Document ID: EPA-HQ-OPP-2003-0264-0001
Agency: epa
Document Type: Rule
Title: Imazapyr; Pesticide Tolerance
Posted Date: 2003-09-26T04:00Z

55475
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
also
not
subject
to
Executive
Order
13211.

J.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
This
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
K.
Petitions
for
Judicial
Review
Under
section
307(
b)(
1)
of
the
Clean
Air
Act,
petitions
for
judicial
review
of
this
action
must
be
filed
in
the
United
States
Court
of
Appeals
for
the
appropriate
circuit
by
November
25,
2003.
Filing
a
petition
for
reconsideration
by
the
Administrator
of
this
final
rule
does
not
affect
the
finality
of
this
rule
for
the
purposes
of
judicial
review
nor
does
it
extend
the
time
within
which
a
petition
for
judicial
review
may
be
filed,
and
shall
not
postpone
the
effectiveness
of
such
rule
or
action.
This
action
to
reclassify
the
Atlanta
area
as
a
severe
ozone
nonattainment
area
and
to
adjust
applicable
deadlines
may
not
be
challenged
later
in
proceedings
to
enforce
its
requirements.
(
See
section
307(
b)(
2).)
List
of
Subjects
in
40
CFR
Part
81
Environmental
protection,
Air
pollution
control,
National
parks,
Wilderness
areas.

Dated:
September
15,
2003.
J.
I.
Palmer,
Jr.,
Regional
Administrator,
Region
4.


40
CFR
part
81
is
amended
as
follows:

PART
81
 
[
AMENDED]


1.
The
authority
citation
for
part
81
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7401
et
seq.


2.
In
§
81.311
the
table
entitled
``
Georgia
 
Ozone
(
1­
hour
standard)''
is
amended
by
revising
the
entry
for
the
Atlanta
area
to
read
as
follows:

§
81.311
Georgia.

*
*
*
*
*

GEORGIA
 
OZONE
(
1­
HOUR
STANDARD)

Designated
area
Designation
Classification
Date
1
Type
Date
1
Classification
Atlanta
Area:
Cherokee
County
.....................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Clayton
County
.........................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Cobb
County
............................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Coweta
County
.........................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
DeKalb
County
.........................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Douglas
County
........................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Fayette
County
.........................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Forsyth
County
.........................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Fulton
County
...........................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Gwinnett
County
.......................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Henry
County
...........................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Paulding
County
.......................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.
Rockdale
County
......................................................
11/
15/
1990
Nonattainment
...............
1/
01/
2004
Severe.

*
*
*
*
*
*
*

1
This
date
is
October
18,
2000,
unless
otherwise
noted.

[
FR
Doc.
03
 
24404
Filed
9
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0264;
FRL
 
7321
 
4]

Imazapyr;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
imazapyr
[
2­
[
4,5­
dihydro­
4­
methyl­
4­(
1­
methylethyl)­
5­
oxo­
1H­
imidazol­
2­
yl]­
3­
pyridinecarboxylic
acid]
in
or
on
grass,
forage;
grass,
hay;
fish;
shellfish;
fats
of
cattle,
sheep,
goats,
and
horses;
kidney
of
cattle,
sheep,
goats,
and
horses;
meat
byproducts
(
except
kidney)
of
cattle,
sheep,
goats,
and
horses;
meat
of
cattle,
sheep,
goats,
and
horses;
and
milk..
BASF
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
September
26,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0264,
must
be
received
on
or
before
November
25,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Jim
Tompkins,
Registration
Division,
7505C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305­
5697;
e­
mail
address:
tompkins.
jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)

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Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
FOR
FURTHER
INFORMATION
CONTACT.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0264.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
August
13,
2003
(
68
FR
48362)
(
FRL
 
7321
 
7),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
0F6166)
by
BASF
Corporation,
P.
O.
Box
13528,
Research
Triangle
Park,
NC
27709
 
