Document ID: EPA-HQ-OPP-2003-0348-0024
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-26T04:00Z

Page
1
of
13
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
CERTIFIED
MAIL
March
7,
2006
Dear
Registrant:

SUBJECT:
AMENDMENT
TO
PROPANIL
RED
The
Reregistration
Eligibility
Decision
(
RED)
document
for
propanil
was
signed
on
9/
30/
2003.
A
public
comment
period
for
the
Propanil
RED
(
and
the
supporting
assessment)
was
conducted
from
2/
25/
2004
to
4/
26/
2004.
The
risk
assessments,
benefit
assessment,
and
public
comments
can
be
found
on
the
federal
docket
system,
available
at
www.
Regulations.
gov
(
docket
#
EPA­
HQ­
OPP­
2003­
0348).
The
Agency
has
reviewed
the
public
comments
submitted
and
has
responded
to
those
that
relate
specifically
to
the
propanil
RED.
The
Agency=
s
responses
are
available
for
viewing
under
the
same
docket
number
on
the
Regulations.
gov
system.
As
a
result
of
its
review
of
the
public
comments
and
review
of
additional
data
submitted
by
the
Propanil
Task
Force,
the
Agency
is
amending
the
Propanil
RED,
where
appropriate.
These
revisions
include
label
changes
and
an
updated
AAppendix
B:
Data
Supporting
Guideline
Requirements
for
the
Reregisrtaion
of
Propanil@.
The
label
changes
related
to
dry
flowable
closed
systems
are
contingent
on
the
outcome
of
exposure
data
that
are
due
in
December
2006.

In
addition,
the
Agency
has
received
a
request
from
the
California
Rice
Commission
to
reexamine
the
tolerance
that
was
proposed
in
the
2003
RED
on
rice
of
10
ppm.
In
order
to
facilitate
trade
in
the
Pacific
region,
the
California
Rice
Commission
would
like
to
maintain
the
existing
tolerance
of
2
ppm.
At
this
time,
the
Agency
is
moving
forward
with
this
Propanil
Amendment
decision,
but
will
look
into
this
request
further
as
more
information
or
supporting
data
are
submitted.

Risk
Mitigation
Measures
Dependent
on
Worker
Monitoring
Studies
In
the
9/
30/
2003
Propanil
RED,
two
handler
exposure
mitigation
measures
depended
upon
the
outcome
of
worker
monitoring
(
exposure)
studies
that,
at
the
time
the
RED
was
signed,
were
under
review
by
the
Agency.
The
first
proposed
measure
would
have
reduced
the
seasonal
application
rate
of
propanil
from
8
lbs
a.
i.
per
acre
to
6
lbs
a.
i.
per
acre.
The
second
measure
would
have
limited
the
maximum
number
of
acres
treated
per
day
to
500.
These
measures
were
Page
2
of
13
to
be
implemented
unless
the
data
from
exposure
monitoring
studies
indicate
that
lesser
or
no
further
mitigation
was
warranted.
As
explained
below,
the
results
of
the
worker
monitoring
study
were
of
only
limited
utility
and
comments
from
stakeholders
raised
concerns
about
the
feasibility
of
the
proposed
measures.
Thus
EPA
has
modified
the
mitigation
measures.

The
Propanil
Task
Force
II
(
PTF
II)
submitted
both
a
bio­
monitoring
study
in
August
2003
and
a
passive
dosimetry
study
in
December
2003,
to
refine
the
exposure
estimates
for
workers
handling
propanil.
Upon
completion
of
the
review
of
the
data
in
May
2004,
the
Agency
accepted
comments
from
the
PTF
II
and
has
responded
to
the
concerns
raised
by
the
PTF
II
in
the
November
23,
2004
memo
from
Alan
Nielsen.
The
Agency
has
determined
that,
due
to
an
insufficient
number
of
acceptable
replicates
and
other
shortcomings,
data
from
these
two
worker
exposure
studies
could
not
be
relied
on
exclusively
to
quantify
the
risk
to
workers
using
propanil.
However,
the
results
do
help
to
characterize
exposure
under
actual
field
conditions
to
aerial
applicators
and
the
mixer/
loaders
supporting
aerial
applications
of
propanil.
For
example,
calculations
based
on
passive
dosimetry
measurements
from
the
study
indicate
that
margins
of
exposure
(
MOEs)
for
aerial
applicators
could
be
up
to
20­
fold
greater
than
those
calculated
based
on
the
Pesticide
Handler
Exposure
Database
(
PHED)
that
was
used
in
the
initial
risk
assessment;
mixer/
loader
MOEs
would
be
about
three­
fold
greater.
While
the
Agency
believes
that
the
passive
dosimetry
data
represent
only
low­
end
exposures,
they
are
useful
in
concluding
that
the
existing
assessment
does
not
underestimate
risk
and,
in­
fact
likely
represents
worst­
case
exposures.
PHED
is
a
database
containing
voluntarily
submitted
empirical
exposure
data
for
workers
involved
in
the
handling
or
application
of
pesticides
in
the
field;
it
currently
contains
data
for
over
2000
monitored
exposure
events.

