the
minimum
quantifiable
limit
(
MQL)
by
DAT
=
14,
DAT
=
10,
and
DAT
=
8
respectively.
These
dissipation
rates,
combined
with
label
specific
use
rates
and
frequency
of
use
specifications,
reinforce
the
hand
to
mouth
short­
term
exposure
scenario;
3)
For
short
term
exposure
to
Children
1­
2
years
old,
the
driving
factors
for
this
risk
assessment
are
hand
to
mouth,
object
to
mouth,
and
dermal
exposure.
Soil
ingestion
is
insignificant
(
MOE>
300,000)
compared
to
these
factors,
indicating
that
the
post
application
scenario
should
be
short
term
only
In
addition
to
using
HED's
SOP
for
residential
assessment,
the
study
specific
turf
transferable
residue
(
TTR)
was
used
in
the
calculation.
A
summary
of
risk
estimates
for
residential
postapplication
risks
for
adults
and
children
is
provided
in
the
following
tables.
HED
combines
risk
values
resulting
from
separate
post­
application
exposure
scenarios
when
it
is
likely
they
can
occur
simultaneously
based
on
the
use­
pattern
and
the
behavior
associated
with
the
exposed
population
(
see
Table
6.3b),
and
all
MOEs
are
above
100,
and
not
of
concern.
[
Note:
Propiconazole
is
classified
as
a
non­
volatile
chemical;
therefore
a
residential
inhalation
postapplication
assessment
is
not
required].
The
assumptions
used
for
each
of
the
scenarios
separately
are
already
high
(
i.
e.,
time
spent
outdoors,
dislodgeable
residues).
So,
combining
all
these
activities
together
is
extra
conservative.

Table
6.3a:
Adult
Residential
Risk
Estimates
for
Post­
application
Exposure
to
Propiconazole
Exposure
Scenario
TC
cm
²
/
hr
Route
of
Exposure
Application
Rate
MOE
at
Day
0
Outdoors
Residential
Turf
(
Gen.
High­
Contact
Activities)
70000
Dermal
1.8
lb
ai/
acre
350
Residential
Turf
(
Mowing)
500
Dermal
1.8
lb
ai/
acre
50,000
Level
of
Concern:
MOE
=
100
Table
6.3b:
Toddler
Residential
Risk
Estimates
for
Post­
application
Exposure
to
Propiconazole
Exposure
Scenario
TC
cm
²
/
hr
Route
of
Exposure
Application
Rate
MOE
at
Day
0
Combined
MOE
Outdoors
Hand
to
Mouth
Activity
on
Turf
N/
A
Oral
1.8
lb
ai/
acre
1100
170
Page
34
of
55
Object
to
Mouth
Activity
on
Turf
N/
A
Oral
1.8
lb
ai/
acre
4500
Soil
Ingestion
N/
A
Oral
1.8
lb
ai/
acre
330,000
Turf
 
General
High­
Contact
Activities
25000
Dermal
1.8
lb
ai/
acre
210
Note:
Combined
MOE
=
NOAEL/(
ADDhand­
to­
mouth
+
ADDobject­
to­
mouth
+
ADDincidental
soil
ingestion
+
ADDdermal)
Level
of
Concern:
MOE
=
100
Residential
post­
application
scenarios
from
antimicrobial
uses
were
also
assessed.
No
postapplication
exposure
to
adult
is
expected
because
of
propiconazole's
low
vapor
pressure
(
therefore,
no
inhalation
exposure)
and
the
registrants'
deletion
of
the
only
other
use
(
i.
e.,
materials
preservative
in
fabrics,
textiles,
area
carpet
fibers).
Propiconazole
is
used
on
many
different
types
of
wood
including
1)
green
or
fresh
cut
lumber,
poles,
posts,
and
timbers;
2)
manufactured
wood
products
such
as
logs
(
including
for
log
home
construction),
wood
chips/
sawdust,
plywood
veneer,
and
particle
board;
3)
dry
lumber;
and
4)
finished
wood
products
such
as
millwork,
shingles,
shakes,
siding,
plywood,
and
structural
lumber
and
composites.
Except
"
dry
lumber"
uses,
the
other
3
groupings
would
result
in
minimal
dermal
and/
or
incidental
oral
exposure.
Inhalation
exposure
(
e.
g.,
in
log
homes
treated
with
propiconazole)
is
also
expected
to
be
negligible
based
on
the
low
vapor
pressure.
For
"
dry
lumber"
uses,
if
propiconazole­
treated
lumber
is
used
to
build
residential
decks
and/
or
play
sets,
then
there
is
the
potential
for
dermal
and
incidental
oral
exposures
to
treated
lumber
used
in
decks
and
or
play
sets.
AD
assessed
the
risk
to
children
playing
on
propiconazole­
treated
structures
using
screening
level
assessment.
Table
6.3c
shows
the
result
of
aggregate
risk
from
incidental
oral
and
dermal
exposure
from
propiconazole
treated
wood.
This
risk
assessment,
based
on
high
end
screening­
level
assumptions,
indicates
no
risk
of
concern.
Confirmatory
data
for
the
surface
residues
are
needed
to
verify
this
screening­
level
assessment.

Table
6.3
c.
Propiconazole
Assessment
of
Children
Playing
on
Treated
Structures.
MOEs
(
Target
=
100)
b
Exposure
Dose
(
mg/
kg/
day)
a
Short­
term
Intermediate
Dermal
Contact
0.0675
450
150
Incidental
Oral
0.00563
5,300
1,800
Aggregate
0.0731
410
140
a
Aggregate
dose
=
dermal
dose
+
oral
dose.
b
MOEs
=
ST
and
IT
NOAELs
(
mg/
kg/
day)
/
Dose
(
mg/
kg/
day).
Where
ST
NOAEL
=
30
mg/
kg/
day
and
IT
NOAEL
=
10
mg/
kg/
day.
Target
MOE
=
100.

7.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATION
In
accordance
with
the
FQPA,
HED
must
consider
and
aggregate
(
add)
pesticide
exposures
and
risks
from
three
major
sources:
food,
drinking
water,
and
residential
exposures.
In
an
aggregate
assessment,
exposures
from
relevant
sources
are
added
together
and
compared
to
quantitative
Page
35
of
55
estimates
of
hazard
(
e.
g.,
a
NOAEL
or
PAD),
or
the
risks
themselves
can
be
aggregated.
When
aggregating
exposures
and
risks
from
various
sources,
HED
considers
both
the
route
and
duration
of
exposure.

For
most
pesticide
active
ingredients,
water
monitoring
data
are
considered
inadequate
to
determine
surface
and
ground
water
drinking
water
exposure
estimates,
so
model
estimates
have
been
used
to
estimate
residues
in
drinking
water
(
EDWCs).
In
the
past,
in
order
to
determine
if
aggregate
risks
are
of
concern,
HED
calculated
drinking
water
levels
of
comparison,
or
DWLOCs.
The
DWLOC
is
the
maximum
amount
of
a
pesticide
in
drinking
water
that
would
be
acceptable
in
light
of
combined
exposure
from
food
and
residential
pathways.
The
calculated
DWLOCs
were
then
compared
to
the
EDWCs
provided
by
EFED;
if
model­
derived
EDWCs
exceed
the
DWLOCs
for
surface
or
ground
water,
there
may
have
been
a
concern
for
dietary
exposure
to
residues
in
drinking
water,
and
monitoring
data
may
have
been
required.

