Document ID: EPA-HQ-OPP-2006-0503-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-06-14T04:00Z

FILE
NAME:
company.
wpt
(
7/
1/
2004)

ATTENTION:
All
commodity
terms
must
comply
with
the
Food
and
Feed
Commodity
Vocabulary
database
(
http://
www.
epa.
gov/
pesticides/
foodfeed/).

COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
7/
1/
2004)

EPA
Registration
Division
contact:
James
A.
Tompkins
703­
305­
5697
.

INSTRUCTIONS:
Please
utilize
this
outline
in
preparing
tolerance
petition
documents.
In
cases
where
the
outline
element
does
not
apply
please
insert
"
NA­
Remove"
and
maintain
the
outline.
The
comment
notes
that
appear
on
the
left
margin
represent
hidden
typesetting
codes
designed
to
expedite
the
processing
of
the
Federal
Register
document.
Please
do
not
remove
or
alter
these
comment
notes
or
change
the
margins,
font,
or
format
in
your
document.
Simply
replace
the
instructions
that
appear
in
italics
and
brackets,
i.
e.,
"[
insert
company
name],"
with
the
information
specific
to
your
action.

[
PP#­­­­]

Summary
of
Petitions
EPA
has
received
a
pesticide
petition
([
pp#­­­­­­])
from
[
Interregional
Research
Project
Number
4
(
IR­
4)],
[
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902­
3390]
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180.

Options
(
pick
one)

1.
by
establishing
a
tolerance
for
residues
of
the
combined
residues
of
the
herbicide
[
N­(
1­
ethylpropyl)­
3,4­
dimethyl­
2,6dinitrobenzenamine,
(
pendimethalin)
and
its
3,5­
dinitrobenzyl
alcohol
metabolite
(
CL
202347)]
in
or
on
the
raw
agricultural
commodities
[
Strawberries]
at
[
0.05]
parts
per
million
(
ppm)
and
[
Crop
Group
Bulb
Vegetables
to
include
Green
Onions,
Leeks,
Spring
Onions
or
Scallions,
Japense
Bunching
Onions,
Green
Shallots,
and
Green
Eschalots]
at
[
0.1]
ppm.
EPA
has
determined
that
the
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
2
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
This
summary
has
been
prepared
by
BASF
Corporation,
Research
Triangle
Park,
NC
27709.

These
individual
summaries
are
printed
below
as
they
were
received
from
the
petitioner.

A.
Residue
Chemistry
1.
Plant
metabolism.
[
The
qualitative
nature
of
the
resideues
of
pendimethalin
in
plants
is
understood
based
on
adequate
studies
conducted
with
14
C
pendimethalin
on
various
crops.
Pendimethalin
and
its
3,5­
dinitrobenzyl
alcohol
metabolite
(
CL202347)
are
the
residues
of
concern.]

2.
Analytical
method.
[
Section
408
(
b)(
3)
of
the
amended
FDCA
requires
EPA
to
determine
that
there
is
a
practical
method
for
Detecting
and
measuring
levels
of
the
pesticide
chemical
residue
in
or
on
food
and
the
tolerance
be
set
at
a
level
at
or
above
of
the
limit
of
detection
of
the
designated
method.
In
plants
the
method
is
aqueous
organic
solvent
extraction,
column
clean
up,
and
quantitation
by
GC.
The
method
has
a
limit
of
quantitation
(
LOQ)
of
0.05
ppm
for
pendimethalin
and
the
alcohol
metabolite.]

3.
Magnitude
of
residues.
[
Field
trials
were
carried
out
in
order
to
determine
the
magnitude
of
residues
in
the
following
crops:
Strawberries
and
Green
Onion.
[
EPA
has
determined
that
the
petitions
contain
data
or
information
regarding
each
crop.
Field
trials
were
conducted
in
the
required
regions.
Field
trials
were
carried
out
using
maximum
label
rate
and
shortest
PHI.]
In
addition,
processing
studies
were
conducted
to
determine
the
following
concentration
factors
during
normal
processing
of
the
raw
agricultural
commodity
into
the
processed
commodities:
tomato
paste
and
puree,
citrus
dried
pulp,
oil,
and
juice,
apple
pomace
and
juice,
dried
stone
fruit
(
prune),
and
mint
oil.]

