Document ID: EPA-HQ-OPP-2005-0497-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-02-15T05:00Z

1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
January
31,
2005
Subj:
Propiconazole:
Revised
Occupational
and
Residential
Exposure
Assessment
for
the
Re­
registration
Eligibility
Decision
Document
(
RED).

PC
Code:
122101
(
Propiconazole)

DP
#:
324682
From:
James
Miller,
Environmental
Scientist
Health
Effects
Division/
Re­
registration
Branch
4
(
7509C)

Through:
Susan
Hummel,
Branch
Senior
Scientist
Health
Effects
Division/
Re­
registration
Branch
4
(
7509C)

To:
Yan
Donovan,
Risk
Assessor
Health
Effects
Division/
Registration
Action
Branch
4
(
7509C)

The
attached
assessment
is
the
revised
occupational
and
non­
occupational
(
residential)
exposure
and
risk
estimates
for
propiconazole
to
support
HED's
Re­
registration
Eligibility
Decision
(
RED)
document
This
assessment
was
reviewed
by
HED's
Science
Council
for
Exposure
(
Expo
SAC)
to
ensure
compliance
with
current
HED
policy
for
conducting
occupational
and
residential
exposure
(
ORE)
assessments.
2
Table
of
Contents
1.0
Executive
Summary
........................................................................................................
4
1.1
Background
and
Purpose
.....................................................................................
4
1.2
Use
Patterns
and
Formulations.............................................................................
4
1.3
Criteria
for
Conducting
Exposure
Assessments
....................................................
4
1.4
Hazard
Identification
..........................................................................................
5
1.5
Occupational
and
Residential
Non­
Cancer
Risks
            ...
6
2.0
Hazard
Identification.......................................................................................................
7
2.1
Acute
Toxicological
Categories
...........................................................................
7
2.2
Toxicological
Endpoints
......................................................................................
8
2.3
Dermal
Absorption
..............................................................................................
9
2.4
Dermal
Exposure:
Short­
Term
...........................................................................
10
2.5
Dermal
Exposure:
General
Population
...............................................................
10
2.6
Dermal
Exposure:
Intermediate
and
Long­
Term
................................................
10
2.7
Inhalation
Exposure:
Short­
Term.......................................................................
11
2.8
Inhalation
Exposure:
Intermediate
and
Long­
Term
............................................
11
2.9
Margins
of
Exposure
...........................................................................................
11
3.0
Summary
of
Use
Patterns
and
Formulations
.................................................................
12
3.1
Mode
of
Action
and
Target
Pests
......................................................................
12
3.2
Occupational/
Agricultural
Use
Sites
..................................................................
12
3.3
Homeowner/
Residential
Use
Sites
.....................................................................
13
3.4
Formulations/
Master
Label
Report.....................................................................
13
3.5
Application
Methods
and
Equipment
.................................................................
16
4.0
Incident
Report.............................................................................................................
17
5.0
Occupational
Exposure
and
Risks.................................................................................
19
5.1
Occupational
Handler
Exposure
and
Risk
..........................................................
19
5.1.1
Data
and
Assumptions
for
Handler
Exposure
Scenarios..........................
20
5.1.2
Exposure
Data
for
Handler
Exposure
Scenarios......................................
21
5.1.3
Agricultural
Handler
Scenarios...............................................................
24
5.1.4
Non­
Cancer
Propiconazole
Handler
Exposure
and
Assessment
..............
25
5.1.4.1
Non­
Cancer
Propiconazole
Handler
Exposure
and
Risk
Calculations................................................................................
25
5.1.4.2
Propiconazole
Non­
Cancer
Risk
Summary
.................................
27
5.1.5
Summary
of
Risk
Concerns
and
Data
Gaps
for
Occupational
Handlers...
31
5.1.6
Recommendations
for
Refining
Occupational
Handler
Risk
Assessment.
31
6.0
Occupational
Post­
application
Exposure
and
Risks.......................................................
31
6.1
Occupational
Post­
application
Exposure
Scenarios
...........................................
32
3
6.1.1
Post­
application
Exposure
Scenarios
and
Rationale
        .
32
6.1.2
Data/
Assumptions
for
Post­
application
Exposure
Scenarios
...................
35
6.1.2.1
Agricultural
Scenarios
..............................................................
35
6.1.3
Occupational
Post­
application
Exposure
and
Non­
Cancer
Risk
.............
42
6.1.3.1
Agricultural
Scenarios/
Calculation
Methods
............................
43
6.1.4
Occupational
Post­
application
Non­
Cancer
Risk
Summary
....................
45
6.1.5
Summary
of
Post­
application
Risk
Concerns
and
Data
Gaps    ...
46
6.1.5.1
Recommendations
for
Refining
Occupational
Post­
application
Risk
Assessment
....................................................................................
47
7.0
Residential
Exposures
and
Risks
...................................................................................
47
7.1
Residential
Handler
Exposure
Scenarios
and
Risks.................................
47
7.1.1
Handler
Exposure
Scenarios...................................................................
47
7.1.2
Data
and
Assumptions
for
Exposure
Risk
Scenarios
...............................
48
7.1.3
Residential
Handler
Exposure
and
Non­
Cancer
Risk
Estimates
..............
50
7.1.4
Summary
of
Risk
Concerns
and
Data
Gaps
for
Handlers
........................
51
7.1.5
Recommendations
for
Refining
Residential
Handler
Risk
Assessment
...
51
7.2
Residential
Post­
application
Exposures
and
Risks.
.............................................
51
7.2.1
Residential
Post­
application
Exposure
Scenarios
....................................
51
7.2.2
Data/
Assumptions
for
Residential
Post­
application
Exposure
Scenarios                         
53
7.2.3
Residential
Post­
application
Exposure
and
Non­
Cancer
Risk
Estimates ................................................................................................
55
7.2.4
Residential
Post­
application
Exposure
and
Non­
Cancer
Risk
Summary ................................................................................................
57
7.2.5
Summary
of
Residential
Post­
application
Risk
Concerns
and
Data
Gaps                          ...
58
7.2.6
Recommendations
for
Refining
Residential
Post­
application
Risk
Assessment                        .
58
Appendix
A:
Occupational
Handler
Exposures
..................................................................... 
59
Appendix
B:
Occupational
Post­
application
Exposures
.............................................................
59
Appendix
C:
Residential
Handler
Exposures.............................................................................
59
Appendix
D:
Residential
Post­
application
Exposures
................................................................
59
4
Executive
Summary
1.0
Background
and
Purpose
The
Health
Effects
Division
(
HED)
has
conducted
an
occupational
and
non­
occupational
(
residential)
exposure
assessment
for
the
active
ingredient
propiconazole
[(
1­[[
2­
2,4­
dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl]
methyl]­
1H­
1,2,4­
triazole
for
the
purpose
of
supporting
HED's
Reregistration
Eligibility
Decision
(
RED)
document.

1.2
Use
Patterns
and
Formulations
Propiconazole
is
a
systemic
triazole
fungicide
with
protective
and
curative
action.
Propiconazole
is
formulated
as
liquids
(
emulsifiable,
soluble,
and
flowable
concentrates
packaged
as
"
mix­
your­
own"
and
"
ready­
to­
use"
(
RTU)
products)
and
wettable
powders
in
water­
soluble
packets
(
WP/
WSP).
Application
rates
vary
depending
upon
the
application
equipment
and
crop
or
use­
site.

Propiconazole
is
registered
for
use
in
a
variety
of
occupational
and
residential
sites.
Occupational
uses
include
conventional
agricultural
and
commercial
sites,
as
well
as
antimicrobial
uses.
Residential
use­
sites
include
ornamentals
(
herbaceous,
woody,
non­
bearing
fruit/
nut
trees),
turf
(
lawn
applications),
and
garden
crops
with
applications
being
performed
by
both
professionals
and
homeowners.
This
document
only
addresses
exposures
and
risks
for
the
agricultural/
commercial/
residential
uses;
antimicrobial
uses
will
not
be
addressed.

Occupational
application
methods
include
aerial,
groundboom,
chemigation,
airblast,
seed
piece
dip,
tree
injection,
and
handheld
equipment
(
i.
e.,
low­
pressure
handwand
and
handgun
sprayer).
Residential
applications
are
done
using
handheld
equipment.

1.3
Criteria
for
Conducting
Exposure
Assessments
An
occupational
and/
or
residential
exposure
assessment
is
required
for
an
active
ingredient
if
(
1)
certain
toxicological
criteria
are
triggered
and
(
2)
there
is
a
potential
for
exposure
to
handlers
(
mixers,
loaders,
applicators)
during
use
or
to
persons
entering
treated
sites
or
exposed
to
vapors
after
application
is
complete.
Toxicological
endpoints
were
selected
for
short­
(
1­
30
days),
intermediate­
(
1­
6
months),
and
long­
term
(>
6
months)
dermal
and
inhalation
exposures
to
propiconazole;
however
exposure
durations
are
expected
to
be
only
of
short
or
intermediate­
term
duration.
There
is
a
significant
potential
for
exposure
in
a
variety
of
occupational
agricultural,
commercial,
as
well
as
in
residential
settings.
Therefore,
risk
assessments
are
required
for
occupational
and
residential
handlers
as
well
as
for
occupational
and
residential
post­
application
exposures
that
can
occur
as
a
result
of
propiconazole
use.
5
1.4
Hazard
Identification
On
February
13,
2003
the
Health
Effects
Division
(
HED)
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
reassessed
FQPA
requirements
(
TXR
0052277)
for
propiconazole
in
response
to
questions
posed
by
the
Natural
Resources
Defense
Council
(
NRDC).
No
new
data
have
been
reviewed
and
no
changes
were
made
to
the
toxicology
endpoints
previously
selected
for
Propiconazole
(
TXR
0050439
&
0051703).
In
October,
2005,
the
registrant
conducted
an
ACN
study
(
MRID
46604601)
with
propiconazole
and
submitted
it
to
the
Agency.
Evaluation
of
this
ACN
study
demonstrated
that
severe
clinical
signs
of
toxicity
were
not
accompanied
by
nervous
tissue
damage
and
neurobehavioral
effects
were
minimal.
The
propiconazole
risk
assessment
team
concluded
that
the
ACN
study
satisfies
the
data
gap
imposed
by
HIARC
and
the
3X
factor
for
the
data
base
uncertainty
factor
(
UFDB)
can
be
reduced
to
1X.
The
rat
acute
study
also
serves
as
the
basis
for
short
term
incidental
oral,
dermal
and
inhalation
scenarios.

Dermal
Endpoints:

The
endpoint
selected
was
based
on
acute
clinical
toxicity
observed
in
the
acute
neurotoxicity
study
in
rats
(
ACN)
(
MRID
46604601)
discussed
above.
It
was
concluded
that
the
LOAEL
for
the
clinical
signs
of
toxicity
in
this
ACN
study
was
100
mg/
kg
and
the
NOAEL
was
30
mg/
kg.
This
endpoint
is
appropriate
since
the
severe
clinical
effects
were
observed
after
administration
of
the
test
material
within
one
day.
Since
an
oral
dose
was
selected,
a
40%
dermal
absorption
factor
is
used
for
route
to
route
extrapolation.

The
intermediate­
and
long­
term
dermal
toxicological
endpoints
are
the
same
at
10
mg/
kg/
day.
The
intermediate­
and
long­
term
dermal
toxicological
exposures
are
based
on
acute
clinical
toxicity
observed
in
the
acute
neurotoxicity
study
in
rats
(
ACN)
(
MRID
46604601)
discussed
above.

Inhalation
Endpoints:

The
short­
term
inhalation
toxicological
endpoint
is
30
mg/
kg/
day
based
on
an
acute
rat
acute
neurotoxicity
study
(
MRID
46604601).

The
intermediate­
and
long­
term
inhalation
toxicological
endpoint
is
10
mg/
kg/
day.
The
intermediate­
and
long­
term
inhalation
toxicological
endpoint
is
based
on
non­
neoplastic
liver
effects
{
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly)}
at
50
mg/
kg/
day
of
propiconazole
administration
derived
from
a
chronic/
oncogenicity
study
in
mice
(
MRID
00129570
and
93194037).
An
inhalation
absorption
factor
of
100%
(
default
value
assuming
equivalent
inhalation
and
oral
absorption)
will
be
used
for
route­
to­
route
extrapolation.

Since
the
short­
term
and
intermediate­/
long­
term
dermal
and
inhalation
toxicological
endpoints
of
concern
are
the
same,
respectively
for
each
duration,
and
based
on
oral
studies,
6
assessments
of
each
exposure
duration
combines
the
dermal
and
inhalation
doses
and
applies
the
appropriate
route­
specific
absorption
factor
explained
above.

The
Agency's
level
of
concern
for
non­
cancer
risks
(
i.
e.,
target
level
for
MOEs
or
Margins
of
Exposure)
is
defined
by
the
uncertainty
factors
that
are
applied
to
the
assessment.
The
Agency
applies
a
10X
factor
to
account
for
inter­
species
extrapolation
and
a
10X
factor
to
account
for
intra­
species
sensitivity.
The
total
uncertainty
factors
that
have
been
applied
to
non­
cancer
risk
assessments
are
100
for
occupational,
100
for
short­
term
residential
and
100
for
intermediate­,
long­
term
residential
scenarios
(
based
on
the
toxicology
endpoint
selection
for
General
Population
including
infants
and
children.

Propiconazole
is
listed
as
a
Group
C,
Possible
Human
Carcinogen.
A
Q1*
was
not
identified
for
propiconazole,
therefore
a
quantitative
cancer
risk
assessment
is
not
required.

1.5
Occupational
and
Residential
Non­
cancer
Risks
Occupational
Handler
Risk
Summary:

The
short­
and
intermediate­
term
occupational
handler
non­
cancer
risk
assessment
for
propiconazole
indicates
that
for
all
occupational
handler
scenarios,
risks
do
not
exceed
HED's
level
of
concern
(
i.
e.,
MOEs
>
100).

Occupational
handler
data
gaps
identified
for
this
assessment
include:

 
Seed
piece
dip
treatments
(
applicator
scenario)
for
sugarcane;
Note:
Labels
call
for
chemical
resistant
gloves,
apron
and
protective
eyewear.

 
Tree
injections;
Note:
Labels
call
for
chemical
resistant
gloves,
protective
eyewear/
face­
shield.

 
Mixing/
Loading/
Applying
wettable
powders
in
water­
soluble
packets
for
handheld
equipment.
Note:
Although
there
is
no
data
to
assess
the
M/
L/
A
wettable
powder
scenarios,
it
is
reasonable
to
assume
that
M/
L/
A
exposures
associated
with
this
formulation
are
lower
than
M/
L/
A
exposures
with
liquid
formulations.
This
rationale
is
based
on
the
assumption
that
the
"
application"
component
of
the
exposure
will
not
be
significantly
different
for
the
same
application
method
(
both
will
be
applied
as
a
spray);
however,
as
seen
in
scenarios
where
the
activities
are
separate,
the
"
mixing/
loading"
exposure
component
is
greater
for
liquid
formulations.
Therefore,
the
M/
L/
A
liquid
scenarios
were
used
as
a
conservative
surrogate.

Occupational
Post­
application
Risk
Summary:

Data
from
propiconazole­
specific
studies
were
used
along
with
crop­
specific
transfer
coefficients
{
from
Science
Advisory
Council
for
Exposure
(
ExpoSAC)
Policy
3.1
 
Agricultural
Transfer
Coefficients}
to
calculate
post­
application
exposures
and
risks.
[
Calculations
for
turf
7
risks
were
generated
using
the
arithmetic
mean
of
data
(
time
zero
residues)
generated
at
the
California,
Indiana
and
Pennsylvania
test
sites.]

The
non­
cancer
occupational
post­
application
worker
risk
assessment
indicates
that
for
most
agricultural
post­
application
exposure
scenarios,
risks
do
not
exceed
HED's
level
of
concern
(
i.
e.,
MOEs
>
100)
on
the
day
of
the
treatment
(
day
after
treatment
(
DAT)
=
0).
The
post­
application
exposure
scenarios
that
exceeded
HED's
level
of
concern
(
i.
e.,
MOEs
<
100)
on
the
day
of
the
treatment
(
day
after
treatment
(
DAT)
=
0)
are
listed
below
and
discussed
in
more
detail
in
(
section
6.1.5).

 
Ornamentals
(
woody
and
herbaceous
plants)
intermediate­/
long­
term.

Residential
Handler
Risk
Summary:

 
The
non­
cancer
residential
handler
risk
assessment
indicates
that
for
all
residential
handler
scenarios,
risks
do
not
exceed
HED's
level
of
concern
(
i.
e.,
MOEs
>
100)
assuming
baseline
level
of
protection
(
for
homeowners:
short­
sleeve
shirt,
short
pants,
shoes,
and
socks).

Residential
handler
data
gaps
identified
for
this
assessment
include:

 
M/
L/
A
wettable
powders
in
water­
soluble
packets
for
handheld
equipment
(
see
note
in
Occupational
Handler
Risk
Summary).

Residential
Post­
application
Risk
Summary:

There
are
no
short­
term
residential
post­
application
risks
of
concern
(
MOEs
>
100)
on
the
day
of
application
(
DAT
=
0).

2.0
Hazard
Identification
2.1
Acute
Toxicological
Categories
Table
1:
Propiconazole
Acute
Toxicity
Profile
Guideline
No.
Study
Type
MRID
#
Results
Toxicity
Category
81­
1
Acute
Oral
­
rat
00058591
LD50
=
1517
mg/
kg
III
81­
2
Acute
Dermal­
rabbit
00058596
LD50
=
>
4000
mg/
kg
III
81­
3
Acute
Inhalation
­
rat
41594801
LC50
=
>
50.84
mg/
L
IV
81­
4
Primary
Eye
Irritation
00058597
Corneal
opacity
reversed
in
72
hours
III
81­
5
Primary
Skin
Irritation
00058598
No
irritation
IV
81­
6
Dermal
Sensitization
00058600
Non
sensitizer
­
8
2.2
Toxicological
Endpoints
The
report
of
the
HIARC
for
Propiconazole
identified
toxicological
endpoints
of
concern
for
propiconazole.
All
calculations
completed
in
this
document
are
based
on
the
most
current
toxicity
information
available
for
propiconazole
as
reported
in
the
HIARC
document.
The
endpoints
that
were
used
to
complete
this
assessment
are
summarized
in
table
2.

Table
2:
Propiconazole
Toxicological
Endpoints
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Short­
Term
(
1­
30
days)
Incidental
Oral
NOAEL=
30
mg
ai/
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
(
General
Population,
including
infants
and
children)
Oral
Maternal
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).

Intermediate­
Term
(
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
Oral
Dev.
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)
9
Table
2:
Propiconazole
Toxicological
Endpoints
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
Oral,
dermal,
inhalation)
Group
C,
possible
human
carcinogen,
RfD
approach
for
risk
characterization.

Note:
¹
UF
=
uncertainty
factor,
FQPA
SF
=
Special
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
²
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic)
³
RfD
=
ref.
dose,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern,
NA
=
Not
App.

Note:
The
Special
FQPA
Safety
Factor
recommended
by
the
HIARC
assumes
that
the
exposure
databases
(
dietary
food,
drinking
water,
and
residential)
are
complete
and
that
the
risk
assessment
for
each
potential
exposure
scenario
includes
all
metabolites
and/
or
degradates
of
concern
and
does
not
underestimate
the
potential
risk
for
infants
and
children.

