Page
1
of
39
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
May
20,
2004
Memorandum
SUBJECT:
Review
of
"
Evaluation
of
the
Potential
Exposure
of
Workers
to
Propanil
During
Mixing/
Loading
and
Aerial
Application
to
Rice
Fields
Using
Simultaneous
Dermal
Dosimetry
and
Biological
Monitoring
Techniques"

FROM:
Shanna
Recore,
Industrial
Hygienist
Bill
Smith,
Environmental
Protection
Specialist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)

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

TO:
Carmen
Rodia,
Chemical
Review
Manager
Reregistration
Branch
Special
Review
and
Reregistration
Division
(
7508C)

DP
Barcode:
293906
PC
Code:
028201
EPA
MRID
No.:
460755­
01
Attached
is
a
review
of
the
propanil
data
from
mixing/
loading
and
aerial
application
to
rice
fields
using
simultaneous
dermal
dosimetry
and
biological
monitoring
techniques
submitted
by
The
Propanil
Task
Force
II.
This
review
was
completed
by
Versar,
Inc.
on
May
18,
2004,
under
supervision
of
HED.
It
has
undergone
secondary
review
in
HED
and
has
been
revised
to
reflect
Agency
policies.
The
data
collected
meets
some
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:
Guidelines,
875.1200
(
dermal)
and
875.1400
(
inhalation).
Page
2
of
39
Reviewers:
Kelly
McAloon/
Sally
McDonald
Date:
May
18,
2004
STUDY
TYPE:
Mixer/
Loader
and
Pilot
Passive
Dosimetry
Study
Using
Passive
Dosimetry
plus
Personal
Air
Sampling
and
Biomonitoring
Study
Using
Urinalysis
TEST
MATERIAL:
Propanil
is
a
herbicide
used
to
control
weedy
grasses
in
rice.
Five
product
formulations
were
used
in
this
study:
Stam
M4
Herbicide,
Arrosolo
®
3­
3E,
Blue
Drum
®
Propanil,
Duet
®
CA,
and
Super
Wham
®
.
Each
formulation
was
an
emulsifiable
concentrate.

SYNONYMS:
propanil,
3,4­
dichloropropionanilide
CITATION:
Authors/
Study
Director:
Richard
C.
Honeycutt,
PhD.
Title:
Evaluation
of
the
Potential
Exposure
of
Workers
to
Propanil
During
Mixing/
Loading
and
Aerial
Application
to
Rice
Fields
Using
Simultaneous
Dermal
Dosimetry
and
Biological
Monitoring
Techniques
Report
Date:
September
13,
2003
Testing
Facility:
H.
E.
R.
A.
C.,
Inc.
220­
1
Swing
Road
Greensboro,
North
Carolina
27409
Analytical
Facility:
EN­
CAS
Analytical
Laboratories
2359
Farrington
Point
Drive
Winston
Salem,
NC
27107
Identifying
Codes:
H.
E.
R.
A.
C.,
Inc.
Study
Number:
03­
01HE
SPONSOR:
Propanil
Task
Force
II
c/
o
Edward
M.
Ruckert,
Chairman
McDermott,
Will
&
Emery
600
13th
Street
N.
W.
Washington,
DC
20003­
3096
EXECUTIVE
SUMMARY:

The
purpose
of
this
study
was
to
quantify
inhalation
and
dermal
exposure
of
handlers
during
mixing/
loading
and
aerial
application
of
propanil
to
rice
fields.
The
following
formulations
were
included
in
the
study:
Stam
M4
Herbicide
(
containing
44.8%
active
ingredient
(
a.
i.)),
Arrosolo
®
3­
3E
(
containing
33.1%
a.
i.),
Blue
Drum
®

Propanil
(
containing
43.5%
a.
i.),
Duet
®
CA
(
containing
41.2%
a.
i.),
and
Super
Wham
®
(
containing
41.2%
a.
i.).
The
sites
for
this
study
were
Texas,
Louisiana,
and
Arkansas,
with
multiple
sites
in
each
state.
Thirty
individuals
participated
in
the
study
at
eleven
test
sites
(
15
mixer/
loaders,
14
pilots,
and
1
combined
mixer/
loader/
pilot).
The
average
amount
of
active
ingredient
handled
was
556
pounds
for
mixers/
loaders
and
416
pounds
for
pilots.
The
average
duration
of
each
replicate
was
2.2
hours
for
mixers/
loaders
and
1.7
hours
for
pilots.
Page
3
of
39
The
study
author
indicates
that
the
study
design
employs
a
"
commonly
used
technique
of
simultaneous
dosimetry
and
biological
monitoring."
The
technique
involves
the
use
of
an
outer
dosimeter
(
long­
sleeve
shirt
and
long
pants)
worn
over
an
inner
dosimeter
(
tee
shirt
and
briefs).
The
author
states
that
this
dosimetry
design
"
allows
for
penetration
of
the
propanil
residues
through
the
clothing
as
would
occur
under
normal
field
agricultural
practices,
and
does
not
block
the
penetration
of
propanil
through
the
skin
as
would
occur
if
a
long
underwear
whole
body
dosimeter
were
worn
under
the
long­
sleeve
shirt
and
long
pants."
The
study
author
does
not
indicate
what
effect
a
chemical­
resistant
apron
or
Tyvek
coveralls
worn
by
mixers/
loaders
over
the
"
outer"
dosimeter
would
have
on
either
the
passive
dosimetry
or
biological
monitoring.

In
the
study,
dermal
exposure
was
estimated
through
passive
dosimetry
using
hand
washes
and
hat
patches
and
by
the
use
of
an
"
outer"
dosimeter
for
the
torso,
arms,
and
legs
and
an
"
inner"
dosimeter
for
the
torso.
The
study
author
compared
the
residues
on
the
inner
dosimeter
to
the
torso
residues
on
the
outer
dosimeter
and
derived
a
"
protection
factor"
attributable
to
the
outer
dosimeter.
Dermal
exposure
to
the
torso,
arms,
and
legs
was
then
estimated
by
applying
the
protection
factor
to
the
outer
dosimeter
residues.
Total
dermal
exposure
was
calculated
by
adding
the
adjusted
torso,
arms,
and
legs
exposure
to
the
hand
exposure
values
and
head/
face/
neck
exposure
values.
Inhalation
exposure
was
measured
using
personal
air
samplers.
The
study
author
provided
exposure
values
expressed
in
micrograms
per
kilogram
of
handler
body
weight
per
day
(:
g/
kg
body
weight/
day)
and
micrograms
per
kilogram
active
ingredient
handled
per
day
(:
g/
kg
a.
i./
day).
Total
exposure
was
calculated
by
the
study
author
by
summing
the
internal
inhalation
dose
(
assuming
100%
lung
absorption
of
the
inhalation
exposure)
and
the
internal
dermal
dose
(
assuming
20%
dermal
absorption
of
the
dermal
exposure).

In
the
study,
total
exposure
was
also
calculated
using
biomonitoring
through
analysis
of
the
handlers'
urine
for
3,4­
dichloroaniline
(
3,4­
DCA),
which
the
study
author
cites
as
the
major
metabolite
of
propanil.
The
study
author
reported
exposures
of
54.7
±
120
:
g/
kg
ai/
day
for
mixer/
loaders
and
35.5
:
g/
kg
ai/
day
for
pilots.
For
both
mixer/
loaders
and
pilots,
the
exposure
values
obtained
from
biomonitoring
are
much
higher
than
those
obtained
from
whole
body
dosimetry.
The
study
author
did
not
provide
an
explanation
for
this
discrepancy.

Versar
calculated
a
mean
potential
inhalation
unit
exposure,
in
micrograms
per
pounds
active
ingredient
handled
(:
g/
lb
ai
handled),
as
per
EPA's
request.
The
mean
inhalation
unit
exposure
for
mixers/
loaders
is
1.37E­
02
:
g/
lb
ai
handled,
for
pilots
is
2.04E­
03
:
g/
lb
ai
handled,
and
for
the
mixer/
loader/
pilot
is
6.94E­
04
:
g/
lb
ai
handled.
Versar
also
calculated
a
mean
potential
dermal
unit
exposure
of
1.27E­
03
mg/
lb
ai
handled
for
pilots.
Versar
has
not
calculated
a
mean
potential
dermal
unit
exposure
for
mixers/
loaders
or
for
the
mixer/
loader/
applicator,
since
appropriate
dermal
exposure
values
for
the
torso,
arms,
and
legs
could
not
be
determined
for
these
handlers
in
this
study.

The
study
met
some
of
the
Series
875.1200
and
875.1400
Guidelines.
However,
there
were
major
issues
of
concern,
including:

(
1)
Mixers/
loaders
in
the
study
wore
either
a
chemical­
resistant
apron
or
a
Tyvek
coverall
over
the
"
outer"
dosimeter
and
also
wore
chemical­
resistant
footwear.
In
calculating
potential
dermal
exposures
to
mixers/
loaders,
the
study
author
does
not
factor
in
this
additional
personal
protective
equipment,
which
exceeds
the
requirements
of
the
product
labeling;
(
2)
The
study
states
that
most
mixers/
loaders
used
a
siphoning
device
to
transfer
the
propanil
from
the
drum
into
the
mix
tank
and
then
used
a
dry­
lock
system
(
an
engineering
control)
to
pump
the
dilute
mixture
into
the
airplane
spray
tank.
This
would
result
in
artificially
low
mixer/
loader
exposures
due
to
the
use
of
the
engineering
control
in
part
of
the
mix/
load
process.
(
3)
The
average
duration
of
each
replicate
was
2.2
hours
for
mixers/
loaders
and
1.7
hours
for
pilots,
rather
than
the
usual
4­
5
hour
replicate
expected
in
handler
exposure
studies;
(
4)
The
average
application
rate
used
in
the
study
was
approximately
3
pounds
active
ingredient
per
acre,
rather
than
the
label
maximum
of
6
pounds
active
ingredient
per
acre
on
the
STAM­
M4
label;
(
5)
Trapping
efficiency
tests
for
the
air
monitoring
media
chosen
were
not
documented;
(
6)
There
was
no
mention
of
breakthrough
tests
being
run
on
the
air
filters;
(
7)
No
information
was
provided
on
how
the
air
filters/
tubes
were
stored
after
sample
collection;
Page
4
of
39
(
8)
There
was
no
mention
of
preliminary
hand
rinse
studies;
and
(
9)
It
was
not
mentioned
if
a
sample
history
sheet
had
been
prepared
by
the
laboratory
upon
receipt
of
samples.

COMPLIANCE:
A
signed
and
dated
Data
Confidentiality
statement
was
provided.
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
stated
that
the
study
was
conducted
under
EPA
Good
Laboratory
Practice
Standards
(
40
CFR
Part
160),
with
certain
exceptions.
The
deviations
identified
were
that:
(
1)
the
test
substance
was
not
characterized
prior
to
the
initiation
of
the
study
since
a
commercial
product
was
used
in
the
study;
(
2)
creatinine
analyses
in
urine
samples
were
not
performed
under
GLPs;
(
3)
the
wind
meter
used
to
determine
wind
speed
at
the
test
sites
was
not
calibrated;
(
4)
the
airplane
used
to
apply
the
test
substance
was
not
calibrated
prior
to
use
on
4/
3/
03,
but
was
calibrated
prior
to
its
use
on
4/
14/
03
and
all
other
airplanes
used
were
calibrated
prior
to
use;
(
5)
the
generation
of
the
data
and
the
writing
of
the
report
on
the
modeling
of
urine
excretion
of
3,4­
DCA
from
the
handlers
was
not
performed
under
GLPs;
and
(
6)
the
tags
on
the
urine
collection
containers
were
not
filled
out
by
the
test
subject
under
GLPs.

GUIDELINE
OR
PROTOCOL
FOLLOWED:
A
study
protocol
was
provided.
OPPTS
Series
875,
Occupational
and
Residential
Exposure
Test
Guidelines,
Group
A:
875.1200
(
dermal
exposure­
indoor
handler),
and
875.1400
(
inhalation
exposure­
indoor
handler)
were
followed
for
the
compliance
review
of
this
study.

I.
MATERIALS
AND
METHODS
A.
MATERIALS
1.
Test
Material:

Formulation:
Stam
M4
Herbicide:
44.8%
active
ingredient
(
a.
i.)
Arrosolo
®
3­
3E:
33.1%
a.
i.
Blue
Drum
®
Propanil:
43.5%
a.
i.
Duet
®
CA:
41.2%
a.
i.
Super
Wham
®
:
41.2%
a.
i.
Lot/
Batch
#
technical:
Not
provided.
Lot/
Batch
#
formulation:
The
Study
Report
provided
lot
numbers
of
the
test
substances
used
at
each
specific
test
site.
(
See
Table
1A
of
Study
Report.)
Purity
in
technical:
Not
provided.
Reference
Substances:
Stam
M4:
Lot/
Batch
No.:
TSN104109
(
45.6%
a.
i.)
Propanil:
Lot/
Batch
No.:
STRL­
99­
AG­
005
(
99.61%
a.
i.)
3,4­
dichloroaniline:
Lot/
Batch
No.:
287­
74A
(
99.5%
a.
i.)
The
certificate
of
analysis
of
the
reference
substance
is
provided
in
Appendix
B
of
the
study.
Other
Relevant
Information:
CAS
No:
709­
98­
8
2.
Relevance
of
Test
Material
to
Proposed
Formulation(
s):

The
test
materials
used
in
this
study
were
the
same
formulations
available
for
commercial
use.
Page
5
of
39
3.
Packaging:

The
packaging
of
the
test
product
was
not
reported
in
the
study.

B.
STUDY
DESIGN
There
were
thirteen
amendments
and
forty
deviations
to
the
study
protocol.
The
amendments
included:
(
1)
clarifying
the
analytical
work
associated
with
the
study,
(
2)
clarifying
the
definition
of
sites
and
sub­
sites,
(
3)
defining
loading
time
as
the
time
"
from
when
the
first
load
is
started
until
the
last
load
is
finished"
and
application
time
as
the
time
"
from
when
the
plane
leaves
the
loading
site
until
it
returns
for
the
next
load.
(
4)
changing
the
level
of
the
field
spike
from
0.05
to
5.0,
(
5)
changing
the
application
rate
per
acre
from
"
6
lb
ai/
acre"
to
"
a
typical
lb
ai/
acre";
(
6)
allowing
the
use
of
several
different
propanil
liquid
end­
use
products
in
the
study,
rather
than
using
only
STAM
­
M4;
(
7)
changing
the
timing
of
urine
specimen
collection
"
to
provide
more
flexibility
in
sampling
since
propanil
application
schedules
are
not
known
well
ahead
of
time;"
(
8)
changing
the
replicate
monitoring
time
for
mixing/
loading
and
applying
from
5
hours
to
3
hours,
(
9)
changing
the
level
of
fortification
from
1
:
g
to
20
:
g,
(
10)
clarifying
the
calibration
method
of
the
plane,
(
11)
clarifying
the
tank
sample
number
designation,
(
12)
clarifying
the
pre­
urine
sample
number
designation,
and
(
13)
changing
the
personal
protective
equipment
worn
by
mixers/
loaders
"
to
allow
for
the
use
of
Tyvek
in
the
field
phase
of
the
study."