The
following
is
an
update
on
the
two
pending
mitigation
measures
that
were
proposed
in
the
2003
RED
to
address
risk
to
handlers
of
propanil.
These
proposed
mitigation
measures
were
specifically
targeting
risk
to
workers
participating
in
mixing
and
loading
liquid
and
dry
flowable
propanil
for
aerial
application,
and
applying
sprays
for
aerial
application.

1.
Mitigation
measure
in
the
2003
Propanil
RED:

The
Agency
proposed
reducing
the
maximum
seasonal
application
rate
from
8
lbs
a.
i.
/
acre
to
6
lbs
a.
i./
acre.

Comments
and
issues:

The
proposed
rate
reduction
from
8
lbs
a.
i./
acre
per
season
to
6
lbs
a.
i./
acre
per
season
was
intended
to
reduce
the
over
all
amount
of
propanil
workers
would
be
handling
in
a
year
and
thus
reduce
worker
exposure.
Comments
were
received
from
growers
concerned
with
limiting
the
maximum
seasonal
application
rate
of
propanil
to
6
lbs
a.
i./
acre.
Page
3
of
13
While
this
6
lb
a.
i./
acre
per
season
rate
is
the
typical
seasonal
rate,
it
is
sometimes
necessary
to
apply
up
to
8
lbs
a.
i./
acre
per
season.
In
some
areas
of
the
U.
S.
it
is
more
effective
to
control
weeds
with
two
4
lbs
a.
i./
acre
applications
of
propanil
in
a
season,
while
in
other
areas
it
is
more
effective
to
apply
one
application
of
propanil
at
6
lbs
a.
i./
acre.
Despite
the
varying
application
rates,
the
Agency=
s
use
data
(
see
page
6
of
the
BEAD
memo
from
V.
Werling,
9/
30/
2003)
indicates
that
less
than
5%
of
all
applications
of
propanil
are
made
at
rates
greater
then
4
lbs
a.
i./
acre
on
a
national
basis.

Given
the
benefits
of
propanil
use
and
the
information
from
the
Agency=
s
use
data,
the
Agency
is
retaining
the
original
8
lbs
a.
i./
acre
seasonal
application
rate
and
establishing
a
maximum
for
a
single
application
rate
at
6
lbs
a.
i./
acre
which
will
continue
to
allow
flexibility
for
growers
in
all
regions
of
the
United
States
to
effectively
control
weeds
in
rice.
Previously
there
was
no
maximum
single
application
rate
restriction
on
all
propanil
product
labels.
MOE
are
not
calculated
on
yearly
maximum
rates,
only
single
application
rates,
assuming
that
rate
is
used
consistently
over
30­
90
days.
Mixer/
loader
MOEs
at
6
lbs
ai/
acre
range
from
50
to
1000
using
only
the
PHED
data
(
with
a
target
of
300)
depending
on
the
formulation,
equipment
and
number
of
acres
treated.
Based
on
usage
information,
it
is
unlikely
that
any
single
applicator
uses
the
6
lb
rate
consistently
for
30
days.
The
most
likely
application
scenario
is
3­
4
lbs/
ai/
acre,
yielding
MOEs
in
the
100­
2000
range.
The
lowest
MOE
represents
3
lbs
ai/
acre,
1,200
acres
treated
daily
for
30
days.

Amended
mitigation
measure
and
data
requirement:

The
maximum
single
application
rate
for
rice
is
6
lbs
a.
i./
acre,
with
a
maximum
seasonal
application
rate
of
8
lbs
a.
i./
acre.

