UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
June
6,
2001
Memorandum
SUBJECT:
Review
of
Determination
of
Dermal
(
Hand
and
Forearm)
and
Inhalation
Exposure
to
Disulfoton
Resulting
from
Residential
Application
of
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
to
Shrubs
and
Flower
Beds
.
MRID
No.
453334­
01.
DP
Barcode:
273144.

FROM:
Shanna
Recore,
Industrial
Hygienist
Reregistration
Branch
2
Health
Effects
Division
(
7509C)

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

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

Attached
is
a
review
of
the
dermal
and
inhalation
exposure
data
submitted
by
Bayer
Corporation.
This
review
was
completed
by
Versar,
Inc.
on
March
20,
2001,
under
supervision
of
HED.
It
has
undergone
secondary
review
in
HED
and
has
been
revised
to
reflect
Agency
policies.

1
Executive
Summary
The
data
collected,
reflecting
the
residential
applicator
dermal
and
inhalation
exposure
of
disulfoton,
meets
most
of
the
criteria
specified
by
the
U.
S.
Environmental
Protection
Agency
 
s
(
US­
EPA)
OPPTS
Series
875,
Occupational
and
Residential
Exposure
Test
Guidelines,
Group
A:
Application
Exposure
Monitoring
Test
Guidelines,
875.1300,
Inhalation
Exposure
­
­
Outdoor
and
875.1100,
Dermal
Exposure
­
­
Outdoor.
used
to
determine
dermal
and
inhalation
exposure
pending
clarification/
response
to
our
outstanding
concerns.
The
data
are
of
sufficient
scientific
quality
to
be
Summary
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.
Disulfoton
is
a
systemic
organophosphate
insecticide
registered
for
use
on
residential
ornamentals
including
rosebushes,
shrubs,
and
flowerbeds.
The
maximum
application
rate
for
flower
beds
(
4
ounces
formulated
product
per
12
square
feet)
and
for
shrubs,
which
includes
rosebushes,
(
4
ounces
formulated
product
per
1
foot
shrub
height)
was
used
in
this
study.

The
field
study
was
conducted
at
the
Bayer
Corporation
Research
Farm,
Vero
Beach,
Florida.
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.
Each
volunteer
applied
granular
disulfoton
around
shrubs
while
wearing
gloves
and
then
again
without
gloves.
A
total
of
60
(
i.
e.
,
15
volunteers
x
4
exposure
scenarios)
replicates
were
monitored.
Only
exposure
data
from
the
30
replicates
who
did
not
wear
gloves
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)
.

Each
volunteer
applied
approximately
10
pounds
of
formulated
product
per
application.
Shrubs
were
treated
by
spreading
16
ounces
of
granules
(
i.
e.
,
4
ounces
per
1
foot
of
shrub)
in
a
circle
around
each
shrub
 
s
base.
The
granules
were
then
incorporated
into
the
top
1­
2
inches
of
soil
using
a
new
garden
rake.
Flower
beds
were
treated
by
sprinkling
4
ounces
of
granules
to
each
12
square
feet
of
a
total
480
square
feet
area,
and
incorporating
the
product
into
the
top
1­
2
inches
of
soil
using
a
new
garden
rake.

All
of
the
inhalation
exposure
data
were
either
non­
detect
or
less
than
the
limit
of
quantitation
(
LOQ)
.
Most
of
the
hand/
forearm
dermal
washing
samples
returned
results
greater
than
the
LOQ.
Disulfoton
residues
found
on
the
hand
and
forearm
samples
collected
from
monitoring
periods
where
volunteers
did
not
wear
gloves
were
highest
when
applying
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®
to
shrubs.
.
All
of
the
samples
collected
while
subjects
treated
oleander
shrubs
were
positive,
with
residue
levels
ranging
from
1.39
to
36
µ
g/
sample
(
N=
15)
and
with
a
mean
value
of
13.5
µ
g.
Ten
of
15
samples
collected
2
while
subjects
treated
flowerbeds
had
results
>
LOQ,
ranging
from
1.88
to
20.6
µ
g/
sample
with
a
mean
of
5.45
µ
g.
The
author
speculates
 
applying
and
working
around
the
larger
plants
in
the
shrub
plots,
and
possibly
opening
and
closing
the
product
container
at
each
shrub
increased
the
hand
and
forearm
exposure
as
compared
to
flower
bed
applications.
 
The
author
reported
that
the
time
it
took
to
treat
shrubs
ranged
between
18
and
29
minutes.
The
time
that
it
took
to
treat
flowerbeds
ranged
between
20
and
40
minutes.

Conclusion
The
dermal
and
inhalation
exposure
study
completed
in
support
of
the
regulatory
requirements
contained
the
following
omissions
and
flaws
with
respect
to
Series
875
Group
A
Application
Exposure
Monitoring
Test
Guidelines.
The
most
important
discrepancies
and
issues
of
concern
include:
(
1)
the
Agency
is
particularly
concerned
with
the
sleeve
length
worn
by
the
study
participants
(
i.
e.
long
sleeves
vs.
short
sleeves)
;
however,
the
clothing
worn
by
each
study
participant
was
not
thoroughly
described,
the
author
stated
only
that
 
for
the
first
three
sessions,
volunteers
wore
new
pairs
of
Tyvek
®
pants
over
their
clothes
 
and
described
participants
 
clothing
as
 
fresh
set
of
clothes
 
and
 
street
clothes;
 
(
(
2)
the
investigator
did
not
test
for
breakthrough
and
it
was
not
ensured
that
collected
material
was
not
lost
from
the
medium
during
sampling;
and
(
3)
calibration
data
for
air
sampling
pumps
was
not
provided
and
it
is
not
indicated
whether
the
air
flow
changed
and
the
mean
flow
was
used
for
all
calculations.

The
following
additional
items
of
concern
have
been
noted:

The
field
fortification
samples
were
prepared
using
liquid
disulfoton.
Although
it
is
difficult
to
prepare
granular
field
spikes,
there
is
no
known
way
to
compare
the
recovery
results
to
recoveries
of
a
granular
formulation.
The
significance
of
this
difference
is
therefore
unknown.

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
study,
as
both
real
plants
and
simulated
plants
were
used:

Use
of
Simulated
Plants:
The
Agency
prefers
that
the
study
use
real
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.
.

The
Agency
requests
a
response
from
the
registrant
on
the
above
mentioned
outstanding
issues.
However,
the
data
collected
in
this
study
are
of
interim
sufficient
scientific
quality
and
HED
will
use
the
results
in
the
RED.
Final
acceptability
of
the
study
will
be
determined
pending
the
registrant
 
s
response
to
our
concerns.