3528.
That
notice
included
a
summary
of
the
petition
prepared
by
BASF
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.500
be
amended
by
establishing
a
tolerance
for
residues
of
the
herbicide
imazapyr,
in
or
on
grass,
forage
at
100
parts
per
million
(
ppm);
grass,
hay
at
30
ppm;
fish
at
1.0
ppm;
shellfish
at
0.10
ppm;
fats
of
cattle,
sheep,
goats,
and
horses
0.05
ppm;
kidney
of
cattle,
sheep,
goats,
and
horses
at
0.20
ppm;
meat
byproducts
(
except
kidney)
of
cattle,
sheep,
goats,
and
horses
at
0.05
ppm;
meat
of
cattle,
sheep,
goats,
and
horses
at
0.05
ppm;
and
milk
at
0.01
ppm.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue....''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
residues
of
imazapyr
on
grass,
forage
at
100
ppm;
grass,
hay
at
30
ppm;
fish
at
1.0
ppm;
shellfish
at
0.10
ppm;
fats
of
cattle,
sheep,
goats,
and
horses
0.05
ppm;
kidney
of
cattle,
sheep,
goats,
and
horses
at
0.20
ppm;
meat
byproducts
(
except
kidney)
of
cattle,
sheep,
goats,
and
horses
at
0.05
ppm;
meat
of
cattle,
sheep,
goats,
and
horses
at
0.05
ppm;
and
milk
at
0.01
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
imazapyr
are
discussed
in
Tables
1
and
2
of
this
unit
as
well
as
the
no­
observed­
adverseeffect
level
(
NOAEL)
and
the
lowestobserved
adverse­
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
ACUTE
TOXICITY
OF
IMAZAPYR
TECHNICAL
GRADE
ACTIVE
INGREDIENT
(
TGAI).

Guideline
No/
Study
Type
Results
Toxicity
Category
870.1100
Acute
Oral
LD50
=
>
5,000
mg/
kg
IV
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/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
TABLE
1.
 
ACUTE
TOXICITY
OF
IMAZAPYR
TECHNICAL
GRADE
ACTIVE
INGREDIENT
(
TGAI).
 
Continued
Guideline
No/
Study
Type
Results
Toxicity
Category
870.1200
Acute
Dermal
LD50
=
>
2,000
mg/
kg
III
870.1300
Acute
Inhalation
LC50
=
>
1.3
mg/
L
(
gravimetric)
>
5.1
mg/
L
(
nominal)
III
870.2400
Primary
Eye
Irritation
Corneal
Opacity;
Conjunctive
redness,
Chemosis
&
Discharge;
Vascularization
of
Cornea
Corrosive:
Irreversible
Eye
Damage
I
870.2500
Primary
Skin
Irritation
Non­
irritating
to
slight
erythema
and
edema
IV
870.2600
Dermal
Sensitization
Negative
TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90­
Day
oral
toxicity
rodents
(
rat)
Dermal
and
Systemic
NOAEL
=
1,695
mg/
kg/
day
for
males
and
=
1,784
mg/
kg/
day
for
females
highest
dose
tested
(
HDT).
This
was
the
HDT;
therefore,
there
is
no
LOAEL.

870.3200
21/
28­
Day
dermal
toxicity
(
rabbit)
Dermal
and
Systemic
NOAEL
=
400
mg/
kg/
day.
This
was
the
HDT;
therefore,
there
is
no
LOAEL.

870.3700
Prenatal
developmental
toxicity
in
rodents
(
rat)
Maternal
NOAEL
=
300
mg/
kg
bw/
day.
LOAEL
=
1,000
mg/
kg
bw/
day,
based
on
salivation.
Developmental
NOAEL
=
1,000
mg/
kg/
day.
This
was
the
HDT;
therefore,
there
is
no
LOAEL.

870.3700
Prenatal
developmental
toxicity
in
nonrodents
(
rabbit)
Maternal
NOAEL
=
400
mg/
kg
bw/
day
This
was
the
HDT;
therefore,
there
is
no
LOAEL.
Developmental
NOAEL
=
400
mg/
kg
bw/
day.
This
was
the
HDT;
therefore,
there
is
no
LOAEL.

