Document ID: EPA-HQ-OPP-2002-0269-0034
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-04-05T16:08:11Z

1
United
States
Prevention,
Pesticides
EPA
xxx­
xxx­
xxxx
Environmental
Protection
and
Toxic
Substances
February
2006
Agency
(
7508C)

Addendum
to
the
2001
Ethoprop
Interim
Reregistration
Decision
(
IRED)

Regulatory
Decision
on
the
Emulsifiable
Concentration
(
EC)
Formulation
of
Ethoprop
2
Addendum
to
the
2001
Ethoprop
Interim
Reregistration
Decision
(
IRED)

Regulatory
Decision
on
the
Emulsifiable
Concentration
(
EC)
Formulation
of
Ethoprop
Case
No.
0106
Approved
by:

______________________
Debra
Edwards,
Ph.
D.
Director,
Special
Review
and
Reregistration
Division
________________________
Date
3
Addendum
to
the
2001
Ethoprop
Interim
Reregistration
Eligibility
Decision
(
IRED)
Regulatory
Decision
on
the
Emulsifiable
Concentration
(
EC)
Formulation
of
Ethoprop
I.
Introduction
This
document
serves
an
addendum
to
the
Ethoprop
IRED,
which
was
completed
in
September
2001,
and
which
presents
the
interim
reregistration
eligibility
decision
for
the
EC
formulation.
The
IRED
is
only
one
of
several
steps
in
the
reregistration
of
ethoprop,
which
is
an
organophosphate
chemical.
The
Agency
is
proceeding
with
a
cumulative
risk
assessment
of
the
organophosphates.
When
the
Agency
has
completed
its
consideration
of
the
cumulative
risks
for
the
OPs,
ethoprop
tolerances
will
be
reassessed
in
that
light,
in
accordance
with
the
Food
Quality
Protection
Act
(
FQPA).
Although
the
Agency
has
not
yet
completed
the
cumulative
risk
assessment,
the
ethoprop
IRED,
in
conjunction
with
this
addendum,
presents
the
Agency's
assessment
of
the
dietary,
occupational,
nonoccupational
and
ecological
risks
associated
with
the
use
of
ethoprop,
and
identifies
risk
mitigation
measures
that
are
necessary
to
support
the
continued
use
of
the
granular
and
EC
formulations.

A.
Background
The
2001
ethoprop
IRED
established
that,
provided
risk
mitigation
measures
stipulated
in
the
IRED
document
are
implemented
and
other
regulatory
decisions
are
fulfilled,
there
are
no
dietary
(
food
and
drinking
water)
risks
of
concern
associated
with
the
current
use
of
ethoprop.
There
are
no
residential
uses
registered.
However,
there
were
estimated
occupational
risks
of
concern,
based
on
cholinesterase
inhibition,
associated
with
both
the
granular
and
the
emulsifiable
concentrate
(
EC)
formulations.
Through
a
number
of
mitigation
actions,
such
as
cancellation
of
certain
uses
and
the
requirement
of
engineering
controls
for
mixing,
loading,
and
application
of
products
that
contain
ethoprop,
the
Agency
determined
the
occupational
risks
associated
with
the
granular
formulation
are
not
of
concern,
and
that
ethoprop,
except
for
the
EC
formulation,
is
eligible
for
reregistration
for
use
on
bananas/
plantains,
beans
(
snap/
lima),
cabbage,
corn,
cucumbers,
pineapples,
white
potatoes,
sweet
potatoes,
sugarcane,
and
tobacco.

The
Agency
did
not
make
a
reregistration
eligibility
decision
on
the
EC
formulation
in
2001
due
to
significant
occupational
risks
of
concern
associated
with
the
use
of
this
formulation
with
most
risks
being
contributed
from
dermal
exposure.
The
assessment
presented
in
the
IRED
showed
occupational
risks
above
the
Agency's
level
of
concern
for
dermal
and
inhalation
exposures
across
most
occupational
scenarios.
The
target
Margin
of
Exposure
(
MOE)
for
chronic
non­
cancer
risks
is
 
100
for
workers
handling
the
liquid
formulation.
In
the
2001
IRED,
combined
dermal
and
inhalation
MOEs
for
all
occupational
handler
scenarios
of
the
EC
formulation
with
the
implementation
of
engineering
controls,
ranged
from
0.18
to
8.5.
For
occupational
exposure
scenarios
where
engineering
controls
are
feasible,
most
of
the
cancer
risks
were
greater
than
4
1
x
10­
6,
but
were
at
or
below
1
x
10­
4.
The
only
scenario
for
which
cancer
risks
exceeded
1
x
10­
4
with
engineering
controls
was
mixing/
loading
EC
formulation
for
chemigation
at
a
12
lb
ai/
A
application
rate
(
2.1
x
10­
4).
The
Agency
determined
that
non­
cancer
risks
are
more
of
a
concern
when
compared
to
the
potential
risk
from
cancer.
For
more
details
on
the
occupation
risk
assessment,
refer
to
Chapter
III
of
the
IRED,
Summary
of
Ethoprop
Risk
Assessment.

