Document ID: EPA-HQ-OPP-2002-0159-0013
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-07-12T04:00Z

Summary
of
Pronamide
Uses
°
Pronamide
is
a
restricted
use
pesticide.

°
It
is
a
selective,
pre­
emergence
herbicide
registered
for
the
control
of
grassy
and
broadleaf
weeds
on
terrestrial
food
crops
[artichoke,
blackberry,
blueberry,
boysenberry,
cherry,
endive
(escarole),
lettuce,
nectarine,
peach,
pear,
plum,
prune,
raspberry,
(black,
red),
rhubarb];
terrestrial
food
and
feed
crops
(agricultural
fallow/
idleland,
apples,
grapes,
peas,
sugar
beets);
terrestrial
nonfood
crops
(Christmas
tree
plantations,
golf
course
turf,
ornamental
herbaceous
plants,
recreation
area
lawns,
and
outdoor
residential
(ornamental
and/
shade
trees,
ornamental
woody
shrubs
and
vines).

Health
Effects
°
Pronamide
is
a
liver
toxicant.
Other
target
organs
include
thyroid,
testes,
kidney,
adrenal
gland,
thymus,
heart,
and
brain.

°
Pronamide
was
previously
classified
as
a
Group
B2
chemical,
probable
human
carcinogen
based
on
thyroid
follicular
cell
adenomas
(male
and
female)
and
benign
interstitial
cell
tumors
(males)
in
rats
and
heptacelluar
carcinomas
in
male
mice.

°
Carcinogenicity
studies
in
rodents
indicate
two
types
of
tumors,
benign
testicular
interstitial
cell
tumors
and
uncommon
thyroid
follicular
cell
adenomas;
and
one
type
of
tumor
in
the
mouse,
hepatocellular
carcinomas.

°
The
cancer
potency
estimate
for
pronamide
using
the
Q1*
model
is
2.59
x
10
­2
(mg/
kg/
day)
­1
.

FQPA
Safety
Factor
°
A
3x
FQPA
Safety
Factor
is
required
for
all
population
subgroups
when
assessing
non­
occupational
exposures
of
all
durations.

Dietary
Food
Risk
°
No
appropriate
toxicologic
endpoint
was
identified
for
acute
dietary
exposure.
Consequently
an
acute
dietary
risk
assessment
was
not
performed
for
pronamide.

°
Chronic
dietary
risk
estimates
from
exposure
to
food
do
not
exceed
the
Agency's
level
of
concern.
The
chronic
dietary
risk
estimate
is
<1%
of
the
cPAD,
for
U.
S.
population
and
for
all
subgroups.
°
The
cancer
dietary
risk
estimate
is
1.06
x
10
­7
for
the
U.
S.
population,
and
does
not
exceed
the
Agency's
level
of
concern
(1.0
x
10
­6
or
one
in
one
million).
Residential
Risk
°
Registrant
has
voluntarily
cancelled
the
residential
use
product.

°
The
registrant
has
agreed
to
limit
use
to
turf
grown
for
seed
or
sod
and
non­
residential
sites
including
golf
courses,
industrial
and
office
building
sites,
stadium
fields
or
professional
athletic
fields.
These
risk
mitigation
measures
make
children's
non­
dietary
exposure
unlikely.
To
minimize
adult
non­
occupational
exposure,
the
registrant
has
agreed
to
amend
pronamide
labels
to
require
a
24
hour
restricted
entry
interval
or
require
watering­
in
as
soon
as
possible
after
application.

°
As
a
result
of
the
risk
assessment,
the
sole
exposure
scenario
for
the
non­
occupational
risk
assessment
is
based
on
low
contact
activity
which
is
represented
and
estimated
by
golf
course
reentry.
The
route
of
exposure
is
dermal.
The
population
at
risk
is
adults.

°
The
short­
term
Margin
of
Exposure
(MOE)
for
golf
course
reentry
using
zero
day
after
treatment
(DAT
0)
turf
transferable
residue
data
from
the
turf
study
is
1000.
Therefore,
the
Agency
is
not
concerned
about
short
term
residential
exposure
to
pronamide.

°
No
intermediate
or
long
term
exposure
scenarios
(i.
e.,
greater
than
30
days)
are
anticipated
based
on
the
results
of
the
turf
transferable
residue
(TTR)
study
which
showed
that
residues
dissipate
to
below
the
level
of
quantification
by
day
14
following
application.