A
new
Data
Call
In
requirement
for
confirmatory
usage
and
application
data
spanning
a
period
of
2
years
is
also
being
required
by
the
Agency.

2.
Mitigation
measure
in
the
2003
Propanil
RED:

The
Agency
proposed
to
restrict
the
number
of
acres
treated
per
day
for
aerial
applications
to
500
acres.

Comments
and
issues:

The
Agency
received
comments
concerned
with
the
difficulties
a
500
acre
daily
application
restriction
would
create
for
rice
growers
and
state
enforcement
agencies.
Rice
growers
and
aerial
applicators
are
concerned
with
being
able
to
effectively
treat
the
rice
crop
with
an
acreage
restriction
in
place.
The
propanil
application
season
is
short
and
aerial
applicators
sometimes
need
to
apply
propanil
to
a
large
number
of
acres
in
a
day
in
order
to
effectively
control
weeds
in
the
rice
crop
due
to
early
season
wet
weather
Page
4
of
13
conditions
which
are
conducive
to
weed
germination.
Comments
received
by
the
Agency
ranged
from
suggesting
the
restriction
be
eliminated
all
together,
to
establishing
a
flexible
weekly
limit,
a
moving
7
day
average,
or
a
30
day
acreage
average.

According
to
the
May
2004
APesticide
Use
Survey
Report
for
Agricultural
Aviation@
from
the
National
Agricultural
Aviation
Association,
the
average
acres
of
rice
treated
with
any
type
of
pesticide
per
day
was
725
acres,
while
the
maximum
number
of
acres
treated
per
day
was
1,344
acres
in
2003.
EPA's
assessment
calculated
MOEs
assuming
up
to
3,200
acres
treated
per
day.
While
growers
have
reported
treating
as
much
as
3,200
acres
in
a
single
day,
there
is
no
evidence
to
support
the
assumption
that
this
high
number
of
acres
is
treated
for
sustained
periods
of
time
by
the
same
aerial
applicator.
Thus,
the
Agency
is
requiring
the
registrant
to
verify
the
use
of
propanil
from
3
high
propanil
use
areas
outside
of
California,
the
results
of
which
will
be
submitted
to
the
Agency
in
two
annual
reports.
Data
are
not
required
for
California
because
an
acreage
limit
of
720
acres
per
day
is
already
in
effect.
This
requirement
is
intended
to
confirm
average
number
of
acres
treated
over
a
month
and
thus
determine
a
realistic
average
exposure
for
aerial
applicators
and
mixers/
loaders
specifically
to
propanil.
Acute
or
single
day
exposures
are
not
a
concern
for
propanil
since
no
adverse
effects
attributed
to
a
single
exposure
were
identified
in
the
toxicity
data.
The
toxic
effect
of
concern
for
propanil
exposure
(
methemoglobin
anemia)
was
observed
in
toxicity
studies
of
short­
term
(
30
day)
duration.

Exposure/
risk
estimates
for
aerial
applicators
using
PHED
only
vary
from
MOEs
of
560
at
350
acres/
day
to
160
at
1,200
acres
per
day.
At
an
average
of
600
acres/
day,
the
Agency
estimates
MOEs
of
approximately
320,
above
the
target
MOE
of
300.
Mixer/
loader
MOEs
range
from
100
to
2000
using
typical
application
rates
and
the
PHED
data,
depending
on
the
formulation,
equipment
and
number
of
acres
treated.

The
use
data
should
be
collected
over
a
2
year
period
and
include
the
specific
information
that
is
listed
in
the
AAdditional
Data
Needs@
section
of
this
document.
If
the
confirmatory
data
do
not
support
the
Agency=
s
use
assumptions
on
the
average
number
of
acres
pilots
treat
with
propanil,
further
mitigation
measures
may
be
taken.
The
Agency
is
not
imposing
any
aerial
acreage
limitations
at
this
time
but
is
requiring
all
aerial
applications
occur
in
an
enclosed
cab
(
see
#
3
below)
which
will
reduce
pilot
exposure
to
propanil.
Mixer/
loader
exposure
will
be
addressed
with
PPE
and
closed
systems
as
discussed
below.

