Document ID: EPA-HQ-OPP-2002-0055-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-06-27T04:00Z

31
May
2001
MEMORANDUM
SUBJECT:
REVISED
RESIDENTIAL
EXPOSURE
ASSESSMENT
AND
RECOMMENDATIONS
FOR
THE
REREGISTRATION
ELIGIBILITY
DECISION
DOCUMENT
FOR
DISULFOTON
FROM:
Shanna
Recore,
Industrial
Hygienist
Christina
Jarvis,
Environmental
Protection
Specialist
Reregistration
Branch
2
Health
Effects
Division
(
7509C)

TO:
Christina
Scheltema
Reregistration
Branch
3
Special
Review
and
Reregistration
Division
(
7508W)

THRU:
Al
Nielsen,
Senior
Scientist
Reregistration
Branch
2
Health
Effects
Division
(
7509C)

Please
find
attached
the
residential
review
of
disulfoton.

DP
Barcode:
D275170
Pesticide
Chemical
Codes:
032501
EPA
Reg
Nos.
:
4­
153,
4­
253,
4­
420,
16­
171,
192­
74,
192­
119,
192­
126,
192­
164,
239­
2134,
769­
908,
802­
426,
869­
76,
869­
223,
904­
138,
3125­
83,
3125­
116,
3125­
152,
3125­
517,
5887­
67,
5887­
171,
7401­
4,
4701­
26,
7401­
235,
7401­
323,
9404­
3,
8660­
125,
8660­
191,
11474­
17,
32802­
32,
42057­
51,
46260­
2,
46260­
12,
46260­
35,
59144­
23
EPA
MRID
No.
:
453334­
01
PHED:
Yes,
Version
1.1
EXPOSURE
AND
RISK
ASSESSMENT/
CHARACTERIZATION
Purpose
In
this
document,
which
is
for
use
in
EPA'
s
development
of
the
disulfoton
Reregistration
Eligibility
Decision
document
(
RED)
,
EPA
presents
the
results
of
its
review
of
the
potential
human
health
effects
of
residential
exposure
to
disulfoton.
This
memorandum
revises
the
residential
exposure
section
of
the
February
7,
2000
memorandum
titled
 
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Disulfoton.
 
2
The
residential
exposure
and
risk
numbers
presented
in
this
document
have
been
revised
based
on
a
new
short­
term
dermal
endpoint,
new
exposure
assumptions
in
the
Residential
Standard
Operating
Procedures
(
SOPs)
,
and
a
new
disulfoton
residential
handler
study
submitted
by
Bayer
Corporation.

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
potential
exposure
to
handlers
(
mixers,
loaders,
applicators,
etc.
)
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
For
disulfoton,
both
criteria
are
met.

Summary
of
Toxicity
Concerns
Relating
to
Residential
Exposure
Acute
Toxicology
Categories
Table
1
presents
the
acute
toxicity
categories
based
on
the
active
ingredient
as
outlined
in
the
Hazard
Identification
document.
12
1
Table
1:
Acute
Toxicity
Categories
for
Disulfoton
Guideline
No.
Study
Type
MRID
#
(
S)
.
Results
Toxicity
Category
81­
1
Acute
Oral
Acc#
072293
LD50
=
M:
6.
2
mg/
kg;
F:
1.
9
mg/
kg
I
81­
2
Acute
Dermal
Acc#
07793
LD50
=
M:
15.
9
mg/
kg;
F:
3.
6
mg/
kg
I
81­
3
Acute
Inhalation
Acc#
258569
LC50
=
M:
0.
06
mg/
L;
F:
0.
89
mg/
L
I
81­
4
Primary
Eye
Irritation
None
Data
requirement
waived.
N/
A
81­
5
Primary
Skin
Irritation
None
Data
requirement
waived.
N/
A
81­
6
Dermal
Sensitization
None
Data
requirement
waived.
N/
A
81­
7
Acute
Delayed
Neurotoxicity
00129384
Equivocal.

81­
8
Acute
Neurotoxicity
42755801
Reversible
neurotoxic
signs
consistent
with
the
cholinesterase
inhibition
1.
5
mg/
kg
in
female
rats
and
5.
0
mg/
kg
in
male
rats.
N/
A
N/
A
=
Not
Applicable
Residential
Endpoints
of
Concern
The
revised
Hazard
Identification
document
for
disulfoton
indicates
that
there
are
toxicological
endpoints
of
concern
for
residential
exposure.
The
endpoints
used
in
assessing
the
residential
risks
for
disulfoton
are
presented
in
the
following
Table
2.
12
2
Table
2:
Endpoints
for
Assessing
Residential
Risks
for
Disulfoton
Test
Results
Short­
term
Dermal
Exposure
(
1
to
7
days)
0.
5
mg/
kg/
day
based
on
plasma
and
brain
cholinesterase
inhibition
in
a
3­
day
dermal
study
in
rats
(
Uncertainty
Factor
=
100)

Intermediate­
term
Dermal
Exposure
(
1
week
to
several
months)
0.03
mg/
kg/
day
based
on
plasma,
red
blood
cell,
and
brain
cholinesterase
inhibition
in
a
special
6
month
cholinesterase
inhibition
feeding
study
in
rats
(
Uncertainty
Factor
=
100)
*
*
this
study
also
used
for
the
incidental
soil
ingestion
scenario*
*

Inhalation
Exposure
(
All­
time
periods)
0.
00016
mg/
L
or
0.045
mg/
kg/
day
based
on
plasma,
red
blood
cell,
and
brain
cholinesterase
inhibition
in
a
90­
day
inhalation
study
in
rats
(
Uncertainty
Factor
=
100)

Dermal
Absorption
(
applied
to
intermediate­
term
dermal
endpoint
only)
36%

Inhalation
Absorption
100%

FQPA
Safety
Factor
The
FQPA
Safety
Factor
Committee
met
on
January
24,
2000
to
re­
evaluate
the
hazard
and
exposure
data
for
disulfoton,
and
recommended
that
the
FQPA
safety
factor
be
removed
(
1X)
for
disulfoton.
10
The
toxicity
data
base
is
complete,
including
neurotoxicity
studies
in
rats
and
there
is
no
evidence
of
either
neurotoxicity
or
increased
susceptibility
of
fetuses
or
offspring
in
prenatal
and
postnatal
studies
in
rabbits
or
rats.
The
1X
FQPA
factor
is
applicable
for
all
populations.

Cancer
Classification
The
HED
RfD/
Peer
Review
classified
disulfoton
as
a
Group
E
chemical,
meaning
that
it
is
not
classifiable
for
carcinogenicity
based
on
a
lack
of
evidence
in
a
carcinogenicity
study
in
mice
and
rats
at
dose
levels
adequate
to
test
for
carcinogenicity.
12
SUMMARY
OF
USE
PATTERN
AND
FORMULATIONS
Homeowner
Use
Products
The
Agency
acknowledges
that
this
assessment
includes
some
non­
occupational
uses
that
are
no
longer
supported
by
Bayer,
but
may
be
available
on
the
market
due
to
production
by
other
3
registrants
or
 
existing
stock
 
provisions.
.
The
only
non­
occupational
uses
supported
by
Bayer,
at
the
time
of
this
assessment,
are
those
stated
on
the
Bayer
ready­
to­
use
one
percent
granular
label
(
roses,
ornamental
flowers,
and
shrubs)
.