°
The
adult
golfer
cancer
risk
is
estimated
at
1.15
x
10
­7
.
In
order
to
exceed
the
cancer
risk
(1.0
x
10
­6
),
an
exposure
frequency
of
8.7
days
per
year
would
be
needed
for
the
activity
of
golf.
Because
pronamide
is
applied
one
time
per
year,
the
Agency
does
not
believe
this
exposure
frequency
will
occur.
Therefore,
the
cancer
risk
for
golfers
does
not
exceed
the
Agency's
level
of
concern.

Drinking
Water
Assessment
°
Short­
term
and
chronic
drinking
water
exposure
to
pronamide
did
not
result
in
a
risk
estimate
of
concern
for
non­
cancer
risks.
The
short
term
EECs
ranged
between
3.7
to
10.3
ppb,
depending
on
the
crop,
compared
to
the
DWLOC
which
ranges
from
560
to
700
ppb.
The
chronic
non­
cancer
EECs
range
between
0.53
to
4.45
ppb,
depending
on
the
crop,
compared
to
the
chronic
DWLOC
which
ranged
between
300
to
1050
ppb.

°
There
are
cancer
risk
estimates
which
slightly
exceed
the
Agency's
level
of
concern.
While
the
modeled
groundwater
EEC
is
1.1
ppb
compared
to
the
cancer
DWLOC
1.06
ppb,
the
modeled
surface
water
EECs
exceed
the
DWLOC
for
some
crops
(the
surface
water
cancer
EECs
range
from
0.54
to
4.3
ppb).
­3­
Aggregate
Risk
°
Risk
estimates
for
all
pathways
of
exposure
are
not
of
concern
for
pronamide
short­
term
exposure
when
pronamide
use
is
restricted
per
the
label
changes
cited
above.
The
chronic
aggregate
risk
estimates
do
not
exceed
the
level
of
concern.

°
The
short­
term
food,
water,
and
low­
contact
dermal
(golfing)
pronamide
exposures
were
aggregated
in
the
Risk
Assessment,
and
the
estimated
environmental
concentration
(EECs)
for
surface
water
(3.69
to
10.3
ppb)
and
ground
water
(1.1
ppb),
modeled
using
SCI­
GROW
and
PRZM­
EXAMS
did
not
exceed
the
DWLOC
(range
560­
700
ppb).
Therefore,
risk
estimates
for
all
pathways
of
exposure
are
not
of
concern
for
pronamide
short­
term
exposure
when
pronamide
use
is
restricted
per
the
label
changes.

°
The
chronic
DWLOCs
(300
­
1050
ppb)
were
greater
than
the
EECs
for
modeled
surface
water
(0.53
­
4.45
ppb),
and
modeled
groundwater
(1.1
ppb).
In
addition,
non­
targeted
USGS
monitoring
data
ranged
from
0.0037
to
0.365
ppb
in
surface
water,
and
from
0.005
­
0.82
ppb
in
ground
water.
The
Agency
concludes
the
chronic
aggregate
risk
estimates
do
not
exceed
the
level
of
concern.

°
While
the
modeled
EECs
(4.35
ppb)
are
slightly
higher
than
the
cancer
DWLOC
(1.06
ppb),
the
Agency
is
not
concerned
because
of
the
conservative
inputs
used
in
the
surface
water
modeling.
The
PRZM­
EXAMS
assessment
was
based
on
the
maximum
label
rates
for
pronamide,
whereas
typical
rates
for
many
crops
are
25%­
50%
less.
The
model
also
assumed
a
Percent
Crop
Area
(PCA)
of
87%,
which
is
likely
to
be
an
overestimate
for
the
commodities
being
assessed.
In
addition,
pronamide
data
exists
for
only
one
soil
in
the
aerobic
soil
metabolism
study.
When
aerobic
soil
metabolism
data
is
only
available
in
one
soil,
a
conservative
extrapolation
factor
is
used
which
is
likely
to
contribute
to
overestimating
potential
persistence
and
exposure.
As
a
result,
Dow
AgroSciences
has
agreed
to
conduct
an
aerobic
soil
metabolism
study
(two
additional
soils)
and
an
aerobic
aquatic
metabolism
study
as
confirmatory
data.