The
deviations
included:

(
1)
the
air
tube
validation
was
carried
out
with
analytical
grade
propanil
instead
of
with
the
propanil
formulation,
(
2)
fortification
solutions
were
prepared
in
smaller
volumes,
(
3)
two
additional
fortification
levels
were
prepared
and
3
mL
were
send
to
the
field,
(
4)
each
fortification
bottle
was
not
wrapped
in
bubble
wrap,
(
5)
the
high
level
samples
of
urine
were
fortified
at
50X
LOQ
rather
than
500X
LOQ,
(
6)
one
of
the
LOQ
fortification
recoveries
in
the
method
validation
was
68%,
(
7)
one
of
the
fresh
LOQ
fortification
recoveries
in
the
14
day
stability
set
for
air
tubes
was
125%,
(
8)
one
of
the
fresh
LOQ
fortification
recoveries
in
the
6
week
stability
set
for
air
tubes
was
123%,
(
9)
for
outer
dosimeters
the
low
fortification
was
10X
LOQ,
(
10)
for
one
set
of
samples
the
calibration
curve
was
constructed
from
only
4
concentrations,
(
11)
one
LOQ
fortification
recovery
in
a
set
of
urine
samples
was
65%,
(
12)
one
LOQ
fortification
recovery
in
a
set
of
air
tube
samples
was
215%,
(
13)
for
one
set
of
samples
the
calibration
curve
was
constructed
from
only
4
concentrations
when
one
sample
needed
a
dilution,
(
14)
the
hat
patch
samples
were
only
quantitated
to
0.5
ng/
cm2,
(
15)
one
LOQ
fortification
recovery
in
a
set
of
outer
dosimeter
samples
was
171%,
(
16)
6
dosimeter
recovery
sets
gave
one
recovery
in
the
60%
range,
(
17)
for
several
chromatographic
runs,
the
calibration
curve
was
only
constructed
from
4
concentrations,
(
18)
control
urine
was
spiked
and
kept
on
blue
ice
for
25
hours
instead
of
24
hours,
(
19)
only
one
mixer/
loader
was
tested
on
4/
1/
03
and
was
designated
VP1
and
was
not
dressed
in
dosimeters,
(
20)
handlers
were
paid
$
150.00
for
participation,
(
21)
weather
data
was
not
taken
hourly
during
mixing/
loading
and
application,
(
22)
dosimeters
were
not
hung
up
to
cut,
Page
6
of
39
(
23)
one
of
the
planes
was
not
calibrated
prior
to
the
application
date
of
4/
3/
03
at
site
1,1A,
and
1B,
(
24)
there
were
not
exactly
five
locations
in
each
of
the
three
states,
(
25)
hand
washes
were
taken
before
initiation
of
exposure
on
day
0
and
at
the
end
of
the
replicate
(
since
replicate
times
were
not
long
enough
so
that
they
included
a
lunch
break
for
the
test
subjects,
(
26)
all
test
subjects
did
not
avoid
contact
with
any
product
containing
propanil
for
3
days
prior
to
the
day
0
application
or
did
not
avoid
contact
with
any
product
containing
propanil
for
3
days
after
day
0,
(
27)
thirteen
test
subjects
handled
propanil
within
3
days
prior
to
the
test
day,
(
28)
four
test
subjects
handled
propanil
within
4­
7
days
prior
to
the
test
day,
(
29)
the
test
substance
expiration
date
was
not
recorded
in
the
field
raw
data
of
the
study,
(
30)
the
daily
max/
min
temperatures
were
not
recorded
at
the
test
sites,
(
31)
the
carrier
rate
was
8­
10
gallons
and
not
10­
15,
(
32)
the
pants,
t­
shirt,
and
briefs
were
taken
off
by
the
test
subject
and
each
laid
on
a
separate
clean
piece
of
aluminum
foil
and
then
collected,
(
33)
during
the
process
of
preparing
field
fortifications,
all
three
field
fortification
type
solutions
were
used
to
fortify
the
field
spikes,
(
34)
field
fortifications
were
not
performed
at
location
sites
1,2,
and
3,
but
at
five
locations
selected
throughout
the
study,
(
35)
field
fortifications
and
field
controls
were
not
always
upwind
from
the
loading
and/
or
treated
rice
fields,
(
36)
only
one
patch
and
not
a
pair
of
patches
were
fortified,
(
37)
outer
dosimeters
were
fortified
at
20
and
100
:
g/
sample,
(
38)
there
was
no
sample
collection
date
on
the
chain
of
custody,
(
39)
spike
solution
"
02"
was
used
on
4/
29/
03
and
5/
1/
03
instead
of
"
01"
and
spike
solution
"
03"
was
used
on
5/
22/
03
and
6/
3/
03
instead
of
"
01",
and
(
40)
the
maximum
and
minimum
temperatures
were
not
reported
where
the
test
substance
was
stored
just
prior
to
the
replicate.

Most
of
these
deviations
were
reported
by
the
study
author
to
have
none
or
minimal
effects
on
the
study,
however,
the
deviations
related
to
contact
with
the
product
did
cause
some
interference
with
the
urine
residues
observed
in
the
baseline.

1.
Number
and
type
of
handlers
and
sites:

Thirty
individuals
participated
in
the
study
at
eleven
test
sites
(
15
mixer/
loaders,
14
pilots,
and
1
combined
mixer/
loader/
pilot).
In
the
Study
Report,
odd
numbered
replicates
(
e.
g.,
V1,
V3)
represented
mixer/
loaders
and
even
number
replicates
represented
applicator
pilots,
except
that
V12
represented
the
mixer/
loader/
pilot.
The
study
was
performed
with
typical,
experienced
(
0.2
to
42
years
of
experience)
handlers
who
mix,
load
and
aerially
apply
propanil
to
rice
fields.
The
age
of
the
handlers
ranged
from
19
to
60
years;
weight
ranged
from
138
to
285
pounds;
and
height
ranged
from
60
to
75
inches
tall.
Each
participant
signed
an
informed
consent
form
prior
to
the
initiation
of
the
study
after
being
provided
with
the
proper
information
regarding
the
study,
products
being
used,
and
proper
precautions.

The
sites
for
this
study
were
located
in
Texas,
Louisiana,
and
Arkansas
and
there
were
multiple
sites
in
each
state.
For
each
site,
the
site
number
provided
in
the
Study
Report
identified
the
aerial
applicator
facility,
the
loading
site
and
the
rice
fields
that
were
treated
if
these
were
in
different
locations.
For
example,
"
site
1,
1A,
1B"
indicates
that
the
aerial
facility,
loading
site
and
treated
rice
fields
were
all
in
different
locations.
Table
1A
of
the
Study
Report
provides
information
on
the
site
numbers
associated
with
each
location.

2.
Meteorology:

Temperature,
relative
humidity,
and
wind
speed
and
direction
were
monitored
at
each
loading
location
on
the
application
date.
Table
1
provides
a
summary
of
the
measurements
taken
during
the
study.
Page
7
of
39
Table
1.
Meteorological
Measurements
Sites
Min
Temp
(
F)
Max
Temp
(
F)
Min
Relative
Humidity
(%)
Max
Relative
Humidity
(%)
Min
Wind
Speed
(
mph)
Max
Wind
Speed
(
mph)
Wind
direction
at
loading
site
1,
1A*
69
69
90
90
3
to
5
3
to
5
Fr
N
1,
1C*
72
78
75
88
2
10
Fr
E
2
67
78
56
76
1
6
W­
S­
SW
3
72
73
88
89
1.5
4
Fr
W
4
64
68
83
93
0
1.2
FrNE
5
81
83
68
72
1.4
5.6
Fr
SE­
SW
6,
6A*
74
76
90
95
7
16
Fr
S­
SW
6,
6D*
76
76
84
84
8
11
Fr
SW
7
74
76
90
100
1
4
Fr
SE
8
74
81
72
90
1
2
Fr
SE
9
64
64
75
85
3
7
Fr
N­
NW
10
62
71
65
88
4
9
Fr
NE
11
73
74
96
98
2
3
Fr
SE
*
Both
sites
1
and
6
had
different
loading
sites
for
the
same
aerial
facility;
and
therefore
different
meteorological
measurements.
3.
Replicates:
This
study
consisted
of
a
total
of
30
replicates
using
one
of
four
propanil
formulations.
The
replicates
included
15
mixer/
loaders,
14
pilots,
and
1
combined
mixer/
loader/
pilot.
Tables
2a­
2c
present
summaries
of
the
mixer/
loader,
pilot,
and
mixer/
loader/
pilot
replicates.
Table
2a.
Summary
of
Mixer/
Loader
Replicates
Mixer/
Loader
Replicate
Location
Product
Formulation
Used
Loads
per
Day
Pounds
AI
Handled
per
Day
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
PPE
Worn
V1
Garwood,
TX
STAM
M­
4
16
1328
3.43
6.2
6.7
apron,
boots
V3
Edna,
TX
Arrosolo
3­
3E
12
1080
2.33
4
4.3
apron,
boots
V5
Edna,
TX
Arrosolo
3­
3E
8
870
2.82
6.5
6.8
apron,
boots
V7
Almyra,
AR
STAM
M­
4
5
644
2.38
2.5
2.8
apron,
boots
V9
Garwood,
TX
STAM
M­
4
16
1328
3.43
6.4
7.2
apron,
boots
V13
Lessie,
TX
Blue
Drum
6
510
1.75
2.3
2.8
apron,
boots
V15
Lessie,
TX
Blue
Drum
6
510
1.75
2.3
2.7
apron,
boots
V17
Weiner,
AR
Blue
Drum
9
776
5.3
6.1
6.4
tyvek,
boots
V19
(
repl
#
1)
Lake
Arthur,
LA
Arrosolo
3­
3E
2
138
0.32
1.9
2.3
apron,
boots
V19
(
repl
#
2)
Lake
Arthur,
LA
Duet
1
156
0.05
Mixer/
Loader
Replicate
Location
Product
Formulation
Used
Loads
per
Day
Pounds
AI
Handled
per
Day
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
PPE
Worn
Page
8
of
39
V19
(
TOTAL)
NA
NA
3
294
0.37
V21
Cheneyville,
LA
Arrosolo
3­
3E
6
579
2.8
3.5
4.1
apron,
boots
V23
Almyra,
AR
STAM
M­
4
2
196
0.53
1.4
1.8
apron,
boots
V25
(
repl
#
1)
Mer
Rouge,
LA
STAM
M­
4
4
600
1.63
3
no
data
tyvek,
boots
V25
(
repl
#
2)
Mer
Rouge,
LA
STAM
M­
4
2
204
0.78
V25
(
TOTAL)
NA
NA
6
804
2.41
V27
Lake
Village,
AR
Super
Wham
3
576
1.32
2.9
5
apron,
boots
V29
Eudora,
AR
STAM
M­
4
5
790
1.62
2.2
2.4
tyvek,
boots
V31
(
repl
#
1)
Weiner,
AR
STAM
M­
4
1
76
0.35
5.6
6
tyvek,
boots
V31
(
repl
#
2)
Weiner,
AR
Blue
Drum
2
192
0.82
V31
(
repl
#
3)
Weiner,
AR
STAM
M­
4
1
96
0.17
V31
(
TOTAL)
NA
NA
4
364
1.34
Mean
7.1
710
2.2
3.8
4.4
N/
A
Table
2b.
Summary
of
Pilot
Replicates
Pilot
Replicate
Location
Product
Formulation
Used
Loads
Pounds
AI
per
Acre
Acres
Treated
per
Replicate
(
acres/
day)
Actual
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
PPE
V2
Garwood,
TX
STAM
M­
4
9
3
246
1.73
6.6
7.1
single
layer,
shoes,
socks
+
gloves
when
entering
or
exiting
V4
Edna,
TX
Arrosolo
3­
3E
6
2.25
240
1.48
4.2
4.7
V6
Edna,
TX
Arrosolo
3­
3E
8
3
334
1.72
6.2
6.5
V8
Garwood,
TX
STAM
M­
4
7
3
197
1.75
6.6
6.8
V10
Lessie,
TX
Blue
Drum
6
2
254
1.70
2.5
2.9
V14
(
repl
#
1)
Almyra,
AR
STAM
M­
4
4
4
137
1.3
3.2
3.9
V14
(
repl
#
2)
Almyra,
AR
STAM
M­
4
1
3
32
0.15
V14
(
TOTAL)
NA
NA
5
N/
A
169
1.45
V16
(
repl
#
1)
Lake
Arthur,
LA
Arrosolo
3­
3E
2
1.9
72
0.38
2.8
3.1
V16
(
repl
#
2)
Lake
Arthur,
LA
Duet
1
3.1
51
0.3
V16
(
TOTAL)
NA
NA
3
N/
A
87
0.68
V20
(
repl
#
1)
Cheneyville,
LA
Arrosolo
3­
3E
2
3
73
0.53
NONE
4
Pilot
Replicate
Location
Product
Formulation
Used
Loads
Pounds
AI
per
Acre
Acres
Treated
per
Replicate
(
acres/
day)
Actual
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
PPE
Page
9
of
39
V20
(
repl
#
2)
Cheneyville,
LA
Arrosolo
3­
3E
4
2.25
160
1.5
V20
(
TOTAL)
NA
NA
6
N/
A
233
2.03
V22
Almyra,
AR
STAM
M­
4
2
4
49
0.87
1.4
2.2
V24
(
repl
#
1)
Mer
Rouge,
LA
STAM
M­
4
4
3
200
1.17
3
3.2
V24
(
repl
#
2)
Mer
Rouge,
LA
STAM
M­
4
2
2
102
0.98
3.1
V24
(
TOTAL)
NA
NA
6
N/
A
302
2.15
6.3
V26
Lake
Village,
AR
Super
Wham
3
4.5
129
1.28
2.3
5
V28
(
repl
#
1)
Weiner,
AR
Blue
Drum
6
1.9
240
2.62
6
6.3
wore
"
flight"
gloves
V28
(
repl
#
2)
Weiner,
AR
Blue
Drum
3
2
156
1.2
V28
(
TOTAL)
NA
NA
9
N/
A
396
3.82
V30
Eudora,
AR
STAM
M­
4
5
4
197.5
1.32
2
2.2
same
as
V2
V32
(
repl
#
1)
Weiner,
AR
STAM
M­
4
1
2
37.5
0.23
5
5.3
wore
"
flight"
gloves
V32
(
repl
#
2)
Weiner,
AR
Blue
Drum
3
2.1
138
1.22
V32
(
TOTAL)
NA
NA
4
N/
A
175.5
1.45
Mean
5.6
2.8
218
1.7
4
4.5
N/
A
Table
2c.
Summary
of
Mixer/
Loader/
Pilot
Replicate
Mixer/
Loader/
Pilot
Replicate
Location
Product
Formulation
Used
Loads
Pounds
AI
per
Acre
Acres
Treated
per
Load
Actual
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
PPE
V12
(
mixing)
Bunkie,
LA
STAM
M­
4
4
4
118
0.4
2.5
3.5
M/
L:
apron,
boots
Pilot:
no
boots,
no
apron
V12
(
applying)
1.4
V12
(
total)
1.8
Page
10
of
39
4.
Personal
Protective
Equipment:

A
summary
of
personal
protective
equipment
worn
by
the
mixer/
loaders
and
pilots
is
presented
in
Tables
2a,
2b,
and
2c.
Mixer/
loaders
and
pilots
wore
100%
cotton
long
sleeve
shirts,
100%
cotton
long
pants,
100%
cotton
t­
shirt,
100%
cotton
briefs,
and
socks.
Mixer/
loaders
also
wore
full
rubber
boots,
a
baseball­
style
cap,
goggles,
chemicalresistant
gloves,
and
either
a
chemical­
resistant
apron
or
Tyvek
coveralls.
Pilots
also
wore
tennis
shoes,
a
helmet
with
a
visor
(
instead
of
baseball­
style
cap
and
goggles),
and
were
given
a
pair
of
chemical­
resistant
gloves
to
wear
when
outside
of
the
airplane.
Two
of
the
pilots
wore
"
flight
gloves"
throughout
the
application
process.
The
mixer/
loader/
pilot
removed
the
chemical­
resistant
apron,
rubber
boots,
and
baseball­
style
cap
and
put
on
tennis
shoes
and
a
helmet
with
a
visor
when
piloting
the
airplane.
The
personal
protective
equipment
worn
by
mixers/
loaders
exceeded
the
requirements
on
the
product
labeling
by
adding
chemical­
resistant
footwear
and
a
chemical­
resistant
apron
or
Tyvek
coveralls.
No
explanation
is
offered
for
the
deviation
from
the
product
labeling
and
the
study
protocol.