At
the
time
of
the
ethoprop
IRED,
the
registrant
maintained
that
the
actual
risk
to
workers
handling
the
ethoprop
EC
formulation
are
much
lower
than
assessed,
and
agreed
to
submit
refined
occupational
biomonitoring
and
supporting
pharmacokinetics
(
PK)
data.
Additionally,
the
National
Potato
Council
expressed
a
great
need
for
the
continued
use
of
ethoprop
EC
for
controlling
pests
in
the
Pacific
Northwest,
as
well
as
in
other
regions
of
the
United
States.
The
Agency
deferred
its
reregistration
eligibility
decision
for
the
EC
formulation
based
on
the
following
conditions:
(
1)
the
registrant
was
to
provide
EPA
with
a
final
report
from
the
ongoing
biomoniotoring
study
of
mixer,
loaders,
and
applicators,
(
2)
the
registrant
was
to
provide
the
Agency
with
sufficient
data
comparing
ethoprop
metabolites
in
rat
and
human
urine,
in
combination
with
a
previously
submitted
rodent
metabolism/
PK
study,
and
(
3)
if
the
Agency
deems
the
new
PK
data
to
not
be
scientifically
acceptable
or
upgradeable,
and
justifies
the
need
for
additional
data,
the
registrant
is
to
conduct
a
human
PK
study.
For
a
detailed
discussion
of
the
Agency's
decisions,
mitigation
actions
and
conditions
of
reregistration
eligibility,
refer
to
Chapter
IV
of
the
IRED,
Interim
Reregistration
Eligibility
and
Risk
Management
Decisions.

II.
Submission
and
Analysis
of
the
Biomonitoring
and
PK
Study
Bayer
CropScience
submitted
its
"
Mixer/
loader/
applicator
inhalation
and
biological
monitoring
study"
(
MRID
#
456215­
01)
to
the
Agency
in
April
2002.
The
study,
conducted
between
March
and
April
2001,
quantified
ethoprop
exposure
for
mixerloaders
applicators,
and
mixer­
loader­
applicators
using
biological
monitoring
and
a
standard
inhalation
monitoring
technique.
The
subjects
in
this
study
used
the
Mocap
®
6EC
formulation
of
ethoprop
with
mechanical
ground
application
equipment
to
treat
potato
fields
in
the
Central
Basin
of
Washington
State
in
the
United
States.
According
to
Bayer
CropScience,
the
growers
determined
the
application
parameters
with
the
commercial
applicators
based
on
the
growers'
needs,
such
as
the
application
rate
in
accordance
with
the
registered
label,
and
acreage
treated.
Bayer
CropScience
only
monitored
the
planned
activity,
and
did
not
determine
any
of
the
application
parameters.
The
Agency
believes
that
this
study
did
not
involve
intentional
exposure
of
a
human
subject
to
ethoprop
because
the
exposure
to
ethoprop
would
have
occurred
whether
or
not
the
study
was
conducted.

The
Central
Basin
of
Washington
State
is
a
large
potato
growing
region
of
the
country
where
ethoprop
is
commonly
used
to
control
nematodes
and
wireworms,
and
the
participants
in
the
study
account
for
approximately
a
third
of
the
commercial
grower
population
in
the
Northwest.
Therefore,
the
Agency
concluded
that
the
activities
evaluated
in
the
study
should
be
considered
representative
of
those
that
would
commonly
be
expected
in
large­
scale
potato
production.
The
participants
were
monitored
5
performing
scheduled
application
activities,
and
the
typical
operations
were
monitored.
As
such,
application
rates,
the
amount
of
acreage
treated,
the
equipment
used,
and
the
PPE
clothing
used
varied.

The
registrant
also
submitted
the
metabolism
data,
"
Metabolite
M1:
A
Urinary
Market
for
Ethoprop
in
The
Adult
Rat"
(
MRID
#
456562­
01),
in
April
2002.
The
Agency
reviewed
the
study,
and
determined
it
to
be
acceptable;
therefore,
an
additional
human
PK
study
is
not
needed.
The
new
metabolism
data
indicated
that
ethoprop
metabolizes
in
rats
to
M1.
The
M1
metabolite
was
quantified
in
the
urine
of
humans
that
were
monitored
under
field
conditions
in
the
biomonitoring
study
discussed
above.
In
order
to
calculate
exposures
and
risks
for
these
workers,
M1
levels
were
converted
to
ethoprop
equivalent
 
this
method
was
used
in
all
of
the
biomonitoring
samples.
It
was
concluded
that
M1
metabolizes
quickly
and
is
excreted
from
the
body
within
24
hours.

A.
Biomonitoring
Study
Parameters
The
study
was
performed
at
13
distinct
test
sites
and
23
handlers
participated
in
the
study.
Most
of
these
individuals
performed
both
loading
and
application
tasks,
while
others
only
loaded
or
applied.
Mocap
®
EC
was
applied
to
the
potato
fields
2
to
3
weeks
prior
to
planting
at
an
application
rate
ranging
from
4
to
12
pounds
of
active
ingredient
per
acre
(
lb
ai/
A).
Most
applications,
however,
were
in
the
9
to
12
lb
ai/
A
range.
In
addition,
the
acres
treated
ranged
from
approximately
25
to
560.
Loading
was
accomplished
through
closed
loading
systems
that
included
a
hard
coupled
mechanical
transfer
system
from
55
gallon
drums
or
closed
2.5
gallon
containers.
In
one
case,
loading
was
accomplished
through
open
pour;
however,
this
loading
method
will
be
prohibited
on
the
revised
labels
as
a
requirement
of
the
2001
IRED.
All
applications
were
made
either
using
large
closed
cab
tractors
coupled
with
deep
injection
equipment
or
large
special
groundboom
field
applicators.
The
test
subjects
wore
several
combinations
of
PPE,
which
varied
by
individual;
however,
most
applicators
wore
full
clothing
(
in
some
cases
Tyvek
suits),
coveralls,
gloves,
rubber
boots,
and
respirators.