870.3800
Reproduction
and
fertility
effects
(
rat)
Parental
systemic,
reproductive
and
offspring
NOAEL
=
10,000
ppm
(
738
mg/
kg
bw/
day
in
males
933.3
mg/
kg
bw/
day
in
females).
This
was
the
HDT;
therefore,
there
is
no
LOAEL.

870.4100
Chronic
toxicity
(
rodent)
NA;
see
870.4300
870.4100
Chronic
toxicity
(
dog)
NOAEL
is
=
10,000
ppm
(
250
mg/
kg/
day).
This
was
the
HDT;
therefore,
there
is
no
LOAEL.

870.4200
Carcinogenicity
(
rat)
NA;
see
870.4300
870.4200
Carcinogenicity
(
mouse)
NOAEL
=
10,000
ppm
(
1,301
mg/
kg/
day
in
males
and
1,639
mg/
kg/
day
in
females).
This
was
the
HDT;
therefore,
there
is
no
LOAEL.

870.4300
Combined
Chronic/
carcinogenicity
(
rat)
Increase
in
brain
astrocytomas
in
male
rats
for
which
there
was
a
statistically
significant
positive
trend,
but
which
was
not
statistically
significant
in
pairwise
comparison
to
controls.
The
CPRC
considered
the
astrocytomas
in
the
male
rats
unrelated
to
treatment
because
there
was
no
statistically
significant
pairwise
increase.
Dosing
was
considered
to
be
adequate
based
on
the
HDT
of
10,000
ppm
which
exceeds
the
limit
dose
of
7000
ppm
for
mice.

870.5100
Bacterial
reverse
mutation
(
Ames
Assay)
Negative
up
to
5,000
µ
g/
plate.

870.5300
In
vitro
mammalian
cell
gene
mutation
Negative
up
to
toxic
doses
(
5,000
µ
g/
ml)
with
and
without
activation.

870.5375
In
vitro
mammalian
chromosome
aberration
(
CHO)
Negative
up
to
toxic
doses
(
5,000
µ
g/
ml)
with
and
without
activation.

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26,
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/
Rules
and
Regulations
TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.5450
Rodent
Dominant
Lethal
Reported
as
negative
(
though
unacceptable).

870.5550
Unscheduled
DNA
synthesis
(
RPH)
Reported
as
negative
(
though
unacceptable).

870.7485
Metabolism
and
pharmacokinetics
(
rat)
No
sex­
related
differences
in
absorption
were
apparent.
Within
48
hours
of
treatment
>
90%
of
the
administered
dose
was
recovered
in
the
excreta
suggesting
that
elimination
of
the
labeled
test
material
was
rapid.
No
specific
sequestering
tissues
or
organs
were
identified.
Seven
days
after
treatment,
essentially
all
the
test
material
had
been
eliminated.
Rats
that
received
the
test
material
by
intravenous
injection
excreted
87­
95%
of
the
administered
dose
in
the
urine
and
approximately
6%
into
the
feces.
This
suggests
that
15­
28%
if
the
administered
dose
recovered
in
the
feces
represents
unabsorbed
material.
Metabolite
characterization
studies
show
that
essentially
all
of
the
test
material
was
excreted
unchanged.
Two
minor
metabolites
CL
252,974
and
CL
60,032
were
detected
in
the
urine
or
feces
of
treated
rats;
however,
their
contribution
combined
was
<
0.5%
of
the
administered
dose.
Up
to
12
additional
unidentified
metabolites
were
isolated,
but
they
constituted
>
3%
of
the
administered
dose.
Based
on
the
results,
the
study
author
suggests
that
what
limited
metabolism
of
CL
243,997
occurs
proceeds
through
hydrolysis
to
form
the
2­
carbonyl
derivatives:
CL
252,974
and
CL
60,032.