5.
Mixing/
application
method:

Most
of
the
mixer/
loaders
used
a
semi­
open
system
(
siphon
device)
to
remove
the
propanil
product
from
30
to
35
gallon
drums
into
a
mix
tank,
where
it
was
mixed
with
water
and
additives.
The
mixture
was
then
pumped
through
a
dry
lock
system
into
an
airplane
with
additional
water.
The
airplane
spray
tank
was
filled
to
capacity
with
water
and
a
bypass
system
was
used
to
agitate
the
mixture.
Therefore,
the
mixing/
loading
system
was
a
combination
of
open
loading
(
siphon)
and
closed
loading
(
dry
lock).
No
open
pour
methods
were
used
in
the
study.

All
airplanes
had
enclosed
cockpits.
They
were
manufactured
by
Air
Tractor
or
Ayres
Thrush
(
except
for
site
2 
Grumman
planes)
and
had
500­
800
gallon
capacity
spray
tanks.
Flaggers
were
not
used
in
this
study
since
each
plane
was
equipped
with
a
SAT­
LOC
®
or
equivalent
computer/
GIS
system
to
guide
the
application
of
the
propanil.

6.
Application
Rate:

Each
of
the
formulations
used
in
this
study
contained
3­
4
pounds
active
ingredient
per
gallon
and
were
applied
using
10
gallons
of
carrier
per
acre.
According
to
the
different
product
labels,
the
maximum
application
rate
varies
among
3,
4,
and
6
pounds
active
ingredient
per
acre.
STAM­
4,
the
formulation
identified
in
the
protocol
as
the
formulation
to
be
used,
has
the
6
pounds
active
ingredient
per
acre
application
rate.
Table
3
provides
the
lbs
a.
i./
gallon,
the
acres
treated,
the
lbs
a.
i./
acre
and
the
carrier
volume
per
acre.

Table
3.
Application
rates
Site
Number
Handler
Replicate
Product
Lbs
a.
i./
gallon
Acres
treated
Lbs
a.
i./
acre
Carrier
(
gal/
acre)

1,
1A,
1B
V4
Arrosolo
3­
3E
3
240
2.25
10
1,
1C,
1D
V6
Arrosolo
3­
3E
3
334
2.6
10
2,
2A,
2B,
2C
V2
STAM
M­
4
4
246
3
9.65
2,
2A,
2B,
2C
V8
STAM
M­
4
4
197
3
8.49
3,
3A,
3B
V10
Blue
Drum
4
254
2
10
4,
4A
V16
Arrosolo
3­
3E
3
72
1.9
10
4,
4B
V16
Duet
4
51
3.1
10
5,
5A
V12
STAM
M­
4
4
118
4
8
6,
6A,
6B
V14
STAM
M­
4
4
137
4
8
Site
Number
Handler
Replicate
Product
Lbs
a.
i./
gallon
Acres
treated
Lbs
a.
i./
acre
Carrier
(
gal/
acre)

Page
11
of
39
6,
6C
V14
STAM
M­
4
4
32
3
8
6,
6D,
6E
V22
STAM
M­
4
4
49
4
10
7,
7A
V20
Arrosolo
3­
3E
3
73
3
10
7,
7B
V20
Arrosolo
3­
3E
3
160
2.25
10
8,
8A
V26
Super
Wham
4
129
4.5
10
9,
9A
V24
STAM
M­
4
4
200
3
10
9,
9B
V24
STAM
M­
4
4
102
2
10
10,
10A,
10B
V28
Blue
Drum
4
240
1.9
10
10,
10C
V28
Blue
Drum
4
156
2
9.6
10,
10D
V32
STAM
M­
4
4
37.5
2
10
10,
10E
V32
Blue
Drum
4
138
2.1
10
11,
11A,
11B
V30
STAM
M­
4
4
197.5
4
10
7.
Exposure
monitoring
methodology:

Dermal
dosimeters:
Inner
and
outer
body
dosimeters
were
used.
Before
the
initiation
of
the
work
period,
the
handlers
would
use
a
private
dressing
room
to
change
out
of
their
street
clothes
into
the
study
dosimeters.
The
handlers
would
put
on
a
pair
of
surgical
gloves,
remove
their
street
clothes
and
then
change
gloves
and
put
on
the
inner
and
outer
dosimeters,
and,
presumably,
any
other
personal
protective
equipment,
such
as
an
apron,
Tyvek
coveralls,
chemical­
resistant
footwear,
and
chemical­
resistant
gloves.
At
the
end
of
the
work
period,
the
handlers
reentered
the
dressing
room,
and
removed
the
footwear,
socks,
outer
dosimeters,
and
inner
dosimeters,
and,
presumably
any
other
personal
protective
equipment,
such
as
an
apron,
Tyvek
coveralls,
chemical­
resistant
footwear,
and
chemical­
resistant
gloves
 
changing
gloves
between
each
removal.
The
dosimeters
were
placed
on
fresh
aluminum
foil.
The
inner
dosimeters
were
wrapped
in
the
aluminum
foil
and
placed
in
a
pre­
labeled
zip
lock
bag.
The
outer
dosimeters
were
cut
into
three
pieces
(
arm,
leg,
and
torso
sections).
Each
section's
samples
were
separately
wrapped
in
aluminum
foil,
placed
in
a
pre­
labeled
plastic
zip
lock
bag
and
frozen
until
analysis.

Hand:
Exposure
to
the
handlers'
hands
was
determined
by
the
hand­
rinse
method.
Hand
wash
samples
were
taken
at
the
beginning
and
end
of
the
work
period.
The
handlers
held
their
hands
over
a
glass
bowl
and
250
mL
of
0.01%
Aerosol
®
OT
solution
was
poured
over
their
hands
while
they
rubbed
their
hands
together
for
approximately
30
seconds.
This
was
repeated
with
another
250
mL
of
hand
wash
solution
and
both
solutions
were
pooled
into
one
sample
jar,
placed
into
a
zip
lock
bag,
wrapped
with
bubble
wrap
and
frozen
until
analysis.

Head
Patches:
A
4"
x4"
cotton
head
patch
was
used
to
estimate
head/
face/
neck
exposure.
The
patches
were
attached
to
the
back
and
front
of
the
baseball­
style
cap
worn
by
mixers/
loaders
and
to
the
right
front
and
center
back
of
the
helmet
worn
by
pilots.
The
patch,
made
of
the
same
material
as
the
pants,
was
stapled
to
an
aluminum­
foil­
covered
backing
that
was
Page
12
of
39
held
to
the
cap
or
helmet
using
Velcro
®
.
After
the
exposure
period,
the
two
head
patches
were
combined
into
one
sample,
wrapped
in
aluminum
foil,
and
placed
in
a
prelabeled
zip
lock
bag,
and
frozen
until
analysis.

Inhalation:
Inhalation
was
monitored
using
MSA
air­
sampling
pumps
attached
to
the
handlers'
belts
and
a
Gelman
filter/
XAD­
4
air
tube
was
pinned
to
the
handlers'
shoulders
with
the
filter
orifice
pointing
downward.
The
pumps
were
calibrated
to
an
airflow
of
2
liters/
minute
and
turned
on
as
the
exposure
period
began.
After
the
work
period,
the
air
pumps
were
turned
off
and
were
removed.

Biological
Monitoring:
Approximately
12
hour
urine
samples
were
collected
one
day
prior
to
application
of
propanil
(
Day
­
1),
on
the
day
of
application
(
Day
0),
and
for
2
days
past
the
test
(
Day
1
and
Day
2).
An
individual
small
cooler
containing
frozen
blue
ice
and
two
polyethylene
urine
collection
vessels
were
provided
to
the
handler
for
the
Day­
1
and
Day
0
samples.
Another
cooler
was
provided
for
the
Day
1
and
Day
2
samples.
Some
of
the
handlers
had
not
been
exposed
to
propanil
for
at
least
4
days
prior
to
the
application
test
period,
however,
many
had
been
exposed
for
several
days
leading
up
to
the
test
day.
The
study
author
indicates
that
this
occurred
because
the
study
was
integrated
into
the
normal
commercial
use
of
propanil
products.
After
collection,
the
samples
were
transported
to
the
H.
E.
R.
A.
C.,
Inc
field
laboratory
where
they
were
weighed
and
stored
frozen
until
analysis.

8.
Analytical
Methodology:

Extraction
method(
s):

OVS
(
Air)
Tubes
­
The
contents
of
the
air
tube
were
emptied
into
a
centrifuge
tube
and
extracted
with
EtOAc
by
sonicating
for
ten
minutes.
The
ethyl
acetate
was
decanted
into
a
clean
tube
and
evaporated
under
nitrogen
to
just
below
1
mL.

Gelman
(
Air)
Filters
­
Filters
were
extracted
with
EtOAc
by
sonicating
for
ten
minutes.
The
sample
solvent
was
taken
to
dryness
under
nitrogen.
The
sample
was
then
reconstituted
in
MeOH
and
HPLC
grade
water
and
cleaned
up
by
loading
onto
a
C­
18
SPE
cartridge
and
eluting
with
EtOAc.
The
sample
was
dried
through
sodium
sulfate
and
brought
to
1
mL
final
volume.

Dosimeters
­
The
inner
dosimeters
were
extracted
with
25:
75
methanol:
water
by
shaking
for
1
hour.
An
aliquot
of
the
extraction
solvent
was
partitioned
with
dicloromethane
(
DCM)
and
then
the
DCM
was
taken
to
dryness
by
rotary
evaporation.
The
sample
was
reconstituted
in
HPLC
grade
water
and
cleaned
up
by
loading
onto
a
C­
18
SPE
cartridge
and
eluting
with
ethyl
acetate.
The
eluate
was
dried
through
sodium
sulfate
and
brought
to
a
final
volume.
The
outer
dosimeters
were
extracted
with
40:
60
acetone:
hexanes
by
shaking
for
one
hour.
An
aliquot
of
the
extraction
solvent
was
taken
to
dryness
by
rotary
evaporation.
The
sample
was
reconstituted
in
HPLC
grade
water,
filtered,
and
cleaned
up
by
loading
onto
a
C­
18
SPE
cartridge
and
eluting
with
75:
25
MeOH:
water.
No
explanation
is
given
in
the
study
why
the
extraction
method
for
the
inner
dosimeters
differed
from
the
extraction
methods
for
the
outer
dosimeters
and
the
head
patches.
All
dosimeters
were
100
percent
cotton.

Head
Patches
­
The
head
patches
were
extracted
with
40:
60
acetone:
hexanes
by
shaking
for
thirty
minutes.
An
aliquot
of
the
extraction
solvent
was
taken
to
dryness
by
rotary
evaporation.
The
sample
was
reconstituted
in
HPLC
grade
water,
filtered,
and
cleaned
up
by
loading
onto
a
C­
18
SPE
cartridge
and
eluting
with
MeOH.
After
the
sample
was
dried,
it
was
reconstituted
in
75:
25
MeOH:
water.
Page
13
of
39
Hand
Washes
­
An
aliquot
of
the
hand
wash
sample
was
diluted
with
HPLC
grade
water
and
phosphate
buffer
(
pH
6.5).
The
aliquot
was
cleaned
up
by
loading
onto
a
C­
18
SPE
cartridge
and
eluting
with
EtOAc.
The
sample
was
dried
through
sodium
sulfate
and
brought
to
a
final
volume
of
10
mL.

Urine
Samples
­
For
hydrolyzed
urine
residues,
a
portion
of
each
sample
was
centrifuged
before
an
aliquot
was
taken.
This
aliquot
was
hydrolyzed
with
hydrochloric
acid
for
one
hour,
had
the
pH
adjusted
to
12
or
13,
and
extracted
with
ethyl
ether
by
shaking.
An
aliquot
of
the
ethyl
ether
was
taken
to
100
:
L
on
an
N­
Evap.
The
aliquot
was
reconstituted
in
1mL
MeOH,
diluted
with
50
mL
of
0.2M
phosphate
buffer,
pH
6.5,
loaded
onto
a
C­
18
SPE
cartridge
and
eluted
with
75:
25
MeOH:
0.02M
ammonium
acetate.
For
non­
hydrolyzed
urine
residues,
the
same
procedure
was
followed
except
the
sample
was
not
hydrolyzed.

Detection
method(
s):
See
Table
4.