In
order
to
fully
implement
the
requirements
of
FQPA,
HED
and
EFED
have
been
working
toward
refining
the
screening­
level
DWLOC
approach
to
conducting
aggregate
risk
assessments
that
combine
exposures
across
all
pathways.
As
part
of
this
process,
EFED
and
HED
have
agreed
that
acute,
chronic
and
cancer
EDWCs
can
be
used
directly
in
dietary
exposure
assessments,
to
calculate
aggregate
dietary
(
food
+
water)
risk.
This
is
done
by
using
the
relevant
PRZM­
EXAMS
value
as
a
residue
for
water
(
all
sources)
in
the
dietary
exposure
assessment.
The
principal
advantage
of
this
approach
is
that
the
actual
individual
body
weight
and
water
consumption
data
from
the
CSFII
are
used,
rather
than
assumed
weights
and
consumption
for
broad
age
groups.
This
refinement
has
been
used
for
propiconazole
acute
and
chronic
aggregate
risk
assessments.

Aggregate
exposure
risk
assessments
were
performed
for
the
following:
acute
aggregate
exposure
(
food
+
drinking
water)
and
chronic
aggregate
exposure
(
food
+
drinking
water).
Short­
term
aggregate
(
food
+
water+
residential
exposure)
risk
assessments
were
also
performed.

7.1
Acute
Aggregate
Risk
Since
the
DEEM
has
included
water
exposure
in
the
acute
analysis,
the
acute
aggregate
risks
are
as
shown
in
Table
7.4
in
Section
7.4
below.

7.2
Short­
Term
Aggregate
Risk
Short­
intermediate
term
aggregate
exposure
takes
into
account
residential
exposure
plus
average
exposure
levels
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Based
on
the
residential
use
pattern,
propiconazole
post­
application
exposures
to
adults
are
from
dermal
exposure
only,
for
infants
and
children
are
from
dermal
and
oral
routes.
Table
7.2a
aggregates
the
short­
term
risk
for
Toddlers
from
incidental
oral,
dermal,
and
food
and
water
(
as
a
background).
Although
both
residential
and
antimicrobial
uses
result
in
incidental
oral
and
dermal
exposure
to
children,
the
highest
incidental
oral
and
dermal
exposure
scenarios
are
from
residential
use
on
turf,
which
were
used
in
the
short
term
aggregate
risk
assessment.
The
short
Page
36
of
55
term
aggregate
risk
does
not
exceed
HED's
level
of
concern.
This
assessment
is
considered
very
conservative
in
that
the
residential
incidental
oral
post­
application
exposure
was
calculated
by
combining
three
screening
level
assessments
(
which
by
themselves
already
have
conservative
estimates).
HED
also
did
a
back­
calculation
to
estimate
room
available
in
the
risk
cup
for
shortterm
aggregate
risk.
In
order
to
obtain
a
short­
term
aggregate
MOE
 
100,
the
MOE
resulting
from
additional
short­
term
exposures
to
Children
1­
2
(
from
possible
dermal
and
incidental
oral
exposure
from
treated
wood
or
other
sources)
needs
to
be
 
270.
As
stated
above
in
Section
6.3,
the
combined
short­
term
MOE
(
dermal
and
incidental
oral)
from
antimicrobial
use
of
propiconazole
in
treated
wood
for
Toddler
is
410,
which
is
greater
than
270.

Table
7.2a:
Short­
term
Aggregate
Risk
Estimates
to
Propiconazole
for
Toddler
(
Children
1­
2years)

Exposure
Scenario
Target
MOE
Route
of
Exposure
Exposure
NOAELs
MOE
at
Day
0
Combined
MOE5
Average
Food
and
Water
(
As
background)
N/
A
Food
and
water
0.014
30
2100
2
Hand
to
Mouth
Activity
on
Turf
100
1
Oral
0.0269
30
1100
3
Object
to
Mouth
Activity
on
Turf
100
1
Oral
0.0067
30
4500
3
Soil
Ingestion
100
1
Oral
0.00009
30
330,000
3
Turf
 
General
High­
Contact
Activities
100
1
Dermal
0.1410
30
210
4
160
Note:
1
Target
MOE=
100,
Developmental
rat­
severe
maternal
clinical
toxicity.
NOAEL=
30
2
MOE
food
=
[(
short­
term
oral
NOAEL)/(
chronic
dietary
exposure)]
3
MOE
oral
=
[(
short
­
term
oral
NOAEL)/(
hand­
to­
mouth
residential
exposure)]
4
MOE
dermal
=
[(
short
­
term
dermal
NOAEL)/(
high­
end
dermal
residential
exposure)]
5
Aggregate
Combined
MOE
(
food,
water,
and
residential)
=
1
÷
[(
1
÷
MOE
food
and
water)
+
(
1
÷
MOE
oral)
+
(
1
÷
MOE
dermal)].

Table
7.2b
aggregates
the
short­
term
risk
fro
adults
from
residential
post
application,
and
average
food
and
water
(
as
a
background).
Based
on
the
low
vapor
pressure
of
propiconazole,
no
post
application
inhalation
exposure
is
anticipated
to
occur.
No
post­
application
exposures
are
expected
to
occur
with
antimicrobial
uses.
The
highest
post
application
exposure
from
residential
use
on
turf
was
used
in
the
short
term
aggregate.
The
aggregate
MOE
is
330,
which
is
greater
than
the
target
MOE
of
100.
This
aggregate
exposure
assessment
is
considered
very
conservative
because
the
assumptions
used
for
each
of
the
scenarios
separately
are
already
high
end
(
i.
e.,
time
spent
outdoors,
dislodgeable
residues).
Page
37
of
55
Table
7.2b:
Short­
term
Aggregate
Risk
Estimates
to
Propiconazole
for
Adults
from
Post­
Application
Activities
Exposure
Scenario
Target
MOE
Route
of
Exposure
Exposure
Or
Daily
dose
NOAELs
MOE
at
Day
0
Combined
MOE4
Average
Food
and
Water
(
As
background)
N/
A
Food
and
water
0.0060
30
5100
2
Residential
Post­
application
(
Residential
Turf
Gen.
High­
Contact
Activities))
100
1
Dermal
0.085
30
350
3
330
Note:
1
Target
MOE=
100,
Developmental
rat­
increased
incidence
of
rudimentary
risks.
NOAEL
=
30
2
MOE
food
and
water
=
[(
short­
term
oral
NOAEL)/(
chronic
dietary
exposure)]
3
MOE
dermal
=
[(
short
­
term
dermal
NOAEL)/(
high­
end
dermal
residential
exposure)]
4
Aggregate
Combined
MOE
(
food,
water,
and
residential)
=
1
÷
[(
1
÷
MOE
food
and
water)
+
(
1
÷
MOE
post
appl.
dermal)].