A
typical
biomonitoring
study
is
designed
to
monitor
the
total
absorbed
dose
resulting
from
a
single
exposure
event
and
normally
does
not
encompass
exposure
over
several
days.
However,
the
intent
of
this
study
was
quite
different
than
a
typical
biomonitoring
study
in
that
it
was
focused
on
conducting
monitoring
of
a
specific,
small
population
of
professional
applicators
to
define
levels
over
the
monitoring
period
for
those
involved
in
treating
potato
fields
with
ethoprop
under
actual
working
conditions.
Under
actual
working
conditions,
workers
may
be
exposed
for
more
than
one
day
at
a
time;
therefore,
urine
was
collected
for
4
consecutive
work
days
(
for
a
few
workers,
urine
was
collected
on
day
5
and
6
as
well).
The
urine
samples
represented
24
hour
periods
(
2
twelve
hour
samples
combined)
and
a
sample
was
collected
24
hours
prior
to
the
first
day
of
work
in
the
study
for
each
subject.
In
some
cases
the
individual
worked
with
ethoprop
during
each
of
the
4
days,
while
in
other
cases
exposure
only
occurred
on
the
first
day.
In
most
cases,
individuals
worked
with
ethoprop
only
on
the
first
two
days
of
the
monitoring
period.
6
B.
Results
and
Analysis
There
were
185
post­
exposure
urine
samples
collected.
Of
those,
slightly
over
50
percent
(
95
samples)
were
either
below
the
level
of
detection
(
LOD)
or
below
the
level
of
quantification
(
LOQ),
which
were
1
ppb
and
3
ppb
respectively,
or
were
at
a
nondetectable
level.
These
results
indicate
that
very
low
exposures
(
i.
e.,
essentially
no
exposure)
occurred
in
this
population
for
more
than
half
of
the
monitoring
period.

Risk
estimates
were
calculated
for
the
remaining
samples
using
the
biological
monitoring
data
in
two
distinct
manners,
as
follows:
(
1)
a
cumulative
dose
approach
and
(
2)
a
daily
dose
approach.
The
cumulative
approach
essentially
added
the
total
residue
for
each
individual
over
the
entire
monitoring
period
(
4
days),
where
as
the
daily
dose
approach
considered
the
single
24
hour
urine
output
and
did
not
account
for
additivity.
Additionally,
the
arithmetric
mean
was
calculated
for
both
the
cumulative
and
daily
dose
MOEs
for
each
task
performed
[
i.
e.
mixing/
loading
only
(
through
open
pour
versus
mechanical
transfer),
applying
only,
and
mixing/
loading/
applying].
Given
that
the
M1
metabolite
has
been
determined
to
rapidly
metabolize
and
be
excreted
from
the
body
within
24
hours,
the
Agency
believes
that
the
daily
dose
risk
calculations
for
each
task,
and
the
respective
arithmetic
means,
are
the
most
appropriate
on
which
to
base
its
conclusions.

As
stated
earlier,
the
majority
of
185
samples
were
below
than
the
LOQ
or
LOD,
and
thus
non­
detectable.
For
the
remaining
exposure
samples,
the
arithmetic
mean
MOE
risk
estimate
with
engineering
controls
was
 
100
for
most
single
day
events.
The
study
showed
low
levels
of
exposure
and
associated
risk
when
the
required
engineering
controls
are
utilized
and
appropriate
PPE
are
worn.
Although
in
some
cases,
the
workers
used
both
engineering
controls
and
various
levels
of
PPE,
the
Agency
believes
that
the
low
exposure
primarily
resulted
from
the
use
of
the
engineering
controls.
For
example,
the
lowest
single
day
MOE
of
0.04
was
a
result
of
the
mixing/
loading
using
open
pour,
which
is
prohibited
based
on
the
label
amendments
in
the
2001
IRED
that
require
closed
mixing
and
loading.

As
expressed
above,
the
daily
dose
MOEs
ranged
widely
among
individual
handlers.
The
Agency
believes
that
these
results
are
to
be
expected
when
considering
the
actual
work
practices
of
multiple
individuals.
The
hazard
concerns
are
a
key
driver
of
occupational
risk
of
handling
the
liquid
formulation
of
ethoprop.
The
study
screened
for
very
low
levels
of
exposure
(
i.
e.,
low
ppb);
therefore,
the
smallest
increase
in
exposure
significantly
affected
(
lowered)
the
MOE.
The
level
of
care
with
which
an
individual
handles
a
pesticide
greatly
influences
the
overall
exposure
to
the
pesticide.
Given
this
study
monitored
the
actual
work
practices
of
23
handlers,
degrees
of
caution
will
differ.
Therefore,
the
Agency
also
considered
the
arithmetic
mean
MOEs
of
the
daily
dose
samples
with
engineering
contols
 
these
ranged
from
14
to
160,
with
most
averages
 
100.

In
addition
to
the
biological
monitoring
data,
inhalation
monitoring
was
also
conducted
and
used
to
examine
the
relative
contribution
of
inhalation
exposure
to
the
overall
risks
7
associated
with
ethoprop
use.
Risk
estimates
for
inhalation
exposure
were
calculated
for
the
twenty
three
workers
in
the
study
using
the
daily
dose
approach,
which
considered
one
exposure
day.
The
MOEs
ranged
from
31
to
6874.
The
calculated
MOEs
indicate
that
inhalation
risks
are
not
a
major
concern
if
an
average
is
considered,
and
are
not
of
concern
for
the
majority
of
individual
workers.
For
three
individuals,
the
MOEs
were
below
100,
the
level
of
concern.
Overall,
these
results
are
consistent
with
the
IRED
assessment,
and
it
is
clear
that
inhalation
is
not
a
key
contributor
to
the
overall
risks
to
ethoprop
handlers
under
the
conditions
monitored.

