Document ID: EPA-HQ-OPP-2006-0294-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-06-28T04:00Z

Reregistration
Eligibility
Decision
Exposure
and
Risk
Assessment
on
Lower
Risk
Pesticide
Chemicals
Naptalam
Sodium
CASE
0183
Special
Review
and
Reregistration
Division
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
1801
South
Bell
Street
Arlington,
VA
22202
Background:
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I.
Executive
Summary
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II.
Use
Information
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III.
Physical/
Chemical
Properties
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IV.
Hazard
Assessment
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Special
Considerations
for
Infants
and
Children:
Toxicological
Endpoint
Selection:

V.
Dietary
(
Food)
Exposure:
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VI.
Drinking
Water
Exposure:
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VII.
Aggregate
Assessment:
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VIII.
Occupational
Exposure
Assessment
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Occupational
Handler
Exposures
and
Risks:
Occupational
Postapplication
Exposures
and
Risks:

IX.
Environmental
Fate
and
Ecotoxicity:
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Environmental
Fate
and
Transport:
Ecotoxicity
and
Environmental
Risk
Assessment:

X.
Cumulative
Exposure:
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XI.
Risk
Mitigation/
Management
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XII.
Endocrine
Disruptor
Effects:
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XIII.
Tolerance
Reassessment:
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"
Risk
Cup"
Determination:
Residue
Analytical
Methods:
Tolerance
Reassessment:

XIV.
References
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Appendix
1.
BEAD
Screening
Level
Estimate
of
Agricultural
Uses
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28
Appendix
2.
Naptalam
Sodium:
Chronic
Dietary
(
Food)
Exposure
Assessment
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33
Appendix
3.
Details
Regarding
PHED,
ORETF
Studies,
and
Dislodgeable
Foliar
Residue
(
DFR)
Studies
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36
1
Background:

The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
was
amended
in
1988
to
accelerate
the
reregistration
of
products
with
active
ingredients
registered
prior
to
November
1,
1984.
The
amended
Act
calls
for
the
development
and
submission
of
data
to
support
the
reregistration
of
an
active
ingredient,
as
well
as
a
review
of
all
submitted
data
by
the
U.
S.
Environmental
Protection
Agency
(
referred
to
as
EPA
or
the
Agency).
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
hazards
arising
from
the
currently
registered
uses
of
the
pesticide;
to
determine
the
need
for
additional
data
on
health
and
environmental
effects;
and
to
determine
whether
or
not
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
criteria
of
FIFRA.

On
August
3,
1996,
the
Food
Quality
Protection
Act
(
FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
to
require
tolerance
reassessment
during
reregistration.
It
also
requires
that
by
2006,
EPA
must
review
all
tolerances
in
effect
on
the
day
before
the
date
of
the
enactment.
FQPA
also
amends
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
to
require
a
safety
finding
in
tolerance
reassessment
based
on
factors
including
an
assessment
of
cumulative
effects
of
chemicals
with
a
common
mechanism
of
toxicity.

This
document
represents
the
Reregistration
Eligibility
Decision
(
RED)
document
for
naptalam
sodium.
This
assessment
summarizes
available
information
on
the
use,
physical/
chemical
properties,
toxicological
effects,
occupational
exposure
profile,
dietary
assessment,
tolerance
reassessment,
and
the
environmental
fate
and
ecotoxicity
for
naptalam
sodium.
EPA
established
a
tolerance
for
residues
of
naptalam
sodium
when
used
on
cantaloupe,
cucumber,
muskmelon
and
watermelon.
The
Agency
has
considered
any
new
data
generated
after
the
tolerance
exemption
was
issued,
new
Agency
guidance
or
other
federal
regulations,
as
well
as
previously
available
information
in
this
assessment.
Currently,
there
are
no
homeowner
products,
so
there
are
no
usepatterns
that
are
likely
to
result
in
residential
handler
or
postapplication
exposures,
and
the
only
use­
patterns
are
for
occupational
use
in
non­
residential
settings.
A
review
meeting
for
an
earlier
draft
of
this
document
was
conducted
by
the
Lower
Risk
Pesticide
Chemical
Focus
Group
(
LRPCFG)
on
August
25,
2004.

I.
Executive
Summary:

Naptalam
sodium
is
registered
for
use
as
a
pre­
emergent
herbicide
for
control
of
broadleaf
weeds
in
cucurbits
and
woody
nursery
stock.
There
is
currently
only
one
end­
use
product
for
naptalam
sodium,
a
liquid
concentrate.
The
product
label
indicates
that
for
its
usage
for
weed
control
in
cucurbits,
it
may
be
applied
as
a
broadcast
application
at
planting
and/
or
over
the
top
of
the
cucurbits
in
the
early
season
before
they
begin
to
vine.
For
weed
control
in
woody
nursery
stock,
the
product
label
indicates
that
it
may
be
applied
as
a
broadcast
spray
prior
to
transplanting
or
as
a
soil­
directed
spray
around
established
stock.
For
both
cucurbits
and
woody
nursery
stock
application,
the
product
label
recommends
watering­
in
following
application.
2
A
chronic
dietary
exposure
assessment
was
conducted
for
naptalam
sodium
using
the
Dietary
Exposure
Evaluation
Model.
There
was
no
acute
endpoint
identified
for
conducting
dietary
assessments.
The
chronic
dietary
(
food
only)
assessment
shows
that
the
estimated
risks
for
naptalam
sodium
are
very
low,
less
than
0.1%
of
the
cPAD
for
the
most
sensitive
age
groups
and
for
the
general
U.
S.
population.
In
addition,
the
estimated
drinking
water
concentrations
(
EDWCs)
were
also
calculated
by
utilizing
models.
The
EDWCs
are
low
for
naptalam
sodium,
658.2
ppb
for
the
annual
peak
concentrations,
and
188.7
ppb
for
the
annual
mean
concentrations
for
surface
waters,
and
3.3
ppb
for
groundwater.

An
oral
NOAEL
(
29.7
mg/
kg/
day)
was
selected
as
the
toxicological
endpoint
of
concern
for
assessing
short­
and
intermediate­
term
dermal
and
inhalation
occupational
exposures.
The
dermal
and
inhalation
doses
were
converted
to
an
equivalent
oral
dose
using
a
default
value
of
100%
absorption,
since
no
data
are
available
on
dermal
or
inhalation
absorption.
The
toxicological
endpoint
was
based
on
reduced
body
weight
gain,
reduced
food
efficiency,
and
increased
organ
weights
in
dogs
from
a
90­
day
oral
toxicity
study.
Since
the
toxicological
endpoint
is
the
same
for
dermal
and
inhalation,
total
risks
(
dermal
plus
inhalation)
must
be
estimated.
The
Agency
determined
that
an
uncertainty
factor
of
100
(
10
for
interspecies
extrapolation
and
10
for
intraspecies
variation)
was
appropriate
for
occupational
risks.

Occupational
handler
and
postapplication
exposures
and
risks
were
assessed
in
this
document.
Naptalam
sodium
may
be
applied
with
groundboom
equipment
to
cucurbits,
and
with
groundboom,
low­
pressure
handwand
or
handgun
equipment
to
the
soil
around
woody
nursery
stock.
The
exposure
scenarios
and
application
rate
chosen
for
this
risk
assessment
were
based
on
the
current
label
for
the
naptalam
sodium
end­
use
product.

For
handlers
mixing/
loading
liquid
concentrates
to
support
groundboom
applications,
risks
did
not
exceed
the
level
of
concern
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire
(
longsleeve
shirt,
long
pants,
shoes,
socks,
and
no
respirator).
Risks
to
handlers
applying
liquids
with
open­
cab
groundboom
equipment
did
not
exceed
the
level
of
concern
at
baseline
attire.
Risks
to
mixers/
loaders/
applicators
using
low­
pressure
handwand
or
handgun
equipment
did
not
exceed
the
level
of
concern
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire.

The
Agency
uses
transfer
coefficients
and
dislodgeable
foliar
residues
(
DFRs)
or
soil
transferrable
residues
to
assess
occupational
postapplication
exposures
to
agricultural
workers
entering
treated
areas
to
perform
various
tasks
after
applications
are
complete,
and
mitigates
these
postapplication
risks
using
a
restricted
entry
interval
(
REI).
The
REI
is
the
time
period
following
a
pesticide
application
during
which
entry
into
the
treated
area
is
restricted.
The
Agency
has
received
a
chemical­
specific
DFR
study
which
shows
a
foliar
half­
life
of
less
than
3
days.
The
Agency
does
not
have
default
transferrable
residue
values
for
contact
with
soil,
but
postapplication
exposures
and
risks
to
workers
who
contact
the
soil
subsurface
are
also
unlikely
to
exceed
the
level
of
concern
at
the
REI
for
other
handlers.
The
Agency
has
determined
that
the
postapplication
risks
are
adequately
mitigated
by
retaining
the
48
hour
REI
specified
on
the
current
label;
due
to
the
eye
irritation
study
showing
severe
opacity
continuing
until
day
7,
the
REI
is
48
hours,
and
protective
eyewear
will
remain
on
the
label
for
pesticide
handlers.
3
As
further
risk
mitigation,
the
registrant
has
voluntarily
agreed
to
place
a
restriction
on
the
label
to
prevent
aerial
applications,
and
will
retain
label
restrictions
against
greenhouse
use
as
well
as
applications
through
any
type
of
irrigation
system.
In
addition,
the
registrant
will
incorporate
label
language
to
insure
that
ground
applications
will
be
made
with
equipment
placed
as
close
to
the
ground
as
feasible,
that
droplet
sizes
will
be
as
large
as
possible
(
no
fine
droplets),
and
that
watering­
in
will
be
clearly
stated
on
the
label
directions.
In
addition,
the
registrant
has
voluntarily
agreed
to
remove
nursery
stock/
woody
ornamentals
from
their
label.
The
registrant
has
also
agreed
to
include
language
on
their
revised
label,
that
the
maximum
application
rate
will
remain
at
4
pounds
active
ingredient
per
acre
per
application,
that
two
applications
per
year
are
permitted,
and
that
the
total
applications
annually
may
not
exceed
8
pounds
per
acre
per
year.

The
environmental
fate
and
mobility
of
naptalam
sodium
is
pH
dependent.
Naptalam
sodium
will
readily
dissociate,
and
exists
predominantly
as
the
sodium
cation
and
the
acidic
anion
in
the
environment.
Anions
often
possess
high
mobility
in
soils,
tend
to
have
significant
leaching
potential,
and
will
not
volatilize
from
water
or
soil
surfaces.
The
hydrolysis
of
naptalam
appears
to
occur
slowly
under
alkaline
and
neutral
conditions,
but
proceeds
rapidly
under
acidic
conditions
with
a
half­
life
on
the
order
of
a
few
days.
Biodegradation
appears
to
be
insignificant
under
anaerobic
conditions,
but
may
be
an
important
environmental
fate
process
in
soil
and
water
under
aerobic
conditions.

Results
of
acute
toxicity
studies
suggest
that
naptalam
is
practically
nontoxic
to
freshwater
fish
and
invertebrates.
No
chronic
toxicity
data
were
submitted
for
freshwater
organisms
and
no
acute
or
chronic
testing
of
marine/
estuarine
fish
or
invertebrates
was
submitted.
A
Tier
1
screening
level
risk
assessment
focusing
on
maximum
proposed
uses
of
naptalam
sodium
on
cucumber,
watermelon,
honeydew
and
cantaloupe
suggests
that
concentrations
of
naptalam
in
the
environment,
when
compared
with
minimum
toxicity
values,
are
unlikely
to
result
in
acute
adverse
effects
to
freshwater
aquatic
organisms.
Adequate
toxicity
data
are
not
available
to
characterize
the
risk
of
chronic
adverse
effects
to
freshwater
organisms,
and
no
data
are
available
to
characterize
the
risk
to
marine/
estuarine
fish
and
invertebrates.

Naptalam
is
categorized
as
slightly
toxic
to
small
mammals
on
an
acute
oral
basis
and
the
potential
for
chronic
reproductive
effects
appears
to
be
low.
However,
there
is
a
potential
for
risks
to
terrestrial
and
avian
species,
but
the
risk
assessment
procedure
is
a
screening
level
and/
or
qualitative
assessment,
and
does
not
constitute
any
findings
under
the
Endangered
Species
Act.
Results
of
acute
oral
toxicity
studies
suggest
that
naptalam
is
practically
non­
toxic
to
birds.
Results
of
reproductive
studies
of
naptalam
in
birds
are
not
available.
Based
on
contact
LD
50
studies
for
the
honey
bee
(
Apis
mellifera),
naptalam
is
classified
as
practically
nontoxic
on
an
acute
contact
basis.

