Document ID: EPA-HQ-OPP-2002-0202-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-08-14T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
Date:
April
24,
2002
MEMORANDUM
SUBJECT:
REVISION
OF
EXPOSURE
ASSESSMENT
FOR
PLANTING
OF
SEED
TREATED
WITH
LINDANE
FROM
David
Jaquith
Reregistration
Action
Branch
4
Health
Effect
Division
(7509C)

TO:
Becky
Daiss
Reregistration
Branch
4
Health
Effect
Division
(7509C)

THRU
Susan
Hummel,
Senior
Scientist
Reregistration
Branch
4
Health
Effects
Division
(7509C)

Please
find
attached
the
occupational
and
residential
exposure
assessment
for
lindane
DP
BARCODE
D282418
Pesticide
Chemical
Codes:
009001
EPA
Reg
Nos:

EPA
MRID
Nos.:
42251901
PHED:
No
1.0
INTRODUCTION
In
March
2001
HED
provided
an
exposure/
risk
assessment
for
seed
treatment
use
of
lindane
(1).
The
document
included
on­
farm
treatments
(using
wheat
as
the
typical
treatment),
planting
the
treated
seed,
and
commercial
seed
treatment
facilities.
The
treatment
of
seeds
using
on
farm
technology
has
not
changed.
The
assessment
of
exposure
during
planting
was
derived
from
PHED
V1.1
using
the
assumption
that
exposure
from
planting
treated
seed
would
be
similar
to
that
received
from
application
of
granular
formulations
of
pesticides.
Since
that
time
HED
has
received
a
study
actually
measuring
exposure
during
planting.
The
seed
planting
exposure
assessment
has
been
reviewed
by
HED
personnel.
The
results
and
review
of
this
study
are
presented
in
Appendix
A.

2.0
CONCLUSIONS
HED
has
reevaluated
the
estimates
of
exposure
and
risk
from
planting
of
wheat
and
canola
seed
with
lindane
using
a
study
specifically
addressing
this
scenario
rather
than
using
PHED
as
a
model
for
planting
seeds.
Using
an
oral
NOAEL
of
1.2
mg/
kg/
day
to
assess
dermal
risk
and
an
inhalation
NOAEL
of
0.13
mg/
kg/
day
the
MOEs
are
:

Estimation
of
Dermal
and
Respiratory
Exposures
or
Risksof
Workers
Planting
Wheat
and
Canola
Seed
Treated
with
Lindane
Dermal
Exposure
(mg/
kg/
day)
Respiratory
Exposure
(mg/
kg/
day)
MOE
Derma
l
Respiratory
Wheat
0.0013
0.00011
920
1200
Canola
0.0015
0.00013
800
1000
Examination
of
the
data
from
the
revised
assessment,
derived
from
a
planting
study
(not
included
in
PHED)
and
the
previous
assessment
from
PHED
indicates
that
there
are
a
large
number
of
non
detect
samples
in
both
of
the
data
sets.
Since
the
original
PHED­
derived
estimates,
which
separated
loading
from
planting
showed
large
numbers
of
non
detects
for
the
planting
function,
it
is
evident
that
the
loading
contributes
the
majority
of
the
exposure
and
that
the
actual
planting
task
contributes
relatively
little
to
the
total
exposure.

3.0
CALCULATION
OF
EXPOSURES
In
order
to
estimate
the
exposures
of
workers
planting
seed
treated
with
lindane
a
number
of
assumptions
regarding
amount
of
seed
planted
and
other
parameters
were
required.

1)
It
is
assumed
that
250
acres
of
wheat
or
canola
can
be
planted
in
a
day
(2).
2)
An
average
worker
has
a
body
weight
of
60
kg
(a
change
from
the
previous
assessment
due
to
changes
in
the
toxicological
parameters)
for
dermal
assessment.
A
weight
of
70
kg
is
used
for
inhalation
assessments.

3)
Wheat
is
planted
at
a
rate
of
120
lbs
of
seed
per
acre.
Canola
is
planted
at
a
rate
of
4
lbs
seed
per
acre.

4)
The
application
rate
of
lindane
on
wheat
seed
is
0.68
oz/
cwt
(0.043
lb/
cwt).
For
canola
the
rate
is
23.3
oz/
cwt
(1.5
lb
ai/
cwt).
See
Appendix
B.

5)
The
dermal
absorption
of
lindane
is
10
percent
(1).

3.1
Exposure
Assessment
for
Wheat
Amount
of
lindane
handled
per
day:

Lbs
ai/
day
=
250
A/
day
x
120
lb
seed/
A
x
0.043
lb
ai/
100
lbs
seed
=
12.9
lb
ai/
day
The
resulting
dermal
exposure
using
arithmetic
mean
values
from
Appendix
A
is:

Dermal
Exposure
(mg/
kg/
day)
=
0.0597
mg/
lb
ai
x
12.9
lb
ai/
day
x
0.1
(abs)
÷
60
kg
bw
=
0.0013
mg/
kg/
day
The
resulting
dermal
MOE
using
a
NOAEL
of
1.2
mg/
kg/
day
is:

MOE
=
1.2
mg/
kg/
day/
0.0013
mg/
kg/
day
=
920
The
respiratory
exposure
is:

Respiratory
Exposure
(mg/
kg/
day)
=
12.9
lb
ai/
day
x
0.0006
mg/
lb
ai
÷
70
kg
=
0.00011
mg/
kg/
day
The
resulting
respiratory
MOE
using
a
NOAEL
of
0.13
mg/
kg/
day
is:

MOE
=
0.13
mg/
kg/
day/
0.00011
mg/
kg/
day
=
1200
3.1
Exposure
Assessment
for
Canola
Amount
of
lindane
handled
per
day:

Lbs
ai/
day
=
250
A/
day
x
4
lb
seed/
A
x
1.5
lb
ai/
100
lbs
seed
=
15
lb
ai/
day
The
resulting
dermal
exposure
using
arithmetic
mean
values
from
Appendix
A
is:
Dermal
Exposure
(mg/
kg/
day)
=
0.0597
mg/
lb
ai
x
15
lb
ai/
day
x
0.1
(abs)
÷
60
kg
bw
=
0.0015
mg/
kg/
day
The
resulting
dermal
MOE
using
a
NOAEL
of
1.2
mg/
kg/
day
is:

MOE
=
1.2
mg/
kg/
day/
0.0015
mg/
kg/
day
=
800
The
respiratory
exposure
is:

Respiratory
Exposure
(mg/
kg/
day)
=
15
lb
ai/
day
x
0.0006
mg/
lb
ai
÷
70
kg
=
0.00013
mg/
kg/
day
The
resulting
respiratory
MOE
using
a
NOAEL
of
0.13
mg/
kg/
day
is:

MOE
=
0.13
mg/
kg/
day/
0.00013
mg/
kg/
day
=
1000
REFERENCES
1)
Memorandum
from
D.
Jaquith
(RRB4)
to
S.
Shallal
(RRB4)
titled
"OCCUPATIONAL
AND
RESIDENTIAL
EXPOSURE
ASSESSMENT
AND
RECOMMENDATIONS
FOR
THE
RE
REGISTRATION
ELIGIBILITY
DECISION
DOCUMENT
FOR
LINDANE",
dated
March
16,
2001.

2)
Memorandum
from
S.
Tadayon
(CEB)
to
A.
Khasawinah
(RRB4)
titled
"OCCUPATIONAL
AND
RESIDENTIAL
EXPOSURE
ASSESSMENT
AND
RECOMMENDATIONS
FOR
THE
RE
REGISTRATION
ELIGIBILITY
DECISION
DOCUMENT
FOR
IMAZALIL"
dated
April
15,
2,000.

cc:
Lindane
file
(009001)
R.
Kent
(RRB4/
7509C)
Correspondence
file
D.
Jaquith
(7509C)
APPENDIX
A.

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
March
03,
2002
Memorandum
SUBJECT:
Exposures
of
Workers
to
Isofenphos
During
Planting
of
Oftanol­
Treated
Canola
FROM:
Seyed
Tadayon,
Chemist
Chemistry
Exposure
Branch
Health
Effect
Division
(7509C)

TO:
Jeff
Evans,
Biologist
Chemistry
Exposure
Branch
Health
Effect
Division
(7509C)

DP
Barcode:
D281351
EPA
MRID
No:
42251901
Attached
is
a
review
of
the
applicator
exposure
during
planting
of
treated
seed
with
Oftanol®
which
was
submitted
by
Mobay
Inc.
This
review
was
completed
by
Versar,
Inc.
on
February
15,
2002,
under
supervision
of
HED.
It
has
undergone
secondary
review
in
the
HED
and
has
been
revised
to
reflect
Agency
policies.

Executive
Summary
Oftanol®
Technical
is
an
insecticide
incorporated
into
a
seed­
coating
material
that
forms
a
hard,
dry,
shell­
like
layer
on
the
outside
of
the
canola
seed.
The
purpose
of
this
study
was
to
quantify
inhalation
and
dermal
exposure
to
workers
planting
treated
seed
using
the
active
ingredients
isofenphos.
The
study
met
most
of
the
criteria
specified
in
Subdivision
K
(currently
referred
to
as
Series
875
.1100
and
875.1300
Group
B).

Summary
This
study
was
conducted
in
Domain,
Manitoba.
Oftanol®
Technical
was
applied
to
canola
seeds
prior
to
this
study
at
a
rate
of
12
g
ai
(isofenphos)
per
kg
of
seed.
Four
workers
were
monitored
four
times,
for
a
total
of
16
replicates,
as
they
opened
and
poured
both
the
contents
of
the
treated
seed
bags
(25
kg)
and
fertilizer
into
their
plant
hoppers.
The
workers
then
drove
a
tractor,
pulling
the
planter
around
the
field
planting
between
six
and
eight
pounds
of
seed
per
acre.
The
workers
used
closed
cab
tractors
with
a
ground
speed
ranging
between
5
to
7
mph.
Both
seed
and
fertilizer
traveled
down
a
tube
to
the
ground,
where
they
were
immediately
covered
with
soil
by
a
disc.
Each
replicate
lasted
an
average
of
3.22
hours
and
each
worker
handled
an
average
of
4.33
lbs
active
ingredient
per
replicate
All
workers
wore
long­
sleeved
shirts,
coveralls,
and
chemical
resistant
gloves,
in
addition
to
their
normal
clothing.
Air
temperatures
ranged
from
69
o
F
to
82
o
F
and
relative
humidity
ranged
from
30
to
73%.