Further,
the
study
protocol
required
that
potential
adverse
effects
of
ethoprop
be
explained
to
each
of
the
study
participants.
The
study
report
provides
detailed
descriptions
of
observations
by
the
study
monitors
of
both
the
workers'
work
practices
and
other
observations.
There
is
no
mention
of
any
worker
exhibiting
any
adverse
effects
or
anything
that
would
be
suggestive
of
cholinergic
clinical
signs.
Therefore,
considering
the
MOEs
for
the
majority
of
biomonitoring
and
inhalation
samples,
as
well
as
the
arithmetic
means,
and
the
absence
of
observable
adverse
effects,
the
Agency
believes
when
engineering
controls
are
utilized
for
mixing,
loading,
and
applying
liquid
ethoprop
the
occupational
exposure
to
ethoprop
is
low.

III.
EC
Formulation
Use
and
Usage
Information
and
Available
Alternatives
Ethoprop
EC
formulation
is
marketed
as
Mocap
®
6EC
and
is
currently
registered
for
use
on
bananas/
plantains,
cabbage,
cucumbers,
ornamentals,
sweet
potatoes,
tobacco,
and
white
potatoes.
According
to
the
registrant,
approximately
378,000
pounds
of
active
ingredient
(
ai)
in
liquid
formulated
products
(
approximately
64,000
gallons
of
Mocap
®
6EC)
were
sold
in
2004.

A.
Use
on
Potatoes
and
Sweet
Potatoes
Use
data
(
1987
through
1996)
presented
in
the
2001
ethoprop
IRED
described
a
combined
usage
of
EC
and
granular
on
approximately
3%
of
total
potato
acres.
According
to
the
National
Potato
Council,
the
use
of
liquid
formulation
of
ethoprop
has
increased
239%
from
1995
to
the
end
of
1999.
The
increase
in
use
is
attributed
to
the
heavy
reliance
on
the
EC
formulation
by
potato
farmers
in
various
regions
where
specific
species
of
wireworms
and
nematodes
present
a
serious
pest
problem,
specifically
the
Columbia
Basin
(
Washington
and
Oregon),
Idaho,
Maine,
Wisconsin,
and
the
Delmarva
Peninsula.
Current
usage
data
available
to
the
Agency
confirms
the
increase
in
ethoprop
EC
used
on
potatoes,
and
shows
that
approximately
180,000
lbs/
ai
of
ethoprop
EC
were
used
on
potatoes
in
2004,
and
applied
to
approximately
19,000
acres
(
3%
of
total
acres)
across
the
U.
S.

Additional
usage
information
submitted
by
the
National
Potato
Council
suggests
that
on
average
Mocap
®
6EC
is
applied
at
a
rate
of
6
lb
ai/
A
and
10
lb
ai/
A
for
wireworm
and
nematode
control,
respectively.
However,
the
labeled
rate
for
potatoes
is
as
high
as
12
lb
ai/
A,
which
is
applied
by
commercial
potato
growers
in
the
Pacific
Northwest,
as
seen
in
the
biomonitoring
study
referenced
above.
The
liquid
formulation
is
often
tank
mixed
8
with
metam
sodium,
which,
according
to
the
National
Potato
Council,
results
in
greater
nematode
control.
Although
the
granular
formulation
is
considered
to
be
equally
as
effective
as
the
EC
formulation,
it
is
believed
to
dissipate
into
the
soil
at
a
slower
rate
than
the
liquid
formulation,
which,
according
to
Agency
data,
can
potentially
result
in
up
to
a
3%
yield
loss
due
to
crop
damage.
Additionally,
unlike
with
the
EC
formulation,
metam
sodium
cannot
be
simultaneous
applied
with
the
granular
application
(
e.
g.,
tank
mixed),
resulting
in
the
need
to
conduct
multiple
passes
over
the
field
and
thus
increase
occupational
activity,
potential
for
industrial
incidents,
and
cost
to
growers.
Other
alternatives
are
available,
such
as
carbofuran
and
phorate
for
wireworm
control
and
1,3
D,
metam
sodium
alone,
aldicarb,
and
oxamyl
for
nematode
control;
however,
these
can
cost
substantially
more
per
acre
(
up
to
$
75
per
acre)
or
are
believed
to
be
less
efficacious.

The
Agency
approximates
Mocap
®
6EC
is
applied
to
approximately
18%
of
sweet
potatoes
in
the
U.
S.
Sweet
potato
growers
rely
on
ethoprop
for
the
control
of
white
grubs,
cucumber
beetle
larvae,
and
wireworms.
The
maximum
labeled
application
rate
is
3.9
lb
ai/
A.
According
to
the
Louisiana
State
University
Agricultural
Center
ethoprop
EC
is
applied
to
sweet
potatoes
in
a
manner
similar
to
the
application
to
white
potatoes,
through
closed
cab
systems
designed
for
in­
furrow
applications
and
soil
incorporation.

B.
Ornamental
(
Field
Nursery
Stock
Only)

The
Agency
received
correspondence
from
the
Oregon
Association
of
Nurseries
(
OAN),
as
well
as
several
letters
from
nurseries
and
growers
in
that
region
expressing
the
need
for
the
use
of
Mocap
®
6EC
on
Ornamental
Field
Nursery
Stock
in
Oregon.
According
to
OAN,
in
2004
the
wholesale
value
of
Oregon
nursery
and
greenhouse
production
totaled
$
844
million.
The
producers
of
field
grown
bareroot
and
balled
and
burlapped
nursery
stock,
which
accounts
for
all
nursery
uses
of
Mocap
®
6EC,
are
responsible
for
over
onethird
of
the
industry's
total
value
of
production,
or
$
310
million.
According
to
these
growers,
Mocap
®
6EC
is
used
for
the
control
of
garden
symphylans,
which
present
a
heavy
pest
pressure
to
field
grown
crops
in
this
region
including
ornamentals
due
to
the
characteristically
high
organic
content
in
the
soil.
According
to
the
registrant,
there
is
a
need
for
Mocap
®
6EC
for
use
on
ornamentals
in
areas
of
California
and
Washington
that
face
similar
pest
pressure
as
well.