Type
of
pesticide/
target
pests
Disulfoton,
(
O,
O­
Diethyl
S­
[
2­
(
ethylthio)
ethyl
]
phosphorodithioate)
)
is
a
selective
systemic
organophosphate
insecticide
used
to
control
a
variety
of
sucking
insects.
Insects
that
disulfoton
controls
include,
but
are
not
limited
to,
the
following:
4
C
Aphids,
Birch
leaf
miner,
Elm
leaf
beetle,
European
elm
scale,
Lace
bug,
Leafhoppers,
Mites,
Thrips,
Whiteflies,
Birch
leafminers,
Camellia
scale,
Holly
leafminer,
Leafhoppers,
Mimosa
webworm,
Pine
tip
moth,
Soft
scale,
Spider
mites,
Tea
scale,
Thrips
and
Whiteflies.

Formulation
types
and
percent
active
ingredient
for
residential
products
Disulfoton
is
formulated
as
a
technical
product
(
98.5
percent
active
ingredient)
and
as
a
residential­
use
granular
product
(
two,
one,
and
0.37
percent
active
ingredient)
.
Bayer
is
currently
only
supporting
the
one
percent
granular
product.
Disulfoton
is
often
formulated
in
combination
with
fertilizers.
4
Registered
use
sites
4,7
Non­
occupational­
use
sites
The
Agency
acknowledges
that
some
non­
occupational
use
sites
listed
below
are
not
supported
by
Bayer;
however,
these
sites
have
been
included
for
informational
purposes
because
they
may
be
supported
by
other
registrants.
Potential
residential
and
non­
occupational
use
sites
may
include
indoor
or
outdoor
residential
sites
(
e.
g.
,
exposure
to
insecticide
use
on
ornamentals)
.
The
non­
occupational
use
sites
in
this
RED
have
been
grouped
as
follows:

C
Residential
Ornamental
Flowers
C
C
Residential
Ornamental
Shrubs
and
Trees
C
Residential
Rose
Bushes
C
Residential
Vegetable
Gardens
C
Residential
Potted
Plants
Residential
Application
Rates
4,7
4
C
Residential
Ornamental
Flowers
:
The
maximum
label
application
rate
of
the
granular
product
not
supported
by
Bayer
is
0.3
lb
ai/
1,000
ft
2
.
The
maximum
application
rate
for
the
Bayer
one
percent
granular
product
is
0.21
lb
ai/
1000
ft
2
.
The
original
assessment
assumed
a
range
of
rates
from
0.005
lb
ai/
1000
ft
2
to
0.3
lb
ai/
1000
ft
2
.

C
Residential
Ornamental
Shrubs
and
Small
Trees:
The
maximum
label
application
rate
for
the
products
not
supported
by
Bayer
is
0.016
lb
ai/
5­
inch
diameter
tree
for
the
insecticidal
spikes.
The
maximum
application
rate
for
the
Bayer
one
percent
granular
product
is
0.010
lb
ai/
four
foot
shrub.
The
original
assessment
assumed
a
range
of
rates
from
0.000321
lb
ai/
four­
foot
shrub
to
1.32
lb
ai/
four­
foot
shrub.

C
Residential
Rose
Bushes:
The
maximum
label
application
rate
to
rose
bushes
using
the
insecticidal
spikes,
which
are
not
supported
by
Bayer,
is
0.048
lb
ai/
bush.
The
maximum
application
rate
for
both
the
Bayer
one
percent
granular
and
the
non­
Bayer
supported
granular
product
is
0.00125
lb
ai/
bush.
The
original
assessment
assumed
a
rate
of
0.00188
lb
ai/
bush.

C
Residential
Vegetable
Gardens:
The
maximum
label
application
rate
is
0.069
lb
ai/
1000
ft
2
.
Bayer
does
not
support
this
use.
The
original
assessment
assumed
a
range
of
rates
from
0.0313
lb
ai/
1000
ft
2
to
0.1125
lb
ai/
1000
ft
2
.

C
Residential
Potted
Plants:
The
maximum
label
application
rate
for
hand
application
of
granulars
to
pots
is
0.00034
lb
ai/
six
inch
pot.
The
maximum
application
using
insecticidal
spikes
is
0.000063
lb
ai/
six
inch
pot.
Bayer
does
not
support
this
use.
The
original
assessment
assumed
a
rate
of
0.00011
lb
ai/
six
inch
pot.

Methods
and
Types
of
Equipment
Used
for
Loading
and
Applying
Residential
Formulations:
4,7
The
Agency
acknowledges
that
some
methods
of
application
listed
below
are
not
supported
by
Bayer;
however,
these
application
methods
and
equipment
have
been
included
for
informational
purposes.

C
Residential
Ornamental
Flowers:
Belly
grinder
and
push­
type
spreader
applications
can
be
used
for
preplanting
treatment,
or
treatments
can
be
applied
using
a
spoon,
measuring
scoop,
shaker
can
or
by
hand,
and
then
soil
incorporated.
Regardless
of
application
method,
the
revised
assessment
assumes
that
1000
ft
2
are
treated
per
day.
The
original
assessment
assumed
10,000
ft
2
were
treated
per
day
using
belly
grinder
equipment
and
1000
ft
2
per
day
using
all
other
equipment.

5
C
Residential
Ornamental
Shrubs
:
Applications
are
made
by
distributing
granules
uniformly
under
the
shrub
canopy
using
a
push­
type
spreader,
spoon,
measuring
scoop,
shaker
can
or
by
hand
and
soil
incorporated
and
then
watered
in.
Both
the
revised
and
original
assessments
assumed
that
25
shrubs
are
treated
per
day.

C
Residential
Rose
Bushes:
Belly
grinder
applications
can
be
made
for
preplanting
treatment.
At
planting,
or
to
established
bushes,
application
of
granulars
is
made
using
a
push­
type
spreader,
spoon,
measuring
scoop,
shaker
can
or
by
hand.
Both
the
revised
and
original
assessments
assumed
that
50
rose
bushes
are
treated
per
day.

C
Residential
Vegetable
Gardens:
Belly
grinder
or
push­
type
spreader
applications
can
be
made
for
preplanting
treatment.
At
planting
application
of
granulars
is
made
using
a
spoon,
measuring
scoop,
shaker
can
or
by
hand.
The
revised
assessment
assumes
that
1000
ft
2
are
treated
per
day.
The
original
assessment
assumed
that
10,000
ft
2
were
treated
per
day.

C
Residential
Potted
Plants:
Applications
are
made
by
hand
by
punching
a
hole
into
soil
and
pouring
granules
into
the
holes
or
sprinkling
granules
on
the
soil
and
soil
incorporating.
Both
the
revised
and
original
assessments
assumed
that
20
six
inch
pots
are
treated
per
day.