3
inc.

MEMORANDUM
TO:
Christina
Jarvis
cc:
000.001­
01
File
Margarita
Collantes
FROM:
Diane
Forrest/
Susan
Anderson
Al
Nielsen
Linda
Phillips
DATE:
March
20,
2001
SUBJECT:
Review
of
Determination
of
Dermal
(
Hand
and
Forearm)
and
Inhalation
Exposure
to
Disulfoton
Resulting
from
Residential
Application
of
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
to
Shrubs
and
Flower
Beds,
MRID
No.
453334­
01
This
report
reviews
an
applicator
exposure
study
,
Determination
of
Dermal
(
Hand
and
Forearm)
and
Inhalation
Exposure
to
Disulfoton
Resulting
from
Residential
Application
of
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
to
Shrubs
and
Flower
Beds
,
submitted
by
Bayer
Corporation.
A
summary
of
the
study
and
its
general
accordance
with
the
U.
S.
EPA
Series
875
Guidelines
is
provided.
The
following
information
may
be
used
to
identify
the
study:

Title:
Determination
of
Dermal
(
Hand
and
Forearm)
and
Inhalation
Exposure
to
Disulfoton
Resulting
from
Residential
Application
of
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
to
Shrubs
and
Flower
Beds
,
178
pages
Sponsor:
Wayne
Carlson,
VP
Regulatory
Affairs
and
Product
Safety
Bayer
Corporation
8400
Hawthorne
Road
Kansas
City,
MO
64120
Testing
Facility:
D.
Larry
Merricks
Agrisearch
Inc.
5734
Industry
Lane
Frederick,
MD
21704­
7293
Analytical
Laboratory:
Michael
Williams
Horizon
Laboratories
1610
Business
Loop,
70
West
Columbia,
MO
65205­
3608
Author:
D.
Larry
Merricks
Report
Date:
February
8,
2001
Identifying
Codes:
MRID
#
453334­
01,
Agrisearch
or
Lab.
Project
ID:
4201;
Report
No.
110136
4
EXECUTIVE
SUMMARY
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.
Disulfoton
is
a
systemic
organophosphate
insecticide
registered
for
use
on
agricultural
crops
(
e.
g.
,
cereals,
potatoes,
tobacco,
cotton,
vegetables)
and
ornamentals.
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.

The
field
study
was
conducted
at
the
Bayer
Corporation
Research
Farm,
Vero
Beach,
Florida.
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.
Each
volunteer
applied
granular
disulfoton
around
shrubs
while
wearing
gloves
and
then
again
without
gloves.
A
total
of
60
(
i.
e.
,
15
volunteers
x
4
exposure
scenarios)
replicates
were
monitored.
Only
exposure
data
from
the
30
replicates
who
did
not
wear
gloves
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)
.

Each
volunteer
applied
approximately
10
pounds
of
formulated
product
per
application.
Shrubs
were
treated
by
spreading
16
ounces
of
granules
(
i.
e.
,
4
ounces
per
1
foot
of
shrub)
in
a
circle
around
each
shrub
 
s
base.
The
granules
were
then
incorporated
into
the
top
1­
2
inches
of
soil
using
a
new
garden
rake.
Flower
beds
were
treated
by
sprinkling
4
ounces
of
granules
to
each
12
square
feet
of
a
total
480
square
feet
area,
and
incorporating
the
product
into
the
top
1­
2
inches
of
soil
using
a
new
garden
rake.

All
of
the
inhalation
exposure
data
were
either
non­
detect
or
less
than
the
LOQ.
Most
of
the
hand/
forearm
dermal
washing
samples
returned
results
greater
than
the
LOQ.
Disulfoton
residues
found
on
the
hand
and
forearm
samples
collected
from
monitoring
periods
where
volunteers
did
not
wear
gloves
were
highest
when
applying
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®
to
shrubs.
.
All
of
the
samples
collected
while
subjects
treated
oleander
shrubs
were
positive,
with
residue
levels
ranging
from
1.39
to
36
µ
g/
sample
(
N=
15)
and
with
a
mean
value
of
13.5
µ
g.
Ten
of
15
samples
collected
while
subjects
treated
flowerbeds
had
results
>
LOQ,
ranging
from
1.88
to
20.6
µ
g/
sample
with
a
mean
of
5.45
µ
g.
The
author
speculates
 
applying
and
working
around
the
larger
plants
in
the
shrub
plots,
and
possibly
opening
and
closing
the
product
container
at
each
shrub
increased
the
hand
and
forearm
exposure
as
compared
to
flower
bed
applications.
 
The
author
reported
that
the
time
it
took
to
treat
shrubs
ranged
between
18
and
29
minutes.
The
time
that
it
took
to
treat
flowerbeds
ranged
between
20
and
40
minutes.
Five
of
these
exposure
periods
exceeded
the
maximum
29
minutes
it
took
to
treat
a
shrub
sub­
plot.

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
issues
of
potential
interest
in
interpreting
the
results:

C
EPA
provided
the
registrant
with
comments
on
study
outlines
submitted
to
the
Agency.
The
following
comment
was
not
addressed
in
the
conduct
of
the
study:

Use
of
Simulated
Plants:
The
Agency
prefers
that
the
study
use
real
plants
because
it
is
5
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.
.

C
For
the
first
three
days
of
exposure
monitoring,
wind
speeds
ranged
between
4.2
and
8.9
mph.
Therefore,
conditions
were
generally
windy.

C
The
test
sites
were
irrigated
once
the
evening
prior
to
each
day
 
s
exposure
monitoring,
and
again
during
the
lunch
break
on
the
first
day
of
exposure
monitoring.
Sprinkler
irrigation
was
used,
and
0.5
inches
of
water
was
applied
to
maintain
a
packed
surface
and
minimize
dust
cross­
contamination.
This
is
not
considered
appropriate
for
a
handler
exposure
study
because
it
may
have
decreased
handler
pesticide
exposure
and
may
not
be
representative
of
typical
residential
handler
behavior.

C
There
were
a
total
of
60
samples
collected
for
inhalation
exposure,
and
60
samples
collected
for
dermal
exposure,
reflecting
15
volunteer
subjects,
applying
disulfoton
to
both
shrubs
and
flowers
bed
test
plots,
with
and
without
gloves.
Only
the
30
samples,
for
the
inhalation
exposure,
and
30
samples,
for
the
dermal
exposure,
representing
the
 
no
glove
 
scenario
were
reported.
.
All
data
should
have
been
reported,
especially
the
inhalation
exposure
samples,
which
would
not
have
been
affected
by
the
use
of
gloves.