In
response
to
the
letters,
the
Agency
contacted
several
nurseries
in
Oregon,
ranging
in
size
from
60
to
1700
acres.
According
to
these
growers,
Mocap
®
6EC
is
applied
to
the
fields
pre­
plant
with
closed
cab
mechanical
ground
systems
with
soil
incorporation.
Further,
Mocap
®
6EC
is
preferred
over
the
granular
formulation
due
to
the
availability
of
application
equipment
at
most
nurseries,
and
the
ability
to
tank
mix
the
EC
formulation
with
fertilizer.
The
maximum
labeled
application
rate
is
3.0
lb
ai/
A.

C.
Cabbage,
Cucumbers,
Pineapples,
and
Tobacco
According
to
Agency
data,
Mocap
®
6EC
is
used
on
<
1%
cucumber
and
tobacco
acres
nationwide,
and
is
not
used
in
the
production
of
pineapples.
The
technical
registrant
confirmed
that
the
EC
formulation
is
not
currently
being
used
on
pineapples
by
9
contacting
pineapple
growers
in
Puerto
Rico
and
Hawaii.
In
addition,
according
to
tobacco
and
cucumber
growers
contacted
by
the
Agency,
Mocap
®
6EC
is
not
a
critical
pesticide
and
better
alternatives
are
available
for
control
of
the
pest
pressures
that
affect
the
respective
growers.
Further,
according
to
the
Florida
Fruit
and
Vegetable
Association,
in
conjunction
with
feedback
from
cucumber
growers,
the
application
of
liquid
ethoprop
is
not
conducive
to
the
manner
in
which
cucumbers
are
grown,
on
raised
beds
covered
with
a
sheet
of
plastic
and
mulch.
Therefore,
there
is
little
to
no
use
of
the
EC
formulation
on
this
crop.
The
Agency
did
not
receive
any
comments
to
the
2001
IRED
from
any
of
these
respective
grower
groups.

Further,
according
to
Agency
data,
Mocap
®
6EC
is
used
to
treat
<
1%
of
cabbage
crop
in
the
United
States.
Feedback
from
the
Florida
Fruit
and
Vegetable
Association,
which
included
outreach
to
cabbage
growers,
indicated
there
is
little
known
use
of
the
EC
formulation
of
ethoprop
and
subsequently
it
is
not
considered
a
critical
pesticide
for
use
on
cabbage.
Conversely,
the
Agency
received
comments
from
the
University
of
California,
Davis
Cooperative
Extension,
which
indicate
that
ethoprop
is
an
important
tool
in
cabbage
maggot
and
symphylan
control
in
the
Central
Coastal
regions
of
California.
Treatment
on
cabbage
in
this
region
includes
both
the
granular
and
EC
formulations
of
ethoprop;
however,
according
to
the
Extension
Agent,
commercial
growers
prefer
the
EC
formulation
which
allows
an
accurate
and
standard
liquid
closedsystem
transfer
and
application
method.
Mocap
®
6EC
is
applied
by
banded­
in
row
application
in
closed
cab
tractors
followed
by
soil
incorporation.

D.
Bananas/
Plantains
Ethoprop,
granular
and
EC
formulations,
is
applied
around
the
base
of
the
banana
plantings,
and
sometimes
the
corms
are
dipped
in
solutions
of
ethoprop
to
control
nematodes.
Ethoprop
granular
is
used
on
plantains
and
bananas
in
Puerto
Rico
at
about
40
grams
per
plant
to
control
banana
weevil
and
nematodes.
According
to
the
USDA
Crop
Profile,
90
 
100%
of
banana
and
plantain
acres
in
Puerto
Rico
are
treated
with
granular
ethoprop.
The
Agency
was
not
able
to
find
any
data
supporting
use
of
the
EC
formulation
of
ethoprop
on
bananas
in
Puerto
Rico.
The
registrant
maintains
that
Mocap
®
6EC
is
not
used
to
treat
bananas
in
Puerto
Rico.
However,
according
to
Agency
data,
Ethoprop
EC
is
applied
to
about
400
acres
of
bananas
per
year
in
Hawaii
to
control
root­
knot
and
reniform
nematodes.