B.
Toxicological
Profile
of
Pendimethalin
The
following
mammalian
toxicological
studies
have
been
conducted
to
support
the
approved
and
proposed
pendimethalin
tolerances.

1.
Acute
toxicity.
[
Pendimethalin
technical
demonstrates
low
acute
toxicity
via
the
oral,
dermal,
and
inhalation
routes
of
exposure.
The
acute
toxicity
studies
place
technical
3
pendimethalin
in
toxicity
category
III
for
the
acute
oral,
category
IV
for
acute
dermal,
and
category
IV
for
acute
inhalation.
Technical
pendimethalin
is
category
IV
for
skin
irritation
and
category
III
for
eye
irritation.
Pendimethalin
did
not
cause
skin
sensitization
in
guinea
pigs.
Two
formulated
end
use
products
are
registered
for
use
on
crops,
an
Emulsifiable
Concentrate
(
EC)
and
an
Encapsulated
Suspension
(
CS).
The
EC
has
an
acute
oral
category
of
III,
acute
dermal
category
of
III,
an
acute
inhalation
category
of
III,
eye
and
skin
irritation
of
III,
and
is
not
a
dermal
sensitizer.
The
CS
has
an
acute
oral
category
of
IV,
and
acute
dermal
category
of
IV,
and
acute
inhalation
category
of
IV,
eye
and
skin
irritation
category
of
IV,
and
is
not
a
dermal
sensitizer.]

2.
Genotoxicty.
[
Extensive
mutagenicity
studies
conducted
to
investigate
point
and
gene
mutations,
DNA
damage
and
chromosomal
aberration,
both
using
vitro
and
in
vivo
test
systems
demonstrate
pendimethalin
to
be
non­
genotoxic.]

3.
Reproductive
and
developmental
toxicity.
[
Pendimethalin
(
BAS
455
H)
is
not
selective
developmental
toxicant.
There
is
no
indication
of
increased
susceptibility
following
prenatal/
postnatal
exposure
to
pendimethalin.

In
a
developmental
(
teratology)
toxicity
study
in
the
rat,
the
results
demonstrated
that
the
NOAELs
for
both
maternal
toxicity
and
fetal
(
prenatal)/
developmental
toxicity
were
500
mg/
kg
b.
w./
day
(
highest
dose
tested)
(
HDT).
In
addition,
there
were
no
indications
of
any
teratogenic
effects
in
the
rat
fetuses
at
500
mg/
kg
b.
w./
day
(
HDT).
Therefore,
pendimethalin
is
considered
to
be
neither
a
developmental
toxicant
nor
a
teratogenic
agent
in
the
rat.

In
a
developmental
(
teratology)
toxicity
study
in
the
rabbit,
the
results
demonstrated
the
NOAEL
for
maternal
toxicity
was
30
mg/
kg
b.
w./
day,
based
on
increased
clinical
signs
of
toxicity
and
decreased
body
weight
gain
during
the
treatment
period
at
60
mg/
kg
b.
w./
day
(
HDT).
The
NOAEL
for
fetal
(
prenatal)/
developmental
toxicity
was
60
mg/
kg/
b.
w./
day
(
HDT).
In
addition,
there
were
no
indications
of
any
teratogenic
effects
in
the
rabbit
fetuses
at
60
mg/
kg
b.
w./
day.
Therefore,
pendimethalin
is
considered
to
be
neither
a
developmental
toxicant
nor
a
teratogenic
agent
in
the
rabbit.

A
two­
generation
reproductive
toxicity
study
in
the
rat
demonstrated
an
absence
of
increased
sensitivity
for
the
developing
offspring
to
pendimethalin.
The
NOAEL
for
parental
toxicity
was
500
ppm
(
approximately
38.5
mg/
kg
b.
w./
day),
based
on
reduced
food
consumption
and
decreased
body
weight/
weight
gain
at
2500
ppm
(
mid­
dietary
concentration).
The
NOAEL
for
pup/
offspring
toxicity
was
also
500
ppm,
based
on
decreased
pup
body
weight
gain
at
2500
ppm.
Lastly,
the
NOAEL
for
reproductive
toxicity
was
2500
ppm
(
approximately
194
mg/
kg
b.
w./
day),
based
on
reduced
mean
live
litter
size
at
5000
ppm
(
highest
concentration
tested)
(
HCT).
These
reductions
in
mean
live
litter
size
and
pup
body
weight
gain
were
only
observed
at
dietary
concentrations
that
were
parentally
toxic.
As
such,
there
is
no
evidence
that
prenatal
4
or
postnatal
exposure
to
pendimethalin
results
in
an
increased
sensitivity
to
developing
offspring.