6
STUDY
REVIEW
Study
Background
The
purpose
of
this
study
was
to
quantify
potential
dermal
(
forearm
and
hand
only)
and
inhalation
exposure
for
residential
applicators
of
Bayer
Advanced
Garden
2­
in­
1
Systemic
Rose
and
Flower
Care
®
,
a
granular
formulation,
containing
1.04
percent
disulfoton
as
the
active
ingredient.
The
CAS
name
for
disulfoton
is
O,
O­
diethyl­
S­
[
2­
ethylthio)
ethyl
]
­
phosphorodithioate,
and
the
CAS
No.
is
#
298­
04­
4.
Disulfoton
is
a
systemic
organophosphate
insecticide
registered
for
use
in
agricultural
crops
(
e.
g.
,
cereals,
potatoes,
tobacco,
cotton,
vegetables)
and
ornamentals.

Exposure
monitoring
took
place
on
four
days:
October
23,
24,
25,
and
26,
2000.
Sample
analyses
were
complete
by
December
16,
2000.

Attestations
The
study
sponsor
waived
claims
of
confidentiality
within
the
scope
of
FIFRA
Section
10
(
d)
(
1)
(
A)
,
(
B)
,
or
(
C)
.
The
study
sponsor
and
author
attested
that
the
study
was
conducted
according
to
current
EPA
FIFRA
Good
Laboratory
Practice
Standards
(
40
CFR
Part
160)
.
There
was
one
notation
to
the
effect
that
a
pocket
penetrometer
(
used
to
gauge
the
degree
of
soil
compaction
in
the
test
plots)
could
not
be
calibrated.
A
Quality
Assurance
Statement
was
included
covering:
test
procedures,
raw
and
final
data
review,
draft
and
final
report.

Test
Plots
The
field
study
was
conducted
at
the
Bayer
Corp.
Research
Farm,
Vero
Beach,
Florida.
The
test
site
a
one
acre
fallow
test
field,
was
disked
and
prepared
in
early
September
2000.
The
exact
soil
type
was
not
reported,
but
the
soil
was
reported
to
be
sandy.

Two
sets
of
sub­
plots
were
established,
one
planted
with
oleander
shrubs
and
the
other
containing
simulated
plants.
There
were
32
shrub
test­
plots,
each
measuring
3
feet
by
39
feet,
and
each
containing
10
oleander
shrubs
which
were
approximately
48
inches
high.
The
shrubs
had
been
planted
approximately
33
days
prior
to
exposure
monitoring.
Each
shrub
test
plot
was
separated
from
the
next
test
plot
by
at
least
4
feet
to
minimize
cross
contamination.

Likewise,
there
were
32
flower
beds,
each
measuring
480
square
feet
(
4
feet
by
120
feet)
.
Each
sub­
plot
contained
simulated
plants,
that
is,
12
to
14
inch
high
stakes
placed
on
approximately
24
inch
centers.
The
beds
were
not
cultivated
for
30
days
prior
to
the
exposure
monitoring.
The
flower
beds
had
enough
separation
between
beds
to
minimize
cross
contamination.

A
pocket
penetrometer
was
used
to
collect
soil
compaction
measurements.
The
soil
was
relatively
uniform
throughout;
the
compaction
ranged
between
0.75
and
1.25
tons
/
square
foot.

Replicates
This
study
collected
hand
and
forearm
dermal
exposure
data
and
inhalation
exposure
data
from
volunteers
applying
granular
disulfoton
around
shrubs,
and
to
flower
beds.
The
product
was
applied
by
pouring
the
granules
into
a
measuring
cup/
lid,
sprinkling
onto
the
soil,
and
soil­
incorporating
with
a
garden
rake.
There
were
15
volunteer
subjects,
each
monitored
for
4
exposure
periods.
Sampling
included
30
replicates
collected
during
gloved
hand
application,
and
30
replicates
collected
during
applications
made
without
the
use
of
protective
gloves.
Only
exposure
data
from
the
30
replicates
who
did
not
wear
gloves
were
reported.

7
Volunteers
ranged
in
age
from
20
to
73
years
old,
had
0
to
40
years
experience
gardening,
and
worked
from
18
minutes
to
50
minutes
during
each
application.
There
were
nine
female
and
six
male
applicators.
Information
on
each
individual
volunteer
such
as
height,
weight,
age,
sex,
and
years
experience
using
residential
pesticide
products
may
be
found
on
page
16
of
the
Study
Report.

Work
Activities
Each
of
the
15
volunteers
was
monitored
for
both
inhalation
and
hand/
forearm
dermal
exposure
at
4
sampling
times
on
the
same
day
(
total
number
of
replicates
=
60)
.
Each
of
the
2
use
pattern
applications
(
rose
bushes/
shrubs
and
flower
beds)
was
conducted
by
volunteers
wearing
gloves.
Then
the
same
use
pattern
applications
were
conducted
by
the
same
volunteers
without
gloves.
Four
volunteers
were
monitored
on
each
of
the
first
three
days,
followed
by
the
monitoring
of
three
volunteers
on
the
fourth
day.
Prior
to
each
exposure
period,
volunteers
washed
their
hands
and
arms
with
soap
and
water.
Volunteers
were
asked
to
wear
a
fresh
set
of
clothes
to
minimize
possible
contamination.
For
the
first
three
sessions,
volunteers
wore
new
pairs
of
Tyvek
®
pants
over
their
clothes.
.
Due
to
heat,
some
of
the
volunteers
did
not
wear
Tyvek
®
trousers
on
their
fourth
application,
since
their
street
clothes
had
been
protected
during
the
three
prior
exposure
periods.
Only
exposure
data
from
the
30
replicates
who
did
not
wear
gloves
were
reported.

Essentially,
each
volunteer
carried
an
unopened
10
pound
container
of
1
percent
disulfoton
granules
to
the
application
location.
The
measuring
cap/
lid
was
removed,
and
the
desired
amount
poured
into
the
cap.
Shrubs
were
treated
by
spreading
16
ounces
of
granules
(
i.
e.
,
4
ounces
per
1
foot
of
shrub)
in
a
circle
around
each
shrub
 
s
base.
The
granules
were
then
incorporated
into
the
top
1­
2
inches
of
soil
using
a
new
garden
rake.
The
applicator
then
carried
the
product
container
to
the
next
shrub
and
repeated
the
procedure
(
pouring,
sprinkling,
incorporating)
.
After
all
10
shrubs
were
treated
the
applicator
replaced
the
measuring
cap
onto
the
container,
tightened
the
cap
and
returned
to
the
staging
area
for
the
hand/
forearm
wash
procedure.
Flower
beds
were
treated
by
sprinkling
4
ounces
of
granules
to
each
12
square
feet
of
the
flower
bed,
and
repeating
the
pouring
and
sprinkling
steps
until
the
whole
480
square
feet
of
area
was
covered.
Then
the
applicators
incorporated
the
granules
into
the
top
1­
2
inches
of
soil
using
a
new
garden
rake.
Finally,
each
volunteer
replaced
the
measuring
cap
and
returned
to
the
staging
area
with
their
closed,
empty
(
or
nearly
empty)
containers.
The
amount
applied
was
estimated
by
weighing
each
container
before
and
after
application.
Each
volunteer
applied
approximately
10.1
pounds
of
formulated
product
per
application,
or
about
40.4
pounds
overall
for
each
day.