7.3
Intermediate­
Term
Aggregate
Risk
The
only
residential
use
scenario
that
will
result
in
potential
intermediate
term
exposure
to
propiconazole
is
post
application
exposure
to
Children
from
wood
treatment
(
antimicrobial
use).
Table
7.3
shows
the
aggregate
risk
for
intermediate
term
exposure
to
Children
1­
2
years
old.
The
aggregate
MOE
is
120,
which
is
greater
than
the
target
MOE
of
100.

Table
7.3:
Intermediate
­
term
Aggregate
Risk
Estimates
to
Propiconazole
for
Toddler
(
Children
1­
2years)

Exposure
Scenario
Target
MOE
Route
of
Exposure
Exposure
NOAELs
MOE
at
Day
0
Combined
MOE5
Average
Food
and
Water
(
As
background)
N/
A
Food
and
water
0.014
10
710
2
Incidental
oral
100
1
Oral
0.0056
10
18003
Dermal
Contact
Activities
100
1
Dermal
0.068
10
150
4
120
Note:
1
Target
MOE=
100,
24
Month
oncogenicity
study.
NOAEL=
10
2
MOE
food
=
[(
intermediate­
term
oral
NOAEL)/(
chronic
dietary
exposure)]
3
MOE
oral
=
[(
intermediate
­
term
oral
NOAEL)/(
hand­
to­
mouth
residential
exposure)]
4
MOE
dermal
=
[(
intermediate
­
term
dermal
NOAEL)/(
high­
end
dermal
residential
exposure)]
5
Aggregate
Combined
MOE
(
food,
water,
and
residential)
=
1
÷
[(
1
÷
MOE
food
and
water)
+
(
1
÷
MOE
oral)
+
(
1
÷
MOE
dermal)].
Page
38
of
55
7.4
Long­
Term
Aggregate
Risk
Since
there
are
no
residential
uses
that
will
likely
result
in
chronic
exposure
to
propiconazole,
chronic
aggregate
includes
food
and
water
only.
Water
exposure
has
been
included
in
the
DEEM
analysis;
therefore,
the
result
of
chronic
aggregate
risk
assessment
is
as
shown
in
Table
7.4
below.
Propiconazole
does
not
possess
a
separate
cancer
dietary
endpoint 
the
RfD
approach
is
considered
protective;
therefore,
the
results
of
only
the
acute
and
chronic
analyses
are
given.

Table
7.4.
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
0.018998
6
0.006020
6
All
Infants
(<
1
year
old)
0.042618
14
0.014109
14
Children
1­
2
years
old
0.039530
13
0.014440
14
Children
3­
5
years
old
0.032646
11
0.012419
12
Children
6­
12
years
old
0.023610
8
0.008441
8
Youth
13­
19
years
old
0.016052
5
0.005401
5
Adults
20­
49
years
old
0.015817
5
0.005132
5
Adults
50+
years
old
0.012248
4
0.004164
4
Females
13­
49
years
old
0.014334
5
0.004718
5
N/
A
7.5
Cancer
Risk
The
HIARC
classified
propiconazole
as
a
Group
C
­
possible
human
carcinogen.
RfD
approach
will
be
protective.

8.0
CUMULATIVE
RISK
CHARACTERIZATION/
ASSESSMENT
Propiconazole
is
a
member
of
the
triazole­
containing
class
of
pesticides.
Although
conazoles
act
similarly
in
plants
(
fungi)
by
inhibiting
ergosterol
biosynthesis,
there
is
not
necessarily
a
relationship
between
this
pesticidal
activity
and
their
mechanism
of
toxicity
in
mammals.
Page
39
of
55
Structural
similarities
do
not
constitute
a
common
mechanism
of
toxicity.
Evidence
is
needed
to
establish
that
the
chemicals
operate
by
the
same,
or
essentially
the
same
sequence
of
major
biochemical
events
(
EPA,
2002).
A
variable
pattern
of
toxicological
responses
are
found
for
conazoles.
Some
are
hepatotoxic
and
hepatocarcinogenic
in
mice.
Some
induce
thyroid
tumors
in
rats.
Some
induce
developmental,
reproductive,
and
neurological
effects
in
rodents.
Furthermore,
the
conazoles
have
a
diverse
range
of
biochemical
events
including
altered
cholesterol
levels,
stress
responses,
and
altered
DNA
methylation.
It
is
not
clearly
understood
whether
these
biochemical
events
are
directly
connected
to
the
toxicological
outcomes.
Thus,
there
is
currently
no
evidence
to
indicate
that
conazoles
share
common
mechanisms
of
toxicity
and
EPA
is
not
following
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity
for
the
conazoles.
For
information
regarding
EPA's
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
of
toxicity,
see
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative
9.0
OCCUPATIONAL
EXPOSURE/
RISK
PATHWAY
Occupational
and
Residential
Exposure
Assessment;
James
Miller,
(
D325817,
6/
15/
06)

9.1
Short/
Intermediate­
Term
Handler
Risk
There
is
potential
for
exposure
to
propiconazole
in
occupational
scenarios
from
handling
propiconazole
products
during
the
application
process
(
i.
e.,
mixer/
loaders,
applicators,
flaggers,
and
mixer/
loader/
applicators)
and
a
potential
for
post­
application
worker
exposure
from
entering
into
areas
previously
treated
with
propiconazole.
As
a
result,
risk
assessments
have
been
completed
for
occupational
handler
scenarios.
HED
uses
the
term
"
handlers"
to
describe
those
individuals
who
are
involved
in
the
pesticide
application
process.
HED
believes
that
there
are
distinct
job
functions
or
tasks
related
to
applications
and
that
exposures
can
vary
depending
on
the
specifics
of
each
task.
Job
requirements
(
e.
g.,
amount
of
chemical
to
be
used
in
an
application),
the
kinds
of
equipment
used,
the
target
being
treated,
and
the
level
of
protection
used
by
a
handler
can
cause
exposure
levels
to
differ
in
a
manner
specific
to
each
application
event.
Occupational
handler
exposure
assessments
are
completed
by
HED
using
different
levels
of
personal
protection.
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
occupational
handler
risk
assessments.
No
chemical
specific
information
was
available
for
propiconazole
handler
exposure
assessments;
all
analyses
were
completed
using
acceptable
surrogate
exposure
data
for
the
scenario
in
question.

There
are
short­
and
intermediate­
term
non­
cancer
commercial/
agricultural
handler
scenarios
for
propiconazole
that
have
risks
of
concern;
however,
these
risks
are
at
baseline
PPE,
whereas
all
labels
call
for
baseline
plus
glove
levels
of
PPE.