Table
4.
Summary
of
GC
Chromatographic
Conditions
Media
Inner
Dosimeters
Outer
Dosimeters
Hand
Washes
Hat
Patches
OVS
Tubes
Gelman
Filters
Urine
Samples
Instrument
Hewlett
Packard
Model
5970
GC/
MSD
Shimadzu
SIL­
10AXL
Hewlett
Packard
Model
5970
GC/
MSD
Shimadzu
SIL­
10AXL
Hewlett
Packard
Model
5970
GC/
MSD
Hewlett
Packard
Model
5970
GC/
MSD
Shimadzu
SIL­
10AXL
#
2
Column
Fused
silica
DB­
17
capillary
column,
10m
x
0.18mm,
0.18
:
m
film
thickness
4.6
mm
Spherisorb
Phenyl,
5
:
m
ps
Fused
silica
DB­
17
capillary
column,
10m
x
0.18mm,
0.18
:
m
film
thickness
4.6
mm
Spherisorb
Phenyl,
5
:
m
ps
Fused
silica
DB­
17
capillary
column,
10m
x
0.18mm,
0.18
:
m
film
thickness
Fused
silica
DB­
17
capillary
column,
10m
x
0.18mm,
0.18
:
m
film
thickness
A
=
4.6
x
150
mm
Zorbax
SBCN
#
174,
5
:
m,
ps
80A
B
=
4.6
x
150
mm
Zorbax
ODS
#
176,
5
:
m,
ps
70A
Temperatures
Detector:
275oC
Injector:
250oC
Oven:
35oC
Detector:
275oC
Injector:
250oC
Oven:
35oC
Detector:
275oC
Injector:
250oC
Detector:
275oC
Injector:
250oC
Oven:
35oC
Injection
Volume
1
:
L
15
:
L
1
:
L
15
:
L
1
:
L
1
:
L
30
:
L
Retention
Time
9
minutes
9
minutes
7.99
minutes
9
minutes
7.99
minutes
7.99
minutes
11.6
minutes
Method
validation:
Method
validation
samples
were
analyzed
prior
to
the
study.
LOQs
for
each
sample
matrix
were
also
determined
prior
to
initiation
of
the
study.
Table
5
provides
the
results
of
the
method
validation
recoveries
and
the
LOQs.
Page
14
of
39
Table
5.
Method
Validation
Recoveries
and
LOQ
Matrix
LOQ
Range
of
Recoveries
(%)
Average
Recovery
(%)
Standard
Deviation
(%)
n
Inner
dosimeter
0.1
ng/
cm2
79­
111
93
12
6
Outer
dosimeter
0.1
ng/
cm2
71­
101
89
12
6
Hand
washes
0.010
:
g/
mL
94­
115
107
7.9
6
Hat
Patches
0.10
:
g/
sample
69­
113
92
16
7
Air
tubes
0.010
:
g/
sample
78­
117
91
15
5
Gelman
Filters
0.010
:
g/
sample
68­
101
83
13
6
Urine
0.01
:
g/
mL
87­
96
90
3.4
6
Recovery
experiments
(
both
procedural
and
field
fortification)
were
performed
for
all
sampling
media
prior
to
the
commencement
of
field
work.
In
an
effort
to
establish
storage
stability,
additional
samples
were
stored
in
a
freezer
and
analyzed
at
a
later
date.

Instrument
performance
and
calibration:
Information
on
instrument
performance
and
calibration
was
not
provided
in
the
Study
Report.

Quantification:
Sample
concentrations
were
calculated
using
linear
regression
equations.
Examples
of
calculations
were
provided
in
the
Study
Report.
Concentrations
of
propanil
in
the
samples
were
determined
directly
from
the
standard
curve.

9.
Quality
Control:

Lab
Recovery:
Concurrent
laboratory
fortifications
were
analyzed
with
each
set
of
samples
to
evaluate
the
validity
of
the
analytical
data.
Table
6
summarizes
the
results
for
the
concurrent
laboratory
fortification
sample
recoveries.
For
each
matrix,
the
mean
recovery
fell
within
the
acceptable
range
of
70%
to
120%
and
the
standard
deviation
was
less
than
20%.

Table
6.
Concurrent
Laboratory
Fortification
Sample
Recovery
Summary
Matrix
Recovery
Range
(%)
n
Average
Recovery
(%)
Standard
Deviation
(%)

Inner
Dosimeters
62­
111
24
86
14
Outer
Dosimeters
63­
111
31
85
14
Hand
Washes
70­
115
26
92
15
Hat
Patches
73­
117
16
100
12
Air
Tubes
79­
120
13
100
14
Gelman
Filters
75­
122
27
97
16
Urine
Samples
86­
114
7
99
9.9
Field
Blanks:
Field
blanks
were
collected
for
each
media.
For
the
air
filters
and
air
tubes,
there
were
some
trace
residues
of
propanil
just
above
the
background
in
certain
sets
of
field
controls.
It
was
suggested
in
the
Study
Report
that
some
traces
of
propanil
may
have
been
picked
up,
since
Page
15
of
39
samples
were
collected
at
the
aerial
facility.
There
were
no
traces
of
propanil
in
any
of
the
hand
wash
field
controls.
For
the
patch
samples,
residues
of
propanil
ranged
from
0.0167
to
0.5312
:
g/
sample.
Outer
dosimeter
control
samples
had
residues
ranging
from
0
to
1.5882
:
g/
sample
and
inner
dosimeter
samples
had
residues
ranging
from
0
to
1.8549.
The
study
author
suggested
that
these
levels
may
have
been
a
results
of
cross
contamination
in
the
field
or
laboratory.

Field
Recovery:
Handwash
Samples:
Hand
wash
fortification
samples
were
prepared
on
five
occasions
during
the
study.
Triplicate
500
mL
hand
wash
solutions
were
fortified
with
5
:
g
or
5000
:
g
of
propanil.
The
fortification
samples
were
immediately
placed
in
frozen
storage.

Air
Filters:
Inhalation
fortification
samples
were
prepared
on
five
occasions
during
the
study.
Triplicate
samples
were
fortified
with
0.5
:
g
propanil.
Another
set
of
triplicate
samples
were
fortified
with
25
:
g
propanil.
After
addition
of
the
propanil,
the
filter
or
air
tube
was
left
to
dry
for
at
least
15
minutes
before
the
air
pump
was
turned
on.
The
pumps
were
then
run
for
approximately
the
time
it
took
to
complete
the
application
replicate
for
that
day.
After
the
specific
time
period,
the
air
tubes
and
filters
were
removed
from
the
pumps,
wrapped
in
a
paper
towel,
taped,
placed
in
pre­
labeled
plastic
zip
lock
bags
and
immediately
placed
in
frozen
storage.

Hat
Patches:
Hat
patch
fortification
samples
were
prepared
on
five
separate
occasions
during
the
study.
Triplicate
control
sets
of
patches
were
fortified
with
1
:
g
propanil
and
another
set
of
patches
with
1000
:
g
propanil.
The
patch
was
folded
four
times
and
placed
on
aluminum
foil.
The
patches
were
weathered
in
the
same
manner
as
that
for
the
air
tubes/
filters,
collected,
wrapped
in
aluminum
foil,
placed
in
pre­
labeled
plastic
bags
and
stored
frozen.

Outer
dosimeters:
Outer
dosimeter
fortification
samples
were
prepared
on
five
occasions
throughout
the
course
of
the
study.
Triplicate
control
dosimeter
sections
were
folded
in
at
least
six
layers
and
pinned
to
a
table
covered
with
aluminum
foil.
Each
sample
was
fortified
with
20
:
g
propanil
or
1000
:
g
propanil.
The
dosimeters
were
weathered
in
the
same
manner
as
that
for
the
air
tubes/
filters,
then
wrapped
separately
in
aluminum
foil,
placed
in
pre­
labeled
plastic
zip
lock
bags
and
stored
frozen.

Inner
dosimeters:
Inner
dosimeter
fortification
samples
were
prepared
on
five
occasions
throughout
the
course
of
the
study.
Triplicate
control
dosimeter
sections
were
folded
in
at
least
six
layers
and
pinned
to
a
table
covered
with
aluminum
foil.
Each
sample
was
fortified
with
1
:
g
propanil
or
1000
:
g
propanil.
The
inner
dosimeter
was
folded
so
that
at
least
one
layer
of
the
cloth
was
left
over
the
fortified
area
and
then
was
weathered
in
the
same
manner
as
that
for
the
air
tubes/
filters.
The
inner
dosimeters
were
then
folded
with
the
treated
area
inside,
wrapped
in
aluminum
foil,
placed
in
plastic
bags,
and
stored
frozen.

Urine
samples:
Control
urine
samples
collected
prior
to
test
initiation
were
used
as
fortification
samples.
400
mL
of
sample
were
taken
and
split
into
eight
50
mL
aliquots
and
placed
in
prelabeled
4­
ounce
amber
bottles
with
Teflon
lids
(
2
samples
kept
as
control,
3
fortified).
The
fortification
samples
were
fortified
with
0.5
:
g
3,4­
DCA
or
5
:
g
3,4­
DCA.
The
samples
were
placed
in
plastic
bags,
wrapped
in
bubble
wrap,
and
placed
in
a
cooler
of
dry
ice
or
stored
frozen.

Table
7.
Field
Fortification
Recoveries
for
Propanil
Media
Set
#
Fortification
level
%
Recovered/
day
Average
Recovery
(%)
Overall
Average
Recovery
(%)
Standard
Deviation
Air
filters
1
0.5
:
g/
sample
69
56
70
16
2
41
Media
Set
#
Fortification
level
%
Recovered/
day
Average
Recovery
(%)
Overall
Average
Recovery
(%)
Standard
Deviation
Page
16
of
39
3
58
4
56
5
56
1
25
:
g/
sample
77
84
2
85
3
86
4
86
5
86
Air
Tubes
1
0.5
:
g/
sample
94
80
88
16
2
66
3
77
4
66
5
97
1
25
:
g/
sample
76
96
2
104
3
109
4
92
5
99
Hand
washes
1
0.01
:
g/
mL
74
82
82
12
2
77
3
63
4
96
5
102
1
25
:
g/
mL
91
81
2
67
3
82
4
82
5
83
Patches
1
1
:
g/
sample
87
73
81
13
2
79
3
66
4
71
5
65
1
1000
:
g/
sample
100
90
2
79
Media
Set
#
Fortification
level
%
Recovered/
day
Average
Recovery
(%)
Overall
Average
Recovery
(%)
Standard
Deviation
Page
17
of
39
3
95
4
101
5
73
Outer
dosimeters
1
20
:
g/
sample
69
71
71
10
2
72
3
68
4
85
5
59
1
1000
:
g/
sample
80
71
2
60
3
64
4
87
5
61
Inner
dosimeters
1
1.0
:
g/
sample
a
110
96
14
2
109
3
96
4
a
5
125
1
1000
:
g/
sample
76
92
2
91
3
101
4
99
5
94
Urine
1
0.01
:
g/
mL
109
105
95
16
2
b
3
b
4
b
5
100
1
0.10
:
g/
mL
89
90
2
115
3
b
4
73
5
83
a
The
recoveries
from
these
replicates
were
not
included
in
the
calculation
of
the
mean
recovery
for
inner
dosimeters
because
assumed
were
outliers.

b
The
recoveries
from
these
replicates
were
not
included
in
the
calculation
of
the
mean
recovery
for
urine
because
close
interference
peaks
prevented
accurate
quantitation.
Page
18
of
39
Formulation:
Not
reported.

Tank
Mix:
Triplicate
tank
mix
samples
were
taken
from
the
airplane
spray
tank
during
the
applications
at
select
sites.
The
amount
of
propanil
found
in
the
tank
mix
samples
was
close
to
the
amount
expected
except
for
one
sample
at
site
3
and
all
samples
at
site
10.
Recoveries
of
propanil
from
the
tank
mix
average
106%
±
38%.

Travel
Recovery:
At
the
field
laboratory,
duplicate
control
samples
of
the
outer
dosimeters,
inner
dosimeters,
and
patches
were
fortified
with
1000
:
g
propanil.
Duplicate
samples
of
air
filters
and
tubes
were
fortified
with
25
:
g
propanil.
Travel
spikes
were
not
weathered
but
were
immediately
placed
in
frozen
storage.
Travel
spike
recoveries
ranged
from
64%
to
108%.

Storage
Stability:
Storage
stability
studies
were
performed
for
all
matrices,
except
patches
since
the
patch
and
dosimeter
material
is
the
same.
Sample
storage
intervals
for
inner
dosimeters,
outer
dosimeters,
hand
washes,
hat
patches,
air
tubes,
air
filters,
and
urine
were
103,
104,
96,
89,
75,
71,
and
73
days,
respectively.
The
Study
Report
states
that
the
inner
and
outer
dosimeter
storage
stability
studies
are
not
complete
and
additional
results
will
be
added
as
an
appendix.
Table
8
provides
a
summary
of
the
results.

Table
8.
Storage
Stability
Results
Matrix
Days
stored
Mean
Recovery
(%)
Standard
Deviation
(%)

Air
Tubes
85
93
7
Air
Filters
85
77
25
Hand
Washes
119
88
6
Outer
Dosimeters
43
86
27
Inner
Dosimeters
43
71
8
Urine
115
92
9
10.
Relevancy
of
Study
to
Proposed
Use:

The
study
monitored
handlers
performing
their
normal
duties
while
mixing/
loading
the
test
product
and
applying
propanil
formulations
aerially.

II.
RESULTS
AND
CALCULATIONS:

A.
EXPOSURE
CALCULATIONS:

The
study
author
provided
total
exposure
values
expressed
as
:
g/
kg
body
weight/
day
and
:
g/
kg
a.
i./
day
(
Tables
9a­
9c).
Total
exposure
was
calculated
by
summing
the
internal
inhalation
dose
(
assuming
100%
lung
absorption
of
the
inhalation
exposure)
and
the
internal
dermal
dose
(
assuming
20%
dermal
penetration).
The
study
author
stated
that
residue
values
were
corrected
for
field
fortification
recoveries
if
the
recoveries
were
below
100%.
It
appears
from
review
of
the
residue
data
provided
that
the
study
author
used
½
LOQ
for
values
below
the
LOQ.
Versar
estimated
inhalation
exposure
values
as
:
g/
lb
ai
handled
as
per
EPA's
request.
Versar
has
only
estimated
dermal
exposure
values
for
the
pilots
(
applicators),
per
instructions
from
EPA.
Versar
corrected
residue
values
for
field
fortification
recoveries
less
than
90%.
Versar
also
used
½
LOQ,
for
values
below
the
LOQ,
in
their
calculations.
Page
19
of
39
Inhalation
Exposure
Inhalation
exposures
were
calculated
by
both
the
study
author
and
Versar
from
the
breathing­
zone
air
concentrations
determined
from
the
amount
of
propanil
found
on
the
air­
sampling
tubes
and
filters
and
the
volume
of
air
sample.
Inhalation
exposure
was
calculated
by
the
study
author
by
dividing
the
micrograms
of
propanil
found
on
the
sample
by
the
total
volume
of
air
that
passed
through
the
sample
and
then
multiplying
by
29
L/
min
and
the
actual
time
of
inhalation
monitoring
during
the
replicate.
The
exposures
for
the
air
tube
and
air
filter
were
combined.

Versar
used
the
NAFTA
recommended
values
for
breathing
rates
to
calculate
the
air
concentration
in
µ
g/
m3
and
ultimately
the
inhalation
exposure
in
µ
g/
lb
ai
handled.
The
new
NAFTA
recommended
inhalation
rates
are
8.3,
16.7
and
26.7
L/
min
for
sedentary
activities
(
e.
g.,
driving
a
tractor),
light
activities
(
e.
g.,
flaggers
and
mixer/
loaders
<
50
lbs
containers),
and
moderate
activities
(
e.
g.,
loading
>
50
lb
containers,
handheld
equipment
in
hilly
conditions),
respectively.
Versar
assumed
that
the
activities
performed
by
the
mixer/
loaders
fell
under
the
light
activities
category
(
16.7
L/
min),
and
the
activities
performed
by
pilots
fell
under
the
sedentary
activities
category
(
8.3
L/
min).
For
the
mixer/
loader/
pilot,
Versar
weighted
the
breathing
rate
by
the
relative
time
spent
mixing/
loading
versus
applying
(
16.7
L/
min
x
25
minutes
mixing/
loading
plus
8.3
L/
min
x
78
minutes
applying
divided
by
total
handling
time
of
103
minutes).
Table
10
provides
Versar's
calculated
inhalation
exposures.
The
average
inhalation
exposure
for
mixer/
loaders
was
1.37E­
02
:
g/
lb
a.
i.
handled,
for
pilots
was
2.04E­
03
:
g/
lb
a.
i.
handled,
and
for
the
mixer/
loader/
pilot
was
6.94E­
04
:
g/
lb
a.
i.
handled.