Alternatives
to
the
EC
formulation
of
ethoprop
for
control
of
nematodes
and
banana
weevil
on
bananas
are
the
granular
formulation
of
ethoprop,
oxamyl
and
Nemacur
(
fenamiphos);
however,
fenamiphos
use
is
being
phased
out.
According
to
feedback
from
the
University
of
Hawaii
at
M noa,
Department
of
Plant
and
Environmental
Protection
Services
growers
indicated
that
ethoprop
is
a
viable
pest
management
tool;
the
growers
were
particularly
concerned
with
maintaining
the
use
of
the
granular
formulation.
According
to
the
growers,
the
granular
application
of
ethoprop
via
backpack
spreader,
which
is
currently
a
registered
application
method
for
bananas
on
the
Mocap
®
15G
label,
is
more
desirable
and
practical
than
the
engineering
controls
required
for
application
of
Mocap
®
6EC.
10
IV.
Occupational
Post­
Application
and
Ecological
Exposures
The
2001
IRED
also
addressed
the
post­
application
risk
to
workers,
as
well
as
the
ecological
risks
associated
with
the
use
of
ethoprop
granular
and
EC
formulations.
For
both
the
granular
and
EC
formulation
of
ethoprop,
the
Agency
believes
the
potential
for
post­
application
work
exposure
is
low.
Ethoprop
is
applied
once
either
at
pre­
plant,
at­
plant,
or
pre­
emergence
for
most
field
crops.
There
are
no
routine
activities
for
most
field
crops
that
lead
to
potential
exposures
during
the
designated
restricted
entry
intervals
(
REI)
on
the
current
labels
of
48
hours,
or
72
hours
in
outdoor
areas
where
average
rainfall
is
less
than
25
inches
per
year,
as
required
by
the
Worker
Protection
Standard.
In
addition,
crops
are
treated
well
before
plants
reach
maturity,
which
mitigates
the
potential
for
post­
application
exposure
from
contact
with
foliage.
In
addition,
for
all
crops,
ethoprop
products
are
to
be
soil
incorporated
or
watered­
in
immediately
after
application.
The
Agency
has
no
risk
concerns
for
post­
application
exposures
to
agricultural
workers,
and
no
risk
mitigation
measures
beyond
the
labeled
REI
are
necessary.

The
ecological
risk
assessment
denoted
risks
of
concern
for
birds,
mammals,
fish,
and
invertebrates
due
to
the
moderately
high
toxic
characteristics
of
ethoprop.
In
general,
the
use
of
liquid
poses
less
risk
concern
to
terrestrial
species,
especially
birds,
than
granular
formulations
because
granules
can
be
available
for
ingestion.
For
aquatic
organisms,
liquid
formulations
generally
pose
a
higher
risk
because
of
the
greater
potential
for
runoff
or
drift
into
near­
by
water
bodies.
The
2001
ethoprop
IRED
required
various
measures
to
mitigate
these
risks
to
both
terrestrial
and
aquatic
organisms,
such
as
soil
incorporation
(
which
significantly
reduces
the
potential
for
ethoprop
to
remain
on
the
soil
surface
to
be
available
for
runoff
or
ingestions),
canceling
certain
uses,
reducing
maximum
application
rates
and
limiting
the
number
of
applications,
deleting
broadcast
application
for
some
uses,
and
imposing
buffer
zones
for
the
EC
formulation.

IV.
Regulatory
Determination
and
Rationale
It
is
the
Agency's
policy
to
mitigate
occupational
risk
to
the
greatest
extent
necessary
and
feasible.
A
wide
range
of
factors
are
considering
in
making
risk
management
decisions
for
worker
risks.
These
factors
include
estimated
MOEs,
cancer
risk
estimates,
incident
data,
the
nature
and
severity
of
adverse
effects
observed
in
animal
studies,
uncertainties
in
the
risk
assessment,
alternative
registered
pesticides,
the
importance
of
the
chemical
in
integrated
pest
management
(
IPM)
programs,
and
other
similar
factors.

The
Agency
believes
when
engineering
controls
are
utilized
for
mixing,
loading,
and
applying
ethoprop
EC
the
occupational
exposure
to
ethoprop
is
low,
and
the
associated
risk
is
not
of
concern
based
on
the
MOEs
for
the
large
majority
of
biomonitoring
and
inhalation
samples,
as
well
as
the
arithmetic
mean
MOEs,
and
the
absence
of
observable
adverse
effects.
Further,
the
most
recent
assessment
of
ethoprop
incidents
was
completed
in
September
2005,
and
relatively
few
incidents
of
illness
have
been
reported
due
to
ethoprop.
The
only
occupational
handler
scenario
that
exceeded
the
Agency's
cancer
level
of
concern
in
the
2001
IRED
was
mixing/
loading
EC
for
chemigation
at
a
rate
of
12
11
lb
ai/
A
(
2.1
x
10­
4).
This
scenario
is
no
longer
applicable
since
the
only
application
method
remaining
on
the
EC
label
will
be
mechanical
ground
closed
cab
equipment
with
soil
incorporation.
Chemigation
is
no
longer
an
available
application
method
since
use
on
pineapples
is
being
voluntarily
deleted
(
see
the
Revised
Appendix
A:
Table
of
Use
Patterns
Eligible
for
Reregistration
for
Ethoprop).
Based
on
these
conclusions,
as
well
as
the
discussion
of
the
significance
of
ethoprop
EC
formulation
to
certain
growers
and
consideration
of
available
alternatives
discussed
in
the
section
above,
the
Agency
determined
that
liquid
(
EC)
products
that
contain
ethoprop
are
eligible
for
reregistration
on
potatoes,
sweet
potatoes,
cabbage
(
CA
only),
and
ornamental
field
nursery
stock
(
CA,
OR,
and
WA
only)
and
are
not
eligible
for
use
on
bananas/
plantains,
cucumbers,
pineapples,
and
tobacco.

A.
Reregister
for
Use
on
Potatoes,
Sweet
Potatoes,
Cabbage,
and
Ornamentals
The
decision
to
reregister
the
EC
formulation
of
ethoprop
for
use
on
potatoes
is
based
in
part
on
the
conclusions
that
the
risks
associated
with
the
handling
of
ethoprop
EC
formulation
are
not
of
concern
when
engineering
controls
are
utilized,
based
on
the
analysis
of
the
biomonitoring
study
performed
on
potato
growers
in
the
Pacific
Northwest.
The
Agency
understands
that
potato
production
in
other
regions
of
the
country
involves
similar
use
practices
and
equipment,
and
therefore,
the
Agency
believes
the
study
is
representative
of
these
regions
as
well.