A
summary
of
the
combined,
dermal
plus
inhalation
short­,
and
intermediate­
term
risks
for
each
exposure
scenario
are
presented
in
Table
9.1.
Page
40
of
55
Table
9.1:
Summary
of
Short­
and
Intermediate­
Term
Propiconazole
Occupational
Handler
Non­
cancer
Risks
S­
Term
MOE
(
Dermal+
Inhalation)
I­
Term
MOE
(
Dermal+
Inhalation)
Exposure
Scenario
Crops
Appl.
Rate
(
lb
ai/
acre
or
lb
ai/
gallon)
Area
Treated
(
acre/
day
or
¹
gal/
day)
Baselin
e
Baseline
+
Gloves
Baseline
Baseline
+
Gloves
Mixer/
Loader
 
Emulsifiable
Concentrate
Cereals
(
Barley,
Oats,
Rye,
Triticale)
Alfalfa,
Sorghum,
Corn
0.1125
1200
13
1500
4.5
500
Celery,
Mint,
Carrots,
Legume
(
Vegetables),
Peanuts,
Strawberries,
Sugar
beets
0.1125
350
46
5100
15
1700
Almonds,
Tree
Nuts,
Filberts,
Onions
0.225
350
23
2600
7.7
850
Soybean
0.169
1200
8.9
1000
3
330
Cranberries
0.169
350
31
3400
10
1100
Wheat
0.08
1200
19
2100
6.3
700
Aerial
Rice
0.28
1200
5.4
600
1.8
200
Cereals
(
Barley,
Oats,
Rye,
Triticale)
Alfalfa,
Sorghum,
Corn
0.1125
200
80
9000
27
3000
Celery,
Mint,
Carrots,
Legume
(
Vegetables),
Peanuts,
Strawberries,
Sugar
beets
0.1125
80
200
22000
67
7500
Almonds,
Tree
Nuts,
Filberts,
Onions
0.225
80
100
11000
33
3700
Soybean
0.169
200
54
6000
18
2000
Cranberries
0.169
80
130
15000
45
5000
Wheat
0.08
200
110
13000
38
4200
Groundboom
Rice
0.28
200
32
3600
11
1200
Airblast
Almonds,
Tree
Nuts,
Filberts
0.1125
40
400
45000
130
15000
Cereals
(
Barley,
Rye,
Oats,
Trticale),
Corn,
Legume
(
vegetables),
Peanuts,
Sorghum,
Sugar
beets
0.1125
350
46
5100
15
1700
Wheat
0.08
350
65
7200
22
2400
Chemigation
Rice
0.28
350
18
2100
6.2
690
Seed
Piece
Dip
Pineapple
(
HI)
0.00021
1000
¹
8600
960000
2900
320000
Applicator 
Emulsifiable
Concentrate
Page
41
of
55
Cereals
(
Barley,
Oats,
Rye,
Triticale)
Alfalfa,
Sorghum,
Corn
0.1125
1200
7500
16000
2500
5500
Celery,
Mint,
Carrots,
Legume
(
Vegetables),
Peanuts,
Strawberries,
Sugar
beets
0.1125
350
26000
56000
8600
19000
Almonds,
Tree
Nuts,
Filberts,
Onions
0.225
350
13000
28000
4300
9400
Soybean
0.169
1200
5000
11000
1700
3600
Cranberries
0.169
350
17000
37000
5700
12000
Wheat
0.08
1200
11000
23000
3500
7700
Aerial
Aerial
Rice
0.28
1200
3000
6600
1000
2200
Cereals
(
Barley,
Oats,
Rye,
Triticale)
Alfalfa,
Sorghum,
Corn
0.1125
200
15000
15000
4900
4900
Celery,
Mint,
Carrots,
Legume
(
Vegetables),
Peanuts,
Strawberries,
Sugar
beets
0.1125
80
37000
37000
12000
12000
Almonds,
Tree
Nuts,
Filberts,
Onions
0.225
80
18000
18000
6100
6100
Soybean
0.169
200
9800
9800
3300
3300
Cranberries
0.169
80
24000
24000
8200
8200
Wheat
0.08
200
2100
2100
6900
6900
Groundboom
(
Open
Cab)

Rice
0.28
200
37000
37000
12000
12000
Air
blast
(
open
cab)
Almonds,
Tree
Nuts,
Filberts
0.1125
40
3100
4600
1000
1500
Seed
Piece
dipping
Pineapple
No
data
Flagger 
Emulsifiable
Concentrate
Cereals
(
Barley,
Oats,
Rye,
Triticale)
Alfalfa,
Sorghum,
Corn
Celery,
Mint,
Carrots,
Legume
(
Vegetables),
Peanuts,
Strawberries,
Sugar
beets
0.1125
350
11000
10000
3700
3500
Almonds,
Tree
Nuts,
Filberts,
Onions
0.225
350
5600
5200
1900
1700
Aerial
Soybean
Cranberries
0.169
350
7500
6900
2500
2300
Page
42
of
55
Wheat
0.08
350
16000
15000
5300
4900
Rice
0.28
350
4500
4200
1500
1400
Note:
­
Baseline
PPE
=
(
long
sleeve
shirt,
long
pants,
no
gloves,
and
no
respirator)
­
MOE
=
NOAEL/
Daily
Dose
where
the
NOAEL
for
both
dermal
and
inhalation
is
30.0
mg/
kg/
day
for
Short­
term
and
10.0
mg/
kg/
day
for
Intermediate/
Long­
term
exposures.
­
The
target
MOE
is
100
for
Short­
and
Intermediate­
term
Dermal/
Inhalation
exposure.
¹
Area
treated:
(
gal/
day)

9.2
Short/
Intermediate­
Term
Post­
application
Risk
HED
uses
the
term
"
post­
application"
to
describe
exposures
to
individuals
that
occur
as
a
result
of
being
in
an
environment
that
has
been
previously
treated
with
a
pesticide
(
also
referred
to
as
re­
entry
exposure).
HED
believes
that
there
are
distinct
job
functions
or
activities
that
occur
in
previously
treated
areas.
These
job
functions
(
e.
g.,
the
kinds
of
jobs
to
cultivate
a
crop),
the
nature
of
the
crop
or
target
that
was
treated,
and
the
how
chemical
residues
degrade
in
the
environment
can
cause
exposure
levels
to
differ
over
time.
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
occupational
post­
application
worker
risk
assessments
for
agricultural
scenarios.
A
total
of
three
residue
dissipation
studies
were
used.
These
studies
described
residue
dissipation
and
exposure
for
corn,
rice,
and
pecans.
The
corn
data
have
been
used
to
complete
all
assessments
for
the
following
agronomic
crop
groups:
Tall
field/
row
crop:
corn
(
field/
pop/
sweet),
sunflowers
breeder's
seed.
The
rice
data
have
been
used
to
complete
all
assessments
for
field/
row
crops,
low/
medium:
wheat,
barley,
mint,
and
rice.
The
pecan
data
have
been
used
to
complete
all
assessments
for
tree
nuts.
The
transfer
coefficients
used
in
this
assessment
are
from
an
interim
transfer
coefficient
policy
developed
by
HED's
Science
Advisory
Council
for
Exposure
using
proprietary
data
from
the
Agricultural
Re­
entry
Task
Force
(
ARTF)
database
(
policy
#
3.1).