Exposure
to
the
treated
seed
was
quantified
by
the
following
methods:

a)
Dermal
exposure
was
estimated
by
10
dermal
patches.
Dosimeters
were
attached
to
the
worker's
coverall
at
10
locations:
With
this
arrangement,
the
coveralls
represented
a
single
layer
of
normal
clothing
and
the
inner
dosimeters
collected
the
isofenphos
that
could
reach
the
workers'skin
if
they
were
wearing
only
a
single
layer
of
clothing.

b)
Exposure
to
the
workers'
hands
was
determined
by
the
hand­
rinse
method.

c)
Inhalation
exposure
was
monitored
by
attaching
a
quartz
microfiber
(QMA)
filters
in
polystyrene
cassettes
to
the
workers'
lapels.

d)
Cholinesterase
activity
was
monitored
by
collecting
blood
samples.

Exposure
values
for
both
potential
(based
on
exterior
patches)
and
actual
(based
on
interior
patches)
dermal
exposures
was
calculated.
The
Registrant
corrected
all
data
for
field
fortification
recoveries,
including
recoveries
above
90%.
For
those
values
below
the
LOD,
the
Registrant
used
½
the
recovery
corrected
LOD
value.
Versar
only
corrected
data
for
field
fortification
recoveries
less
<90%
and
reported
non­
detect
values
as
½
LOD.

Total
potential
dermal
exposures
ranged
from
0.0095
to
1.2369
mg/
lb
ai
handled.
The
primary
body
region
contributors
were
the
lower
arm
(0.1110
mg/
lb
ai
handled)
and
the
lower
leg
(0.0712
mg/
lb
ai
handled).
The
overall
average
total
potential
dermal
exposure
was
0.3326
±
0.3555
mg/
lb
ai
handled.
The
actual
dermal
exposure
estimates
ranged
from
0.0028
to
0.1053
mg/
lb
ai
handled
with
an
overall
average
actual
dermal
exposure
of
0.0296
±
0.0314
mg/
lb
ai
handled.
Total
dermal
exposure
estimates
included
both
actual
dermal
exposures
and
hand
exposures
and
averaged
0.0597
±
0.1001
mg/
lb
ai
handled.
Total
exposure
was
calculated
by
taking
the
sum
of
all
exposure
routes
(dermal­
hands,
dermal­
body,
and
inhalation).
The
Registrant
calculated
a
geometric
mean
total
exposure
of
0.15
mg/
lb
ai
applied.
Versar's
calculated
total
exposure
is
presented
in
Table
8
and
averaged
0.060
±
0.101
mg/
lb
ai
handled.

Conclusions
Dermal
and
inhalation
exposures
were
assessed
during
the
planting
of
treated
canola
seed.
The
workers
performed
both
loading
of
the
treated
seed
into
seed
hoppers
and
planting
of
the
seed.
Table
1
provides
a
summary
of
the
total
exposure
to
isofenphos
during
loading
and
planting
of
treated
seed,
as
calculated
by
Versar.
Versar's
calculated
average
total
exposure
was
0.060
±
0.101
mg/
lb­
ai
handled.
The
geometric
mean
total
exposure,
as
calculated
by
the
Registrant,
to
isofenphos
during
planting
of
treated
canola
seed
was
0.15
mg/
lb
ai
applied.
The
study
author
also
reported
total
exposure
in
mg/
replicate
and
assumed
that
a
worker
is
able
to
complete
three
replicates
per
day.
The
study
author
estimated
an
average
daily
exposure
of
1.9
mg,
but
noted
that
a
worker
would
probably
not
routinely
work
what
is
equivalent
to
three
replicates
per
day
during
the
planting
season
so
that
actual
daily
exposure
would
likely
be
less
than
1.9
mg/
day.

Table
1:
Summary
of
Total
Exposure
to
Oftanol
During
Loading
and
Planting
Treated
Canola.
Replicate
Exposure
(mg/
lb
ai
handled)

Dermal­
body
Dermal­
hands
Dermal­
Total
Inhalation
Inhalation
+
Dermal
Total
1
0.
0731
0.0104
0.0835
0.0011
0.085
2
0.
1053
0.0069
0.1122
0.0018
0.114
3
0.
0033
0.0034
0.0067
0.0002
0.007
4
0.
0053
0.0046
0.01
0.0002
0.01
5
0.
0249
0.0046
0.0295
0.029
6
0.
016
0.0056
0.0216
0.0002
0.022
8
0.
0028
0.0028
0
0.
003
9
0.
0411
0.3333
0.3745
0.0024
0.377
11
0.0108
0.0068
0.0176
0.0004
0.018
13
0.058
0.0043
0.0623
0
0.
062
14
0.0124
0.0051
0.0174
0
0.
017
15
0.0199
0.0032
0.0231
0.0002
0.023
16
0.0117
0.0037
0.0153
0.0002
0.016
Average
0.
0296
0.0327
0.0597
0.0006
0.06
Standard
Deviation
0.101
9
Attachment
Versar
Review
Memo
dated
Febuary
15,
2002
10
Reviewer:
Kelly
McAloon/
Marit
Espevik
Date
February
15,
2002
STUDY
TYPE:
Applicator
Passive
Dosimetry
Study
Using
Patch
Dosimetry,
Hand
Washes,
Inhalation
Monitoring,
and
Cholinesterase
Monitoring.

TEST
MATERIAL:
OFTANOL®
Technical
insecticide,
a
viscous
liquid
material
formulation
containing
90%
isofenphos
as
the
active
ingredient.

SYNONYMS:
1­
Methylethyl­
2­[[
ethoxy[(
1­
methylethyl)
amino]
phosphinothioyl]
oxy]
benzoate
(CAS
#
25311­
71­
1);
Isofenphos
(ISO­
E,
BSI);
Isophenphos
(ISO­
F)

CITATION:
Author:
V.
C.
Dean
Title:
Exposures
of
Workers
to
Isofenphos
During
Planting
of
Oftanol­
Treated
Canola
Seeds
Report
Date:
January
20,
1990
Performing
Organization:
Mobay
Corporation
Corporate
Occupational
and
Product
Safety
Agricultural
Chemicals
Division
P.
O.
Box
4913,
Hawthorn
Rd.
Kansas
City,
MO
64120
Identifying
Codes:
MRID
422519­
01;
Report
Number
99799;

SPONSOR:
Mobay
Corporation
Agricultural
Chemicals
Division
Research
&
Development
Department
EXECUTIVE
SUMMARY:

The
purpose
of
this
study
was
to
quantify
inhalation
and
dermal
exposure
of
workers
handling
canola
seed
treated
with
OFTANOL®
Technical,
containing
90%
isofenphos
as
the
active
ingredient.
The
seeds
had
been
treated
with
OFTANOL®
Technical
prior
to
this
study
and
25
kg
bags
of
treated
seed
were
provided
for
this
exposure
study.
The
study
was
conducted
in
Domain,
Manitoba
from
May
16­
23,
1989.
Four
workers
were
monitored
four
times,
for
a
total
of
16
replicates,
as
they
loaded
the
treated
seed
into
seed
hoppers
and
drove
tractors,
planting
between
six
and
eight
pounds
of
seed
per
acre.
Each
replicate
lasted
an
average
of
3.22
hours
and
each
worker
handled
an
average
of
4.33
lbs
active
ingredient
per
replicate.

Dermal
exposure
was
estimated
by
handwashes
and
by
dermal
patches
attached
to
the
inner
and
outer
clothing
of
each
worker.
Total
dermal
exposure
was
calculated
by
adding
the
dermal
exposure
to
the
hand
exposure
values.
Inhalation
exposure
was
measured
using
a
conventional
industrial
hygiene
methodology.
The
Registrant
provided
exposure
values
expressed
in
mg/
hr,
mg/
replicate,
and
mg/
lb
ai
applied.
Total
dermal
exposure
to
isofenphos,
determined
by
the
Registrant,
ranged
from
0.076
mg/
lb
ai
applied
to
0.42
mg/
lb
ai
applied.
The
geometric
mean
total
dermal
exposure
was
estimated
as
0.15
mg/
lb
ai
applied.
The
geometric
mean
inhalation
exposure
to
isofenphos
was
estimated
as
0.0003
mg/
lb
ai
applied.
Total
exposure
to
isofenphos
ranged
from
0.076
mg/
lb
ai
applied
to
0.43
mg/
lb
ai
applied
and
the
geometric
mean
was
0.15
mg/
lb
ai
applied.
The
study
author
also
reported
an
average
daily
total
exposure
of
1.9
mg/
day,
assuming
that
a
worker
is
able
to
complete
three
replicates
per
day.

Versar
calculated
exposure
estimates
in
mg/
lb
ai
handled,
as
per
EPA's
request.
Raw
residue
data
were
corrected
using
the
field
fortification
recoveries.
Versar
only
corrected
for
field
recoveries
less
than
90%.
Versar
calculated
a
mean
potential
11
inhalation
exposure
of
0.0006
±
0.0008
mg/
lb
ai
handled.
The
overall
average
dermal
exposure
and
the
average
hand
exposure,
as
calculated
by
Versar,
were
0.0296
±
0.0314
and
0.0327
±
0.0947
mg/
lb
ai
handled,
respectively.
Total
dermal
exposure
was
calculated
as
the
sum
of
the
overall
dermal
exposure
and
hand
exposure
and
averaged
0.0597
±
0.1001
mg/
lb
ai
handled.
Versar
also
calculated
total
exposure
as
the
sum
of
all
exposure
routes.
The
average
total
exposure
was
estimated
0.060
±
0.101
mg/
lb
ai
handled.