870.7600
Dermal
penetration
NA
B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
margin
of
exposure
(
MOE).
A
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
A
summary
of
the
toxicological
endpoints
for
imazapyr
used
for
human
risk
assessment
is
shown
in
Table
3
of
this
unit:

TABLE
3.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
IMAZAPYR
FOR
USE
IN
HUMAN
RISK
ASSESSMENT.

Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13­
50
years
of
age
and
General
population
including
infants
and
children)
none
none
An
acute
dietary
endpoint
was
not
selected
based
on
the
absence
of
an
appropriate
endpoint
attributable
to
a
single
dose.

Chronic
Dietary
(
All
populations)
Oral
Study
NOAEL=
250
mg/
kg/
day
UF
=
100
Chronic
RfD=
2.5
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD/
FQPA
SF
=
2.5
mg/
kg/
day
1­
Year
Dog
[
feeding]
Study
No
LOAEL
was
demonstrated
with
imazapyr
at
doses
up
to
250
mg/
kg/
day
(
HDT);
HIARC
recommended
this
dose
for
RA
for
imazapyr,
based
on
skeletal
muscle
effects
seen
in
dogs
with
structural
analog
imazapic
Short­
and
Intermediate­
Term
Incidental
Oral
(
1­
30
days
and
1­
6
months)
Oral
Study
NOAEL=
250
mg/
kg/
day
LOC
for
MOE=
NA
(
Occupational
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF
­
At
present
time
no
residential
uses)
1­
Year
Dog
[
feeding]
Study
No
LOAEL
was
demonstrated
with
imazapyr
at
doses
up
to
250
mg/
kg/
day
(
HDT);
HIARC
recommended
this
dose
for
RA
for
imazapyr,
based
on
skeletal
muscle
effects
seen
in
dogs
with
structural
analog
imazapic
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Federal
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/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
TABLE
3.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
IMAZAPYR
FOR
USE
IN
HUMAN
RISK
ASSESSMENT.
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Short­
and
Intermediate­
and
Long­
Term
Dermal
(
1
to
30
days,
1
to
6
months,
 
6
months)
Oral
study
NOAEL=
250
mg/
kg/
day
(
dermal
absorption
rate
=
100
%)
LOC
for
MOE
=
100
(
Occupational
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF
­
At
present
time
no
residential
uses)
1­
Year
Dog
[
feeding]
Study
No
LOAEL
was
demonstrated
with
imazapyr
at
doses
up
to
250
mg/
kg/
day
(
HDT);
HIARC
recommended
this
dose
for
RA
for
imazapyr,
based
on
skeletal
muscle
effects
seen
in
dogs
with
structural
analog
imazapic.

Short­
and
Intermediate­
and
Long­
Term
Inhalation
(
1
to
30
days,
1
to
6
months,
>
6
months
)
Oral
study
NOAEL=
250
mg/
kg/
day
(
inhalation
absorption
rate
=
100%
LOC
for
MOE
=
100
(
Occupational
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF
­
At
present
time
no
residential
uses)
1­
Year
Dog
[
feeding]
Study
No
LOAEL
was
demonstrated
with
imazapyr
at
doses
up
to
250
mg/
kg/
day
(
HDT);
HIARC
recommended
this
dose
for
RA
for
imazapyr,
based
on
skeletal
muscle
effects
seen
in
dogs
with
structural
analog
imazapic
Cancer
Risk
A
quantitative
cancer
risk
assessment
is
not
required
for
imazapyr
N/
A
2­
Year
Chronic
[
feeding]
Toxicity/
Carcinogenicity
Study
in
Rats:
Group
E
­
``
no
evidence
of
carcinogenicity
in
at
least
2
adequate
animal
tests
in
different
species.''