4.
Subchronic
toxicity.
[
Subchronic
(
90­
day)
feeding
studies
were
conducted
in
rats
and
dogs.
For
the
rat,
the
NOAEL
for
systemic
toxicity
was
500
ppm
(
41
mg/
kg
b.
w./
day),
based
on
slightly
decreased
body
weight,
increased
absolute
and
relative
liver
weights,
and
liver
histopathology
(
hepatocellular
hypertrophy)
in
males
and
females
at
5000
ppm
(
HCT).
For
the
dog,
the
NOAEL
for
systemic
toxicity
was
2500
ppm
(
62.5
mg/
kg
b.
w./
day),
based
on
decreased
body
weight
at
10000
ppm
(
250
mg/
kg
b.
w./
day).]

5.
Chronic
toxicity.
[
The
chronic
Reference
Dose
(
Rfd)
was
established
based
on
the
results
of
subchronic
special
studies
demonstrating
the
thyroid
hormone
related
endpoint
in
rats.
The
NOAEL
of
10
mg/
kg
b.
w./
day
was
established
from
the
collective
results
of
the
subchronic
oral
92­
day
thyroid
function
study,
the
subchronic
oral
56­
day
thyroid
function
study,
and
the
14­
day
intrathyroidal
metabolism
study.
A
LOAEL
of
31
mg/
kg
b.
w./
day
was
based
on
homonal
and
histopathological
changes
in
the
thyroid
gland.
The
chronic
RfD
was
calculated
to
be
0.10
mg/
kg
b.
w./
day
using
an
Uncertainty
Factor
(
UF)
of
100X
(
10X
for
interspecies
extrapolation
and
10X
for
intraspecies
variability).

Chronic
toxicity
studies
were
conducted
in
rats,
mice,
and
dogs.
For
the
2­
year
rat
feeding
study,
the
NOAEL
for
systemic
toxicity
was
500
ppm
(
25
mg/
kg
b.
w./
day),
based
on
decreased
body
weight
gain
(
approximately
20­
30%),
increased
clinical
signs
of
toxicity,
increased
relative
liver
weights,
and
slight
but
statistical
increase
in
the
incidence
of
benign
follicular
cell
adenomas
of
the
thyroid
gland
in
males
and
females
at
5000
ppm
(
250
mg/
kg
b.
w./
day)
(
HCT).
For
the
18­
month
mouse
feeding
study,
the
NOAEL
for
systemic
toxicity
was
500
ppm
(
75
mg/
kg
b.
w./
day),
based
on
slightly
decreased
mean
body
weights
and
reduced
survival
at
5000
ppm
(
750
mg/
kg
b.
w./
day)
(
HCT).
There
were
no
oncogenic
effects
up
to
5000
ppm
(
750
mg/
kg
b.
w./
day)
(
HCT).
Lastly,
for
the
1­
year
oral
(
via
gelatin
capsules)
chronic
dog
study,
the
NOAEL
for
systemic
toxicity
was
200
mg/
kg
b.
w./
day,
the
highest
dose
tested.

[
Pendimethalin
has
been
classified
as
a
Group
C
"
possible
human
carcinogen,"
based
on
a
statistically
significantly
increased
incidence
of
benign
follicular
cell
adenomas
of
the
thryroid
gland
in
male
and
female
rats
at
5000
ppm
(
250
mg/
kg
b.
w./
day)
(
highest
concentration
tested).
For
risk
assessment,
OPP
recommends
using
the
RfD
(
non­
linear)
approach
for
quantification
of
human
risk.
The
Agency
Committee
has
determined
that
the
hypothesis,
that
benign
thyroid
tumors
associated
with
pendimethalin
are
due
to
a
thyroid­
pituitary
imbalance,
can
be
supported.
Finally,
pendimethalins's
mechanism
of
threshold
oncogenic
activity
only
occurs
at
high
doses
in
rats,
a
mammalian
species
that
is
5
expected
to
be
much
more
sensitive
than
humans
to
the
indcution
of
thyroid
tumors
via
conditions
which
result
in
hypothyroidism.]