The
Study
Report
also
included
cholinesterase
monitoring
results.
These
results
show
that
the
isofenphos
exposures
to
the
workers
were
well
within
the
acceptable
limits.
The
greatest
deviations
observed
were
7.7%
in
the
plasma
and
3.7
%
in
the
erythrocytes.
The
study
author
attributed
these
deviations
to
natural
variations.

The
study
met
most
of
the
Series
875.1100
and
875.1300
Guidelines.
The
major
issues
of
concern
were:
(1)
this
study
was
performed
at
only
one
test
site,
(2)
raw
field
data
were
corrected
for
all
recoveries,
even
those
greater
than
90%,
(3)
concurrent
laboratory
fortification
recoveries
were
not
provided
in
the
Study
Report,
(4)
the
limit
of
quantification
was
not
provided
for
any
media,
only
the
limit
of
detection,
(5)
the
analysis
dates
were
not
provided
for
any
of
the
samples
in
this
study
in
order
to
verify
storage
stability
results,
(6)
individual
field
blank
results
were
not
provided
in
the
Study
Report,
(7)
there
was
only
one
field
fortification
level
for
air
filter
samples,
(8)
the
Registrant
used
½
the
recovery
corrected
sample
quantification
limits
for
non­
detect
values,
rather
than
½
the
method
limit
of
detection
for
that
media,
(9)
method
validation
recoveries
were
not
provided
for
handwash
samples,
(10)
information
on
the
individuals
who
participated
in
this
study
was
not
provided,
(11)
the
inhalation
methodology
was
calibrated
with
an
airflow
of
1L/
min
instead
of
2L/
min,
(12)
the
Registrant
used
the
inhalation
geometric
mean
for
replicate
5
since
no
sample
was
collected,
(13)
the
Registrant
used
values
slightly
different
from
the
NAFTA
recommended
body
region
surface
areas,
and
(14)
the
Registrant
calculated
face
exposures
from
head
exposures.

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
stated
that
the
EPA
Good
Laboratory
Practice
Standards
(40
CFR
part
160)
did
not
apply
to
the
study.

GUIDELINE
OR
PROTOCOL
FOLLOWED:
A
study
protocol
was
provided
with
the
Study
Report.
OPPTS
Series
875,
Occupational
and
Residential
Exposure
Test
Guidelines,
Group
A:
875.1100
(dermal
exposure),
and
875.1300
(inhalation
exposure)
were
followed
for
the
compliance
review
of
this
study.

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

Formulation:
OFTANOL®
Technical
insecticide
contains
90%
(by
weight)
of
isofenphos
as
the
active
ingredient
(ai).
This
product
is
a
viscous
liquid
material
that
is
used
as
a
seed
treatment.

Lot/
Batch
#
technical:
8­
00­
5270A
Lot/
Batch
#
formulation:
Not
provided.
Purity
in
technical:
The
OFTANOL®
Technical
was
assayed
during
production
at
91.8%
isofenphos.
CAS
#(
s):
25311­
71­
1
Other
Relevant
Information:
EPA
Registration
number
is
3125­
326.

2.
Relevance
of
Test
Material
to
Proposed
Formulation(
s):

The
product
label
was
not
provided
for
the
test
material
used
in
this
study.
Versar
was
able
to
locate
a
product
label
with
the
same
product
name
as
the
one
used
in
this
study.
.

3.
Packaging:
12
The
packaging
of
the
test
product
was
not
reported
in
the
study.
All
seed
coating
was
performed
prior
to
this
study
and
25
kg
bags
of
treated
seed
were
provided
for
this
study.

B.
STUDY
DESIGN
There
were
3
deviations
to
the
protocol:
(1)
in
addition
to
the
analyses
of
plasma
and
erythrocyte
levels,
whole
blood
levels
were
also
evaluated.
Mobay
Corporation's
cholinesterase
analysis
procedure
includes
whole
blood
and
it
was,
therefore,
routinely
included
in
the
analysis,
(2)
one
blood
sample
was
collected
the
morning
after
a
worker
completed
his
monitored
work
cycle
rather
than
immediately
afterwards,
and
(3)
for
replicate
sampling,
three
of
the
sixteen
replicates
monitored
were
not
included
in
the
data
evaluation.
No
adverse
effects
due
to
these
deviations
were
reported
in
the
Study
Report.

1.
Number
and
type
of
workers
and
sites:

Four
individuals
participated
in
the
study
at
one
test
site,
each
serving
as
a
subject
four
times,
for
a
total
of
sixteen
replicates.
Each
test
subject
was
a
private
grower.
The
number
of
years
of
experience
per
worker
was
not
provided.
Each
participant
signed
an
informed
consent
form
prior
to
the
initiation
of
the
study
after
being
provided
the
proper
information
regarding
the
study,
products
being
used,
and
proper
precautions.

The
seed
treatment
was
performed
on
canola
seed
prior
to
this
study
in
Nisku,
Alberta,
Canada,
from
January
17­
19,
1989.
This
study
took
place
in
Domain,
Manitoba
where
the
treated
canola
seeds
were
planted
from
May
16­
23,
1989.

2.
Meteorology:

Air
temperatures,
relative
humidity,
and
wind
speed
and
direction
were
reported
for
the
four
sampling
days.
Air
temperatures
ranged
from
69
o
F
to
82
o
F
and
relative
humidity
ranged
from
30
to
73%.
Wind
speed
was
reported
as
gusty
for
the
first
two
sampling
days,
with
wind
speeds
ranging
from
10­
30
mph.
Wind
speed
on
the
remaining
two
sampling
days
ranged
from
0­
10
mph.
Wind
direction
was
reported
as
variable.

3.
Replicates:

Each
of
the
four
workers
were
monitored
for
four
replicates
as
they
opened
and
poured
both
the
contents
of
the
seed
bags
and
fertilizer
into
their
plant
hoppers.
The
workers
then
drove
a
tractor,
pulling
the
planter
around
the
field
planting
between
six
and
eight
pounds
of
seed
per
acre.
Table
1
presents
a
summary
of
the
hours
worked
and
the
lb
ai
handled
for
all
of
the
replicates.

Table
1.
Summary
of
Replicates
13
Date
Replicates
*
Worker
ID
Hours
Worked
lb
ai
handled
37391
1
A
2.73
1.92
37391
2
A
2.25
2.88
37391
3
B
4.33
5.95
37391
4
B
3.08
4.32
37391
5
C
3.03
4.32
37391
6
C
3.08
3.6
37392
8
D
1.83
4.32
37392
9
A
4.75
5.76
37392
11
B
3.
62
2.
94
37393
13
D
2.
87
4.
62
37393
14
D
2.
58
3.
96
37398
15
C
4.
62
6.
24
37398
16
C
3.
13
5.
46
*
Replicates
7,
10,
and
12
not
used.

4.
Protective
clothing:

All
workers
wore
long­
sleeved
65%
polyester/
35%
cotton
work
shirts,
65%
polyester/
35%
cotton
coveralls,
and
chemical
resistant
(nitrile,
Best
No.
730)
gloves,
in
addition
to
their
normal
clothing
(denim
trousers,
cotton
shirts,
boots
or
tennis
shoes,
and
baseball
caps).
The
long­
sleeved
shirts,
coveralls
and
caps
were
supplied
by
Mobay
Corporation
and
served
as
attachment
sites
for
dermal
dosimeters.
The
gloves,
also
supplied
by
Mobay
Corporation,
were
used
only
as
protective
equipment.

5.
Planting
method:

Worker
A:
Worker
A
used
an
International
310
Diskall
pulled
by
a
closed
cab
tractor
at
a
ground
speed
of
7
mph.
The
worker
opened
the
bags
of
treated
seed
and
poured
them
into
the
seeder
hopper.
Fertilizer
was
also
loaded
into
a
hopper.
Both
seed
and
fertilizer
dropped
to
the
ground
and
were
immediately
covered
with
soil
by
a
disc.
This
equipment
arrangement
provided
for
a
45
ft
swath.

Worker
B:
Worker
B
used
a
Coop­
Implements
­
G­
100
Disker
pulled
by
a
John
Deer
8630
close
cab
tractor
at
a
ground
speed
of
5
mph.
The
worker
cut
the
bags
open
with
a
pocket
knife,
stood
on
the
back
of
the
seeder
and
poured
the
25
kg
bag
of
treated
seed
into
the
trough
of
the
seeder.
Fertilizer
was
also
poured
into
the
seeder.
Both
seed
and
fertilizer
traveled
down
a
tube
to
the
ground,
where
they
were
immediately
covered
with
soil
by
a
disc.
This
equipment
arrangement
provided
for
a
30
ft
swath.

Worker
C:
Worker
C
used
an
Air
System
1502
Concord
seeder,
pulled
by
a
Steiger/
Cougar
1000
closed
cab
tractor
at
a
ground
speed
of
6
mph.
The
Concord
Air
tank
is
attached
to
an
EZZE­
On
Cultivator.
The
worker
loaded
the
bags
of
treated
seed
into
the
back
of
a
fertilizer
truck.
The
truck
was
driven
to
the
field
and
poured
into
the
hopper
of
the
seeder.
Fertilizer
was
conveyed
from
the
truck
by
an
auger
to
a
hopper
on
the
seeder.
Both
seed
and
fertilizer
were
conveyed
by
air
up
to
the
planter,
where
they
were
deposited
into
the
soil.
This
equipment
arrangement
provided
for
a
36
ft
swath.

Worker
D:
Worker
D
used
a
Chinook
1203,
pulled
by
a
Steiger
CP
1360
closed
cab
tractor
at
a
ground
speed
of
6
mph.
The
Chinook
1203
has
two
hoppers,
one
for
seed
and
one
for
fertilizer.
The
worker
opened
the
25
kg
bags
of
treated
seed
and
poured
them
into
the
seed
hopper
of
the
Chinook
1203.
Seed
and
fertilizer
traveled
from
the
hoppers
through
tubing
to
the
ground
and
were
deposited
into
the
soil.
This
equipment
arrangement
provided
for
a
40
ft.
swath.