The
study
author
included
a
table
briefly
noting
observations
made
of
each
worker
during
each
disulfoton
granule
application
(
see
page
19
of
the
Study
Report)
.
 
Some
volunteers
worked
upwind
while
applying
or
cultivating
the
product
and
did
not
enter
the
test
plot
bedding
area,
and
some
worked
downwind
while
applying
or
cultivating
the
product
or
worked
in
the
test
plot
bedding
area.
Overall,
volunteers
were
observed
working
in
the
test
plot
beds
more
when
working
with
the
shrubs
than
during
the
flower
bed
applications
since
they
worked
around
larger
plants
as
opposed
to
simulated
plants.
Some
volunteers
walked
in
treated
beds
to
rake,
at
least
one
volunteer
rubbed
their
eye
with
their
hands.
Some
volunteers
were
observed
wiping
sweat
from
their
face
with
their
forearms.
In
general,
the
author
stated
that
it
took
about
20
percent
more
time
to
apply
and
incorporate
disulfoton
granules
into
flower­
bed
soil.

Meteorology
and
Irrigation
The
test
sites
were
irrigated
once
the
evening
prior
to
each
day
 
s
exposure
monitoring,
and
again
during
the
lunch
break
on
the
first
day
of
exposure
monitoring
(
October
23,
2000)
.
Sprinkler
irrigation
was
used,
and
0.5
inches
of
water
was
applied
to
maintain
a
packed
surface
and
minimize
dust
cross­
contamination.

An
onsite
weather
station
was
set
up
at
the
test
site,
and
recorded
hourly
average
(
collected
at
1­
minute
intervals)
ambient
air
temperature,
relative
humidity,
wind
speed
and
wind
direction
on
each
8
application
day.
In
general,
meteorological
monitoring
was
conducted
between
approximately
8
AM
and
4
PM
(
ending
times
each
day
were
different)
.
Ambient
air
temperatures
ranged
between
69.6
E
F
and
83.3
E
F,
relative
humidity
ranged
between
51.9
and
92.9
percent,
and
wind
speeds
ranged
between
1.3
mph
and
8.9
mph.
For
the
first
three
days
of
exposure
monitoring,
wind
speeds
ranged
between
4.2
and
8.9
mph.
Therefore,
conditions
were
generally
windy.
No
historical
weather
data
were
provided
for
review.

Pesticide
Use
History
Paraquat
was
applied
once
to
the
flower
bed
plots
and
Roundup
®
was
applied
as
needed
to
both
plots,
prior
to
the
exposure
monitoring
dates,
to
control
unwanted
vegetation.
No
other
pesticide
use
history
information
was
provided.

Materials
and
Application
Method
The
product
used
in
the
study
was
EPA
Reg.
No.
3125­
517,
containing
10
pounds
granular
product,
packaged
as
a
plastic
container
with
a
measuring
cup/
lid.
The
product
contains
approximately
1
percent
disulfoton
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.
Application
was
made
by
pouring
the
product
into
the
measuring
cap/
lid
and
then
sprinkling
around
shrubs
or
on
flower­
bed
test
plots,
followed
by
soil
incorporation
using
a
garden
rake.

Sample
Collection
Personal
air
monitoring
samples
and
hand/
forearm
wash
samples
were
collected
in
this
study.

1.
Inhalation
Exposure
Samples
Personal
air
samples
were
collected
from
each
volunteer
using
OVS
tubes
containing
two
sections
(
140
mg/
270
mg)
of
XAD­
2
resin,
connected
via
plastic
tubing
to
Gilian
®
air
sampling
pumps
calibrated
to
an
approximate
flow
rate
of
2.
0
liters/
minute.
Pump
on­
and
off­
times
were
recorded.
There
were
a
total
of
60
breathing
zone
samples
collected,
reflecting
15
volunteer
subjects,
applying
disulfoton
to
both
shrub
and
flower
bed
test
plots,
with
and
without
gloves.
Again,
data
for
only
30
of
the
60
samples
were
reported.

2.
Dermal
Exposure
Samples
Exposure
to
the
hands
and
forearms
was
determined
by
detergent
washed
hand
and
foreaarm
solutions
collected
at
the
staging
area.

One
500
mL
aliquot
of
an
aqueous
solution
of
anionic
surfactant
(
i.
e.
sodium
dioctyl
sulfosuccinate
(
OTS)
­
0.01
percent
w/
v
in
distilled
water)
was
used
to
wash
subjects
 
hands
and
forearms.
As
reported
by
the
author:
 
The
volunteer
placed
his
hands
and
forearms
in
and
over
a
metal
container
while
an
investigator
slowly
poured
the
aliquot
of
OTS
over
them
ensuring
complete
contact
of
all
skin
surfaces.
At
the
end
of
sixty
seconds
of
the
volunteer
scrubbing
his/
her
hands
and
forearms
in
the
OTS,
the
solution
was
carefully
poured
into
a
labeled
glass
jar.
 
There
were
a
total
of
60
dermal
exposure
samples
collected,
reflecting
15
volunteer
subjects,
applying
disulfoton
to
both
shrub
and
flower
bed
test
plots,
with
and
without
gloves.
Data
for
only
30
of
the
60
samples
collected
overall
were
reported
(
i.
e.
,
the
no
glove
scenarios)
.

9
QA/
QC
Sample
Handling
&
Storage
Each
jar
of
OTS
skin
washing
solution
was
capped
with
a
Teflon
®
­
­
lined
lid,
heat
sealed
in
a
plastic
bag,
and
stored
in
freezer
conditions
until
shipment
to
the
laboratory.
Each
OVS
sample
was
capped
in
the
field
at
both
ends,
labeled,
placed
in
a
reclosable
plastic
bag,
and
placed
into
freezer
storage
until
shipment
to
the
laboratory.
Field
freezers
ranged
in
temperature
between
(
­
)
25.8
E
C
and
(
­
)
12.2
E
C.
Samples
were
packed
with
shock
insulators
and
shipped
frozen
on
dry
ice.
Air
samples
were
sent
on
October
26,
2000,
the
final
sampling
day.
All
samples
received
by
the
analytical
laboratory
were
stored
in
freezers
at
temperatures
ranging
between
(
­
)
26
E
C
and
(
­
)
10
E
C.

