Document ID: EPA-HQ-OPP-2004-0162-0034
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-12-23T05:00Z

1
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON
D.
C.,
20460
MEMORANDUM
Date:
September
22,
2005
SUBJECT:
EFED
RED
Chapter
for
Napropamide
chronic
risk
recalculations
for
mammals
PC
Code
No.
103001;
DP
Barcode
308276
FROM:
Donna
M.
Randall,
Senior
Effects
Scientist,
ERB
II
Environmental
Fate
and
Effects
Division
(
7507C)
Office
of
Pesticide
Programs
THRU:
Tom
Bailey,
Branch
Chief,
ERB
II
Environmental
Fate
and
Effects
Division
(
7507C)
Office
of
Pesticide
Programs
TO:
Demson
Fuller,
Chemical
Review
Manager
Special
Reregistration
Review
Division
(
7508C)
Office
of
Pesticide
Programs
In
the
Napropamide
RED
(
August
15,
2005;
DP
Barcodes:
D305594,
D305593,
D303452)
a
typo
was
identified
in
the
spreadsheets
used
to
calculate
chronic
risk
quotients
(
RQs)
for
mammals
exposed
to
napropamide
residue
levels
on
dietary
food
items.
This
typo
consisted
of
the
30
mg/
kg­
bw/
day
no
observable
adverse
effect
level
(
NOAEL)
for
rats
being
entered
as
30
mg/
kg­
diet
(
no
observable
adverse
effect
concentration;
NOAEC).
A
revised
Table
16
with
the
footnote
clearly
identifying
this
value
as
a
NOAEL
in
mg/
kg­
bw/
day
is
provided.

Mammalian
dose­
based
chronic
RQs
for
napropamide
residue
levels
on
dietary
food
items
were
recalculated
using
30
mg/
kg­
bw/
day
and
are
summarized
in
the
attached
revised
Table
22.
While
this
correction
resulted
in
chronic
RQs
for
mammals
being
reduced
it
did
not
change
the
primary
conclusions
of
the
risk
characterization.
Mammalian
dose­
based
RQs
exceed
the
non­
endangered
and
endangered
chronic
LOC
for
all
uses
as
concluded
in
the
August
15,
2005
Napropamide
RED.

For
comparison
purposes,
Table
22
from
the
August
15,
2005
RED,
which
is
based
on
dietary
RQs,
is
also
provided.
It
should
be
noted
that
the
RQs
in
the
revised
Table
22
are
dosebased
and
take
into
consideration
adjustments
of
the
laboratory
test
animal
dose­
based
NOAEL
to
other
wildlife
body
weights
(
small,
15
g;
mid,
35
g;
and
large
1000
g)
whereas
the
values
in
the
August
15,
2005
table
did
not,
it
listed
dietary­
based
RQs.
If
the
dose­
based
RQs,
which
would
have
been
converted
from
the
dietary
NOAEC
and
adjusted
to
other
wildlife
body
weights
had
been
reported
then
the
dose­
based
RQs
would
have
been
higher
than
the
listed
dietary­
based
2
RQs.
For
example,
while
the
dietary­
based
RQ
was
38
for
short
grass
at
a
broadcast
application
of
6
lbs
ai/
A,
the
dose­
based
RQs
for
short
grass
ranges
from
187
to
415.

Revised
Table
22.
Mammalian
chronic
dose­
based
RQ
values
for
napropamide
using
upper
bound
Kenega
residue
levels.

Mammalian
(
15,
35
and
1000
g
animals)
Chronic
Risk
Quotients1
Application
rate
Short
grass
Tall
grass
Broadleaf
plants/
small
insects
Fruits/
pods/
large
insects
6
lbs
ai/
A
x
1
(
broadcast)
9.5
­
21
4.4
 