6.
Application
Rate:
14
OFTANOL®
Technical
is
an
insecticide
incorporated
into
a
seed­
coating
material
that
forms
a
hard,
dry,
shell­
like
layer
on
the
outside
of
the
canola
seed.
According
to
the
study
author,
the
coated
seeds
are
virtually
dust­
free,
when
applied
in
this
manner.
The
insecticide
protects
newly
sprouted
canola
plants
against
the
flee
beetle.

OFTANOL®
Technical
was
applied
to
canola
seeds
prior
to
this
study
at
a
rate
of
12
g
ai
(isofenphos)
per
kg
of
seed.
All
of
the
seed
coating
was
done
in
Nisku,
Alberta,
Canada,
from
January
17­
19,
1989.
A
product
label
was
not
provided
in
the
Study
Report.
Versar
was
able
to
obtain
a
product
label,
but
the
label
did
not
provide
a
recommended
application
rate.

Since
OFTANOL®
Technical
is
not
registered
in
Canada,
this
study
was
conducted
under
Research
Permit
Sub.
No.
89­
007.

7.
Exposure
monitoring
methodology:

Dermal
dosimeters:
Dermal
exposure
was
estimated
by
10
dermal
patches.
Dosimeter
units
consisted
of
a
3­
inch
by
3­
inch
12­
ply
gauge
surgical
sponge
enclosed
in
an
aluminized
paperboard
holder.
Dosimeters
were
attached
to
the
worker's
coverall
at
10
locations:
both
upper
arms,
both
palmar
forearms
three
inches
above
the
wrists,
right
chest
just
above
the
pocket,
left
back
at
the
shoulder
blade,
the
front
of
both
thighs,
and
both
shins.
Each
paperboard
holder
had
a
circular
opening,
5.6
cm
in
diameter,
which
faced
away
from
the
body
to
allow
isofenphos
to
collect
on
the
gauze
sponge.
One
dosimeter
was
also
attached
to
the
worker's
cap
just
above
the
bill
and
a
second
set
of
dosimeters
was
attached
to
the
worker's
clothing
inside
the
coveralls
at
the
following
locations:
both
upper
arms,
both
palmar
forearms,
left
chest,
right
back,
both
thighs,
and
both
shins.
With
this
arrangement,
the
coveralls
represented
a
single
layer
of
normal
clothing
and
the
inner
dosimeters
collected
the
isofenphos
that
could
reach
the
workers'
skin
if
they
were
wearing
only
a
single
layer
of
clothing.

Dosimeters
were
worn
until
the
completion
of
the
monitoring
period,
including
maintenance,
checking
seed
and
fertilizer
levels,
and
changing
sites.
At
the
end
of
the
monitoring
interval,
the
dosimeters
were
removed
from
the
clothing
and
placed
on
a
table.
When
all
the
dosimeters
were
removed,
the
gauze
sponges
were
removed
from
their
paperboard
holders
with
tweezers
and
placed
in
labeled
1­
ounce
glass
bottles
which
were
capped
with
polyseal­
lined
screw
caps
and
stored
on
dry
ice.

Hand:
Exposure
to
the
workers'
hands
was
determined
by
the
hand­
rinse
method.
At
the
end
of
the
monitoring
period,
and
at
intermediate
times
when
hands
would
normally
be
washed,
the
worker's
hands
were
rinsed
using
the
following
procedure:
200
mL
portion
of
absolute
ethanol
was
placed
into
a
42­
oz
Whirl­
Pak
bag.
The
worker
placed
one
hand
into
the
bag
and
the
bag
was
held
tightly
around
the
wrist.
The
hand
and
bag
were
shaken
50
times.
The
ethanol
was
stored
in
the
plastic
bag
and
used
for
subsequent
washes
during
the
monitoring
period
until
the
final
wash.
After
the
final
wash,
it
was
transferred
into
a
800
mL
bottle
for
storage.
Each
hand
was
washed
twice,
for
a
total
of
four
washed
per
replicate.
After
each
of
the
four
washes,
the
solution
was
transferred
into
a
800
mL
bottle
and
vigorously
shaken
50
times.
An
aliquot
of
the
combined
solution
(left
and
right
hand)
was
then
transferred
into
a
one­
ounce
labeled
sample
bottle
and
placed
on
dry
ice.
The
remaining
solution
was
discarded.
On
seven
occasions,
the
outsides
of
the
workers'
gloves
were
washed
by
the
same
method
to
provide
a
comparison
of
the
amounts
of
isofenphos
residues
on
hands
and
gloves.

Inhalation:
Inhalation
exposure
was
monitored
using
a
conventional
industrial
hygiene
methodology.
Quartz
microfiber
(QMA)
filters
in
polystyrene
cassettes
were
attached
to
the
workers'
lapels.
Air
was
drawn
through
the
filters
at
approximately
1
L/
min
by
a
portable,
battery­
powered
pump
(Gilian
HFS
113A)
attached
to
the
workers'
belt
and
connected
to
the
filter
cassette
with
PVC
tubing.
The
filters
removed
particulates
and
aerosols
containing
isofenphos
from
the
air
during
exposure
sampling.
When
sampling
was
complete,
the
cassette
was
removed,
capped,
placed
in
a
Whirl­
Pak
and
stored
on
dry
ice.

Cholinesterase:
Blood
samples
were
collected
by
venipuncture
for
determination
of
cholinesterase
activity
in
the
erythrocyte
and
plasma
fractions.
The
puncture
site
was
washed
thoroughly
with
alcohol
before
sampling
to
sterilize
and
remove
any
isofenphos
contamination
that
could
affect
the
cholinesterase
results.
The
following
schedule
was
used:
1)
Three
pre­
exposure
samples
were
collected
to
establish
the
baseline
value
for
each
participant.
They
were
collected
during
the
week
before
planting
began.
Participants
and
Chemargro
Ltd.
technical
personnel
gave
assurances
that
participants
had
not
15
worked
with
cholinesterase­
inhibiting
materials
for
a
two­
week
period
prior
to
the
baseline
sampling;
and
2)
one
sample
was
collected
at
the
end
of
each
workday,
when
all
work
with
isofenphos
was
completed.
All
samples
were
collected
by
a
locally
licensed
nurse.
They
were
shipped
by
overnight
express
to
the
Mobay
Corporation
Toxicology
Laboratory
in
Stilwell,
Kansas.
The
samples
were
analyzed
the
following
morning,
using
an
automated
modified
Ellman
method.
Results
were
communicated
by
telephone
to
the
study
site
at
mid­
day
on
the
day
following
sample
collection.

All
samples
collected
during
mornings
were
stored
in
ice
chests
on
dry
ice
for
approximately
four
hours
until
field
collection
activities
for
the
afternoon
replicates
were
complete.
All
samples
were
then
repacked
on
dry
ice
for
shipping
to
the
Mobay
Corporation
Analytical
Laboratory
in
Kansas
City,
Missouri.
At
the
analytical
laboratory,
the
samples
were
stored
in
freezers
at
­7
degrees
Celsius.

8.
Analytical
Methodology:

Extraction
method(
s):

Dermal
Exposure
Patches
­
15
mL
of
ethanol
was
pipetted
into
sample
vials
and
the
vials
were
recapped.
The
sample
vials
were
placed
in
a
vertical
position
on
a
rotator
and
spun
for
30
minutes
to
ensure
complete
absorption.
Five
mL
of
the
sample
solution
was
pipetted
into
a
clean
15­
mL
vial
and
0.5
mL
of
a
0.5%
carbowax
solution
was
added.
The
solvent
was
evaporated
from
the
sample
solution
using
a
stream
of
dry
nitrogen
and
a
heating
block
at
43
o
C.
The
sample
residue
was
reconstituted
by
pipetting
5
mL
of
t­
butyl
methyl
ether
(MTBE)
into
the
sample
vial.
The
vial
was
capped
with
a
polyseal
and
shaken
for
30
seconds.

Handrinse
Samples
­
The
samples
were
shaken
vigorously
and
then
a
portion
was
filtered
using
a
LID/
X
filter.
A
portion
of
the
filtered
solution
was
immediately
transferred
into
an
autosampler
vial
and
the
vial
was
capped.

Air
Filters­
Filters
were
transferred
to
0.5­
ounce
vials
and
2.0
mL
of
MTBE
was
added.
The
vial
was
sealed
with
a
polyseal
lid
and
gently
swirled
to
wet
the
filter
thoroughly.
The
sample
vial
was
placed
on
a
rotator,
the
rotator
wheel
was
put
in
a
vertical
position,
and
the
vial
was
spun
for
30
minutes
to
ensure
complete
desorption.

Detection
method(
s):
See
Table
2.
16
Table
2.
Summary
of
GC
Chromatographic
and
HPLC
Conditions
Media
Air
Filters
Dermal
pads
Hand
Rinses
Instrument
Varian
Model
3400
Varian
Model
3400
Shimadzu
CR­
3A
/Varian
4270
Column
J&
W,
0.541mm
i.
d.
x
15m
length
DB­
Wax
fused­
silica
capillary
column
with
a
1.0
:
m
film
thickness
J&
W,
0.541mm
i.
d.
x
15m
length
DB­
Wax
fused­
silica
capillary
column
with
a
1.0
:
m
film
thickness
DuPont
Zorbax
C­
8
column,
4.6mm
i.
d.
x
25
cm
length
with
a
0.45
:
m
pore
size
Detector
Nitrogen/
phosphorous
detector
Nitrogen/
phosphorous
detector
Temperatures
Column:
Initial:
100
o
C
Final:
185
o
Injector:
250
o
C
Detector:
300
o
C
Column:
Initital:
100
o
C
Final:
185
o
Injector:
250
o
C
Detector:
300
o
C
Column:
Ambient
Injection
Volume
9
µL
9
µL
100
µL
Retention
Time
Isofenphos:
12.3
min
Isofenphos
oxygen
analog:
13.5
min
Isofenphos:
11.6
min
Isofenphos
oxygen
analog:
12.7
min
Isofenphos:
10.5
min
Isofenphos
oxygen
analog:
3.8
min
Quantitative
Range
0.0025­
0.05
ng/
:
L
0.
0025­
0.05
ng/
:
L
0.
2­
10
ng/
:
L
Method
validation:
The
limit
of
detection
(LOD)
for
air
filters,
gauze
pads,
and
handwash
samples
was
approximately
5ng/
sample,
38
ng/
sample,
and
40
:
g/
sample,
respectively.
For
method
validation,
five
air
filter
samples
were
fortified
at
the
0.2
:
g
level
for
both
isofenphos
and
its
oxygen
analog.
Fourteen
dermal
gauze
samples
were
fortified
at
loadings
of
1.0,
10,
100,
and
1000
:
g
of
isofenphos
under
field
conditions.
Handwash
samples
were
fortified
at
loadings
of
100
and
1000
:
g
using
field
samples.
Method
validation
recoveries
for
the
air
filter
samples
averaged
109.0%
±
3.6%
for
isofenphos
and
94.4%
±
7.3%
for
its
oxygen
analog.
Recoveries
for
the
dermal
gauze
pads
averaged
96.9%±
6%
and
94.2%±
3%,
for
the
1.0
and
1000
:
g
loadings
respectively.
Method
validation
recoveries
for
handwash
samples
were
not
reported
in
the
Study
Report.