Based
on
the
data
from
the
plant
metabolism
and
crop
field
trials
studies,
the
tolerances
have
also
been
reassessed
for
naptalam
sodium.
The
tolerances
for
some
commodities
(
i.
e.,
cantaloupe,
muskmelon,
and
watermelon)
will
be
revoked,
and
in
their
place,
a
tolerance
will
be
established
for
the
melon
subgroup
(
Crop
Group
9A).
4
II.
Use
Information:

Naptalam
sodium
(
OPP
Chemical
Code
030703;
CAS
Reg.
No.
132­
67­
2)
was
first
developed
by
the
Uniroyal
Chemical
Company
in
1949;
therefore,
its
first
registration
was
with
the
U.
S.
Department
of
Agriculture,
and
predates
the
Environmental
Protection
Agency.
It
is
a
List
A
reregistration
chemical,
and
was
the
subject
of
a
Registration
Standard
document,
Guidance
for
the
Reregistration
of
Pesticide
Products
Containing
Naptalam/
Naptalam
Sodium
as
the
Active
Ingredient,
dated
March
30,
1985.
The
current
registrant
is
a
successor
company
to
its
parent
Uniroyal,
Crompton
Manufacturing
Company,
Inc.
Crompton
applied
for
a
low
volume/
minor
use
waiver
in
1993,
and
on
May
5,
1994,
the
Agency
granted
this
waiver
and
applied
a
somewhat
reduced
set
of
guideline
requirements.

Naptalam
sodium
is
registered
for
use
as
a
pre­
emergent
herbicide
for
control
of
broadleaf
weeds
in
cucumbers
and
the
melons
subgroup
(
with
the
following
crops
listed
on
the
current
label:
cucumber,
watermelon,
muskmelon,
cantaloupe,
honeydew
melon,
Persian
melon,
and
casaba
are)
and
woody
nursery
stock
(
transplants
and
established
plants,
with
use
in
greenhouses
prohibited).
It
had
previously
been
registered
for
applications
to
soybeans,
peanuts,
and
cranberries,
but
uses
on
these
crops
have
now
been
cancelled.
According
to
the
BEAD
Quantitative
Usage
Analysis
(
QUA),
the
weighted
average
amount
applied
is
about
84,000
pounds
of
active
ingredient
used
per
year
in
the
United
States,
with
an
estimated
maximum
of
about
149,000
pounds
per
year.
(
See
Appendix
A
for
additional
details
concerning
the
BEAD
QUA,
and
other
label
information).
Naptalam
sodium
controls
weeds
at
germination
and
early
growth,
but
is
ineffective
against
emerged
weeds.
The
sole
end­
use
product
formulation
(
EPA
Registration
Number:
400­
49)
is
a
liquid
concentrate
(
23.7%
active
ingredient),
although
in
the
past,
there
had
also
been
registrations
for
soluble
liquid
concentrate
and
granular
formulations.
There
is
no
technical
product
registration.

Naptalam
is
the
common
name
of
the
acid
from
which
the
subject
sodium
salt
is
derived,
the
scientific
name
of
this
acid
being
2­((
1­
naththalenyl­
amino)
carbonyl)­
benzoic
acid
(
also
know
as
N­
1­
naphthylphthalamate).
The
OPP
Chemical
Code
of
naptalam
is
030702,
and
its
CAS
Reg.
No.
is
132­
66­
1.
According
to
the
OPP
REFS
database
(
and
its
successor
database,
OPPIN),
there
have
never
been
any
registered
products
for
naptalam.
Note
that
some
of
the
Agency
documents
which
refer
to
naptalam
(
and
are
listed
as
having
MRIDs
associated
with
naptalam)
are
actually
for
the
sodium
salt,
and
will
be
included
herein
under
the
assumption
as
referring
to
naptalam
sodium.

III.
Physical/
Chemical
Properties:

Naptalam
sodium
is
highly
soluble
(
Table
1).
It
is
a
solid,
since
it
has
a
melting
point
in
excess
of
185
°
C.
Its
molecular
weight
is
313.3
(
EPA
Reg.
Standard,
1985),
and
it
has
a
multi­
ring
structure
(
Figure
1),
thus,
naptalam
sodium
exhibits
only
limited
volatility,
with
a
vapor
pressure
of
9.1x10­
11
mm
Hg.
5
Table
1.
General
Physical
and
Chemical
Properties
for
Naptalam
Sodium
Chemical
Molecular
formula
Molecular
weight
Solubility
in
Water
Density/
Specific
Gravity
Naptalam
sodium
C18H13NO3.
Na
313.30
230,800
ppm
@
25oC
1.386
Reference:
Toxnet
(
2004).

Figure
1.
Molecular
Structure
of
Naptalam
Sodium
+
Na
C
O
NH
C
O
O
IV.
Hazard
Assessment:

Key
toxicological
data
for
naptalam
sodium
are
provided
in
Tables
2
and
3.
These
data
were
obtained
from
EPA
reviewed
toxicological
studies
(
EPA,
1994,
1996)
and
from
a
recent
toxicity
overview
(
EPA,
2004).

Table
2.
Acute
Toxicity
Profile
­
Naptalam
Sodium
Study
Type
Species
MRID
Results
Toxicity
Category
Acute
oral
Rat
29172
LD50
=
1,700
mg/
kg
III
76205
(
Naptalam
acid:
no
deaths
at
8192
mg/
kg)
(
IV)

Acute
dermal
Rat
60402
LD50
>
2,000
mg/
kg
III
Rabbit
427397­
01
LD50
>
5,000
mg/
kg
IV
Acute
inhalation
Rat
439364­
01
LC50
>
2.0
mg/
L
IV
Acute
eye
irritation
Rabbit
78530
slight
irritation
(
liquid:
Alanap
[
product])
III
(
or
II)

60404
severe
opacity
(
granular:
Alanap
[
Tech.])
I
Acute
dermal
irritation
Rabbit
060408
non­
irritant
IV
Skin
sensitization
Guinea
Pig
15185
dermal
sensitizer
Naptalam
sodium
has
low
toxicity
via
the
inhalation
route,
and
is
not
dermally
irritating
to
the
skin
(
Toxicity
Category
IV
for
both),
but
is
in
Toxicity
Category
III
for
oral
and
dermal
toxicity
to
the
rat.
(
Note
that
testing
with
naptalam
acid
in
the
rat
indicates
Toxicity
Category
IV.)
For
dermal
toxicity
and
inhalation
testing
in
the
rat,
Limit
Dose
tests
were
performed,
with
no
deaths
observed
in
either
study.
In
a
Limit
Dose
dermal
toxicity
study
in
the
rabbit,
no
mortality
was
observed;
thus,
results
in
the
rabbit
indicate
acute
dermal
is
Toxicity
Category
IV.
Alanap
liquid
6
was
found
to
be
slightly
irritating
to
the
eye
(
Toxicity
Category
III)
or
moderately
irritating
(
II,
as
reported
in
MRID
78530),
but
"
Alanap
(
Tech.)",
described
as
a
granular
material,
was
found
to
cause
severe
irritation
in
the
rabbit
eye,
accompanied
by
corneal
opacity
which
had
not
recovered
by
day
7
after
instillation,
in
6
of
6
rabbits
tested.
Naptalam
sodium
is
a
dermal
sensitizer.

Table
3.
Subchronic,
Chronic
and
Other
Toxicity
Profile
­
Naptalam
Sodium
Study
Type
(
species)
[
Accession
or
MRID
No.]
Classification/
Doses
Results
90­
Day:
oral
toxicity
(
rat)
[
106276;
410575­
01]
Acceptable
­
Non­
Guideline
0,
500,
1000,
5000
ppm
0,
25,
50,
250
mg/
kg/
day
NOAEL
=
1000
ppm
(
50
mg/
kg/
day)
LOAEL
=
5000
ppm
(
250
mg/
kg/
day)
based
on
reduced
body
weight
gain,
reduced
food
efficiency,
decreased
organ
weights.

90­
Day:
oral
toxicity
(
dog)
[
106277]
Acceptable
­
Non­
Guideline
0,
300,
1000,
3000,
5000
ppm
Males:
0,
11.4,
29.7,
124.7
mg/
kg/
day
Females:
0,
9.7,
29.9,
123.6
mg/
kg/
day
NOAEL
=
1000
ppm
(
29.7­
29.9
mg/
kg/
day)
LOAEL
=
3000
ppm
(
123.6­
124.7
mg/
kg/
day)
based
on
reduced
body
weight
gains,
reduced
food
efficiency,
increased
absolute
and
relative
liver
weights.

1­
Year:
oral
toxicity
(
dog)
[
410575­
01]
Acceptable
­
Non­
Guideline
0,
200,
1000,
5000
ppm
0,
5.3,
25.8,
121
mg/
kg/
day
NOAEL
=
1000
ppm
(
25.8
mg/
kg/
day)
LOAEL
=
5000
ppm
(
121
mg/
kg/
day)
based
on
liver
weights,
increased
enzyme
activity
and
bilirubin
Prenatal
developmental
(
rat)
[
106320;
437671­
01;
437744­
01]
Acceptable
0,
15,
115,
500
mg/
kg/
day
Maternal
NOAEL
=
15
mg/
kg/
day
LOAEL
=
115
mg/
kg/
day
based
on
reduced
body
weight
gain.
Developmental
NOAEL
=
115
mg/
kg/
day
LOAEL
=
500
mg/
kg/
day
based
on
reduced
fetal
weights,
increased
skeletal
observations.

Prenatal
developmental
(
rabbit)
[
157186]
Core
­
Minimum
0,
50,
200,
650
mg/
kg/
day
Maternal
NOAEL
=
200
mg/
kg/
day
LOAEL
=
650
mg/
kg/
day
based
on
reduced
body
weight
gain,
mortality,
clinical
observations.
Developmental
NOAEL
=
200
mg/
kg/
day
LOAEL
=
650
mg/
kg/
day
based
on
increased
skeletal
observations.

Reproduction
and
fertility
effects
(
rat)
[
31684]
Core
­
Minimum
0,
120,
600,
3000
ppm
0,
6,
30,
150
mg/
kg/
day
Parental/
Systemic
NOAEL
=
600
ppm
(
30
mg/
kg/
day)
LOAEL
=
3000
ppm
(
150
mg/
kg/
day)
based
on
reduced
body
weights.
Reproductive
NOAEL
>=
3000
ppm
(
150
mg/
kg/
day)
LOAEL
>
3000
ppm
(
150
mg/
kg/
day).
Offspring
NOAEL
=
600
ppm
(
30
mg/
kg/
day)
LOAEL
=
3000
ppm
(
150
mg/
kg/
day)
based
on
reduced
mean
pup
body
weights.

Chronic
toxicity
(
rat)
[
77053;
418388­
01;
418600­
01]
Acceptable
­
Guideline
0,
120,
600,
3000
ppm
0,
5.6,
27,
140
mg/
kg/
day
NOAEL
>=
140
mg/
kg/
day
LOAEL
>
140
mg/
kg/
day.
Table
3.
Subchronic,
Chronic
and
Other
Toxicity
Profile
­
Naptalam
Sodium
Study
Type
(
species)
[
Accession
or
MRID
No.]
Classification/
Doses
Results
7
Chronic
toxicity
(
dog)
[
410575­
01]
Acceptable
­
Guideline
0,
200,
1000,
5000
ppm
0,
5.3,
25.8,
121
mg/
kg/
day
NOAEL
=
1000
ppm
(
25.8
mg/
kg/
day)
LOAEL
=
5000
ppm
(
121
mg/
kg/
day)
based
on
increased
liver
weights,
increased
levels
of
alkaline
phosphatase
and
bilirubin.

Carcinogenicity
(
rat)
Unacceptable
­
Guideline
see
chronic
toxicity
­
rat
study
classified
as
Unacceptable­
Guideline;
thus,
cancer
potential
could
not
be
addressed
based
on
this
study.

Carcinogenicity
(
mouse)
[
119003]
Minimum
0,
50,
2500,
5000
ppm
Males:
0,
8,
376,
737
mg/
kg/
day
Females:
0,
9,
437,
870
mg/
kg/
day
NOAEL
=
50
ppm
(
Males:
8
mg/
kg/
day;
Females:
9
mg/
kg/
day)
LOAEL
=
2500
ppm
(
Males:
376
mg/
kg/
day;
Females:
437
mg/
kg/
day)
based
on
decreased
body
weight
gain
in
both
sexes,
liver
hypertrophy
of
the
centrilobular
parenchymal
cells
in
males.