2.3
Dermal
Absorption
Dermal
Absorption
Factor:
40%

Study
Selected:
Dermal
Absorption
­
Rat
§
85­
3
MRID
No.:
42415701,
00164469,
45345901
Executive
Summary:
In
a
dermal
absorption
study
(
MRID's
42415701,
45345901),
groups
(
4/
group)
of
young
adult
male,
Harlan
Sprague­
Dawley
rats
(
age
not
given)
were
exposed
to
triazole­[
3,5­]
14C­
CGA­
64250
(
95%
radiochemical
purity,
specific
activity
28.2
µ
Ci/
mg
for
low
and
mid­
dose
levels
and
2.01
µ
Ci/
mg
for
the
high­
dose
level)
at
doses
of
0.1,
1.0
or
10
mg/
rat
(
0.01,
0.1
or
1
mg/
cm2,
respectively)
to
a
10
cm2
shaven
dorso­
lumbar
area.
The
radioactive
test
compound
was
added
to
the
3.6EC
formulated
product
(
45.8%
active
ingredient
and
54.2%
inert
substances)
and
applied
as
an
aqueous
suspension.
One
group
of
four
rats/
dose
were
exposed
for
24
hours,
while
two
other
groups
of
four
rats
each/
dose
were
exposed
for
10
or
24
hours
followed
by
a
72­
hour
depletion
phase.
This
study
is
an
addendum
to
an
earlier
study
where
groups
of
four
male
rats
each
were
treated
similarly
but
exposed
for
2,
4
or
10
hours
(
MRID
00164469).
In
both
studies,
following
the
exposure
period,
the
test
compound
remaining
on
the
skin
was
removed
with
a
soap
rinse.
Fecal
and
urinary
samples
were
collected
at
the
end
of
the
exposure
periods
and
at
24
hour
intervals
(
for
the
depletion
groups)
following
the
exposure.
The
amount
of
test
compound
absorbed
was
directly
proportional
to
the
applied
dose.
The
rate
of
absorption
appeared
to
be
saturated
at
the
highest
dose
level;
at
the
low
dose
level,
there
was
a
time
dependent
increase
in
the
amount
of
compound
absorbed.
After
24
hours,
57.1,
271
and
3010
:
g/
cm2
(
57.13,
27.14
and
30.10%
of
total
dose
were
absorbed
at
the
low,
mid
and
high
dose
levels,
respectively).
During
the
72­
hour
depletion
phase
essentially
allof
the
compound
was
eliminated
in
the
urine
and
feces;
urinary
elimination
predominated
at
the
mid
and
high
dose
levels.
At
the
end
of
the
72
hour
depletion
phase,
less
than
2%
of
the
test
compound
was
still
present
in
the
carcass.
The
results
of
the
earlier
study
(
MRID
00164469)
demonstrated
that
26­
10
35%
of
the
applied
radioactivity
(
at
all
dose
levels)
is
absorbed
within
the
first
two
hours
and
remained
fairly
constant
for
the
longer
exposure
periods
of
4
and
8
hours
except
for
the
low
dose
of
0.01
mg/
cm2
where
it
increased
to
54%.
The
average
dermal
absorption
of
propiconazole
over
a
10
hour
period
at
an
exposure
level
of
0.01
mg/
cm2
is
approximately
40%.
The
two
studies
were
classified
Acceptable/
guideline
and
both
satisfy
the
guideline
requirement
(
870.7600;
85­
3)
for
a
dermal
absorption
study.

2.4
Dermal
Exposure:
Short­
Term
Previously
(
12/
11/
01),
the
HIARC
had
selected
the
developmental
endpoint
for
all
populations
for
the
short­
term
dermal
exposure
scenario.
The
developmental
endpoint
is
not
relevant
for
assessing
risks
to
infants
and
children
from
residential
exposures.
Therefore,
the
HIARC
re­
evaluated
the
data
and
selected
endpoints
that
are
relevant/
applicable
to
the
populations
of
concern
via
this
exposure
pathway.
See
table
2
for
description
of
endpoint
selection.

2.5
Dermal
Exposure:
Short­
Term
(
1
­
30
days)
Gen.
Pop.,
incl.
infants
and
Children.

HIARC
had
selected
a
developmental
NOAEL
of
30
mg/
kg/
day
from
the
developmental
rat
study
(
MRID
40425001)
to
assess
short
term
dermal
risks
to
females
13­
50,
and
a
maternal
NOAEL
of
90
mg/
kg/
day
from
the
developmental
rat
study
to
assess
dermal
risks
to
all
other
population
subgroups.
The
propiconazole
risk
assessment
team
recommends
that
the
recently
submitted
rat
acute
neurotoxicity
study
(
MRID
46604601)
with
a
NOAEL
of
30
mg/
kg/
day
is
appropriate
for
assessing
risks
of
this
exposure
duration
and
is
applicable
to
all
population
subgroups.
Since
an
oral
study
was
selected,
a
40%
dermal
absorption
factor
is
used
for
route
to
route
extrapolation
2.6
Dermal
Exposure:
Intermediate­
Term
(
1
­
6
Months)
and
Long­
Term
(>
6
Months)

HIARC
selected
NOAEL
of
10
mg/
kg/
day
based
on
non­
neoplastic
liver
effects
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly))
at
50
mg/
kg/
day
of
propiconazole
administration
derived
from
a
chronic/
oncogenicity
study
in
mice
(
MRID
00129570
and
93194037).

2.7
Inhalation
Exposure:
Short­
Term
(
1
­
30
days)

HIARC
had
selected
a
developmental
NOAEL
of
30
mg/
kg/
day
based
on
increased
incidence
of
rudimentary
ribs,
unossified
sternebrae
and
shortened
and
absent
renal
papillae,
and
increased
cleft
palate
seen
at
the
developmental
LOAEL
of
90
mg/
kg/
day
in
a
developmental
rat
study
(
MRID
40425001).
The
propiconazole
risk
assessment
team
recommends
that
the
recently
submitted
rat
acute
neurotoxicity
study
(
MRID
46604601)
with
a
NOAEL
of
30
mg/
kg/
day
is
appropriate
for
assessing
inhalation
risks
of
this
exposure
duration
and
is
applicable
to
all
population
subgroups.
An
inhalation
absorption
factor
of
100%
(
default
value
assuming
equivalent
inhalation
and
oral
absorption)
will
be
used
for
route­
to­
route
extrapolation.
11
2.8
Inhalation
Exposure:
Intermediate­
Term
(
1
­
6
Months)
and
Long­
Term
(>
6
Months)

HIARC
selected
NOAEL
of
10
mg/
kg/
day
based
on
non­
neoplastic
liver
effects
(
increased
liver
weight
in
males
and
increase
in
liver
lesions
(
masses/
raised
areas/
swellings/
nodular
areas
mainly))
at
50
mg/
kg/
day
of
propiconazole
administration
derived
from
a
chronic/
oncogenicity
study
in
mice
(
MRID
00129570
and
93194037).
An
inhalation
absorption
factor
of
100%
(
default
value
assuming
equivalent
inhalation
and
oral
absorption)
will
be
used
for
route­
to­
route
extrapolation.

2.9
Margins
of
Exposure:

Table
3:
Propiconazole
Acceptable
Margins
of
Exposure
Route
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
For
Occupational
exposure:
All
durations,
a
MOE
of
100
is
required.
This
is
based
on
the
conventional
uncertainty
factor
of
100X
(
10X
for
intra­
species
extrapolation
and
10X
for
interspecies
variation).

For
Residential
exposure:
Short­
term,
a
MOE
of
100
is
required.
This
is
based
on
the
conventional
uncertainty
factor
of
100X
(
10X
for
intra­
species
extrapolation
and
10X
for
interspecies
variation).

Body
Weight:
Since
the
adverse
effects
for
a
study
utilized
in
the
propiconazole
dermal
and
inhalation
risk
assessment
is
based
on
a
developmental
toxicity
study
of
rats,
the
body
weight
used
for
estimating
exposures
is
70
kg
(
ie.,
General
Population
including
infants
and
children).
12
3.0
Use
patterns
and
Formulations
3.1
Mode
of
Action
and
Targets
Controlled
Propiconazole
[(
1­[[
2­
2,4­
dichlorophenyl)­
4­
propyl­
1,3­
dioxolan­
2­
yl]
methyl]­
1H­
1,2,4­
triazole)
is
used
as
a
contact
fungicide
in
commercial,
agriculture
and
residential
settings.
The
pests
controlled
include:

 
On
Terrestrial
Food
Crops:
black
sheath
rot;
brown
blotch;
brown
leaf
spot;
brown
rot;
blossom
blight;
early
blight;
sheath
blight;
early
leaf
spot;
fruit
brown
rot;
late
leaf
spot;
leaf
smut;
narrow
brown
leaf
spot;
sheath
spot;
southern
stem
rot;
stem
rot.
 
On
Terrestrial
Food
Crops
and
Feed
Crops:
barley
scald;
brown
rot
blossom
blight;
eye
spot;
foot
rot;
fruit
brown
rot;
early
leaf
spot;
gray
leaf
spot;
glume
blotch;
helminthosporium
leaf
blight;
late
leaf
spot;
leaf
blight;
net
blotch;
powdery
mildew;
rusts;
southern
stem
rot;
tan
spot.

 
On
Terrestrial
Non
Food
Crops:
altrnia
leaf
spot;
anthracnose;
blackspot;
cercospora
leaf
spot;
coccomyces
heimalis;
collectrichum
leaf
spot;
diplodia
tip
blight;
downy
spot;
Dutch
elm
disease;
erysiphe;
fabraea
maculata;
greasy
spot;
gymnosporangium
juniperivirginianae;
heterosporium
echinulatum;
leaf
diseases
of
crabapple;
leaf
scorch;
melampsora
occidentialis;
microsphaera;
monilinia;
oak
wilt;
oidium;
ovulinia;
phragmidium;
phomopsis
blight;
podospaera;
puccinia;
pucciniastrum
goeppertianum;
ray
blight;
scab;
sphaerotheca
pannosa;
spilocaea
pyracanthae;
sycamore
anthracnose;
tip
blight;
tubakia
dryina;
uromyces
dianthi;
venturia
inaequalis;
zonate
leaf
spot.

 
On
Lawns/
Turf:
anthracnose;
brown
patch;
dichondria
rust;
dollar
spot;
fusarium
patch;
gray
leafspot;
gray
snowmold;
leaf
spot;
melting
out;
necrotic
ring
spot;
pink
patch
;
pink
snowmols;
poa
patch;
powdery
mildew;
red
thread;
rusts;
selenophoma
stem
eyespot;
spring
dead
spot;
stripe
smut;
summer
patch;
take­
all
patch;
yellow
patch;
zosia
patch.

 
On
seed
pieces:
butt
rot
diseases;
pineapple
disease
of
sugarcane.

3.2
Occupational/
Agricultural
Use
sites:

Occupational
populations
are
potentially
exposed
to
propiconazole
while
applying
and/
or
during
post­
application
activities
to
the
following
targets:

 
Terrestrial
Food
Crops:
mint,
peanuts,
rice,
wild
rice,
bananas,
plantains,
celery,
sugarcane,
pineapple,
apricots,
cherries,
nectarines,
peaches,
plums,
pecans.

 
Terrestrial
Food
and
Feed
Crops:
barley,
rye,
oats,
wheat,
corn,
and
sunflower
breeder's
seed.
13
 
Terrestrial
Non­
Food
Crop:
commercial/
recreational
turf,
golf
course
turf,
sod
farms,
grasses
grown
for
seed,
ornamentals
(
herbaceous
plants,
non­
bearing
fruit
and
nut
trees,
non­
bearing
blueberries,
woody
shrubs
and
vines,
shade
trees),
and
residential
lawns
­
lawn
care
operators
(
LCO).

3.3
Homeowner/
Residential
Use
sites:

 
Turf:
golf
courses,
homeowner
lawn
applications
 
Ornamentals
(
Herbaceous):
calendula,
carnation,
chrysanthemums,
delphinium,
gomphrena,
iris,
marigold,
monarada,
phlox,
roses,
snapdragons,
sweet
william,
zinnia.

 
Ornamentals
(
Woody):
amelachier,
ash,
azalea,
crabapple,
crepe
myrtle,
dogwood,
douglas
fur,
hawthorn,
Jeffery
pine,
juniper,
lilac,
oak,
pines,
poplars,
pyracantha,
red
tip,
photinia,
rhododendron,
shasta
fir.

 
Ornamentals
(
Non­
bearing
fruit
and
nut
trees):
apple,
cherry,
citrus,
peach,
pecan,
hazelnuts,
plum,
nectarine.

3.4
Formulations
and
Uses
Based
on
EPA's
pesticide
registration
database,
propiconazole
is
available
as
a
liquid
(
emulsifiable
concentrate,
flowable
concentrate,
ready­
to­
use
(
RTU)
liquid,
soluble
concentrate)
and
wettable
powder
in
water­
soluble
packets.

Table
4:
Propiconazole
Uses
Crop
Max.
Appl.
Rate
(
Reg.
#)
Maximum
#
Applications/
Crop
Cycle
Max.
amt.
(
lb
ai/
A/
yr.)
Timing
Pre­
Harvest
Interval
(
Days)
Minimum
Retreatment
Interval
(
Days)
Application
Methods
Section
3
uses
Barley
0.1125
lb
ai/
A
(
100­
617)
(
100­
780)
NS
(
1
for
post
emergence
and
tillering)
0.1125
Post­
Emergence
14­
40
NS
Aerial,
Groundboom,
Chemigation
Celery
0.1125
lb
ai/
A
(
100­
617)
(
100­
780)
4
NS
Foliar
14­
45
7
Aerial,
Groundboom,
Chemigation
Corn
(
field,
pop,
sweet)
0.1125
lb
ai/
A
(
100­
617)
(
100­
780)
NS
(
no
more
than
16
oz
of
Tilt
per
season)
0.45
Foliar
14­
30
7
Aerial,
Groundboom,
Chemigation
Grasses
Grown
for
Seed
(
forage
fodder
grasses)
0.225
lb
ai/
A
(
100­
617)
NS
(
no
more
than
32
fl
oz/
A/
CC)
(
do
not
feed
hay
cut
within
20
days
of
last
application)
0.90
Foliar
N/
A
14
Aerial,
Groundboom,
Chemigation
14
Table
4:
Propiconazole
Uses
Crop
Max.
Appl.
Rate
(
Reg.
#)
Maximum
#
Applications/
Crop
Cycle
Max.
amt.
(
lb
ai/
A/
yr.)
Timing
Pre­
Harvest
Interval
(
Days)
Minimum
Retreatment
Interval
(
Days)
Application
Methods
Non­
bearing
Apple
0.08
lb
ai/
100
gal
(
100­
741)
(
100­
617)
NS
(
7.2
lb/
yr
for
Banner,
Tilt
and
Banner
Maxx)
NS
7.2
lb
ai/
A/
year
for
Tilt
Foliar
N/
A
As
needed
Airblast,
LPHW,
HPHW,
Backpack
Non­
bearing
Cherry,
Nectarine,
Peach,
Plum
0.04
lb
ai/
100
gal
(
100­
741)
(
100­
617)
NS
(
7.2
lb/
yr
for
Banner,
Tilt
and
Banner
Maxx)
NS
7.2
lb
ai/
A/
year
for
Tilt
Foliar
1yr.
14
Airblast,
LPHW,
HPHW,
Backpack
Non­
bearing
Pecan
0.12
lb
ai/
100
gal
(
100­
741)
(
100­
617)
Deleted
nonbearing
pecan
for
100­
702
3
NS
7.2
lb
ai/
A/
yr
for
Tilt
Nonbearing
N/
A
14
Aerial,
ground,
Airblast,
LPHW,
HPHW,
Backpack
Non­
bearing
Citrus
0.225
lb
ai/
A
(
100­
702)
NS
(
7.2
lb/
yr
for
Banner,
Tilt
and
Banner
Maxx)
NS
June
July
August
1yr.
NS
Aerial,
Groundboom,
Airblast,
LPHW,
HPHW,
Backpack
Oats
0.1125
lb
ai/
A
(
100­
617)
NS
(
typically
1)
0.1125
Postemergence
14­
40
NS
Aerial,
Groundboom,
Chemigation
Peanuts
0.225
lb
ai/
A*
(
100­
617)
NS
(
no
more
than
16
oz
of
Tilt
per
season)
0.45
Post­
plant
When
needed
7­
14
10
Aerial,
Groundboom,
Chemigation
Pecans
0.225
lb
ai/
A
9
(
45
oz
of
Super
Tin
80WP
NS
NS
N/
A
14
Aerial,
Groundboom
Pineapple
(
HI
only)
0.021
lb
ai/
100
gal
(
100­
617)
NS
(
typically
1,
water
dip)
NS
Planting
N/
A
NS
Seed
Piece
Dip
Rice
0.28
lb
ai/
A
(
100­
617)
1
(
at
10
fl.
oz
rate)
2
(
at
6
fl.
oz
rate)
0.34
Internode
Elongation
N/
A
10
Aerial
Rice,
wild
0.225
lb
ai/
A
(
100­
780)
1
(
8
fl
oz)
2
(
6
fl
oz)
0.34
Boot
N/
A
NS
Aerial
Rye
0.1125
lb
ai/
A
(
100­
780)
(
100­
617)
NS
(
no
more
than
4
oz
of
Tilt
per
season)
0.1125
Foliar
Postemergence
14­
40
NS
Aerial,
Groundboom,
Chemigation
Stone
Fruits­
Apricot,
Cherry,
Nectarine,
Peach,
and
0.1125
lb
ai/
A
(
100­
780)
(
100­
617)
(
100­
702)
5
0.56
Pre­
harvest
Bloom
Petal
Fall
N/
A
NS
Aerial,
Airblast,
Groundboom
15
Table
4:
Propiconazole
Uses
Crop
Max.
Appl.
Rate
(
Reg.
#)
Maximum
#
Applications/
Crop
Cycle
Max.
amt.
(
lb
ai/
A/
yr.)
Timing
Pre­
Harvest
Interval
(
Days)
Minimum
Retreatment
Interval
(
Days)
Application
Methods
Plum
Sugarcane
(
Hawaii
only)
0.021
lb
ai/
100
gal
(
100­
617)
NS
(
seed
treatment)
NS
Seed
piece
N/
A
NS
Seed
Piece
Dip
Triticale
0.1125
lb
ai/
A
(
100­
780)
(
100­
617)
NS
(
typically
1)
0.1125
Post­
Emergence
14­
40
NS
Aerial,
Groundboom,
Chemigation
Turf
­
Lawns,
Golf
Courses,
Recreational
Areas
1.78
lb
ai/
A
(
100­
741)
NS
(
7.2
max
per
year)
(
100­
617)
7.2
Foliar
N/
A
NS
Handgun
Sprayer,
LPHW,
Backpack
Ornamental
Shade
Trees
(
injection)
0.0069
lb
ai/
DBH
(
100­
741)
1
NS
Injection
N/
A
NS
Tree
Injection
0.24
lb
ai/
100
gal
(
100­
741)
Ornamental
Shade
Trees,
Herbaceous
Plants,
Woody
Shrubs
and
Vines
0.37
lb
ai/
A
(
based
on
assumption
of
150
gallons/
A)
NS
(
7.2
max
per
year)
(
100­
617)
NS
NS
N/
A
NS
Airblast,
Handgun
Sprayer,
LPHW,
Backpack
Turf
­
Sod
Farm
1.79
lb
ai/
A
(
100­
741)
NS
(
7.2
max
per
year)
(
100­
617)
7.2
NS
N/
A
NS
Aerial,
Groundboom
Wheat
0.08
lb
ai/
A
(
264­
779)
2
NS
NS
14­
40
NS
Aerial,
Groundboom,
Chemigation
Section
(
24C)
Uses
Bananas
and
Plantain
(
Hawaii,
Puerto
Rico)
0.084
lb
ai/
A
(
HI91000900)
(
PR­
040005)
8
(
mist
blower­
rest
4)
0.675
HI­
when
needed
PR­
April
August
June
May
October
September
N/
A
21
Airlbast,
HPHW,
Backpack
Corn
(
post
silk)
0.1125
lb
ai/
A
IL­
040004
NS
(
no
more
than
16
oz
of
Tilt
per
season)
0.45
Post­
silk
14­
30
NS
Aerial,
Groundboom,
Chemigation
Grasses
Grown
for
Seed
(
forage
fodder
grasses)
0.225
lb
ai/
A
(
ID95001200)
(
WA95003300
NV­
010004)
4
­
(
no
more
than
32
fl
oz/
A/
CC)
(
do
not
feed
hay
cut
within
20
days
of
last
application)
0.90
Pre­
bloom
N/
A
7
Aerial,
Groundboom,
Chemigation
16
Table
4:
Propiconazole
Uses
Crop
Max.
Appl.
Rate
(
Reg.
#)
Maximum
#
Applications/
Crop
Cycle
Max.
amt.
(
lb
ai/
A/
yr.)
Timing
Pre­
Harvest
Interval
(
Days)
Minimum
Retreatment
Interval
(
Days)
Application
Methods
Mint
0.1125
lb
ai/
A
(
OR­
050011)
2
0.23
Foliar
14­
40
10
Groundboom
Non­
bearing
Blueberries
0.169
lb
ai/
A
(
FL9400500)
5
(
4
week
interval
from
June
through
October)
NS
Nonbearing
N/
A
28
HPHW,
Backpack
Non­
bearing
Hazelnuts
0.225
lb
ai/
A
(
OR­
040003)
NS
(
no
more
than
32
oz
of
Orbit/
A/
season)
0.90
At
emergence
N/
A
14
Aerial,
Groundboom
Sugarcane
Seed
Piece
0.021
lb
ai/
A
(
FL88001600)
1
(
at
planting)
NS
NS
N/
A
NS
Dip
tank
and
conveyor
belt
spray
Sunflower
Breeder
=

s
Seed
0.1125
lb
ai/
A
(
IL000001)
(
IL940001)
(
MI950007)
(
TX000006)
NS
(
no
more
than
16
oz
of
Tilt/
A/
season)
0.45
When
disease
first
appears
14­
40
7
Aerial,
Groundboom,
Chemigation
Wheat
(
past
Feekes
8)
0.1125
lb
ai/
A
NV01000400
1
0.1125
Spring
and
Winter
14­
40
NS
Aerial,
Groundboom,
Chemigation
Active
Section
18
Blueberries
(
ME)
0.169
lb
ai/
A
NS
(
no
more
than
30
fl.
oz/
A/
season)
0.84
Leaf
bud
break
N/
A
7
N/
A
Sorghum
(
KS)
0.1125
lb
ai/
A
3
application,
no
more
than
2
fl.
oz
0.34
Prior
to
flowering
N/
A
5
N/
A
Filbert
(
WA)
0.225
lb
ai/
A
4
application,
no
more
than
32
fl.
oz
0.90
Bud
break
N/
A
10
N/
A
Note:
­
Information
was
provided
by
Syngenta
Crop
Protection,
Inc.
in
a
November
9,
2001
letter
to
the
Agency,
subject:
Correction
to
Propiconazole
Use
Patters.
­
Updated
use
information
was
provided
by
Syngenta
Crop
Protection,
Inc.,
in
an
e­
mail
correspondence
on
4/
13/
2005,
to
supplement
the
1999
use
information
in
the
LUIS
report.