Instrument
performance
and
calibration:
According
to
the
Study
Report,
analytical
calibration
standard
curve
data
were
generated
before
and
after
each
set
of
samples
analyzed.
Standard
concentrations
were
chosen
to
bracket
the
sample
concentrations.
Only
concentrations
within
the
validated
range
for
each
media
were
used.

Quantification:
Sample
concentrations
were
calculated
using
the
linear
regression
function
of
a
chromatography
software.
Concentrations
of
isofenphos
in
the
samples
were
determined
directly
from
the
standard
curve.

9.
Quality
Control:

Lab
Recovery:
Laboratory
recoveries
were
not
reported
in
the
Study
Report.

Field
blanks:
Field
blanks
were
collected
for
each
media.
All
values
were
reported
to
be
less
than
the
LOD,
except
for
2
gauze
pad
samples
(0.170
and
11.7
:
g).

Field
recovery:
Handwash
Samples:
Duplicate
handwash
samples
were
fortified
at
200
and
2000
:
g
levels
each
sampling
17
day
at
the
site
by
spiking
a
200
mL
ethanol
portion
with
isofenphos
formulation
solutions.
The
spiked
solutions
were
transferred
into
separate
polyethylene
bags
and
shaken
50
times.
A
portion
of
each
sample
was
transferred
from
the
plastic
bags
into
1­
oz
bottles
and
the
bottles
were
capped
with
polyseal
lids
to
simulate
the
procedure
for
collecting
field
samples.

Air
Filters:
Seven
replicate
filter
samples
were
prepared
each
day
by
spiking
37­
mm,
acetonitrile
washed
Whatman
QM­
A
filters
with
isofenphos
formulation
solution
at
a
loading
of
approximately
0.2
:
g
of
isofenphos.
The
spiked
filters
were
then
placed
in
separate
filter
cassettes.
Each
filter
was
supported
by
a
stainless
steel
screen.
Each
cassette
was
then
sealed
tight
with
a
cellulose
shrink
band
and
the
two
open
ends
were
capped.
To
simulate
the
collection
of
field
samples,
the
caps
of
each
cassette
were
removed
immediately
before
sampling
and
each
filter
unit
was
connected
to
a
sampling
pump
which
had
been
calibrated
to
a
sampling
rate
of
1.0
L
per
minute.
In
addition,
two
blank
filters
were
prepared
at
the
same
time
to
determine
potential
interference
or
contamination
problems.

Dermal
samples:
Seven
replicate
samples
were
generated
at
loading
levels
of
approximately
1.0,
10,
100,
and
1000
:
g
of
isofenphos
to
simulate
anticipated
exposure
levels
for
the
outer
gauze
and
1.0,
and
10
:
g
to
simulate
inner
gauze
pads.
To
spike
the
outer
gauze
pads,
0.5
mL
of
spiking
solutions
containing
approx
2.0,
20,
200,
and
2000
:
g/
mL
of
isofenphos
was
pipetted
onto
separate
gauze
pads.
Once
the
gauze
pads
were
spiked,
the
solvent
was
allowed
to
evaporate.
The
spiked
pads
were
placed
in
direct
sunlight
and
exposed
to
the
environment
for
approximately
the
same
duration
as
the
field
samples.
The
inner
pads
were
spiked
in
the
same
manner,
but
were
placed
under
coverall
material
and
were
not
exposed
to
sunlight.

Field
fortification
recoveries
for
isofenphos
are
presented
in
Table
3.
18
Table
3.
Field
Fortification
Recoveries
for
Isofenphos
Sample
Type
Fortification
Level
(
:
g)
Sampling
Day
Average
Fortification
Recovery
per
Day
(%)
Average
Isofenphos
Recovery
per
Level
(%)
Overall
Average
(%)
Standard
Deviation
Handwash
samples
200
1234
111.3
109.1
97.5
98.3
104.1
102.4
6.
6
2000
1234
108.1
103.4
98.2
92.8
100.6
Filters
0.2
1234
100.1
69.9
86.0
93.9
88.1
88.1
12.2
Outer
Gauze
Pads
1
1234
107.3
73.3
100.8
88.9
92.6
90.1
12.1
10
1234
98.2
73.0
84.2
97.0
88.2
100
1234
87.0
86.1
78.4
110.4
90.9
1000
1234
82.7
89.8
85.4
96.2
88.6
Inner
Gauze
Pads
1
1234
112.7
78.2
84.8
116.3
98.5
96.3
17.1
10
1234
92.9
75.8
92.8
114.6
94.1
Formulation:
The
test
products
used
were
not
characterized
for
this
study.

Storage
Stability:
The
Study
Report
indicated
that
storage
stability
experiments
were
performed
prior
to
the
commencement
of
this
study.

Air
filters:
Approximately
0.2
:
g
isofenphos
and
its
oxygen
analog
were
field
spiked
onto
QM­
A
filters.
Air
19
was
pulled
through
the
spiked
filters
at
1.0
L/
min
±
5%
for
3.5
hours.
The
samples
were
then
shipped
to
the
Environmental
Analysis
Laboratory
in
Kansas
City
and
stored
in
the
freezer
at
­7
o
C
for
up
to
72
days.
Average
recoveries
ranged
from
91.9%
±
12
to
110%
±
24.

Gauze
pads:
A
field
study
was
conducted
at
Vero
Beach,
Florida,
using
isofenphos
canola
seed
formulation
to
fortify
gauze
pads.
Seven
pads
were
fortified
at
0.990
:
g
isofenphos
and
exposed
to
outdoor
environmental
conditions
for
4.5
hours.
The
samples
were
shipped
to
the
Environmental
Analysis
Laboratory
in
Kansas
City
and
stored
in
the
freezer
for
40
days
prior
to
analysis.
The
average
total
recovery
from
the
gauze
pad
samples
was
104%
±
2%.
Three
indoor
sampling
field
studies
were
also
conducted
at
a
seed
coating
facility
in
Nisku,
Alberta,
Canada.
Gauze
pads
were
fortified
with
isofenphos
canola
seed
formulation
and
exposed
to
the
indoor
environment
of
the
seed
coating
facility
for
8
hours.
The
samples
were
shipped
to
the
Environmental
Analysis
Laboratory
in
Kansas
City
and
stored
for
up
to
159
days.
Average
recoveries
ranged
from
94.0%
±
1.7%
to
118%
±
4%.

Hand
Rinses:
The
study
author
reported
an
average
storage
recovery
of
110%
±
5%
for
storing
samples
of
isofenphos
in
absolute
ethanol
at
a
100­
:
g
loading
for
117
days
at
­7
o
C.
The
study
author
also
reported
average
recoveries
for
storing
samples
spiked
with
203
or
2031
:
g
isofenphos
at
­7
o
C
for
158
days
of
112%
±
1%
and
110%
±
3%,
respectively.

10.
Relevancy
of
Study
to
Proposed
Use:

The
study
monitored
workers
performing
their
normal
duties
during
planting
of
treated
canola
seed.

II.
RESULTS
AND
CALCULATIONS:

A.
EXPOSURE
CALCULATIONS:

The
study
author
provided
exposure
values
expressed
as
mg/
replicate,
mg/
hour,
and
mg/
lb
ai
applied
for
both
dermal
and
inhalation
exposure.
The
total
amount
of
isofenphos
recovered
from
the
air
filters
was
divided
by
the
total
volume
of
air
sample,
multiplied
by
the
respiration
rate
and
hours
worked
per
replicate
to
provide
the
amount
of
isofenphos
in
mg/
replicate.
The
dermal
gauze
pad
values
were
multiplied
by
the
location
area
in
cm
2
to
provide
the
exposure
in
mg
isofenphos
per
location.
These
values
were
summed
to
provide
dermal
gauze
exposure
values
in
mg/
replicate.
Handwash
samples
were
calculated
using
the
same
calculations
as
dermal
exposures,
assuming
an
area
of
410
cm
2
.

Versar
estimated
exposure
values
as
mg/
lb
ai
handled
as
per
EPA's
request.
Versar
calculated
both
potential
(based
on
exterior
patches)
and
actual
(based
on
interior
patches)
dermal
exposures.
The
Registrant
corrected
all
data
for
field
fortification
recoveries,
including
recoveries
above
90%.
For
those
values
below
the
LOD,
the
Registrant
used
½
the
recovery
corrected
LOD
value.
Versar
only
corrected
data
for
field
fortification
recoveries
less
<90%
and
reported
non­
detect
values
as
½
LOD.