Dermal
Exposure
Dermal
exposure
was
calculated
by
the
study
author.
First,
a
penetration
factor
was
derived
by
dividing
the
amount
of
residue
on
the
inner
dosimeter
(
tee
shirt
and
briefs)
by
the
residue
on
the
torso
section
of
the
outer
dosimeter.
Then
outer
dosimeter
residues
for
arms,
legs,
and
torso
were
multiplied
by
the
penetration
factor.
The
study
author
indicates
that
this
method
provides
an
estimate
of
the
amount
of
residue
that
would
penetrate
the
outer
dosimeter
and
be
deposited
on
the
skin
of
the
torso,
arms,
and
legs.

The
amount
of
propanil
on
the
head,
face
and
neck
was
estimated
by
the
study
author
by
multiplying
the
hat/
helmet
patch
residue
by
a
factor
of
10.7,
which
was
derived
from
EPA's
estimated
face,
head
and
neck
area
of
2210
cm2
divided
by
the
surface
area
of
the
two
hat/
helmet
patches
(
206.5
cm2).

The
amount
of
propanil
on
the
hands
was
estimated
by
the
study
author
by
multiplying
the
hand
residue
by
the
sample
volume
of
500
mL.

The
study
author
then
calculated
total
dermal
exposure
by
summing
the
estimated
residues
on
the
head/
face/
neck
area,
with
the
estimated
hand
residues,
and
with
the
estimated
residues
on
the
skin
of
the
torso,
arms,
and
legs.
The
study
author
did
not
calculate
individual
hand
exposures
or
head/
face/
neck
exposures.
Only
residue
values
were
provided
in
the
Study
Report,
which
were
then
incorporated
into
the
calculation
of
dermal
exposure.

Versar
calculated
hand
exposures
(
under
chemical­
resistant
gloves)
which
are
reported
in
Table
11.
For
mixers/
loaders,
hand
unit
exposures
averaged
0.61
±
1.41
:
g/
lb
ai
handled.
For
pilots,
hand
unit
exposures
averaged
0.46
±
0.72
:
g/
lb
ai
handled.
(
Versar
notes
that
in
two
of
the
study
replicates
(
V28
and
V32),
the
pilots
wore
flight
gloves
throughout
the
replicate.)
For
the
mixer/
loader/
pilot,
hand
unit
exposures
were
0.75
:
g/
lb
ai
handled.

Versar
also
calculated
head,
face,
and
neck
exposures
which
are
reported
in
Table
12.
For
mixers/
loaders,
these
unit
exposures
averaged
9.4
±
23.0
:
g/
lb
ai
handled.
For
pilots,
these
unit
exposures
averaged
0.58
±
1.0
:
g/
lb
ai
handled.
For
the
mixer/
loader/
pilot,
the
head,
face,
and
neck
unit
exposure
was
74.58
:
g/
lb
ai
handled.

Versar
calculated
dermal
unit
exposure
to
the
torso,
arms,
and
legs
for
the
pilot
scenarios
only.
Versar
did
not
calculate
dermal
unit
exposure
to
the
torso,
arms,
and
legs
for
the
mixer/
loader
or
for
the
mixer/
loader/
applicator
scenarios,
since
an
appropriate
protection
factor
could
not
be
calculated
from
the
data
as
presented
in
the
study.
Versar
calculated
this
unit
exposure
using
the
same
method
as
the
study
author.
First,
a
penetration
factor
was
derived
by
dividing
the
amount
of
residue
on
the
inner
dosimeter
(
tee
shirt
and
briefs)
by
the
residue
on
the
torso
section
of
the
outer
dosimeter.
Then
outer
dosimeter
residues
for
arms,
legs,
and
torso
were
multiplied
by
the
Page
20
of
39
penetration
factor.
Dermal
unit
exposures
averaged
1.05E­
04
mg/
lb
ai
for
the
arms,
4.82E­
05
mg/
lb
ai
for
the
legs,
and
7.46E­
05
mg/
lb
ai
for
the
torso
(
see
Table
13).

Versar
then
calculated
total
dermal
unit
exposure
for
pilots.
Total
dermal
unit
exposure
estimates
averaged
1.27E­
03
mg/
lb
ai
handled
for
the
pilots.
Table
14
provides
the
total
dermal
exposures
for
pilots.
Total
dermal
exposure
to
mixers/
loaders
and
to
the
mixer/
loader/
applicator
were
not
calculated
by
Versar,
since
dermal
exposure
to
the
torso,
arms,
and
legs
was
not
calculated
for
these
two
scenarios,
because
an
appropriate
protection
factor
could
not
be
calculated
from
the
data
as
presented
in
the
study.
.

Total
Dermal
+
Inhalation
Exposure
The
study
author
calculated
mean
total
unit
exposures
of
2.10
±
3.80
:
g/
kg
ai/
day
for
mixer/
loaders
and
0.481
±
0.905
:
g/
kg
ai/
day
for
pilots.

Total
unit
exposure
was
calculated
by
Versar
for
pilots
by
adding
the
dermal
and
inhalation
exposures
to
pilots.
Versar
did
not
calculate
total
unit
exposures
to
mixers/
loaders
or
to
the
mixer/
loader/
applicator,
since
an
appropriate
protection
factor
could
not
be
calculated
from
the
data
as
presented
in
the
study
for
dermal
exposure
to
the
torso,
arms,
and
legs
for
these
two
scenarios.
Versar's
calculated
average
total
unit
exposure
to
pilots
was
1.28
±
2.63
:
g/
lb
ai
handled
(
see
Table
15).

Biomonitoring
The
study
protocol
required
that
handlers
participating
in
the
study
would
not
have
be
exposed
to
propanil
for
at
least
3
days
prior
to
and
at
least
3
days
following
the
day
of
the
study.
In
the
study
itself
,
however,
only
two
handlers
out
of
the
30
participants
were
known
to
have
had
no
exposure
in
the
3
days
before
and
3
days
following
the
study.
Six
other
handlers
may
not
have
had
exposures
in
the
3
days
before
and
3
days
following
the
study,
but
there
was
some
uncertainty.
The
remaining
22
participants
were
known
to
have
had
exposures
in
one
or
more
of
the
3
days
before
and
3
days
following
the
study.
The
urine
data
collected
for
eight
handlers
who
were
presumed
to
have
had
no
propanil
exposures
for
three
days
before
or
three
days
after
the
study
were
input
into
a
model
to
determine
the
half­
life
of
the
excretion
of
detectable
urine
residues.
The
half­
life
of
the
excretion
of
propanil
metabolites
was
found
to
be
23.9
hours.
Using
a
model
to
adjust
for
propanil
residues
that
handlers
may
have
received
other
than
during
the
study,
the
study
author
calculated
an
approximate
dose
of
propanil
for
each
handler
on
day
0.
The
study
author
calculated
exposures
of
54.7
±
120
:
g/
kg
ai/
day
for
mixer/
loaders
and
35.5
:
g/
kg
ai/
day
for
pilots.
For
both
mixer/
loaders
and
pilots,
the
exposure
values
obtained
from
biomonitoring
are
much
higher
than
those
obtained
from
whole
body
dosimetry.
The
study
did
not
provide
an
explanation
for
this
discrepancy.

III.
DISCUSSION
A.
LIMITATIONS
OF
THE
STUDY:

The
study
met
some
of
the
Series
875.1200
and
875.1400
Guidelines.
However,
there
are
major
issues
of
concern,
including:

(
1)
Mixers/
loaders
in
the
study
wore
either
a
chemical­
resistant
apron
or
a
Tyvek
coverall
over
the
"
outer"
dosimeter
and
also
wore
chemical­
resistant
footwear.
In
calculating
potential
dermal
exposures
to
mixers/
loaders,
the
study
author
does
not
factor
in
this
additional
personal
protective
equipment,
which
exceeds
the
requirements
of
the
product
labeling
and
makes
the
use
of
a
protection
factor
infeasible;
(
2)
The
average
duration
of
each
replicate
was
2.2
hours
for
mixers/
loaders
and
1.7
hours
for
pilots,
rather
than
the
6­
12
hours
stated
in
the
study
protocol;
(
3)
The
average
application
rate
used
in
the
study
was
approximately
3
pounds
active
ingredient
per
acre,
rather
than
the
label
maximum
of
6
pounds
active
ingredient
per
acre
on
the
STAM­
M4
label;
(
4)
Trapping
efficiency
tests
for
the
air
monitoring
media
chosen
were
not
documented;
(
5)
There
was
no
mention
of
breakthrough
tests
being
run
on
the
air
filters;
(
6)
No
information
was
provided
on
how
the
air
filters/
tubes
were
stored
after
sample
collection;
Page
21
of
39
(
7)
There
was
no
mention
of
preliminary
hand
rinse
studies;
and
(
8)
It
was
not
mentioned
if
a
sample
history
sheet
had
been
prepared
by
the
laboratory
upon
receipt
of
samples.

B.
DISCUSSION
OF
DERMAL
CALCULATIONS:

Versar
calculated
dermal
exposures
to
the
arms,
legs,
and
torso
for
pilots
only.
Versar
did
not
calculate
dermal
exposure
to
the
torso,
arms,
and
legs
for
the
mixer/
loader
or
for
the
mixer/
loader/
applicator
scenarios,
since
an
appropriate
protection
factor
could
not
be
calculated
from
the
data
as
presented
in
the
study.
Tables
9,
10,
and
11
summarize
the
study
authors'data.
Versar's
issues
include:

1.
The
study
did
not
follow
its
protocol
or
the
product
label
in
determining
the
personal
protective
equipment
worn
by
mixers/
loaders.
The
protocol
and
label
indicate
that
mixers/
loaders
would
wear
long­
sleeved
shirts,
long
pants,
shoes,
socks,
and
chemical­
resistant
gloves.
However,
in
the
study,
the
mixers/
loaders
wore
chemical­
resistant
footwear
 
described
as
"
boots"
instead
of
shoes.
In
addition,
the
four
mixers/
loaders
wore
a
Tyvek
coverall
over
the
long­
sleeved
shirt
and
long
pants
and
the
remaining
eleven
mixers/
loaders
wore
a
chemical­
resistant
apron
over
the
long­
sleeved
shirt
and
long
pants.
Versar
is
concerned
that
the
chemical­
resistant
boots
will
greatly
alter
the
amount
of
residues
measured
on
the
lower
legs
area
of
the
"
outer"
dosimeter.
Similarly,
Versar
is
concerned
that
the
chemical­
resistant
apron
or
Tyvek
coveralls
greatly
alter
the
amount
of
residue
measured
on
the
upper
legs
and
torso
area
of
the
"
outer"
dosimeter.
Versar
notes
that
on
page
133
of
the
study
report,
the
residues
found
in/
on
Tvyek
suits
is
reported.
However,
these
data
are
not
used
in
any
of
the
dermal
exposure
calculations.

2.
Versar
questions
the
validity
of
the
study
author's
use
of
a
protection
factor
to
determine
dermal
exposure
to
mixers/
loaders.
The
study
author
divides
the
residue
in
the
inner
dosimeter
(
tee
shirt
and
briefs)
by
the
residue
in
the
torso
section
of
the
outer
dosimeter
to
determine
what
percentage
of
residue
penetrates
the
outer
dosimeter.
Then
the
study
author
applies
this
protection
factor
to
the
total
residue
measured
on
the
outer
dosimeter
to
estimate
dermal
exposure
to
the
handlers'
skin
surface.
Versar
suggests
that
the
use
of
a
protection
factor
in
this
study
is
questionable
due
to
the
use
of
additional
PPE
over
the
"
outer"
dosimeter
(
see
issue
1
above).

3.
Versar
questions
the
validity
of
using
data
from
abbreviated
handling
times
and
lower
than
maximum
application
rates
in
determining
dermal
exposures
to
mixers/
loader
or
pilots.
It
is
Versar's
understanding
that
penetration
of
a
residue
through
a
matrix
is
dependent
on
three
factors:
composition
of
the
matrix,
concentration
of
the
residue
on
the
matrix
surface,
and
time
of
residue
contact
with
the
matrix
surface.
This
study
used
application
rates
lower
than
the
maximum
6
pounds
active
ingredient
listed
in
the
protocol
and
on
the
product
labeling
(
STAM
M4),
with
an
average
application
rate
in
the
study
less
than
3
pounds
active
ingredient
per
acre.
In
addition,
this
study
involved
much
lower
handling
times
than
were
listed
in
the
protocol
or
are
routinely
found
in
other
handler
exposure
studies.
The
average
handling
time
for
mixers/
loaders
was
only
2.2
hours
and
for
pilots
was
only
1.7
hours
and
the
average
dermal
monitoring
time
was
less
than
4.5
hours
for
both
handling
tasks.
The
application­
rate
factor
would
be
expected
to
result
in
less
residue
being
deposited
on
the
outer
dosimeter
and
the
handling
time
factor
would
be
expected
to
result
in
less
time
for
the
residue
to
penetrate
the
outer
dosimeter.

4.
Versar
questions
the
validity
of
combining
dermal
exposure
data
from
mixers/
loaders
wearing
aprons
with
mixers/
loaders
wearing
Tyvek
coveralls.
Versar
also
questions
the
validity
of
using
hand
wash
data
for
pilots
who
wore
"
flight
gloves"
throughout
the
replicate.

5.
The
study
author
chose
to
eliminate
the
head
patch
data
for
the
mixer/
loader
portion
of
the
mixer/
loader/
pilot
replicate.
Versar
questions
the
validity
of
that
decision,
particularly
since
the
head
patch
residues
were
very
high
for
the
mixer/
loader
portion
of
the
replicate
and
very
low
for
the
pilot
portion
of
the
replicate.