Due
to
the
similar
manner
in
which
ethoprop
EC
formulation
is
applied
to
sweet
potatoes,
and
ornamental
field
crops
and
cabbage
in
the
areas
of
California,
Oregon,
and
Washington,
as
discussed
in
the
section
above,
the
Agency
believes
that
the
biomonitoring
study
performed
on
potato
growers
is
transferable
to
these
uses
as
well.
Further,
the
application
rates
of
Mocap
®
6EC
for
use
on
cabbage,
ornamental
field
nursery
stock,
and
sweet
potatoes
are
1.65,
3.0,
and
3.9
lb
ai/
A,
respectively,
which
are
much
lower
than
the
maximum
application
rate
for
registered
use
on
white
potatoes,
12
lb
ai/
A,
and
the
rates
used
in
the
biomonitoring
study
(
4
to
12
lb
ai/
A).
The
Agency
concluded
that
the
occupational
risk
for
use
on
potatoes
is
not
of
concern,
and
therefore,
considering
transferability
of
the
biomonitoring
study,
the
lower
application
rate,
the
requirement
of
engineering
controls,
and
the
importance
of
the
EC
formulation
for
these
uses,
the
Agency
is
concluding
that
the
occupational
risks
associated
with
use
on
sweet
potatoes,
ornamental
field
nursery
stock
(
CA,
OR,
and
WA)
and
cabbage
(
CA
only)
are
not
of
concern
as
well.

B.
Cancel
use
on
Bananas/
Plantains,
Cucumbers,
Pineapples,
and
Tobacco
Agency
data
indicate
that
the
ethoprop
EC
use
on
these
crops
is
extremely
low
(<
1%).
As
discussed
in
the
section
above,
the
feedback
from
respective
grower
groups
indicated
that
the
deletion
of
these
uses
on
the
ethoprop
EC
formulation
products
would
not
be
a
critical
loss
due
to
lack
of
use,
the
availability
of
preferred
alternatives,
and/
or
infeasibility
of
required
engineering
controls
for
handler
activities.
Based
on
this
information
and
the
availability
of
alternatives,
the
Agency
received
a
request
from
the
12
technical
registrant
to
voluntarily
cancel
the
EC
formulation
for
use
on
bananas/
plantains,
cucumbers,
pineapples,
and
tobacco.

V.
Label
Amendment
The
technical
registrant
has
voluntarily
deleted
the
following
uses
from
the
Mocap
®
EC
label:
bananas/
plantains,
cucumbers,
pineapples,
and
tobacco.
Additionally,
as
a
result
of
the
2001
IRED,
the
registrant
submitted
to
the
Agency
Requests
for
Voluntary
Cancellation
of
Products
and
Voluntary
Use
Deletions.
Appendix
A:
Table
of
Use
Patters
Eligible
for
Reregistration
for
Ethoprop
has
been
revised
to
reflect
these
product
cancellation
and
use
deletions,
and
supercedes
the
Appendix
A
in
the
2001
Ethoprop
IRED
document.

This
addendum
confirms
the
handler
personal
protective
equipment
and
engineering
control
specifications
for
the
EC
and
granular
formulations
specified
in
Table
14
of
the
2001
ethoprop
IRED
document,
Summary
of
Labeling
Changes
for
Ethoprop.
No
further
changes
to
product
labels,
beyond
what
is
stipulated
in
Table
14,
are
needed
as
a
result
of
this
regulatory
determination.
13
Appendix
A.
Table
of
Use
Patterns
Eligible
for
Reregistration
for
Ethoprop
Site:
Application
Type
Application
Timing
Application
Equipment
Formulation
[
EPA
Reg.
No./

SLN
No.]
Maximum
Single
Application
Ratea
Maximum
Number
of
Appls.
b
Minimum
Retreatment
Interval
Use
Limitation
Food/
Feed
Crops
Uses
Bananans/
Plantains
Application
to
soil
adjacent
to
stem
Growing
plants
Ground
Equipment
G
[
264­
457]
10.6
lb
ai/
A;

rate
on
a
per
plant
basis:

0.2
oz
(
6
grams)
of
ai
2
per
year
6
months
Treat
only
the
soil
within
a
radius
of
30
inches
(
3/
4
meters)
of
plant
stern.

Use
of
EC
on
bananas
has
been
voluntarily
deleted.

Beans
(
Lima/
Snap)

Broadcast
Preplant
or
at
planting
Ground
equipment
8.1
lb
ai/
A
G
[
264­
457]
3
lb
ai/
A;

0.21
lb
ai/
1000
ft
of
row
(
minimum
of
12
 
band,
36
 

row
spacing)
1
NA
Use
of
EC
on
both
lima
and
snap
beans
has
been
voluntarily
deleted.