Inhalation
Exposure
Inhalation
exposures
were
calculated
by
both
the
Registrant
and
Versar
from
the
breathing­
zone
air
concentrations
determined
from
the
amount
of
isofenphos
found
on
the
air­
sampling
filters
and
the
volume
of
air
sample.
A
moderate
workrate
respiratory
rate
of
0.029
m
3
/min
was
assumed
by
the
Registrant
for
the
duration
of
the
sampling
period.
Versar
used
the
NAFTA
recommended
inhalation
rate
of
0.029
m
3
/min
for
moderate
activities.
According
to
the
Registrant's
calculations,
the
geometric
mean
of
the
inhalation
exposure
was
0.0003
mg/
lb
ai
with
a
geometric
standard
deviation
of
3.7.
Since
no
sample
was
collected
for
replicate
5,
the
Registrant
used
the
geometric
mean
of
all
inhalation
exposures
as
the
value
for
replicate
5
in
their
calculations.
Table
4
provides
the
Versar­
calculated
potential
inhalation
exposures.
The
average
exposure
was
0.0006
±
0.0008
mg/
lb
ai
handled.

Potential
Dermal
Exposure
Potential
dermal
exposure
estimates
were
calculated
by
extrapolating
values
from
exterior
patches
to
the
total
surface
area
of
the
appropriate
region.
The
Registrant
did
not
report
potential
dermal
exposures,
although
exterior
dermal
patches
were
analyzed
and
raw
data
were
reported
in
the
Study
Report.
Versar
calculated
potential
dermal
estimates
for
each
region
of
the
20
body
using
the
exterior
patches
(see
Table
5).
The
total
surface
area
of
the
exposed
surfaces
of
the
dermal
patches
was
24.63
cm
2
.
Versar
used
the
default
NAFTA
surface
areas
to
calculate
the
potential
dermal
exposure
for
each
body
region.
Total
potential
dermal
exposures
ranged
from
0.0095
to
1.2369
mg/
lb
ai
handled.
The
primary
body
region
contributors
were
the
lower
arm
(0.1110
mg/
lb
ai
handled)
and
the
lower
leg
(0.0712
mg/
lb
ai
handled).
The
overall
average
total
potential
dermal
exposure
was
0.3326
±
0.3555
mg/
lb
ai
handled.

Actual
Dermal
Exposure
Actual
dermal
exposure
estimates
were
calculated
by
extrapolating
patch
values
from
interior
patches
to
the
total
surface
area
of
the
appropriate
region.
The
Registrant
extrapolated
these
values
using
recommended
surface
area
estimates
found
in
the
EPA
Pesticide
Registration
Guidelines,
Subdivision
U,
Applicator
Exposure.
The
surface
area
of
the
exposed
surfaces
of
the
dermal
patches
was
24.63
cm
2
.
For
actual
dermal
exposure
to
the
head,
the
Registrant
used
the
interior
head
patch
value
multiplied
by
a
penetration
factor
of
0.13.
This
factor
was
calculated
from
the
gauze
dosimeter
data
by
dividing
the
amount
on
an
inner
dosimeter
by
the
amount
on
the
adjacent
outer
dosimeter,
in
every
case
where
both
dosimeters
had
measurable
amounts.
The
Registrant
reported
total
dermal
exposure
as
the
sum
of
the
values
for
covered
skin,
head
and
neck,
and
hands.
The
Registrant
calculated
hand
exposures
assuming
an
exposed
area
of
410
cm
2
and
followed
the
same
calculations
as
those
used
for
dermal
exposure.
According
to
the
Registrant's
calculations,
hand
exposures
ranged
from
0.059
to
0.42
mg/
lb
ai
applied,
with
an
average
hand
exposure
of
0.11
mg/
lb
ai
applied.
Versar's
calculated
hand
exposures
are
reported
in
Table
6.
These
exposures
ranged
from
0.003
to
0.333
mg/
lb
ai
handled.
The
overall
average
hand
exposure
was
0.033
±
0.095
mg/
lb
ai
handled.

The
Registrant
calculated
a
geometric
mean
total
dermal
exposure
of
0.15
mg/
lb
ai
applied.
Versar
calculated
actual
dermal
estimates
for
each
region
of
the
body
using
the
interior
patches
(except
for
the
head)
(see
Table
7).
Versar
used
the
default
NAFTA
surface
areas
to
calculate
the
actual
dermal
exposure
for
each
body
region.
The
actual
dermal
exposure
estimates
ranged
from
0.0028
to
0.1053
mg/
lb
ai
handled
with
an
overall
average
actual
dermal
exposure
of
0.0296
±
0.0314
mg/
lb
ai
handled.
Total
dermal
exposure
estimates
included
both
actual
dermal
exposures
and
hand
exposures
and
averaged
0.0597
±
0.1001
mg/
lb
ai
handled.

Total
Exposure
Total
exposure
was
calculated
by
taking
the
sum
of
all
exposure
routes
(dermal­
hands,
dermal­
body,
and
inhalation).
The
Registrant
calculated
a
geometric
mean
total
exposure
of
0.15
mg/
lb
ai
applied.
Versar's
calculated
total
exposure
is
presented
in
Table
8
and
averaged
0.060
±
0.101
mg/
lb
ai
handled.
21
III
DISCUSSION
A.
LIMITATIONS
OF
THE
STUDY:

The
study
met
most
of
the
Series
875.1100
and
875.1300
Guidelines.
The
major
issues
of
concern
were:
(1)
this
study
was
performed
at
only
one
test
site,
(2)
raw
field
data
were
corrected
for
all
recoveries,
even
those
greater
than
90%,
(3)
concurrent
laboratory
fortification
recoveries
were
not
provided
in
the
Study
Report,
(4)
the
limit
of
quantification
was
not
provided
for
any
media,
only
the
limit
of
detection,
(5)
the
analysis
dates
were
not
provided
for
any
of
the
samples
in
this
study
in
order
to
verify
storage
stability
results,
(6)
individual
field
blank
results
were
not
provided
in
the
Study
Report,
(7)
there
was
only
one
field
fortification
level
for
air
filter
samples,
(8)
the
Registrant
used
½
the
recovery
corrected
sample
quantification
limits
for
non­
detect
values,
rather
than
½
the
method
limit
of
detection
for
that
media,
(9)
method
validation
recoveries
were
not
provided
for
handwash
samples,
(10)
information
on
the
individuals
who
participated
in
this
study
was
not
provided,
(11)
the
inhalation
methodology
was
calibrated
with
an
airflow
of
1L/
min
instead
of
2L/
min,
(12)
the
Registrant
used
the
inhalation
geometric
mean
for
replicate
5
since
no
sample
was
collected,
(13)
the
Registrant
used
values
slightly
different
from
the
NAFTA
recommended
body
region
surface
areas,
and
(14)
the
Registrant
calculated
face
exposures
from
head
exposures.

B.
CONCLUSIONS:

Dermal
and
inhalation
exposures
were
assessed
during
the
planting
of
treated
canola
seed.
The
workers
performed
both
loading
of
the
treated
seed
into
seed
hoppers
and
planting
of
the
seed.
Table
8
provides
a
summary
of
the
total
exposure
to
isofenphos
during
loading
and
planting
of
treated
seed,
as
calculated
by
Versar.
Versar's
calculated
average
total
exposure
was
0.060
±
0.101
mg/
lb­
ai
handled.
The
geometric
mean
total
exposure,
as
calculated
by
the
Registrant,
to
isofenphos
during
planting
of
treated
canola
seed
was
0.15
mg/
lb
ai
applied.
The
study
author
also
reported
total
exposure
in
mg/
replicate
and
assumed
that
a
worker
is
able
to
complete
three
replicates
per
day.
The
study
author
estimated
an
average
daily
exposure
of
1.9
mg,
but
noted
that
a
worker
would
probably
not
routinely
work
what
is
equivalent
to
three
replicates
per
day
during
the
planting
season
so
that
actual
daily
exposure
would
likely
be
less
than
1.9
mg/
day.
22
Table
4.
Potential
Inhalation
(mg/
lb
ai
handled)
Based
on
Residue
Levels
Found
on
Air
Filters.

Replicate
Residue
(
:

g/
sample)
Corrected
Value
(
:

g/
sample)
b
Replicate
length
(min)
Volume
of
air
sampled
(L)
Concentration
(mg/
m
3
)
c
lb
ai
handled
Respiration
Rate
(m
3
/min)
Inhalation
exposure
(mg/
lb
ai
handled)
d
1
0.
0664
0.0754
164
164
0.00046
1.92
0.029
0.00114
2
0.
1530
0.1737
135
135
0.00129
2.88
0.029
0.00175
3
0.
0339
0.0385
260
286
0.00013
5.95
0.029
0.00017
4
0.
0289
0.0328
185
203.5
0.
00016
4.32
0.029
0.00020
6
0.
0219
0.0249
185
203.5
0.
00012
3.60
0.029
0.00018
8
a
0.0050
110
107.8
0.
00002
4.32
0.029
0.00002
9
0.
2260
0.1793
285
107.8
0.
00166
5.76
0.029
0.00239
11
0.0608
0.0482
217
238.7
0.
00020
2.94
0.029
0.00043
13
a
0.
0050
172
189.2
0.
00001
4.62
0.029
0.00001
14
a
0.
0050
155
170.5
0.
00001
3.96
0.029
0.00002
15
0.0426
0.0454
277
304.7
0.
00015
6.24
0.029
0.00019
16
0.0460
0.0490
188
206.8
0.
00024
5.46
0.029
0.00024
Mean
0.0006
Geometric
Mean
0.0002
Standard
Deviation
0.0008
Coefficient
of
Variance
(%)
138.58
a
Residue
was
not
detected.
Therefore,
½
the
LOD
(0.
005
:

g/
sample)
was
used.