Sample
History
A
sample
history
table
was
not
provided.
Exposure
monitoring
took
place
on
four
days:
October
23,
24,
25,
and
26,
2000.
The
field
OVS
air
samples
were
received
at
the
analytical
laboratory
on
October
27,
2000.
Field
dermal
wash
samples
were
received
at
the
analytical
laboratory
on
November
7,
2000.
Raw
data
sheets
attached
to
the
analytical
report
included
some
sample
tracking
information.

Product
Analyses
Each
lot
of
test
substance
was
analyzed
for
purity
and
the
percentage
of
active
ingredient
was
verified.
The
Certificate
of
Analysis
was
provided
as
an
attachment
to
the
Study
Report.

Analytical
Methodology
It
appears
that
a
proprietary
method
was
used.
A
copy
of
the
method
was
not
included
in
the
study
report.

1.
OVS
Air
Sampling
Tubes
Tube
contents
were
analyzed
as
a
single
sample.
Disulfoton
was
desorbed
from
the
tube
contents
with
acetone.
The
acetone
extract
was
filtered,
diluted
to
an
appropriate
volume
in
acetone,
and
residues
quantified
via
GC/
FPD(
P)
.

2.
OTS
Dermal
Washing
Samples
Dermal
washing
samples
were
thawed,
mixed
with
an
equal
volume
of
methanol
(
500
mLs)
,
and
aliquots
were
cleaned
up
on
a
conditioned
C­
18
SPE
column.
The
analyte
was
eluted
from
the
column
with
acetone.
Disulfoton
residues
were
quantified
via
GC/
FPD(
P)
.

Chromatographic
conditions
are
listed
on
page
80
of
the
Study
Report.
The
method
employed
a
DB­
5MS
column
(
30M
x
0.25
mm,
0.25
µ
M
film
thickness)
.
Retention
time
for
disulfoton
was
about
6.7
minutes.
Calibration
standards
were
run
with
each
set,
at
levels
ranging
between
5
ng/
mL
and
250
ng/
mL.
Data
were
collected
using
the
Chrom
Perfect
for
Windows
®
(
(
CPWIN)
data
acquisition
system.
Data
were
imported
into
Quattro
Pro
®
spreadsheets
and
calculations
were
performed
using
Horizon
 
s
LINCURV4
®
calculation
program,
which
prepares
standard
curves
of
response
vs.
ng/
mL
using
least
squares
regression.
This
system
was
validated
on
each
computer
with
a
model
data
set
prior
to
each
day
 
s
run.

10
Limits
of
Detection
(
LOD)
&
Limits
of
Quantitation
(
LOQ)

The
LOD
was
not
defined.
The
reported
LOQs
were
0.3
µ
g/
air
sampling
tube,
and
1.5
µ
g/
dermal
wash
sample.
The
basis
for
the
determination
of
LOQ
was
not
reported.

Concurrent
Laboratory
Recovery
Field
samples
were
analyzed
in
sets
containing
from
12
to
20
samples
each.
Laboratory
controls
were
included
in
each
set.
These
fortified
controls
were
fortified
at
4
levels
as
follows:
untreated,
LOQ,
10X
LOQ
and
100X
LOQ.
A
summary
of
the
results
is
presented
on
page
92
of
the
Study
Report.
The
overall
mean
percent
recovery
of
concurrent
laboratory
fortifications
from
OVS
air
sampling
tubes
was
99.9
±
6.42
percent
(
N=
15)
.
The
overall
mean
percent
recovery
from
hand/
forearm
wash
solution
was
99.
5
±
9.15
percent
(
N=
24)
.

Five
out
of
the
8
untreated
control
air
sampling
tube
samples
contained
apparent
disulfoton
residues
greater
than
zero.
The
residues
were
less
than
10
percent
of
the
LOQ,
and
the
authors
state
that
this
residue
had
a
negligible
effect
on
recoveries
at
any
level.
Laboratory
recovery
samples,
but
not
field
fortification
samples,
were
corrected
for
residues
found
in
the
companion
untreated
control
samples.
No
residue
in
any
field
sample
was
corrected
for
laboratory
fortification
recoveries.

No
disulfoton
residues
were
detected
in
any
of
the
untreated
hand/
forearm
wash
control
solutions.

Field
Fortification
Recovery
Fortified
disulfoton
solutions
and
pre­
fortified
sorbent
OVS
tubes
were
prepared
by
Horizon
Laboratories,
and
then
shipped
on
dry
ice
overnight
to
the
field
facility,
where
they
were
also
kept
frozen.

Field­
fortified
controls
were
prepared
once
each
day
of
exposure
monitoring
(
i.
e.
,
four
times)
.
They
were
prepared
at
the
test
site
staging
area,
near
to
the
test
sites,
but
away
from
possible
contamination.
Specifically,
a
vial
of
fortification
solution
was
uncapped
and
the
entire
vial
(
contents
plus
container)
was
dropped
into
a
500
mL
aliquot
of
OTS
solution.
Pre­
fortified
OVS
air
sampling
tubes
were
brought
to
ambient
temperature
in
the
field,
connected
to
a
multiport
pump
and
manifold
system
and
the
pump
was
run
for
the
approximate
length
of
a
replicate
exposure
period
at
2.0
liters
per
minute.

Five
replicates
of
each
exposure
matrix
were
fortified
on
each
of
the
four
monitoring
days,
at
three
fortification
levels.
For
dermal
wash
samples,
the
fortification
levels
were
1.5,
15,
and
150
µ
g/
sample,
and
for
the
air
samples
the
fortification
levels
were
0.3,
3
and
30
µ
g/
sample.
The
field
fortification
samples
were
packaged,
stored,
and
shipped
under
the
same
environmental
conditions
as
the
field
samples.

For
air
samples,
the
overall
average
fortified
field
recovery
was
98.2
±
6.32
percent
(
N=
62)
with
no
apparent
differences
in
mean
recoveries
between
days
or
fortification
levels.
Table
1
summarizes
field
recoveries
by
fortification
level.
No
measurable
disulfoton
was
measured
in
any
field
fortification
untreated
control
sample
except
for
one
sample
which
had
a
reading
of
0.022
F
g
(
<
LOQ)
.