3.5
Application
Methods
and
Equipment
Propiconazole
is
applied
with
the
following
types
of
equipment:
aerial,
groundboom,
chemigation,
airblast,
low­
pressure
handwand,
high­
pressure
handwand,
handgun
sprayer,
seed
piece
dip,
hose­
end
sprayer,
and
tree
injection.
17
4.0
Incident
Report
 
Poison
Control
Center
Data
­
1993
through
2003
Results
for
the
years
1993
through
2003
are
presented
below
for
occupational
and
nonoccupational
reports
involving
incidents
related
to
Propiconazole
by
adults,
older
children
and
for
children
under
age
six.
Cases
involving
exposures
to
multiple
products
or
unrelated
outcome
are
excluded.
Tables
A
and
B
present
the
hazard
information
for
propiconazole
compared
with
all
other
pesticides
on
six
measures:
percent
with
symptoms,
percent
with
moderate,
major,
or
fatal
outcome,
percent
with
major
or
fatal
outcome,
percent
of
exposed
cases
seen
in
a
health
care
facility,
and
percent
hospitalized
and
percent
seen
in
a
critical
care
facility.
Table
A
reports
the
number
of
cases
on
which
the
data
derived
in
Table
B
is
based.
Table
B
presents
this
information
for
non­
occupational
cases
involving
adults
and
older
children.

Table
A.
Number
of
propiconazole
exposures
reported
to
the
Toxic
Exposure
Surveillance
System
(
AAPCC),
number
with
determined
outcome,
number
seen
in
a
health
care
facility
for
occupational
and
non­
occupational
cases
(
adults
and
children
six
years
and
older)
and
for
children
under
six
years
of
age
only,
1993­
2003.

Subgroup
Exposures
Outcome
determined
Seen
in
Health
Care
Facility
Occupational:
adults
and
older
children
13
4
4
Non­
occupational:
adults
and
older
children
63
27
10
Children
under
age
six
13
8
1
Table
B.
Comparison
between
propiconazole
and
all
pesticides
for
percent
cases
with
symptomatic
outcome
(
SYM),
moderate
or
more
severe
outcome
(
MOD),
life­
threatening
or
fatal
outcome
(
LIFE­
TH),
seen
in
a
health
care
facility
(
HCF),
hospitalized
(
HOSP),
or
seen
in
an
intensive
care
unit
(
ICU)
reported
to
Poison
Control
Centers,
1993­
2003
for
non­
occupational
cases
involving
adults
and
older
children.

Pesticide
SYM*
MOD*
LIFE­
TH*
HCF*
HOSP*
ICU*

Propiconazole
0.815%
0.296%
0.00%
0.159%
0.00%
0.00%

All
Pesticides
68.8%
10.98%
0.414%
15.0%
6.88%
2.94%

Ratio
.012
.027
0.00
.011
0.00
0.00
*
Symptomatic
cases
based
on
those
cases
with
a
minor,
moderate,
major,
or
fatal
medical
outcome.
Denominator
for
SYM,
MOD,
and
LIFE­
TH
is
the
total
cases
where
medical
outcome
18
was
determined.
Denominator
for
HCF
is
all
exposures.
Denominator
for
HOSP
and
ICU
is
all
cases
seen
in
a
health
care
facility.
For
children
less
than
six
years
old,
there
were
too
few
cases
to
warrant
analysis
to
draw
any
conclusions.
In
the
occupational
category,
there
was
only
one
case
categorized
as
moderate
medical
outcome.
For
children
less
than
six
years
old,
there
were
only
2
cases
with
minor
medical
outcome.
For
non­
occupational
cases
involving
adults
and
older
children,
there
were
much
lower
levels
of
minor
and
moderate
symptoms
and
visits
to
a
health
care
facility.
There
were
no
life­
threatening
or
hospitalized
cases.
The
most
common
symptoms
were
headache,
dermal
irritation,
erythema,
vomiting,
ataxia,
dizziness,
difficulty
breathing,
and
coughing
(
reported
in
three
or
more
cases).
In
general,
propiconazole
appears
to
be
less
hazardous
than
other
pesticides.

 
California
Data
­
1982
through
2003
Detailed
descriptions
of
13
cases
submitted
to
the
California
Pesticide
Illness
Surveillance
Program
(
1982­
2003)
were
reviewed.
In
8
of
these
cases,
propiconazole
was
used
alone
or
was
judged
to
be
responsible
for
the
health
effects.
Only
cases
with
a
definite,
probable
or
possible
relationship
were
reviewed.
In
the
first
case,
a
mixer/
loader,
who
did
not
wear
personal
protective
equipment,
held
a
container
of
the
product
in
one
hand
and
punctured
the
foil
shield
with
his
finger.
The
product
splashed
into
his
right
eye
and
he
reported
eye
pain
and
conjunctiva.
In
the
second
case,
a
home
health
nurse,
who
has
a
history
of
sinus
allergies,
inhaled
the
product
after
it
was
applied
to
a
peach
orchard
about
10
yards
from
his
patient's
home.
The
nurse
reported
sinus
pain
and
dry
throat.
In
the
third
case,
several
workers
harvested
nectarines
in
an
orchard.
One
worker
reported
chest
tightness
and
difficulty
breathing
and
was
treated
by
a
physician.
In
the
fourth
case,
a
field
worker
inhaled
the
product
after
it
was
applied
to
an
almond
orchard
about
150
yards
away.
The
worker
reported
vomiting
,
nausea,
diarrhea,
and
headache
about
fifteen
to
thirty
minutes
later.
In
the
fifth
case,
the
product
was
applied
about
1/
4
mile
from
a
field.
A
field
worker
moved
pipes
in
the
field
and
inhaled
the
product.
The
worker
reported
stomach
cramps,
vomiting,
difficulty
breathing,
and
chest
pain.
In
the
sixth
case,
the
product
was
applied
on
a
golf
course.
A
golfer
reported
repeated
occurrences
of
dermatitis
on
the
back
of
his
legs
and
ankles
after
playing
golf
several
times
in
the
morning.
In
the
seventh
case,
a
worker
reported
a
rash
while
picking
plums.
The
next
day,
the
worker
was
treated
by
a
physician.
In
the
eighth
case,
a
pest
control
operator
applied
the
product
to
a
tree
near
a
residential
office
building.
An
employee,
who
works
in
the
building,
reported
a
headache
after
it
drifted
through
the
air
conditioner.

In
conclusion,
from
the
review
of
the
Incident
Data
System,
it
appears
that
a
majority
of
cases
involved
skin
symptoms
such
as
rash,
itching,
skin
irritation
and
respiratory
effects
such
as
difficulty
breathing.
Poison
Control
Center
data
would
tend
to
support
the
Incident
Data
Systems
results;
dermal
irritation,
erythema,
and
difficulty
breathing
were
among
the
most
common
effects
reported.
[
Note:
All
incident
report
findings
were
taken
from
a
Memorandum
dated
July
26,
2005
and
written
by
Monica
S.
Hawkins,
M.
P.
H.,
Environmental
Health
Scientist/
Chemistry
and
Exposure
Branch/
HED].
19
5.0
Occupational
Exposure
and
Risk
Short­,
and
intermediate­
term
dermal
and
inhalation
exposures
have
been
assessed
for
each
occupational
scenario.
Long­
term
exposure
is
not
expected.

5.1
Occupational
Handler
Exposure
and
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
as
well
as
occupational
post­
application
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.
Exposure
scenarios
can
be
thought
of
as
ways
of
categorizing
the
kinds
of
exposures
that
occur
related
to
the
use
of
a
chemical.
The
use
of
scenarios
as
a
basis
for
exposure
assessment
is
very
common
as
described
in
the
U.
S.
EPA
Guidelines
for
Exposure
Assessment
(
U.
S.
EPA;
Federal
Register
Volume
57,
Number
104;
May
29,
1992).
Information
from
the
current
labels,
use
and
usage
information,
toxicology
data,
and
exposure
data
were
all
key
components
in
developing
the
exposure
scenarios.

The
first
step
in
the
handler
risk
assessment
process
is
to
identify
the
kinds
of
individuals
that
are
likely
to
be
exposed
to
propiconazole
during
the
application
process.
In
order
to
do
this
in
a
consistent
manner,
HED
has
developed
a
series
of
general
descriptions
for
tasks
that
are
associated
with
pesticide
applications.
Tasks
associated
with
occupational
pesticide
use
(
i.
e.,
for
"
handlers")
can
generally
be
categorized
using
one
of
the
following
terms:

 
M/
L:
these
individuals
perform
tasks
in
preparation
for
an
application.
For
example,
prior
to
application,
mixer/
loaders
would
mix
the
propiconazole
and
load
it
into
the
holding
tank
of
the
airplane
or
groundboom.

 
Applicators:
these
individuals
operate
application
equipment
during
the
release
of
a
pesticide
product
into
the
environment.
These
individuals
can
make
applications
using
equipment
such
as
airplanes
or
groundboom.

 
M/
L/
A:
these
individuals
are
involved
in
the
entire
pesticide
application
process
(
i.
e.,
they
do
all
job
functions
related
to
a
pesticide
application
event).
These
individuals
would
transfer
propiconazole
into
the
application
equipment
and
then
also
apply
it.

 
Occupational
Flaggers:
these
individuals
guide
aerial
applicators
during
the
release
of
a
pesticide
product
onto
an
intended
target.
20
Next,
assessors
must
understand
how
exposures
to
propiconazole
occur
(
i.
e.,
frequency
and
duration)
and
how
the
patterns
of
these
occurrences
can
cause
the
effects
of
the
chemical
to
differ
(
referred
to
as
dose
response).
Wherever
possible,
use
and
usage
data
determine
the
appropriateness
of
certain
types
of
risk
assessments.
Other
parameters
are
also
defined
from
use
and
usage
data
such
as
application
rates
and
application
frequency.
HED
believes
that
occupational
propiconazole
exposures
can
occur
over
a
single
day
or
up
to
weeks
at
a
time
for
many
use­
patterns
and
intermittent
exposures
over
several
weeks
are
also
anticipated.
Custom
or
commercial
applicators
may
apply
propiconazole
over
a
period
of
weeks
completing
applications
for
a
number
of
different
clients.
HED
classifies
exposures
up
to
30
days
as
short­
term
and
exposures
greater
than
30
days
up
to
several
months
as
intermediate­
term.
HED
completes
both
short­
and
intermediate­
term
assessments
for
occupational
scenarios
in
essentially
all
cases,
because
these
kinds
of
exposures
are
likely
and
acceptable
use/
usage
data
are
not
available
to
justify
deleting
intermediate­
term
scenarios.

Occupational
handler
exposure
assessments
are
completed
by
HED
using
different
levels
of
personal
protection.
HED
typically
evaluates
all
exposures
with
a
tiered
approach.
The
lowest
tier
is
represented
by
the
baseline
exposure
scenario
(
i.
e.,
long­
sleeve
shirt,
long
pants,
shoes,
and
socks)
followed
by
increasing
the
levels
of
personal
protective
equipment
or
PPE
(
e.
g.,
gloves,
double­
layer
body
protection,
and
respirators)
and
engineering
controls
(
e.
g.,
enclosed
cabs
and
closed
mixing/
loading
systems).
This
approach
is
always
used
by
HED
in
order
to
be
able
to
define
label
language
using
a
risk­
based
approach.
In
addition,
the
minimal
level
of
adequate
protection
for
a
chemical
is
generally
considered
by
HED
to
be
the
most
practical
option
for
risk
reduction
(
i.
e.,
over­
burdensome
risk
mitigation
measures
are
not
considered
a
practical
alternative.

5.1.1
Data
and
Assumptions
for
Handler
Exposure
Scenarios
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
occupational
handler
risk
assessments.
Each
assumption
and
factor
is
detailed
below
on
an
individual
basis.
The
assumptions
and
factors
used
in
the
risk
calculations
include:

 
Occupational
handler
exposure
estimates
were
based
on
surrogate
data
from:
(
1)
the
Pesticide
Handlers
Exposure
Database
(
PHED),
(
2)
Outdoor
Residential
Exposure
Task
Force
(
ORETF).

 
Average
body
weight
of
an
adult
handler
is
70
kg
because
a
toxicity
endpoint
was
identified
for
general
population
including
infants
and
children.
(
See
section
2.2
Table
2
for
toxicological
information).

 
Generic
protection
factors
(
PFs)
were
used
to
calculate
exposures
when
data
were
not
available.

 
Exposure
factors
used
to
calculate
daily
exposures
to
handlers
are
based
on
applicable
data
if
available.
For
lack
of
appropriate
data,
values
from
a
scenario
deemed
similar
enough
by
the
assessor
might
be
used.
21
 
For
non­
cancer
assessments,
HED
assumes
the
maximum
application
rates
allowed
by
labels
in
its
risk
assessments
(
see
Table
4).

 
The
average
occupational
workday
is
assumed
to
be
8
hours.

 
The
daily
areas
treated
were
defined
for
each
handler
scenario
(
in
appropriate
units)
by
determining
the
amount
that
can
be
reasonably
treated
in
a
single
day
(
e.
g.
acres,
square
feet,
cubic
feet,
or
gallons
per
day).
When
possible,
the
assumptions
for
daily
areas
treated
are
taken
from
the
HED
ExpoSAC
SOP
#
9:
Standard
Values
for
Daily
Acres
Treated
in
Agriculture
which
was
completed
on
July
5,
2000.

Aerial
applications:
The
assumptions
for
the
number
of
acres
treated
used
in
the
exposure
equation
is
350
acres
for
typical
field
crops,
grasses
grown
for
seed,
wild
rice,
sod
farm
turf
and
1200
acres
for
high­
acre
crops.

Flagging:
The
assumption
for
the
number
of
acres
treated
used
in
the
exposure
equation
is
350
acres.

Groundboom:
The
assumption
for
the
number
of
acres
treated
used
in
the
exposure
equation
is
80
acres
for
typical
field
crops,
turf
and
grasses
grown
for
seed,
200
acres
for
high
acreage
crops
and
40
acres
for
golf
course
turf.

Airblast:
The
assumption
for
the
number
of
acres
treated
used
in
the
exposure
equation
is
40
acres.

Chemigation:
The
assumption
for
the
number
of
acres
treated
used
in
the
exposure
equation
is
350
acres.

Low
Pressure
Handwand
Sprayer:
The
assumption
for
the
number
of
gallons
used
in
the
exposure
equation
is
40
gallons
per
day.

High
Pressure/
Volume
Handwand:
The
assumption
for
the
number
of
gallons
used
in
the
exposure
equation
is
1000
gallons
per
day.

Handgun
Sprayer:
The
assumption
for
the
number
of
acres,
for
which
a
worker
would
M/
L
is
100
acres
(
20
trucks
x
5
acres/
truck
=
100
acres).
For
M/
L/
A
applications,
5
acres
is
used.

5.1.2
Exposure
Data
for
Handler
Exposure
Scenarios
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.

HED
uses
a
concept
known
as
unit
exposure
as
the
basis
for
the
scenarios
used
to
assess
handler
exposures
to
pesticides.
Unit
exposures
numerically
represent
the
exposures
one
would
22
receive
related
to
an
application.
They
are
generally
presented
as
mg
active
ingredient
exposure/
pounds
of
active
ingredient
handled
(
mg
ai/
lb).
HED
has
developed
different
unit
exposures
for
different
types
of
application
equipment;
job
functions;
and
levels
of
protection.
The
unit
exposure
concept
has
been
established
in
the
scientific
literature
and
also
through
various
exposure
monitoring
guidelines
published
by
the
U.
S.
EPA
and
international
organizations
such
as
Health
Canada
and
OECD
(
Organization
for
Economic
Cooperation
and
Development).

 
Pesticide
Handler
Exposure
Database
(
PHED)
Version
1.1
(
August
1998):
PHED
was
designed
by
a
task
force
of
representatives
from
the
U.
S.
EPA,
Health
Canada,
the
California
Department
of
Pesticide
regulation,
and
member
companies
of
the
American
Crop
Protection
Association.
PHED
is
a
software
system
consisting
of
two
parts,
a
database
of
measured
exposures
for
workers
involved
in
the
handling
of
pesticides
under
actual
field
conditions
and
a
set
of
computer
algorithms
used
to
subset
and
statistically
summarize
the
selected
data.
Currently,
the
database
contains
values
for
over
1,700
monitored
individuals
(
i.
e.,
replicates)

Users
select
criteria
to
subset
the
PHED
database
to
reflect
the
exposure
scenario
being
evaluated.
The
sub
setting
algorithms
in
PHED
are
based
on
the
central
assumption
that
the
magnitude
of
handler
exposures
to
pesticides
are
primarily
a
function
of
activity
(
e.
g.,
mixing/
loading,
applying),
formulation
type
(
e.
g.,
wettable
powders,
granulars),
application
method
(
e.
g.,
aerial,
groundboom),
and
clothing
scenarios
(
e.
g.,
gloves,
double
layer
clothing).

Once
the
data
for
a
given
exposure
scenario
have
been
selected,
the
data
are
normalized
(
i.
e.,
divided
by)
by
the
amount
of
pesticide
handled
resulting
in
standard
unit
exposures
(
milligrams
of
exposure
per
pound
of
active
ingredient
handled).
Following
normalization,
the
data
are
statistically
summarized.
The
distribution
of
exposures
for
each
body
part
(
e.
g.,
chest
upper
arm)
is
categorized
as
normal,
lognormal,
or
"
other"
(
i.
e.,
neither
normal
nor
lognormal).
A
central
tendency
value
is
then
selected
from
the
distribution
of
the
exposures
for
each
body
part.
These
values
are
the
arithmetic
mean
for
normal
distributions,
the
geometric
mean
for
lognormal
distributions,
and
the
median
for
all
"
other"
distributions.
Once
selected,
the
central
tendency
values
for
each
body
part
are
composed
into
a
"
best
fit"
exposure
value
representing
the
entire
body.

The
unit
exposures
calculated
by
PHED
generally
ranges
from
the
geometric
mean
to
the
median
of
the
selected
data
set.
To
add
consistency
and
quality
control
to
the
values
produced
from
this
system,
the
PHED
Task
Force
has
evaluated
all
data
within
the
system
and
has
developed
a
set
of
grading
criteria
to
characterize
the
quality
of
the
original
study
data.
The
assessment
of
data
quality
is
based
on
the
number
of
observations
and
the
available
quality
control
data.
These
evaluation
criteria
and
the
caveats
specific
to
each
exposure
scenario
are
summarized
in
Appendix
A.
While
data
from
PHED
provide
the
best
available
information
on
handler
exposures,
it
should
be
noted
that
some
aspects
of
the
included
studies
(
e.
g.,
duration,
acres
treated,
pounds
of
23
active
ingredient
handled)
may
not
accurately
represent
labeled
uses
in
all
cases.
HED
has
developed
a
series
of
tables
of
standard
unit
exposures
for
many
occupational
scenarios
that
can
be
utilized
to
ensure
consistency
in
exposure
assessments.
Unit
exposures
are
used
which
represent
different
levels
of
personal
protection
as
described
above.
Protection
factors
were
used
to
calculate
unit
exposures
for
varying
levels
of
personal
protection
if
data
were
not
available.