b
Corrected
for
average
field
fortification
recovery
(88.1%)

c
Concentration
(mg/
m
3
)
=
(Residue
(
:

g/
sample)
x
0.001)/(
sample
volume
(L)
x
m
3
/1000L)

d
Exposure
(mg/
lb
ai
handled)
=
[(
Concentration
(mg/
m
3
)
x
Respiration
rate
(m
3
/min)
x
replicate
length
(min)]/
lb
ai
handled
23
Table
5.
Potential
Dermal
Exposure
(mg/
lb
ai
handled)
Based
on
Exterior
Patches
Replicate
Residues
(ug/
cm
2
)
a
Body
Region
Exposure
(mg/
lb
ai
handled)
c
Head
Back
Chest
Upper
Arm
Lower
Arm
Upper
Leg
Lower
Leg
lb
ai
applied
Head
(1300
cm
2
)
Back
(3550
cm
2
)
Chest
(3550
cm
2
)
Upper
Arm
(2910
cm
2
)
Lower
Arm
(1210
cm
2
)
Upper
Leg
(382
cm
2
)
Lower
Leg
(2380
cm
2
)
Total
1
0.
008
0.007
0.016
0.026
0.333
0.510
0.069
1.92
0.0054
0.1306
0.0302
0.0388
0.2096
0.1014
0.0856
0.6015
2
0.
041
0.007
0.229
0.107
1.473
0.327
0.096
2.88
0.0185
0.0856
0.2828
0.1085
0.6188
0.0434
0.0794
1.2369
3
0.
001
b
0.001
b
0.014
0.017
0.140
0.353
0.093
5.95
0
0.
005
0.009
0.0083
0.0284
0.0227
0.0373
0.1101
4
0.
001
b
0.001
b
0.001
b
0.011
0.029
0.294
0.037
4.32
0
0.
006
0
0.
0077
0.0083
0.026
0.0201
0.0693
5
0.
008
0.006
0.147
0.003
0.190
0.308
0.519
4.32
0.0025
0.05
0.1211
0.002
0.0531
0.0272
0.2861
0.5421
6
0.
020
0.001
b
0.097
0.013
0.043
0.179
0.161
3.6
0.
0071
0.008
0.0961
0.0103
0.0143
0.019
0.1066
0.2609
8
0.
001
b
0.001
b
0.001
b
0.001
b
0.007
0.001
b
0.001
b
4.32
0
0.
006
0
0.
001
0.002
0
0
0.0103
9
0.
050
0.024
0.217
0.074
0.353
0.522
0.036
5.76
0.0113
0.1491
0.1339
0.0373
0.0742
0.0346
0.0148
0.4552
11
0.010
0.001
b
0.001
b
0.007
0.038
0.073
0.035
2.94
0.0044
0.009
0
0.
0072
0.0158
0.01
0.028
0.0751
13
0.008
0.008
0.073
0.029
1.469
0.327
0.183
4.62
0.0021
0.0608
0.0565
0.0184
0.3847
0.027
0.0941
0.6437
14
0.001
b
0.001
b
0.001
b
0.001
b
0.001
0.004
0.001
b
3.96
0
0.
007
0
0.
001
0
0
0
0.
0095
15
0.008
0.006
0.026
0.047
0.143
0.184
0.299
6.24
0.0017
0.0321
0.0133
0.022
0.0278
0.0113
0.1139
0.2222
16
0.001
b
0.001
b
0.014
0.001
b
0.024
0.127
0.134
5.46
0
0.
005
0.009
0
0.
0053
0.009
0.0585
0.0877
Average
0.012
0.005
0.064
0.026
0.326
0.247
0.128
4.33
0.0042
0.0427
0.0581
0.0202
0.111
0.0255
0.0712
0.3326
Standard
Deviation
0.3555
a
Residue
(
:

g/
cm
2
)
=
Residue
(
:

g/
sample)/
Patch
surface
area
(24.63
cm
2
)

b
Residue
was
not
detected.
Therefore,
½
the
LOD
(0.
038
:

g/
sample)
was
used.

c
Body
Region
Exposure
(mg/
lb­
ai)=
(Exposure
(
u
g/
cm
2
)
x
Body
Region
(cm
2
)/
lb
ai
applied)
x
0.001
24
Table
6.
Summary
of
Hand
Exposure
(mg/
lb
ai
handled)
based
on
Hand
Washes
Replicate
Residue
­
both
hands
(
:

g/
sample
)
lb
ai
handled
Hand
exposure
(
:

g
/lb
ai
handled)
Hand
exposure
(mg/
lb
ai
handled)

1
0.
33333333333
1.92
10.4
0.
010
2
0.
33333333333
2.88
6.9
0.
007
3
0.
33333333333
5.95
3.4
0.
003
4
0.
33333333333
4.32
4.6
0.
005
5
0.
33333333333
4.32
4.6
0.
005
6
0.
33333333333
3.60
5.6
0.
006
9
1920
5.76
333.3
0.
333
11
0.33333333333
2.94
6.8
0.
007
13
0.33333333333
4.62
4.3
0.
004
14
0.33333333333
3.94
5.1
0.
005
15
0.33333333333
6.24
3.2
0.
003
16
0.33333333333
5.46
3.7
0.
004
Mean
0.033
Geometric
Mean
0.007
Standard
Deviation
0.095
Coefficient
of
Variance
(%)
289.98
a
Residue
value
not
detected.
Therefore,
½
the
LOD
(40
:

g/
sample)
was
used.

Table
7.
Actual
Dermal
Exposure
(mg/
lb
ai
handled)
Based
on
Interior
Patches
(except
for
Head)
25
Replicate
Residues
(ug/
cm
2
)
a
Body
Region
Exposure
(mg/
lb
ai
handled)
c
Neck
b
Head
Back
Chest
Upper
Arm
Lower
Arm
Upper
Leg
Lower
Leg
lb
ai
applied
Neck
b
Head
(1300
cm
2
)
Back
(3550
cm
2
)
Chest
(3550
cm
2
)
Upper
Arm
(2910
cm
2
)
Lower
Arm
(1210
cm
2
)
Upper
Leg
(382
cm
2
)
Lower
Leg
(2380
cm
2
)
Total
1
0.
023
0.008
0.001
0.001
0.001
0.081
0.033
0.004
1.92
0.002
0.005
0
0
0
0.05
0.007
0.004
0.073
2
0.
236
0.041
0.001
0.022
0.006
0.076
0.036
0.004
2.88
0.0122
0.0185
0
0.
03
0
0.03
0.005
0.003
0.1053
30.
0150.
0010.
0010.
0010.
0010.
0010.
0160.
0015.
95000
0
0
00.
00100
40.
0020.
0010.
0010.
0010.
0010.
0060.
0130.
0014.
32000
0
0
00.
00100.
01
50.
1540.
0080.
0010.
0010.
0010.
0170.
0240.
0154.
320.
0050.
0030
0
0
00.
0020.
0080.
025
60.
0980.
0200.
0010.
0010.
0010.
0010.
0040.
0033.
60.
0040.
0070
0
0
000.
0020.
016
8
0.
0015
0.001
0.001
0.001
0.001
0.001
0.001
0.001
4.32
0
0
0
0
0
0000
9
0.
241
0.030
0.001
0.014
0.003
0.020
0.061
0.012
5.76
0.006
0.0113
0
0
0
00.
0040.
0050.
041
11
0.0015
0.010
0.001
0.001
0.001
0.004
0.010
0.001
2.94
0
0.
004
0
0
0
00.
00100.
011
13
0.081
0.008
0.016
0.003
0.016
0.030
0.059
0.029
4.62
0.003
0.002
0.01
0
0.
01
0
0.005
0.0152
0.058
14
0.0015
0.001
0.005
0.001
0.001
0.001
0.010
0.009
3.96
0
0
0
0
0
00.
0010.
0050.
012
15
0.0291
0.008
0.001
0.007
0.001
0.041
0.023
0.009
6.24
0
0.
002
0
0
0
00.
0010.
0030.
02
16
0.0152
0.001
0.001
0.001
0.008
0.003
0.011
0.010
5.46
0
0
0
0
0
000.
0040.
012
Average
0.
0690.
0120.
0020.
0040.
0030.
0220.
0230.
0084.
330.
0030.
0040
0
0
00.
0020.
0040.
03
Standard
Deviation
0.031
a
Residue
(
:

g/
cm
2
)
=
Residue
(
:

g/
sample)/
Patch
surface
area
(24.63
cm
2
)

b
Sum
of
the
calculations
for
both
front
and
back
neck
(Areas:
150
and
110
cm
2
,
respectively)

c
Body
Region
Exposure
(mg/
lb
ai
handled)=
(Exposure
(ug/
cm
2
)
x
Body
Region
(cm
2
)/
lb
ai
applied)
x
0.001
26
Table
8.
Total
Exposure
(mg/
lb
ai
handled)

Replicate
Exposure
(mg/
lb
ai
handled)

Dermal­
body
Dermal­
hands
Dermal­
Total
Inhalation
Inhalation
+
Dermal
Total
1
0.
0731
0.0104
0.0835
0.0011
0.085
2
0.
1053
0.0069
0.1122
0.0018
0.114
3
0.
0033
0.0034
0.0067
0.0002
0.007
4
0.
0053
0.0046
0.01
0.0002
0.01
5
0.
0249
0.0046
0.0295
0.029
6
0.
016
0.0056
0.0216
0.0002
0.022
8
0.
0028
0.0028
0.00002
0.003
9
0.
0411
0.3333
0.3745
0.0024
0.377
11
0.0108
0.0068
0.0176
0.0004
0.018
13
0.058
0.0043
0.0623
0.00001
0.062
14
0.0124
0.0051
0.0174
0.00002
0.017
15
0.0199
0.0032
0.0231
0.0002
0.023
16
0.0117
0.0037
0.0153
0.0002
0.016
Average
0.0296
0.0327
0.0597
0.0006
0.06
Standard
Deviation
0.101
27
_______
___________________________
Name:
Name:
Evaluator
Peer
Reviewer
Occupational
Exposure
Assessment
Section
Occupational
Exposure
Assessment
Section
__________________
____________________
Date
Date
_________________________
Name:
Head,
Occupational
Exposure
Assessment
Section
_________________________
Date
28
Compliance
Checklist
Compliance
with
OPPTS
Series
875,
Occupational
and
Residential
Exposure
Test
Guidelines,
Group
A:
Guidelines,
875.1300
(inhalation),
and
875.1100
(dermal)
is
critical.
The
itemized
checklist
below
describes
compliance
with
the
major
technical
aspects
of
OPPTS
875.1300,
and
875.1100.