Gene
Mutation:
CHO/
HGPRT
[
400691­
03;
427397­
03]
Acceptable
Negative
Cytogenetics:
CHO
[
400691­
04]
Acceptable
Positive
Cytogenetics:
Micronucleus
[
400691­
05]
Unacceptable
Positive;
repeat
assay
requested
Cytogenetics:
UDS
[
401498­
01]
Acceptable
Negative
Metabolism
and
Pharmacokinetics
(
rat)
[
402745­
02;
418600­
03;
438818­
01]
Acceptable
­
Non­
Guideline
14C­
labeled
naptalam
was
rapidly
absorbed,
distributed,
and
then
excreted,
with
7­
day
recovery
of
the
radiolabeled
material
being
reported
as
85%.

The
primary
target
organ
for
the
effects
of
naptalam
sodium
is
the
liver.
These
toxic
effects
on
the
liver
were
noted
in
the
rat,
mouse,
and
dog
involving
changes
in
liver
weight
and
liver
enzyme
activities
(
Table
3).
In
some
of
the
repeated
dose
studies,
body
weights
were
observed
to
be
somewhat
reduced,
but
without
concomitant
observations
of
clinical
signs,
tissue/
organ
effects
on
microscopic
examination,
or
adverse
effects
based
on
clinical
chemistry
observations.
In
addition,
in
some
studies
there
were
wide
spacings
in
the
dosage
groupings;
for
example,
the
differences
between
NOAELs
and
LOAELs
were
7.67­
fold
in
one
study
and
50­
fold
in
another
study.
In
general,
regardless
of
the
NOAEL
doses
reported
in
the
various
studies
conducted,
adverse
effects
were
not
observed
unless
the
administered
doses
were
in
excess
of
115
mg/
kg/
day.

The
absorption,
distribution,
metabolism,
and
excretion
of
naptalam
were
studied
in
groups
of
8
male
and
female
rats
administered
a
single
oral
gavage
or
injected
dose
of
radiolabeled
naptalam.
Naptalam
was
rapidly
absorbed,
distributed,
and
excreted
in
rats.
Naptalam
and/
or
its
metabolites
do
not
bioaccumulate
to
an
appreciable
extent
following
oral
exposure
since
all
tissues
contained
negligible
levels
of
radioactivity
at
7
days
post­
exposure.
The
elimination
data
suggest
that
absorption
of
naptalam
is
rapid,
bioaccumulation
is
low,
and
excretion
occurs
in
the
feces
and
urine.
Based
on
the
study
results,
absorption,
distribution,
and
elimination
of
naptalam
did
not
appear
to
be
sex
or
dose
related.

In
the
various
studies
reported,
there
were
no
significant
developmental
or
reproductive
toxicity
noted
in
the
development
effects
studies
in
the
rat
and
rabbit,
and
a
reproductive
and
fertility
effects
study
in
the
rat
(
Table
3).
All
effects
on
the
offspring
(
fetuses
and
pups)
occurred
above
the
levels
of
maternal/
paternal
toxicity
and
were
not
different
from
what
was
seen
in
the
adult
animal.
For
example,
in
a
prenatal
developmental
study
in
the
rat
(
MRID
106320,
4376710­
01,
and
437744­
01)
developmental
toxicity
was
noted
in
the
500
mg/
kg/
day
dose
group,
based
on
lower
mean
fetal
weight
compared
to
the
control
group
and
an
increased
incidence
of
unspecified
missing
sternebrae,
incomplete
ossification
of
unspecified
vertebrae,
unspecified
skull
bones,
unspecified
extremities
and
increased
missing
or
reduced
hyoid
bone
in
the
500
mg/
kg/
day
group;
however,
maternal
toxicity
was
noted
in
the
115
mg/
kg/
day
dose
group
and
above
in
the
form
of
reduced
body
weight
gain
during
the
dosing
period
(
gestation
days
6­
15),
the
post
dosing
period
(
gestation
days
15­
20),
for
the
combined
dosing
plus
post
dosing
period
(
gestation
days
6­
20)
and
for
the
entire
gestation
period
(
except
115
mg/
kg/
day).
Therefore,
the
Agency
has
concluded
that
there
was
no
indication
of
offspring
(
fetus/
pup)
susceptibility
or
sensitivity.

Naptalam
sodium
was
positive
in
2
mutagenicity
studies,
and
negative
in
2
studies.
Based
on
these
various
genotoxicity/
mutagenicity
assays,
the
weight­
of­
evidence
for
naptalam
sodium
being
characterized
as
genotoxic
and/
or
mutagenic
is
equivocal.
In
addition,
naptalam
sodium
showed
no
carcinogenic
effects
in
any
studies,
and
is
classified
by
the
Agency
as
a
Group
"
D"
carcinogen,
which
means
there
is
inadequate
data
for
assessing
potential
human
carcinogenicity.

Special
Considerations
for
Infants
and
Children:
Based
on
the
results
of
prenatal
developmental
studies
in
the
rat
and
the
rabbit
and
a
reproductive
and
fertility
effects
study
in
the
rat,
the
fetuses
and
offspring
do
not
exhibit
more
sensitivity
than
the
maternal
dams.
Thus,
at
this
time,
there
is
no
concern
for
potential
sensitivity
to
infants
and
children
resulting
from
exposure
to
naptalam
sodium.
Therefore,
a
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reason,
the
additional
tenfold
FQPA
safety
factor
(
SF
10X)
is
unnecessary,
and
has
been
removed
(
equivalent
to
1x).

Toxicological
Endpoint
Selection:
For
dietary
exposures
for
naptalam
sodium,
there
was
no
single
dose
(
i.
e.,
acute)
effect
endpoint
identified.
For
chronic
dietary
exposures,
the
toxicological
endpoint
of
concern
selected
was
a
NOAEL
of
25.8
mg/
kg/
day
from
the
1­
year
oral
toxicity
study
in
the
dog
(
Table
4).
9
Table
4.
Summary
of
Toxicological
Endpoints
and
Other
Factors
Used
in
Human
Dietary
Risk
Assessment
for
Naptalam
Sodium
Exposure
Dose
Endpoint
Study
(
Accession
or
MRID
No.)

Acute
NOAEL
=
none
identified
None
identified.
None
identified.

Chronic
(
Non­
Cancer)
NOAEL
=
25.8
mg/
kg/
day
LOAEL
=
121
mg/
kg/
day,
based
on
increased
liver
weights,
and
increased
levels
of
alkaline
phosphatase
and
bilirubin.
1
Year
Oral
Toxicity
Dog
(
410575­
01)

UF
=
100
FQPA
SF
=
1
cPAD
=
0.258
mg/
kg/
day
Chronic
(
Cancer)
Classified
as
a
"
Group
"
D"
carcinogen,
which
means
there
is
inadequate
data
for
assessing
potential
human
carcinogenicity
for
naptalam
sodium.

For
the
occupational
handlers,
inhalation
and
dermal
exposure
were
examined,
as
well
as
postapplication
dermal
exposures.
Inhalation
exposures
are
thought
to
be
negligible
in
outdoor
postapplication
scenarios
due
to
the
dilution
expected
outdoors.
As
such,
inhalation
postapplication
exposures
are
not
considered
in
this
assessment.
Since
there
are
no
inhalation
or
dermal
toxicological
studies
available,
a
subchronic
oral
NOAEL
was
used
to
assess
short­
and
intermediate­
term
dermal
and
inhalation
exposures
(
Table
5).
The
dermal
and
inhalation
doses
were
converted
to
an
equivalent
oral
dose
using
a
100%
absorption
factor,
since
no
dermal
or
inhalation
absorption
data
are
available.
The
oral
toxicological
endpoint
(
NOAEL)
of
29.7
mg/
kg/
day
was
used,
as
being
the
most
appropriate
health
protective
value.
This
NOAEL
was
based
on
reduced
body
weight
gain,
reduced
food
efficiency,
and
increased
organ
weights
in
the
dog
from
a
90­
day
oral
toxicity
study
(
EPA,
1994,
1996,
2004).
According
to
the
data
listed
in
Table
4,
there
are
studies
listed
with
lower
NOAEL
values,
but
the
Agency
has
determined
that
this
is
the
most
reliable,
most
toxicologically
justifiable
NOAEL
for
use
in
short­
and
intermediate­
term
assessments,
and
not
ones
from
these
other
studies.
(
See
the
recent
Agency
Toxicity
Overview
for
details.)
For
example,
there
is
a
reported
NOAEL
in
the
prenatal
developmental
study
in
the
rat,
in
which
the
dams
were
dosed
at
15
mg/
kg/
day
from
gestation
day
6
to
15,
but
the
Agency
has
determined
that
"
the
maternally
toxic
effects
noted
in
this
study
(
MRID#
00106320)
at
115
mg/
kg/
day
are
minimal
at
best
and
not
supported
by
any
other
observations.
The
actual
NOAEL
is
probably
much
higher.
The
rabbit
teratology
study
had
effects
at
a
much
higher
dose
levels.
This
dose
(
from
the
rat
teratology
study)
should
not
be
used
for
short
term
risk
assessments."
Thus,
the
Agency
has
utilized
a
weight­
of­
evidence
approach
to
identify
the
best
supported
toxicity
endpoint
for
short­
and
intermediate­
term
exposures
of
29.7
mg/
kg/
day,
the
NOAEL
from
the
90­
day
oral
toxicity
study
in
the
dog.
10
Table
5.
Summary
of
Occupational
Toxicological
Endpoints
for
Naptalam
Sodium
Exposure
Dose
Endpoint
Study
(
Accession
or
MRID
No.)
UF
Short­
and
Intermediate­
Term
Dermal
1
Oral
NOAEL
=
29.7
mg/
kg/
day
LOAEL
=
3000
ppm
(
123.6
mg/
kg/
day),
based
on
reduced
body
weight
gains,
reduced
food
efficiency,
increased
absolute
and
relative
liver
weights.
90­
Day:
oral
toxicity
(
dog)
(
106277)
100
Short­
and
Intermediate
Term
Inhalation
2
Oral
NOAEL
=
29.7
mg/
kg/
day
LOAEL
=
3000
ppm
(
123.6
mg/
kg/
day),
based
on
reduced
body
weight
gains,
reduced
food
efficiency,
increased
absolute
and
relative
liver
weights.
90­
Day:
oral
toxicity
(
dog)
(
106277)
100
Long­
Term
Dermal
or
Inhalation
N/
A
3
There
are
currently
no
long­
term
exposures,
so
these
risk
assessments
are
not
required
for
non­
cancer
risk
assessments.
None
N/
A
Chronic
(
Cancer)
N/
A
Classified
as
"
Group
"
D"
carcinogen,
which
means
there
is
inadequate
data
for
assessing
potential
human
carcinogenicity
for
naptalam
sodium.
N/
A
N/
A
1
Dermal
absorption
is
assumed
to
be
equivalent
to
oral
absorption
(
100%)
for
risk
assessment
purposes.

2
Inhalation
absorption
is
assumed
to
be
equivalent
to
oral
absorption
(
100%)
for
risk
assessment
purposes.
3
N/
A
=
Not
Applicable.

A
toxicological
endpoint
of
concern
was
also
selected
for
long­
term
dermal
and
inhalation
exposures,
specifically
a
NOAEL
of
25.8
mg/
kg/
day
from
a
1­
year
oral
toxicity
study
in
the
dog.
However,
long­
term
(
chronic)
exposures
(>
180
days)
are
not
anticipated
with
the
current
use
patterns
for
naptalam
sodium.

V.
Dietary
(
Food)
Exposure:

The
Population
Adjusted
Dose
(
PAD)
characterizes
the
dietary
risk
of
a
chemical,
and
reflects
the
Reference
Dose
(
RfD),
either
acute
or
chronic,
that
has
been
adjusted
to
account
for
the
FQPA
SF.
The
acute
PAD
(
aPAD)
is
an
estimate
of
the
one­
day
dietary
exposure
to
a
pesticide
residue
which
is
believed
to
have
no
significant
deleterious
effects.
The
chronic
PAD
(
cPAD)
is
an
estimate
of
the
level
of
daily
dietary
exposure
to
a
pesticide
residue
which,
over
a
70­
year
human
life
span,
is
believed
to
have
no
significant
deleterious
effects.