9.5
5.4
 
12
0.6
 
1.3
6
lbs
ai/
A
x
1
(
banded)
3.2
 
6.9
1.5
 
3.2
1.8
 
3.9
0.2
 
0.4
4
lbs
ai/
A
x
2
(
broadcast)
2
8.3
­
18
3.8
 
8.3
4.7
­
10
0.5
 
1.1
4
lbs
ai/
A
x
1
(
broadcast)
6.4
­
14
2.9
 
6.4
3.6
 
7.8
0.4
 
0.9
3
lbs
ai/
A
x
2
(
broadcast)
2
6.2
­
14
2.8
 
6.2
3.5
 
7.6
0.4
 
0.8
2
lbs
ai/
A
x
1
(
broadcast)
3.2
 
6.9
1.5
 
3.2
1.8
 
3.9
0.2
 
0.4
2
lbs
ai/
A
x
1
(
banded)
1.1
­
2.3
0.5
 
1.1
0.6
 
1.3
0.07
 
0.1
1.33
lbs
ai/
A
x
2
(
banded)
2
0.9
 
2.0
0.4
 
0.9
0.5
 
1.1
0.06
 
0.1
1
lb
ai/
A
x
1
(
broadcast)
3
1.6
 
3.5
0.7
 
1.6
0.9
 
2.0
0.1
 
0.22
1Rat
NOAEC
=
30
mg/
kg­
bw/
day
2Application
interval
of
60
days
3Lowest
average
use
rate
(
tobacco)

Exceedances
of
the
chronic
LOC
are
indicated
in
bold
(
Chronic
RQs
for
granivores
do
not
exceed
the
chronic
LOC
for
any
of
these
uses.)

August
15,
2005
RED
Table
22.
Mammalian
chronic
RQ
values
for
napropamide
Mammalian
Chronic
Risk
Quotients1
Application
rate
Short
grass
Tall
grass
Broadleaf
plants/
small
insects
Fruits/
pods/
large
insects
6
lbs
ai/
A
x
1
(
broadcast)
38.00
22.00
27.00
3.00
6
lbs
ai/
A
x
1
(
banded)
16.00
7.33
9.00
1.00
4
lbs
ai/
A
x
2
(
broadcast)
2
41.77
19.13
23.50
2.60
4
lbs
ai/
A
x
1
(
broadcast)
32.00
14.67
18.00
2.00
3
lbs
ai/
A
x
2
(
broadcast)
31.30
14.37
17.60
1.97
2
lbs
ai/
A
x
1
(
broadcast)
16.00
7.33
9.00
1.00
2
lbs
ai/
A
x
1
(
banded)
5.33
2.43
3.00
0.33
1.33
lbs
ai/
A
x
2
(
banded)
4.57
2.13
2.60
0.30
1
lb
ai/
A
x
1
(
broadcast)
3
8.00
3.67
4.50
0.50
1Rat
NOAEC
=
30
mg/
kg/
diet
2Application
interval
of
60
days
3Lowest
average
use
rate
(
tobacco)

exceedances
indicated
in
bold
3
Revised
Table
16.
Summary
of
Napropamide
Acute
and
Chronic
Terrestrial
Organism
Toxicity
Data
Acute
Toxicity
Chronic
Toxicity
Species
Oral
Toxicity
LD50
(
mg
ai/
kg)
(
except
where
noted)
MRID
Subacute
Dietary
LC50
(
mg
ai/
kg)
MRID
NOAEC
(
mg
ai/
kgdiet
(
except
where
noted)
MRID
Affected
Endpoints
Mallard
Duck
Anas
platyrhynchos
>
4640
229652
a
>
5620
258393
113820
1,000
b
79548
and
79555
NA
b
Laboratory
Rat
Rattus
norvegicus
>
5000
230602
a
NA
NA
30
c
40362902
growth
&

reproduction
Honey
bee
(
Apis
mellifera)
>
113.5
ug
ai/
bee
464591­
15
NA
NA
NA
NA
NA
a)
Accession
number
b)
The
effect
demonstrated
on
body
weight
was
deemed
not
related
to
the
toxicant
effects
of
napropamide.
This
is
because
the
effect
was
only
demonstrated
in
the
3000
ppm
males
during
the
last
two
weeks
of
the
study.
The
differences
observed
were
slight,
and
appeared
to
be
related
to
a
slightly
lighter
initial
body
weight
of
the
males
in
this
group.
Furthermore,
there
were
no
significant
differences
in
mean
body
weight
change
between
the
control
group
and
the
3000
ppm
treatment
group
at
any
time
during
the
course
of
the
study.
Therefore,
EFED
conclusion
is
that
a
LOAEC
was
not
established
in
the
study.
Therefore,
this
NOAEC
will
not
be
used
to
calculate
an
RQ.

c)
NOAEL
mg
ai/
kg­
bw/
day