*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.500)
for
the
residues
of
imazapyr,
in
or
on
corn,
field,
forage;
corn,
field,
grain;
and
corn
field,
stover
at
0.05
ppm.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
imazapyr
in
food
as
follows:
i.
Acute
exposure.
Quantitative
acute
dietary
risk
assessments
are
performed
for
a
food­
use
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
No
appropriate
endpoint
attributable
to
a
single
exposure
was
identified
for
imazapyr.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
dietary
exposure
analysis
assumed
100%
crop
treated
tolerances
and
residues.
Based
on
total
food
exposure
for
imazapyr,
all
population
subgroups
are
below
1%
cPAD
(
Chronic
Population
Adjusted
Dose).
iii.
Cancer.
Imazapyr
showed
no
evidence
of
carcinogenicity
in
at
least
2
adequate
animal
tests
in
different
species,
and
therefore,
a
quantitative
cancer
risk
assessment
was
not
performed.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
imazapyr
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
imazapyr.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
SCI­
GROW
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
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
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
imazapyr
they
are
further
discussed
in
the
aggregate
risk
section
E.
Based
on
the
FIRST
and
SCI­
GROW
models
the
estimated
environmental
concentrations
(
EECs)
of
imazapyr
for
acute
exposures
are
estimated
to
be
137
parts
per
billion
(
ppb)
for
surface
water
and
1,700
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
81
ppb
for
surface
water
and
1,700
ppb
for
ground
water.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).
Imazapyr
is
currently
registered
for
use
on
the
following
residential
sites
that
could
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26,
2003
/
Rules
and
Regulations
result
in
non­
occupational,
non­
dietary
exposure:
Driveways,
parking
areas,
brick
and
gravel
pathways,
patios,
and
along
sidewalks
and
bare
ground.
In
addition
to
residential
sites
on
which
imazapyr
is
registered,
there
is
the
possibility
of
recreational
exposure
for
post
application
exposure
from
the
registered
use
on
golf
courses
and
fairgrounds
and
exposure
from
incidental
ingestion
and
dermal
exposure
from
swimming
in
treated
water
from
the
proposed
aquatic
weed
control
use.
The
risk
assessment
was
conducted
using
the
following
exposure
assumptions:
i.
Residential
handler.
Short­
term
(
1
to
30
days)
dermal
and
inhalation
exposure
from
mixing,
loading
and
application
via
sprinkler
can
could
occur.
For
the
Outdoor
Residential
Exposure
Task
Force
study
reviewed,
the
Health
Effects
Division
(
HED)
used
a
hose­
end
sprayer
as
surrogate
data
for
the
sprinkler
can
scenario.
The
registered
label
states
that
the
product
offers
long­
term
weed
control
and
prevents
re­
growth
for
up
to
one
year
with
a
single
application;
therefore
only
short­
term
handler
exposures
are
anticipated.
ii.
Residential
post­
application.
Adults
and
children
are
anticipated
to
have
short­
term
dermal
exposures;
however,
given
that
the
product
is
not
intended
for
lawn
use,
dermal
exposures
by
adults
and
children
are
considered
to
be
negligible
as
compared
to
recreational
post­
application
exposures.
(
See
fairground
postapplication
However,
toddlers
could
potentially
ingest
soil
from
treated
bare
ground
in
the
residential
use
scenario.
The
assumptions
used
to
assess
the
soil
ingestion
scenario
were:
Day
of
treatment
residues
are
assumed
to
be
available
for
short­
term
exposure,
toddler
body
weight
is
estimated
at
15
kg,
100
%
of
application
rate
is
available
in
the
top
1
cm
of
soil
for
soil
ingestion
exposures,
and
a
toddler
can
possibly
ingest
100
mg
soil/
day.
iii.
Golfer
post­
application.
Golfer
exposure
assumptions
are:
One
round
of
golf
(
18
holes)
takes
4
hours
and
an
average
golfer
plays
18
times
per
year,
so
short­
term
dermal
exposures
are
anticipated.
Inhalation
exposures
are
considered
to
be
negligible
since
the
vapor
pressure
of
imazapyr
was
reported
by
the
registrant
to
be
<
2x
10­
7
mm
Hg
(
vs.
HED
ExpoSAC
vapor
pressure
threshold
of
1
x
10­
5
mm
Hg).
5%
of
the
maximum
application
rate
is
available
as
turf
transferrable
residues
(
TTR)
available
on
Day
0
(
assumes
no
dissipation).
The
transfer
coefficient
(
TC)
for
dermal
exposure
is
assumed
to
be
500
cm2/
hr
based
on
golfers
wearing
short
pants
and
short­
sleeved
shirts.
The
exposure
estimate
for
child
golfers
is
1.7
times
the
adult
exposure
estimate
to
account
for
differences
in
body
weight
and
surface
area.
Maximum
labeled
application
rate
is
0.0041
lb
ae/
A
broadcast
liquid
formulation
applications.
iv.
Fairground
post­
application.
 