Amended
requirement:

A
new
Data
Call
In
requirement
for
confirmatory
usage
and
application
data
spanning
a
period
of
2
years
is
being
required
by
the
Agency.
Page
5
of
13
Additional
Amended
Risk
Mitigation
Measures
Additional
comments
were
received
on
other
risk
mitigation
measures
required
in
the
2003
Propanil
RED.
Based
on
public
comments
the
following
changes
are
being
made:

3.
Mitigation
measure
in
the
2003
Propanil
RED:

Closed
cabs
would
be
required
for
all
applications
of
propanil
(
ground
and
aerial).

Comments
and
issues:

Ground
At
typical
application
rates
(
3
lbs
ai/
acre)
and
acreage
(
80
and
200
acres
per
day)
for
ground
applications,
the
MOEs
for
propanil
ranged
from
300
to
740,
are
above
the
target
MOE
of
300,
and
are
not
of
concern
to
the
Agency.
Only
one
scenario,
at
the
maximum
application
rate
(
6
lbs.
ai/
acre)
and
area
treated
(
200
acres/
day),
did
not
meet
the
target
MOE
at
baseline
attire.
MOEs
for
the
one
outlier
ranged
from
150
at
baseline
to
500
with
closed
cabs.
The
Agency
initially
required
closed
cabs
for
ground
applications
due
to
this
maximum
application
scenario
calculation
and
to
be
consistent
with
the
aerial
enclosed
cab
requirements.
After
receiving
comments
expressing
difficulty
in
modifying
ground
equipment
used
in
rice
fields
with
closed
cabs
and
after
further
consideration,
the
Agency
has
decided
that
requiring
closed
cabs
for
ground
applications
would
add
a
greater
burden
than
necessary
for
all
ground
applicators.
Therefore,
applicators
will
be
required
to
wear
baseline
attire
when
making
ground
applications
of
propanil.

Aerial
Due
to
the
large
acreage
that
aerial
applicators
are
able
to
treat
and
the
potential
for
high
exposure,
combined
with
data
from
the
PTF
II
indicating
that
closed
cockpits
are
the
current
cultural
practice
used
in
the
field,
the
Agency
is
requiring
a
closed
cab
for
all
aerial
applications
of
propanil.
With
closed
cabs,
exposure/
risk
estimates
for
aerial
applicators
using
PHED
data
only,
vary
from
MOEs
of
560
at
350
acres/
day
to
160
at
1,200
acres
per
day.
At
an
average
of
600
acres/
day,
the
Agency
estimates
MOEs
of
approximately
320,
above
the
target
MOE
of
300.
Because
of
the
benefits
of
propanil
and
existing
information
that
high
acreage
and
high
rate
applications
do
not
co­
occur
frequently
or
repeatedly,
the
Agency
is
allowing
this
use.

Amended
mitigation
measure:

Baseline
attire
is
required
for
groundboom
applicators:
long
pants,
long
sleeved
shirt,
shoes
and
socks.
A
closed
cab
is
required
for
all
aerial
applications
of
propanil.
Page
6
of
13
4.
Liquid
and
dry
flowable
mitigation
measure
in
the
2003
Propanil
RED:

The
Agency
proposed
to
require
a
closed
mixing
and
loading
system
for
all
formulations
of
propanil
(
liquid
and
dry
flowables
applied
both
aerially
and
with
groundboom).

Liquid
Formulations
Comments
and
issues
on
liquid
formulations:

Comments
were
received
from
propanil
user
groups
explaining
the
lack
of
current
technology
for
a
Acompletely@
closed
mixing
and
loading
systems
for
liquid
propanil
formulations.
The
California
Rice
Commission,
USA
Rice
Federation,
and
the
Arkansas
State
Plant
Board
expressed
concerns
and
raised
potential
problems
associated
with
conforming
to
this
requirement.
They
felt
that
closed
mixing
and
loading
systems
would
slow
their
loading
speed
and
hinder
their
ability
to
mix
propanil
with
other
products
and
not
provide
additional
protection
for
workers,
which
would
make
the
requirement
of
closed
mixing
and
loading
system
unworkable
under
field
conditions.
These
additional
comments
can
be
viewed
under
this
docket,
OPP­
2003­
0348.