RESIDENTIAL
RISK
ASSESSMENT
AND
CHARACTERIZATION
Non­
Occupational
Exposure
Scenarios
HED
has
determined
that
residential
and
other
non­
occupational
handlers
are
likely
to
be
exposed
during
disulfoton
use.
The
anticipated
use
patterns
and
current
labeling
indicate
several
exposure
scenarios
based
on
the
types
of
equipment
that
potentially
can
be
used
to
make
disulfoton
applications.
The
Agency
acknowledges
that
some
exposure
scenarios
listed
below
are
not
supported
by
Bayer;
however,
these
exposure
scenarios
have
been
included
for
informational
purposes.
These
scenarios
include:
(
1)
loading/
applying
granulars
with
a
belly
grinder;
(
2)
loading/
applying
granulars
with
a
push­
type
spreader;
(
3)
loading/
applying
granulars
using
a
spoon,
measuring
scoop,
shaker
can
or
by
hand;
(
4)
loading/
applying
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®
Disulfoton
1%
%
granulars
by
hand
using
a
measuring
cup/
lid;
or
(
5)
application
of
insecticidal
spikes.
Registrants
indicate
that
only
dry
formulations
(
i.
e.
,
only
granulars
or
pellets/
tablets/
spikes)
are
permitted
to
be
used
around
residences.

Handler
Exposure
Data
­
Surrogate
PHED
6
Chemical­
specific
data
for
assessing
human
exposures
during
pesticide
handling
activities
were
not
submitted
to
the
Agency
in
support
of
the
reregistration
of
disulfoton,
with
the
exception
of
a
homeowner
garden
study
(
MRID
453334­
01)
.
It
is
the
policy
of
HED
to
use
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
Version
1.1
to
assess
handler
exposures
8
for
regulatory
actions
when
chemical­
specific
monitoring
data
are
not
available.

The
PHED
Task
Force
is
comprised
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
exposure
values
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)
.
8
Users
select
criteria
to
subset
the
PHED
database
to
reflect
the
exposure
scenario
being
evaluated.
The
subsetting
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)
.
8
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
exposure
values
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
exposure
values
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
composited
into
a
 
best
fit
 
exposure
value
representing
the
entire
body.
8
The
unit
exposure
values
calculated
by
PHED
generally
range
from
the
geometric
mean
to
the
median
of
the
selected
data
set.
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
active
ingredient
handled)
may
not
accurately
represent
labeled
uses
in
all
cases.
HED
has
developed
a
series
of
tables
of
standard
unit
exposure
values
for
many
occupational
scenarios
that
can
be
utilized
to
ensure
consistency
in
exposure
assessments.
8
In
the
revised
assessment,
PHED
data
are
used
to
assess
exposure
from
loading/
applying
granulars
with
a
belly
grinder.
In
the
original
assessment,
PHED
data
were
used
to
assess
exposure
from
loading/
applying
granulars
with
belly
grinder
and
push­
type
spreader
equipment,
and
from
loading/
applying
granulars
by
hand
using
a
spoon,
shaker
can,
or
measuring
scoop.

7
ORETF
Some
of
the
handler
exposure
data
used
in
this
assessment
are
from
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
.
The
task
force
recently
submitted
proprietary
data
to
the
Agency
on
hose­
end
sprayers,
push­
type
granular
spreaders,
and
handgun
sprayers
(
MRID
#
44972201)
.
The
ORETF
data
were
used
in
this
assessment
in
place
of
PHED
data
for
the
 
loading/
applying
granulars
using
a
push­
type
spreader
 
scenario.
.
The
ORETF
data
were
designed
to
replace
the
present
PHED
data
with
higher­
confidence,
higher
quality
data
that
1
contains
more
replicates
than
the
PHED
data
for
those
scenarios.

Other
Handler
exposure
data
from
a
proprietary
granular
mixer/
loader/
applicator
study
(
MRID
452507­
02)
in
bananas
using
fipronil
(
Regent
20GR)
were
used
in
place
of
PHED
data
for
the
 
loading/
applying
granulars
using
a
spoon,
measuring
scoop,
shaker
can
or
by
hand
 
scenario.
.
This
fipronil
study
is
considered
to
be
an
appropriate
source
of
surrogate
handler
exposure
data
for
disulfoton
because
formulation
types
are
similar
(
granular)
and
application
methods
are
similar
(
applying
granulars
with
a
spoon)
.
The
study
is
considered
to
be
of
sufficient
quality
for
use
in
risk
assessment.
3
Several
factors
should
be
considered
when
using
fipronil
data
in
the
disulfoton
exposure
assessment.
Protection
factors
used
to
calculate
disulfoton
dermal
unit
exposure
values,
based
on
the
fipronil
unit
exposure
values,
include
a
standard
50%
protection
factor
for
the
torso,
a
10%
protection
factor
for
legs,
based
on
shorts,
and
a
10%
protection
factor
for
arms,
based
on
a
short­
sleeved
shirt.
These
protection
factors
represent
the
typical
attire
assumed
to
be
worn
by
a
homeowner
during
pesticide
application
(
shorts
and
short­
sleeved
shirt)
.
The
10%
protection
factor
for
shorts
and
the
10%
protection
factor
for
a
short­
sleeved
shirt
are
not
standard
protection
factors
used
by
the
Agency;
rather,
these
values
are
based
on
the
best
professional
judgement
of
Agency
scientists
and
are
appropriate
for
calculating
range­
finding
estimates
only.

Some
other
issues
and
limitations
to
be
considered
when
using
the
fipronil
study
include
the
following:

 
Agency
guidelines
require
that
15
replicates
be
completed
in
exposure
studies
in
three
different
locations.
In
the
fipronil
study,
only
ten
replicates
were
completed
using
spoons,
and
at
only
one
location.
However,
the
events
that
were
monitored
seemed
to
be
reasonable
representations
of
actual
agricultural
practices,
so
it
is
unlikely
that
additional
replicates
would
significantly
alter
the
final
unit
exposure
results.
Additionally,
it
is
unlikely
that
cultural
practices
would
significantly
vary
if
the
study
was
completed
at
different
locations.

 
The
individual
amounts
of
chemical
applied
were
not
recorded
in
this
study.
Instead,
the
investigators
determined
how
much
product
was
applied
by
the
application
teams
used.
Using
this
information,
the
investigators
calculated
the
amount
used
for
each
individual
8
by
assuming
that
each
was
equally
productive
(
i.
e.
,
dividing
the
total
amount
used
per
team
by
the
number
of
team
members)
.

 
One
applicator
using
the
spoons
had
a
spoon
with
no
handle.
The
results
for
this
individual
were
included
with
the
other
spoon
applicators
as
it
is
a
plausible
variation
of
that
application
method.

The
Agency
notes
that
the
geometric
mean
unit
exposure
value
for
spoon
applications
of
fipronil
was
used
for
disulfoton
risk
assessment
purposes.

Handler
Exposure
Data
­
Chemical­
Specific
Data
Review
of
MRID
#
453334­
01:
Disulfoton
1%
Granular
Residential
Applicator
Exposure
and
Risk
Estimates
5
In
support
of
the
reregistration
of
disulfoton
Bayer
Corporation
submitted
a
study
estimating
handler
exposures.
The
purpose
of
this
study
was
to
quantify
potential
dermal
(
forearm
and
hand)
and
inhalation
exposure
for
residential
applicators
of
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®
,
a
granular
formulation,
which
contains
1.04
percent
disulfoton
as
the
active
ingredient.
The
maximum
application
rate
for
flower
beds
(
4
ounces
formulated
product
per
12
square
feet)
and
for
shrubs
(
4
ounces
formulated
product
per
1
foot
shrub
height)
was
used
in
this
study.