For
hand/
forearm
wash
samples
collected
from
volunteers
who
did
not
wear
gloves,
5
of
30
samples
were
less
than
LOQ.
The
highest
level
of
disulfoton
found
in
any
sample
was
36
µ
g/
sample.
Therefore,
the
fortification
levels
analyzed
covered
the
full
range
of
field
sample
levels.
Overall
field
fortified
recovery
for
these
samples
was
99.4
±
7.95
percent
(
(
N=
36)
with
no
apparent
differences
in
recovery
values
between
days.
As
noted
by
the
author,
there
was
a
slight
trend
towards
increased
mean
recovery
values
as
the
disulfoton
11
concentration
increased,
however,
all
recovery
values
were
well
within
guideline
specifications
(
i.
e.
,
70
to
120
percent)
.
Table
1
presents
a
summary
of
field
fortifications
recoveries
by
fortification
level.
No
measurable
disulfoton
residue
was
measured
in
any
field
fortification
untreated
control
hand
wash
sample.

Table
1.
Summary
of
Field
Fortification
Recoveries
Sample
Fortification
Level
Average
Recovery
(
Percent)

Day
1
Day
2
Day
3
Day
4
Air
Sampling
Tubes
0.3
F
g
95.7
±
5.26
(
N
=
5)
96.0
±
4.38
(
N
=
3)
97.2
±
4.54
(
N
=
3)
98.4
±
2.86
(
N
=
3)

3.0
F
g
105
±
2.60
(
N
=
5)
103
±
3.45
(
N
=
3)
103
±
2.48
(
N
=
3)
99.9
±
0.500
(
N
=
3)

30
F
g
94.0
±
11.4
(
N
=
5)
91.8
±
7.42
(
N
=
3)
102
±
2.13
(
N
=
3)
93.5
±
2.88
(
N
=
3)

Dermal
Wash
Solution
1.5
F
g
92.1
±
5.65
(
N
=
3)
96.8
±
2.75
(
N
=
3)
91.8
±
5.14
(
N
=
3)
92.0
±
3.69
(
N
=
3)

15
F
g
104
±
2.92
(
N
=
3)
104
±
4.70
(
N
=
3)
94.3
±
16.1
(
N
=
3)
97.7
±
9.96
(
N
­
3)

150
F
g
107
±
0.907
(
N
=
3)
108
±
1.75
(
N
=
3)
101
±
4.09
(
N
=
3)
105
±
2.90
(
N
=
3)

Storage
Stability
Recovery
No
storage
stability
samples
were
prepared.
Instead,
the
authors
relied
on
field
recovery
samples,
which
were
handled
and
analyzed
in
conjunction
with
the
field
test
samples.

Results
Tables
2
and
3
summarize
the
exposure
monitoring
results
by
replicate
for
application
to
shrubs
and
flower
beds,
respectively.
All
of
the
inhalation
exposure
data
were
either
non­
detect
or
less
than
the
LOQ.
Possible
reasons
for
these
finding
include:
1)
disulfoton
is
not
volatile,
and
the
formulation
used
was
granular;
2)
samples
were
collected
on
sorbent
tubes;
3)
the
exposure
periods
were
very
brief,
ranging
between
18
and
38
minutes;
and
4)
samples
were
collected
outdoors
under
rather
windy
conditions
and
small
air
volumes
were
collected,
ranging
between
36
and
76
liters
per
sample.

12
Table
2.
Summary
of
Exposure
Data
By
Replicate
­
Shrub
Application
Volunteer
Body
Weight
(
kg)
Formulation
Applied
(
lb
ai)
rounded
Hours
Worked
Air
Volume
(
Liters)
Inhalation
Exposure
(
F
g/
sample)
Hand/
Forear
m
Exposure
(
F
g/
sample)

1
68
0.
1
0.35
42
ND
13.40
2
66
0.
1
0.30
36
<
LOQ
30.20
3
114
0.1
0.
32
38
<
LOQ
18.70
4
64
0.
1
0.38
46
<
LOQ
15.00
5
66
0.
1
0.45
54
ND
3.53
6
73
0.
1
0.40
48
ND
17.20
7
57
0.
1
0.45
54
<
LOQ
4.51
8
55
0.
1
0.38
46
<
LOQ
1.63
9
59
0.
1
0.38
46
ND
9.46
10
70
0.1
0.
37
44
ND
36.00
11
80
0.1
0.
35
42
<
LOQ
4.
11
12
132
0.1
0.
35
42
ND
24.50
13
66
0.1
0.
40
48
<
LOQ
1.
39
14
102
0.1
0.
48
58
ND
6.
99
15
77
0.1
0.
37
44
ND
16.10
Arithmetic
Mean
­
­
­
­
­
12.9
Standard
Deviation
­
­
­
­
­
10.0
Coefficient
of
Variance
­
­
­
­
­
78
percent
LOQ
=
0.3
F
g/
air
sampling
tube
(
½
LOQ
or
0.15
F
g
was
assigned
to
values
<
LOQ
or
ND)

13
Table
3.
Summary
of
Exposure
Data
By
Replicate
­
Flower
Bed
Application
Volunteer
Body
Formulation
Hours
Air
Volume
Inhalation
Hand/
Forear
Weight
(
kg)
Applied
(
lb
ai)
(
rounded)
Worked
(
Liters)
Exposure
(
F
g/
sample)
m
Exposure
(
F
g/
sample)

1
68
0.
1
0.37
44
<
LOQ
<
LOQ
2
66
0.
1
0.42
50
<
LOQ
2.94
3
114
0.1
0.
33
40
<
LOQ
1.
88
4
64
0.
1
0.37
44
<
LOQ
20.60
5
66
0.
1
0.63
76
<
LOQ
8.45
6
73
0.
1
0.57
68
<
LOQ
<
LOQ
7
57
0.
1
0.53
64
<
LOQ
<
LOQ
8
55
0.
1
0.67
80
<
LOQ
<
LOQ
9
59
0.
1
0.47
56
<
LOQ
4.24
10
70
0.1
0.
40
48
<
LOQ
5.
00
11
80
0.1
0.
42
50
<
LOQ
12.10
12
132
0.1
0.
43
52
<
LOQ
3.
16
13
66
0.1
0.
45
54
<
LOQ
11.90
14
102
0.1
0.
52
62
<
LOQ
<
LOQ
15
77
0.1
0.
45
54
<
LOQ
8.
20
Arithmetic
Mean
­
­
­
­
0.15
5.4
Standard
Deviation
­
­
­
­
­
5.8
Coefficient
of
Variance
­
­
­
­
­
106
percent
LOQ
=
0.3
F
g/
air
sampling
tubes
(
½
LOQ
or
0.15
F
g
was
assigned
to
values
<
LOQ)
LOQ
=
1.5
F
g/
dermal
wash
(
½
LOQ
or
0.75
F
g
was
assigned
to
values
<
LOQ
for
calculation
of
mean)