The
Agency
understands
these
concerns
regarding
the
closed
mixing
and
loading
requirement
for
liquid
formulations.
Nonetheless,
the
Agency
continues
to
have
concerns
for
pesticide
handlers
exposed
to
the
liquid
formulations
of
propanil
when
mixing
and
loading
large
quantities
of
concentrated
product.
Closed
mixing
and
loading
systems
are
important
to
ensure
workers
are
not
exposed
to
excessive
levels
of
propanil
through
dermal
exposure
when
making
both
ground
and
aerial
applications.
Applications
of
propanil
to
rice
are
often
made
over
a
very
short
time
frame
(
usually
about
30
days)
due
to
early
season
wet
weather
conditions
which
are
conducive
to
weed
germination.
When
these
conditions
exist,
there
is
pressure
to
apply
propanil
to
large
acreage
over
a
short
time
frame.
These
conditions
could
lead
to
handlers
being
exposed
to
quantities
of
liquid
propanil
that
exceed
the
Agency=
s
level
of
concern
for
dermal
exposure.
The
implementation
of
closed
mixing
and
loading
systems
will
help
reduce
handler
dermal
exposure.

In
order
to
be
eligible
for
reregistration
all
liquid
formulations
of
propanil,
including
emulsifiable
concentrates,
flowable
concentrates,
ready
to
use
solutions,
soluble
concentrates,
and
other
liquid
formulations,
must
be
mixed
and
loaded
in
a
closed
system
that
will:
(
1)
remove
the
pesticide
from
the
container
and
transfer
it
into
a
mix
tank,
and
(
2)
transfer
it
from
the
mix
tank
into
the
application
equipment
in
a
closed
system
that
prevents
dermal
contact
of
handlers.
EPA
has
published
Pesticide
Registration
(
PR)
Notice
2000­
9
about
closed
mixing
and
loading
systems
that
describes
a
closed
system
as
Aa
system
designed
by
the
manufacturer
to
enclose
the
pesticide
to
prevent
it
from
Page
7
of
13
contacting
individuals
while
it
is
being
handled.@
This
PR
Notice
may
be
viewed
at
http://
www.
epa.
gov/
PR_
Notices/
pr2000­
9.
pdf.

In
addition
to
this
PR
Notice,
the
Propanil
Task
Force
II,
along
with
the
California
Rice
Commission,
presented
to
the
Agency
one
of
the
current
methods
of
liquid
propanil
transfer
in
some
rice
growing
areas
(
see
Letter
from
McDermott
Will
and
Emory
dated
July
29th,
2005).
This
method
utilizes
a
probe
that
is
inserted
into
the
drum
and
pumps
the
liquid
propanil
out
and
into
a
mixing
tank.
There
is
potential
for
dermal
exposure
to
the
liquid
propanil
concentrate
if
an
un­
rinsed
probe
is
removed
from
a
partially
used
container.
It
is
necessary
to
remove
probes
from
partially
empty
propanil
containers
when
all
of
the
propanil
product
cannot
be
utilized
in
one
application.
In
these
cases,
the
use
of
an
anti­
drip
flange
and
additional
PPE
when
an
un­
rinsed
probe
is
removed
could
help
reduce
the
potential
for
dermal
exposure
to
liquid
concentrate.
While
this
specific
probe
system
does
not
match
all
of
the
criteria
of
a
closed
mixing
and
loading
system
as
defined
in
the
Worker
Protection
Standard
(
WPS)
and
in
PR
Notice
2000­
9,
the
Agency
believes
this
probe
system
will
allow
mixers
and
loaders
to
be
adequately
protected
from
dermal
exposure
to
propanil.
A
description
of
specific
directions
for
mixing
and
loading
liquid
propanil
are
listed
in
the
attached
label
table.

Amended
mitigation
measure
for
liquid
formulations:

Mixers
and
loaders
must
use
a
closed
system
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(
WPS)
for
dermal
protection
of
agricultural
pesticides
[
40
CFR
170.240(
d)(
4)]
or
the
probe
system
described
in
the
attached
label
table.
A
dry
disconnect
or
dry
couple
shut­
off
device
must
be
used
at
every
disconnect
point
for
both
ground
and
aerial
mixing/
loading
operations.