6.
Animal
metabolism.
[
In
the
rat,
pendimethalin
is
metabolized
mainly
through
oxidation
of
the
4­
methyl
group
attached
to
the
benzene
ring
as
well
as
oxidation
of
the
alkyl
side
chain
of
the
N­
substituted
dinitroaniline
compound.
When
C14­
pendimethalin
is
administered
to
rates,
about
70%
of
the
radioactivity
is
excreted
in
feces
and
20%
is
in
the
urine
within
24
hours.
Within
96
hours,
the
radioactivity
found
in
the
tissues
was
0.3
ppm
or
less,
except
fat
which
is
0.9
ppm.
The
major
portion
of
the
radioactivity
that
was
excreted
in
the
feces
was
identified
as
the
parent
compound.

Although
not
relevant
to
this
petition,
adequate
goat
and
poultry
metabolism
studies
are
available
for
pendimethalin.
The
Agency
has
determined
that
there
is
no
reasonable
expectation
of
finite
pendimethalin
residues
of
concern
in
animal
commodities
as
a
result
of
use
on
multiple
crops
and
no
tolerances
for
pendimethalin
residues
of
concern
in
livestock
commodities
are
needed.]

7.
Metabolite
toxicology.
[
Pendimethalin
has
no
metabolites
of
toxicological
concern
that
are
not
accounted
for
in
the
tolerance
expression.
In
most
cases,
a
tolerance
is
the
combined
residues
of
pendimethalin
N­(
1­
ethylpropyl)­
3,
4­
dimethyl­
2,
6­
dinitrobenzenamine
and
its
3,5­
dinitrobenzyl
alcohol
metabolite,
4­[(
1­
ethylpropyl)
amino]­
2­
methyl­
3,
5­
dinitrobenzyl
alcohol.
In
peanut
hulls,
an
additional
2,4­
dinitrobezyl
alcohol
metabolite,
3­[(
1­
ethylpropyl)
amino]­
6­
methyl­
2,4­
dinitrobenzyl
alcohol,
occurs.
Since
these
metabolites
are
found
in
the
rat
metabolism
study,
they
are
not
considered
of
toxicological
concern.]

8.
Endocrine
disruption.
[
It
is
known
that
pendimethalin
affects
the
hypothalamuspituitary
thyroid
axis.
However,
as
the
chronic
RfD
(
0.10
mg/
kg
b.
w./
day)
is
based
on
the
thyroid
hormone
related
endpoint
in
rats,
as
noted
in
the
subchronic
special
studies
in
Section
5
above,
which
additionally
demonstrated
reversibility
of
the
thyroid
effects
in
the
oral
56­
day
thyroid
function
study,
these
effects
are
already
taken
into
consideration
in
the
characterization
of
potential
risks
to
humans.]

C.
Aggregate
Exposure
Pendimethalin
is
widely
used
as
a
pre­
emergent
herbicide
to
control
broadleaf
weeds
in
both
food
and
non­
food
crops,
as
well
as
non­
agricultural
use
sites
including
residential
lawns.
In
examining
aggregate
exposure,
FQPA
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
(
dietary)
and
all
other
non
6
occupational
exposures.
The
primay
non­
food
sources
of
exposure
are
through
pesticides
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).
The
potential
for
aggregate
exposure
from
all
registered
and
proposed
uses
is
discussed
below:

1.
Dietary
exposure.
[
An
assessment
was
conducted
to
evaluate
the
potential
risk
due
to
chronic
dietary
exposure
of
the
U.
S.
Population
to
residues
of
pendimethalin
(
BAS
455
H).
Tolerance
values
have
previously
been
established
for
lima
beans,
corn,
cottonseed,
dry
bulb
onions,
succulent
peas,
peanuts,
potatoes,
rice,
sorghum,
soybeans,
sugarcane,
sunflower
seeds,
and
garlic
and
are
listed
in
the
U.
S.
40
CFR
§
180.361.