As
indicated
above,
the
FQPA
Safety
Factor
has
been
removed,
and
in
addition,
there
is
no
identified
acute
RfD.
For
chronic
dietary
exposures,
the
chronic
RfD
is
0.258
mg/
kg/
day,
based
on
the
selected
toxicological
endpoint
of
concern,
a
NOAEL
of
25.8
mg/
kg/
day
from
the
1­
year
oral
toxicity
study
in
the
dog,
and
based
a
total
uncertainty
factor
(
UF)
of
100x,
based
on
the
uncertainty
factor
of
10x
for
interspecies
extrapolation
and
the
10x
for
intraspecies
variability.
A
dietary
risk
estimate
of
less
than
100%
of
the
aPAD
or
cPAD
is
not
of
concern
to
the
Agency.
11
The
Agency
usually
prefers
to
utilize
data
from
USDA's
Pesticide
Data
Program
(
PDP)
for
the
dietary
risk
assessments.
However,
for
naptalam
sodium,
these
data
could
not
be
quantitatively
used
in
the
risk
assessment,
because
the
Agency
usually
requires
that
there
be
at
least
100
samples
for
each
commodity
to
incorporate
the
USDA
PDP
monitoring
data
into
risk
assessments.
Not
enough
samples
were
monitored
among
the
crops
for
which
the
Agency
needed
to
establish
naptalam
sodium
tolerances,
and
many
of
the
commodity
groups
for
which
the
Agency
has
tolerances
were
not
even
included
in
the
USDA
PDP
monitoring
program.
For
naptalam
sodium,
field
trial
data
have
been
utilized
to
estimate
residues
in
the
respective
food
commodities
(
MRID
402745­
04).
These
data
were
developed
for
the
following
crops:
cantaloupe
treated
at
4
lb
ai/
A
and
harvested
47­
54
days
after
treatment;
cucumbers
treated
at
4
lb
ai/
A
preemergent;
and
watermelon
treated
at
4
lb
ai/
A
and
harvested
33­
68
days
after
treatment.
All
residues
reported
in
field
trials
were
non­
detectable
(<
0.1
ppm).
Based
on
these
non­
detectable
data,
the
amounts
of
naptalam
in
each
commodity
were
estimated
to
be
0.1
ppm.
This
value
represents
a
high­
end
estimate
for
each
commodity,
based
on
utilizing
the
limit
of
quantification
(
LOQ)
from
the
naptalam
analytical
method.

The
chronic
dietary
risk
assessment
for
naptalam
sodium
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEMFCID
 
,
Version
2.03),
which
incorporates
consumption
data
from
US
Department
of
Agriculture
(
USDA)
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
These
CSFII
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
non­
consecutive
survey
days.
For
the
chronic
exposure
assessment,
consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups.
Based
on
an
analysis
of
these
CSFII
consumption
data,
which
took
into
account
dietary
patterns
and
survey
respondents,
the
Agency
concluded
that
it
is
most
appropriate
to
report
risk
for
the
following
population
subgroups:
the
general
U.
S.
population,
all
infants
(<
1
year
old),
children
1­
6
years
old,
children
7­
12,
youth
13­
19,
adults
20­
49,
females
13­
49,
and
adults
50+
years
old.

For
chronic
dietary
exposure
assessment,
an
estimate
of
the
residue
level
in
each
food
or
foodform
(
e.
g.,
fresh
cucumbers
or
pickles)
on
the
food
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
average
estimated
exposure.
The
exposure
is
expressed
in
mg/
kg
body
weight/
day,
and
as
a
percent
of
the
chronic
Population
Adjusted
Dose
(
cPAD).
The
value
for
the
PAD
was
taken
as
equal
to
the
Reference
Dose
(
RfD)
of
0.258
mg/
kg/
day,
and
the
exposure
estimation
procedure
for
dietary
exposures
is
performed
for
each
population
subgroup.

The
Agency
is
generally
not
concerned
when
exposure
estimates
are
less
than
100%
of
the
cPAD.
The
estimates
for
naptalam
sodium
are
less
than
0.1%
of
the
cPAD
for
each
population
subgroup
(
Table
6).
Note
that
no
acute
dietary
(
food)
exposures
have
been
estimated
for
naptalam
sodium,
because
there
has
been
no
acute
toxicological
endpoint
identified,
and
similarly,
no
cancer
dietary
(
food)
exposures
have
been
estimated
because
the
Agency
have
classified
naptalam
sodium
(
and
naptalam)
as
a
Group
"
D"
carcinogen,
which
means
there
is
inadequate
data
for
assessing
potential
human
carcinogenicity.
12
Table
6.
Summary
of
Chronic
Dietary
(
Food)
Exposure
and
Risk
for
Naptalam
Sodium.

Dietary
Exposure
(
mg/
kg/
day)
%
cPAD*

General
U.
S.
Population
0.000040
<
0.1
All
Infants
(<
1
year
old)
0.000045
<
0.1
Children
1­
6
years
old
0.000077
<
0.1
Children
7­
12
years
old
0.000051
<
0.1
Youth
13­
19
years
old
0.000032
<
0.1
Adults
20­
49
years
old
0.000029
<
0.1
Adults
50+
years
old
0.000043
<
0.1
Females
13­
49
years
old
0.000032
<
0.1
VI.
Drinking
Water
Exposure:

Tier
I
Estimated
Drinking
Water
Concentrations
(
EDWCs)
for
naptalam
were
calculated
by
utilizing
the
FIRST
V.
1.0
(
surface
water)
and
SCIGROW
V.
2.3
(
ground
water)
models
for
use
in
the
human
health
risk
assessment,
following
applications
of
naptalam
sodium.
For
surface
waters,
the
estimated
peak
concentration
of
naptalam
was
658.2
ppb,
and
the
annual
average
concentration
was
188.7
ppb
(
Table
7).
The
estimated
ground
water
concentration,
suitable
for
both
peak
and
annual
average
concentrations,
was
3.31
ppb
for
naptalam.
These
values
represent
"
conservative"
(
i.
e.,
high­
end)
estimates
of
the
concentrations
of
naptalam
that
could
be
found
in
surface
and
ground
water
following
the
applications
to
cucurbits
and
ornamentals,
the
crop
sites
on
the
current
label.
There
are
no
available
monitoring
data
for
assessing
these
EDWCs
in
either
surface
waters
or
ground
water.

Table
7.
Estimated
Environmental
Concentrations
(
ppb)
of
Naptalam
Sodium
in
Surface
and
Groundwater
at
Two
Applications
of
4.0
lb/
acre
with
14­
day
Intervals.

Scenario
Peak
(
ppb)
Long­
Term
Average,
Peak
(
ppb)

Annual
21­
day
60­
day
Surface
water
drinking
water
(
FIRST)
658.2
188.7
Ambient
surface
water
(
GENEEC)
435.5
421.4
395.3
Groundwater
drinking
water
(
SCI­
GROW)
3.31
VII.
Aggregate
Assessment:

The
Food
Quality
Protection
Act
amendments
to
the
Federal
Food,
Drug,
and
Cosmetic
Act
[
FFDCA,
Section
408(
b)(
2)(
A)(
ii)]
require
"
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
13
typically
includes
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide,
and
other
non­
occupational
sources
of
exposure.
For
an
aggregate
assessment
of
naptalam
sodium,
the
only
significant
exposure
routes
are
oral
exposure
through
food
and
water
consumption,
because
there
are
no
registered
residential
uses
or
other
non­
occupational
sources
of
exposure.

To
determine
the
maximum
contribution
allowed
from
water
in
the
diet,
the
Agency
first
looks
at
how
much
of
the
overall
allowable
risk
is
contributed
by
food
to
determine
a
"
drinking
water
level
of
comparison"
(
DWLOC).
The
modeled
drinking
water
estimates
are
then
compared
to
the
DWLOC
to
ensure
that
they
do
not
exceed
this
level.
A
chronic
dietary
exposure
assessment
was
conducted,
which
shows
that
naptalam
sodium
represents
an
extremely
small
percent
of
the
PAD,
specifically,
less
than
0.1%
of
the
cPAD
for
all
population
subgroups.
The
Agency
is
generally
not
concerned
when
dietary
exposure
estimates
are
less
than
100%
of
the
PAD.
As
discussed
above,
the
estimated
peak
concentration
of
naptalam
in
surface
waters
was
658.2
ppb,
and
the
annual
average
surface
water
concentration
was
188.7
ppb.
The
estimated
ground
water
concentration,
suitable
for
both
peak
and
annual
average
concentrations,
was
3.31
ppb
for
naptalam.

Since
the
dietary
contribution
is
significantly
below
the
PAD
and
the
estimated
drinking
water
exposure
levels
are
in
the
moderate
range,
the
Agency
considers
it
very
unlikely
that
levels
of
concern
would
be
reached
from
the
combination
of
these
two
exposure
sources.
As
support
for
this
position,
the
chronic
risk
estimates
for
exposure
to
food
and
drinking
water
sources
for
two
population
subgroups,
children
1­
6
years
old
and
for
the
general
U.
S.
population,
have
been
determined
(
Table
8).
Considering
that
the
conservatively
estimated
environmental
concentrations
of
naptalam
are
significantly
below
the
DWLOC
for
the
most
sensitive
population
subgroup
(
children
1­
6)
and
for
the
general
population,
and
the
relatively
low
production
volume
and
total
amount
applied
of
this
chemical,
the
risks
associated
with
food
and
drinking
water
exposures
to
naptalam
are
not
of
concern
to
the
Agency.

Table
8.
Summary
of
Aggregate
Risk
Estimates
for
Chronic
Food
and
Water
Exposures
to
Naptalam
Population
Subgroup
Chronic
PAD
(
mg/
kg/
d)
Food
Exposure
(
mg/
kg/
d)
Allowable
Water
Exposure
(
mg/
kg/
d)
Annual
Peak
in
Drinking
Water
(
ppb)
Annual
Mean
in
Drinking
Water
(
ppb)
DWLOC
(
ppb)

Children
1­
6
yrs.
old
0.258
0.000077
0.257923
658.2
188.7
2580
General
U.
S.
Population
0.258
0.000040
0.25796
658.2
188.7
9029
VIII.
Occupational
Exposure
Assessment:

Naptalam
sodium
is
formulated
as
liquid
concentrate
for
use
as
a
pre­
emergent
broadleaf
herbicide
on
cucurbit
crops
and
woody
nursery
stock.
It
may
be
applied
with
groundboom
equipment
to
cucurbits
and
with
groundboom,
low­
pressure
handwand,
and
handgun
equipment
14
to
the
soil
around
established
or
transplanted
woody
nursery
stock.
The
current
label
does
not
specify
whether
aerial
applications
are
permitted,
but
the
registrant
has
indicated
they
know
of
no
current
aerial
applications,
and
are
willing
to
place
such
restrictions
on
their
revised
label.
In
addition,
the
registrant
has
recently
placed
a
restriction
against
use
in
greenhouses
on
their
label.
The
label
also
prohibits
use
through
any
type
of
irrigation
system.

Table
9
provides
the
acres
treated
per
day
and
the
maximum
application
rates.
The
daily
areas
treated
were
defined
for
each
handler
scenario
(
in
appropriate
units)
by
determining
the
amount
that
can
be
reasonably
treated
in
a
single
day
(
e.
g.,
acres).
It
was
assumed
that
the
average
occupational
workday
is
8
hours.
Since
the
toxicological
endpoint
is
the
same
for
dermal
and
inhalation,
total
risks
(
dermal
plus
inhalation)
must
be
estimated.
An
uncertainty
factor
of
100
(
10
for
interspecies
extrapolation
and
10
for
intraspecies
variation)
was
used
for
this
assessment.
Since
the
toxicological
endpoint
of
concern
is
not
sex­
specific,
the
average
body
weight
of
an
adult
(
70
kg)
was
used
to
calculate
doses.