Dry
Flowable
Formulations
Comments
and
issues
on
dry
flowable
formulations:

The
Agency
is
encouraging
the
registrant
to
work
with
growers
and
equipment
manufactures
in
order
to
address
their
specific
concerns
about
closed
mixing
and
loading
systems
for
propanil
dry
flowable
formulations.
Currently
the
only
engineering
control
the
Agency
is
aware
of
for
mixing
and
loading
dry
flowable
formulations
is
through
the
use
of
water
soluble
packages.
While
the
Agency
acknowledges
different
chemicals
have
different
physical
properties
that
can
make
formulating
into
water
soluble
packages
more
challenging
than
others,
there
are
currently
no
alternative
engineering
controls
for
this
formulation.
Therefore,
the
Agency
is
requiring
all
wettable
powder
formulations
to
be
formulated
in
closed
systems.
In
order
to
allow
sufficient
time
to
repackage
the
dry
flowable
formulation,
registrants
will
have
until
December
1,
2007
to
implement
this
requirement.
Page
8
of
13
In
addition,
because
of
concerns
from
the
propanil
registrants
and
rice
growers
about
repackaging
the
dry
flowable
formulation,
the
Agency
is
requiring,
within
the
same
time
frame,
registrants
individually
or
in
collaboration
with
existing
task
forces,
develop
exposure
data
for
the
dry
flowable
formulation.
If
reliable
data
indicate
that
exposures
are
less
than
currently
estimated,
the
Agency
will
consider
changing
the
mitigation
measures
for
dry
flowable
formulations.

Amended
dry
flowable
mitigation
measure:

All
dry
flowable
products
must
be
formulated
into
water
soluble
packages
or
other
closed
systems
by
December
1,
2007
unless
exposure
data
on
the
dry
flowable
indicate
they
are
not
needed
to
achieve
adequate
margins
of
exposure.

Response
to
Comments
on
Mitigation
Measures
or
Data
Requirements
That
Are
Not
Being
Modified
Additionally,
there
are
some
clarifications
to
the
2003
Propanil
RED
that
include:

5.
Mitigation
measure:

Apply
only
when
the
wind
speed
is
less
than
or
equal
to
10
mph
at
the
application
site.
This
applies
to
both
ground
and
aerial
applications.

Comments
and
issues:

Comments
were
received
requesting
the
label
language
change
to
allow
more
flexibility
in
making
applications
when
the
wind
speed
is
above
the
10
mph
limit.

The
Agency
is
not
changing
the
wind
speed
requirement
at
this
time.
Spraying
at
the
edge
of
the
application
area
while
wind
speeds
exceed
10
mph
could
lead
to
adverse
effects
for
non­
target
plants
and
organisms
from
spray
drift.
Therefore,
to
ensure
spray
drift
exposures
and
risks
are
adequately
controlled,
applications
will
only
be
allowed
when
the
wind
speed
is
10
mph
or
less.

6.
Mitigation
measure:

60­
day
plant
back
interval
for
all
rotational
crops.

Comments
and
issues:

Many
rice
growers
commented
that
a
60
day
plant
back
interval
is
not
practical
Page
9
of
13
due
to
the
short
window
of
opportunity
growers
have
to
replant
fields
when
the
rice
crop
fails.
In
order
to
shorten
the
60
day
plant
back
interval
the
Agency
would
need
data
demonstrating
no
detectable
residues
at
a
shorter
plant
back
interval
were
found
in
crops
planted
after
propanil
applications.
Growers
are
encouraged
to
work
with
the
registrant
to
develop
data
that
would
support
the
rotational
crops
the
growers
are
interested
in
planting.
Until
the
Agency
has
data
on
rotated
crops
following
propanil
applications,
the
Agency
can
not
shorten
the
60
day
plant
back
interval.

Therefore,
the
60­
day
plant
back
interval
for
all
rotational
crops
will
be
required
until
data
are
submitted
to
support
a
different
time
interval.

7.
Required
data:

Development
of
toxicity
and
fate
data
on
the
major
metabolic
degradate
of
propanil,
3,4­
DCA.

Comments
and
issues:

The
Propanil
Task
Force
II
submitted
comments
on
the
lack
of
a
need
for
a
number
of
the
data
requirements
for
3,4­
DCA
due
to
the
availability
of
existing
published
literature
on
propanil.
The
Agency
will
issue
the
Data
Call
In
(
DCI)
with
all
data
requirements
as
listed
in
the
Propanil
RED.
If
the
registrant
believes
a
study
is
not
warranted
they
may
submit
a
waiver
request
and
supporting
information
along
with
their
90­
day
response
to
the
DCI
that
will
be
issued
concurrent
with
the
Propanil
Amendment
document.
The
Agency
will
review
all
data
waiver
requests
when
they
are
received.