A
total
of
15
volunteers
were
monitored
using
passive
dosimetry
(
hand/
forearm
wash
solutions
and
personal
air
monitors)
.
Application
of
the
product
was
made
by
pouring
the
granules
into
the
measuring
cup/
lid
attached
to
the
product
package,
and
then
distributing
the
granules
onto
the
soil
around
the
base
of
a
shrub
or
onto
a
flower
bed.
The
granules
were
then
soil­
incorporated
with
a
garden
rake.
A
total
of
30
replicates
were
reported.
The
test
site
was
a
fallow
test
field,
approximately
1
acre
in
size.
Two
sets
of
sub­
plots
were
established:
(
1)
shrub
test­
plots,
each
containing
10
oleander
shrubs
(
approximately
48
inches
high)
;
and
(
2)
flower­
bed
sub­
plots,
each
containing
simulated
plants,
(
e.
g.
,
12
to
14
inch
high
stakes
placed
on
approximately
24
inch
centers)
.

All
of
the
inhalation
exposure
data
were
either
non­
detect
or
less
than
the
limit
of
quantitation
(
LOQ
=
0.3
F
g)
.
Most
of
the
hand/
forearm
dermal
washing
samples
returned
results
greater
than
the
LOQ.

The
study
was
conducted
in
compliance
with
the
major
technical
aspects
of
OPPTS
Group
A:
875.1300,
Inhalation
Exposure
­
­
Outdoor
and
875.1100,
Dermal
Exposure
­
­
Outdoor,
and
Series
875
Group
B,
Part
C,
as
they
relate
to
this
study.
Reviewers
noted
the
following
deficiency:

C
EPA
provided
the
registrant
with
comments
on
study
outlines
submitted
to
the
Agency.
The
following
comment
was
not
fully
addressed
in
the
conduct
of
the
9
study,
as
both
real
plants
and
simulated
plants
were
used:

:
The
Agency
prefers
that
the
study
use
real
plants
Use
of
Simulated
Plants
because
it
is
difficult,
if
not
impossible,
to
tell
how
closely
the
 
simulated
 
plant
environment
reflects
what
is
actually
encountered
by
a
homeowner.
If
the
registrant
could
not
find
a
study
site
with
enough
roses
or
shrubs
to
treat,
the
Agency
recommended
that
the
study
at
least
include
a
subset
of
real
plants
in
established
beds
to
compare
the
 
real
 
and
the
 
simulated
 
plants.
.

Data
from
this
study
were
used
in
place
of
PHED
data
for
estimating
residential
handler
exposure
and
risk
from
applying
Bayer
Advanced
2­
in­
1
Systemic
Rose
and
Flower
Care
®
to
roses,
flowerbeds,
and
shrubs
by
hand.
The
geometric
mean
unit
exposure
value
was
used
for
risk
assessment
purposes.

Non­
Occupational
Handler
Exposure
Scenario
Data
and
Assumptions
Residential
handler
exposure
assessments
were
completed
by
HED
using
a
baseline
exposure
scenario.
PHED
values
used
to
estimate
daily
unit
exposure
values
were
taken
from
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
and
the
 
Recommended
Revisions
to
the
Standard
Operating
Procedures
for
Residential
Exposure
Assessments
 
Science
Advisory
Council
for
Exposure
Policy
#
#
12.
6,11
Table
3
summarizes
the
caveats
and
parameters
specific
to
the
surrogate
data
used
for
each
scenario
and
corresponding
exposure/
risk
assessment.
The
following
assumptions
and
factors
were
used
in
order
to
complete
this
exposure
assessment:

 
Calculations
are
completed
at
the
maximum
application
rates
recommended
by
the
available
disulfoton
labels
to
indicate
worst­
case
risk
levels
associated
with
the
various
use
patterns.
Application
rates
and
exposure
values
were
calculated
separately
for
Bayer
1%
granular
product
labels.

 
Generally,
the
use
of
PPE
and
engineering
controls
are
not
considered
acceptable
options
for
products
sold
for
use
by
homeowners
because
they
are
not
available,
and/
or
inappropriate
for
the
exposure
scenario.

 
PHED
values
represent
a
handler
wearing
typical
residential
clothing
attire
of
short
sleeve
shirt,
short
pants,
socks,
shoes,
and
no
gloves.

 
The
number
of
rose
bushes
assumed
for
treatment
per
day
by
a
homeowner
is
50
rose
bushes.

 
The
number
of
pots
assumed
for
treatment
per
day
by
a
homeowner
is
20
six­
inch
pots.

 
The
number
of
ornamental
shrubs
or
trees
assumed
for
treatment
per
day
by
a
10
homeowner
is
25
shrubs.

 
The
area
treated
with
granulars
for
flower
or
vegetable
gardens
by
a
homeowner
is
assumed
to
be
1,000
ft
2
.
For
pre­
planting
treatment
of
flower
and
vegetable
gardens
with
a
belly
grinder
or
push­
type
spreader,
the
treatment
area
is
assumed
to
be
1,000
ft
2
.

 
A
respiratory
rate
of
16.7
L/
min
was
assumed,
based
on
the
draft
NAFTA
recommended
inhalation
rates.

Non­
occupational
Handler
Exposure
and
Risk
Estimates
The
calculations
of
daily
dermal
and
inhalation
exposure,
short­
term
doses,
and
total
short­
term
MOEs
were
made
using
the
following
formulae.
8
Potential
daily
dermal
exposure
is
calculated
using
the
following
formula:

Daily
Dermal
Exposure
mg
ai
 
Unit
Exposure
mg
ai
xUse
Rate
lb
ai
x
Daily
Acres
Treated
A
day
lb
ai
A
day
The
potential
short­
term
dermal
doses
were
calculated
using
the
following
formulae:

Short
 
term
Daily
Dermal
Dose
mg
ai
 
Short
 
term
Daily
Dermal
Exposure
mg
ai
x
1
kg
/
day
day
Body
Weight
(
kg
)

The
short­
term
MOEs
were
calculated
using
a
NOAEL
of
0.5
mg/
kg/
day.
The
previous
assessment
used
a
short­
term
dermal
NOAEL
of
0.4
mg/
kg/
day
from
a
dermal
rabbit
study.
The
intermediate­
term
MOEs
were
calculated
using
a
NOAEL
of
0.03
mg/
kg/
day
assuming
36
percent
dermal
absorption
and
70
kg
body
weight.

Potential
daily
inhalation
exposure
was
calculated
using
the
following
formula:

Daily
Inhalation
Exposure
mg
ai
 
day
1
mg
A
Unit
Exposure
F
gai
x
Conversion
Factor
1,
000
F
g
xUse
Rate
lb
A
ai
x
Daily
Acres
Treated
day
lb
ai
The
potential
short­
term
inhalation
doses
were
calculated
using
the
following
formulae:

Short
 
term
Daily
Inhalation
Dose
mg
ai
 
Short
 
term
Daily
Inhalation
Exposure
mg
ai
x
1
kg
/
day
day
Body
Weight
(
kg
)

11
For
disulfoton,
the
inhalation
doses
were
calculated
using
a
70
kg
body
weight
and
an
inhalation
absorption
rate
of
100
percent.