875.1300
S
Investigators
should
submit
protocols
for
review
purposes
prior
to
the
inception
of
the
study.
This
criterion
was
probably
met.

3)
Expected
deviations
from
GLPs
should
be
presented
concurrently
with
any
protocol
deviations
and
their
potential
study
impacts.
The
study
sponsor
stated
that
GLP's
did
not
apply
to
this
study.

4)
The
test
substance
should
be
a
typical
end
use
product
of
the
active
ingredient.
This
criterion
was
met.

5)
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.
It
is
uncertain
whether
this
criterion
was
met.
A
product
label
was
not
provided
in
the
study
and
the
label
obtained
by
Versar
did
not
provide
a
maximum
application
rate.

6)
Selected
sites
and
seasonal
timing
of
monitoring
should
be
appropriate
to
the
activity.
It
is
uncertain
whether
these
criteria
were
met.
The
study
site
was
located
in
Canada
and
the
study
occurred
during
the
month
of
May.

7)
A
sufficient
number
of
replicates
should
be
generated
to
address
the
exposure
issues
associated
with
the
population
of
interest.
For
outdoor
exposure
monitoring,
each
study
should
include
a
minimum
of
15
individuals
(replicates)
per
activity.
This
criterion
was
met.
Four
individuals
participated
in
this
study,
for
a
total
of
16
replicates.

8)
The
quantity
of
active
ingredient
handled
and
the
duration
of
the
monitoring
period
should
be
reported
for
each
replicate.
This
criterion
was
met.

9)
Test
subjects
should
be
regular
workers,
volunteers
trained
in
the
work
activities
required,
or
typical
homeowners.
This
criterion
was
met.

10)
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
met.

11)
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.

12)
The
analytical
procedure
must
be
capable
of
measuring
exposure
to
1
µg/
hr
(or
less,
if
the
toxicity
of
the
material
under
study
warrants
greater
sensitivity).
This
criterion
was
met.

13)
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.

14)
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.

15)
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.
The
number
of
laboratory
fortified
controls
and
types
of
laboratory
controls
were
not
provided
in
the
Study
Report.
29
Field
fortification
results
were
provided
and
all
were
greater
than
50%.

16)
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.
The
Registrant,
however,
did
not
provide
the
actual
dates
of
analysis.

17)
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
probably
not
met.
Personal
monitoring
pumps
were
calibrated
to
1
L/
min
and
it
was
not
reported
if
airflow
was
measured
at
the
beginning
and/
or
end
of
the
exposure
period.

18)
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
air
filters
and
absorption
tubes.

19)
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.
This
criterion
was
probably
met.
The
Registrant
states
that
after
collection
of
the
fiberglass
filters,
the
air
filter
cassettes
were
removed,
capped,
and
place
in
Whirl­
Pak
bags.

20)
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.
The
cassette
containing
the
air
filter
was
attached
to
the
worker's
lapel.

21)
Field
calibration
of
personal
monitors
should
be
performed
at
the
beginning
and
end
of
the
exposure
period.
It
is
uncertain
whether
this
criterion
was
met.
There
was
no
mention
of
calibration
procedures
in
the
Study
Report.

22)
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
Registrant
mentioned
that
both
field
fortified
samples
and
field
blanks
were
collected.

23)
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
Registrant
corrected
all
data
for
field
recoveries,
even
those
greater
than
90%.

24)
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.

25)
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
partially
met.
Brief
descriptions
of
the
test
product
used,
the
work
activities
being
monitored,
the
planting
equipment
used,
the
application
rate,
the
location
of
the
study,
and
weather
conditions
were
provided
in
the
Study
Report.
However,
no
information
regarding
the
individuals
used
in
the
study
was
provided.

26)
Analysis
methods
should
be
documented
and
appropriate.
This
criterion
was
met.

27)
A
sample
history
sheet
must
be
prepared
by
the
laboratory
upon
receipt
of
samples.
This
criterion
was
not
met.

875.1100
30
28)
Investigators
should
submit
protocols
for
review
purposes
prior
to
the
inception
of
the
study.
This
criterion
was
probably
met.

29)
Expected
deviations
from
GLPs
should
be
presented
concurrently
with
any
protocol
deviations
and
their
potential
study
impacts.
The
study
sponsor
stated
that
GLP's
did
not
apply
to
this
study.

30)
The
test
substance
should
be
a
typical
end
use
product
of
the
active
ingredient.
This
criterion
was
met.

31)
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.
It
is
uncertain
whether
this
criterion
was
met.
A
product
label
was
not
provided
in
the
study
and
the
label
obtained
by
Versar
did
not
provide
a
maximum
application
rate.

32)
Selected
sites
and
seasonal
timing
of
monitoring
should
be
appropriate
to
the
activity.
It
is
uncertain
whether
these
criteria
were
met.
The
study
site
was
located
in
Canada
and
the
study
occurred
during
the
month
of
May.

33)
A
sufficient
number
of
replicates
should
be
generated
to
address
the
exposure
issues
associated
with
the
population
of
interest.
For
outdoor
exposure
monitoring,
each
study
should
include
a
minimum
of
15
individuals
(replicates)
per
activity.
This
criterion
was
met.
Four
individuals
participated
in
this
study,
for
a
total
of
16
replicates.

34)
The
quantity
of
active
ingredient
handled
and
the
duration
of
the
monitoring
period
should
be
reported
for
each
replicate.
This
criterion
was
met.

35)
Test
subjects
should
be
regular
workers,
volunteers
trained
in
the
work
activities
required,
or
typical
homeowners.
This
criterion
was
met.

36)
Any
protective
clothing
worn
by
the
test
subjects
should
be
identified
and
should
be
consistent
with
the
product
label.
This
criterion
was
met.
The
protective
clothing
worn
by
the
test
subjects
was
identified
and
was
consistent
with
the
product
label
obtained
by
Versar.

37)
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
met.

38)
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
with
residue
analysis.
This
should
be
determined
prior
to
using
the
pads
in
exposure
tests
.This
criterion
is
not
applicable
to
this
study.

39)
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.
These
criteria
were
partially
met.
The
exposure
pads
were
constructed
from
a
surgical
sponge
and
had
a
circular
opening
5.6
cm
(2.2
in)
in
diameter.
It
was
not
stated
whether
the
gauze
was
checked
for
material
that
would
interfere
with
analysis.

40)
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
met.

41)
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
was
not
met.
Gauze
pads
were
stored
in
1­
ounce
glass
bottles
capped
with
poly­
seal
screw
caps
and
stored
on
dry
ice.
31
42)
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.
It
is
unknown
if
this
criterion
was
met.
The
study
author
made
no
mention
of
preliminary
hand
rinse
studies.

43)
The
analytical
procedure
must
be
capable
of
quantitative
detection
of
residues
on
exposure
pads
at
a
level
of
1
ug/
cm
2
(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
quantification
was
not
provided
in
the
study.
The
limit
of
detection
for
exposure
pads
was
reported
as
38
ng/
sample.

44)
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.
The
number
of
laboratory
fortified
controls
and
types
of
laboratory
controls
were
not
provided
in
the
Study
Report.
Field
fortification
recovery
results
were
provided
and
all
were
greater
than
50%.

45)
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.
These
criteria
were
met.
A
storage
stability
test
was
conducted.
The
Registrant,
however,
did
not
provide
the
actual
dates
of
analysis.

46)
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
Registrant
corrected
all
raw
residue
data
for
field
recoveries.

47)
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
partially
met.
Brief
descriptions
of
the
test
produce
used,
the
work
activities
being
monitored,
the
planting
equipment
used,
the
application
rate,
the
location
of
the
study,
and
the
weather
conditions
were
provided
in
the
Study
Report.
However,
no
information
regarding
the
individuals
used
in
the
study
was
provided.

48)
A
sample
history
sheet
must
be
prepared
by
the
laboratory
upon
receipt
of
samples.
This
criterion
was
not
met.
32
APPENDIX
B
Comparison
of
Application
Rates
of
Lindane
Among
Registered
Crops
Group
Crop
Ounce
ai/
cwt
Max
Seed
Lb
ai/
acre
Max
Seed
cwt/
acre
Max
Ounce
ai/
acre
Max
Pound
ai/
acre
Root
&
Tuber
Radish
0.53
20
0.2
0.
106
0.0066
Leafy
Veggies
Celery
1.31
2
0.
02
0.
0262
0.0016
Lettuce
1.31
3
0.
03
0.
0393
0.0025
Swiss
1.
31
8
0.08
0.1048
0.0066
Spinach
1.
31
15
0.
15
0.
1965
0.0123
Cereal
Grains
Corn
2
18
0.
18
0.
36
0.
0225
Barley
0.5
96
0.
96
0.
48
0.
0300
Oats
0.6
128
1.28
0.768
0.0480
Rye
0.
5
112
1.12
0.56
0.0350
Soughum
1.13
75
0.75
0.8475
0.0530
Wheat
0.68
120
1.2
0.
816
0.0510
Misc.
Canola
23.3
4
0.04
0.932
0.0583
Brassica
Broccoli
1.91
1.5
0.
015
0.02865
0.0018
Brussels
1.91
1.5
0.
015
0.02865
0.0018
Cabbage
1.91
1.5
0.
015
0.02865
0.0018
Cauli
1.
91
1.
5
0.015
0.02865
0.0018
Collards
1.
91
4
0.04
0.0764
0.0048
Kale
1.91
4
0.
04
0.
0764
0.0048
Kohlrabi
1.91
5
0.
05
0.
0955
0.0060
Mustard
1.91
5
0.
05
0.
0955
0.0060
Source
for
Maximum
Lb
Seed
per
Acre:
Martin,
J.
H.,
W.
H.
Leonard,
and
D.
L.
Stamp,
"Principles
of
Field
Crop
Production,
Third
Edition:,
Macmillan
Publishing
Co.,
Inc.,
1976.