 
ORETF
Handler
Studies
(
MRID
449722­
01):
A
report
was
submitted
by
the
ORETF
(
Outdoor
Residential
Exposure
Task
Force)
that
presented
data
in
which
the
application
of
various
products
used
on
turf
by
homeowners
and
lawn
care
operators
(
LCOs)
was
monitored.
All
of
the
data
submitted
in
this
report
were
completed
in
a
series
of
studies.
The
study
that
monitored
LCO
exposure
scenarios
using
a
low
pressure,
high
volume
turf
handgun
(
ORETF
Study
OMA002)
is
summarized
below.
A
study
that
monitored
homeowner
exposures
while
using
a
hose­
end
sprayer
(
ORETF
Study
OMA004)
is
described
in
a
later
section
on
residential
handlers.

LCO
Handgun
Sprayer:
A
mixer/
loader/
applicator
study
was
performed
by
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
using
"
Dacthal"
as
a
surrogate
compound
to
determine
"
generic"
exposures
to
individuals
applying
a
pesticide
to
turf
with
a
low­
pressure
"
nozzle
gun"
or
"
handgun"
sprayer.
Dermal
and
inhalation
exposures
were
estimated
using
whole­
body
passive
dosimeters
and
breathing­
zone
air
samples
on
OVS
tubes.
Inhalation
exposure
was
calculated
using
an
assumed
respiratory
rate
of
17
liters
per
minute
for
light
work
(
NAFTA,
1999),
the
actual
sampling
time
for
each
individual,
and
the
pump
flow
rate.
All
results
were
normalized
for
pounds
active
ingredient
handled.
A
total
of
90
replicates
were
monitored
using
17
different
subjects.

Four
different
formulations
of
dacthal
[
75%
wettable
powder
(
packaged
in
4
and
24
pound
bags),
75%
wettable
powder
in
water
soluble
bags
(
3
pound
bag),
75%
water
dispersable
granules
(
2
pound
bag)
and
55%
liquid
flowable
(
2.5
gallon
container)]
were
applied
by
five
different
LCOs
to
actual
residential
lawns
at
each
site
in
three
different
locations
(
Ohio,
Maryland,
and
Georgia)
for
a
total
of
fifteen
replicates
per
formulation.
An
additional
ten
replicates
at
each
site
were
monitored
while
they
performed
spray
application
only
using
the
75
percent
wettable
powder
formulation.
A
target
application
rate
of
2
pounds
active
ingredient
was
used
for
all
replicates
(
actual
rate
achieved
was
about
2.2
pounds
active
ingredient
per
acre).

Each
replicate
treated
a
varying
number
of
actual
client
lawns
to
attain
a
representative
target
of
2.5
acres
(
1
hectare)
of
turf.
The
exposure
periods
averaged
five
hours
twenty­
one
minutes,
five
hours
thirty­
nine
minutes,
and
six
hours
twentyfour
minutes,
in
Ohio,
Maryland
and
Georgia,
respectively.
Average
time
spent
spraying
at
all
sites
was
about
two
hours.
All
mixing,
loading,
application,
adjusting,
calibrating,
and
spill
clean
up
procedures
were
monitored,
except
for
typical
end­
of­
day
clean­
up
activities,
e.
g.
rinsing
of
spray
tank,
etc.
24
In
general,
concurrent
lab
spikes
produced
mean
recoveries
in
the
range
of
78­
120
percent,
with
the
exception
of
OVS
sorbent
tube
sections
which
produced
mean
recoveries
as
low
as
65.8
percent.
Adjustment
for
recoveries
from
field
fortifications
were
performed
on
each
dosimeter
section
or
sample
matrix
for
each
study
participant,
using
the
mean
recovery
for
the
closest
field
spike
level
for
each
matrix
and
correcting
the
value
to
100
percent.

Table
5:
Unit
Exposures
Obtained
From
ORETF
LCO
Handgun
Studies
(
MRID
449722­
01)

Total
Dermal
Unit
Exposure
(
mg/
lb
ai)

Application
Method
Single
Layer,
No
Gloves
Single
Layer,
Gloves
Double
Layer,
Gloves
2
Inhalation
Unit
Exposure
(
Fg/
lb
ai)
1
LCO
Handgun
Spray
Mixer/
Loader/
Applicator
Liquid
Flowable3
No
Data
0.45
0.245
1.8
LCO
Handgun
Spray
Mixer/
Loader/
Applicator
Wettable
Powder
in
Water
Soluble
Bags
3
No
Data
0.64
0.37
7.2
[
Note
the
data
were
found
to
be
lognormal
distributed.
As
a
result,
all
exposures
are
geometric
means.]
Note:

1Air
concentration
(
mg/
m3/
lb
ai)
calculated
using
NAFTA
`
99
standard
breathing
rate
of
17
lpm
(
1
m3/
hr)
2Exposure
calculated
using
OPP/
HED
50%
protection
factor
(
PF)
for
cotton
coveralls
on
torso,
arms,
legs.
3All
commercial
handlers
wore
long
pants,
long­
sleeved
shirt,
nitrile
gloves
and
shoes.

5.1.3
Agricultural
Handler
Scenarios
Mixing/
Loading:
 
mixing
and
loading
liquids
for
aerial
application.
 
mixing
and
loading
liquids
for
groundboom
application.
 
mixing
and
loading
liquids
for
airblast
application.
 
mixing
and
loading
liquids
for
chemigation
application.
 
mixing
and
loading
liquids
for
handgun
sprayer
application
 
mixing
and
loading
wettable
powders
in
water­
soluble
packets
for
aerial
applications.
 
mixing
and
loading
wettable
powders
in
water­
soluble
packets
for
chemigation
application
.
 
mixing
and
loading
wettable
powders
in
water­
soluble
packets
for
groundboom
application.
 
mixing
and
loading
wettable
powders
in
water­
soluble
packets
for
airblast
application.
 
mixing
and
loading
wettable
powders
in
water­
soluble
packets
for
handgun
sprayer
application.
25
Applicators:
 
applying
sprays
aerially.
 
applying
sprays
with
ground
boom
sprayer.
 
applying
sprays
with
airblast
sprayer.

Mixing/
Loading/
Applicators:
 
mixing,
loading
and
applying
liquids
with
high
pressure
handwand.
 
mixing,
loading
and
applying
liquids
with
low
pressure
handwand.
 
mixing,
loading
and
applying
liquids
with
handgun
sprayer
applications.
 
mixing,
loading
and
applying
wettable
powders
in
water­
soluble
packets
with
low
pressure
hand
wand
 
mixing,
loading
and
applying
wettable
powders
in
water­
soluble
packets
for
highpressure
handwand
applications
 
mixing,
loading
and
applying
wettable
powders
in
water­
soluble
packets
for
handgun
sprayer
applications.

Flaggers:
 
flagging
for
aerial
spray
application.

5.1.4
Non­
cancer
Propiconazole
Handler
Exposure
and
Assessment
The
occupational
handler
exposure
and
non­
cancer
risk
calculations
are
presented
in
this
section.

5.1.4.1
Non­
cancer
Propiconazole
Handler
Exposure
and
Risk
Calculations
Non­
cancer
risks
were
calculated
using
the
Margin
of
Exposure
(
MOE)
which
is
a
ratio
of
the
daily
dose
to
the
toxicological
endpoint
of
concern.
Daily
dose
values
are
calculated
by
first
calculating
exposures
by
considering
application
parameters
(
i.
e.,
rate
and
area
treated)
along
with
unit
exposures.
Exposures
are
then
normalized
by
body
weight
and
adjusted
for
absorption
factors
as
appropriate
to
calculate
dose
levels.

Daily
Exposure:
The
daily
exposure
and
daily
dose
to
handlers
were
calculated
as
described
below.
The
first
step
was
to
calculate
daily
exposure
(
dermal
or
inhalation)
using
the
following
formula.

Daily
exp.
{
mg
ai/
day}
=
Unit
exp.
{
mg
ai/
lb
ai
hadl.}
x
Appl.
rate
{
lbs
ai/
area}
x
DAT
{
area/
day}

Where:

Daily
Exposure
=
Amount
(
mg
ai/
day)
deposited
on
the
surface
of
the
skin
that
is
available
for
dermal
absorption
or
amount
inhaled
that
is
available
for
inhalation
absorption;
26
Unit
Exposure
=
Unit
exposures
(
mg
ai/
lb
ai)
derived
from
August
1998
PHED
data,
from
ORETF
data,
from
CMA
data,
or
from
Proprietary
data;

Application
Rate
=
Normalized
application
rate
based
on
a
logical
unit
treatment,
such
as
acres,
square
feet,
gallons,
or
cubic
feet.
Maximum
values
are
generally
used
(
lb
ai/
A,
lb
ai/
sq
ft,
lb
ai/
gal,
lb
ai/
cu
ft);
and
Daily
Area
Treated
=
Normalized
application
area
based
on
a
logical
unit
treatment
such
as
acres
(
A/
day),
square
feet
(
sq
ft/
day),
gallons
per
day
(
gal/
day),
or
cubic
feet
(
cu
ft/
day).

Daily
Dose:
Daily
dose
(
inhalation
or
dermal)
was
calculated
by
normalizing
the
daily
dermal
or
inhalation
exposure
value
by
body
weight
and
accounting
for
dermal
or
inhalation
absorption.
For
adult
handlers
using
propiconazole,
an
average
body
weight
of
60
kilograms
was
used
for
all
exposure
scenarios.

Since
the
short­
term
and
intermediate­/
long­
term
dermal
and
inhalation
toxicological
endpoints
of
concern
are
the
same,
respectively
for
each
duration,
and
based
on
oral
studies,
each
exposure
duration
combines
the
dermal
and
inhalation
doses
and
applies
an
appropriate
route­
specific
absorption
factor.
A
40%
absorption
factor
was
applied
to
the
dermal
daily
dose
based
on
a
dermal
absorption
study
while
a
100%
inhalation
factor
is
assumed
(
standard
HED
policy
when
no
study
data
is
available).

Ave.
Daily
Dose
{
mg/
kg/
day}
=
Daily
exp.
{
mg
ai/
day}
x
{
absorption
factor
(
40%)/
Bodyweight}

Where:

Average
Daily
Dose
=
Absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);

Daily
Exposure
=
Amount
(
mg
ai/
day)
deposited
on
the
surface
of
the
skin
that
is
available
for
dermal
absorption
or
amount
inhaled
that
is
available
for
inhalation
absorption;

Absorption
Factor
=
A
measure
of
the
amount
of
chemical
that
crosses
a
biological
boundary
such
as
the
skin
or
lungs
(%
of
the
total
available
absorbed);
and
Body
Weight
=
Body
weight
determined
to
represent
the
population
of
interest
in
a
risk
assessment
(
kg).

Margins
of
Exposure:
Finally,
the
calculations
of
daily
dermal
dose
and
daily
inhalation
dose
received
by
handlers
were
then
compared
to
the
appropriate
endpoint
(
i.
e.,
NOAEL)
27
to
assess
the
total
risk
to
handlers
for
each
exposure
route
within
the
scenarios.
All
MOE
values
were
combined
for
dermal
and
inhalation
exposure
levels
and
calculated
using
the
formula
below:

Margin
Of
Exposure
(
MOE)
=
NOAEL/
Average
Daily
Dose
(
ADD)

Where:

MOE
=
Margin
of
exposure,
value
used
by
HED
to
represent
risk
or
how
close
a
chemical
exposure
is
to
being
a
concern
(
unitless);

ADD
=
(
Average
Daily
Dose)
or
the
amount
as
absorbed
dose
received
from
exposure
to
a
pesticide
in
a
given
scenario
(
mg
pesticide
active
ingredient/
kg
body
weight/
day);
and
NOAEL
=
Dose
level
in
a
toxicity
study,
where
no
observed
adverse
effects
occurred
(
NOAEL)
in
the
study
5.1.4.2
Propiconazole
Non­
cancer
Risk
Summary
All
of
the
non­
cancer
risk
calculations
for
occupational
propiconazole
handlers
completed
in
this
assessment
are
included
in
Appendix
A.
A
summary
of
the
combined,
dermal
plus
inhalation
short­,
and
intermediate­
term
risks
for
each
exposure
scenario
are
presented
in
Table
6.
28
Table
6:
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
2
gal/
day)
Baseline
Baseline
+
Gloves
Baseline
Baseline
+
Gloves
Mixer/
Loader
­
Liquid
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower
0.1125
1200
13
1500
4.5
500
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,
Triticale
0.1125
350
46
5100
15
1700
Non­
bearing
Citrus,
Pecans,
Non­
bearing
Hazelnuts,
Peanuts
0.225
350
23
2600
7.7
850
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Wild
Rice
0.225
350
23
2600
7.7
850
Sod­
farm
turf
1.8
350
2.9
320
1.0
110
Wheat
0.08
1200
19
2100
6.3
700
Aerial
Rice
0.28
1200
5.4
600
1.8
200
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower
0.1125
200
80
9000
27
3000
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,
Triticale
0.1125
80
200
22000
67
7500
Non­
bearing
Citrus,
Nonbearing
Hazelnuts,
Pecans,
Peanuts
0.225
80
100
11000
33
3700
Grasses
grown
for
seed
(
forage
and
fodder
grasses)
0.225
80
100
11000
33
3700
Sod
farm
turf
80
13
1400
4.2
470
Golf
Course
turf
1.8
40
25
2800
8.4
930
Groundboom
Wheat
0.08
200
110
13000
38
4200
Pecans,
Non­
bearing
Citrus
0.225
40
200
22000
67
7500
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum)
0.1125
40
400
45000
130
15000
Ornamental
(
Flowering
and
Woody
plants)
0.37
40
120
14000
41
4500
Airblast
Bananas
and
Plantains
0.084
40
540
60000
180
20000
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower,
Celery
0.1125
350
46
5100
15
1700
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Non­
bearing
citrus,
Peanut
0.225
350
23
2600
7.7
850
Wheat
0.08
350
65
7200
22
2400
Chemigation
Rice
0.28
350
18
2100
6.2
690
Handgun
Sprayer
Turf
1.8
100
10
1100
3.3
370
29
Mixer/
Loader
­
Wettable
Powder
in
Water
Soluble
Packets
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower
0.1125
1200
1800
3700
600
1200
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,
Triticale
0.1125
350
6200
13000
2100
4300
Non­
bearing
Citrus,
Pecans,
Non­
bearing
Hazelnuts,
Peanuts
0.225
350
3100
6400
100
2100
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Wild
rice
0.225
350
3100
6400
100
2100
Sod­
farm
turf
1.8
350
390
800
130
270
Wheat
0.08
1200
2500
5300
840
1800
Aerial
Rice
0.28
1200
720
1500
240
500
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower
0.1125
200
11000
22000
3600
7500
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,
Triticale
0.1125
80
27000
56000
9000
19000
Non­
bearing
Citrus,
Nonbearing
Hazelnuts,
Pecans,
Peanuts
0.225
80
14000
28000
4500
9300
Grasses
grown
for
seed
(
forage
and
fodder
grasses)
0.225
80
14000
28000
4500
9300
Sod
Farm
turf
80
1700
3500
560
1200
Golf
Course
turf
1.8
40
3400
7000
110
2300
Groundboom
Wheat
0.08
200
15000
32000
5100
11000
Pecans,
Non­
bearing
Citrus
0.225
40
27000
56000
9000
19000
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum)
0.1125
40
54000
110000
18000
37000
Ornamental
(
Flowering
and
Woody
plants)
0.37
40
16000
34000
5500
11000
Airblast
Bananas
and
Plantains
0.084
40
72000
150000
24000
50000
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower,
Celery
0.1125
350
6200
13000
2100
4300
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Non­
bearing
citrus,
Peanut
0.225
350
3100
6400
1000
2100
Wheat
0.08
200
8700
18000
2900
6000
Chemigation
Rice
0.28
350
2500
5200
830
1700
Handgun
Sprayers
Turf
1.8
100
1400
2800
450
930
30
Applicator
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower
0.1125
1200
7500
16000
2500
5500
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,
Triticale
0.1125
350
26000
56000
8600
19000
Non­
bearing
Citrus,
Pecans,
Non­
bearing
Hazelnuts,
Peanuts
0.225
350
31000
28000
4300
9400
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Wild
rice
0.225
350
31000
28000
4300
9400
Sod­
farm
turf
1.8
350
1600
3500
540
1200
Wheat
0.08
1200
11000
23000
3500
7700
1
Aerial
Rice
0.28
1200
3000
6600
1000
2200
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower
0.1125
200
15000
15000
4900
4900
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,
Triticale
0.1125
80
37000
37000
12000
12000
Non­
bearing
Citrus,
Nonbearing
Hazelnuts,
Pecans,
Peanuts
0.225
80
18000
18000
6100
6100
Grasses
grown
for
seed
(
forage
and
fodder
grasses)
0.225
80
18000
18000
6100
6100
Sod
Farm
turf
1.8
80
2300
2300
770
770
Groundboom
(
Open
Cab)

Wheat
0.08
200
21000
21000
6900
6900
Pecans,
Non­
bearing
Citrus
0.225
40
1600
2300
520
770
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum)
0.1125
40
3100
4600
1000
1500
Ornamental
(
Flowering
and
Woody
plants)
0.37
40
960
1400
320
470
Airblast
Bananas
and
Plantains
0.084
40
4200
6200
1400
2100
Flagger
Barley,
Rye,
Oats,
Wheat
(
Past
Feekes
8),
Corn,
Sunflower
Celery,
Stone
Fruits
(
Apricots,
Cherry,
Nectarine,
Peach,
Plum),
Mint,
Triticale
0.1125
350
11000
10000
3700
3500
Non­
bearing
Citrus,
Pecans,
Non­
bearing
Hazelnuts,
Peanuts
Grasses
grown
for
seed
(
forage
and
fodder
grasses),
Wild
rice
0.225
350
5600
5200
1900
1700
Sod­
farm
turf
1.8
350
700
650
230
220
1
Aerial
applications
Wheat
0.08
350
16000
15000
5300
4900
31
Rice
0.28
350
4500
4200
1500
1400
Mixer/
Loader/
Applicator
(
Liquid
formulations)

High
Pressure
Handwand
Non­
bearing
Fruits
and
Nuts,
Ornamental
Woody
and
Flowering
plants
2
1000
NA
780
NA
260
Low
Pressure
Handwand
Non­
bearing
Fruits
and
Nuts,
Ornamental
Woody
and
Flowering
plants
0.0024
2
40
550
110000
180
36000
Handgun
Sprayer
Turf
1.8
5
NA
12000
NA
390
Seed
piece
Dip
Sugarcane
(
HI
only)
.00021
21000
8600
960000
2900
320000
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
Application
and
Flagging
for
Aerial
scenarios
are
accessed
without
gloves;
therefore
data
is
(
N/
A)
2
Area
treated:
(
gal/
day)

5.1.5
Summary
of
Risk
Concerns
and
Data
Gaps
for
Occupational
Handlers
There
are
short­
and
intermediate­
term
non­
cancer
occupational
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.

Data
gaps
for
occupational
handler
scenarios
for
propiconazole
include:

 
Mixing/
loading/
applying
wettable
powder
in
water
soluble
packets
via
high
and
low
pressure
handwands,
backpack
and
handgun
sprayers
(
see
note
in
Section
1.5);

 
Seed
piece
dip
treatments
(
sugarcane);
Application
scenario
only,
whereas
the
M/
L
scenario
has
been
assessed.

 
Tree
injections.

5.1.6
Recommendations
for
Refining
Occupational
Handler
Risk
Assessment
In
order
to
refine
this
occupational
risk
assessment,
exposure
studies
for
many
equipment
types
that
lack
data
or
that
are
not
well
represented
in
PHED
(
e.
g.,
because
of
low
replicate
numbers
or
data
quality)
should
be
considered
based
on
the
data
gaps
identified
above.

6.0
Occupational
Post­
application
Exposures
and
Risks
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
32
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.
Each
factor
has
been
considered
in
this
assessment.

6.1
Occupational
Post­
application
Exposure
Scenarios
Propiconazole
use
is
extremely
varied
as
it
can
be
used
on
a
wide
variety
of
agricultural
crops
(
food,
feed,
ornamentals,
and
turf).
As
a
result,
a
wide
array
of
individuals
can
potentially
be
exposed
by
working
in
areas
that
have
been
previously
treated.