Table
9:
Summary
of
Maximum
Application
Rates
for
Naptalam
Sodium
Crop
Type/
Use
Site
Maximum
Application
Rate
Application
Equipment
Acres
Treated
Per
Day
Cucurbits
(
i.
e.,
cucumber,
watermelon,
muskmelon,
cantaloupe,
honeydew
melon,
Persian
melon,
and
casaba)
4
lb
ai/
acrea
groundboom
80
Woody
nursery
stock
transplants
or
established
plants
(
The
label
indicates
"
Not
for
use
in
a
greenhouse.")
8
lb
ai/
acreb
groundboom
40
handgun
5
low­
pressure
handwand
2
a
From
product
label,
2
lbs
of
naptalam
sodium
per
gallon
of
product;
apply
2
gallons/
acre
maximum
b
From
product
label,
2
lbs
of
naptalam
sodium
per
gallon
of
product;
apply
4
gallons/
acre
maximum
The
Agency
has
determined
that
there
is
a
potential
for
exposure
to
naptalam
sodium
in
occupational
scenarios
from
handling
naptalam
sodium
products
during
the
application
process
(
i.
e.,
mixer/
loaders,
applicators,
and
mixers/
loaders/
applicators)
and
a
potential
for
postapplication
worker
exposure
from
entering
into
areas
previously
treated
with
naptalam
sodium.
As
a
result,
risk
assessments
have
been
completed
for
occupational
handler
scenarios
as
well
as
occupational
postapplication
scenarios.
The
label
lists
the
various
cucurbit
crops,
with
the
possibly
of
staggered
plantings
of
the
different
species
in
the
same
area,
and
with
the
applications
to
both
pre­
emergent
(
immediately
after
planting)
and
pre­
vining
plants
listed
on
the
label.
The
registrant
has
provided
information
that
usually
a
grower
would
utilize
only
a
single
treatment
(
immediately
after
planting
or
pre­
vining),
but
since
the
label
permits
a
second
treatment,
both
treatment
have
been
assessed.
The
registrant
also
indicates
that
the
time
period
between
these
two
treatments
may
be
between
2
to
6
weeks
apart.
Therefore,
the
Agency
has
included
assessments
for
both
short­
and
intermediate­
term
exposures,
with
short­
term
exposures
being
1
to
30
days,
and
intermediate­
term
being
1
to
6
months
duration.
In
addition,
the
label
lists
treatment
for
broadleaf
weed
control
in
nursery
stock
transplants
or
established
plants,
without
any
restrictions
on
the
time
of
year
of
treatment,
except
for
conditions
of
extreme
temperatures.
15
The
exposure
scenarios
and
application
rates
chosen
for
this
risk
assessment
were
based
on
the
anticipated
use
patterns
and
the
current
label
for
the
naptalam
sodium
product
(
see
Table
9).

Occupational
Handler
Exposures
and
Risks:
The
occupational
handler
exposure
assessments
were
completed
considering
different
levels
of
possible
risk
mitigation.
A
tiered
approach
was
used,
with
the
lowest
tier
represented
by
the
baseline
attire
exposure
scenario
(
i.
e.,
long­
sleeve
shirt,
long
pants,
shoes,
socks,
and
no
respirator),
followed
by
increasing
levels
of
personal
protective
equipment
or
PPE
(
e.
g.,
gloves,
double­
layer
body
protection,
and/
or
respirators)
and
engineering
controls
(
e.
g.,
enclosed
cabs,
enclosed
cockpits,
and
closed
mixing/
loading
systems).
Occupational
handler
exposure
estimates
were
based
on
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
and
the
Outdoor
Residential
Exposure
Taskforce
(
ORETF).
(
See
Appendix
2
for
additional
details
concerning
PHED
and
ORETF
studies.)

Based
on
the
exposure
assessments
reported
in
Table
10,
the
results
of
the
occupational
handler
exposure
and
risk
assessment
indicate
that
total
(
dermal
+
inhalation)
risks
did
not
exceed
the
level
of
concern:

°
For
handlers
mixing/
loading
liquid
concentrates
to
support
aerial
and
groundboom
applications,
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire.
°
For
handlers
applying
liquids
with
enclosed­
cockpit
aerial
and
open­
cab
groundboom
equipment
with
baseline
attire.
°
For
handlers
mixing/
loading/
applying
with
low­
pressure
handwand
or
handgun
equipment
with
the
addition
of
chemical­
resistant
gloves
to
baseline
attire.
16
Table
10.
Short­
and
Intermediate
Term
Dermal
and
Inhalation
Handler
Risks
­
Naptalam
Sodium
Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
acre)
Area
Treated
Dailyb
(
acres)
Unit
Exposures
Dermal
MOEsf
Inhalation
MOEg
Combined
Dermal
+

Inhalation
MOEs
Dermal
Baseline
Attirec
(
mg/
lb
ai)
Inhalation
Baselined
(
µ
g/
lb
ai)
Dermal
PPEe
(
baseline
plus
gloves)

(
mg/
lb
ai)
Baseline
PPE­

(
baseline
plus
gloves)
Baseline
Baseline
Dermal
+

Baseline
Inhalation
PPE
Dermal
(
baseline
plus
gloves)

+
Baseline
Inhalation
Mixer/
Loader
Mixing/
Loading
Liquid
Concentrates
for
Groundboom
Applications
nurseries
8
40
2.9
1.2
0.023
2.3
290
5400
2.3
270
cucurbits
4
80
2.9
1.2
0.023
2.3
290
5400
2.3
270
Applicator
Applying
Liquid
Sprays
via
Groundboom
Equipment
nurseries
8
40
0.014
0.74
0.014
460
460
8900
440
440
cucurbits
4
80
0.014
0.74
0.014
460
460
8900
440
440
Mixer/
Loader/
Applicator
Mixing/
Loading/

Applying
Liquid
Concentrates
with
Low
Pressure
Handwand
(
PHED)
nurseries
8
2
100
30
0.43
1.3
300
4300
1.3
290
Table
10.
Short­
and
Intermediate
Term
Dermal
and
Inhalation
Handler
Risks
­
Naptalam
Sodium
Exposure
Scenario
Crop
or
Target
Application
Ratea
(
lb
ai/
acre)
Area
Treated
Dailyb
(
acres)
Unit
Exposures
Dermal
MOEsf
Inhalation
MOEg
Combined
Dermal
+

Inhalation
MOEs
Dermal
Baseline
Attirec
(
mg/
lb
ai)
Inhalation
Baselined
(
µ
g/
lb
ai)
Dermal
PPEe
(
baseline
plus
gloves)

(
mg/
lb
ai)
Baseline
PPE­

(
baseline
plus
gloves)
Baseline
Baseline
Dermal
+

Baseline
Inhalation
PPE
Dermal
(
baseline
plus
gloves)

+
Baseline
Inhalation
17
Mixing/
Loading/

Applying
Liquid
Concentrates
with
a
Handgun
Sprayer
(
LCO
ORETF
data)
nurseries
8
5
No
Data
1.8
0.45
No
Data
113
29000
No
Data
113
a
Application
rates
are
the
maximum
application
rates
determined
from
the
EPA
registered
label
for
naptalam
sodium.

b
Amount
handled
per
day
values
are
estimates
of
acres
treated
daily.

c
Dermal
baseline
attire
is
long­
sleeve
shirt,
long
pants,
and
no
gloves.

d
Inhalation
baseline
is
no
respirator.

e
PPE­
single
layer
plus
gloves
is
baseline
attire
plus
chemical­
resistant
gloves.

f
Dermal
MOE
=
NOAEL
(
29.7
mg/
kg/
day)
/
dermal
daily
dose
(
mg/
kg/
day),
where
dermal
dose
=
daily
unit
exposure
(
mg/
lb
ai)
x
application
rate
x
amount
handled
per
day
/
body
weight
(
70
kg
adult).

g
Inhalation
MOE
=
NOAEL
(
29.7
mg/
kg/
day)
/
inhalation
daily
dose
(
mg/
kg/
day),
where
inhalation
dose
=
daily
unit
exposure
(
µ
g/
lb
ai)
x
application
rate
x
amount
handled
per
day
x
conversion
factor
(
1mg/
1,000
µ
g)
/
body
weight
(
70
kg
adult).
18
Occupational
Postapplication
Exposures
and
Risks:
Occupational
postapplication
exposures
to
agricultural
workers
are
estimated,
in
general,
using
transfer
coefficients
and
dislodgeable
foliar
residue
values
or
soil
transferrable
residue
values
to
estimate
the
postapplication
exposures.
Transfer
coefficients
are
linked
to
specific
worker
tasks,
such
as
irrigating,
scouting,
weeding,
harvesting,
etc.
These
tasks
are
typically
crop­
specific
and
may
involve
light
to
heavy
contact
with
the
crop
at
various
stages
of
growth,
depending
on
the
timing
of
application.
Dislodgeable
foliar
residues
(
DFRs)
are
the
amounts
of
pesticide
available
on
the
leaf
surface
that
can
potentially
be
transferred
to
the
skin
of
agricultural
workers
who
contact
treated
foliage
or
other
surfaces.
DFRs
are
measured
using
techniques
that
specifically
determine
the
amount
of
residues
on
the
surface
treated
leaves
or
other
plant
surfaces.
Soil
transferrable
residues
(
STRs)
are
the
amounts
of
pesticide
active
ingredient
available
in
the
soil
that
can
potentially
be
transferred
to
the
skin
of
agricultural
workers
who
contact
treated
soil.

The
product
label
indicates
that
for
weed
control
in
cucurbits,
naptalam
sodium
may
be
applied
as
a
broadcast
application
at
planting
and/
or
over
the
top
of
the
cucurbits
in
the
early
season
before
they
begin
to
vine.
For
weed
control
in
woody
nursery
stock,
the
product
label
indicates
that
it
may
be
applied
as
a
broadcast
spray
prior
to
transplanting
or
as
a
soil­
directed
spray
around
established
stock.
For
both
cucurbits
and
woody
nursery
stock
application,
the
product
label
recommends
watering­
in
following
application.
For
the
over­
the­
top
application
to
cucurbits,
residues
would
be
on
plant
foliage;
therefore,
a
DFR
value
would
be
used
in
the
postapplication
risk
assessment.
The
registrant
submitted
a
study
(
MRID
449725­
01)
designed
to
fulfill
the
requirements
under
Occupational
and
Residential
Exposure
Test
Guidelines:
875.2100,
Dislodgeable
Foliar
Residue
Dissipation.
Based
on
the
information
available
in
this
DFR
study,
the
data
indicate
that
the
calculated
dissipation
half­
lives
for
naptalam
sodium
ranged
from
1.45
to
1.66
days
for
the
portion
of
the
study
conducted
in
Indiana,
and
from
2.82
to
2.88
days
for
the
portion
of
the
study
conducted
in
Washington
State.
Since
the
foliar
applications
are
made
only
in
early
season
before
the
cucurbits
begin
to
vine,
and
exposures
would
be
limited
to
immature
crops,
so
it
was
considered
there
to
be
the
potential
for
only
low
exposure
activities.

It
should
be
noted
that
the
current
label
for
the
naptalam
sodium
product
recommends
that
soil
watering
regimen
after
application
is
very
important
for
the
proper
use
of
this
product.
Water
is
needed
to
carry
this
product
to
the
seeds
or
roots
of
the
weeds.
Irrigation
therefore,
may
be
needed
in
dry
conditions.

The
Agency
generally
mitigates
postapplication
risks
to
agricultural
workers
using
a
restricted
entry
interval
(
REI),
which
is
a
period
of
time
following
a
pesticide
application
during
which
entry
into
the
treated
area
is
restricted.
The
naptalam
sodium
product
is
intended
for
early­
season
applications
to
cucurbits,
both
soil­
directed
and
foliar,
with
watering­
in,
to
control
preemergent
weeds.
The
Agency
has
determined
that
there
is
a
low
potential
for
occupational
post­
application
exposure
when
a
pre­
emergent
herbicide
is
used,
since
most
pre­
emergent
herbicides
are
applied
to
the
soil
directly
and/
or
are
soil­
incorporated
well
before
the
crops
are
mature.
This
is
the
situation
for
the
naptalam
sodium
product.
In
addition,
the
timing
of
the
applications,
relative
to
harvest
activities,
can
greatly
reduce
the
potential
for
post­
application
exposure.
With
applications
to
high
acreage
field
crops,
mechanically
planted
early
in
the
season,
there
is
a
minimal
potential
for
dermal
contact.
But
there
is
a
somewhat
greater
concern
for
the
postapplication
exposure
when
a
pre­
emergent
herbicide
is
used
on
crops
that
must
be
hand­
planted
or
transplanted,
such
as
the
cucurbits.
However,
most
of
the
activities
associated
with
these
crops
are
low
contact.
19
The
Agency
has
decided
to
use
a
qualitative
approach
to
address
the
post­
application
exposures
for
naptalam
sodium,
based
on
several
key
factors:
the
pre­
emergent
use
pattern
of
this
chemical;
the
label
recommends
that
soil
watering
regimen
is
very
important
for
watering­
in
the
herbicide,
thus
limiting
DFR
residues;
and,
worker
exposure
would
be
limited
to
immature
crops.
For
naptalam
sodium,
a
pre­
emergent
herbicide
used
on
crops
that
are
hand
planted
or
transplanted,
the
postapplication
assessment
on
the
exposure
through
the
treated
soil
has
been
considered
in
this
qualitative
approach,
and
an
REI
is
not
being
assessed
for
postapplication
exposures.
The
decision
not
to
assess
an
REI
is
based
on
the
low
potential
for
occupational
post­
application
exposure
when
pre­
emergent
herbicides
are
used.
Naptalam
sodium
is
applied
to
the
soil
directly
and
the
label
recommends
watering­
in,
so
the
product
is
soil
incorporated
well
before
the
crops
are
mature.
The
timing
of
the
application
of
naptalam
sodium
can
greatly
reduce
the
potential
for
post­
application
exposure.
Also,
most
agricultural
operations
mechanically
plant
the
cucurbits
early
in
the
season,
which
minimizes
the
potential
for
dermal
contact.
Minimal
exposure
during
harvesting
or
any
other
late
season
activities
is
expected
since
naptalam
sodium
is
applied
early
in
the
growing
season
to
control
pre­
emergent
weeds.