Table
4
presents
residential
dermal
and
inhalation
exposures
associated
with
the
handling
of
disulfoton.
Table
5
presents
the
short­
term
dermal
and
inhalation
risks
as
well
as
total
MOEs
resulting
from
those
exposures.
The
Agency
only
assessed
for
short­
term
non­
occupational
(
residential)
risks
and
not
intermediate­
term
non­
occupational
(
residential)
risks
since
it
is
assumed
that
handlers
will
be
exposed
less
than
seven
days
at
a
time.
The
Agency
acknowledges
that
some
exposure
scenarios
presented
in
the
following
tables
may
not
be
supported
by
Bayer;
however,
they
may
be
supported
by
other
registrants.

Summary
of
Concerns
for
Non­
occupational
Handlers,
Data
Gaps,
and
Confidence
in
Exposure
and
Risk
Estimates
Short­
term
dermal
and
inhalation
risks
for
homeowner­
handlers
were
assessed
as
well
as
the
total
risks
associated
with
the
handling
of
disulfoton.

Handler
Scenarios
with
Risk
Concerns
The
calculations
of
short­
term
dermal
and
inhalation
risks
indicate
that
the
following
total
short­
term
MOEs
are
greater
than
100
at
baseline:

(
2)
loading/
applying
granulars
using
a
push­
type
spreader
(
3)
loading/
applying
granulars
using
a
spoon,
measuring
scoop,
shaker
can,
or
by
hand
for
application
to
vegetable
gardens,
potted
plants,
and
roses.

The
calculations
of
short­
term
dermal
and
inhalation
risks
indicate
that
the
following
total
short­
term
MOEs
are
less
than
100
at
baseline:

(
1)
loading/
applying
granulars
with
a
belly
grinder
for
flower
and
vegetable
gardens
(
pre­
planting)
using
an
application
rate
of
0.3
lb
ai/
1000
ft
2
(
flower
gardens,
MOE
=
1.1)
and
0.069
lb
ai/
1000
ft
2
(
vegetable
gardens,
MOE
=
4.6)
.

(
3)
loading/
applying
granulars,
using
a
spoon,
measuring
scoop,
shaker
can
or
by
hand,
to
flower
gardens
and
ornamental
shrubs/
small
trees
using
an
application
rate
of
0.3
lb
ai/
1000
ft
2
(
flower
gardens,
MOE
=
34)
and
0.01
lb
ai/
four
foot
shrub
(
shrubs/
small
trees,
MOE
=
41)
.

The
calculations
of
short­
term
dermal
and
inhalation
risks
indicate
that
all
total
short­
term
MOEs
are
greater
than
100
at
baseline
for
Bayer
 
s
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®
:

(
4)
loading/
applying
granulars
using
a
measuring
cup/
lid
at
an
application
rate
of
0.21
lb
ai/
1000
ft
2
(
flowerbeds,
MOE
=
5500)
,
0.01
lb
ai/
four
foot
shrub
(
shrubs,
MOE
=
1500)
,
and
12
0.0013
lb
ai/
bush
(
rosebushes,
MOE
=
5800)
.

The
Agency
notes
that
the
Advanced
Garden
2­
in­
1
product
is
the
only
homeowner
product
that
Bayer
intends
to
support.
Residential
risks
from
the
use
of
this
product
are
not
of
concern.

Data
Gaps
Data
gaps
exist
for
the
following
scenario:

(
5)
applying
insecticidal
spikes
to
rose
bushes,
or
ornamental
shrubs
and
trees.

Data
Quality
and
Confidence
in
Assessment
Several
issues
must
be
considered
when
interpreting
the
non­
occupational
exposure
risks
 
Factors
used
to
calculate
daily
exposures
to
handlers
(
e.
g.
square
footage
treated
per
day,
number
of
pots
treated
and
number
of
shrubs
or
trees
treated
in
a
day)
are
based
on
the
best
professional
judgement
due
to
a
lack
of
pertinent
data.

Non­
occupational
Postapplication
Scenarios
HED
has
determined
that
there
are
potential
postapplication
exposures
to
residents
based
on
the
following
scenarios:

 
transplanting,
hoeing,
and
weeding
treated
ornamental
shrubs
and
trees
(
including
rose
bushes)
;

 
transplanting,
hoeing,
and
weeding
treated
ornamental
flowers;

 
non­
harvest
activities
such
as
weeding
and
hoeing
of
home
vegetable
crops;

 
incidental
granular
ingestion;
and
 
incidental
soil
ingestion.

Data
Source
Descriptions
for
Scenarios
Considered
A
surrogate
postapplication
exposure
assessment
was
conducted
to
determine
potential
risks
for
incidental
soil
ingestion.
Other
postapplication
scenarios
were
not
assessed
because
disulfoton
granulars
and
insecticidal
spikes
are
applied
directly
to
the
soil
and
EPA
has
no
data
13
upon
which
to
base
postapplication
contact
with
treated
soil
through
activities
such
as
weeding,
hoeing,
and
transplanting
home
ornamentals
and
vegetable
crops
or
houseplants.
Furthermore,
it
is
HED
 
s
policy
to
routinely
conduct
screening
level
assessments
(
based
on
standard
values
in
the
Residential
SOPs)
for
children
 
s
incidental
ingestion
of
granules
when
a
granular
pesticide
may
be
applied
in
residential
settings;
however,
the
Agency
has
no
data
upon
which
to
base
this
postapplication
scenario.
The
Agency
requests
information
on
particle
density
(
number
of
particles
per
pound
or
gram)
,
carrier
type,
granular
color,
and
average
granular
size
in
order
to
conduct
an
exposure
assessment
for
this
scenario.

Assumptions
Used
in
Postapplication
Exposure
Calculations
The
assumptions
used
in
the
calculations
for
residential
postapplication
risks
include
the
following
items:

 
The
oral
NOAEL
of
0.03
mg/
kg/
day
from
the
six­
month
feeding
study
in
rats
was
used
in
the
assessment.

C
On
the
day
of
application,
it
was
assumed
that
20
percent
of
the
application
rate
is
located
with
the
soil
 
s
uppermost
1
cm.
The
Residential
SOP
 
s
specify
a
100
percent
assumption;
however
after
disulfoton
treatment
followed
by
soil
incorporation,
the
insecticide
should
be
uniformly
dispersed
into
the
top
2
inches
of
soil.
6
C
The
soil
ingestion
rate
for
children
(
ages
1­
6
years)
was
assumed
to
be
100
mg/
day.

C
Application
rates
used
in
the
residential
assessment
are
described
in
a
previous
section.

C
Toddlers
(
3
years
old)
used
to
represent
the
1
to
6
year
old
age
group,
were
assumed
to
weigh
15
kg.

C
Postapplication
was
assessed
on
the
same
day
the
pesticide
is
applied
because
it
was
assumed
that
the
toddler
could
be
exposed
to
soil
immediately
after
application.
Therefore,
postapplication
exposures
were
based
on
day
0.