6.1.1
Post­
application
Exposure
Scenarios
and
Rationale
When
assessing
post­
application
exposures
to
agricultural
crops,
HED
uses
a
concept
known
as
the
transfer
coefficient
to
numerically
represent
the
post­
application
exposures
one
would
receive
(
i.
e.,
generally
presented
as
cm2/
hour).
The
transfer
coefficient
concept
has
been
established
in
the
scientific
literature
and
through
various
exposure
monitoring
guidelines
published
by
the
U.
S.
EPA
and
international
organizations
such
as
Health
Canada
and
OECD
(
Organization
for
Economic
Cooperation
and
Development).
The
establishment
of
transfer
coefficients
also
forms
the
basis
of
the
work
of
the
Agricultural
Reentry
Task
Force.
The
transfer
coefficient
is
essentially
a
measure
of
the
contact
with
a
treated
surface
one
would
have
while
doing
a
task
or
activity.
These
values
are
defined
by
calculating
the
ratio
of
an
exposure
for
a
given
task
or
activity
to
the
amount
of
pesticide
on
leaves
(
or
other
surfaces)
that
can
rub
off
on
the
skin
resulting
in
an
exposure.
For
post­
application
exposures,
the
amounts
that
can
rub
off
on
the
skin
are
measured
using
techniques
that
specifically
determine
the
amount
of
residues
on
treated
leaves
or
other
surfaces
(
referred
to
as
transferable
residues
or
dislodgeable
foliar
residues)
rather
than
the
total
residues
contained
both
on
the
surface
and
absorbed
into
treated
leaves.
HED
has
developed
a
series
of
standard
transfer
coefficients
that
are
unique
for
variety
of
job
tasks
or
activities
that
are
used
in
lieu
of
chemical­
and
scenario­
specific
data.

As
with
the
handler
risk
assessment
process,
the
first
step
in
the
post­
application
risk
assessment
process
is
to
identify
the
kinds
of
individuals
that
are
likely
to
be
exposed
to
propiconazole
after
application.
In
order
to
do
this
in
a
consistent
manner,
HED
has
developed
a
series
of
general
descriptions
for
tasks
that
are
associated
with
post­
application
exposures.
Common
examples
include:
agricultural
harvesters,
scouting
activities
in
agriculture,
crop
maintenance
tasks
(
e.
g.,
irrigating,
hoeing
and
weeding),
and
turf
maintenance
(
e.
g.,
golf
course
mowing).

The
next
step
in
the
risk
assessment
process
is
to
define
how
and
when
pesticides
are
applied
in
order
to
determine
the
level
of
transferable
residues
to
which
individuals
could
be
exposed
over
time.
Wherever
available,
use
and
usage
data
are
included
in
this
process
to
define
values
such
as
application
rates
and
application
frequency.
HED
always
completes
risk
assessments
using
maximum
application
rates
for
each
scenario
because
what
is
possible
under
the
label
(
the
legal
means
of
controlling
pesticide
use)
must
be
evaluated,
for
complete
stewardship,
in
order
to
ensure
HED
has
no
concern
for
the
specific
use.
Additionally,
whenever
33
HED
has
additional
information,
such
as
typical
or
average
application
rates
or
frequency
data,
it
uses
the
information
to
further
evaluate
the
overall
risks
associated
with
the
use
of
the
chemical.
In
order
to
define
the
amount
of
transferable
residues
to
which
individuals
can
be
exposed,
HED
relies
on
chemical­
and
crop­
specific
studies
as
described
in
HED
guidelines
for
exposure
data
collection
(
Series
875,
Occupational
and
Residential
Exposure
Test
Guidelines:
Group
B
 
Post­
application
Exposure
Monitoring
Test
Guidelines).
HED
has
also
developed
a
standard
modeling
approach
that
can
be
used
to
predict
transferable
residues
over
time
in
lieu
of
chemical­
and
scenario­
specific
data
(
best
described
in
HED's
SOPs
for
Residential
Exposure
Assessment).
All
agricultural
scenarios
were
evaluated
using
propiconazole­
specific
DFR/
TTR
dissipation
data.

Next,
assessors
must
understand
how
exposures
to
propiconazole
occur
(
i.
e.,
frequency
and
duration)
and
how
the
patterns
of
these
occurrences
can
alter
the
effects
of
the
chemical
in
the
population
after
being
exposed
(
referred
to
as
dose
response).
This
is
supported
by
the
fact
that
several
areas
within
a
work
environment
may
be
treated
at
different
times.
For
example,
parts
of
agricultural
fields
in
a
localized
area
might
be
treated
over
several
weeks
because
of
an
infestation
with
a
concurrent
need
for
hand
labor
activities.
Therefore,
individuals
working
in
those
fields
might
be
exposed
from
contact
with
treated
foliage
over
an
extended
period
of
time
that
could
be
categorized
as
an
intermediate­
term
exposure
as
they
work
on
different
sections
of
fields.
Two
different
types
of
non­
cancer
risk
calculations
were
required
for
each
exposure
duration
considered.
The
durations
of
exposure
that
were
considered
for
non­
cancer
toxicity
were
short­
term
(#
30
days)
and
intermediate­
term
(
30
days
up
to
several
months).
[
Note:
Although
it
is
not
clear
if
long­
term
occupational
post­
application
scenarios
exist,
intermediate­,
and
long­
term
NOAEL's
are
the
same,
therefore
possible
long­
term
exposure
scenarios
are
covered
by
this
assessment].
A
complete
array
of
calculations
were
completed
for
all
identified
exposure
scenarios
using
the
short­
intermediate
and
long­
term
endpoint,
because
HED
believes
that
propiconazole
uses
fit
the
criteria
for
both
of
these
durations.
These
assumptions
were
selected
based
on
best
professional
judgment
and
due
to
the
fact
that
post­
application
exposures
can
vary
depending
on
the
activity
and
type
of
worker
(
i.
e.,
migrant
farm
workers
vs.
the
farmers/
growers
themselves).
Inhalation
exposures
are
thought
to
be
negligible
in
outdoor
postapplication
scenarios
because
of
the
low
vapor
pressure
and
due
to
the
infinite
dilution
expected
outdoors.
As
such,
inhalation
post­
application
exposures
are
not
considered
in
this
assessment.
The
use
of
personal
protective
equipment
or
other
types
of
equipment
to
reduce
exposures
for
post­
application
workers
is
not
considered
a
viable
alternative
for
the
regulatory
process.
This
is
described
in
some
detail
in
EPA's
Worker
Protection
Standard
(
40CFR170).
As
such,
an
administrative
approach
is
used
by
HED
to
reduce
the
risks
and
is
referred
to
as
the
Restricted
Entry
Interval
or
REI.
The
REI
is
time
period
following
a
pesticide
application
during
which
entry
into
the
treated
area
is
restricted.
At
this
time,
there
are
some
labels
that
have
12­
hour
REIs.
All
labels,
based
on
acute
toxicity,
should
have
24
hour
REIs
(
i.
e.,
dermal
toxicity,
eye
irritation
potential,
or
skin
irritation
potential).
Post­
application
risk
levels
are
generally
calculated
in
the
risk
assessment
process
on
a
chemical­,
crop­,
and
activity­
specific
basis.
To
establish
REIs,
post­
application
risks
are
considered
on
varying
days
after
application.

HED
has
used
the
basic
approach
described
above
since
the
mid
1980s
for
calculating
postapplication
risks
to
pesticides.
From
that
time
to
the
present,
several
revisions
and
modifications
were
made
to
HED
policies
as
data
which
warranted
such
changes
became
available.
In
1995,
34
HED
issued
a
Data
Call­
In
for
post­
application
agricultural
data
that
prompted
the
formation
of
the
Agricultural
Reentry
Task
Force
(
ARTF).
This
task
force
has
generated
a
number
of
exposure
studies
and
associated
documents
that
are
currently
under
review
by.
The
work
of
the
ARTF
is
not
yet
complete;
however,
sufficient
data
were
available
from
the
Environmental
Protection
Agency
that
warranted
a
significant
interim
change
in
HED's
Standard
Operating
Procedures
(
SOP's)
related
to
the
data
which
were
already
available
as
the
efforts
of
the
ARTF
paralleled
push
for
tolerance
reassessment
stipulated
by
the
timelines
established
by
FQPA.
As
a
result
of
the
need
for
the
revision
and
using
the
latest
data,
HED
developed
a
revised
policy
on
August
7,
2000
entitled
Standard
Operating
Procedure
(
SOP
003.1)
Science
Advisory
Council
For
Exposure
Policy
Regarding
Agricultural
Transfer
Coefficients.
The
revision
to
this
policy
entailed
linking
worker
activities
to
more
specific
crop/
agronomic
groupings
and
making
better
use
of
the
available
occupational
post­
application
exposure
data.
In
the
new
policy,
transfer
coefficients
were
selected
to
represent
the
activities
associated
with
18
distinct
crop/
agronomic
groupings
based
on
different
types
of
vegetables,
trees,
berries,
vine/
trellis
crops,
turf,
field
crops,
and
bunch/
bundle
crops
(
e.
g.,
tobacco).
In
this
new
scheme
which
HED
uses
to
develop
scenarios
for
occupational
post­
application
exposures,
propiconazole
uses
were
identified
in
the
following
crop
groupings
from
(
SOP
003);

C
Field/
row
crops,
low/
medium
(
e.
g.,
barley,
rice);

C
Field/
row
crops,
tall
(
e.
g.,
corn);

C
Cut
flowers
(
e.
g.,
floriculture
crops);

C
Trees/
fruit,
deciduous
(
e.
g.,
apples,
apricots,
cherries,
peaches,
pears);

C
Trees/
evergreen,
deciduous
(
e.
g.,
Non­
bearing
citrus);

C
Trees/
nut
(
e.
g.,
pecans);

C
Turf/
sod
(
e.
g.,
golf
courses,
sod
farms);

C
Bunch/
bundle
(
e.
g.,
bananas
and
plantains);

C
Berry/
low
(
e.
g.,
Non­
bearing
blueberries);

C
Nursery
crops
(
e.
g.,
ornamentals
­
woody
and
herbaceous
plants);

Within
each
agronomic
group,
a
variety
of
cultural
practices
are
required
to
maintain
the
included
crops.
These
practices
are
varied
and
typically
involve
light
to
heavy
contact
with
immature
plants
as
well
as
with
more
mature
plants.
HED
selected
transfer
coefficient
values
in
its
revision
of
(
SOP
003)
to
represent
this
range
of
exposures
within
each
agronomic
group.
In
the
policy,
transfer
coefficients
were
placed
in
1
of
5
generic
categories
based
on
the
exposures
relative
to
that
group.
These
5
categories
include:
very
low
exposure,
low
exposure,
medium
exposure,
high
exposure,
and
very
high
exposure.
Selections
depended
upon
the
actual
agronomic
practices
that
were
identified
for
each
group
(
i.
e.,
some
groups
had
2
assigned
transfer
coefficients
while
others
had
5).
The
transfer
coefficient
values
which
have
been
used
are
excerpted
directly
from
HED
policy
003.
The
nursery
crop
group
data
have
not
yet
been
formally
included
in
EPA
Policy
3.
However,
the
studies
in
this
area
submitted
by
ARTF
have
been
reviewed
and
used
since
they
will
be
integrated
into
(
SOP
003).
35
6.1.2
Data/
Assumptions
for
Post­
application
Exposure
Scenarios
6.1.2.1
Agricultural
Scenarios
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
occupational
post­
application
worker
risk
assessments
for
agricultural
scenarios.
Each
assumption
and
factor
is
detailed
below
on
an
individual
basis.
In
addition
to
these
values,
transfer
coefficient
values
were
used
to
calculate
risk
estimates.
Several
chemical­
specific
residue
dissipation
studies
were
also
submitted
which
were
used
in
the
development
of
the
risk
estimates.
The
transfer
coefficients
were
taken
from
HED's
revised
policy
entitled
Policy
003.1
Science
Advisory
Council
for
Exposure
Policy
Regarding
Agricultural
Transfer
Coefficients
(
August
7,
2000).
The
assumptions
and
factors
used
in
the
risk
calculations
are
presented
below:

 
There
are
many
factors
that
are
common
to
handler
and
post­
application
risk
assessments
such
as
body
weights,
duration,
and
ranges
of
application
rates.
Please
refer
to
the
assumptions
and
factors
in
Section
5.1.1
for
further
information
concerning
these
values
which
are
common
to
both
handler
and
post­
application
risk
assessments.
In
the
post­
application
risk
assessment,
only
maximum
application
rates
were
considered.

 
Levels
of
Concern:
HED
has
established
the
following
levels
of
concern
(
LOC)
for
occupational
post­
application
risks:

o
Margin
of
Exposure
of
less
than
100
for
occupational
non­
cancer
risks;

 
The
transfer
coefficient
in
Policy
003
for
tree
fruit
thinning
has
been
reduced
since
the
issuance
of
the
policy
from
8000
cm2/
hour
to
3000
cm2/
hour
based
on
a
re­
evaluation
of
the
data
from
the
cited
study
(
i.
e.,
the
change
is
based
on
an
altered
analytical
recovery
correction
factor
that
was
erroneously
used
in
the
initial
study
report).
This
modification
has
been
made
in
the
tree
fruit
group
and
any
other
scenarios
which
have
used
this
value.

 
The
tree
fruit
harvester
transfer
coefficient
used
in
this
assessment
of
1500
cm2/
hr
was
reduced
in
this
assessment
from
a
value
of
3000
cm2/
hr.
This
modification
was
discussed
at
HED's
Science
Advisory
Council
for
Exposure
(
i.
e.,
EXPOSAC)
and
has
been
permanently
incorporated
into
its
(
SOP
003)
for
agricultural
transfer
coefficients.
This
modification
was
made
by
considering
the
results
of
six
different
tree
harvester
studies
conducted/
owned
by
the
Agricultural
Reentry
Task
Force.
A
range
of
crops
was
represented
in
these
data
including
pome
fruit
(
apples),
stone
fruit
(
peaches),
and
citrus.

 
Transfer
coefficients
for
ornamentals
activities
include
the
following:

o
Outdoor
ornamental
pruning
and
tying
(
TC
=
110).
MRID
454695­
01.
ARTF
study
No.
ARF043.
36
o
Ornamentals
in
5,
7,
and
15
gallon
pots;
workers
transporting
and
re­
organizing
potted
plants
(
TC
=
400).
MRID
454695­
02.
ARTF
Study
No.
ARF044.

o
Ornamentals
(
Cut
Flowers)
hand­
harvesting
(
TC/
short­
term
=
5100)
and
(
TC/
intermediate­
term
=
2700).
MRID
465139­
01
Determination
of
Dermal
and
Inhalation
Exposure
to
Reentry
Workers
During
Harvesting
in
Greenhouse
Grown
Cut
Flowers,
Study
Number
ARF­
055,
Agricultural
Reentry
Task
Force,
April
1,
2005.

 
Turf/
sod
crop
grouping:
Recent
ARTF
data
for
this
cluster
should
be
used
instead
of
the
existing
transfer
coefficients
of
500
cm
²
/
hour
and
16500
cm
²
/
hour
which
were
based,
respectively,
on
a
chlorothalonil
turf
mowing
study
and
a
5
percent
transferability
estimate
and
use
of
the
Jazzercise
approach
for
the
high
intensity
contact
activity.
The
two
studies
conducted
by
ARTF
were
golf
course
maintenance
and
sod
farm
harvesting.
Both
studies
used
chlorothanlonil
and
the
ORETF
roller
technique
to
define
turf
transferable
residue
(
TTR)
levels.
There
was
a
significant
issue
with
the
golf
course
maintenance
study
related
to
the
manner
in
which
the
TTRs
were
measured,
because
the
turf
which
was
sampled
was
repeatedly
mowed
therefore
driving
down
TTR
values
and
driving
the
transfer
coefficients
up.
The
problem
with
this
approach
is
that
most
TTR
studies
are
not
conducted
with
this
technique,
so
an
adjustment
based
on
the
exposure
rates
(
mg/
hour)
for
the
workers
compared
to
the
sod
farm
harvesters
was
completed
in
order
to
use
the
carbaryl­
specific
TTR
data
for
all
activities.
For
the
sod
farm
harvesting
activity,
transfer
coefficients
were
calculated
by
both
the
ARTF
and
Health
Canada,
and
the
arithmetic
mean
calculated
by
Health
Canada
of
6800
cm
²
/
hour
was
used
to
represent
this
activity
for
risk
assessment
purposes.
When
adjusted
for
application
rate,
the
exposure
rate
(
mg/
hour)
for
golf
courses
workers
(
turf
maintenance)
was
approximately
half
that
of
sod
farm
harvesters,
so
a
transfer
coefficient
of
3400
cm
²
/
hour
was
used
to
represent
that
activity.
In
the
sod
farm
harvesting
study,
the
majority
of
activity
was
mowing
and
the
transferability
was
approximately
1
percent,
whereas
the
500cm
²
/
hour
TC
value
was
based
on
a
transferability
of
5
percent.
As
such,
it
is
recommended
that
for
occupational
postapplication
the
TC
of
3400
cm
²
/
hour
be
used
to
represent
the
mowing
activity.
However,
for
residential
mowing,
a
transfer
coefficient
of
500
cm
²
/
hour
was
used
to
represent
that
activity.
This
modification
was
discussed
and
adopted
at
HED's
Science
Advisory
Council
for
Exposure
(
i.
e.,
EXPOSAC).

 
Chemical
specific
dislodgeable
foliar
residue
(
DFR)
and
turf
transferable
residue
(
TTR)
data
were
used
to
complete
all
post­
application
risk
assessments.
The
chemicalspecific
residue
data
is
described
in
detail
below
and
summarized
in
Appendix
B.

 
Exposure
calculations
reflect
chemical­
specific
residue
dissipation
rates
over
time
coupled
with
surrogate
transfer
coefficients
as
outlined
in
HED's
revised
(
SOP's).
Three
DFR
studies
were
submitted
that
meet
current
HED
guidelines
for
sampling
techniques
and
data
quality
(
a
fourth,
for
ornamental
crops,
uses
results
from
a
37
previously
submitted
study).
Additional
DFR
data
from
two
worker
exposure
studies
(
data
which
was
incorporated
into
PHED)
were
also
used.

 
A
pseudo­
first
order
kinetics
analysis
was
used
to
analyze
propiconazole
residue
dissipation
over
time
as
outlined
in
EPA's
draft
Series
875
Post­
application
Exposure
Monitoring
Guidelines.
A
more
sophisticated
curve­
fitting
approach
was
not
warranted
because
any
sophistication
gained
with
a
curve
fitting
technique
would
be
lost
in
an
extrapolation
to
another
crop).

 
A
turf
transferable
residue
(
TTR)
study
was
submitted
and
used
in
exposure
and
risk
calculations.
There
are
various
techniques
used
to
measure
turf
transferable
residues
(
TTR)
all
of
which
have
varying
transfer
efficiencies.
The
transfer
efficiency
for
the
Modified
California
roller
is
less
than
1
percent.
This
value
is
below
the
lower
limit
compatibility
with
Agency
transfer
coefficients
for
chemicals
applied
to
turf
grass,
as
delineated
in
Exposure
Sac
Policy
12.
An
appropriate
study
for
use
with
TTR
data
generated
using
the
modified
California
roller
is
presented
in
the
Outdoor
Residential
Exposure
Task
Force
Study
entitled:
The
ORETF
Algorithm
for
Defining
the
Relationship
for
Transferable
Turf
Residues
to
Post­
Application
Dermal
Exposure
[
MRID
4661905­
01].
In
that
study,
post­
application
exposure
to
a
turf­
grass
pesticide
was
measured
using
passive
dosimetry
and
TTR
data
generated
using
the
modified
California
roller.
The
efficiency
of
the
TTR
measurement
in
the
ORETF
study
was
0.5%
making
it
appropriate
for
this
assessment.
A
preliminary
review
of
these
data
suggests
a
transfer
coefficient
of
70,000
cm
²
/
hour
representing
an
adult
wearing
short
pants,
a
short
sleeved
shirt
and
enclosed
footwear
(
Residential
Post­
application
Dermal/
General
Activities)
as
well
as,
a
transfer
coefficient
of
25,000
cm
²
/
hour
representing
a
child
(
see
Appendix
D
for
both
scenarios).

 
When
extrapolating
the
available
DFR
data
to
other
crops,
HED
adjusted
the
data
for
differences
in
application
rate
using
a
simple
proportional
approach.
This
approach
seems
to
be
the
most
appropriate
given
the
data
which
are
available.
This
approach
is
commonly
used
in
HED
post­
application
risk
assessments.

 
Where
chemical
specific
data
is
unable
or
not
applicable,
the
following
HED
default
values
are
used
in
post­
application
exposure
calculations:

o
5%
of
the
application
rate
represents
the
initial
fraction
of
residue
available
on
turf;

o
20%
of
the
application
rate
represents
the
initial
fraction
of
residue
available
on
conventional
agricultural
crops;
and
o
10%
for
the
daily
residue
dissipation
rate
for
all
crops.
38
Post­
application
Studies:
A
total
of
six
studies
are
described
in
this
section.
These
studies
described
residue
dissipation
and
exposure
for
corn,
peaches,
rice,
pecans,
ornamentals
and
turf.
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).
Each
study
can
be
identified
with
the
following
information.

 
MRID
42564003:
Propiconazole
 
Dislodgeable
Residue
on
Corn
(
North
Carolina)
EPA
MRID
425640­
03;
Report
dated
1991.
Author
Avakian,
M;
Sponsor:
Ciba­
Geigy
Corporation
Agriculture
Division.
Submitted
by
Environmental
Technologies
Institute,
Inc.
and
EN­
CAS
Labs.