All
agricultural
scenarios
were
evaluated
using
propiconazole­
specific
DFR/
TTR
dissipation
data.
A
summary
of
the
post­
application
risks
for
each
crop/
activity
combination
is
shown
in
Table
9.2.
Table
9.2:
Summary
of
Propiconazole
Non­
cancer
Post­
application
Worker
Risk
Estimates
Crop
Activity
TC
cm2/
hr
Max.
App.
Rate
(
lb
ai/
A
or
Gal/
day)
DFR
ug/
cm
2
(
adjusted)
Short­
Term
MOE
Int­
Term
MOE
irrigating,
scouting,
hand­
weeding
100
0.184
36000
12000
irrigating,
scouting
1500
0.184
2400
800
Alfalfa,
Celery,
Mint,
Barley,
Legume,
Oats,
Peanuts,
Rice,
Rye,
Soybean,
Sugar
beets,
Triticale,
Wheat,
hand­
harvesting
2500
0.28
0.184
1400
500
scouting
,
weeding
100
0.059
110000
37000
scouting
,
weeding
(
more
mature
foliaged
plants)
400
0.059
28100
9000
scouting,
weeding,
irrigation
1000
0.059
11000
3700
Corn
(
field,
pop,
sweet),
Sorghum
detasseling,
handharvesting
17000
0.1125
0.059
660
220
scouting,
handweeding
irrigation,
thinning
300
0.505
4000
1400
irrigating,
scouting
1500
0.505
870
290
Carrots,
Onions
irrigating,
scouting
2500
0.225
0.505
520
170
hand­
weeding,
thinning,
pruning,
irrigating,
scouting
400
0.379
4300
400
Cranberries,
Strawberries,
hand­
pruning,
harvest,
pinch,
train
1500
0.169
0.379
1200
390
hand­
weeding,
thinning,
irrigating,
scouting
500
0.255
5200
1700
Almonds,
Tree
Nuts,
Filberts
hand­
pruning,
thinning
2500
0.225
0.255
1000
340
Note:
All
DFR
and
Margin
of
Exposure
data
are
measured
at
DAT
=
0.

Most
occupational
post­
application
short­,
intermediate
and
long­
term
risks
do
not
exceed
HED's
level
of
concern
(
i.
e.,
MOEs
>
100)
at
day
0.
The
occupational
post­
application
short­
and
intermediate­
and
long­
term
risks
that
exceed
HED's
level
of
concern
(
i.
e.,
MOE's
<
100)
at
Day
=
0
are
as
follows:
Page
44
of
55
Short­
Term:
All
short­
term
occupational
risks
are
below
HED's
level
of
concern
(
i.
e.,
MOEs
>
100)
at
day
0.

Intermediate­
Term:
All
intermediate­
term
occupational
risks
are
below
HED's
level
of
concern
(
i.
e.,
MOEs
>
100)
at
day
0.

10.0
DATA
NEEDS
AND
LABEL
REQUIREMENTS
Since
propiconazole
is
a
triazole
generating
pesticide,
as
specified
in
HED's
February
7,
2006
risk
assessment
(
M.
Doherty
et
al,
DP#
322215)
for
1,2,4­
triazole
and
its
metabolites
triazole
alanine
and
triazole
acetic
acid,
HED
recommended
that
resolution
of
various
issues
be
a
condition
of
registration
for
new
uses
of
triazole­
derivative
fungicides
and
for
new
active
ingredients
which
contain
the
1,2,4­
triazole
ring.
The
requirement
for
a
chronic
toxicity/
oncogenicity
study
in
male
rats
and
female
mice
in
the
2/
7/
2006
memo
was
later
modified
by
HED
to
a
1­
year
chronic
study
in
male
and
female
rats
(
Kit
Farwell,
DP#
321328,
5/
10/
2006).
Therefore,
HED
recommends
that
the
registration
of
the
proposed
new
uses
of
propiconazole
be
conditioned
upon
resolution
of
the
following
issues:

 
Chemistry:
­
Final
two­
year
storage
stability
study
with
1,2,4­
triazole;
­
Resolution
of
concerns
regarding
the
prevalence
of
conjugated
residues
of
TA
and
the
ability
of
the
analytical
method
to
quantify
them.
 
Toxicology:
­
Free
triazole:

 
Developmental
neurotoxicity
study
in
rats;

 
Chronic
toxicity
 
1
year
chronic
rat
study
in
males
and
females
 
Acute
neurotoxicity
study
in
rats
[
This
study,
included
in
the
original
data
requirements,
was
placed
in
reserve
pending
the
results
of
the
combined
subchronic/
neurotoxicity
study,
in
response
to
a
previous
waiver
request.
A
new
waiver
request
for
this
study
was
submitted
in
August
2005,
and
is
under
review.];
­
Triazole
alanine:

 
Developmental
toxicity
study
in
rabbits;

 
Chronic
toxicity
study
in
rats,
conducted
according
to
current
guidelines
that
include
neurobehavioral
assessments,
with
additional
neuropathology
evaluations
conducted
according
to
the
neurotoxicity
guidelines;
­
Triazole
acetic
acid:

 
Developmental
toxicity
study
in
rabbits;

 
Combined
90­
day
feeding/
neurotoxicity
study
in
rats.

In
addition
to
the
above
data
requirements,
the
following
data
requirements
are
also
needed
for
this
particular
registration
action.
Page
45
of
55
10.1
Residue
Chemistry
Data
Needs
 
HED
recommends
that
the
registrant
analyze
parent
and
metabolites
separately
in
all
future
field
trials,
so
that
more
realistic
tolerances
can
be
set
in
the
future.

 
Label
directions
for
the
EC
and
WP
formulations
must
be
amended
to
include
the
recommended
changes
listed
under
the
`
Directions
for
use'
section
in
the
Residue
Chemistry
Summary
Chapter.

 
To
support
the
use
of
the
EC
formulation
on
sugar
beets,
an
additional
8
sugar
beet
field
trials
are
required
using
a
representative
EC
formulation.
As
the
available
data
indicate
that
residues
in/
on
roots
are
similar
for
the
WP
and
EC
formulations,
only
residue
data
on
sugar
beet
tops
are
required
from
these
trials.
HED
recommends
that
registration
of
the
EC
on
sugar
beets
be
conditional
upon
the
data
on
tops.

 
A
total
of
12
dry
bean
field
trials
and
5
dry
pea
field
trials
are
required
to
support
the
proposed
tolerance
on
the
dry
pea
and
bean
subgroup
6C.
Only
five
dry
bean
field
trials
are
available,
and
they
support
a
28­
day
PHI
rather
than
the
proposed
14­
day
PHI.
Additional
7
trials
on
dry
beans
and
5
trials
on
dry
peas
at
the
proposed
rates
are
needed.

 
Since
data
are
available
supporting
tolerances
on
soybean
forage
and
hay,
the
petitioner
may
delete
the
"
prohibit
animal
grazing"
or
"
prohibit
feeding
hay
to
livestock"
on
the
label.

 
The
available
wheat
field
trial
will
only
support
a
maximum
use
rate
of
0.11
lb
ai/
A
prior
to
the
harvest
of
forage
or
hay.
Label
must
be
revised
to
specify
that
no
more
than
0.11
lbs
ai/
A
be
applied
before
the
harvest
of
forage
and
hay.
If
the
petitioner
intends
to
support
the
use
of
two
applications
totaling
0.22
lb
ai/
A
prior
to
harvest
of
forage
and
hay,
then
an
additional
8
field
trials
are
required
on
forage
and
a
complete
set
of
20
field
trials
are
required
for
hay.