Postapplication
Exposure
and
Risk
Estimates
Table
6
presents
the
postapplication
risks
from
the
incidental
soil
ingestion
by
toddlers
of
soil
treated
with
disulfoton.
The
following
equations
were
used:

Incidental
Soil
Ingestion:

ADD
=
(
SRt
*
IgR
*
CF1)
/
BW
14
where:
ADD
=
average
daily
dose
(
mg/
kg/
day)
SRt
=
soil
residue
on
day
"
t"
(
F
g/
g)
,
assuming
average
day
of
reentry
 
t
 
is
day
0
IgR
=
ingestion
rate
of
soil
(
mg/
day)
,
assumed
to
be
100
mg/
day
CF1
=
weight
unit
conversion
factor
to
convert
the
F
g
of
residues
on
the
soil
to
grams
to
provide
units
of
mg/
day
(
1E­
6
g/
F
g)
BW
=
body
weight
(
kg)
,
assumed
15
kg
for
toddlers
and
SRt
=
AR
*
F
*
(
1­
D)
t
*
CF2
*
CF3
*
CF4
where:

AR
=
application
rate
(
lb
ai/
acre)
F
=
fraction
of
ai
available
in
uppermost
cm
of
soil
(
fraction/
cm)
,
assumed
to
be
20
percent
based
on
soil
incorporation
into
top
2
inches
of
soil
after
application
D
=
fraction
of
residue
that
dissipates
daily
(
unitless)
t
=
postapplication
day
on
which
exposure
is
being
assessed
CF2
=
weight
unit
conversion
factor
to
convert
the
lbs
ai
in
the
application
rate
to
F
g
for
the
soil
residue
value
(
4.54E8
F
g/
lb)
CF3
=
area
unit
conversion
factor
to
convert
the
surface
area
units
(
ft
2
)
in
the
application
rate
to
cm
2
for
the
SR
value
(
2.47E­
8
acre/
cm
2
if
the
application
rate
is
per
acre)
CF4
=
volume
to
weight
unit
conversion
factor
to
convert
the
volume
units
(
cm
3
)
to
weight
units
for
the
SR
value
(
0.67
cm
3
/
g
soil)
7
t
=
postapplication
day
on
which
exposure
is
being
assessed,
assumed
to
be
day
0
Summary
of
Residential
Postapplication
Risks
The
target
residential
MOE
is
100
for
disulfoton.
The
resulting
surrogate
residential
postapplication
assessment
for
toddlers
indicates
that
the
disulfoton
MOEs
for
incidental
soil
ingestion
are
greater
than
100
for
flower
garden
soil
and
vegetable
garden
soil
(
application
rates
13
lbs
ai/
A
and
3
lbs
ai/
A,
respectively)
.

Data
Gaps
Data
gaps
exist
for
the
following
scenarios:

 
transplanting,
hoeing,
and
weeding
treated
ornamental
shrubs
and
trees
(
including
rose
bushes)
;

 
transplanting,
hoeing,
and
weeding
treated
ornamental
flowers;

15
 
non­
harvest
activities
such
as
weeding
and
hoeing
of
home
vegetable
crops;

 
incidental
granular
ingestion
(
information
on
particle
density,
carrier
type,
granular
color,
and
average
granular
size)

16
Table
3.
Residential
Exposure
Scenario
Descriptions
for
the
Use
of
Disulfoton
Exposure
Scenario
(
Scenario
#
)
Data
Source
Comments
a
Standard
Assumptions
6,11
Loading/
applying
granulars
using
a
belly
grinder
(
1)
PHED
V1.
1
Baseline:
Dermal
and
hands
data
=
ABC
grades,
inhalation
=
AB
grade.
Dermal
20­
45
replicates;
hands
=
23
replicates;
and
inhalation
=
40
replicates.
Medium
confidence
for
hands
and
dermal,
and
high
confidence
for
inhalation.

PPE
and
Engineering
Controls
:
Not
required
for
assessment.
1,
000
ft
2
for
pre­
planting
of
flower/
vegetable
gardens
per
day
Loading/
applying
granulars
using
a
push­
type
spreader
(
2)
Summary
of
HED
 
s
Reviews
of
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
Chemical
Handler
Exposure
Studies;

MRID
449722­
01.
April
30,

2001.
Baseline:
Dermal,
hands,
and
inhalation
data
=
A/
B
grade.
Dermal,
hands,
and
inhalation
data
=
30
replicates.
High
confidence
in
all
data.

PPE
and
Engineering
Controls
:
Not
required
for
assessment.
1,
000
ft
2
for
pre­
planting
of
flower/
vegetable
gardens
and
25
shrubs
per
day
Loading/
applying
granulars
using
a
spoon,
measuring
scoop,
shaker
can
or
by
hand
(
3)
Review
of
fipronil
granular
mixer/
loader/
applicator
study
as
a
source
of
surrogate
data,

MRID
452507­
01.
J.
Dawson
memo,
D270065,
1/
5/
01.
Baseline:
A
90%
protection
factor
was
applied
to
gloved
hands
data
to
backcalculate
 
no
glove
 
hand
exposure.
.
A
standard
50%
protection
factor
was
used
for
the
torso.
A
10%
protection
factor
was
used
to
represent
the
protection
afforded
by
shorts
and
a
short­
sleeved
shirt.

PPE
and
Engineering
Controls
:
Not
required
for
assessment.
1,
000
ft
2
for
pre­
planting
of
flower/
vegetable
gardens,
25
shrubs,
and
50
rose
bushes
per
day
Loading/
applying
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®

Disulfoton
1%
granulars
using
a
measuring
cup/
lid
(
4)
Disulfoton
1%
Granular
Residential
Applicator
Exposure
and
Risk
Estimates:

Report
Number:
110137
5
25
shrubs
and
50
rose
bushes
per
day
Application
of
insecticidal
spikes
(
5)
NA
NA
NA
a
"
Best
Available"
grades
are
defined
by
HED
SOP
for
meeting
Subdivision
U
Guidelines.
Best
available
grades
are
assigned
as
follows:
matrices
with
grades
A
and
B
data
and
a
minimum
of
15
replicates;
if
not
available,
then
grades
A,
B
and
C
data
and
a
minimum
of
15
replicates;
if
not
available,
then
all
data
regardless
of
the
quality
and
number
of
replicates.
Data
confidence
are
assigned
as
follows:

High
=
grades
A
and
B
and
15
or
more
replicates
per
body
part
Medium
=
grades
A,
B,
and
C
and
15
or
more
replicates
per
body
part
Low
=
grades
A,
B,
C,
D
and
E
or
any
combination
of
grades
with
less
than
15
replicates
NA
=
Not
Applicable
17
Table
4:
Residential
Handler
Dermal
and
Inhalation
Exposures
to
Disulfoton
at
Baseline
Exposure
Scenario
(
Scenario
#
)
(
mg/
lb
ai)
a
Baseline
Dermal
Unit
Exposure
(
g/
lb
ai)
b
Baseline
Inhalation
Unit
Exposure
Maximum
Application
Rate
c
Crop
Type
or
Target
d
Amount
Handled
Per
Day
e
Daily
Dermal
Exposure
(
mg/
day)
f
Daily
Inhalation
Exposure
(
mg/
day)
g
Mixer/
Loader/
Applicator
Exposure
Loading/
applying
granulars
using
a
belly
grinder
(
1)
110
62
0.3
lb
ai/
1000
ft
2
Flower
Gardens
(
pre­

planting)
1,000
ft
2
33
0.019
0.069
lb
ai/
1000
ft
2
Vegetable
Gardens
(
pre­
planting)
1,000
ft
2
7.8
0.
0043
Loading/
applying
granulars
using
a
push­
type
spreader
(
2)
0.68
0.91
0.069
lb
ai/
1000
ft
2
Vegetable
Gardens
1,
000
ft
2
0.047
6.3E­
5
0.3
lb
ai/
1000
ft
2
Flower
Gardens
1,
000
ft
2
0.20
2.7E­
4
0.01
lb
ai/
4
ft
shrub
Ornamental
Shrubs
25
shrubs
0.17
2.3E­
4
0.0013
lb
ai/
bush
Roses
50
bushes
0.043
5.7E­
4
18
Table
4:
Residential
Handler
Dermal
and
Inhalation
Exposures
to
Disulfoton
at
Baseline
(
continued)

