Document ID: EPA-HQ-OPP-2006-0489-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-06-14T04:00Z

FILE
NAME:
company.
wpt
(
1/
1/
2005)
(
xml)
Template
Number
P25
Pendimethalin:
fruiting
vegetables,
Pome
fruit,
juneberry,
Stone
fruit,
pomegranate;
May
2006
ATTENTION:

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

All
text
in
blue
font
(
instructions
for
preparing
the
document),
should
be
removed
prior
to
sending
the
document
to
the
Federal
Register
Staff.
Instructional
text
and
prompts
in
green
font
should
also
be
removed.

COMPANY
FEDERAL
REGISTER
DOCUMENT
SUBMISSION
TEMPLATE
(
1/
1/
2005)

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

[
BASF
Corporation]

[
0E6175,
2E6450,
2E6464,
2E6449]
EPA
has
received
pesticide
petitions
([
0E6175,
2E6450,
2E6464,
and
2E6449])
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
by
establishing
a
tolerance
for
residues
of
[
N­(
1­
ethylpropyl)­
3,4­
dimethyl­
2,6dinitrobenzenamine,
(
pendimethalin)
and
its
3,
5­
dinitrobenzyl
alcohol
metabolite
(
CL
202347)]
in
or
on
the
raw
agricultural
commodity
[
Fruiting
Vegetables
group
8]
at
[
0.1]
parts
per
million
(
ppm),
[
Pome
Fruits
group
11]
at
[
0.05]
parts
per
million
(
ppm),
[
apple
pomace]
at
[
0.20]
parts
per
million
(
ppm),
[
juneberry]
at
[
0.05]
parts
per
million
(
ppm),
[
Stone
Fruit
group
12]
at
[
0.05]
parts
per
million
(
ppm),
and
[
pomegranate]
at
[
0.05]
parts
per
million
(
ppm).
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
[
The
qualitative
nature
of
the
residues
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
that
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
in
major
growing
areas
were
carried
out
in
order
to
determine
the
magnitude
of
residues
in
the
fruiting
vegetables
group,
the
pome
fruit
group,
juneberry,
the
stone
fruit
group
and
pomegranate
commodities.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
above
aforementioned
crops.
Field
trials
were
conducted
in
the
required
regions.
Field
trials
were
carried
out
using
maximum
label
rate
and
shortest
PHI.]

B.
Toxicological
Profile
1.
Acute
toxicity.
[
Pendimethalin
technical
demonstrates
low
acute
toxicity
via
the
oral,
dermal,
and
inhalation
routes
of
exposure.
The
acute
toxicity
studies
place
technical
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,
an
acute
dermal
category
of
IV,
an
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
in
vitro
and
in
vivo
test
systems
demonstrate
pendimethalin
to
be
non­
genotoxic.

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
thyroid
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,
pendimethalin's
mechanism
of
threshold
oncogenic
activity
only
occurs
at
high
doses
in
rats,
a
mammalian
species
that
is
expected
to
be
much
more
sensitive
than
humans
to
the
induction
of
thyroid
tumors
via
conditions
which
result
in
hypothyroidism.

3.
Reproductive
and
developmental
toxicity.
[
Pendimethalin
(
BAS
455
H)
is
not
a
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
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
hormonal
and
histopathological
changes
in
the
thyroid
gland.
The
chronic
RfD
was
calculated
to
be
0.03
mg/
kg
b.
w./
day
using
an
Uncertainty
Factor
(
UF)
of
30X
(
3X
for
interspecies
extrapolation
and
10X
for
intraspecies
variability)
and
a
10X
database
uncertainty
factor
(
UFDB)
retained
pending
receipt
of
a
developmental
thyroid
toxicity
study.
EPA/
HED
currently
recommends
a
FQPA
Safety
Factor
of
1X.
Therefore,
the
chronic
Population
Adjusted
Dose
(
PAD)
is
0.03
mg/
kg
b.
w./
day.

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.]

6.
Animal
metabolism.
[
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.

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.]

7.
Metabolite
toxicology.
[
The
main
pendimethalin
plant
metabolite,
CL
202347,
has
been
tested
for
toxicity.
The
acute
oral
toxicity
in
mice
was
determined
to
be
2140
mg/
kg
bw.
An
Ames
assay
showed
the
metabolite
to
be
non­
mutagenic.]

8.
Endocrine
disruption.
[
It
is
known
that
pendimethalin
affects
the
hypothalamus­
pituitary­
thyroid
axis.
However,
as
the
chronic
RfD
(
0.03
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
1.
Dietary
exposure.
[
Pendimethalin
is
widely
used
as
a
pre­
emergent
herbicide
to
control
broadleaf
and
grass
weeds
in
food
and
non­
food
crops,
as
well
as
nonagricultural
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
occupational
exposures.
The
primary
non­
food
sources
of
exposure
are
through
pesticide
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.]

i.
Food.
[
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,
garlic,
carrots,
mint,
citrus
fruits
crop
group,
and
tree
nut
crop
group
and
are
listed
in
the
U.
S.
40
CFR
§
180.361.