 
The
available
field
corn
and
sorghum
field
trial
data
will
only
support
applications
totaling
0.22
lb
ai/
A
prior
to
the
harvest
of
forage.
If
the
petitioner
intends
to
support
total
application
rate
up
to
0.44
lb
ai/
A
prior
to
the
harvest
of
forage,
than
additional
field
corn
and
sorghum
forage
data
will
be
required
to
support
the
higher
use
rate.

 
As
propiconazole
is
one
of
the
triazole
producing
pesticides,
any
requests
for
new
uses
submitted
after
September
1,
2005
will
require
data
related
to
assessing
the
common
metabolites.
For
detailed
information,
please
refer
to
HED
memo
of
4/
25/
06,
M.
Doherty,
D327788,
"
Guidance
on
Residue
Chemistry
Data
Submission".
Page
46
of
55
10.2
ORE
Data
Needs
 
None.

10.3
Toxicology
Data
Needs
None.

11.0
RECOMMENDED
TOLERANCES
Table
11
lists
the
Agency's
recommended
tolerances.
The
Agency
notes
that
these
recommended
tolerance
levels
are
relatively
conservative,
as
they
are
based
on
data
for
combined
residues
instead
of
propiconazole,
per
se.

The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
propiconazole
in/
on
various
raw
agricultural
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
propiconazole
per
se,
which
is
the
same
as
the
US
tolerance
expression,
recommended
by
the
RED
for
existing
tolerances
and
for
the
new
uses
in
the
present
action.
In
addition,
both
Canada
and
Mexico
have
established
MRLs/
tolerances
on
several
commodities
which
also
have
U.
S.
tolerances.
To
the
extent
possible,
U.
S.
tolerances
have
been
harmonized
with
Codex,
Canadian,
and
Mexican
MRLs;
however,
differences
in
use
patterns
and
the
supporting
residue
data
have
precluded
reducing
many
tolerances.
A
comparison
of
Codex
MRLs,
Canadian
MRLs,
and
Mexican
tolerances
and
the
corresponding
U.
S.
tolerances
is
presented
in
Appendix
I.
Page
47
of
55
Table
11.
Tolerance
Summary
for
Propiconazole
Crop
Commodity
Proposed
or
(
Established)
Tolerance
(
ppm)
6
HED
Recommend
ed
Tolerance
(
ppm)
Comments
(
Correct
Commodity
Definition)
Tolerances
under
§
180.434(
a)

AGF
17
30
Based
on
the
maximum
expected
residues
in
AGF
from
corn
(
1.28
ppm),
sorghum
(
10.9
ppm),
soybeans
(
44.8
ppm),
and
wheat
(
4.14
ppm),
the
tolerance
for
AGF
should
be
based
on
the
available
soybean
data.
Grain,
aspirated
fractions
Alfalfa
0.1
None
As
the
tolerance
is
for
rotated
alfalfa,
it
should
be
established
under
§
180.434(
d)
for
inadvertent
residues
Almond,
hulls
8.0
7.0
1
Adequate
data
are
available.
Almond,
hulls
Banana
(
0.2)
0.2
The
existing
tolerance
is
adequate
Barley,
grain
0.5
0.3
Barley,
hay
2.0
1.4
Barley,
straw
13
10
Barley,
bran
2.5
0.6
Tolerances
for
barley
commodities
are
based
on
residue
data
translated
from
wheat.

Cattle,
fat
(
0.1)
0.05
Cattle,
kidney
(
2.0)
2.0
Cattle,
liver
(
2.0)
2.0
Cattle,
meat
(
0.1)
0.05
Cattle,
meat
byproducts,
except
liver
and
kidney
(
0.1)
0.05
The
recalculated
MTDB
for
beef
cattle
(
28
ppm).
Estimated
combined
residues
are:
1.7
ppm
in
kidney,
1.6
ppm
in
liver,
0.03
ppm
in
muscle,
0.05
ppm
in
fat.

Celery
(
5.0)
Delete
Once
the
tolerance
of
the
leaf
petioles
subgroup
is
established
the
separate
tolerance
on
celery
should
be
deleted
Crop
Subgroup
4­
B,
leaf
petioles
5.0
5.0
1
The
available
residue
data
on
celery
will
support
the
5
ppm
tolerance
on
Vegetable,
leaf
petioles,
subgroup
4B
Crop
Subgroup
6­
C,
Dried
shelled
peas
and
bean
(
except
soybean)
0.5
None
5
Insufficient
residue
data
to
support
a
tolerance
on
the
Pea
and
bean,
dried
shelled,
except
soybean,
subgroup
6C
Crop
Group
13­
Berries
Group
1.0
1.0
1
Adequate
residue
data
are
available
on
blueberries,
black
berries,
and
raspberries
to
support
a
tolerance
for
Berry,
group
13
Carrot
0.2
0.25
1
Adequate
residue
data
are
available.
Carrot,
root
Corn,
field,
forage
4.0
12
Adequate
residue
data
are
available
supporting
a
30­
day
PHI
for
field
corn
forage
following
applications
totaling
0.44
lb
ai/
A.
Corn,
field,
forage
Page
48
of
55
Table
11.
Tolerance
Summary
for
Propiconazole
Crop
Commodity
Proposed
or
(
Established)
Tolerance
(
ppm)
6
HED
Recommend
ed
Tolerance
(
ppm)
Comments
(
Correct
Commodity
Definition)

Corn,
sweet,
forage
None
6.0
3
A
separate
tolerance
should
be
established
for
sweet
corn
forage.
Based
on
the
available
sweet
corn
field
trials,
in
which
maximum
residues
were
5.0
ppm
in/
on
forage
from
a
test
conducted
at
a
0.9x
rate,
a
6.0
ppm
tolerance
should
be
established
for
residues
in/
on
Corn,
sweet,
forage.

Corn,
field,
grain
0.3
0.2
2
Adequate
residue
data
are
available
supporting
the
reduced
30­
day
PHI.

Corn,
pop,
grain
None
0.22
Adequate
residue
data
are
available
supporting
the
reduced
30­
day
PHI.

Corn,
sweet,
K+
CWHR
(
0.1)
0.1
Adequate
residue
data
are
available
supporting
the
existing
tolerance.
Corn,
sweet,
K+
CWHR
Corn,
stover
25
30
1
Adequate
residue
data
are
available
supporting
the
reduced
30­
day
PHI.

Corn,
pop,
stover
None
30
1
Based
on
the
field
corn
stover
data.

Corn,
sweet,
stover
None
30
1
Based
on
the
field
corn
stover
data.

Corn,
oil
0.5
None
Processing
factors
for
corn
oil
were
0.6x­
1.6x
and
averaged
1x;
therefore,
a
separate
tolerance
is
not
required
for
corn
oil
Fruit,
stone,
group
12
None
1.0
Tolerance
was
reassessed
by
the
Agency
(
HED
memo
of
propiconazole
RED,
6/
28/
06,
Y.
Donovan,
D329668).
Goat,
fat
(
0.1)
0.05
Goat,
kidney
(
2.0)
2.0
Goat,
liver
(
2.0)
2.0
Goat,
meat
(
0.1)
0.05
Goat,
meat
byproducts,
except
liver
and
kidney
(
0.1)
0.05
See
comments
under
cattle.