Exposure
Scenario
(
Scenario
#
)
Baseline
Dermal
Unit
Exposure
(
mg/
lb
ai)
a
Baseline
Inhalation
Unit
Exposure
(
g/
lb
ai)
b
Maximum
Application
Rate
Crop
Type
or
Target
d
Amount
Handled
Per
Day
e
Daily
Dermal
Exposure
(
mg/
day)
f
Daily
Inhalation
Exposure
(
mg/
day)
g
Loading/
applying
granulars
using
a
spoon,
measuring
scoop,

shaker
can
or
by
hand
(
3)
3.5
0.
045
0.069
lb
ai/
1,000
ft
2
Vegetable
Gardens
1,
000
ft
2
0.24
3.1E­
6
0.3
lb
ai/
1000
ft
2
Flower
Gardens
1,
000
ft
2
1.04
1.4E­
5
0.01
lb
ai/
4
ft
shrub
Ornamental
Shrubs
25
shrubs
0.86
1.1E­
5
0.00034
lb
ai/
6"
pot
Potted
Plant
20
pots
0.
023
3.0E­
7
0.0013
lb
ai/
bush
Roses
50
bushes
0.22
2.8E­
6
Loading/
applying
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®
Disulfoton
1%
%
granulars
using
a
measuring
cup/
lid
(
4)
0.03
0.013
0.21
lb
ai/
1000
ft
2
Flowerbeds
1,000
ft
2
0.0063
2.7E­
6
0.092
0.013
0.01
lb
ai/
4
ft.
bush
Shrubs
25
0.023
3.3E­
6
0.092
0.013
0.0013
lb
ai/
bush
Roses
50
bushes
0.
0060
8.5E­
7
Application
of
insecticidal
spikes
(
5)
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
Table
4:
Residential
Handler
Dermal
and
Inhalation
Exposures
to
Disulfoton
at
Baseline
(
continued)

19
Footnotes:
a
Baseline
Dermal
Unit
Exposure
represents
short
pants,
short
sleeved
shirt,
no
gloves,
and
open
mixing/
loading.

b
Baseline
Inhalation
Exposure
represents
no
respirator.

c
Application
Rates
are
maximum
rate
values
found
on
disulfoton
labels
(
EPA
Reg.
No.
4­
153,
3125­
517,
7401­
323,
8660­
191,
9404­
3,
46260­
2,
46260­
12,
46260­
35)
.

d
Crop
Type
or
Target
provides
a
general
description
of
the
intended
uses
of
disulfoton.
Separate
categories
are
presented
because
of
the
distinct
differences
in
application
rates
and
amount
handled.

e
Daily
Amount
Handled
values
are
default
estimates
from
Exposure
SAC
Policy
12,
or
the
best
professional
judgement
of
square
footage,
or
number
of
bushes,
shrubs,
or
pots
that
could
be
treated
in
a
single
day
for
each
exposure
scenario.
12
f
Daily
Dermal
Exposure
(
mg/
day)
=
Unit
Exposure
(
mg/
lb
ai)
*
Appl.
rate
*
Amount
Handled
per
day.

g
Daily
Inhalation
Exposure
(
mg/
day)
=
Unit
Exposure
(
µ
g/
lb
ai)
*
(
1mg/
1000
µ
g)
Conversion
*
Application
Rate
(
lb
ai/
A)
*
Acres
treated
(
acres/
day)
.

h
Residential
application
of
disulfoton
using
a
belly
grinder
are
applicable
for
pre­
plant
treatment
applications
only.

I
Unit
exposure
data
for
application
of
granules
by
hand
were
used
as
surrogate
values
for
these
scenarios.

j
Application
rates
for
small
vegetable
gardens
are
based
on
38­
inch
row
spacing
(
EPA
Reg.
No.
7401­
323)
.

20
Table
5:
Residential
Handler
Short­
term
Risks
from
Disulfoton
at
Baseline
Exposure
Scenario
(
Scenario
#
)
Crop
Type
or
Target
a
Amount
Handled
Per
Day
b
Maximum
Application
Rate
Baseline
Dermal
Baseline
Inhalation
Baseline
Total
Daily
Dose
(
mg/
kg/
day)
c
Short
term
MOE
d
Daily
Dose
(
mg/
kg/
day)
e
Short
term
MOE
f
Short­
term
MOE
g
Mixer/
Loader/
Applicator
Risks
Loading/
applying
granulars
using
a
belly
grinder
(
1)
Flower
Gardens
(
pre­

planting)
1,000
ft
2
0.3
lb
ai/
1000
ft
2
0.47
1.1
2.
7E­
4
170
1.1
Vegetable
Gardens
(
pre­
planting)
1,000
ft
2
0.069
lb
ai/
1000
ft
2
0.11
4.6
6.
1E­
5
740
4.6
Loading/
applying
granulars
using
a
push­

type
spreader
(
2)
Vegetable
Gardens
1,
000
ft
2
0.069
lb
ai/
1,000
ft
2
h
6.7E­
4
750
1.0E­
6
5.0E4
740
Flower
Gardens
1,
000
ft
2
0.3
lb
ai/
1,000
ft
2
0.0029
172
4.0E­
6
1.2E4
170
Ornamental
Shrubs/

Small
Trees
25
shrubs
0.01
lb
ai/
4
ft.
shrub
0.
0024
210
3.0E­
6
1.4E4
200
Roses
50
bushes
0.
00126
lb
ai/
bush
6.
1E­
4
820
1.0E­
6
5.5E4
810
21
Table
5:
Residential
Handler
Short­
term
Risks
from
Disulfoton
at
Baseline
(
continued)

Exposure
Scenario
(
Scenario
#
)
Crop
Type
or
Target
a
Amount
Handled
Per
Day
b
Maximum
Application
Rate
Baseline
Dermal
Baseline
Inhalation
Baseline
Total
Daily
Dose
(
mg/
kg/
day)
c
Short
term
MOE
d
Daily
Dose
(
mg/
kg/
day)
e
Short
term
MOE
f
Short­
term
MOE
g
Mixer/
Loader/
Applicator
Risks
Loading/
applying
granulars
using
a
spoon,
measuring
scoop,
shaker
can
or
by
hand
(
3)
Vegetable
Gardens
1,
000
ft
2
0.069
lb
ai/
1,000
ft
2
h
0.0034
150
4.4E­
8
1.0E6
150
Flower
Gardens
1,
000
ft
2
0.3
lb
ai/
1,000
ft
2
0.015
34
1.9E­
7
2.3E5
34
Ornamental
Shrubs/

Small
Trees
25
shrubs
0.01
lb
ai/
4
ft.
shrub
0.
012
41
1.6E­
7
2.8E5
41
Potted
Plants
20
pots
0.
00034
lb
ai/
6"
pot
3.3E­
4
1500
4E­
9
1.0E7
1500
Roses
50
bushes
0.
00126
lb
ai/
bush
0.
0031
160
4.1E­
8
1.1E6
160
22
Table
5:
Residential
Handler
Short­
term
Risks
from
Disulfoton
at
Baseline
(
continued)