Tolerance
Reassessment
Summary
°
Pronamide
tolerances
are
established
under
40
CFR
§180.317
(a),
(b)
and
(c).
The
tolerance
expression,
listed
in
(a)
and
(c),
is
in
terms
of
the
combined
residues
of
the
residues
of
the
herbicide
propyzamide
and
its
metabolites
(containing
the
3,
5­
dichlorobenzoyl
moiety
and
calculated
as
3,
5
dichloro­
N­
(1,1­
dimethyl­
2­
propynyl)
benzamide).
The
tolerance
expression,
listed
in
(b),
is
in
terms
of
the
parent
only.
The
Agency
recommends
that
the
tolerance
expression
under
(b)
be
modified
to
include
the
metabolites.
The
Agency
also
recommends
the
following:
decreasing
the
established
tolerance
for
artichokes,
increasing
the
tolerances
for
cattle
fat,
goat
fat,
hog
fat,
horse
fat,
and
sheep
fat,
revoking
the
tolerance
for
poultry,
kidney;
grass,
forage
and
proposing
a
tolerance
for
alfalfa
seed.
­4­
Data
Requirements
Most
pertinent
product
chemistry
data
requirements
are
satisfied
for
technical
grade
active
ingredients.
The
following
information
is
required:

°
Product
Chemistry
GDLN
Description
860.1200
Direction
for
use
860.1380
Storage
Stability
Data
°
Additional
data
are
also
required
for
the
51%
Formulation
Intermediate
(FI)
concerning
the
following:

GDLN
Description
830.6314
oxidation/
reduction
830.6316
explodability
830.6317
storage
stability
830.6320
corrosion
characteristics
The
registrant
must
either
certify
that
the
supplier
of
beginning
materials
and
the
manufacturing
processes
have
not
changed
since
the
last
comprehensive
product
chemistry
reviews
or
submit
complete
updated
product
chemistry
data
packages.

Although
there
is
confidence
in
the
overall
scientific
quality
of
the
available
toxicity
data,
several
data
gaps
were
identified
which
are
required
to
fulfill
the
OPPTS
harmonized
test
guidelines:

°
Toxicity
GDLN
Description
870.3700
developmental
study
in
rats
870.3200
21­
day
dermal
toxicity
study
Non
GDLN
28­
day
inhalation
study
870.7600
dermal
penetration
study
Non
GDLN
comparative
thyroid
rat
assay
in
adult
animals
and
offspring
A
review
of
product
labels
and
the
supporting
residue
chemistry
data
indicates
the
following
reside,
data
are
required:

°
Residue
(GDLN
860.1500
Crop
Field
Trials)

Description
dried
winter
peas
vines
and
hay
of
winter
peas
­5­
°
The
following
label
amendments
are
required
for
rotational
crops
lettuce,
peas
(winter),
and
alfalfa
grown
for
seed:

GDLN
Description
860.1850
Confined
Accumulation
in
Rotational
Crops
860.1900
Field
Accumulation
in
Rotational
Crops
°
30­
day
plant­
back
interval
for
leafy
vegetables
(except
Brassica
vegetables)
°
90­
day
plant­
back
interval
for
root
and
tuber
vegetables
°
360­
day
plant­
back
interval
for
cereal
grains,
forage
and
fodder,
and
straw
of
cereal
grain
°
Confirmatory
storage
stability
data
(GDLN
860.1380)
are
required
for
regulated
pronamide
metabolites
on
the
following:

Description
alfalfa
apples
grapes
lettuce
peaches
plums
°
A
confirmatory
aerobic
soil
metabolism
study
(835.4100)
and
the
aerobic
aquatic
metabolism
study
(835.4300).

The
registrant
is
required
to
further
optimize/
improve
the
revised
animal
enforcement
method
(TR
34­
91­
68)
to
yield
acceptable
recoveries
at
a
fortification
level
equal
to
established
animal
tolerances.
Following
method
improvement,
the
registrant
is
required
to
submit
bridging
independent
laboratory
validation
(ILV)
data;
the
required
ILV
data
should
include
two
control
samples
fortified
at
0.4
ppm,
the
reassessed
tolerance
level
for
the
kidney
and
liver
of
ruminants.