Grass,
forage
(
0.5)
0.5
Grass,
hay
(
0.5)
0.5
Grass,
straw
(
40)
40
The
existing
tolerances
are
adequate.
(
HED
memo
of
propiconazole
RED,
6/
28/
06,
Y.
Donovan,
D329668).
Hog,
fat
(
0.1)
Delete
Hog,
kidney
(
2.0)
0.2
Hog,
liver
(
2.0)
0.2
Hog,
meat
(
0.1)
Delete
Hog,
meat
byproducts,
except
liver
and
kidney
(
0.1)
Delete
The
recalculated
MTDB
for
swine
(
2.3
ppm)
and
estimated
residues
in
liver
(
0.13
ppm),
kidney
(
0.14
ppm),
muscle
(<
0.005
ppm)
and
fat
(
0.005
ppm)
at
a
1x
feeding
level.

Horse,
fat
(
0.1)
0.05
See
comments
under
cattle.
Page
49
of
55
Table
11.
Tolerance
Summary
for
Propiconazole
Crop
Commodity
Proposed
or
(
Established)
Tolerance
(
ppm)
6
HED
Recommend
ed
Tolerance
(
ppm)
Comments
(
Correct
Commodity
Definition)
Horse,
kidney
(
2.0)
2.0
Horse,
liver
(
2.0)
2.0
Horse,
meat
(
0.1)
0.05
Horse,
meat
byproducts,
except
liver
and
kidney
(
0.1)
0.05
Mint,
spearmint,
tops
3.0
3.5
1
Adequate
data
are
available.
Mint,
peppermint,
tops
3.0
3.5
1
Adequate
data
are
available.

Milk
(
0.05)
0.05
MTDB
for
dairy
cattle
is
18.5
ppm.
The
estimated
combined
residue
on
milk
at
1x
MTDB
based
on
feeding
study
is
0.03
ppm.
Mushroom
(
0.1)
0.1
The
existing
tolerance
is
adequate.
Oats,
forage
10.0
1.7
Oats,
grain
0.1
0.32
Oats,
hay
30.0
1.4
Oats,
straw
1.0
10
As
the
proposed
changes
to
the
label
directions
will
also
cover
oats
in
addition
to
wheat,
the
wheat
residue
data
will
also
be
translated
to
oats
to
reassess
the
existing
tolerances.

Onion,
bulb
0.3
0.2
2
Adequate
residue
data
are
available.
Maximum
combined
residues
were
0.18
ppm
in/
on
dry
bulb
onions.
Onion,
dry
bulb
Onion,
green
8.0
9.0
1
Adequate
residue
data
are
available.
Onion,
green
Peanut,
nut
meat
(
0.2)
0.2
Peanut,
hay
(
20)
20
The
existing
tolerances
are
adequate.

Pecans
(
0.1)
Delete
Once
the
tree
nut
crop
group
tolerance
is
established,
the
separate
tolerance
for
pecans
should
be
deleted
Pineapple
(
0.1)
0.1
The
existing
tolerance
is
adequate.

Pistachio
0.2
0.1
Tolerance
is
based
on
residue
data
from
almonds
and
pecans
Rice,
bran
28
15
Based
on
HAFT
residues
of
5.05
ppm
for
rice
grain
and
an
average
processing
factor
of
2.9x
for
bran,
the
maximum
expected
residues
in
bran
would
be
14.6
ppm.
Rice,
bran
Rice,
grain
7.0
7.0
4
Adequate
field
trial
data
are
available.
Rice,
grain
Rice,
hulls
28
20
Based
on
HAFT
residues
of
5.05
ppm
for
rice
grain
and
an
average
processing
factor
of
3.8x
for
hulls,
the
maximum
expected
residues
in
hulls
would
be
19.2
ppm.
Rice,
hulls
Rice,
straw
18
18
1
Adequate
field
trial
data
are
available.
Page
50
of
55
Table
11.
Tolerance
Summary
for
Propiconazole
Crop
Commodity
Proposed
or
(
Established)
Tolerance
(
ppm)
6
HED
Recommend
ed
Tolerance
(
ppm)
Comments
(
Correct
Commodity
Definition)
Rice,
straw
Rye,
grain
0.5
0.3
Rye,
forage
3.0
1.7
Rye,
straw
13
10
Rye,
bran
2.5
0.6
Tolerances
for
rye
commodities
are
based
on
residue
data
translated
from
wheat.

Grain
sorghum,
forage
10
12
1
Grain
sorghum,
grain
2.5
3.5
1
Grain
sorghum,
(
stover)
15
15
1
Adequate
field
trial
data
are
available
for
sorghum.
Sorghum,
grain,
forage;
Sorghum,
grain;
and
Sorghum,
grain,
stover
Sheep,
fat
(
0.1)
0.05
Sheep,
kidney
(
2.0)
2.0
Sheep,
liver
(
2.0)
2.0
Sheep,
meat
(
0.1)
0.05
Sheep,
meat
byproducts,
except
liver
and
kidney
(
0.1)
0.05
See
comments
under
cattle.

Soybean,
forage
8.0
11
1
Soybean,
hay
32
30
1
Adequate
field
trial
data
are
available
at
the
1x
rate
to
support
a
30­
day
PHI
for
Soybean,
forage
and
Soybean,
hay
Soybean,
seed
2.0
2.0
Field
trial
data
are
available
to
support
Soybean
seed
following
applications
up
to
Stage
R6.

Strawberry
1.5
1.3
1
Adequate
residue
data
are
available.
Strawberry
Sugar
beet,
dried
pulp
2.0
1.0
Based
on
HAFT
residues
of
0.18
ppm
for
roots
and
a
4.9x
processing
factor
for
dried
pulp,
maximum
expected
residues
in
dried
pulp
would
be
0.88
ppm.
Beet,
sugar,
dried
pulp
Sugar
beet,
roots
0.3
0.3
2
Adequate
residue
data
are
available
and
indicate
that
there
is
no
difference
in
residue
levels
in/
on
roots
between
the
WP
and
EC
formulations.
Tolerance
in
based
on
maximum
residues
of
0.23
ppm
in/
on
roots
Beet,
sugar,
roots
Page
51
of
55
Table
11.
Tolerance
Summary
for
Propiconazole
Crop
Commodity
Proposed
or
(
Established)
Tolerance
(
ppm)
6
HED
Recommend
ed
Tolerance
(
ppm)
Comments
(
Correct
Commodity
Definition)

Sugar
beet,
tops
10
10
5
Adequate
residue
data
are
available
for
the
WP
formulation
and
suggest
a
tolerance
level
of
4.5
ppm.
However,
the
limited
field
trial
data
for
the
EC
formulation
indicate
that
a
higher
tolerance
is
required.
A
tolerance
should
be
set
at
10
ppm,
with
the
registration
conditioned
upon
the
submission
of
additional
residue
data
on
tops
for
the
EC
formulation.
Beet,
sugar,
tops
Sugar
beet,
molasses
3.0
1.5
Based
on
HAFT
residues
of
0.18
ppm
for
roots
and
a
7.4x
processing
factor
for
molasses,
maximum
expected
residues
in
molasses
would
be
1.33
ppm.
Beet,
sugar,
molasses
Tree
nuts
crop
group
0.2
0.12
Adequate
residue
data
are
available
on
pecans
and
almonds.
Tolerance
is
based
on
maximum
residues
of
0.09
ppm
for
almonds
and
<
0.1
ppm
for
pecans.
Nut,
tree,
group
14
Wheat,
bran
2.5
0.6
Based
on
HAFT
combined
residues
of
0.18
ppm
for
wheat
grain
and
an
average
3.2x
processing
factor
for
wheat
bran,
maximum
expected
residues
in
bran
would
be
0.58
ppm.
Wheat,
bran
Wheat,
forage
3.0
1.71
Adequate
residue
data
are
available
to
support
only
a
single
application
prior
to
the
harvest
of
Wheat,
forage.