This
analysis
included
the
crops
with
established
tolerance
values
and
proposed
crop
tolerances
for
wheat,
carrots,
mint,
green
onions,
strawberry,
pomegranate,
stone
fruit,
pome
fruit
plus
Juneberry,
fruiting
vegetables,
citrus,
and
tree
nuts
including
pistachios.

i.
Food.
[
An
acute
assessment
was
not
needed
since
the
U.
S.
EPA
Toxicological
Endpoint
Selection
(
TES)
Committee
had
previously
evaluated
the
pendimethalin
toxicity
data
and
determined
there
was
no
revelant
toxicologic
endpoints
for
acute
dietary
exposure
and
that
a
risk
assessment
was
not
required.

The
chronic
dietary
exposure
estimates
were
based
on
established
and
proposed
tolerance
values,
percent
crop
treated
(
CT)
values
for
the
crops
with
established
tolerances,
100%
CT
values
for
pending
and
proposed
crops.
A
process
factor
of
1
was
used
with
consumption
data
from
the
USDA
Continuing
Survey
of
Food
Intake
by
Individuals
(
CSFII
1994
­
1996,
1998).
The
EPA
Food
Commodity
Ingredient
Database
(
FCID)
was
also
used
in
Exponent's
Dietary
Exposure
Evaluation
Module
(
DEEM­
FCID)
software.
Secondary
residues
were
not
included
for
meat,
milk,
eggs,
and
poultry
since
it
has
been
determined
that
there
is
no
likelihood
of
residues
in
these
animal
commodities
and
therefore,
tolerance
have
not
been
required
by
the
EPA.

Dietary
exposure
estimates
were
compared
against
the
worst­
case
pendimethalin
chronic
Population
Adjusted
Dose
(
cPAD)
of
0.1
mg/
kg
b.
w./
day
for
the
general
population.
Results
of
the
chronic
dietary
assessments
are
listed
in
the
table
below.
The
estimated
chronic
dietary
exposure
from
crops
(
both
established
and
proposed
tolerances)
was
less
than
2.1
%
of
the
cPAD
for
all
subpopulations.
Additional
refinements
such
as
the
use
of
anticipated
residues
would
further
reduce
the
estimated
chronic
dietary
exposure.
The
results
in
the
Table
below
demonstrate
that
there
are
no
safety
concerns
for
any
subpopulation
based
on
established
and
new
uses,
and
that
the
results
clearly
meet
the
FQPA
standard
of
reasonable
certainty
of
no
harm.
7
Table
1.
Summary
of
Chronic
Dietary
Exposure
Assessment
considering
crops
with
established
and
proposed
tolerances
for
pendimethalin.
Population
Subgroups
Exposure
Estimate
(
mg/
kg
b.
w./
day)
%
cPAD
U.
S.
Population
0.000663
0.68
All
Infants
0.001302
1.32
1­
2
years
0.002056
2.04
3­
5
years
0.001615
1.6
1­
6
years
0.001714
1.72
6­
12
years
0.000984
1.00
13­
19
years
0.00058
0.60
Females
13­
49
years
0.000496
0.48
Adults
20­
49
years
0.00049
0.48
Males
20+
years
0.00049
0.48
Adults
50+
years
0.000485
0.48
%
cPAD
=
percent
of
chronic
population
adjusted
dose
Exposure
estimates
based
on
tolerance
values,
percent
crop
treated
values
for
established
crop
tolerances,
100%
CT
for
crops
with
proposed
tolerances
ii.
Drinking
water.
[
There
are
no
established
maximum
contaminant
levels
or
health
advisory
levels
for
residues
of
pendimethalin
(
BAS
455
H)
in
drinking
water.
A
tier
II
drinking
water
modeling
assessment
for
pendimethalin
using
the
PRZM/
EXAMS
model
(
for
surface
water)
and
SCI­
GROW
(
for
ground
water)
produced
estimated
maximum
chronic
concentrations
of
22
ppb
for
surface
water,
and
0.0557
ppb
for
ground
water.
PRZM/
EXAMS
model
(
for
surface
water)
and
SCI­
GROW
(
for
ground
water)
produced
estimated
maximum
acute
concentrations
of
37.6
ppb
for
surface
water,
and
0.0557
ppb
for
ground
water.
Both
the
ground
water
and
surface
water
estimates
were
based
on
the
onion
label
(
2
lb
ai/
a
x
3
apps)
and
model
scenario
since
it
produced
the
greatest
predicted
environmental
concentration
of
any
use
pattern.