For
consistency
of
establishing
a
postapplication
REI,
the
current
product
label
lists
an
REI
of
48
hours.
This
REI
was
based
on
the
eye
irritation
study
(
MRID
60404),
which
determined
that
naptalam
sodium
causes
severe
eye
irritation.
Consequently,
this
RED
now
finds
that
the
REI
of
48
hours
should
be
retained,
and
that
the
stipulation
that
PPE
for
applicators
and
other
handlers
must
include
protective
eyewear
is
also
retained.

IX.
Environmental
Fate
and
Ecotoxicity:

Environmental
Fate
and
Transport:
The
environmental
fate
database
for
naptalam
sodium
is
sufficient
to
conduct
a
preliminary
assessment.
The
physical
and
chemical
properties
important
in
assessing
the
environmental
fate
and
transport
of
naptalam
sodium
are
listed
in
Table
11.
The
environmental
fate
and
mobility
of
naptalam
sodium
is
pH
dependent.
The
herbicide
is
formulated
as
a
sodium
salt,
and
will
dissociate
readily
and
will
predominantly
exist
as
the
sodium
cation
and
acid
anion
in
the
environment.
Anions
often
possess
high
mobility
in
soils,
tend
to
have
significant
leaching
potential
and
will
not
volatilize
from
water
or
soil
surfaces.
The
hydrolysis
of
naptalam
appears
to
occur
slowly
under
alkaline
and
neutral
conditions,
but
proceeds
rapidly
under
acidic
conditions
with
a
half­
life
on
the
order
of
a
few
days.
Biodegradation
appears
to
be
insignificant
under
anaerobic
conditions,
but
may
be
an
important
environmental
fate
process
in
soil
and
water
under
aerobic
conditions.
A
major
degradation
product
of
naptalam
is
1­
naphthylamine
which
has
been
classified
as
a
carcinogen
by
the
Occupational
Safety
and
Health
Administration
(
OSHA),
although
this
degradate
was
not
detected
in
the
submitted
plant
metabolism
studies.
20
Table
11.
Physical
and
Chemical
Properties
Important
for
the
Environmental
Fate
and
Transport
of
Naptalam
Sodium.

Parameter
Value
Source
Scientific
name
2­((
1­
naththalenyl­
amino)
carbonyl)­
benzoic
acid,
sodium
salt
Molecular
formula
C18H13NO3.
Na
Toxnet
(
2004)

Molecular
weight
313.3
Toxnet
(
2004)

Melting
Point
greater
than
185
°
C
Toxnet
(
2004)

Density/
Specific
Gravity
1.386
Toxnet
(
2004)

Vapor
Pressure
(
25
°
C)
9.1x10­
11
mm
Hg
EPIWIN
Henry's
Law
Coeffiicient
2.4x10­
15
atm­
m3/
mol
EPIWIN
Estimated
Octanol/
Water
Partition
Coefficient
(
log
Kow)
5.42
(
naptalam)
­
0.39
(
sodium
salt)
Tomlin,
1997
EPIWIN
Dissociation
Constant
(
pKa)
4.6
Tomlin,
1997
Water
Solubility
(
mg/
L
at
25oC)
200
mg/
L
(
naptalam)
300,000
mg/
L
(
sodium
salt)
249,000
mg/
L
(
sodium
salt)
Tomlin,
1997
Tomlin,
1997
Weed
Science
Society
of
America,
7th
edition,
1994
Hydrolysis
Half­
life
(
days)
2.9
(
at
pH
5)
No
data
at
pH
7
and
9
MRID
436477­
01
Aerobic
Soil
Metabolism
Half­
life
(
days)
36.7
MRID
414272­
01
<
3
MRID
00145416
Anaerobic
Soil
Metabolism
Half­
life
(
days)
246
MRID
414272­
02
Aerobic
Aquatic
Metabolism
Half­
life
(
days)
"
137.25"
No
study;
value
calculated
as
3x
the
aerobic
soil
t
½
from
MRID
416477­
01,
in
accordance
with
EFED
policy
(
2002)

Aqueous
Photolysis
Half­
life
(
days)
6.2­
6.9
10.3
MRID
413854­
01
MRID
413854­
01
Soil
photolysis
half­
life
15.9
days
MRID
413854­
02
Estimated
Soil
Sorption
Coefficient
(
Adsorption
coefficient,
Koc
2)
20
Weber
1994
Ecotoxicity
and
Environmental
Risk
Assessment:
Results
of
acute
toxicity
studies
suggest
that
naptalam
is
practically
nontoxic
to
freshwater
fish
and
invertebrates.
No
chronic
toxicity
data
were
submitted
for
freshwater
organisms
and
no
acute
21
or
chronic
testing
of
marine/
estuarine
fish
or
invertebrates
was
submitted.
A
Tier
1
screening
level
risk
assessment
focusing
on
maximum
proposed
uses
of
naptalam
on
cucumber,
watermelon,
honeydew
and
cantaloupe
suggests
that
concentrations
of
naptalam
in
the
environment,
when
compared
with
minimum
toxicity
values,
are
unlikely
to
result
in
acute
adverse
effects
to
freshwater
aquatic
organisms.
Insufficient
toxicity
data
are
available
to
characterize
the
risk
of
chronic
adverse
effects
to
freshwater
organism,
and
no
data
are
available
to
characterize
the
risk
to
marine/
estuarine
fish
and
invertebrates.

Naptalam
is
categorized
as
slightly
toxic
to
small
mammals
on
an
acute
oral
basis
and
the
potential
for
chronic
reproductive
effects
appears
to
be
low.
Risks
to
terrestrial
and
avian
species
may
occur,
but
are
expected
to
be
unlikely
due
to
the
rapid
breakdown
of
the
naptalam
acid
in
soils
and
the
surfaces
of
plants,
and
due
to
the
label­
mediated
practice
of
watering­
in
the
naptalam
into
the
soil
following
application.

Results
of
acute
oral
toxicity
studies
suggest
that
naptalam
is
practically
non­
toxic
to
birds.
Results
of
reproductive
studies
of
naptalam
in
birds
are
not
available.
Based
on
contact
LD
50
studies
for
the
honey
bee
(
Apis
mellifera),
naptalam
is
classified
as
practically
nontoxic
on
an
acute
contact
basis.
Because
naptalam
is
an
herbicide,
it
is
anticipated
that
non­
target
plants
might
be
susceptible
to
adverse
effects;
however,
no
data
were
submitted
to
assess
the
toxicity
of
naptalam
toward
aquatic
or
terrestrial
non­
target
plants.

The
Agency's
ecological
risk
assessment
compares
toxicity
endpoints
from
ecological
toxicity
studies
to
estimated
environmental
concentrations
(
EECs)
based
on
environmental
fate
characteristics
and
pesticide
use
data.
To
evaluate
the
potential
risk
to
nontarget
organisms
from
the
use
of
naptalam
sodium
products,
the
Agency
calculates
Risk
Quotient
(
RQ)
values,
which
are
the
ratio
of
the
EEC
to
the
most
sensitive
toxicity
endpoint
value,
such
as
the
median
lethal
dose
(
LD
50
)
or
the
median
lethal
concentration
(
LC
50
).
These
RQ
values
are
then
compared
to
the
Agency's
level
of
concern
(
LOC)
values
to
estimate
whether
a
chemical,
when
used
as
directed,
has
the
potential
to
cause
adverse
effects
on
nontarget
organisms.
When
the
RQ
exceeds
the
LOC
for
a
particular
category,
the
Agency
presumes
a
potential
risk
of
concern
to
that
category
of
organisms.

A
Tier
1
screening
level
risk
assessment
focusing
on
maximum
proposed
uses
of
naptalam
sodium
on
cucumber,
watermelon,
honeydew
and
cantaloupe
has
been
conducted.
The
results
suggest
that
concentrations
of
naptalam
in
the
environment,
when
compared
with
minimum
toxicity
values,
are
unlikely
to
result
in
acute
adverse
effects
to
freshwater
aquatic
organisms.
Insufficient
toxicity
data
are
available
to
characterize
the
risk
of
chronic
adverse
effects
to
freshwater
organisms,
and
no
data
are
available
to
characterize
the
risk
to
marine/
estuarine
fish
and
invertebrates.

Naptalam
sodium
is
absorbed
by
seeds
and
primary
roots,
and
interferes
with
normal
growth,
but
it
exhibits
minimal
foliar
activity
and
minimal
activity
on
grassy
weeds.
Thus,
while
no
data
were
submitted
to
assess
the
toxicity
of
naptalam
toward
aquatic
or
terrestrial
non
target
plants,
it
is
expected
that
there
are
minimal
adverse
risks
to
terrestrial
non­
target
plants.
In
addition,
the
results
indicate
that
there
are
no
risk
concerns
for
avian
species.

Screening
level
risk
estimates
have
been
conducted
for
terrestrial
mammalian
species,
and
the
acute,
chronic,
endangered
species,
and
restricted
use
triggers
are
summarized
below:
22
°
In
mammalian
species,
acute
exposure
to
naptalam
under
maximum
residues
conditions
on
short
grass
to
small
mammals
(
15
g)
indicates
a
potential
for
acute
risk,
because
the
RQ
is
0.58,
as
well
as
five
other
potential
exceedances
of
acute
restricted
use
LOCs
in
tall
grass
and
in
broadleaf
plants
and
small
insects,
as
well
as
three
potential
exceedances
of
the
endangered
species
LOC.

°
In
mammalian
species,
chronic
exposure
to
naptalam
on
short
grass
for
maximum
residue
conditions
also
indicates
the
potential
for
chronic
risk
to
mammals,
because
the
RQ
of
1.74
exceeds
the
LOC
of
1.

Note
that
with
respect
to
endangered
species,
this
is
only
a
screening
level
and/
or
qualitative
assessment,
and
does
not
constitute
any
findings
by
the
Agency
with
regard
to
specifications
under
the
Endangered
Species
Act.

X.
Cumulative
Exposure:

Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
If
chemicals
are
structurally
related
and
all
are
low
toxicity
chemicals,
then
the
risks
either
separately
or
combined
should
also
be
low.

EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
naptalam
sodium
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
naptalam
sodium
and
any
other
substances,
and
naptalam
sodium
does
not
appear
to
produce
toxic
metabolites
produced
by
other
substances.

For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
naptalam
sodium
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
the
Agency's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

XI.
Risk
Mitigation/
Management:

The
assessments
of
occupational
handler
and
postapplication
exposures
to
naptalam
sodium
indicate
that
there
are
risks
associated
with
its
use
as
an
herbicide
on
cucurbits
and
nursery
stocks.
Risks
to
handlers
can
be
mitigated
with
baseline
attire,
and
for
mixer/
loader
and
mixer/
loader/
application
scenarios,
with
the
addition
of
chemical­
resistant
gloves.
Thus,
the
revised
label
for
the
end­
use
product
will
now
include
chemical­
resistant
gloves
for
mixer/
loaders
and
mixer/
loader/
applicators.
Due
to
lack
of
exposure
data,
the
only
mitigation
for
aerial
23
applications
would
have
been
engineering
controls
(
enclosed
cockpit
and
probably
closed
transfer
mixing
and
loading
systems);
however,
due
to
these
factors
and
apparently
minimal
usage
of
aerial
applications,
the
registrant
has
agreed
to
place
label
restrictions
against
aerial
applications
on
their
revised
label.
Postapplication
risks
to
agricultural
workers
can
be
mitigated
with
a
restrictedentry
interval,
with
an
REI
of
24
hours,
which
actually
is
a
shorter
time
interval
than
the
48
hours
on
the
current
label.
In
addition,
soil
exposures
were
also
unlikely
to
exceed
the
level
of
concern
at
an
REI
conservatively
estimated
to
be
24
hours
after
application.
However,
due
to
an
eye
irritation
study
showing
severe
opacity
continuing
until
day
7,
both
the
REI
of
48
hours
and
the
requirement
for
protective
eyewear
will
remain
on
the
label.