Therefore,
the
data
requirement
to
develop
toxicity
and
fate
data
on
3,4­
DCA
will
remain
in
the
DCI.

8.
Mitigation
measure:

Establish
a
7­
day
water
holding
(
discharge)
interval
for
all
propanil
application
sites
with
two
exceptions
listed
below:
1)
a
10­
day
discharge
interval
in
South
Texas,
south
of
I­
10
from
the
Texas/
Louisiana
border
to
Houston
and
east
of
State
Highway
35
from
Houston
to
Port
Lavaca;
and
2)
a
15­
day
discharge
interval
in
Southern
Louisiana,
south
of
highway
14,
to
address
Agency
risk
concerns
for
aquatic
species,
including
those
for
endangered
species.
Flood
water
must
be
held
for
the
time
specified
unless
excessive
rainfall
completely
submerges
the
rice
crop
and
forces
premature
release.
Page
10
of
13
Comments
and
issues:

Various
comments
and
suggestions
were
received
about
the
water
holding
interval,
specifically
regarding
the
release
provision.
Many
grower
groups
suggested
defining
the
release
provision
with
broader
language
allowing
more
exceptions
for
water
to
be
released
such
as
in
cases
of
potential
crop
failure
or
delayed
phytotoxicity
syndrome.
Water
holds
are
required
in
order
to
reduce
the
potential
exposure
of
propanil
to
aquatic
species
including
endangered
species.
The
Agency
feels
the
effectiveness
of
the
water
hold
would
be
reduced
if
too
many
exceptions
are
allowed.

Therefore,
the
water
hold
specifications
will
remain
as
listed
above
with
the
only
exception
for
releasing
water
prematurely
when
excessive
rainfall
completely
submerges
the
rice
crop
and
forces
premature
release.

Risk
Mitigation
Measures
or
Data
Requirements
That
Received
No
Comments
And
Are
Still
Required
by
this
Amendment
9.
Mitigation
measure:

All
labels
with
use
directions
on
rice
must
be
amended
to
specify
restrictions
against
application
to
fields
where
catfish
farming
is
practiced
and
draining
water
from
treated
fields
into
areas
where
catfish
farming
is
practiced.

An
updated
label
table
attached
to
this
document
includes
the
following
restriction
for
catfish
farming:

AApplication
to
fields
where
catfish
farming
is
practiced
and
draining
water
from
fields
into
areas
where
catfish
farming
is
practiced
is
prohibited.
Water
drained
from
treated
rice
fields
must
not
be
used
to
irrigate
other
crops
or
released
within
2
mile
upstream
of
a
potable
water
intake
in
flowing
water
(
e.
g.,
river,
stream,
etc.)
or
within
2
mile
of
a
potable
water
intake
in
a
standing
body
of
water,
such
as
a
lake,
pond,
or
reservoir.@

10.
Mitigation
measure:

There
is
a
restricted
entry
interval
(
REI)
of
24
hours
for
rice.
Page
11
of
13
Required
Mitigation
Measures
From
the
2003
Propanil
Red
That
Have
Been
Satisfied
11.
Mitigation
measure:

Voluntary
cancellation
of
use
on
small
grains
(
spring
(
hard
red)
wheat,
oats,
spring
barley
and
durum
wheat).

All
small
grain
use
sites
have
been
cancelled
as
indicated
in
68
FR
68901
on
December
10,
2003,
and
can
be
viewed
on
the
federal
docket
system,
available
at
www.
Regulations.
gov,
under
docket
number
EPA­
HQ­
OPP­
2003­
0200.

12.
Mitigation
measure:

For
turf,
the
registrant
had
agreed
to
reduce
the
maximum
application
rate
on
turf
to
5
lbs
a.
i./
acre
and
eliminate
aerial
applications
of
propanil
to
turf.

Subsequent
to
the
RED,
the
only
propanil
turf
product
has
been
cancelled
due
to
non­
payment
of
maintenance
fees
as
indicated
in
70
FR
44637
and
published
on
August
3,
2005.