Most
of
the
hand/
forearm
dermal
washing
samples
returned
residue
levels
greater
than
the
LOQ.
All
of
the
samples
collected
while
subjects
treated
oleander
shrubs
were
positive,
ranging
from
1.
39
to
36
µ
g/
sample
(
N=
15)
.
Ten
of
15
samples
collected
while
subjects
treated
flowerbeds
were
positive.
For
those
10
positive
samples,
values
ranged
between
1.88
to
20.6
µ
g/
sample.
The
author
reported
that
the
time
it
took
to
treat
shrubs
ranged
between
18
and
29
minutes.
The
time
that
it
took
to
treat
flowerbeds
ranged
between
20
and
40
minutes;
five
of
these
exposure
periods
exceeded
the
maximum
29
minutes
it
took
to
treat
a
shrub
sub­
plot.

Tables
4
and
5
present
the
exposure
data
in
unit
exposure
values,
normalized
to
pounds
active
ingredient
per
amount
handled
per
sampling
period,
and
pounds
active
ingredient
per
amount
handled
per
hour,
and
pounds
active
ingredient
per
amount
handled
per
kilogram
body
weight
per
sampling
period.
These
values
were
calculated
by
Versar.
An
inhalation
unit
exposure
volume
was
not
determined
for
shrub
plot
applications
because
no
numerical
value
was
assigned
in
the
report
to
non­
detect
values.
In
the
risk
assessment
accompanying
the
Study
Report
(
MRID
453334­
02)
the
registrant
using
a
value
of
30
percent
of
the
LOQ
(
0.09
F
g)
for
non­
detects.

14
Table
4.
Unit
Exposure
Values
­
Shrubs
Type
mg/
lb
ai
mg/
hour
e
mg/
kg/
sampling
period
f
Dermal
a,
d
Inhalation
b,
c
Dermal
a
Inhalation
b
Dermal
a
Inhalation
b
Arithmetic
Mean
0.14
0.013
0.038
0.0004
0.0002
0.0000055
Std.
Dev.
0.11
0.000079
0.032
0.00005
0.00018
0.0000013
Geo
Mean
0.092
0.013
0.024
0.0004
0.00013
0.0000053
25th
%
tile
0.043
0.012
0.011
0.00038
0.000061
0.0000051
75th
%
tile
0.18
0.013
0.051
0.00043
0.00024
0.0000062
90th
%
tile
0.27
0.013
0.086
0.00045
0.00049
0.0000070
95th
%
tile
0.32
0.013
0.098
0.00048
0.00053
0.0000073
99th
%
tile
0.35
0.013
0.10
0.0005
0.00056
0.0000075
LOQ
=
0.3
F
g/
air
sampling
tube
LOQ
=
1.5
F
g/
dermal
wash
A
respiratory
rate
of
16.7
L/
min
was
assumed,
based
on
the
draft
NAFTA
recommended
inhalation
rates.
a
The
unit
exposure
value
is
base
on
data
where
some
values
are
<
LOQ
b
The
unit
exposure
value
is
based
on
data
where
all
values
are
<
LOQ.
Inhalation
unit
exposure
(
mg/
lb
ai)
=
[
residue
(
F
g*
0.001)
/
air
volume
(
l)
]
*
16.7
l/
min(
minute
volume
of
human)
*
minutes
worked
/
pounds
ai
handled.
d
residue
(
F
g*
0.001)
/
pounds
ai
handled
e
residue
(
F
g*
0.001)
/
hours
worked
f
residue
(
F
g*
0.001)
/
body
weight/
hours
worked
Table
5.
Unit
Exposure
Values
­
Flower
Beds
Type
mg/
lb
ai
mg/
hour
e
mg/
kg/
sampling
period
f
Dermal
a,
d
Inhalation
b,
c
Dermal
a
Inhalation
b
Dermal
a
Inhalation
b
Arithmetic
Mean
0.054
0.013
0.013
0.00033
0.000079
0.0000045
Std.
Dev.
0.058
0.0000829
0.015
0.000065
0.000087
0.0000011
Geo
Mean
0.030
0.013
0.0066
0.00033
0.00044
0.0000044
25th
%
tile
0.0075
0.012
0.0017
0.00029
0.00015
0.0000038
75th
%
tile
0.083
0.013
0.016
0.00037
0.00012
0.0000054
90th
%
tile
0.12
0.013
0.028
0.00041
0.00017
0.0000057
95th
%
tile
0.15
0.013
0.037
0.00042
0.00022
0.0000061
99th
%
tile
0.19
0.013
0.052
0.00045
0.0003
0.0000063
LOQ
=
0.3
F
g/
air
sampling
tube
LOQ
=
1.5
F
g/
dermal
wash
A
respiratory
rate
of
16.7
L/
min
was
assumed,
based
on
the
draft
NAFTA
recommended
inhalation
rates.
a
The
unit
exposure
value
is
base
on
data
where
some
values
are
<
LOQ
b
The
unit
exposure
value
is
based
on
data
where
all
values
are
<
LOQ.
c
Inhalation
unit
exposure
(
mg/
lb
ai)
=
[
residue
(
F
g*
0.001)
/
air
volume
(
l)
]
*
16.7
l/
min(
minute
volume
of
human)
*
minutes
worked
/
pounds
ai
handled.
d
residue
(
F
g*
0.001)
/
pounds
ai
handled
e
residue
(
F
g*
0.001)
/
hours
worked
f
residue
(
F
g*
0.001)
/
body
weight/
hours
worked
15
c
Compliance
Checklist
s
Compliance
with
OPPTS
Series
875,
Occupational
and
Residential
Exposure
Test
Guidelines
is
critical.
The
itemized
checklist
below
outlines
compliance
with
the
major
technical
aspects
of
OPPTS
Group
A:
875.1300,
Inhalation
Exposure
­
­
Outdoor
and
875.1100,
Dermal
Exposure
­
­
Outdoor,
as
they
relate
to
the
study.

C
Typical
end
use
product
of
the
active
ingredient
used.
This
criterion
was
met.