6.
The
biomonitoring
measurements
in
the
study
are
complicated
further
by
the
fact
that
most
mixers/
loaders
and
pilots
were
exposed
to
propanil
within
3
days
prior
to
and/
or
within
three
Page
22
of
39
days
following
day
of
the
study.
In
addition,
other
mixers/
loaders
and
pilots
may
have
been
exposed
to
propanil
in
the
few
days
before
and/
or
after
the
study
date
 
their
exposure
during
those
days
is
unknown.
The
study
authors
adjusted
the
biomonitoring
results
for
those
handlers
exposed
within
3
days
prior
or
3
days
following
the
study
using
a
modeling
program
and
basing
the
calculation
of
excretion
half­
life
on
only
those
handlers
who
had
no
propanil
exposure,
except
on
the
day
of
the
study.
Twenty­
two
of
the
thirty
participants
had
propanil
exposures
on
days
other
than
just
the
study
day.
Urine
data
from
the
remaining
eight
participants
was
used
to
calculate
excretion
half­
life.
However,
two
of
those
eight
may
have
had
multiple
exposures
to
propanil
 
the
study
states
"
The
amount
applied
is
not
sure.
Exposure
may
happen."
And
four
other
of
those
eight
are
not
explicitly
known
to
have
no
exposures
 
the
study
states
"
No
dates
or
amount
applied
in
the
record
and
is
regarded
as
no
exposure."
The
two
remaining
participants
of
those
eight
in
the
"
single
exposure"
group
both
had
exposure
to
propanil
five
days
before
the
study
date.
Versar
questions
the
validity
of
adjusting
biomonitoring
data
on
the
basis
of
8
replicates
 
some
of
which
may
not
be
single
exposure
at
all.
Versar
notes
that
the
results
of
the
biomonitoring
study
indicate
much
higher
exposure
to
propanil
that
the
results
of
the
passive
dosimetry
and
personal
air
sampling
study.
Page
23
of
39
C.
CONCLUSIONS:

Dermal
and
inhalation
exposures
to
professional
handlers
were
assessed
during
the
mixing/
loading
and
aerial
application
of
propanil
to
rice
fields.
The
study
author
calculated
mean
total
exposures
(
doses)
of
2.10
±
3.80
:
g/
kg
ai/
day
for
mixers/
loaders
and
0.481
±
0.905
:
g/
kg
ai/
day
for
pilots
,
using
passive
dosimetry
and
personal
air
sampling.
The
study
author
also
calculated
total
exposures
(
doses)
of
54.7
±
120
:
g/
kg
ai/
day
for
mixer/
loaders
and
35.5
:
g/
kg
ai/
day
for
pilots
using
biomonitoring.
This
review
found
several
concerns
with
this
study.
Page
24
of
39
Table
9a.
Summary
of
Study
Report
Results
for
Mixer/
Loader
Replicates
Mixer/
Loader
Replicate
Loads
per
Day
Pounds
AI
Handled
per
Day
Actual
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
PPE
Worn
Exposed
Just
Before
or
Just
After
Study
Study
Reported
Total
Internal
Exposure
(:
g/
kg
ai/
day)

Dosimetry
+
Air
Sampling
Biomonitoring
V1
16
1328
3.43
6.2
6.7
apron,

boots
Before
0.0911
6.82
V3
12
1080
2.33
4
4.3
apron,

boots
No
0.253
2.16
V5
8
870
2.82
6.5
6.8
apron,

boots
No
1.022
4.75
V7
5
644
2.38
2.5
2.8
apron,

boots
Before
2.18
43.8
V9
16
1328
3.43
6.4
7.2
apron,

boots
Before
&

After
1
28.4
V13
6
510
1.75
2.3
2.8
apron,

boots
Before
0.0744
1.79
V15
6
510
1.75
2.3
2.7
apron,

boots
Before
&

After
0.0138
2.23
V17
9
776
5.3
6.1
6.4
tyvek,

boots
Before
6.50
11.2
V19
(
repl
#
1)
2
138
0.32
1.9
2.3
apron,

boots
Unknown
0.885
32.9
V19
(
repl
#
2)
1
156
0.05
V19
(
TOTAL)
3
294
0.37
V21
6
579
2.8
3.5
4.1
apron,

boots
No
0.239
20.9
V23
2
196
0.53
1.4
1.8
apron,

boots
Before
5.039
452
Mixer/
Loader
Replicate
Loads
per
Day
Pounds
AI
Handled
per
Day
Actual
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
PPE
Worn
Exposed
Just
Before
or
Just
After
Study
Study
Reported
Total
Internal
Exposure
(:
g/
kg
ai/
day)

Dosimetry
+
Air
Sampling
Biomonitoring
Page
25
of
39
V25
(
repl
#
1)
4
600
1.63
3
no
data
tyvek,

boots
After
0.0142
11.3
V25
(
repl
#
2)
2
204
0.78
V25
(
TOTAL)
6
804
2.41
V27
3
576
1.32
2.9
5
apron,

boots
Before
&

After
0.0967
3.78
V29
5
790
1.62
2.2
2.4
tyvek,

boots
After
0.117
9.97
V31
(
repl
#
1)
1
76
0.35
5.6
6
tyvek,

boots
Before
13.9
189
V31
(
repl
#
2)
2
192
0.82
V31
(
repl
#
3)
1
96
0.17
V31
(
TOTAL)
4
364
1.34
Mean
7.1
710
2.2
3.8
4.4
N/
A
N/
A
2.10
54.7
Page
26
of
39
Table
9b.
Summary
of
Pilot
(
Applicator)
Replicates
Pilot
Replicate
Loads
Acres
Treated
per
Replicate
(
total
=

acres/
day)
Actual
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
Pounds
AI
per
Acre
PPE
Exposed
Just
Before
or
Just
After
Study
Study
Reported
Total
Internal
Exposure
(:
g/
kg
ai/
day)

Dosimtery
+
Air
Sampling
Biomonitoring
V2
9
246
1.73
6.6
7.1
3
single
layer,
shoes,

socks
+

gloves
when
entering
or
exiting
After
1.62
17
V4
6
240
1.48
4.2
4.7
2.25
No
0.0572
8.28
V6
8
334
1.72
6.2
6.5
3
No
0.0423
2.38
V8
7
197
1.75
6.6
6.8
3
After
3.41
69.3
V10
6
254
1.70
2.5
2.9
2
After
0.0221
3.81
V14
(
repl
#
1)
4
137
1.3
3.2
3.9
4
Before
0.224
9.94
V14
(
repl
#
2)
1
32
0.15
3
V14
(
TOTAL)
5
169
1.45
N/
A
V16
(
repl
#
1)
2
72
0.38
2.8
3.1
1.9
Unknown
0.298
13.2
V16
(
repl
#
2)
1
51
0.3
3.1
V16
(
TOTAL)
3
87
0.68
N/
A
V20
(
repl
#
1)
2
73
0.53
NONE
4
3
No
0.0952
5.5
V20
(
repl
#
2)
4
160
1.5
2.25
V20
(
TOTAL)
6
233
2.03
N/
A
V22
2
49
0.87
1.4
2.2
4
Before
0.423
208
V24
(
repl
#
1)
4
200
1.17
3
3.2
3
After
0.0065
1.92
V24
(
repl
#
2)
2
102
0.98
3.1
2
V24
(
TOTAL)
6
302
2.15
6.3
N/
A
Pilot
Replicate
Loads
Acres
Treated
per
Replicate
(
total
=

acres/
day)
Actual
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
Pounds
AI
per
Acre
PPE
Exposed
Just
Before
or
Just
After
Study
Study
Reported
Total
Internal
Exposure
(:
g/
kg
ai/
day)

Dosimtery
+
Air
Sampling
Biomonitoring
Page
27
of
39
V26
3
129
1.28
2.3
5
4.5
Before
0.0157
0.495
V28
(
repl
#
1)
6
240
2.62
6
6.3
1.9
wore
"
flight"

gloves
Before
&

After
0.111
52.7
V28
(
repl
#
2)
3
156
1.2
2
V28
(
TOTAL)
9
396
3.82
N/
A
V30
5
197.5
1.32
2
2.2
4
same
as
V2
After
0.0809
16.9
V32
(
repl
#
1)
1
37.5
0.23
5
5.3
2
wore
"
flight"

gloves
Before
0.453
105
V32
(
repl
#
2)
3
138
1.22
2.1
V32
(
TOTAL)
4
175.5
1.45
N/
A
Mean
5.6
218
1.7
4.0
4.5
2.8
N/
A
N/
A
0.481
35.5
Table
9c.
Summary
of
Mixer/
Loader/
Pilot
Replicate
Mixer/
Loader/

Pilot
Replicate
Loads
Acres
Treated
per
Load
Actual
Time
Spent
in
Handling
Task
(
hours)
Inhalation
Monitoring
Time
(
hours)
Dermal
Monitoring
Time
(
hours)
Pounds
AI
per
Acre
Exposure
Just
Before
or
Just
After
Study
Study
Reported
Total
Internal
Exposure
(:
g/
kg
ai/
day)

Dosimetry
+

Air
Sampling
Biomonitoring
V12
(
mixing)
4
118
0.4
2.5
3.5
4
Before
&
Unknown
After
0.351
18.3
V12
(
applying)
1.4
V12
(
total)
1.8
Page
28
of
39
Table
10.
Potential
Inhalation
(:
g/
lbs
ai
handled)
Based
on
Residue
Levels
Found
on
Air
Filters
and
Air
Tubes
Site
Number
Replicate
No.
Flow
Rate
(
L/
min)
Combined
inhalation
residue
(
µ
g)
a
Duration
(
min)
Concentratio
n
(
µ
g/
m3)
b
lbs
ai
handle
d
Vent.
Rate
L/
min
*
0.001
for
m3/
min
at
16.7
l/
min
Inhalation
Exposurec
(
µ
g/
lb
ai
handled)
Mean
(
µ
g/
lb
ai
handled)
Geometric
Mean
(
µ
g/
lb
ai
handled)
Standard
Deviation
CV
(%)

Mixers/
loaders
1,
1A,
1B
3
1.9
0.038
242
0.08
1080
0.0167
3.11E­
04
1.37E­
02
6.08E­
03
0.02
0.01
1,
1C,
1D
5
2
0.889
389
1.14
870
0.0167
8.53E­
03
2,
2A,
2B,
2C
1
1.5
0.401
374
0.71
1328
0.0167
3.36E­
03
2,
2A,
2B,
2C
9
1.5
0.556
381
0.97
1328
0.0167
4.66E­
03
3,
3A,
3B
13
2
0.050
139
0.18
510
0.0167
8.16E­
04
3,
3A,
3B
15
2
0.100
138
0.36
510
0.0167
1.63E­
03
4,
4A;
4,
4B
19
1.9
0.190
115
0.87
294
0.0167
5.68E­
03
6,
6A,
6B,
6C
7
1.9
0.951
152
3.29
156
0.0167
5.36E­
02
6,
6D,
6E
23
2
0.370
81
2.28
196
0.0167
1.58E­
02
7,
7A,
7B
21
2
0.170
208
0.41
579
0.0167
2.45E­
03
8,
8A
27
2
0.561
172
1.63
576
0.0167
8.13E­
03
9,
9A;
9,
9B
25
2
0.663
180
1.84
804
0.0167
6.89E­
03
10,
10A,
10B,
10C
17
2
0.822
364
1.13
776
0.0167
8.85E­
03
10,
10D;
10,
10E;
31
2
0.455
334
0.68
76
0.0167
5.00E­
02
11,
11A,
11B
29
2
1.546
131
5.90
364
0.0167
3.55E­
02
Pilots
(
Applicator)

1,
1A,
1B
4
2
0.078
89
0.44
540
0.0083
6.02E­
04
2.04E­
03
9.26E­
04
0.003
0.01
1,
1C,
1D
6
2
0.180
103
0.87
870
0.0083
8.59E­
04
2,
2A,
2B,
2C
2
1.9
1.435
104
7.26
738
0.0083
8.49E­
03
2,
2A,
2B,
2C
8
2
0.060
105
0.29
591
0.0083
4.23E­
04
Page
29
of
39
3,
3A,
3B
10
2.1
0.088
102
0.41
510
0.0083
6.78E­
04
4,
4A;
4,
4B
16
2
0.256
43
2.98
156
0.0083
6.81E­
03
6,
6A,
6B;
6,
6C
14
2
0.217
97
1.12
644
0.0083
1.40E­
03
6,
6D,
6E
22
2
0.015
52
0.15
196
0.0083
3.21E­
04
7,
7A;
7,
7Bd
20
8,
8A
26
2
0.142
77
0.92
576
0.0083
1.02E­
03
9,
9A;
9,
9B
24
2
0.030
129
0.12
804
0.0083
1.54E­
04
10,
10A,
10B;
10,

10C
28
2
0.661
229
1.44
776
0.0083
3.54E­
03
10,
10D;
10,
10E
32
2
0.189
87
1.09
364
0.0083
2.16E­
03
11,
11A,
11B
30
2
0.015
79
0.10
790
0.0083
7.97E­
05
Mixer
loader
and
applicator
5,
5Ae
12
2
0.063
150
0.21
472
0.010339
6.94E­
04
NA
NA
NA
NA
a
Combined
inhalation
residue
(:
g)
=
Corrected
air
filters
residue
(:
g)
+
Corrected
air
tubes
residues
(:
g);
Air
filter
residues
corrected
for
56%
fortification
recovery
and
air
tube
residues
corrected
for
80%
fortification
recoveries
b
Concentration
(:
g/
m3)
=
[
Combined
inhalation
residue
(:
g)
/
(
Flow
rate
(
L/
min)
*
Duration
(
min))]*
1000
c
Inhalation
Exposure
(:
g/
lb
ai
handled)
=
(
Concentration
(:
g/
m3)
*
Vent.
Rate
(
m3/
min)
*
Duration
(
min))/
lbs
a.
i.
handled
d
Replicate
not
included
in
calculations
e
Inhalation
ventilation
rate
calculated
by
weighting
the
ventilation
rate
for
mixing/
loading
by
the
time
spent
mixing/
loading
and
the
ventilation
rate
for
applying
by
the
time
spent
applying.
Page
30
of
39
Table
11.
Summary
of
Hand
Exposure
(
µ
g/
lb
ai
handled)
based
on
Hand
Washes
Site
Number
Replicate
No.
Corrected
residue
(
µ
g/
mL)
a
Sample
volume
(
mL)
Concentration
(
µ
g)
b
lbs
ai
handled
Hand
exposure
(
µ
g/
lb
ai
handled)
c
Mean
(
µ
g/
lb
ai
handled)
Geometric
Mean
(
µ
g/
lb
ai
handled)
Standard
Deviation
CV
(%)

Mixers/
loaders
1,
1A,
1B
3
1.0073
500
504
1080
0.466
0.61
0.09
1.41
0.02
1,
1C,
1D
5
0.0813
500
41
870
0.047
2,
2A,
2B,
2C
1
0.1765
500
88
1328
0.066
2,
2A,
2B,
2C
9
0.1055
500
53
1328
0.040
3,
3A,
3B
13
0.0155
500
8
510
0.015
3,
3A,
3B
15
0.0061
500
3
510
0.006
4,
4A;
4,
4B
19
0.2359
500
118
294
0.401
6,
6A,
6B,
6C
7
0.1476
500
74
156
0.473
6,
6D,
6E
23
0.4301
500
215
196
1.097
7,
7A,
7B
21
0.0938
500
47
579
0.081
8,
8A
27
0.0140
500
7
576
0.012
9,
9A;
9,
9B
25
0.0061
500
3
804
0.004
10,
10A,
10B,
10C
17
1.2983
500
649
776
0.837
10,
10D;
10,
10E
31
0.8426
500
421
76
5.543
11,
11A,
11B
29
0.0123
500
6
364
0.017
Pilot
(
Applicators)

1,
1A,
1B
4
0.1000
500
50
540
0.093
0.46
0.14
0.72
0.02
1,
1C,
1D
6
0.0605
500
30
870
0.035
2,
2A,
2B,
2C
2
2.9407
500
1470
738
1.992
2,
2A,
2B,
2C
8
2.6268
500
1313
591
2.222
3,
3A,
3B
10
0.0315
500
16
510
0.031
Page
31
of
39
4,
4A;
4,
4B
16
0.1160
500
58
156
0.372
6,
6A,
6B;
6,
6C
14
0.4699
500
235
644
0.365
6,
6D,
6E
22
0.1417
500
71
196
0.361
7,
7A,
7B
20
0.1324
500
66
579
0.114
8,
8A
26
0.0061
500
3
576
0.005
9,
9A;
9,
9B
24
0.0061
500
3
804
0.004
10,
10A,
10B;
10,