In
addition
to
the
risk
mitigation
of
the
registrant
voluntarily
agreeing
to
place
a
restriction
on
the
label
to
prevent
aerial
applications,
the
registrant
will
retain
label
restrictions
against
greenhouse
use,
as
well
as
applications
through
any
type
of
irrigation
system.
In
addition,
the
registrant
will
incorporate
label
language
to
insure
that
ground
applications
will
be
made
with
equipment
placed
as
close
to
the
ground
as
feasible,
that
droplet
sizes
will
be
as
large
as
possible
(
no
fine
droplets),
and
that
the
watering­
in
requirement
will
be
clearly
stated
on
the
label
directions.
In
addition,
the
registrant
has
voluntarily
agreed
to
remove
nursery
stock/
woody
ornamentals
from
their
label.
The
registrant
has
also
agreed
to
include
on
the
revised
label
that
the
maximum
application
rate
will
remain
at
4
pounds
active
ingredient
per
acre
per
application,
that
two
applications
are
permitted
(
a
first
may
be
made
immediately
after
planting
and
a
second
may
be
made
before
the
plants
start
to
vine
but
before
weeds
have
emerged),
and
that
the
total
applications
annually
may
not
exceed
8
pounds
per
acre
per
year.

The
Agency's
screening
level
risk
assessment
for
naptalam
sodium
indicated
the
possibility
of
risks
to
endangered
species.
Note,
however,
that
with
respect
to
endangered
species,
this
is
only
a
screening
level
and/
or
qualitative
assessment,
and
does
not
constitute
any
findings
by
the
Agency
with
regard
to
specifications
under
the
Endangered
Species
Act.

The
Agency
is
not
requiring
specific
mitigation
at
the
present
time
relative
to
threatened
and
endangered
species.
However,
the
general
risk
mitigation
required
through
this
RED
will
serve
to
reduce
exposures
somewhat,
until
such
time
as
the
Agency
completes
a
full
endangered
species
risk
assessment.
If
in
the
future
specific
measures
are
necessary
for
the
protection
of
listed
species,
the
Agency
will
implement
them
through
the
Endangered
Species
Protection
Program.

XII.
Endocrine
Disruptor
Effects:

The
Agency
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
the
Agency
determined
that
there
were
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
The
Agency
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
the
Agency
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
24
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).

When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
naptalam
sodium
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

XIII.
Tolerance
Reassessment:

"
Risk
Cup"
Determination:
As
part
of
the
FQPA
tolerance
reassessment
process,
the
Agency
assessed
the
risks
associated
with
the
naptalam
sodium.
FQPA
requires
the
Agency
to
evaluate
food
tolerances
on
the
basis
of
cumulative
risk
from
substances
sharing
a
common
mechanism
of
toxicity,
such
as
the
toxicity
expressed
through
a
common
biochemical
interaction.
The
Agency
does
not
know
of
any
cumulative
risk
posed
by
an
entire
class
of
chemicals
including
naptalam
sodium.

Thus,
the
Agency
has
determined
that
the
dietary
risk
from
exposure
to
naptalam
sodium
is
within
its
own
"
risk
cup."
In
other
words,
if
naptalam
sodium
did
not
share
a
common
mechanism
of
toxicity
with
other
chemicals,
the
Agency
would
be
able
to
conclude
today
that
the
food
tolerances
for
naptalam
sodium
meet
the
FQPA
safety
standards.
In
reaching
this
determination
concerning
the
FQPA
safety
standards,
the
Agency
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
both
the
chronic
and
acute
food
exposure.
An
aggregate
assessment
was
conducted
for
exposures
through
food
and
drinking
water.
Based
on
the
results
of
this
aggregate
assessment,
the
Agency
has
determined
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels,
because
the
combined
risks
from
all
exposures
to
naptalam
sodium
do
not
"
fill"
the
aggregate
risk
cup.

Residue
Analytical
Methods:
PAM
II
lists
two
colorimetric
methods:
(
1)
Smith
and
Stone
(
Method
A),
and
(
2)
Lane,
et.
al.
(
Method
B).
Recovery
of
the
parent
acid
of
naptalam
sodium
using
FDA
PAM
I
protocols
A,
D,
and
E
is
unlikely.
FDA
has
not
reported
any
analyses
for
the
parent
acid
of
naptalam
sodium
from
1999
to
2002.

Tolerance
Reassessment:
Due
to
various
recent
changes
in
the
Agency
commodity
definitions,
the
Agency
is
revoking
the
current
tolerances
for
cantaloupe,
muskmelon,
and
watermelon.
Instead
of
these
three
commodities,
the
Agency
is
now
establishing
a
single
tolerance
for
the
Melon
subgroup
(
Crop
Group
9A).
In
addition,
the
"(
N)"
designation
for
negligible
residues,
as
listed
in
the
current
40
CFR
§
180.279
entries,
is
now
being
deleted
from
all
the
entries.

The
current
tolerance
expression
for
residues
is
expressed
at
40
CFR
180.297
as
"
established
for
residues
of
the
herbicide
N­
1­
naphthyl
phthalamic
acid
from
application
of
its
sodium
salt
in
or
on
the
following
raw
agricultural
commodities."
This
RED
has
reassessed
these
tolerances
and
has
determined
that
the
tolerances
should
now
be
expressed
as
in
Table
12.
25
Table
12.
The
reassessed
Tolerance
Summary
will
now
be
as
follows:
"
Residues
of
the
herbicide
Naptalam
Sodium,
as
established
for
residues
of
N­
1­
naphthyl
phthalamic
acid,
from
application
of
its
sodium
salt
in
or
on
the
following
raw
agricultural
commodities:"

Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comments
[
Correct
Commodity
Definition]

Tolerances
Listed
Under
40
CFR
§
180.297
Cantaloupe
0.1
(
N)
a
Revoke
While
this
tolerance
should
be
maintained
at
0.1
ppm,
based
on
available
field
trial
data
for
cantaloupe
that
indicate
all
measured
residues
of
naptalam
are
less
than
the
detection
limit
of
0.1
ppm,
the
Agency
determined
that
cantaloupe
should
be
combined
into
a
group
tolerance
at
0.1
ppm
for
Melon
Subgroup.

[
Melon
Subgroup,
Crop
Group
9A]

Cucumber
0.1
(
N)
0.1
Muskmelon
0.1
(
N)
Revoke
While
this
tolerance
should
be
maintained
at
0.1
ppm,
based
on
available
field
trial
data
for
surrogate
crops
(
cantaloupe
and
watermelon)
that
indicate
all
their
measured
residues
of
naptalam
are
less
than
the
detection
limit
of
0.1
ppm,
the
Agency
determined
that
muskmelon
should
be
combined
into
a
group
tolerance
at
0.1
ppm
for
Melon
Subgroup.

[
Melon
Subgroup,
Crop
Group
9A]

Watermelon
0.1
(
N)
Revoke
While
this
tolerance
should
be
maintained
at
0.1
ppm,
based
on
available
field
trial
data
for
watermelon
that
indicate
all
measured
residues
of
naptalam
are
less
than
the
detection
limit
of
0.1
ppm,

the
Agency
determined
that
cantaloupe
should
be
combined
into
a
group
tolerance
at
0.1
ppm
for
Melon
[
Melon
Subgroup,
Crop
Group
9A]

Melon
subgroup
(
Crop
Group
9A)
0.1
The
Agency
intends
to
establish
this
new
tolerance
with
the
concomitant
revocation
of
the
tolerances
for
Cantaloupe,

Muskmelon,
and
Watermelon.

a:
(
N)
=
Negligible
residue
There
are
no
established
Codex
maximum
residue
limits
(
MRLs)
or
tolerances
for
residues
of
naptalam.
Therefore,
international
harmonization
is
not
an
issue.

XIV.
References:

Environmental
Protection
Agency
(
EPA).
1994,1996.
Toxicological
Reviews
for
Naptalam,
Sodium
Salt.
TX0012040,
TX0011972,
TX0011936,
TX0010989,
TX0010741.

Environmental
Protection
Agency
(
EPA).
2004.
Toxicology
Overview:
Naptalam
and
Sodium
26
Naptalam.
Stephen
Dapson,
August
12,
2004.

Science
Advisory
Council
(
SAC)
for
Exposure
(
2000)
Policy
Memo
#
003.1:
Agricultural
Transfer
Coefficients
(
August
17,
2000).

Toxnet.
2004.
Hazardous
Substances
Data
Bank.
Sodium
N­
1­
Naphthylphthalamate.
National
Library
of
Medicine.
http://
www.
toxnet.
nlm.
nih.
gov/
cgi­
bin/
sis/
htmlgen?
HSDB.
27
Appendix
1.
BEAD
Screening
Level
Estimate
of
Agricultural
Uses
and
Other
Information
28
The
tables
below
contain
"
screening
level"
usage
data
for
agricultural
crops.
This
information
is
retrieved
from
our
principal
agricultural
pesticide
usage
databases.
At
the
present
time
data
from
1998
to
2002
is
being
used.

All
numbers
reported
are
rounded.
'<
500'
indicates
less
than
500
pounds
of
active
ingredient.
'<
2.5'
indicates
less
than
2.5
percent
of
crop
is
treated.

Maximum
percent
of
crop
treated
is
the
highest
observed
percent
crop
treated
during
this
time
period.
For
some
crops
there
may
have
been
only
one
or
two
observations
and
it
is
quite
possible
that
if
usage
information
had
been
available
for
more
years
that
higher
usage
might
have
been
observed.
This
situation
is
more
likely
to
occur
with
low
acreage
crops.

'(
CA
only)'
indicates
information
was
available
only
for
California.
California
requires
reporting
of
all
agricultural
pesticide
use.
Their
database
may
indicate
small
amounts
of
usage
of
a
pesticide
on
crops
on
which
the
pesticide
is
not
registered.
Possible
reasons
for
this
include:
­
This
use
may
actually
have
occurred
either
as
an
unregistered
use
or
as
an
experimental
or
other
use
in
which
the
crop
was
not
intended
for
consumption.
­
Data
input
errors
may
have
occurred
and
either
the
crop
or
the
pesticide
is
incorrect
in
the
database.

Use
of
the
chemical
on
crops
for
which
only
California
use
is
reported
may
possibly
have
occurred
in
other
states.

In
some
cases
the
percent
crop
treated
column
is
blank.
This
is
because
information
on
acres
grown
was
not
readily
available.

Some
of
the
numbers
may
be
based
on
information
that
does
not
cover
all
50
states.
Therefore,
it
is
possible
that
if
the
remaining
(
usually
minor
states
for
the
crop)
had
been
included
that
pounds
of
active
ingredient
would
be
slightly
higher.

Last
revised
by
BEAD:
Feb
06,
2004
29
SAS
Thursday,
September
9,
2004
15:
22
1
Screening
Level
Estimates
of
Agricultural
Uses
of
naptalam
Sorted
Alphabetically
OBS
Crop
Pounds
Percent
Crop
Treated
Active
Typical
Likely
Ingredients
Average
Maximum
1
Cantaloupes
3,000
<
1
5
2
Cucumbers
30,000
10
15
3
Pumpkins
2,000
<
1
5
4
Soybeans
80,000
<
1
<
2.5
5
Squash
1,000
<
1
<
2.5
6
Sweet
Corn
<
500
7
Watermelons
20,000
5
10
_____________________________________

All
numbers
rounded.
'<
500'
indicates
less
than
500
pounds
of
active
ingredient.
'<
2.5'
indicates
less
than
2.5
percent
of
crop
is
treated.
'(
CA
only)'
indicates
information
was
available
only
for
California.
Use
of
naptalam
on
this
crop
may
also
have
occurred
in
other
states.