D.
Cumulative
Effects
8
[
The
Agency
has
not
yet
published
guidelines
to
determine
whether
pendimethalin
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
pendimethalin
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
it
is
assumed
that
pendimethalin
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.]

E.
Safety
Determination
1.
U.
S.
population.
/
2.
Infants
and
children
[
The
systemic
exposure
from
the
use
of
pendimethalin
on
residential
turf
was
calculated
following
the
current
EPA
Standard
Operating
Procedures
(
SOPs)
for
residential
exposure
assessment
(
EPA
1997b;
EPA
1999a),
as
revised
by
EPA
Policy
12
(
EPA,
2001),
and
using
the
Residential
Exposure
Assessment
Spreadsheet
Tool
(
REx),
Version
4.0G.

The
following
table
provides
the
route
specific
and
aggregate
exposure
assessment
results
for
each
population
subgroup,
along
with
the
percentage
of
the
cPAD
(
0.1
mg
kg
BW/
day)
utilized,
and
MOE
(
NOAEL/
Aggregate
systemic
Exposure).
.

Table
2.
Summary
of
Residential
Exposure
including
the
route
specific
and
aggregate
exposure
assessment
results
for
each
population
subgroup.

Population
subgroup
Route
of
Exposure
Route
Specific
Systemic
Exposure
(
mg/
kg
BW/
day)
Aggregate
Systemic
Exposure
(
mg/
kg
BW/
day)
1
%
cPAD
MOE
Adult
(
20­
49)
Post­
application
dermal
0.00655
0.00655
6.4
1527
Female
(
13­
49)
Post­
application
dermal
0.00764
0.00764
7.6
1309
Child
(
1­
6)
Post­
application
dermal
0.0110
0.0121
12.0
826
Post­
application
(
Hand
to
Mouth
ingestion)
0.00119
Child
(<
1)
Post­
application
dermal
0.0164
0.0182
18.4
549
Post­
application
(
Hand
to
Mouth
ingestion)
0.00178
1
Based
3%
dermal
absorption
9
2.
Acute
Aggregate
Exposure
and
Risk
(
Food
and
water)

Since
the
U.
S.
EPA
Toxicological
Endpoint
Selection
(
TES)
Committees
has
evaluated
the
pendimethalin
toxicity
data
and
determined
there
was
no
relevant
toxicologic
endpoint
for
acute
dietary
exposure,
the
determination
of
an
acute
aggregate
exposure
and
risk
evaluation
was
not
required.

3.
Short­
Term
Aggregate
Exposure
and
Risk
(
Food,
Water
and
Residential
Exposure)

Table
3.
Summary
of
Aggregate
Short­
Term
Risk
for
Pendimethalin.

Population
Subgroup
Chronic
Food
Exposure
(
mg/
kg/
day
Residential
Exposure
(
mg/
kg/
day)
2
Aggregate
MOE
(
food
and
residential)
Maximum
Allowable
Water
Exposure
(
mg/
kg/
b.
w./
day)
1
DWLOC
(
ug/
L)
Sci­
Grow
ground
water
(
ug/
L)
3
PRZM/
EXAMS
surface
water
(
ug/
L)
3,4
Infants
(
0­
1year)
0.001302
0.0182
512.8
0.080498
2817.4
0.0557
22
Children
(
1­
6
years)
0.001714
0.0121
723.9
0.086186
3016.5
Adult
Females
(
13­
49)
0.000496
0.00764
1229.1
0.091864
3215.2
Adult
Males
(
20­
49)
0.00049
0.00655
1420.5
0.092960
3253.6
1
NOAEL
=
10
mg/
kg
bw/
day.
Safety
Factor
=
100,
Max
allowable
dose
=
0.1
mg/
kg
bw/
day,
Max
allowable
water
exposure
=
0.1
mg/
kg
bw/
day
 