10C
28
0.2696
500
135
776
0.174
10,
10D;
10,
10E
32
0.4133
500
207
364
0.568
11,
11A,
11B
30
0.2549
500
127
790
0.161
Mixer/
Loader/
Applicator
5,
5Ad
12
0.7068
500
353
472
0.75
NA
NA
NA
NA
a
Corrected
residue
(
µ
g/
mL)
=
Hand
wash
residue
(
µ
g)
*
Field
fortification
recovery
(
82%)

b
Concentration
(
µ
g)
=
Corrected
residue
(
µ
g/
mL)
*
Sample
volume
(
mL)

c
Hand
exposure
(
µ
g/
lb
ai
handled)
=
Concentration
(
µ
g)/
lbs
ai
handled
d
Hand
exposure
for
person
performing
mixing/
loading
and
applying
tasks.
Page
32
of
39
Table
12.
Summary
of
Face/
Neck
Exposure
(
µ
g/
lb
ai
handled)
based
on
Hat
Patches
Site
Number
Replicate
No.
Residue
(
µ
g/
sample)
Patches
surface
area
(
cm2)
a
Residue
(
µ
g/
cm2)
b
Fortification
recovery
Corrected
residue
(
µ
g/
cm2)
c
Combine
surface
area
of
face/
head/

neck
(
cm2)
Total
Concentration
(
µ
g)
d
lbs
ai
handled
Face/
Neck
exposure
(
µ
g/
lb
ai
handled)
Mean
(
µ
g/
lb
ai
handled)
Geometric
Mean
(
µ
g/
lb
ai
handled)
Standard
Deviation
CV
(%)

Mixers/
loaders
1,
1A,
1B
3
2.4691
206.45
0.0120
0.73
0.0164
2210
36.21
1080
0.034
9.4
0.65
23.06
0.02
1,
1C,
1D
5
137.9199
206.45
0.6681
0.73
0.9151
2210
2022.47
870
2.325
2,
2A,
2B,
2C
1
10.0646
206.45
0.0488
0.73
0.0668
2210
147.59
1328
0.111
2,
2A,
2B,
2C
9
219.4563
206.45
1.0630
0.73
1.4562
2210
3218.12
1328
2.423
3,
3A,
3B
13
1.117
206.45
0.0054
0.73
0.0074
2210
16.38
510
0.032
3,
3A,
3B
15
0.1827
206.45
0.0009
0.73
0.0012
2210
2.68
510
0.005
4,
4A;
4,
4B
19
8.2237
206.45
0.0398
0.73
0.0546
2210
120.59
294
0.410
6,
6A,
6B,
6C
7
226.5144
206.45
1.0972
0.73
1.5030
2210
3321.62
156
21.292
6,
6D,
6E
23
145.7732
206.45
0.7061
0.73
0.9673
2210
2137.63
196
10.906
7,
7A,
7B
21
6.3378
206.45
0.0307
0.73
0.0421
2210
92.94
579
0.161
8,
8A
27
20.8759
206.45
0.1011
0.73
0.1385
2210
306.13
576
0.531
9,
9A;
9,
9B
25
14.535
206.45
0.0704
0.73
0.0964
2210
213.14
804
0.265
10,
10A,
10B,

10C
17
793.6982
206.45
3.8445
0.9
4.2717
2210
9440.40
776
12.165
10,
10D;
10,
10E
31
464.3179
206.45
2.2491
0.73
3.0809
2210
6808.79
76
89.589
11,
11A,
11B
29
5.0092
206.45
0.0243
0.73
0.0332
2210
73.46
364
0.202
Pilot
(
Applicators)

1,
1A,
1B
4
0.2916
206.45
0.0014
0.73
0.0019
2210
4.28
540
0.008
0.58
0.05
1.0
0.03
1,
1C,
1D
6
1.495
206.45
0.0072
0.73
0.0099
2210
21.92
870
0.025
2,
2A,
2B,
2C
2
43.5914
206.45
0.2111
0.73
0.2892
2210
639.23
738
0.866
2,
2A,
2B,
2C
8
226.5144
206.45
1.0972
0.73
1.5030
2210
3321.62
591
5.620
3,
3A,
3B
10
0.177
206.45
0.0009
0.73
0.0012
2210
2.60
510
0.005
4,
4A;
4,
4B
16
7.9601
206.45
0.0386
0.73
0.0528
2210
116.73
156
0.748
Page
33
of
39
6,
6A,
6B;
6,
6C
14
0.8105
206.45
0.0039
0.73
0.0054
2210
11.89
644
0.018
6,
6D,
6E
22
8.4006
206.45
0.0407
0.73
0.0557
2210
123.19
196
0.629
7,
7A,
7B
20
6.30773
206.45
0.0306
0.73
0.0419
2210
92.50
579
0.160
8,
8A
26
0.4091
206.45
0.0020
0.73
0.0027
2210
6.00
576
0.010
9,
9A;
9,
9B
24
0.2244
206.45
0.0011
0.73
0.0015
2210
3.29
804
0.004
10,
10A,
10B;
10,

10C
28
0.2261
206.45
0.0011
0.73
0.0015
2210
3.32
776
0.004
10,
10D;
10,
10E
32
1.4476
206.45
0.0070
0.73
0.0096
2210
21.23
364
0.058
11,
11A,
11B
30
0.438
206.45
0.0021
0.73
0.0029
2210
6.42
790
0.008
Mixer/
Loader/
Applicator
5,
5A
(
mix/
load)
f
12
2959.333
206.45
14.3344
0.9
15.9271
2210
35198.87
472
74.57
74.58
NA
NA
NA
5,
5A
(
apply)
f
12
0.3464
206.45
0.0017
0.73
0.0023
2210
5.08
472
0.01
a
Two
hat
patches
(
one
on
front
and
one
on
back
of
cap
or
helmet)
were
4"
x4"
(
206.45
cm2
total
area).

b
Residue
(
µ
g/
cm2)
=
Residue
(
µ
g/
sample)/
Patches
surface
area
(
cm2)

c
Corrected
residue
(
µ
g/
cm2)
=
Residue
(
µ
g/
cm2)/
Fortification
Recovery
(
73%
for
residues
closest
to
low
level
fortification
and
90%
for
residues
closest
to
high
level
fortification)

d
Total
Concentration
(
µ
g)
=
Corrected
residue
(
µ
g/
cm2)
*
Combine
surface
area
of
face/
head/
neck
(
cm2)

e
Face/
Neck
exposure
(
µ
g/
lb
ai
handled)
=
Total
Concentration
(
µ
g)/
lbs
ai
handled
f
Mixer/
loader/
applicator
replicate
includes
residue
from
patches
while
mixing/
loading
plus
residues
from
patches
while
applying.
Page
34
of
39
Table
13.
Summary
of
Arms,
Legs,
and
Torso
Exposure
(
µ
g/
lb
ai
handled)
to
Pilots
Site
Number
Replicate
Number
Outer
Dosimeter
(
coverall)
Residues
corrected
for
77%
Field
Fortification
Recovery
(
µ
g)
Penetration
Factora
"
Inner
dosimeter"
residues
(
µ
g)
lbs
ai
handled
Dermal
Exposures
b
(
mg/
lb
ai)

Arm
Leg
Torso
Arm
Leg
Torso
Arm
Leg
Torso
1,
1A,
1B
4
134
183
344
0.016
2.1
2.9
5.5
540.0
3.93e­
06
5.37E­
06
1.01E­
05
1,
1C,
1D
6
1242
586
3471
0.002
2.7
1.3
7.6
870.0
3.13E­
06
1.48E­
06
8.75E­
06
2,
2A,
2B,
2C
2
3755
4618
819
0.061
230.5
283.5
50.3
738.0
3.12E­
04
3.84E­
04
6.81E­
05
2,
2A,
2B,
2C
8
133855
20844
91493
0.005
622.4
96.9
425.4
591.0
1.05E­
03
1.64E­
04
7.20E­
04
3,
3A,
3B
10
3.6
16.3
13.8
0.045
0.2
0.7
0.6
510.0
3.20E­
07
1.45E­
06
1.23E­
06
4,
4A;
4,
4B
16
780
2493
3197
0.003
2.2
7.2
9.2
156.0
1.44E­
05
4.61E­
05
5.91E­
05
6,
6A,
6B;
6,

6C
14
452
312
845
0.041
18.6
12.9
34.8
644.0
2.89E­
05
2.00E­
05
5.41E­
05
6,
6D,
6E
22
743
324
1445
0.003
2.1
0.9
4.1
196.0
1.08E­
05
4.72E­
06
2.10E­
05
7,
7A;
7,
7B*
20
87.5
97.7
3045.2
0.001
0.1
0.1
2.3
579.0
1.16E­
07
1.30E­
07
4.06E­
06
8,
8A
26
5.6
13.5
39.1
0.033
0.2
0.4
1.3
576.0
3.21E­
07
7.67E­
07
2.22E­
06
9,
9A;
9,
9B
24
1.8
13.9
6.0
0.104
0.2
1.4
0.6
804.0
2.31E­
07
1.80E­
06
7.77E­
07
10,
10A,
10B;

10,
10C
28
223
264
1056
0.006
1.3
1.5
6.0
776.0
1.64E­
06
1.95E­
06
7.78E­
06
10,
10D;
10,

10E
32
201
236
457
0.063
12.6
14.8
28.6
364.0
3.46E­
05
4.05E­
05
7.85E­
05
11,
11A,
11B
30
34.8
45.5
132
0.053
1.8
2.4
7.0
790.0
2.32E­
06
3.04E­
06
8.81E­
06
Mean
1.05E­
04
4.82E­
05
7.46E­
05
a
Penetration
factor
=
Inner
dosimeter
(
tee
shirt
and
briefs)
residue/
Torso
section
of
outer
dosimeter
b
Dermal
Exposures
=
("
Inner
dosimeter"
(
calculated
using
penetration
factor)/
lbs
ai
handled)/
1000
µ
g/
mg
Page
35
of
39
Table
14.
Summary
of
Total
Dermal
Exposures
for
Pilots
(
Applicators)

Site
Number
Replicate
Hand
exposure
(
mg/
lb
ai)
Face/
Neck
exposure
(
mg/
lb
ai)
Arm
Exposure
(
mg/
lb
ai)
Leg
Exposure
(
mg/
lb
ai)
Torso
Exposure
(
mg/
lb
ai)
Total
Dermal
Exposure
(
mg/
lb
ai)

Pilots
(
Applicators)

1,
1A,
1B
4
9.26E­
05
7.92E­
06
3.93E­
06
5.37E­
06
1.01E­
05
1.20e­
04
1,
1C,
1D
6
3.48E­
05
2.52E­
05
3.13E­
06
1.48E­
06
8.75E­
06
7.33e­
05
2,
2A,
2B,
2C
2
1.99E­
03
8.66E­
04
3.12E­
04
3.84E­
04
6.81E­
05
3.62e­
03
2,
2A,
2B,
2C
8
2.22E­
03
5.62E­
03
1.05E­
03
1.64E­
04
7.20E­
04
9.78e­
03
3,
3A,
3B
10
3.08E­
05
5.09E­
06
3.20E­
07
1.45E­
06
1.23E­
06
3.89e­
05
4,
4A;
4,
4B
16
3.72E­
04
7.48E­
04
1.44E­
05
4.61E­
05
5.91E­
05
1.24e­
03
6,
6A,
6B;
6,
6C
14
3.65E­
04
1.85E­
05
2.89E­
05
2.00E­
05
5.41E­
05
4.86e­
04
6,
6D,
6E
22
3.61E­
04
6.29E­
04
1.08E­
05
4.72E­
06
2.10E­
05
1.03e­
03
7,
7A;
7,
7B*
20
1.14E­
04
1.60E­
04
1.16E­
07
1.30E­
07
4.06E­
06
2.78e­
04
8,
8A
26
5.29E­
06
1.04E­
05
3.21E­
07
7.67E­
07
2.22E­
06
1.90e­
05
9,
9A;
9,
9B
24
3.79E­
06
4.09E­
06
2.31E­
07
1.80E­
06
7.77E­
07
1.07e­
05
10,
10A,
10B;
10,
10C
28
1.74E­
04
4.27E­
06
1.64E­
06
1.95E­
06
7.78E­
06
1.89e­
04
10,
10D;
10,
10E
32
5.68E­
04
5.83E­
05
3.46E­
05
4.05E­
05
7.85E­
05
7.80e­
04
11,
11A,
11B
30
1.61E­
04
8.13E­
06
2.32E­
06
3.04E­
06
8.81E­
06
1.84e­
04
Mean
1.27e­
03
Standard
Deviation
2.63e­
03
Page
36
of
39
Table
15.
Total
Dermal
+
Inhalation
Exposures
for
Pilots
(
Applicators)

Site
Number
Replicate
Inhalation
Exposure
(
µ
g/
lb
ai)
Hand
exposure
(
µ
g/
lb
ai)
Face/
Neck
exposure
(
µ
g/
lb
ai)
Arm
Exposure
(
µ
g/
lb
ai)
Leg
Exposure
(
µ
g/
lb
ai)
Torso
Exposure
(
µ
g/
lb
ai)
Total
Exposure
(
µ
g/
lb
ai)

Pilots
(
Applicators)

1,
1A,
1B
4
6.02E­
04
0.093
0.008
3.93E­
03
5.37E­
03
1.01E­
02
0.12
1,
1C,
1D
6
8.59E­
04
0.035
0.025
3.13E­
03
1.48E­
03
8.75E­
03
0.07
2,
2A,
2B,
2C
2
8.49E­
03
1.992
0.866
3.12E­
01
3.84E­
01
6.81E­
02
3.63
2,
2A,
2B,
2C
8
4.23E­
04
2.222
5.620
1.05E+
00
1.64E­
01
7.20E­
01
9.78
3,
3A,
3B
10
6.78E­
04
0.031
0.005
3.20E­
04
1.45E­
03
1.23E­
03
0.04
4,
4A;
4,
4B
16
6.81E­
03
0.372
0.748
1.44E­
02
4.61E­
02
5.91E­
02
1.25
6,
6A,
6B;
6,
6C
14
1.40E­
03
0.365
0.018
2.89E­
02
2.00E­
02
5.41E­
02
0.49
6,
6D,
6E
22
3.21E­
04
0.361
0.629
1.08E­
02
4.72E­
03
2.10E­
02
1.03
7,
7A;
7,
7B*
20
0.114
0.160
1.16E­
04
1.30E­
04
4.06E­
03
0.28
8,
8A
26
1.02E­
03
0.005
0.010
3.21E­
04
7.67E­
04
2.22E­
03
0.02
9,
9A;
9,
9B
24
1.54E­
04
0.004
0.004
2.31E­
04
1.80E­
03
7.77E­
04
0.01
10,
10A,
10B;
10,
10C
28
3.54E­
03
0.174
0.004
1.64E­
03
1.95E­
03
7.78E­
03
0.19
10,
10D;
10,
10E
32
2.16E­
03
0.568
0.058
3.46E­
02
4.05E­
02
7.85E­
02
0.78
11,
11A,
11B
30
7.97E­
05
0.161
0.008
2.32E­
03
3.04E­
03
8.81E­
03
0.18
Mean
1.28
Standard
Deviation
2.63
Page
37
of
39
Compliance
Checklist
Compliance
with
OPPTS
Series
875,
Occupational
and
Residential
Exposure
Test
Guidelines,
Group
A:
Guidelines,
875.1400
(
inhalation),
and
875.1200
(
dermal)
is
critical.
The
itemized
checklist
below
describes
compliance
with
the
major
technical
aspects
of
OPPTS
875.1400,
and
875.1200.