(
slua0001.
sas
naptalam
)
30
SAS
Thursday,
September
9,
2004
15:
22
2
Screening
Level
Estimates
of
Agricultural
Uses
of
naptalam
Sorted
by
descending
quantity
of
naptalam
applied
to
each
crop
OBS
Crop
Pounds
Percent
Crop
Treated
Active
Typical
Likely
Ingredients
Average
Maximum
1
Soybeans
80,000
<
1
<
2.5
2
Cucumbers
30,000
10
15
3
Watermelons
20,000
5
10
4
Cantaloupes
3,000
<
1
5
5
Pumpkins
2,000
<
1
5
6
Squash
1,000
<
1
<
2.5
7
Sweet
Corn
<
500
______________________________________

All
numbers
rounded.
'<
500'
indicates
less
than
500
pounds
of
active
ingredient.
'<
2.5'
indicates
less
than
2.5
percent
of
crop
is
treated.
'(
CA
only)'
indicates
information
was
available
only
for
California.
Use
of
naptalam
on
this
crop
may
also
have
occurred
in
other
states.

(
slua0001.
sas
naptalam
)
31
SAS
Thursday,
September
9,
2004
15:
22
3
Screening
Level
Estimates
of
Agricultural
Uses
of
naptalam
Sorted
by
descending
percent
of
crop
treated
with
naptalam
OBS
Crop
Pounds
Percent
Crop
Treated
Active
Typical
Likely
Ingredients
Average
Maximum
1
Cucumbers
30,000
10
15
2
Watermelons
20,000
5
10
3
Soybeans
80,000
<
1
<
2.5
4
Cantaloupes
3,000
<
1
5
5
Pumpkins
2,000
<
1
5
6
Squash
1,000
<
1
<
2.5
7
Sweet
Corn
<
500
______________________________

All
numbers
rounded.
'<
500'
indicates
less
than
500
pounds
of
active
ingredient.
'<
2.5'
indicates
less
than
2.5
percent
of
crop
is
treated.
'(
CA
only)'
indicates
information
was
available
only
for
California.
Use
of
naptalam
on
this
crop
may
also
have
occurred
in
other
states.

(
slua0001.
sas
naptalam
)

Prepared
by:
BEAD
September
10,
2004
32
Appendix
2.
Naptalam
Sodium:
Chronic
Dietary
(
Food)
Exposure
Assessment
33
U.
S.
Environmental
Protection
Agency
Ver.
2.00
DEEM­
FCID
Chronic
analysis
for
NAPTALAM
(
1994­
98
data)

Residue
file
name:
H:\
Briefcase\
Chemistry
Reviews\
DEEM
Runs\
Naptalam.
R98
Adjustment
factor
#
2
NOT
used.

Analysis
Date
09­
27­
2004/
10:
18:
18
Residue
file
dated:
09­
27­
2004/
10:
17:
56/
8
Reference
dose
(
RfD,
Chronic)
=
25.8
mg/
kg
bw/
day
===============================================================================

Total
exposure
by
population
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­

U.
S.
Population
(
total)
0.000040
0.0%

U.
S.
Population
(
spring
season)
0.000044
0.0%

U.
S.
Population
(
summer
season)
0.000077
0.0%

U.
S.
Population
(
autumn
season)
0.000022
0.0%

U.
S.
Population
(
winter
season)
0.000015
0.0%

Northeast
region
0.000043
0.0%

Midwest
region
0.000037
0.0%

Southern
region
0.000033
0.0%

Western
region
0.000050
0.0%

Hispanics
0.000043
0.0%

Non­
hispanic
whites
0.000039
0.0%

Non­
hispanic
blacks
0.000027
0.0%

Non­
hisp/
non­
white/
non­
black
0.000084
0.0%

All
infants
(<
1
year)
0.000045
0.0%

Nursing
infants
0.000044
0.0%

Non­
nursing
infants
0.000046
0.0%

Children
1­
6
yrs
0.000077
0.0%

Children
7­
12
yrs
0.000051
0.0%

Females
13­
19
(
not
preg.
or
nursing)
0.000027
0.0%

Females
20+
(
not
preg.
or
nursing)
0.000038
0.0%

Females
13­
50
yrs
0.000035
0.0%

Females
13+
(
preg./
not
nursing)
0.000028
0.0%

Females
13+
(
nursing)
0.000073
0.0%

Males
13­
19
yrs
0.000038
0.0%

Males
20+
yrs
0.000030
0.0%

Seniors
55+
0.000045
0.0%

Children
1­
2
yrs
0.000072
0.0%
34
Children
3­
5
yrs
0.000083
0.0%

Children
6­
12
yrs
0.000054
0.0%

Youth
13­
19
yrs
0.000032
0.0%

Adults
20­
49
yrs
0.000029
0.0%

Adults
50+
yrs
0.000043
0.0%

Females
13­
49
yrs
0.000032
0.0%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
35
Appendix
3.
Details
Regarding
PHED,
ORETF
Studies,
and
Dislodgeable
Foliar
Residue
(
DFR)
Studies
36
Pesticide
Handler
Exposure
Database
(
PHED)
Version
1.1
(
August
1998):
PHED
was
designed
by
a
task
force
of
representatives
from
the
U.
S.
EPA,
Health
Canada,
the
California
Department
of
Pesticide
regulation,
and
member
companies
of
the
American
Crop
Protection
Association.
PHED
is
a
software
system
consisting
of
two
parts
­­
a
database
of
measured
exposure
values
for
workers
involved
in
the
handling
of
pesticides
under
actual
field
conditions
and
a
set
of
computer
algorithms
used
to
subset
and
statistically
summarize
the
selected
data.
Currently,
the
database
contains
values
for
over
1,700
monitored
individuals
(
i.
e.,
replicates)

Users
select
criteria
to
subset
the
PHED
database
to
reflect
the
exposure
scenario
being
evaluated.
The
subsetting
algorithms
in
PHED
are
based
on
the
central
assumption
that
the
magnitude
of
handler
exposures
to
pesticides
are
primarily
a
function
of
activity
(
e.
g.,
mixing/
loading,
applying),
formulation
type
(
e.
g.,
wettable
powders,
granulars),
application
method
(
e.
g.,
aerial,
groundboom),
and
clothing
scenarios
(
e.
g.,
gloves,
double
layer
clothing).

Once
the
data
for
a
given
exposure
scenario
have
been
selected,
the
data
are
normalized
(
i.
e.,
divided
by)
by
the
amount
of
pesticide
handled
resulting
in
standard
unit
exposures
(
milligrams
of
exposure
per
pound
of
active
ingredient
handled).
Following
normalization,
the
data
are
statistically
summarized.
The
distribution
of
exposure
values
for
each
body
part
(
e.
g.,
chest
upper
arm)
is
categorized
as
normal,
lognormal,
or
"
other"
(
i.
e.,
neither
normal
nor
lognormal).
A
central
tendency
value
is
then
selected
from
the
distribution
of
the
exposure
values
for
each
body
part.
These
values
are
the
arithmetic
mean
for
normal
distributions,
the
geometric
mean
for
lognormal
distributions,
and
the
median
for
all
"
other"
distributions.
Once
selected,
the
central
tendency
values
for
each
body
part
are
composited
into
a
"
best
fit"
exposure
value
representing
the
entire
body.

The
unit
exposure
values
calculated
by
PHED
generally
range
from
the
geometric
mean
to
the
median
of
the
selected
data
set.
To
add
consistency
and
quality
control
to
the
values
produced
from
this
system,
the
PHED
Task
Force
has
evaluated
all
data
within
the
system
and
has
developed
a
set
of
grading
criteria
to
characterize
the
quality
of
the
original
study
data.
The
assessment
of
data
quality
is
based
on
the
number
of
observations
and
the
available
quality
control
data.
These
evaluation
criteria
and
the
caveats
specific
to
each
exposure
scenario
are
summarized
in
Appendix
A,
Table
A1.
While
data
from
PHED
provide
the
best
available
information
on
handler
exposures,
it
should
be
noted
that
some
aspects
of
the
included
studies
(
e.
g.,
duration,
acres
treated,
pounds
of
active
ingredient
handled)
may
not
accurately
represent
labeled
uses
in
all
cases.
HED
has
developed
a
series
of
tables
of
standard
unit
exposure
values
for
many
occupational
scenarios
that
can
be
utilized
to
ensure
consistency
in
exposure
assessments.
Unit
exposures
are
used
which
represent
different
levels
of
personal
protection
as
described
above.
Protection
factors
were
used
to
calculate
unit
exposure
values
for
varying
levels
of
personal
protection
if
data
were
not
available.

ORETF
Handler
Studies
(
MRID
449722­
01):
A
report
was
submitted
by
the
ORETF
(
Outdoor
Residential
Exposure
Task
Force)
that
presented
data
in
which
the
application
of
various
products
used
on
turf
by
homeowners
and
lawncare
operators
(
LCOs)
was
monitored.
All
of
the
data
submitted
in
this
report
were
completed
in
a
series
of
studies.
The
study
that
monitored
LCO
exposure
scenarios
using
a
low
pressure,
high
volume
turf
handgun
(
ORETF
Study
OMA002)
is
summarized
below.
37
LCO
Handgun
Sprayer:
A
mixer/
loader/
applicator
study
was
performed
by
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
using
Dacthal
as
a
surrogate
compound
to
determine
"
generic"
exposures
to
individuals
applying
a
pesticide
to
turf
with
a
low­
pressure
"
nozzle
gun"
or
"
handgun"
sprayer.
Dermal
and
inhalation
exposures
were
estimated
using
whole­
body
passive
dosimeters
and
breathing­
zone
air
samples
on
OVS
tubes.
Inhalation
exposure
was
calculated
using
an
assumed
respiratory
rate
of
17
liters
per
minute
for
light
work
(
NAFTA,
1999),
the
actual
sampling
time
for
each
individual,
and
the
pump
flow
rate.
All
results
were
normalized
for
pounds
active
ingredient
handled.
A
total
of
90
replicates
were
monitored
using
17
different
subjects.
Four
different
formulations
of
dacthal
[
75%
wettable
powder
(
packaged
in
4
and
24
pound
bags),
75%
wettable
powder
in
water
soluble
bags
(
3
pound
bag),
75%
water
dispersable
granules
(
2
pound
bag)
and
55%
liquid
flowable
(
2.5
gallon
container)]
were
applied
by
five
different
LCOs
to
actual
residential
lawns
at
each
site
in
three
different
locations
(
Ohio,
Maryland,
and
Georgia)
for
a
total
of
fifteen
replicates
per
formulation.
An
additional
ten
replicates
at
each
site
were
monitored
while
they
performed
spray
application
using
only
the
75
percent
wettable
powder
formulation.
A
target
application
rate
of
2
pounds
active
ingredient
was
used
for
all
replicates
(
actual
rate
achieved
was
about
2.2
pounds
active
ingredient
per
acre).
Each
replicate
treated
a
varying
number
of
actual
client
lawns
to
attain
a
representative
target
of
2.5
acres
(
1
hectare)
of
turf.
The
exposure
periods
averaged
five
hours
twenty­
one
minutes,
five
hours
thirtynine
minutes,
and
six
hours
twenty­
four
minutes,
in
Ohio,
Maryland
and
Georgia,
respectively.
Average
time
spent
spraying
at
all
sites
was
about
two
hours.
All
mixing,
loading,
application,
adjusting,
calibrating,
and
spill
clean
up
procedures
were
monitored,
except
for
typical
end­
of­
day
clean­
up
activities,
e.
g.
rinsing
of
spray
tank,
etc.
Dermal
exposure
was
measured
using
inner
and
outer
whole
body
dosimeters,
hand
washes,
face/
neck
washes,
and
personal
air
monitoring
devices.
All
test
subjects
wore
one­
piece,
100
percent
cotton
inner
dosimeters
beneath
100
percent
cotton
long­
sleeved
shirt
and
long
pants,
rubber
boots
and
nitrile
gloves.
Gloves
are
typically
worn
by
most
LCOs,
and
required
by
many
pesticide
labels
for
mixing
and
loading.
Overall,
residues
were
highest
on
the
upper
and
lower
leg
portions
of
the
dosimeters
In
general,
concurrent
lab
spikes
produced
mean
recoveries
in
the
range
of
78­
120
percent,
with
the
exception
of
OVS
sorbent
tube
sections
which
produced
mean
recoveries
as
low
as
65.8
percent.
Adjustment
for
recoveries
from
field
fortifications
were
performed
on
each
dosimeter
section
or
sample
matrix
for
each
study
participant,
using
the
mean
recovery
for
the
closest
field
spike
level
for
each
matrix
and
correcting
the
value
to
100
percent.
The
unit
exposures
are
presented
below.
[
Note
the
data
were
found
to
be
lognormally
distributed.
As
a
result,
all
exposures
are
geometric
means.]
38