(
food
+
residential
exposure)
2
Dermal
adsorption
of
3%
used
3
Using
EFED
selected
input
parameters
4
Based
on
worst
case
label
­
CA
onion
scenario
of
2
lb
ai/
a
x
3
apps
The
results
in
the
summary
table
of
aggregate
short­
term
risk
demonstrate
that
there
are
no
safety
concerns
for
any
subpopulation
based
on
established
and
new
uses,
and
that
the
results
clearly
meet
the
FQPA
standard
of
reasonable
certainty
of
no
harm.

In
summary,
we
can
conclude
with
reasonable
certainty
that
no
harm
will
occur
from
short­
term
aggregate
exposure
of
pendimethalin
residues.
10
4.
Chronic
Aggregate
Exposure
and
Risk
(
food
and
water)

Table
4.
Summary
of
chronic
drinking
water
levels
of
comparison
for
pendimethalin
Population
Subgroup
Chronic
Food
Exposure
(
mg/
kg/
day
cPAD1
Maximum
Allowable
Water
Exposure
(
mg/
kg/
b.
w./
day)
DWLOC
(
ug/
L)
Sci­
Grow
2
ground
water
(
ug/
L)
PRZM/
EXAMS
2,3
surface
water
(
ug/
L)

Infants
(
0­
1year)
0.001302
0.1
0.09870
987
0.0557
22
Children
(
1­
2
years)
1
0.002056
0.1
0.09794
979
Children
(
1­
6
years)
0.001714
0.1
0.09829
983
Adult
Females
(
13­
49)
0.000496
0.1
0.09950
2985
Adult
Males
(
20­
49)
0.00049
0.1
0.09951
3483
US
Population
0.000663
0.1
0.09934
993
1
Inter/
inter
species
safety
factor
=
100
FQPA
safety
factor
=
1,
NOAEL
=
10
mg/
kg
bw/
day
2
Using
EFED
selected
input
parameters
and
worst
case
label
of
2
lb
ai/
a
x
3
apps
3
CA
onion
scenario
The
results
in
the
summary
table
of
chronic
drinking
water
levels
of
comparsion
demonstrate
that
there
are
no
safety
concerns
for
any
subpopulation
based
on
established
and
new
uses,
and
that
the
results
clearly
meet
the
FQPA
standard
of
reasonable
certainty
of
no
harm.
In
summary,
we
can
conclude
with
reasonable
certainty
that
no
harm
will
occur
from
chronic
aggregate
exposure
of
pendimethalin
residues.

Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead,
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
points
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
A
DWLOC
is
a
theoretical
upper
limit
on
a
pesticide's
concentration
in
drinking
water
which
considers
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
through
residential
uses.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
body
weights,
and
pesticide
uses.

Different
populations
will
have
different
DWLOCs.
If
the
DWLOC
is
greater
than
the
model
water
concentrations,
the
EPA
concludes
that
exposure
from
drinking
water
is
11
not
a
risk
issue.
The
modeled
water
concentration
is
obtained
from
PRZM/
EXAMS
model
for
surface
water
and
SCIGROW
for
groundwater.
The
values
used
for
comparison
the
DWLOC
are
the
maximum
concentrations
for
any
use.

Based
on
these
risk
assessments,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
to
infants
and
children,
or
any
subpopulation
from
aggregate
exposure
to
pendimethalin
residues.

Other
considerations
The
nature
of
the
residue
in
plants
is
adequately
understood.
The
regulatory
residue
in
plant
commodities
is
pendimethalin
and
its
3,5­
dinitrobenzyl
alcohol
metabolite
(
CL
202347),
as
per
40
CFR
180.361(
a).
Adequate
enforcement
methodology,
GC/
ECD,
is
available
in
the
Pesticide
Analytical
Manual,
Vol.
II,
to
enforce
the
tolerance
expression.

F.
International
Tolerances
[
There
are
no
CODEX,
Canadian
or
Mexican
International
Maximum
Residue
Levels
(
MRL's)
established
for
residues
of
pendimethalin
in
these
crops
at
this
time.]