875.1400
°
Investigators
should
submit
protocols
for
review
purposes
prior
to
the
inception
of
the
study.
This
criterion
was
met.

°
Expected
deviations
from
GLPs
should
be
presented
concurrently
with
any
protocol
deviations
and
their
potential
study
impacts.
This
criterion
was
met.

°
The
test
substance
should
be
a
typical
end
use
product
of
the
active
ingredient.
This
criterion
was
met.

°
The
application
rate
used
in
the
study
should
be
provided
and
should
be
the
maximum
rate
specified
on
the
label.
However,
monitoring
following
application
at
a
typical
application
rate
may
be
more
appropriate
in
certain
cases.
This
criterion
was
not
met.
The
study
protocol
specified
that
the
maximum
label
rate
of
6
pounds
active
ingredient
per
acre
would
be
used
in
the
study.
However,
a
range
of
application
rates
(
1.9
to
4.5
lb
ai/
A)
were
used
in
the
study,
with
the
average
at
2.8
lb
ai/
A.

°
Selected
sites
and
indoor
conditions
of
monitoring
should
be
appropriate
to
the
activity.
This
criterion
was
met.

°
A
sufficient
number
of
replicates
should
be
generated
to
address
the
exposure
issues
associated
with
the
population
of
interest.
For
exposure
monitoring,
each
study
should
include
a
minimum
of
15
individuals
(
replicates)
per
activity.
This
criterion
was
partially
met.
There
were
15
mixer/
loader
replicates,
but
only
14
pilot
replicates
and
1
mixer/
loader/
pilot
replicate.

°
The
quantity
of
active
ingredient
handled
and
the
duration
of
the
monitoring
period
should
be
reported
for
each
replicate.
This
criterion
was
met.

°
Test
subjects
should
be
regular
workers,
volunteers
trained
in
the
work
activities
required,
or
typical
homeowners.
This
criterion
was
met.

°
The
monitored
activity
should
be
representative
of
a
typical
working
day
for
the
specific
task
in
order
to
capture
all
related
exposure
activities.
This
criterion
was
not
met.
The
protocol
specified
that
mixers/
loaders
and
pilots
would
be
monitored
for
an
entire
workday
and
included
hand
washes
that
assumed
a
lunch
break.
For
mixers/
loaders,
actual
exposure
times
ranged
from
0.37
to
5.30
(
average
=
2.2
hours),
whereas
dermal
monitoring
times
ranged
from
1.8
to
7.2
hours
(
average
=
4.4
hours)
and
inhalation
monitoring
times
ranged
from
1.4
to
6.5
hours
(
average
=
3.8
hours).
For
pilots,
actual
exposure
times
ranged
from
0.68
to
3.82
hours
(
average
=
1.7
hours),
whereas
dermal
monitoring
times
ranged
from
2.2
to
7.1
hours
(
average
=
4.49
hours)
and
inhalation
monitoring
times
ranged
from
1.4
to
6.6
hours
(
average
=
3.9
hours).

°
When
both
dermal
and
inhalation
monitoring
are
required,
field
studies
designed
to
measure
exposure
by
both
routes
on
the
same
subjects
may
be
used.
This
criterion
was
met.

°
The
analytical
procedure
must
be
capable
of
measuring
exposure
to
1
µ
g/
hr
(
or
less,
if
the
toxicity
of
the
material
under
study
warrants
greater
sensitivity).
This
criterion
was
met.

°
A
trapping
efficiency
test
for
the
monitoring
media
chosen
must
be
documented.
This
criterion
was
not
met.
Trapping
efficiency
tests
were
not
documented
for
any
of
the
media
used
in
this
study.

°
Air
samples
should
also
be
tested
for
breakthrough
to
ensure
that
collected
material
is
not
lost
from
the
medium
during
sampling.
It
is
recommended
that
at
least
one
test
be
carried
out
where
the
initial
trap
contains
10X
the
highest
amount
of
residue
expected
in
the
field.
This
criterion
was
not
met.
There
was
no
mention
of
any
breakthrough
tests
being
run
on
the
air
filters
used
in
the
study.

°
The
extraction
efficiency
of
laboratory
fortified
controls
is
considered
acceptable
if
the
lower
limit
of
the
95%
confidence
interval
is
greater
than
75%,
unless
otherwise
specified
by
the
Agency.
At
a
minimum,
seven
determinations
should
be
made
at
each
fortification
level
to
calculate
the
mean
and
standard
deviation
for
recovery.
Total
recovery
from
field­
fortified
Page
38
of
39
samples
must
be
greater
than
50%
for
the
study.
These
criteria
were
partially
met.
Only
five
determinations
were
made
for
each
matrix
at
each
fortification
level.
Field
fortification
results
were
provided
and
all
were
greater
than
50%.

°
If
trapping
media
or
extracts
from
field
samples
are
to
be
stored
after
exposure,
a
stability
test
of
the
compound
of
interest
must
be
documented.
Media
must
be
stored
under
the
same
conditions
as
field
samples.
Storage
stability
samples
should
be
extracted
and
analyzed
immediately
before
and
at
appropriate
periods
during
storage.
The
time
periods
for
storage
should
be
chosen
so
that
the
longest
corresponds
to
the
longest
projected
storage
period
for
field
samples.
This
criterion
was
met.
A
storage
stability
test
was
conducted,
however,
the
final
results
for
the
inner
and
outer
dosimeters
were
not
reported
in
this
Study
Report.
It
was
stated
that
they
would
be
included
in
an
appendix
to
this
report.

°
A
personal
monitoring
pump
capable
of
producing
an
airflow
of
at
least
2
L/
min.
should
be
used
and
its
batteries
should
be
capable
of
sustaining
maximum
airflow
for
at
least
4
hours
without
recharging.
Airflow
should
be
measured
at
the
beginning
and
end
of
the
exposure
period.
This
criterion
was
met.
Personal
monitoring
pumps
were
calibrated
to
2
L/
min
and
airflow
was
measured
at
the
beginning
and
end
of
the
exposure
period.

°
Appropriate
air
sampling
media
should
be
selected.
The
medium
should
entrap
a
high
percentage
of
the
chemical
passing
through
it,
and
it
should
allow
the
elution
of
a
high
percentage
of
the
entrapped
chemical
for
analysis.
This
criterion
was
met.
The
study
utilized
personal
air
samplers
containing
Gelman
filters
and
air
tubes.

°
If
exposed
media
are
to
be
stored
prior
to
extraction,
storage
envelopes
made
from
heavy
filter
paper
may
be
used.
The
envelope
must
be
checked
for
material
that
will
interfere
with
analysis.
Unwaxed
sandwich
bags
should
be
used
to
contain
the
filter
paper
envelopes
to
help
protect
against
contamination.
It
is
unclear
if
this
criterion
was
met.
The
Study
Report
does
not
provide
information
on
how
the
filters
and
tubes
were
stored.

°
Personal
monitors
should
be
arranged
with
the
intake
tube
positioned
downward,
as
near
as
possible
to
the
nose
level
of
the
subject.
This
criterion
was
met.

°
Field
calibration
of
personal
monitors
should
be
performed
at
the
beginning
and
end
of
the
exposure
period.
This
criterion
was
met.

°
Field
fortification
samples
and
blanks
should
be
analyzed
for
correction
of
residue
losses
occurring
during
the
exposure
period.
Fortified
samples
and
blanks
should
be
fortified
at
the
expected
residue
level
of
the
actual
field
samples.
Fortified
blanks
should
be
exposed
to
the
same
weather
conditions.
These
criteria
were
met.
The
study
author
stated
that
both
field
fortified
samples
and
field
blanks
were
collected.

°
Respirator
pads
should
be
removed
using
clean
tweezers
and
placed
in
protective
white
crepe
filter
paper
envelopes
inside
sandwich
bags.
The
pads
should
be
stored
in
a
chest
containing
ice
until
they
are
returned
to
the
laboratory,
where
they
should
be
stored
in
a
freezer
prior
to
extraction.
This
criterion
was
not
applicable
to
this
study.

°
Field
data
should
be
documented,
including
chemical
information,
area
description,
weather
conditions,
application
data,
equipment
information,
information
on
work
activity
monitored,
sample
numbers,
exposure
time,
and
any
other
observations.
These
criteria
were
met.

°
Analysis
methods
should
be
documented
and
appropriate.
This
criterion
was
met.

°
A
sample
history
sheet
must
be
prepared
by
the
laboratory
upon
receipt
of
samples.
This
criterion
was
not
met.

875.1200
°
Any
protective
clothing
worn
by
the
test
subjects
should
be
identified
and
should
be
consistent
with
the
product
label.
This
criterion
was
partially
met.
Pilots
wore
the
personal
protective
equipment
specified
on
the
product
labeling.
However,
mixers/
loaders
in
the
study
wore
either
a
chemical­
resistant
apron
or
a
Tyvek
coverall
over
the
"
outer"
dosimeter
and
also
wore
chemical­
resistant
footwear
 
in
calculating
potential
dermal
exposures
to
mixers/
loaders,
the
study
author
does
not
factor
in
this
additional
personal
protective
equipment,
which
exceeds
the
requirements
of
the
product
labeling;

°
Dermal
exposure
pads
used
for
estimating
dermal
exposure
to
sprays
should
be
constructed
from
paper­
making
pulp
or
similar
material
(
i.
e.,
alpha­
cellulose),
approximately
1
mm
thick,
that
will
absorb
a
considerable
amount
of
spray
without
disintegrating.
The
alpha­
cellulose
material
should
not
typically
require
preextraction
to
remove
substances
that
interfere
Page
39
of
39
with
residue
analysis.
This
should
be
determined
prior
to
using
the
pads
in
exposure
tests
.
This
criterion
probably
was
met
through
the
use
of
100%
cotton
dosimeters
in
this
study.

°
Dermal
exposure
pads
used
for
estimating
dermal
exposure
to
dust
formulations,
dried
residues,
and
to
dust
from
granular
formulation
should
be
constructed
from
layers
of
surgical
gauze.
The
pad
should
be
bound
so
that
an
area
of
gauze
at
least
2.5
inch
square
is
left
exposed.
The
gauze
must
be
checked
for
material
that
would
interfere
with
analysis
and
be
preextracted
if
necessary.
This
criterion
is
not
applicable
to
this
study.
°
°
A
complete
set
of
pads
for
each
exposure
period
should
consist
of
10
to
12
pads.
If
the
determination
of
actual
penetration
of
work
clothing
is
desired
in
the
field
study,
additional
pads
can
be
attached
under
the
worker's
outer
garments.
Pads
should
be
attached
under
both
upper
and
lower
outer
garments,
particularly
in
regions
expected
to
receive
maximum
exposure.
Pads
under
clothing
should
be
near,
but
not
covered
by,
pads
on
the
outside
of
the
clothing.
This
criterion
was
partially
met
through
the
use
of
the
whole
body
outer
dosimeters
in
this
study.
However,
the
inner
dosimeter
covered
the
torso
area
only,
and
therefore
did
not
allow
determination
of
actual
penetration
of
work
clothing
to
arms
and
legs.
Also,
mixers/
loaders
wore
either
a
chemical­
resistant
apron
or
Tyvek
coveralls
over
the
outer
dosimeter
 
limiting
the
amount
of
residue
on
the
outer
dosimeter.

°
If
exposed
pads
are
to
be
stored
prior
to
extraction,
storage
envelopes
made
from
heavy
filter
paper
may
be
used.
The
envelope
must
be
checked
for
material
that
will
interfere
with
analysis.
Unwaxed
sandwich
bags
should
be
used
to
contain
the
filter
paper
envelopes
to
help
protect
against
contamination.
This
criterion
probably
was
met.
Dosimeters
were
stored
in
aluminum
foil
and
placed
in
zip
lock
plastic
bags.

°
Hand
rinses
should
be
performed
during
preliminary
studies
to
ensure
that
interferences
are
not
present.
Plastic
bags
designed
to
contain
0.5
gal
and
strong
enough
to
withstand
vigorous
shaking
(
i.
e.,
at
least
1
mil
inch
thickness)
should
be
used.
During
preliminary
studies,
plastic
bags
must
be
shaken
with
the
solvent
to
be
used
in
the
study
to
ensure
that
material
which
may
interfere
with
analysis
is
not
present.
This
criterion
was
not
met.
The
study
author
made
no
mention
of
preliminary
hand
rinse
studies.

°
The
analytical
procedure
must
be
capable
of
quantitative
detection
of
residues
on
exposure
pads
at
a
level
of
1
ug/
cm2
(
or
less,
if
the
dermal
toxicity
of
the
material
under
study
warrants
greater
sensitivity).
It
is
unknown
if
this
criterion
was
met.
The
limit
of
quantitation
was
provided
as
ug/
sample.

°
The
extraction
efficiency
of
laboratory
fortified
controls
is
considered
acceptable
if
the
lower
limit
of
the
95%
confidence
interval
is
greater
than
75%,
unless
otherwise
specified
by
the
Agency.
At
a
minimum,
seven
determinations
should
be
made
at
each
fortification
level
to
calculate
the
mean
and
standard
deviation
for
recovery.
Total
recovery
from
field­
fortified
samples
must
be
greater
than
50%
for
the
study.
These
criteria
were
partially
met.
Only
five
determinations
were
made
for
each
matrix
at
each
fortification
level.
Field
fortification
results
were
provided
and
all
were
greater
than
50%.

°
If
the
stability
of
the
material
of
interest
is
unknown,
or
if
the
material
is
subject
to
degradation,
the
investigator
must
undertake
and
document
a
study
to
ascertain
loss
of
residues
while
the
pads
are
worn.
It
is
recommended
that
collection
devices
be
fortified
with
the
same
levels
expected
to
occur
during
the
field
studies.
The
dosimeters
should
be
exposed
to
similar
weather
conditions
and
for
the
same
time
period
as
those
expected
during
field
studies.
This
criterion
was
partially
met.
A
storage
stability
test
was
conducted,
however,
the
final
results
for
the
inner
and
outer
dosimeters
were
not
reported
in
this
Study
Report.
It
was
stated
that
they
would
be
included
in
an
appendix
to
this
report.

°
Data
should
be
corrected
if
any
appropriate
field
fortified,
laboratory
fortified
or
storage
stability
recovery
is
less
than
90
percent.
This
criterion
was
met.
The
study
author
corrected
data
for
all
field
recoveries
less
than
100%.

°
Field
data
should
be
documented,
including
chemical
information,
area
description,
weather
conditions,
application
data,
equipment
information,
information
on
work
activity
monitored,
sample
numbers,
exposure
time,
and
any
other
observations.
These
criteria
were
met.

°
A
sample
history
sheet
must
be
prepared
by
the
laboratory
upon
receipt
of
samples.
This
criterion
was
not
met.