Cabbage
Broadcast
Preplant
or
at
planting
Ground
equipment
G
[
264­
457]
5.1
lb
ai/
A
Banded
At
planting
Ground
equipment
G
[
264­
457]
1.95
lb
ai/
A;

0.135
lb
ai/
1000
ft
of
row
(
15
 
band,
36
 
row
spacing)
1
NA
Banded
At
planting
Ground
equipment
6
lb/
gal
EC
[
264­
458]
1.65
lb
ai/
A;

2.4
fl
oz
of
EC/
1000
ft
of
row
(
minimum
of
12
 
band,

36
 
row
spacing)
1
NA
CA
Only
Only
banded
applications
to
cabbage
are
allowed
for
the
EC
because
broadcast
applications
of
EC
to
cabbage
have
been
voluntarily
deleted.
14
Site:
Application
Type
Application
Timing
Application
Equipment
Formulation
[
EPA
Reg.
No./

SLN
No.]
Maximum
Single
Application
Ratea
Maximum
Number
of
Appls.
b
Minimum
Retreatment
Interval
Use
Limitation
Corn
(
Field
and
Sweet)

Broadcast
Preplant
or
at
planting
Ground
equipment
G
[
264­
457]
6
lb
ai/
A
Banded
At
planting
Ground
equipment
G
[
264­
457]
4
lb
ai/
A:

0.15
lb
ai/
1000
ft
of
row
(
minimum
of
12
 
band,
20­

40
 
row
spacing)
1
NA
Use
of
the
EC
formulation
on
both
field
and
sweet
corn
has
been
voluntarily
deleted.

Application
by
layby
has
been
voluntarily
deleted.

Cucumbers
Banded
At
planting
Ground
equipment
G
[
264­
457]
1.95
lb
ai/
A:

0.315
lb
ai/
1000
ft
of
row
(
minimum
of
12
 
band,
7
ft
row
spacing)
1
NA
Use
of
EC
on
cucumbers
has
been
voluntarily
deleted.

Pineapple
Post­
plant
Apply
at
base
of
each
plant
1­
2
months
after
planting
Ground
equipment
G
[
264­
457]
6
lb
ai/
A
4
per
year
3
months
Do
not
treat
within
120
days
of
harvest.

Use
of
EC
on
pineapples
has
been
voluntarily
deleted.

Potatoes
Broadcast
Preplant
to
preemergence
Ground
equipment
G
[
264­
457]

6
lb/
gal
EC
[
264­
458]
12
lb
ai/
A
(
see
Use
Limitation
for
additional
information
on
geographical
restrictions)

G
[
264­
457]
3
lb
ai/
A;

0.21
lb
ai/
1000
ft
of
row
(
12
 

band,
36
 
row
spacing)

Banded
At
planting
Ground
equipment
6
lb/
gal
EC
[
264­
458]
3
lb
ai/
A;

4.4
fl
oz
of
EC/
1000
ft
of
row
(
12
 
band,
36
 
row
spacing)
1
NA
The
maximum
application
rate
for
the
treatment
of
nematodes
west
of
the
Mississippi
River
is
12/
lb
ai/
A.
For
nematodes
east
of
the
Mississippi
River,

the
maximum
rate
is
9
lb
ai/
A.
For
wireworms,

the
maximum
application
rate
is
6
lb
ai/
A
nationally.
15
Site:
Application
Type
Application
Timing
Application
Equipment
Formulation
[
EPA
Reg.
No./

SLN
No.]
Maximum
Single
Application
Ratea
Maximum
Number
of
Appls.
b
Minimum
Retreatment
Interval
Use
Limitation
Sugarcane
Broadcast
At
planting
Ground
equipment
G
[
264­
457]
6
lb
ai/
A
Banded
At
planting
Ground
equipment
G
[
264­
457]
4
lb
ai/
A;

0.56
lb
ai/
1000
ft
of
row
(
minimum
of
12
 
band,
6
ft
row
spacing)
1
NA
Sweet
Potatoes
G
[
264­
457]
3.9
lb
ai/
A;

0.315
lb
ai/
1000
ft
of
row
(
minimum
of
12
 
band,
42
 

row
spacing)

Broadcast
Preplant
Ground
equipment
6
lb/
gal
EC
[
264­
458]
3.9
lb
ai/
A;

6.9
fl
oz
of
EC/
1000
ft
of
row
(
minimum
of
12
 
band,
42
 

row
spacing)
1
NA
Only
banded
applications
to
sweet
potatoes
are
allowed,
because
broadcast
applications
to
sweet
potatoes
have
been
voluntarily
deleted.

Non
Food/
Feed
Uses
Ornamentals
(
Field
nursery
stock
only)

Broadcast
only
to
soil
Preplant
Ground
equipment
6
lb/
gal
EC
3
lb
ai/
A
1
NS
CA,
OR,
and
WA
only.

Nursery
stock
may
only
be
mechanically
transplanted
into
the
treated
area,
and
not
until
72
hours
after
treatment.

Tobacco
Broadcast
Preplant
or
at
planting
Ground
equipment
G
[
264­
457]
6
lb
ai/
A
Banded
Preplant
or
at
planting
Ground
equipment
G
[
264­
457]
6
lb
ai/
A;

0.96
lb
ai/
1000
ft
of
row
(
minimum
of
18
 
band,
42
 

row
spacing)
1
NA
Use
of
EC
on
tobacco
has
been
voluntarily
deleted.

a
For
banded
applications,
the
maximum
rate
is
expressed
both
as
the
maximum
rate
per
acre
as
lb
ai/
A,
as
well
as
the
maximum
rate
per
linear
1000
ft
row,
as
lb
ai
(
for
granular
products)
or
fl.
Oz.
ai
(
for
the
EC)
per
1000
ft
linear
row,
with
the
minimum
band
width
and
row
spacing
listed
in
parentheses.
16
b
Maximum
number
of
applications
for
the
growing
crop.
Note
that
for
tropical
crops
(
bananas,
plantains,
and
pineapples),
the
at
planting
and
the
ratoon
crops
may
take
more
than
a
year
to
mature.
In
addition,
for
some
agricultural
row
crops,
in
some
parts
of
the
country,
more
than
one
crop
per
year
may
be
grown,
but
each
growing
crop
may
only
be
treated
one
time
(
i.
e.,
one
treatment
per
crop
season).