This
analysis
included
the
crops
(
listed
above)
with
established
tolerance
values
and
proposed
crop
tolerances
for
the
Fruiting
Vegetables
(
except
cucurbits)
crop
group
8,
the
Pome
Fruit
crop
group
11,
apple
pomace,
juneberry,
pomegranate,
the
Stone
Fruit
crop
group
12,
and
pistachios.

Acute
Dietary
Exposure
Assessment
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
relevant
toxicological
endpoints
for
acute
dietary
exposure
and
that
a
risk
assessment
was
not
required.

Chronic
Dietary
Exposure
Assessment
The
chronic
dietary
exposure
estimates
were
based
on
established
and
proposed
tolerance
values,
and
100%
CT
values.
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
0.03
mg/
kg
b.
w./
day
for
all
populations
subgroups.
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
8
%
of
the
cPAD
for
all
subpopulations.
Additional
refinements
such
as
the
use
of
anticipated
residues
and
percent
crop
treated
values
for
the
proposed
new
crops
would
further
reduce
the
estimated
chronic
dietary
exposure.
The
results
in
Table
1
below
demonstrate
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.

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
0.000903
2.7
All
Infants
0.00168
5.0
1­
2
years
0.002387
7.2
3­
5
years
0.001993
6.0
6­
12
years
0.001283
3.9
13­
19
years
0.000865
2.6
Females
13­
49
years
0.000727
2.2
Adults
20­
49
years
0.000736
2.2
Adults
50+
years
0.000629
1.9
%
cPAD
=
percent
of
chronic
population
adjusted
dose
Exposure
estimates
based
on
tolerance
values
and
100
%
CT
values
]
ii.
Drinking
water.
[
There
are
no
established
maximum
contaminant
levels
or
health
advisory
levels
for
residues
of
pendimethalin
(
BAS
455
H)
in
drinking
water.
The
drinking
water
exposure
values
used
in
this
assessment
were
obtained
from
the
most
recent
pendimethalin
assessment
conducted
by
EPA
published
on
March
3,
2006.
The
pendimethalin
water
values
were
calculated
using
PRZM­
EXAMS
and
SCI­
GROW2.
The
modeled
acute
and
chronic
surface
water
concentrations
were
38.8
and
4.8
ug/
L,
respectively.
The
modeled
groundwater
concentration
was
0.024
ug/
L.

Drinking
water
contributions
were
assessed
based
on
the
a
pendimethalin
water
concentration
of
4.8
ug/
L
for
chronic
exposure
and
water
consumption
and
body
weights
reported
in
CSFII,
using
DEEM­
FCID
software.
The
chronic
estimated
water
exposure
values
are
summarized
in
Table
2.
Table
2.
Summary
of
chronic
dietary
exposure
assessment
for
drinking
water
considering
direct
and
indirect
sources.

Population
Subgroups
Exposure
Estimate
(
mg/
kg
b.
w./
day)
%
cPAD
U.
S.
Population
0.000101
0.3
All
Infants
0.000332
1.0
1­
2
years
0.00015
0.5
3­
5
years
0.000141
0.4
6­
12
years
0.000097
0.3
13­
19
years
0.000073
0.2
Females
13­
49
years
0.000094
0.3
Adults
20­
49
years
0.000094
0.3
Adults
50+
years
0.000099
0.3
%
cPAD
=
percent
of
chronic
population
adjusted
dose
Exposure
based
on
the
maximum
estimated
water
concentration
of
4.8
ug/
L
Acute
Aggregate
Exposure
and
Risk
(
Food
and
water)
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
relevant
toxicological
endpoints
for
acute
dietary
exposure
and
that
a
risk
assessment
was
not
required.

Short­
and
Intermediate­
Term
Aggregate
Exposure
and
Risk
(
food,
water,
and
residential)
Short­
term
aggregate
risk
from
pendimethalin
takes
into
account
exposures
from
dietary
consumption
(
food
and
water)
and
residential
exposure
from
turf
use.
Post
application
exposure
from
the
turf
use
is
considered
short­
term.
The
aggregate
MOE
from
food,
water,
and
residential
exposure
are
2096
(
children
1­
2
years)
and
6265
(
US
population)
for
the
EC
formulation
and
936
(
children
1­
2
years)
and
3287
(
US
population)
for
the
CS
formulation,
respectively.
These
MOEs
are
greater
than
the
target
MOE
of
300,
which
indicates
there
is
no
safety
concern.
The
results
of
the
analysis
are
shown
in
Tables
3
and
4.

Table
3.
Estimated
short/
intermediate
term
aggregate
exposure
and
risk
of
pendimethalin
for
the
EC
formulation.

Population
NOAEL
(
mg/
kg/
day)
Target
MOE1
Food
Exposure
(
mg/
kg/
day)
Water
Exposure
(
mg/
kg/
day)
Residential
Exposure
(
mg/
kg/
day)
Total
Exposure
(
mg/
kg/
day)
MOE2
US
10
300
0.000903
0.000101
0.000592
0.001596
6265
Child
1­
2
yr
old
10
300
0.002387
0.00015
0.002235
0.004772
2096
1
Target
MOE
is
300.
2
Aggregate
MOE
=
(
NOAEL
/
(
Food
+
Water
+
Residential
Exposure)
Table
4.
Estimated
short/
intermediate
term
aggregate
exposure
and
risk
of
pendimethalin
for
the
CS
formulation.