 
MRID
44959701:
Dissipation
of
Dislodgeable
Foliar
Residue
of
Two
formulations
of
Propicoanzole
(
Orbit
 
and
Orbit
 
45W)
Applied
to
Peaches.
EPA
MRID
44959701(
0442);
Report
dated
1999;
Author;
Rosenheck,
L.
Report:
Lab
report
Number:
260­
98:
44580:
AG­
561
Performing
Laboratories:
ABC
Laboratories.,
Inc.

 
MRID
45288601:
Determination
of
Transferable
Turf
Residue
on
Turf
treated
with
Banner
MAXX;
Report
dated
(
2000);
Authors;
Rosenheck,
L.;
Meyer,
L.
Lab
Project
Number
990046:
179­
99.
Performing
Laboratories:
Central
California
Research
Laboratories,
Inc.

 
MRID
40279806:
Author;
Honeycutt,
R.
CGA
64250
(
Tilt)
Worker
Exposure
in
Pecans
Unpublished.
Sponsored
by:
Ciba­
Geigy
 
MRID
133390:
Author;
Honeycutt,
R.
(
1983)
CGA
64250
(
Tilt)
Worker
Exposure
in
Rice:
Report
No.
EIR­
83011.
(
Unpublished
study
received
Dec
12,
1983
under
100­
617;
submitted
by
Ciba­
Geigy
Corp.,
Greensboro,
NC;
CDL:
07222­
C)

 
MRID
44959702:
Dissipation
of
Dislodgeable
Foliar
Residues
of
Propiconazole
(
Banner
MAXX)
Applied
to
Commercial
Ornamentals.
Rosenheck,
L.;
Meyer,
L.(
1999)
Final
report:
Lab
Project
Number:
1134­
99.
Unpublished
study
prepared
by
Novartis
Crop
Protection,
Inc.
51
p.

MRID
42564003
(
Corn
DFR
data):
This
DFR
study
is
summarized
below
for
use
in
the
propiconazole
risk
assessment.
This
study
was
designed
to
collect
data
to
evaluate
dislodgeable
foliar
residue
(
DFR)
dissipation
for
propiconazole
at
a
test
site
in
North
Carolina.
Tilt
®
3.6E
Emulsive,
an
emulsifiable
formulation
of
propiconazole,
was
applied
using
a
John
Deere
High
Boy
sprayer
with
CO2
propellant.
One
application
was
made
at
the
maximum
application
rate
of
0.11
lb.
active
ingredient
(
ai)
per
acre.
The
site
consisted
of
a
control
(
untreated)
plot
and
a
treated
plot,
split
into
six
sampling
subplots
(
three
untreated
and
three
treated).
The
treated
plot
was
sampled
in
triplicate
at
each
sampling
interval.
One
sample
was
collected
from
the
control
39
plot
at
each
sampling
interval.
Soil,
leaf
punch,
tassel,
and
tassel
stalk
samples
were
collected
from
one
day
prior
to
application
to
35
days
following
application.

The
study
author
reported
that
detectable
DFR
values
were
found
on
leaf
punch
samples
on
the
day
of
application
(
0.059
:
g/
cm2)
and
up
to
7
days
after
treatment
(
DAT).
DFR
values
for
propiconazole
declined
to
less
than
the
limit
of
quantification
(
LOQ)
by
DAT­
14
for
the
leaf
punch
samples.
DFR
values
for
tassel
samples
were
detected
on
one
or
more
tassel
samples
on
each
sampling
date
(
DAT­
0
through
DAT­
14),
with
the
average
residue
decreasing
from
11.1
:
g
on
DAT­
1
to
1.7
:
g
on
DAT­
14.
Residues
were
detected
in
soil
samples
collected
on
DAT­
0
and
DAT­
7,
averaging
0.13
ppm,
and
0.37
ppm,
respectively.

All
residues
were
corrected
for
the
average
recovery,
if
any
recovery
values
were
less
than
100%.
Dissipation
rates
were
modeled
by
the
study
author
assuming
first­
order
kinetics
to
estimate
propiconazole
half­
lives
of
3.5
days
and
5.1
days
for
leaf
punch
and
tassel
samples,
respectively.
All
of
the
data
points
(
not
averages)
were
utilized
in
conducting
the
regression
analysis.
The
estimated
half
life,
based
on
leaf
punch
samples,
was
3.14
days
(
R2=
0.75).
Halflife
was
not
calculated
based
on
the
tassel
samples
due
to
the
number
of
non­
detect
samples.
One
rainfall
event
occurred
on
DAT­
2,
with
a
total
of
4.4
inches
of
rainfall
occurring
between
DAT­
0
and
DAT­
35.

[
Note:
Today's
standard
is
to
examine
double
sided
leaf
residues.]
The
results
of
the
study
are
presented
in
detail
in
Appendix
B.
The
results
of
the
pseudo­
first
order
statistical
analysis
of
the
data
are
summarized
below
in
Table
7.

Table
7:
Corn
DFR
Data
(
MRID
42564003)

Location
App.
Rate
(
lb
ai/
acre)
App.
Method
Corr.
Coeff.
Slope
(
Ln
DFR
vs.
t)
[
T0]
(
Fg/
cm2)
T1/
2
(
days)
Day
0
(%
trans.)
NC
(
Tilt
3.
E)
0.1125
Groundboom
0.750
­
0.22061
0.0585
3.14
4.6
*
LOQ
=
0.0044(
Fg/
cm
2
)

MRID
449597­
01
(
Peach
DFR
data):
This
DFR
study
is
summarized
below
for
use
in
the
propiconazole
risk
assessment.
This
study
was
designed
to
collect
data
to
calculate
dislodgeable
foliar
residue
(
DFR)
dissipation
curves
and
to
generate
"
time­
zero"
dislodgeable
residue
for
propiconazole
on
peach
leaf
foliage
at
three
test
sites
in
California,
South
Carolina
and
Georgia.
Two
different
end­
use
formulations
(
emulsifiable
concentrate
and
wettable
powder
in
water
soluble
packets)
were
applied
by
ground
airblast
sprayer.
The
maximum
application
rate
was
applied
(
0.1125
pound
active
ingredient
(
ai)
per
acre),
and
the
application
frequency
of
two
applications
(
7
to
14
day
intervals)
were
relevant
to
the
use
pattern
proposed.
Three
sites
were
monitored
with
three
replicates
per
sampling
time
per
treatment
site
(
i.
e.,
untreated
control
plot,
wettable
powder
in
water
soluble
packets
treated
plot
and
emulsifiable
treated
plot).

The
authors
report
that
the
average
DFR
value
found
immediately
after
the
second
application
(
for
either
formulation)
was
12.1
percent
of
the
amount
applied.
DFR
declined
to
<
LOQ
by
DAT­
14
at
the
South
Carolina
test
site,
and
by
DAT­
7
at
the
Georgia
test
site.
By
DAT­
35,
DFR
had
only
declined
to
approximately
4
times
LOQ
at
the
California
test
site.
Little
difference
was
found
between
DFR
measured
for
the
two
formulations.
Dissipation
rates
were
40
modelled
utilizing
pseudo­
first
order
kinetics
to
estimate
t
½
=
1.5
days
in
Georgia,
4.0
days
in
South
Carolina,
and
6.3
days
in
California
where
there
was
no
rainfall
during
the
study
period.

The
study
met
most
of
the
Series
875.2100
Guidelines.
Residues
were
detected
within
the
fortification
level
limits
and
well
above
the
quantization
limits.
Fortified
field
recovery,
concurrent
laboratory
recovery,
storage
recovery,
and
untreated
control
sample
data
were
adequate,
and
indicate
that
DFR
data
do
not
need
to
be
corrected
for
losses.

The
results
of
the
studies
in
California,
South
Carolina
and
Georgia
are
presented
in
detail
in
Appendix
B.
To
present
the
most
conservative
assessment,
the
data
for
the
emulsifiable
concentrate
formulation
applied
in
California
was
used.
The
results
of
the
pseudo­
first
order
statistical
analysis
of
this
data
are
shown
below
in
Table
8.

Table
8:
Peach
DFR
Data
(
MRID
449597­
01)

Location
App.
Rate
(
lb
ai/
acre)
App.
Method
Corr.
Coeff.
Slope
(
Ln
DFR
vs.
t)
[
T0]
(
Fg/
cm2)
T1/
2
(
days)
Day
0
(%
trans.)
CA
(
Break
EC)
0.1125
Airblast
0.900
­
0.0708
0.25
9.79
20.1
MRID
452886­
01
(
Turf
Transferable
Residue
data):
A
TTR
study
was
conducted
at
individual
sites
in
three
states
using
the
Modified
California
Roller
Technique.
This
study
was
designed
to
collect
data
to
characterize
dissipation
of
propiconazole
turf
transferable
residues
when
applied
to
turf
at
three
test
sites
in
Indiana,
California,
and
Pennsylvania.
Banner
®
MAXX,
an
emulsifiable
concentrate
formulation
of
the
test
product
was
applied
once
to
each
site.
A
tractor
powered
Spraying
Systems
Handgun
was
used
to
apply
the
fungicide
at
all
three
test
sites.
Each
application
was
made
at
the
maximum
application
rate
of
1.79
pounds
active
ingredient
(
ai)
per
acre.
Turf
transferable
residues
(
TTR)
were
collected
using
the
modified
California
Roller
Technique.
The
application
method,
rate,
and
frequency
(
number
and
timing)
were
relevant
to
the
use
pattern
proposed
by
the
product
label.
Triplicate
samples
from
each
control
plot
and
four
treated
replicate
samples
(
one
sample
from
each
of
four
sections)
were
collected
at
each
test
site
immediately
before
and
after
the
application;
4
hours,
8
hours,
and
24
hours
after
the
application
as
well
as
2,
3,
5,
8,
10,
14,
and
21
days
after
treatment
(
DAT).
At
the
Indiana
site,
the
average
total
propiconazole
residues
reached
a
maximum
of
0.0326
µ
g/
cm2
immediately
after
the
application
and
declined
to
below
the
minimum
quantifiable
limit
(
MQL)
of
0.00179
µ
g/
cm2
by
DAT
14.
At
the
California
site,
the
average
total
propiconazole
residues
reached
a
maximum
of
0.195
µ
g/
cm2
immediately
after
the
application
and
declined
to
below
MQL
(
0.00179
µ
g/
cm2)
by
DAT
10.
At
the
Pennsylvania
site,
the
average
total
propiconazole
residues
reached
a
maximum
of
0.0902
µ
g/
cm
immediately
after
the
application
and
declined
to
below
MQL
(
0.00179
µ
g/
cm2)
by
DAT
8.
However,
residues
were
also
found
on
DAT
14.

The
average
total
propiconazole
residues
found
immediately
after
the
application
at
the
Indiana,
California,
and
Pennsylvania
sites
were
approximately
0.091%,
0.542%,
and
0.251%
of
the
target
application,
respectively.
All
of
the
maximum
average
propiconazole
residues
occurred
immediately
after
the
application.
A
dissipation
rate
was
modeled
by
the
study
author
assuming
first­
order
kinetics
to
estimate
total
propiconazole
half­
lives
of
2.2
days
(
R2=
0.751),
1.3
days
(
R2=
0.943)
and
1.9
days
(
R2=
0.871)
on
turf
at
the
Indiana,
California,
and
Pennsylvania
41
sites,
respectively.
The
registrant
corrected
the
TTR
values
for
the
California
sites
since
the
overall
average
field
fortification
recovery
was
less
than
90
percent
(
87.8%).

The
results
of
the
studies
for
California,
Indiana,
and
Pennsylvania
sites
are
presented
in
Table
9
below.

Table
9:
TTR
Data
(
MRID
452886­
01)

Location
App.
Rate
(
lb
ai/
acre)
App.
Method
Corr.
Coeff.
Slope
(
Ln
TTR
vs.
t)
[
T0]
(
Fg/
cm2)
T1/
2
(
days)
Day
0
(%
trans.)
Indiana
0.721
­
0.3145
0.0326
2.20
0.2
California
0.922
­
0.5451
0.1945
1.27
1.0
Pennsylvania
1.79
Power
Handgun
Sprayer
0.864
­
0.3694
0.0902
1.88
0.4
MRID
40279806
(
Pecan
DFR
data):
A
DFR
study
was
conducted
in
a
pecan
orchard
that
was
treated
with
Tilt
3.6E
located
in
Lugoff,
South
Carolina.
The
orchard
consisted
of
400
acres
of
mature
pecan
trees.
Four
three­
acre
plots
in
the
orchard
were
treated
with
Tilt
3.6E.
The
applications
rate
of
12
fl.
oz./
acre
(
0.34
lbs.
ai.
acre)
in
a
100
gallons/
acre,
was
applied
using
an
air
blast
sprayer
pulled
by
an
open
tractor.
Three
 
acre
plots
containing
36
mature
pecan
trees
each
about
60
feet
high,
were
treated
with
8
applications
through
out
the
season.
Leaf
samples
were
collected
during
two
periods
from
June
21
(
day
0)
to
July
5,
1982,
and
from
September
1
(
day
0)
to
September
15,
1982.
Samples
were
taken
immediately
before
and
after
CGA­
64250
application
and
on
days
2,
3,
7,
and
14
following
the
June
21
application
and
on
days
0,
1,
3,
5,
7
and
14
following
the
September
1
application.
Four
replicate
samples
taken
from
each
threeacre
plot
during
each
sampling
period.
The
immature
pecan
leaves
had
an
average
surface
area
of
952
cm
²
/
40
leaves,
while
the
leaf
discs
had
an
average
surface
area
of
405
cm
²
/
40
leaf
discs.
Two
replicate
leaf
samples
were
taken
each
day
for
untreated
control
pecan
orchards.
Two
additional
control
samples
were
taken
from
control
plot
prior
to
application
and
on
the
5th
and
14th
days
following
application
for
use
by
the
analytical
laboratory
to
determine
recoveries.
Dislodgeable
residues
were
measured
on
pecan
leaf
surfaces
for
14
days
following
applications
of
Tilt
3.6E.
The
maximum
mean
dislodgeable
residues
were
0.19
µ
g/
cm
²
and
0.39
µ
g/
cm
²
immediately
(
day
0)
after
treatment
for
mature
and
immature
pecan
leaves
respectively.
The
half
life
values
of
dislodgeable
residues
on
immature
and
mature
leaves
were
3.1
and
5.5
days,
respectively.

Table
10:
Pecan
DFR
Data
(
MRID
40279806)

Location
App.
Rate
(
lb
ai/
acre)
App.
Method
Corr.
Coeff.
Slope
(
Ln
DFR
vs.
t)
[
T0]
(
Fg/
cm2)
T1/
2
(
days)
Day
0
(%
trans.)
So.
Carolina
0.34
Air
blast
0.922
­
0.12589
0.385
5.50
10.1
MRID
133390
(
Rice
DFR
data):
A
DFR
study
was
conducted
in
a
rice
field
that
was
treated
with
Tilt
3.6E
located
in
Jerome,
Arkansas.
Two
50
acre
plots
on
in
this
field
were
treated
with
Tilt
for
this
exposure
study.
Tilt
3.6E
was
applied
to
10
fl.
oz/
acre
(
0.28
lbs/
ai/
acre)
in
5
gallons
of
water/
acre.
Aerial
application
at
20
lbs/
in.
²
was
used
for
each
application.
Two
applications
were
made
throughout
the
season.
Leaf
samples
were
collected
during
the
period
from
July
15
(
day
0)
to
July
27,
1982.
Samples
were
taken
immediately
before
and
after
application
and
on
days
1,
3,
4,
7,
and
14
following
the
July
15
application.
Control
samples
were
taken
from
42
control
fields
prior
to
application
on
July
15
1982.
Twenty
leaf
samples
were
taken
from
the
100­
acre
treated
rice
field.
It
was
determined
that
a
rice
leaf
had
an
average
surface
area
of
1,364
cm
²
(
two
sides).
Twenty
rice
leaves
about
30
cm
in
length
were
placed
in
an
8
oz.
jar.
100
ml
of
Sur­
ten
wetting
solution
was
added.
Mean
total
exposure
to
workers
performing
mixerloader
functions
was
38.8
mg/
hour
if
a
short
sleeved
shirt
was
worn
and
34.4
mg/
hour
for
a
long
sleeved
shirt.
Aerial
applications
of
Tilt
3.6E
resulted
in
a
mean
of
0.59
mg/
hour
total
exposure
to
applicators
wearing
short
sleeved
shirts
or
long
sleeved
shirts.
Respiratory
exposure
was
15%
(
0.09
mg/
hour)
of
total
exposure.
Flaggers
who
worked
in
the
direct
line
of
application
were
exposed
to
a
mean
of
4.4
mg/
hour.
Dislodgeable
residues
were
measured
on
rice
leaf
surfaces
for
14
days
following
applications
of
Tilt
3.6E.
Maximum
mean
residues
of
0.18
µ
g/
cm
²
were
measured
immediately
(
day
0)
after
treatment.
The
half
life
value
of
dislodgeable
residues
on
leaves
was
2.2
days.
The
maximum
dose
density
rate
for
exposure
of
scouts
to
rice
leaves
was
0.03
µ
g/
cm
²
skin/
hour.
Results
maintained
that
aerial
applicators
received
0.59
mg/
hour
mean
total
exposure
if
a
short
sleeved
shirt
or
a
long
sleeved
shirt
was
worn
during
application.
Respiratory
exposure
to
applicators
was
0.09
mg/
hour
and
was
15%
of
total
exposure.
The
mean
exposure
lever
for
a
mixer­
loader
was
estimated
to
be
38.8
mg/
hour
for
a
worker
wearing
a
short
sleeved
shirt.
Residues
were
reduced
by
12%
to
a
mean
of
34.3
mg/
hour.
The
total
exposure
(
dermal
and
respiratory)
to
a
flagger
wearing
a
short
sleeved
shirt
and
stands
inside
was
a
mean
total
of
4.4
mg/
hour.
Flaggers
wearing
long
sleeved
shorts
were
able
to
reduced
exposure
by
25%
for
a
mean
total
of
3.3
mg/
hour.
A
flagger
outside
the
area
of
application
received
0.08
mg/
hour,
whereas
a
98%
reduction
was
noted
due
to
standing
outside
the
spraying
area.

Table
11:
Rice
DFR
Dissipation
Data
(
MRID
133390)

Location
App.
Rate
(
lb
ai/
acre)
App.
Method
Corr.
Coeff.
Slope
(
Ln
DFR
vs.
t)
[
T0]
(
Fg/
cm2)
T1/
2
(
days)
Day
0
(%
trans.)
Arkansas
0.28
Aerial
0.946
­
0.30837
0.184
2.25
5.9
MRID
44959702
(
Ornamental
DFR
data):
A
propiconazole
DFR
study
was
conducted
by
Novartis
on
1998
on
peaches
in
fulfillment
of
the
1995
Agricultural
Data
Call­
In.
Data
from
that
study
was
used
as
surrogate
to
determine
residues
that
would
be
found
on
commercially
treated
ornamental
and
landscape
plants.

6.1.3
Occupational
Post­
application
Exposure
and
Non­
cancer
Risks
The
occupational
post­
application
exposure
and
non­
cancer
risk
estimates
are
presented
in
this
section.
Non­
cancer
risk
estimates
were
calculated
using
the
Margin
of
Exposure
(
MOE)
which
is
a
ratio
of
the
daily
dose
to
the
toxicological
endpoint
of
concern.
Daily
dose
values
are
calculated
by
first
calculating
exposures
by
considering
application
parameters
(
i.
e.,
rate
and
area
treated)
along
with
unit
exposures.
Exposures
were
calculated
by
multiplying
these
factors
by
an
8
hour
work
day.
Exposures
are
then
normalized
by
body
weight
and
adjusted
for
dermal
absorption
to
calculate
absorbed
dose.
MOEs
were
then
calculated.
Post­
application
risks
diminish
over
time
because
propiconazole
residues
eventually
dissipate
in
the
environment.
As
a
result,
risk
estimates
were
calculated
over
time
based
on
changing
residue
levels.
43
6.1.3.1
Agricultural
Scenarios/
Calculation
Methods
Dissipation
Kinetics:
The
first
step
in
the
post­
application
risk
assessment
was
to
complete
an
analysis
of
the
available
dislodgeable
foliar
and
turf
transferable
residue
(
DFR
and
TTR)
data.
As
discussed
in
Section
6.1.2.1
above,
data
from
four
DFR
studies
and
default
values
for
TTR
were
used
to
calculate
risks
for
all
agronomic
crop
groups.
Best
fit
DFR
levels
were
calculated
based
on
empirical
data
using
the
equation
D2­
16
from
Series
875­
Occupational
and
Residential
Test
Guidelines:
Group
B­
Post­
application
Exposure
Monitoring
Test
Guidelines.
The
summary
of
the
available
chemical­
specific
DFR
and
TTR
data
were
developed
based
on
a
semilog
regression
of
the
empirical
dissipation
data
using
a
commercial
spreadsheet
linear
regression
function.
Half­
lives
were
calculated
using
the
algorithm
(
T1/
2
=
­
Ln
2/
slope).
The
results
of
the
regression
analyses
were
used
to
calculate
best
fit
concentrations
over
time
using
the
following
pseudo­
first
order
equation:
Cenvir
(
t)
=
Cenvir
(
o)
*
e
PAI
(
t)
*
M
Where:

Cenvir
(
t)
=
dislodgeable
foliar
or
turf
transferable
residue
concentration
(:
g/
cm2)
that
represents
the
amount
of
residue
on
the
surface
of
a
contacted
leaf
surface
that
is
available
for
dermal
exposure
at
time
(
t);
Cenvir
(
o)
=
dislodgeable
foliar
or
turf
transferable
residue
concentration
(:
g/
cm2)
that
represents
the
amount
of
residue
on
the
surface
of
a
contacted
leaf
surface
that
is
available
for
dermal
exposure
at
time
(
0);

e
=
natural
logarithms
base
function;

PAI
(
t)
=
post­
application
interval
or
dissipation
time
(
e.
g.,
days
after
treatment
or
DAT);

M
=
slope
of
line
generated
during
linear
regression
of
data
[
ln(
Cenvir)
versus
Post­
application
interval
(
PAI)].