13.
Required
data:

Development
and
submission
of
worker
exposure
(
bio­
monitoring)
data
for
the
liquid
formulation
were
required
in
the
2003
RED.

Biomonitoring
and
passive
dosimetry
data
was
submitted
by
the
registrant
and
reviewed
by
the
Agency
(
See
May
20,
2004
memo
from
Shanna
Recore).
The
review
and
other
related
documents
can
be
found
on
the
federal
docket
system,
available
at
www.
regulations.
gov
under
docket
number
EPA­
HQ­
OPP­
2003­
0348.

Additional
Data
Needs
In
addition
to
the
AAdditional
Data
Requirements@
listed
in
the
2003
Propanil
RED,
the
Agency
is
requiring
the
following
data:

(
1)
GLN
810.1000:
Usage
and
application
data
from
the
registrants.
Data
are
needed
to
confirm
the
Agency=
s
assumptions
for
handler
and
applicator
exposure
to
propanil.
Data
from
3
high
propanil
use
areas
outside
of
California
will
be
collected
and
include
:

(
a)
how
many
pounds
of
propanil
are
handled/
applied
per
day
by
individual
mixers,
loaders,
and
applicators,
(
b)
how
many
hours
per
day
a
handler
mixes
and
loads
propanil,
Page
12
of
13
(
c)
the
application
rate
of
the
active
ingredient
(
pounds
of
propanil
per
acre
per
application),
(
d)
the
formulation
of
propanil
used,
(
e)
how
many
hours
individual
aerial
applicators
apply
propanil
per
day,
and
(
f)
how
many
acres
individual
aerial
applicators
treat
per
day.

The
use
data
should
be
collected
over
a
2
year
period
the
results
of
which
will
be
submitted
to
the
Agency
in
two
annual
reports,
the
first
of
which
is
due
one
year
after
the
Data
Call
In
is
issued.
The
second
report
should
summarize
the
findings
of
the
entire
2
year
period,
and
is
due
2
years
after
the
Data
Call
In
is
issued.

(
2)
GLN
875.1100:
Data
on
worker
exposure
to
dry
flowables.
Registrants
are
required
to
submit
data
on
exposure
to
dry
flowable
formulations
either
individually
or
in
collaboration
with
existing
task
forces.

If
you
have
questions
on
the
propanil
RED,
the
amendments
listed
in
this
document,
or
questions
about
the
Generic
DCI,
please
contact
the
Chemical
Review
Manager,
Cathryn
O=
Connell
at
(
703)
308­
0136.
For
questions
about
product
reregistration
and/
or
the
Product
Specific
DCI
that
accompanies
this
document,
please
contact
Moana
Appleyard
at
(
703)
308­
8175.

Sincerely,

Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Attachments:
­
Revised
Propanil
Label
Table
­
Updated
Appendix
B:
Data
Supporting
Guideline
Requirements
for
the
Reregisrtaion
of
Propanil
­
GDCI
­
PDCI
­
2003
Propanil
RED
Page
13
of
13
Documents
Cited:

Evaluation
of
the
Potential
Exposure
of
Workers
to
Propanil
during
Mixing./
Loading
and
Aerial
Application
to
Rice
Fields
Using
Simultaneous
Dermal
Dosimetry
and
Biological
Monitoring
Techniques.
Alan
Nielsen.
November
23,
2004.

Fong,
Harvard,
AAn
Overview
of
Closed
System
Use
in
California
2001­
2002.@
HS­
1849,
June
2003.
(
http://
www.
cdpr.
ca.
gov/
docs/
whs/
pdf/
hs1849.
pdf)

Letter
from
McDermott
Will
and
Emory
dated
July
29th,
2005
APesticide
Use
Survey
Report
for
Agricultural
Aviation.@
National
Agriculture
Aviation
Association.
May
2004.

Response
of
Propanil
Task
Force
II
to
the
Review
of
the
U.
S.
Environmental
Protection
Agency.

Response
to
AEvaluation
of
the
Potential
Exposure
of
Workers
to
Propanil
During
Mixing/
Loading
and
Aerial
Application
to
Rice
Fields
Using
Simultaneous
Dermal
Dosimetry
and
Biological
Monitoring
Techniques@.
Shanna
Recore.
May
20,
2004.