Exposure
Scenario
(
Scenario
#
)
Crop
Type
or
Target
a
Amount
Handled
Per
Day
b
Maximum
Application
Rate
Baseline
Dermal
Baseline
Inhalation
Baseline
Total
Daily
Dose
(
mg/
kg/
day)
c
Short
term
MOE
d
Daily
Dose
(
mg/
kg/
day)
e
Short
term
MOE
f
Short­
term
MOE
g
Mixer/
Loader/
Applicator
Risks
Loading/
applying
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®
Disulfoton
1%
%

granulars
using
a
measuring
cup/
lid
(
4)
Flowerbeds
1000
ft
2
0.21
lb
ai/
1000
ft
2
9.0E­
5
5600
3.9E­
8
1.2E6
5500
Shrubs
25
shrubs
0.01
lb
ai/
4
ft
shrub
3.
3E­
4
1500
4.6E­
8
9.7E5
1500
Roses
50
bushes
0.
0013
lb
ai/
bush
9.
0E­
5
5900
1.2E­
8
3.7E6
5800
Application
of
insecticidal
spikes
(
5)
Roses/
Trees
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
No
Data
Footnotes:
a
Crop
Type
or
Target
provides
a
general
description
of
the
intended
use
of
various
products
containing
disulfoton.
Separate
categories
are
presented
because
of
the
distinct
differences
in
application
rates
and
acres
treated.

b
Amount
Handled
Per
Day
values
are
from
default
estimates
of
square
footage
or
number
of
bushes,
shrubs,
or
pots
treated
a
single
day
for
each
exposure
scenario
of
concern.

Daily
Dermal
Dose
(
mg/
kg/
day)
=
Daily
Dermal
Exposure
(
mg/
day)
/
Body
weight
(
70
kg)
.

d
Short­
term
Dermal
MOE
=
NOAEL
(
0.5
mg/
kg/
day)
/
Daily
Dermal
Dose
(
mg/
kg/
day)
.

e
Daily
Inhalation
Dose
(
mg/
kg/
day)
=
Daily
Inhalation
Exposure
(
mg/
day)
/
Body
weight
(
70
kg)
.

f
Short­
term
Inhalation
MOE
=
NOAEL
(
0.045
mg/
kg/
day)
/
Daily
Inhalation
Dose
(
mg/
kg/
day)
.

g
Total
Short­
term
MOE
=
1/
[
(
1/
Short­
term
Dermal
MOE)
+
(
1/
Short­
term
Inhalation
MOE)
]
.

h
Application
rates
for
small
vegetable
gardens
are
based
on
38­
inch
row
spacing
(
EPA
Reg
No.
7401­
323)
.

23
c
Table
6.
Residential
Post­
application
Risks
from
Incidental
Soil
Ingestion
of
Disulfoton
Scenario
Receptor
Application
Rate
Per
Treatment
(
AR)
(
lbs
ai/
A)
a
Srt
(
g/
g)
b
IgR
(
mg/
day)
BW
(
kg)
ADD
(
mg/
kg/
day)
MOE
d
Incidental
soil
ingestion
(
flowerbeds)
Toddler
13
20
100
15
0.00013
230
Incidental
soil
ingestion
(
vegetable
garden
beds)
Toddler
3
4.
5
100
15
0.00003
1000
Footnotes:
a
Application
rate
for
flower
and
vegetable
gardens
b
Soil
residue
(
ug/
g)
=
[
AR
(
lbs
ai/
A)
*
4.54E+
8
ug/
lb
*
2.47E­
8
A/
cm
2
*
0.67
cm
3
/
g
soil
*
0.2/
cm
]
.

Average
daily
dose
(
ADD)
(
mg/
kg/
day)
=
[
SRt
(
ug/
g)
*
IgR
(
mg/
day)
*
g/
1,000,000
ug
]
/
/
[
BW
(
kg)
]
.

d
MOE
=
NOAEL
(
0.03
mg/
kg/
day)
/
ADD.
24
c
References
1)
Bangs,
G.
(
2001)
Summary
of
HED
 
s
Reviews
of
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
Chemical
Handler
Exposure
Studies;
MRID
449722­
01.
Memorandum
from
Gary
Bangs
(
HED)
to
Demson
Fuller
(
Special
Review
and
Reregistration
Division)
,
April
30,
2001.

2)
Becker,
J.
(
2000)
Revised
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Disulfoton.
Washington,
D.
C.
:
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
February
7,
2000.

3)
Dawson,
J.
(
2001)
Ethoprop.
Review
of
fipronil
granular
mixer/
loader/
applicator
study
(
MRID
452507­
01)
in
bananas
as
a
source
of
surrogate
data
and
accompanying
ethoprop
risk
assessment
Washington,
D.
C.
:
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
January
5,
2001.

4)
Disulfoton
Labels
(
4­
153,
4­
420,
16­
171,
192­
74,
192­
119,
192­
126,
192­
164,
239­
2134,
769­
908,
802­
426,
869­
76,
869­
223,
904­
138,
3125­
83,
3125­
116,
3125­
152,
3125­
152,
3125­
517,
5887­
67,
5887­
171,
7401­
4,
4701­
26,
7401­
235,
7401­
323,
9404­
3,
8660­
125,
8660­
191,
11474­
17,
32802­
32,
42057­
51,
46260­
2,
46260­
35,
59144­
23)
.

5)
Merricks,
D.
Larry.
(
2001)
Determination
of
Dermal
(
Hand
and
Forearm)
and
Inhalation
Exposure
to
Disulfoton
Resulting
from
Residential
Application
of
Bayer
Advanced
Garden
2­
in­
1Systemic
Rose
and
Flower
Care
to
Shrubs
and
Flower
Beds.
MRID
#
45333401.
February
8,
2001.

6)
U.
S.
EPA
(
1997)
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments,
draft
report.
Washington,
D.
C.
:
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
December
18,
1997.

7)
U.
S.
EPA
(
1998)
Disulfoton
LUIS
Table
for
Exposure
Assessors
(
PRD
report
dated
11/
06/
96
and
report
run
date
02/
04/
98)
.

8)
U.
S.
EPA
(
1998)
PHED
Surrogate
Exposure
Guide,
Version
1.1.
Washington,
D.
C.
:
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
August
1991.

9)
U.
S.
EPA
(
1999)
Use
of
Values
from
the
PHED
Surrogate
Table
and
Chemical­
Specific
Data,
Science
Advisory
Council
for
Exposure
Policy
No.
7.
Washington,
D.
C.
:
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
January
28,
1999.

10)
U.
S.
EPA
(
2000)
Disulfoton.
Report
of
the
FQPA
Committee.
Washington,
D.
C.
:
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
February
10,
2000
25
11)
U.
S.
EPA
(
2001)
Recommended
Revisions
to
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments,
Science
Advisory
Council
for
Exposure
Policy
No.
12.
Washington,
D.
C.
:
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
February
22,
2001.

12)
U.
S.
EPA
(
2001)
Disulfoton:
Revised
(
3
rd
)
Report
of
Hazard
Identification
Assessment
Review
Committee.
Washington,
D.
C.
:
U.
S.
Environmental
Protection
Agency,
Office
of
Pesticide
Programs.
April
10,
2001.

cc:
David
Anderson,
OPP/
HED/
RRB2
OREB
Files
26