C
End
use
product
handled
and
applied
using
recommended
equipment,
application
rates,
and
typical
work
practices.
It
is
uncertain
whether
this
criteria
was
met.
The
application
technique
employed
in
this
study
might
not
represent
the
typical
method
of
application
of
granular
pesticide
to
rose
bushes
or
shrubs.
It
is
likely
that
a
homeowner
could
apply
the
product
while
on
hands
and
knees
and
reaching
underneath
foliage
(
with
hands
or
hand
trowel)
to
reach
the
base
of
the
plant.
If
this
work
practice
was
assessed,
additional
dermal
monitoring
would
be
required
in
order
to
adequately
characterize
potential
dermal
exposure
(
i.
e.
,
exposure
to
knees,
upper
and
lower
legs,
and
feet)
.

C
A
minimum
of
five
replicates
each
at
a
minimum
of
three
different
sites
are
to
be
employed.
This
criterion
was
met.

C
Dermal
and/
or
inhalation
exposure
should
be
monitored
by
validated
methodologies.
This
criterion
was
met.

C
There
should
be
a
minimum
of
one
field­
fortified
sample
per
worker
per
monitoring
period
for
each
fortification
level,
plus
unfortified
field
blanks
.
This
criterion
was
met.

C
The
efficiency
of
extraction
of
hand
rinses
conducted
in
one
solvent
with
subsequent
partition
into
a
second
solvent
for
analysis
should
be
determined
.
This
criterion
was
met.
Method
validation,
laboratory
and
field­
fortified
recovery
values
were
satisfactory.

C
The
stability
of
the
analyte
of
interest
in
the
medium
of
interest
must
be
determined
.
This
criterion
was
met
as
demonstrated
by
satisfactory
field
fortification
recoveries.

C
The
following
information
should
be
reported
for
agricultural
applications,
yards,
gardens:
(
1)
description
of
the
crop,
plot
size,
row
spacing;
(
2)
description
of
application
(
including
rate,
type
of
formulation,
tank
capacity,
type
of
carrier,
final
mix
concentration,
total
pounds
active
ingredient
applied
or
mixed)
;
(
3)
description
of
application
equipment
(
type,
model)
;
(
4)
weather
data:
relative
humidity,
wind
speed,
wind
direction,
and
temperature;
(
5)
work
activity
monitored;
(
6)
exposure
observations;
(
7)
exposure
time
.
These
criteria
were
met.

C
After
collection,
field
samples
should
be
stored
immediately
in
a
freezer
pending
further
treatment.
This
criterion
was
met.

C
A
sample
history
sheet
should
be
included
in
the
report,
tracking
sample
number,
date
of
collection,
date
of
extraction,
date
of
analysis,
and
identification
of
who
participated
in
each
stage
.
This
criterion
was
partially
met.
While
a
history
sheet
as
such
was
not
provided,
most
of
the
information
was
available
in
the
report.

16
C
Clothing
worn
by
each
study
participant
should
be
thoroughly
described.
This
criterion
was
not
met.
The
author
states
that
 
for
the
first
three
sessions,
volunteers
wore
new
pairs
of
Tyvek
®
pants
over
their
clothes
 
.
The
other
clothing
worn
by
study
participants
(
e.
g.
,
long
sleeved
vs.
short
sleeved
shirt)
is
described
only
as
 
fresh
set
of
clothes
 
and
 
street
clothes
 
.

C
Quantity
of
active
ingredient
handled
and
duration
of
monitoring
period
should
be
reported
for
each
replication.
This
criterion
was
met.

C
Testing
should
include
at
least
one
field
fortification
sample
per
worker
per
monitoring
period
per
fortification
level
for
each
matrix
should
and
at
least
one
field
blank
per
worker
per
monitoring
period
for
each
matrix.
This
criterion
was
met.

C
Efficiency
of
extraction
in
laboratory
provided
as
a
mean
plus
or
minus
one
standard
deviation.
This
criterion
was
met.

C
The
analytical
method
for
inhalation
monitoring
should
be
sufficiently
sensitive
so
that,
coupled
with
the
trapping
and
extraction
procedures
chosen,
it
is
capable
of
measuring
exposure
to
1
µ
g/
hour
(
or
less)
.
This
criterion
was
met.
The
LOQ
for
the
method
was
0.3
µ
g/
sample.
Samples
were
collected
on
OVS­
XAD
sorbent
tubes.
Exposure
periods
ranged
between
18
and
38
minutes,
and
were
collected
at
2
liters/
minute,
yielding
sample
volumes,
ranging
between
36
and
76
liters
per
sample.

C
To
ensure
that
collected
material
is
not
lost
from
the
medium
during
sampling,
the
investigator
should
also
test
for
breakthrough
.
This
criterion
was
not
met.
The
investigator
did
not
test
for
breakthrough
to
ensure
that
collected
material
was
not
lost.

C
If
trapping
media
are
to
be
stored
after
exposure,
a
test
for
the
storage
stability
of
the
compound
should
be
documented.
The
time
periods
for
storage
are
to
be
chosen
so
that
the
longest
corresponds
to
the
longest
projected
storage
period
for
field
samples
.
This
criterion
was
met.
Field­
fortified
recovery
samples
analyzed
at
about
the
same
time
as
the
field
samples
indicated
satisfactory
storage
stability.

C
Applicator
 
s
inhalation
exposure
should
be
measured
with
battery­
powered
personal
monitoring
pumps
capable
of
producing
an
airflow
of
at
least
2
liters
per
minute
and
pump
batteries
should
be
capable
of
sustaining
maximum
airflow
for
at
least
4
hours
without
recharging.
This
criterion
was
met.

C
The
intake
tube
of
any
pump­
powered
sampler
unit
should
be
positioned
so
that
the
opening
is
downward.
The
intake
tube
should
be
placed
as
near
as
possible
to
the
nose
level
of
the
test
subject
.
It
is
not
known
whether
these
criteria
were
met,
as
these
details
were
not
reported.
The
author
did,
however,
state
that
monitoring
occurred
in
the
breathing
zone.

C
Calibration
data
for
air
sampling
pumps
should
be
provided.
If
the
air
flow
has
been
found
to
change,
the
mean
flow
should
be
used
for
all
calculations
.
This
criterion
was
not
met.
Calibration
data
for
air
sampling
pumps
was
not
provided.

The
following
additional
items
of
concern
have
been
noted:

The
field
fortification
samples
were
prepared
using
liquid
disulfoton.
Although
it
is
difficult
to
prepare
granular
field
spikes,
there
is
no
known
way
to
compare
the
recovery
results
to
recoveries
of
a
granular
formulation.
The
significance
of
this
difference
is
therefore
unknown.

17
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
study,
as
both
real
plants
and
simulated
plants
were
used:

Use
of
Simulated
Plants:
The
Agency
prefers
that
the
study
use
real
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.
.

18