In
cases
where
no
chemical­
specific
residue
dissipation
data
are
available,
HED
typically
uses
a
generic
dissipation
model
to
complete
risk
calculations.
In
this
case,
HED
determined
that
it
is
more
appropriate;
however,
to
extrapolate
using
propiconazole­
specific
dissipation
data
in
the
risk
assessment
for
other
currently
labeled
crops
(
except
for
turf)
than
it
is
to
use
the
generic
dissipation
model.
This
approach
is
consistent
with
current
HED
policies
for
generating
transferable/
dislodgeable
residue
data.
The
existing
residue
data
were
extrapolated
to
the
currently
labeled
crops
as
follows:

C
Corn
DFR
Data:
This
data
has
been
used
to
complete
all
assessments
for
the
following
agronomic
crop
groups
defined
in
HED's
revised
transfer
coefficient
policy
003:

<
Tall
field/
row
crop:
corn
(
field/
pop/
sweet),
sunflowers
breeder's
seed.
44
C
Peach
DFR
Data:
This
data
has
been
used
to
complete
all
assessments
for
the
following
agronomic
crop
groups
defined
in
HED's
revised
transfer
coefficient
policy
003.

<
Tree
fruit:
non­
bearing
citrus
and
non
bearing
fruit;

<
Stone
Fruit:
apricot,
cherry,
nectarine,
peach,
plum;

<
Bunch/
bundle:
bananas,
plantains;

<
Ornamentals:
woody
and
flowering
plants.

C
Turf
TTR
Data:
This
data
has
been
used
to
complete
all
assessments
for
the
following
agronomic
crop
groups
defined
in
HED's
revised
transfer
coefficient
policy
003:

<
Turf:
Sod­
farm,
recreational
areas
and
golf
courses
C
Pecan
DFR
Data:
This
data
has
been
used
to
complete
all
assessments
for
the
following
agronomic
crop
groups
defined
in
HED's
revised
transfer
coefficient
policy
003:

<
Tree
nuts:
non­
bearing
hazelnuts
and
pecans
C
Rice
DFR
Data:
These
data
have
been
used
to
complete
all
assessments
for
the
following
agronomic
crop
groups
defined
in
HED's
revised
transfer
coefficient
policy
003:

<
Field/
row
crops,
low/
medium:
peanuts,
wheat,
barley,
mint,
rice
The
extrapolations
noted
above
were
completed
because
of
similarities
in
application
methods
between
the
study
and
selected
crop
groups,
the
crop
canopy,
and
application
rates
(
i.
e.,
between
the
study
and
current
labels).

Daily
Exposure:
The
next
step
in
the
risk
assessment
process
was
to
calculate
dermal
exposures
on
each
day
after
application
using
the
following
equation
(
see
equation
D2­
20
from
Series
875­
Occupational
and
Residential
Test
Guidelines:
Group
B­
Post­
application
Exposure
Monitoring
Test
Guidelines
and
Residential
SOP
3.2:
Post­
application
Dermal
Potential
Doses
from
Pesticide
Residues
On
Gardens):

DE(
t)
(
mg/
day)
=
(
TR(
t)
(
Fg/
cm2)
x
TC
(
cm2/
hr)
x
Hr/
Day)/
1000
(
Fg/
mg)
Where:

DE(
t)
=
Daily
exposure
or
amount
deposited
on
the
surface
of
the
skin
at
time
(
t)
attributable
for
activity
in
a
previously
treated
area,
also
referred
to
as
potential
dose
(
mg
ai/
day);

TR(
t)
=
Transferable
residues
that
can
either
be
dislodgeable
foliar
or
turf
transferable
residue
at
time
(
t)
where
the
longest
duration
is
dictated
by
the
decay
time
observed
in
the
studies
(
Fg/
cm2);
45
TC
=
Transfer
Coefficient
(
cm2/
hour);

hr/
day
=
Exposure
duration
meant
to
represent
a
typical
workday
(
hours).

Daily
Dose
and
Margins
of
Exposure:
Once
daily
exposures
are
calculated,
the
calculation
of
daily
absorbed
dose
and
the
resulting
Margin
of
Exposures
use
the
same
algorithms
that
are
described
above
for
the
handler
exposures
(
See
Section
5.1.3).
These
calculations
are
completed
for
each
day
or
appropriate
block
of
time
after
application.

6.1.4
Occupational
Post­
application
Non­
cancer
Risk
Summary
All
non­
cancer
post­
application
risk
calculations
are
included
in
Appendix
B.
A
summary
of
the
post­
application
risks
for
each
crop/
activity
combination
are
shown
in
Table
12.

Table
12:
Summary
of
Propiconazole
Non­
cancer
Post­
application
Worker
Risk
Estimates
Crop
Activity
TC
cm2/
hr
Max.
App.
Rate
(
lb
ai/
A)
DAT
(
days)
DFR
ug/
cm2
(
adjusted)
Short­
Term
MOE
1Int/
Long
­
Term
MOE
irrigating,
scouting,
handweeding
100
0
0.184
36000
12000
irrigating,
scouting
1500
0
0.184
2400
800
Celery,
Mint,
Wild
rice,
(
MN
only),
Barley,
Oats,
Rye,
Wheat,
Rice,
Peanuts
hand­
harvesting
2500
0.28
0
0.184
1400
500
hand­
weeding
100
0
0.059
110000
37000
irrigating,
scouting
1000
0
0.059
1100
3700
Corn
(
field,
pop,
sweet),
Sunflower
detasseling,
hand­
harvesting
17000
0.1125
0
0.059
700
220
irrigating,
scouting
1000
0
0.254
2600
860
hand­
weeding,
hand
harvesting,
hand­
pruning,
1500
0
0.254
1700
570
Stone
Fruits,
Peaches,
Non­
bearing
Apples,

thinning
3000
0.1125
0
0.254
860
290
irrigation,
scouting,
handweeding
1000
0
0.508
1300
430
Non­
bearing
Citrus
hand­
pruning,
thinning
3000
0.225
0
0.508
430
140
irrigation,
hand­
weeding
100
0
0.190
35000
12000
scouting,
irrigation
1300
0
0.190
2700
900
Bananas,
Plantains
hand­
harvesting,,
thinning,
hand­
weeding/
pruning
2000
0.084
0
0.190
1700
600
scouting,
hand­
weeding/
pruning,
irrigation,
thinning
400
0
0.382
4300
1400
Non­
bearing
Blueberries
hand­
pruning
1500
0.169
0
0.382
1200
380
46
Table
12:
Summary
of
Propiconazole
Non­
cancer
Post­
application
Worker
Risk
Estimates
Crop
Activity
TC
cm2/
hr
Max.
App.
Rate
(
lb
ai/
A)
DAT
(
days)
DFR
ug/
cm2
(
adjusted)
Short­
Term
MOE
1Int/
Long
­
Term
MOE
pruning,
tying
110
0
0.835
7100
2040
transporting,
moving
potted
plants
400
0
0.835
2000
560
0
0.835
150
97
Ornamentals
(
Woody
and
Herbaceous)
plants
hand­
harvesting
(
cut
flowers)
S­
Term
5100
Int­
term
2700
0.37
1
.725
170
112
hand­
weeding,
thinning,
irrigating,
scouting
500
0
0.255
5200
1700
Pecans,
Non­
bearing
Hazelnuts
hand­
pruning,
thinning
2500
0.225
0
0.255
1000
340
Turf
maintenance
3400
1.8
0
0.0106
1800
600
Turf
(
grasses
grown
for
seed,
golf
courses,
sod
farms)
hand­
weeding/
harvesting
transplanting,
hand­
harvest
mech­
harvesting
6800
1.8
0
0.0106
900
300
Note:
¹
Intermediate­,
and
Long­
term
NOAEL's
are
the
same,
therefore
Intermediate­
term
exposure
scenarios
represent
possible
long­
term
scenario
MOE's.

6.1.5
Summary
of
Occupational
Post­
application
Risk
Concerns
and
Data
Gaps
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
shortand
intermediate­
and
long­
term
risks
that
exceed
HED's
level
of
concern
(
i.
e,
MOE's
<
100)
at
Day
=
0
are
as
follows:

Short­
Term:

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

Intermediate/
Long­
term:

 
Post­
application
ornamental
activities,
hand­
harvesting
(
cut
flowers),
risks
are
of
concern
on
the
day
of
application
(
DAT
=
0)
and
do
not
reach
the
target
MOE
of
100
until
1day
after
treatment
(
DAT
=
1)

o
Day
0
(
MOE
=
97)
o
Day
1
(
MOE
=
104)

[
Note:
The
day­
0
intermediate­/
long­
term
MOE
of
concern
(
97)
for
hand­
harvesting
cut
flowers
was
calculated
using
the
average
of
day­
0
residues
and
represents
a
conservative
estimate].

HED
has
used
the
latest
information
to
complete
this
post­
application
risk
assessment
for
propiconazole.
Several
data
gaps
exist
such
as
a
lack
of
post­
application
studies
in
different
crop
47
groupings
and
lack
of
exposure
data
on
mechanized
or
partially
mechanized
cultural
practices
where
there
is
a
potential
for
exposure.

6.1.5.1
Recommendations
for
Refining
Occupational
Post­
application
Risk
Assessment
To
refine
this
occupational
risk
assessment,
data
on
actual
use
patterns
including
rates,
timing,
and
the
kinds
of
tasks
that
are
required
to
produce
agricultural
commodities
typical
products
would
better
characterize
propiconazole
risks.
Exposure
studies
for
many
cultural
practices
that
lack
data
or
that
are
not
well
represented
in
the
revised
transfer
coefficient
policy
should
also
be
considered
based
on
the
data
gaps
identified
above.

7.0
Residential
Exposures
and
Risks
It
has
been
determined
there
is
a
potential
for
exposure
in
residential
settings
during
the
application
process
for
homeowners
who
use
products
containing
propiconazole.
There
is
also
a
potential
for
exposure
from
entering
propiconazole­
treated
areas,
such
as
lawns
or
home
gardens
that
could
lead
to
exposures
to
adults
and
children.
Risk
assessments
have
been
completed
for
both
residential
handler
(
homeowner)
and
post­
application
scenarios.

7.1
Residential
Handler
Exposures
and
Risks
HED
uses
the
term
"
handlers"
to
describe
those
individuals
who
are
involved
in
the
pesticide
application
process.
HED
believes
that
there
are
distinct
tasks
related
to
applications
and
that
exposures
can
vary
depending
on
the
specifics
of
each
task
as
was
described
above
for
occupational
handlers.
Residential
handlers
are
addressed
somewhat
differently
by
HED
as
homeowners
are
assumed
to
complete
all
elements
of
an
application
without
use
of
any
protective
equipment.

7.1.1
Handler
Exposure
Scenarios
Scenarios
are
used
to
define
risks
based
on
the
U.
S.
EPA
Guidelines
For
Exposure
Assessment
(
U.
S.
EPA;
Federal
Register
Volume
57,
Number
104;
May
29,
1992).
Assessing
exposures
and
risks
resulting
from
residential
uses
is
very
similar
to
assessing
occupational
exposures
and
risks,
with
the
following
exceptions:

C
Residential
handler
exposure
scenarios
are
considered
to
be
short­
term
only
due
to
the
infrequent
uses
associated
with
homeowner
products;

C
A
tiered
approach
for
personal
protection
using
increasing
levels
of
PPE
is
not
used
in
residential
handler
risk
assessments.
Homeowner
handler
assessments
are
based
on
the
assumption
that
individuals
are
wearing
shorts,
short­
sleeved
shirts,
socks,
and
shoes;

C
Homeowner
handlers
are
expected
to
complete
all
tasks
associated
with
the
use
of
a
pesticide
product
including
mixing/
loading
if
needed
as
well
as
the
application;
48
C
Label
use­
rates
and
use­
information
specific
to
residential
products
serve
as
the
basis
for
the
risk
calculations;
and
C
Area/
volumes
of
spray
or
chemical
used
in
the
risk
assessment
are
based
on
HED's
guidance
specific
to
residential
use­
patterns.

The
anticipated
use
patterns
and
current
labeling
indicate
two
major
residential
exposure
scenarios
based
on
the
types
of
equipment
and
techniques
that
can
potentially
be
used
to
make
propiconazole
applications.
The
quantitative
exposure/
risk
assessment
developed
for
residential
handlers
is
based
on
these
scenarios:

 
Mixer/
Loader/
applying
liquids
and
wettable
powder
in
water
soluble
packets
via
1)
Low
Pressure
Handwand,
and
2)
Hose­
End
Sprayer.

7.1.2
Data
and
Assumptions
for
Handler
Exposure
Scenarios
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
the
residential
handler
risk
assessments.
Each
assumption
and
factor
is
detailed
below.
In
addition
to
these
factors,
unit
exposures
were
used
to
calculate
risk
estimates.
Mostly,
these
unit
exposures
were
taken
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
and
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
studies.
Both
PHED
and
the
individual
studies
are
presented
below.
[
Note:
Several
of
the
assumptions
and
factors
used
for
the
assessment
are
similar
to
those
used
in
the
occupational
assessment.
As
such,
only
factors
that
are
unique
to
the
residential
scenarios
are
presented
below.]

Assumptions
and
Factors:
The
assumptions
and
factors
used
in
the
risk
calculations
include:

C
Propiconazole
is
a
systemic
fungicide.
HED
has
developed
this
risk
assessment
on
a
series
of
representative
scenarios
that
are
believed
to
represent
the
vast
majority
of
propiconazoles
uses.
Refinements
to
the
assessment
will
be
made
as
more
detailed
information
about
propiconazole
use­
patterns
become
available.

C
Exposure
factors
used
to
calculate
daily
exposures
to
handlers
were
based
on
applicable
data
if
available.
When
appropriate
data
are
unavailable,
values
from
a
scenario
deemed
similar
might
be
used.

C
HED
always
considers
the
maximum
application
rates
allowed
by
labels
in
its
risk
assessments.
If
additional
information
such
as
average
or
typical
rates
is
available,
these
values
also
may
be
used
to
allow
risk
managers
to
make
a
more
informed
risk
management
decision.
Average/
typical
application
rates
were
not
available
for
residential
scenarios.

C
Residential
risk
assessments
are
based
on
estimates
of
what
homeowners
would
typically
treat,
such
as
the
size
of
a
lawn,
or
the
size
of
a
garden.
The
factors
used
for
the
propiconazole
assessment
were
from
the
Health
Effects
Division
Exposure
Science
Advisory
Council
Policy
12:
Recommended
Revisions
to
The
Standard
Operating
49
Procedures
for
Residential
Exposure
Assessment
which
was
completed
on
February
22,
2001
and
on
best
professional
judgment.

Residential
Handler
Exposure
Studies:
The
unit
exposures
that
were
used
in
this
assessment
were
based
on
the
Outdoor
Residential
Exposure
Task
Force
studies
and
the
Pesticide
Handler
Exposure
Database
(
PHED,
Version
1.1
August
1998).

EPA
MRID
449722­
01
(
ORETF
Handler
Studies):
A
report
was
submitted
by
the
ORETF
(
Outdoor
Residential
Exposure
Task
Force)
that
presented
data
in
which
the
application
of
various
products
used
on
turf
by
homeowners
and
lawn
care
operators
(
LCOs)
was
monitored.
All
of
the
data
submitted
in
this
report
were
completed
in
a
series
of
studies.

Homeowner
Hose
End
Sprayer:
A
mixer/
loader/
applicator
study
was
performed
by
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
using
Diazinon
as
a
surrogate
compound
to
determine
"
generic"
exposures
to
individuals
applying
a
pesticide
to
turf
with
a
dial
type
hose
end
sprayer.
Dermal
and
inhalation
exposures
were
estimated
using
whole­
body
passive
dosimeters
and
breathing­
zone
air
samples
on
OVS
tubes.
Inhalation
exposure
was
calculated
using
an
assumed
respiratory
rate
of
17
liters
per
minute
for
light
work
(
NAFTA,
1999),
the
actual
sampling
time
for
each
individual,
and
the
pump
flow
rate.
All
results
were
normalized
for
pounds
active
ingredient
handled.
A
total
of
30
replicates
were
monitored
throughout
the
study.

Diazinon
(
25%
emulsifiable
concentrate)
was
applied
by
homeowners
to
actual
residential
lawns
at
a
site
in
Maryland.
A
target
application
rate
of
4
pounds
active
ingredient
was
used
for
all
replicates.
Each
replicate
monitored
the
test
subject
treating
5,000
ft2
of
turf
and
handling
a
total
of
0.5
lb
ai/
replicate.
The
exposure
periods
(
mixing/
loading/
applying)
averaged
seventy­
five
minutes.
Dermal
exposure
was
measured
using
inner
and
outer
whole
body
dosimeters,
hand
washes,
face/
neck
washes,
and
personal
air
monitoring
devices.
In
general,
concurrent
lab
spikes
produced
mean
recoveries
in
the
range
of
87­
103
percent.
Adjustment
for
recoveries
from
field
fortifications
(
79­
104
%)
were
performed
on
each
dosimeter
section
or
sample
matrix
for
each
study
participant,
using
the
mean
recovery
for
the
closest
field
spike
level
for
each
matrix
and
correcting
the
value
to
100
percent.
The
unit
exposures
are
presented
in
table
13.
[
Note
the
data
were
found
to
be
lognormally
distributed.
As
a
result,
all
exposures
are
geometric
means.]

Table
13:
Unit
Exp.
Obtained
From
ORETF
Hose
End
Sprayer
Studies
(
MRID
449722­
01)

Type
Dermal:
Short
Pants,
Short
Sleeves
(
mg
ai/
lb
handled)
Inhalation
(
Fg
ai/
lb
handled)

Hose­
end
(
Mix­
your­
own)
11
17
All
unit
exposures
are
geometric
means.
50
7.1.3
Residential
Handler
Exposure
and
Non­
Cancer
Risk
Estimates
The
residential
handler
exposure
and
non­
cancer
risk
estimations
are
presented
in
this
section.
Non­
cancer
risks
were
estimated
using
the
Margin
of
Exposure
(
MOE)
as
described
above.
Assessing
exposures
and
risks
resulting
from
residential
uses
is
very
similar
to
assessing
occupational
exposures
and
risks,
except
as
described
above
in
Section
7.1.1.
The
other
major
difference
with
residential
risk
assessments
is
that
the
uncertainty
factor
which
defines
the
level
of
risk
concern
has
the
additional
FQPA
safety
factor
applied.
The
overall
uncertainty
factor
applied
to
propiconazole
for
residential
handler
risk
assessments
of
100
is
based
on
the
10x
for
inter­
species
extrapolation
and
10x
for
intra­
species
sensitivity
(
see
Section
1.4
for
more
information).

Non­
cancer
Risk
Summary:
All
of
the
non­
cancer
risk
estimates
for
residential
handlers
completed
in
this
assessment
are
included
in
Appendix
C.
A
brief
summary
of
the
results
for
each
exposure
scenario
is
also
provided
below.

HED
believes
that
the
scenarios
assessed
in
this
document
represent
worse­
case
exposures
and
risks
resulting
from
use
of
propiconazole
in
residential
environments.
It
should
also
be
noted
that
there
were
many
other
scenarios
where
medium
to
low
quality
PHED
data
were
used
to
complete
the
assessment.
Data
quality
should
be
considered
in
the
interpretation
of
the
uncertainties
associated
with
each
risk
presented.