Population
NOAEL
(
mg/
kg/
day)
Target
MOE1
Food
Exposure
(
mg/
kg/
day)
Water
Exposure
(
mg/
kg/
day)
Residential
Exposure
(
mg/
kg/
day)
Total
Exposure
(
mg/
kg/
day)
MOE2
US
10
300
0.000903
0.000101
0.002038
0.003042
3287
Child
1­
2
yr
old
10
300
0.002387
0.00015
0.008148
0.010685
936
1
Target
MOE
is
300.
2
Aggregate
MOE
=
(
NOAEL
/
(
Food
+
Water
+
Residential
Exposure)

Chronic
Aggregate
Exposure
and
Risk
(
food
and
water)
The
aggregate
chronic
risk
includes
residues
of
pendimethalin
from
food
and
water
(
Table
5).
Exposures
from
residential
uses
are
not
included
in
the
chronic
aggregate
assessment.
The
results
demonstrate
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.

Table
5.
Estimated
chronic
aggregate
exposure
and
risk
of
pendimethalin
Population
Subgroup
cPAD
(
mg/
kg/
day)
Food
Exposure
(
mg/
kg/
day)
Water
Exposure
(
mg/
kg/
day)
Total
Exposure
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
0.03
0.000903
0.000101
0.001004
3.0
All
Infants
(<
1
yr
old)
0.03
0.00168
0.000332
0.002012
6.0
Children
1­
2
years
0.03
0.002387
0.00015
0.002537
7.6
Children
3­
5
years
0.03
0.001993
0.000141
0.002134
6.4
Children
6
 
12
years
0.03
0.001283
0.000097
0.00138
4.1
Youth
13­
19
years
0.03
0.000865
0.000073
0.000938
2.8
Females
13­
49
years
0.03
0.000727
0.000094
0.000821
2.5
Adults
20­
49
years
0.03
0.000736
0.000094
0.00083
2.5
Adults
+
50
0.03
0.000629
0.000099
0.000728
2.2
]
2.
Non­
dietary
exposure.
[
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.
Exposure
values
were
derived
from
the
use
of
a
product­
specific
hand
press
study
to
estimate
hand­
to­
mouth
transfer
in
children
and
a
formulation­
specific
turf
transferable
residue
study
to
determine
dermal
exposure
to
adults
and
children.
Residential
exposure
to
both
the
Pendulum
®
3.3
EC
herbicide
and
Pendulum
®
AquaCap
 
herbicide
are
presented
below.
The
following
table
provides
the
route
specific
and
aggregate
exposure
assessment
results
for
each
population
subgroup,
along
with
the
percentage
of
the
cPAD
(
0.03
mg
kg
BW/
day)
utilized,
and
MOE
(
NOAEL/
Aggregate
systemic
Exposure).

Table
6.
Summary
of
residential
exposure
to
pendimethalin
following
the
use
of
the
Pendulum
®
3.3
EC
herbicide
formulation
including
the
route
specific
and
aggregate
exposure
assessment
results
for
the
population
subgroups.

Table
7.
Summary
of
residential
exposure
to
pendimethalin
following
the
use
of
the
Pendulum
®

AquaCap
 
herbicide
formulation
including
the
route
specific
and
aggregate
exposure
assessment
results
for
the
population
subgroups.

]

D.
Cumulative
Effects
[
Exposure
to
Substances
with
Common
Mechanism
of
Toxicity.
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
Population
subgroup
Route
of
Exposure
Route
Specific
Systemic
Exposure
(
mg/
kg
BW/
day)
1
Aggregate
Systemic
Exposure
(
mg/
kg
BW/
day)
%
cPAD
MOE
Adult
(
20­
49)
Post­
application
dermal
0.000592
0.000592
1.8
16892
Post­
application
dermal
0.000990
Child
(
1­
6)
Post­
application
(
Hand
to
Mouth
ingestion)
0.001245
0.002235
6.7
4474
1
Based
3%
dermal
absorption
Population
subgroup
Route
of
Exposure
Route
Specific
Systemic
Exposure
(
mg/
kg
BW/
day)
1
Aggregate
Systemic
Exposure
(
mg/
kg
BW/
day)
%
cPAD
MOE
Adult
(
20­
49)
Post­
application
dermal
0.002038
0.002038
6.1
4907
Post­
application
dermal
0.003411
Child
(
1­
6)
Post­
application
(
Hand
to
Mouth
ingestion)
0.004737
0.008148
24.4
1227
1
Based
3%
dermal
absorption
that
pendimethalin
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
]

E.
Safety
Determination
1.
U.
S.
population.
[
Based
on
these
risk
assessments,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population
or
any
subpopulation
from
aggregate
exposure
to
pendimethalin
residues.]
2.
Infants
and
children.
[
Based
on
these
risk
assessments,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
or
children,
or
any
subpopulation
from
aggregate
exposure
to
pendimethalin
residues.]

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.]