Wheat,
grain
0.5
0.3
2
Tolerance
is
based
on
maximum
values
of
0.20
ppm
for
combined
residues
or
0.05
ppm
for
parent
residues.
Wheat,
grain
Wheat,
hay
2.0
1.41
Adequate
residue
data
are
available
reflecting
only
a
single
application
prior
to
harvest
of
Wheat,
hay.

Wheat,
straw
13
101
Adequate
residue
data
are
available.
Wheat,
straw
Tolerances
under
§
180.434(
c)

Cranberry
1.0
1.0
Adequate
residue
data
are
available.
Although
the
tolerance
spreadsheet
recommends
a
0.9
ppm
tolerance,
a
slightly
higher
1.0
ppm
tolerance
was
selected
to
harmonize
with
the
berries
crop
group.
Cranberry
Page
52
of
55
Table
11.
Tolerance
Summary
for
Propiconazole
Crop
Commodity
Proposed
or
(
Established)
Tolerance
(
ppm)
6
HED
Recommend
ed
Tolerance
(
ppm)
Comments
(
Correct
Commodity
Definition)

Mint,
tops
(
leaves
and
stems)
0.3
Delete
Adequate
data
are
available
for
all
major
mint
growing
regions.
The
tolerance
under
180.434(
c)
should
be
deleted
once
the
new
tolerance
on
mint
is
established
under
180.434(
a)
Tolerances
under
§
180.434(
d)

Alfalfa
0.1
0.1
2
Adequate
residue
data
are
available
to
support
a
75­
day
PBI
for
alfalfa.
Separate
tolerances
should
be
established
for
inadvertent
residues
in/
on
alfalfa,
forage
and
alfalfa,
hay,
each
at
0.1
ppm
1
Tolerance
level
was
calculated
using
the
tolerance
spreadsheet
and
the
relevant
Agency
guidance.
2
Recommended
tolerance
is
based
on
maximum
residue
levels
due
to
the
large
portion
(>
15%)
of
samples
having
residues
<
LOQ.
3
The
residue
data
on
sweet
corn
were
reviewed
under
PP#
8F3674
(
C.
Deyrup,
12/
14/
88).
4
The
tolerance
spreadsheet
recommended
a
tolerance
of
16
ppm
for
rice
grain
assuming
that
the
data
are
distributed
lognormally.
However,
an
examination
of
the
plot
suggests
that
the
data
are
not
log
normal;
therefore,
a
tolerance
of
7
ppm
was
selected
using
the
California
Method
(
µ
+
3 ).
Combined
residues
in/
on
rice
grain
were
<
0.05­
5.20
ppm
and
averaged
1.49
ppm.
5
Additional
residue
data
are
required.
Therefore
only
a
conditional,
time­
limited
tolerance
is
being
recommended.
6
Tolerances
in
parenthesis
are
currently
established
under
40
CFR
§
180.434.
Page
53
of
55
Appendix
I
 
International
Residue
Limits
INTERNATIONAL
RESIDUE
LIMIT
STATUS
Chemical
Name:
1­[[
2­
(
2,4­
dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl]
methyl]­
1H­
1,2,4­
triazole
Common
Name:
Propiconazole
X
Proposed
tolerances
9
Reevaluated
tolerance
9
Other
Date:
7/
14
/
06
Codex
Status
(
Maximum
Residue
Limits)
U.
S.
Tolerances
X
No
Codex
proposal
step
6
or
above
9
No
Codex
proposal
step
6
or
above
for
the
crops
requested
Petition
Number:
2F6371,
6E4788,
7E4860,
and
8E4931
DP
Barcode:
D238458
Other
Identifier:

Reviewer/
Branch:
Y.
Donovan/
RAB4
Residue
definition
(
step
8/
CXL):
Propiconazole
Residue
definition:
Tolerances
are
currently
expressed
as
the
combined
residues
of
propiconazole
and
its
metabolites
determined
as
2,4­
DCBA
and
expressed
as
parent.
However,
HED
has
recommended
that
the
tolerance
expression
be
changed
to
include
only
parent.

Crop
(
s)
1
MRL
(
mg/
kg)
Crop(
s)
Proposed
or
Established
Tolerance
(
ppm)

Almonds
0.05
Tree
nuts
0.10
Banana
0.1
Banana
0.2
Barley
0.05
Barley,
grain
0.3
Coffee
beans
0.1
Not
registered
use
Liver
and
Kidneys
of
cattle,
goats,
horses,
hogs,
and
sheep
2.0
Edible
offal
(
mammalian)
0.05
Meat
byproducts,
except
liver
and
kidney
0.1
Eggs
0.05
Tolerance
not
required
Grapes
0.5
No
registered
uses
Mango
0.05
No
registered
uses
Meat
(
from
mammals
other
than
marine
0.05
Meat
and
fat
of
cattle,
goats,
horses,
hogs,
and
0.1
Page
54
of
55
mammals)
sheep
Milks
0.01
Tolerance
not
required
Oats
0.05
Oats,
grain
0.3
Peanut
0.05
Peanut,
whole
0.1
Peanut
0.2
Pecan
0.05
Tree
Nuts
0.10
Poultry
meat
0.05
Tolerance
not
required
Rape
seed
0.05
No
registered
uses
Rye
0.05
Rye,
grain
0.3
Stone
fruits
1.0
Fruit,
Stone,
group
12
1.0
Sugar
beet
0.05
Beet,
sugar,
roots
Sugar
beet
leaves
or
tops
0.5
Beet,
sugar,
tops
10
Sugar
cane
0.05
No
registered
uses
Wheat
0.05
Wheat
Grain
0.3
Limits
for
Canada
Limits
for
Mexico
9
No
Limits
9
No
Limits
for
the
crops
requested
9
No
Limits
9
No
Limits
for
the
crops
requested
Residue
definition:
Propiconazole
and
its
metabolites
including
the
2,4­
DCBA
moiety
Residue
definition:
Propiconazole
Crop(
s)
MRL
(
mg/
kg)
Crop(
s)
MRL
(
ppm)
Liver
and
kidney
of
cattle
2
Barley
0.1
Apricots,
cherries,
peaches/
nectarines,
plums
1
Beans
0.5
Dried
blueberries
0.15
Walnut
0.1
Asparagus
0.1
Banana
0.2
Barley,
oats,
wheat
0.05
Wheat
0.1
Blueberries
0.02
blackberries,
loganberries
and
raspberries
0.7
proposed
Notes/
Special
Instructions:
Page
55
of
55
CC:
Yan
Donovan