Short­
term
risks
for
residential
handlers
are
presented
in
Table
14.
For
all
scenarios,
risks
are
below
HED's
level
of
concern
(
i.
e.,
MOEs
are
>
100)
assuming
handlers
are
wearing
shortsleeve
shirt,
short
pants,
shoes,
and
socks.

Table
14:
Summary
of
Residential
Handler
Exposure
Estimates
1
Max
Appl.
Rate
2
Daily
Area
Treated
Handler
Scenario
Short­
Term
MOE
.
Application.
Equip.
Crop(
s)

lb
ai/
Acre
or
lb
ai/
gal*
Acre/
day
or
gal/
day*
M/
L/
A
Derml.+
Inhln.
Baseline
(
Liquids)
4400
Low
Pressure
Handwand
5*
(
WP/
WSP)
N/
A
(
Liquids)
40000
Hose­
end
Sprayer
Ornamentals
(
woody
and
flowering
plants),
Shade
Trees,
Woody
Shrubs
and
Vines
0.0024*

5*
(
WP/
WSP)
N/
A
(
Liquids)
1300
Low
Pressure
Handwand
0.023
(
WP/
WSP)
N/
A
(
Liquids)
530
Hose­
end
Sprayer
Turf
(
Lawns)
1.8
0.5
(
WP/
WSP)
N/
A
Note:
¹
Application
rates
are
the
maximum
rates
provided
for
propiconazole
in
all
cases.
²
Amount
handled
per
day
values
are
HED
estimates
of
area
treated
based
on
Exposure
SAC
SOP
#
12
"
Recommended
Revisions
to
the
Standard
Operating
Procedures
for
Residential
Exposure
Assessments,"
and
HED
estimates.
51
7.1.4
Summary
of
Risk
Concerns
and
Data
Gaps
for
Handlers
All
residential
handler
exposure
scenarios
did
not
exceed
HED's
level
of
concern.
[
Note:
Although
the
risk
for
mixing/
loading/
applying
propiconazole
with
a
low
pressure
handwand
is
not
a
concern,
(
MOE
=
1100)
it
is
important
to
note
that
most
labels
identify
a
hose­
end
sprayer
as
the
method
of
application.
Additionally,
all
risk
calculations
were
conducted
using
the
maximum
turf
application
rate
(
1.8
lb
ai/
acre).
However,
a
turf
application
rate
of
0.51
lb
ai/
acre
was
identified
on
a
residential­
use
product
label
(
100­
773).
This
lower
application
rate
may
better
represent
homeowner
use.

Key
data
gaps
have
been
identified
and
noted
in
the
above
table
as
N/
A.
Neither
ORETF
nor
PHED
currently
have
data
for
hose­
end
sprayer
applications
using
wettable
powder
in
water
soluble
packets
(
see
note
in
Section
1.5).

7.1.5
Recommendations
for
Refining
Residential
Handler
Risk
Assessment
In
order
to
refine
this
residential
risk
assessment,
more
data
on
actual
use
patterns
including
typical
rates,
timing,
and
areas
treated
would
help
better
characterize
propiconazole
risks.
Exposure
studies
for
many
equipment
types
that
lack
data
or
that
are
not
well
represented
in
PHED
(
e.
g.,
because
of
low
replicate
numbers
or
data
quality)
should
also
be
considered
based
on
the
data
gaps
identified
above
and
based
on
a
review
of
the
quality
of
the
data
used
in
this
assessment.

7.2
Residential
Post­
application
Exposures
and
Risks
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.
Propiconazole
can
be
used
in
many
areas
that
can
be
frequented
by
the
general
population
including
residential
areas
(
e.
g.,
home
lawns,
golf
courses).
As
a
result,
individuals
can
be
exposed
by
entering
these
areas
if
they
have
been
previously
treated.

7.2.1
Residential
Post­
application
Exposure
Scenarios
A
wide
array
of
individuals
of
varying
ages
can
potentially
be
exposed
to
propiconazole
when
they
do
activities
in
areas
that
have
been
previously
treated.
Post­
application
exposure
scenarios
were
developed
for
each
residential
setting
where
propiconazole
can
be
used.
Assessing
post­
application
exposures
and
risks
resulting
from
residential
uses
is
very
similar
to
assessing
occupational
post­
application
exposures
and
risks,
except
in
residential
assessments:

 
Residential
exposure
assessments
for
propiconazloe
were
classified
as
short­
term
exposure
scenarios
(
1­
30
days).

 
Exposures
were
calculated
for
children
as
well
as
adults.
52
 
Non­
dietary
ingestion
exposures
to
toddlers
were
calculated
(
i.
e.,
soil
ingestion,
hand­
/
object­
to­
mouth).

HED
relies
on
a
standardized
approach
for
completing
residential
risk
assessments
that
is
based
on
current
propiconazole
labels
and
guidance
contained
in
the
following
three
documents.

 
Series
875,
Occupational
and
Residential
Exposure
Test
Guidelines:
Group
B
 
Post­
application
Exposure
Monitoring
Test
Guidelines
(
V
5.4,
Feb.
1998)
This
document
provides
general
risk
assessment
guidance
and
criteria
for
analysis
of
residue
dissipation
data.

 
Standard
Operating
Procedures
for
Residential
Exposure
Assessment
(
Dec.
1997).
This
document
provides
the
overarching
guidance
for
developing
residential
risk
assessments
including
scenario
development,
algorithms,
and
values
for
inputs.

 
Science
Advisory
Council
For
Exposure
Policy
12
(
Feb.
2001):
Recommended
Revisions
To
The
Standard
Operating
Procedures
(
SOPs)
For
Residential
Exposure
Assessment
This
document
provides
additional,
revised
guidance
for
completing
residential
exposure
assessments.
When
the
guidance
in
current
labels
and
these
documents
is
considered,
it
is
clear
that
HED
should
consider
children
as
well
as
adults
in
its
assessments.
It
is
also
clear
that
different
age
groups
should
be
considered
in
different
situations.
The
populations
that
were
considered
in
the
assessment
include:

 
Residential
Adults:
these
individuals
are
members
of
the
general
population
that
are
exposed
to
chemicals
by
engaging
in
activities
at
their
residences
(
e.
g.,
in
their
lawns)
and
also
in
areas
not
limited
to
their
residence
(
e.
g.,
golf
courses
or
parks)
previously
treated
with
a
pesticide.
These
kinds
of
exposures
are
attributable
to
a
variety
of
activities
and
usually
addressed
by
HED
in
risk
assessments
by
considering
a
representative
activity
as
the
basis
for
the
exposure
calculation.

 
Residential
Children:
children
are
members
of
the
general
population
that
can
also
be
exposed
in
their
residences
(
e.
g.,
on
lawns)
as
well
as
other
areas
previously
treated
with
a
pesticide
(
e.
g.,
parks).
These
kinds
of
exposures
are
attributable
to
a
playing
outside.
Toddlers
have
been
selected
as
a
sentinel
(
or
representative)
population
for
turf.
They
are
usually
addressed
by
HED
in
risk
assessments
by
considering
representative
activities
in
an
exposure
calculation.

The
SOPs
for
Residential
Exposure
Assessment
defines
several
scenarios
that
apply
to
uses
specified
in
current
labels.
These
scenarios
served
as
the
basis
for
the
residential
postapplication
assessment
along
with
the
modifications
to
them
and
the
additional
data
and
approaches
described
above.
HED
used
this
guidance
to
define
the
exposure
scenarios
that
essentially
include
dermal
and
non­
dietary
ingestion
exposure
to
toddlers
and
adults
on
treated
lawns.
The
SOPs
and
the
associated
scenarios
are
presented
below:
53
 
Post
Application
Dermal
Potential
Dose
from
Pesticide
Residues
on
Turf:
Postapplication
dermal
dose
calculations
for
toddlers
and
adults
from
playing
on
treated
turf;

 
Post
Application
Potential
Dose
among
Toddlers
from
Incidental
Non­
dietary
Ingestion
of
Pesticide
Residues
on
Residential
Lawns
from
hand­
to­
mouth
Transfer:
Postapplication
dose
calculations
for
toddlers
from
incidental
non­
dietary
ingestion
of
pesticide
residues
on
treated
turf
from
hand­
to­
mouth
transfer
(
i.
e.,
those
residues
that
are
swallowed
when
toddlers
get
pesticide
residues
on
their
hands
from
touching
treated
turf
and
then
put
their
hands
in
their
mouth);

 
Post
Application
Potential
Dose
among
Toddlers
from
Incidental
Non­
dietary
Ingestion
of
Pesticide
Residues
on
Residential
Lawns
from
object­
to­
mouth
Transfer:
Postapplication
dose
calculations
for
toddlers
from
incidental
non­
dietary
ingestion
of
pesticide
residues
on
treated
turf
from
object­
to­
mouth
transfer
(
i.
e.,
those
residues
that
are
swallowed
when
toddlers
put
treated
turf
in
their
mouths);

 
Post
Application
Potential
Dose
among
Toddlers
from
Incidental
Ingestion
of
Soil
from
Pesticide­
Treated
Residential
Areas:
Post­
application
dose
calculations
for
toddlers
from
incidental
non­
dietary
ingestion
of
pesticide
residues
from
ingesting
soil
in
a
treated
turf
area
(
i.
e.,
those
soil
residues
are
swallowed
when
toddlers
get
pesticide
residues
on
their
hands
from
touching
treated
soil
and
then
put
their
hands
in
their
mouth);

The
detailed
residential
post­
application
calculations
are
presented
in
Appendix
D
of
this
document.

7.2.2
Data
and
Assumptions
for
Residential
Post­
application
Exposure
Scenarios
A
series
of
assumptions
and
exposure
factors
served
as
the
basis
for
completing
residential
post­
application
risk
assessments.
The
assumptions
and
factors
used
in
the
risk
calculations
are
consistent
with
current
HED
policy
for
completing
residential
exposure
assessments
(
i.
e.,
SOPs
For
Residential
Exposure
Assessment).
The
assumptions
and
exposure
factors
used
in
this
assessment
include:

 
Factors
that
are
common
to
the
occupational
and
residential
Post­
application
risk
assessments,
such
as
body
weights
for
adults,
analysis
of
residue
dissipation
data,
and
transfer
coefficients
are
used
in
this
assessment
for
the
garden
exposure
scenarios.
Please
refer
to
the
assumptions
and
factors
in
Section
5.1.1
for
further
information
concerning
these
common
values.

 
HED
combines
risks
resulting
from
exposures
to
individual
chemicals
when
it
is
likely
they
can
occur
simultaneously
based
on
the
use
pattern
and
the
behavior
associated
with
the
exposed
population.
Within
a
residential
assessment,
the
approach
is
to
add
together
risks
for
individual
exposure
scenarios
from
all
likely
sources
of
exposure
such
54
as
after
an
application
to
turf
or
use
on
a
pet.
For
propiconazole,
HED
has
combined
risks
(
i.
e.,
MOEs)
for
different
kinds
of
exposures
for
the
turf
scenarios
(
i.
e.,
dermal,
hand­
to­
mouth,
object­
to­
mouth,
and
soil
ingestion).

 
Exposures
to
adults
and
children
on
treated
turf
have
been
addressed
using
the
latest
HED
standard
operating
procedures
for
this
scenario
including:

 
Study
specific
data
was
used
for
Turf
Transferable
Residue
(
TTR)
values
in
each
scenario
(
see
note
about
submitted
TTR
data
in
Section
6.1.2.1);

 
A
percent
of
the
application
rate
has
been
used
to
calculate
the
day­
zero
residue
levels
used
for
assessing
risks
from
hand­
to­
mouth
behaviors;

 
20
percent
of
the
application
rate
has
been
used
to
calculate
the
day­
zero
residue
levels
used
for
assessing
risks
from
object­
to­
mouth
behaviors
(
a
higher
percent
transfer
has
been
used
for
object­
to­
mouth
behaviors,
because
it
involves
a
teething
action
believed
to
be
more
analogous
to
DFR/
leaf
wash
sample
collection
where
20
percent
is
also
used);

 
The
transfer
coefficients
used
are
those
presented
at
the
1999
Agency
presentation
before
the
FIFRA
Science
Advisory
Panel
that
have
been
adopted
in
routine
practice
by
HED;

 
Year
old
toddlers
are
expected
to
weigh
15
kg
(
average
of
1
to
6
year
olds);

 
Hand­
to­
mouth
exposures
are
based
on
a
frequency
of
20
events/
hour
and
a
surface
area
per
event
of
20
cm2
representing
the
palmar
surfaces
of
three
fingers;

 
Saliva
extraction
efficiency
is
50
percent
meaning
that
every
time
the
hand
goes
in
the
mouth
approximately
½
of
the
residues
on
the
hand
are
removed;

 
Object­
to­
mouth
exposures
are
based
on
a
25
cm2
surface
area;

 
Exposure
durations
are
assumed
to
be
2
hours
based
on
information
in
HED's
Exposure
Factors
Handbook
except
for
golfing
which
is
4
hours
per
day;

 
100
percent
of
the
application
rate
has
been
used
to
calculate
the
day­
zero
soil
residue
levels
used
for
assessing
risks
from
soil
ingestion
behavior;
soil
residues
are
contained
in
the
top
centimeter
and
soil
density
is
0.67
mL/
gram.

 
Dermal,
hand­
and
object­
to­
mouth,
and
soil
ingestion
are
combined
to
represent
an
overall
risk
from
exposure
to
turf
while
granular
ingestion
is
considered
to
be
a
much
more
episodic
behavior
and
is
considered
separately
by
HED.
55
7.2.3
Residential
Post­
application
Exposure
and
Non­
cancer
Risk
Estimates
Dermal
exposures
and
risks
from
residential
uses
were
calculated
in
the
same
manner
as
described
above
in
Section
6.1.3.
The
algorithms
used
for
each
type
of
calculation
which
have
not
been
previously
addressed
in
Section
6.1.3
are
presented
below.

 
Dermal
Exposure
from
Treated
Lawns
(
adult
and
toddler)

The
approach
used
to
calculate
the
dermal
exposures
that
are
attributable
to
exposure
from
contacting
treated
lawns
is:

ADD
=
(
TTR0
*
ET
*
TC
*
DA
*
CF1)
/
BW
Where:

ADD
=
average
daily
dose
(
mg/
kg/
day);

TTRt
=
turf
transferable
residue
on
day
"
0"
(
Fg/
cm2
);

ET
=
exposure
time
(
2
hr/
day);

TC
=
transfer
coefficient
(
14,500
cm2/
hr
for
adults
and
5,200
cm2/
hr
for
toddlers);
DA
=
dermal
absorption
factor
(
40%);

CF1
=
weight
unit
conversion
factor
to
convert
:
g
units
to
mg
for
the
daily
exposure
(
0.001
mg/:
g);

BW
=
body
weight
(
70
kg
for
general
population
and
15
kg
for
toddlers).

Non­
dietary
Ingestion
Exposure
from
Treated
Turf:
Non­
dietary
ingestion
exposure
from
treated
turf
were
calculated
using
the
following
equations.

 
Hand­
to­
mouth
Transfer
of
Pesticide
Residues
on
Lawns
(
toddler)

The
approach
used
to
calculate
the
non­
dietary
ingestion
exposures
that
are
attributable
to
handto
mouth
behavior
on
treated
turf
is:

ADD
=
(
TTR0
*
SA
*
FQ
*
ET
*
SE
*
CF1)
/
BW
Where:

ADD
=
average
daily
dose
(
mg/
kg/
day);

TTRt
=
turf
transferable
residue
on
day
"
0"
(
Fg/
cm2
);
56
SA
=
surface
area
of
the
hands
(
20
cm2/
event);

FQ
=
frequency
of
hand­
to­
mouth
activity
(
20
events/
hr);

ET
=
exposure
time
(
2
hr/
day);

SE
=
extraction
by
saliva
(
50%);

CF1
=
weight
unit
conversion
factor
to
convert
Fg
units
in
the
DFR
value
to
mg
for
the
daily
exposure
(
0.001
mg/
Fg);
and
BW
=
body
weight
(
15
kg).

 
Object­
to­
mouth
Transfer
of
Pesticide
Residues
on
Lawns
(
toddler)

The
approach
used
to
calculate
exposures
that
are
attributable
to
object­
to­
mouth
behavior
on
treated
turf
that
is
represented
by
a
child
mouthing
on
a
handful
of
turf
is:

ADD
=
(
TTR0
*
IgR*
CF1)
/
BW
Where:

ADD
=
average
daily
dose
(
mg/
kg/
day);

TTRt
=
turf
transferable
residue
on
day
"
0"
(
Fg/
cm2);

IgR
=
ingestion
rate
of
grass
(
25
cm2/
day);

CF1
=
weight
unit
conversion
factor
to
convert
the
Fg
of
residues
on
the
grass
to
mg
to
provide
units
of
mg/
day
(
1E­
3
mg/
Fg);
and
BW
=
body
weight
(
15
kg).

 
Incidental
Ingestion
of
Soil
from
Pesticide­
Treated
Residential
Areas
(
toddler).

The
approach
used
to
calculate
exposures
that
are
attributable
to
soil
ingestion
is:

ADD
=
(
SR0
*
IgR
*
CF1)
/
BW
Where:

ADD
=
average
daily
dose
(
mg/
kg/
day);

SR0t
=
soil
residue
on
day
"
0"
(
0.0022
Fg/
g);

IgR
=
ingestion
rate
of
soil
(
100
mg/
day);
57
CF1
=
weight
unit
conversion
factor
to
convert
the
Fg
of
residues
on
the
soil
to
grams
to
provide
units
of
mg/
day
(
1E­
6
g/
Fg);
and
BW
=
body
weight
(
15
kg).

7.2.4
Residential
Post­
application
Non­
cancer
Risk
Summary
Detailed
risk
calculations
for
the
various
residential
propiconazole
assessments
are
included
in
Appendices
C
and
D.
A
summary
of
risk
estimates
for
residential
post­
application
risks
for
adults
and
children
is
provided
in
the
following
tables.
Additionally,
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
16).
[
Note:
Propiconazole
is
classified
as
a
non­
volatile
chemical;
therefore
a
residential
(
inhalation)
post­
application
assessment
is
not
needed].

Table
15:
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
50000
Note:
Level
of
Concern:
MOE
=
100
Table
16:
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
1
Combined
MOE
Outdoors
Hand
to
Mouth
Activity
on
Turf
N/
A
Oral
1.8
lb
ai/
acre
1100
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
330000
Turf
 
General
High­
Contact
Activities
25000
Dermal
1.8
lb
ai/
acre
210
170
Note:
¹
Combined
MOE
=
NOAEL/(
PDRhand­
to­
mouth
+
PDRobject­
to­
mouth
+
PDRincidental
soil
ingestion
+
ADDdermal)
Level
of
Concern:
MOE
=
100
58
7.2.5
Summary
of
Residential
Post­
application
Risk
Concerns
and
Data
Gaps
HED
considered
a
number
of
exposure
scenarios
for
products
that
can
be
used
in
the
residential
environment
representing
different
segments
of
the
population
including
toddlers
and
adults.
In
residential
settings,
HED
does
not
use
restricted­
entry
intervals
or
other
mitigation
approaches
to
limit
post­
application
exposures
because
they
are
viewed
as
impractical
and
not
enforceable.
As
such,
risk
estimates
on
the
day
of
application
are
the
key
concern.

 
For
all
short­
term
post­
application
scenarios,
risks
did
not
exceed
HEDs
level
of
concern
(
MOEs
>
100).

HED
combines
risks
resulting
from
different
routes
of
exposures
to
individuals
when
it
is
likely
they
can
occur
simultaneously
based
on
the
use
pattern
and
the
behavior
associated
with
the
exposed
population.
For
propiconazole,
HED
has
combined
risk
values
(
i.
e.,
MOEs)
for
children,
the
different
routes
of
exposures
associated
with
the
turf
(
dermal,
hand­
to­
mouth,
object­
to­
mouth,
and
soil
ingestion).
These
are
typically
added
together
when
pesticides
are
used
on
turf,
because
it
is
logical
they
can
co­
occur.
The
combined
risks
did
not
exceed
HED's
level
of
concern
(
i.
e.,
the
MOEs
>
100).

7.2.6
Recommendations
for
Refining
Residential
Post­
application
Risk
Assessment
In
order
to
refine
this
residential
assessment,
data
on
actual
use
patterns
including
rates,
timing,
and
the
kinds
of
tasks
that
are
required
to
better
characterize
propiconazole
risks.
59
Appendices.

(
A).
Occupational
(
B).
Occupational
Post­
Application
(
C).
Residential
(
D).
Residential
Post­
Application
60