a.
The
following
assumptions
were
used
to
assess
dermal
exposures
to
adults
and
toddlers
after
contact
with
treated
lawns:
Adult
and
toddler
body
weights
are
70
kg
and
15
kg
respectively,
5%
of
the
maximum
application
rate
represents
fraction
of
imazapyr
available
as
dislodgeable
foliar
reside
(
DFR)
on
the
day
of
treatment.
Dermal
TC
for
adults
is
14,500
cm2/
hr,
and
for
toddlers,
5,200
cm2/
hr
with
an
exposure
duration
of
2
hours.
b.
To
assess
hand­
to­
mouth
exposures
for
toddlers
after
contact
with
treated
turf,
the
following
assumptions
were
used:
residues
are
assumed
to
be
available
for
the
short­
term
and
intermediate­
term
exposure
durations.
Toddler
body
weight
is
15
kg,
hand
surface
area
is
20
cm2,
and
a
toddler
performs
20
hand­
to­
mouth
events
per
hour
for
short­
term
exposures.
5%
of
application
rate
represents
fraction
of
imazapyr
available
for
transfer
to
hands
on
the
day
of
treatment
with
a
50%
saliva
extraction
factor.
100%
of
the
application
rate
is
available
in
the
top
1
cm
of
soil
for
soil
ingestion
exposures,
and
a
toddler
can
ingest
100
mg
of
soil
a
day.
The
exposure
duration
is
2
hours
per
day.
c.
To
assess
object­
to­
mouth
exposures
for
toddlers
after
contact
with
treated
turf,
the
following
assumptions
were
used:
Residues
are
assumed
to
be
available
for
the
short­
term
and
intermediate­
term
exposure
durations,
the
toddlers'
body
weight
is
15
kg,
20%
of
the
application
rate
is
available
as
dislodgeable
residues
on
the
day
of
treatment,
the
object
area
is
25
cm2,
100%
of
the
application
rate
is
available
in
the
top
1
cm
of
soil
for
soil
ingestion
exposures,
a
toddler
can
ingest
100
mg
of
soil
a
day,
and
the
exposure
duration
is
2
hours
per
day.
v.
Swimmer
post­
application.
For
incidental
ingestion
and
dermal
exposure,
the
following
assumptions
are
made:
The
worst­
case
estimate
of
imazapyr
in
the
top
one­
foot
of
the
water
column
in
a
treated
waterbody
is
550
ppb.
100%
of
this
concentration
is
assumed
available
for
ingestion
at
a
rate
of
0.05
L/
hr.
The
exposure
duration
is
2
hours
a
day
for
non­
competitive
adult
and
child
swimmers.
Body
weights
of
70
kg
for
adults,
29
kg
for
children,
and
15
kg
for
toddlers
are
assumed.
For
dermal
exposure,
the
body
surface
area
of
an
adult
is
20,670
cm2
and
14,580
cm2
for
toddlers
and
children.
The
permeability
coefficient
is
assumed
at
5.85
x
10­
5
cm/
hr.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
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.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
imazapyr
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,
imazapyr
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
imazapyr
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
ten­
fold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
No
prenatal
or
postnatal
sensitivity
was
found.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
imazapyr
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
Agency
has
determined
that
the
Special
FQPA
SF
of
10x
can
be
reduced
to
1x
because:

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Regulations
i.
Lack
of
concern
for
pre­
and
postnatal
toxicity.
ii.
No
qualitative/
quantitative
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
to
in
utero
exposure
was
reported
in
the
developmental
studies
at
doses
up
to
1,000
mg/
kg/
day
(
limit
dose)
in
the
rat
and
400
mg/
kg/
day
(
HDT)
in
the
rabbit.
iii.
There
is
no
concern
for
developmental
neurotoxicity
resulting
from
exposure
to
imazapyr.
While
there
were
no
neurotoxicity
studies
available
from
the
published
literature,
there
was
no
evidence
of
neurotoxicity/
neuropathology
in
adult
animals
in
the
available
studies.
iv.
The
toxicology
database
is
complete
based
on
the
developmental
studies
in
the
rat
and
rabbit
and
the
2­
generation
reproduction
study
in
the
rat
v.
No
developmental
neurotoxicity
(
DNT)
study
was
required.
vi.
No
residual
uncertainties
were
identified
in
the
exposure
database.
vii.
The
chronic
dietary
food
exposure
assessment
utilizes
tolerance
level
residues
and
100%
CT
information
for
all
commodities.
By
using
these
screening
level
assumptions,
actual
exposures/
risks
will
not
be
underestimated.
viii.
The
dietary
drinking
water
assessment
utilizes
water
concentration
values
generated
by
models
and
associated
modeling
parameters
which
are
designed
to
provide
conservative,
health­
protective,
high­
end
estimates
of
water
concentrations
which
will
not
likely
be
exceeded.
ix.
Residential
exposure
and
risk
were
assessed
using
standard
assumptions
from
Science
Advisory
Council
on
Exposure
(
Expo
SAC)
Standard
Operating
Procedure
(
SOP).
These
assumptions
are
not
expected
to
underestimate
risk.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
the
Office
of
Pesticide
Programs
(
OPP)
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
No
acute
risk
from
exposure
to
imazapyr
is
expected
because
there
were
no
toxic
effects
of
concern
attributable
to
a
single
dose
identified
in
available
data.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
imazapyr
from
food
will
utilize
<
1%
of
the
cPAD
for
the
U.
S.
population,
<
1%
of
the
cPAD
for
all
infants
(<
1
year
old)
and
<
1%
of
the
cPAD
for
children
ages
1
 
2
years
old.
Based
the
use
pattern,
chronic
residential
exposure
to
residues
of
imazapyr
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
imazapyr
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
4
of
this
unit:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
IMAZAPYR.

Population
Subgroup
cPAD
(
mg/
kg/
day)
Chronic
Food
Exposure
(
mg/
kg/
day)
Maximum
Chronic
Water
Exposure1
(
mg/
kg/
day)
Ground
Water
EEC2
ppb
Surface
Water
EEC2
ppb
Chronic
DWLOC3
ppb
U.
S.
Population
2.5
0.00034
2.499
1,700
81
87,000
All
infants
(<
1
year
old)
2.5
0.000273
2.499
1,700
81
25,000
Children
(
1­
2
years
old)
2.5
0.000828
2.499
1,700
81
25,000
Children
(
3­
5
years
old)
2.5
0.00073
2.499
1,700
81
25,000
Children
(
6­
12
years
old)
2.5
0.000499
2.499
1700
81
75,000
Youth
(
13­
19
years
old)
2.5
0.000309
2.499
1,700
81
75,000
Adults
(
20­
49
years
old)
2.5
0.000267
2.499
1,700
81
87,000
Females
(
13­
49
years
old)
2.5
0.000257
2.499
1,700
81
87,000
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Rules
and
Regulations
TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
IMAZAPYR.
 
Continued
Population
Subgroup
cPAD
(
mg/
kg/
day)
Chronic
Food
Exposure
(
mg/
kg/
day)
Maximum
Chronic
Water
Exposure1
(
mg/
kg/
day)
Ground
Water
EEC2
ppb
Surface
Water
EEC2
ppb
Chronic
DWLOC3
ppb
Adults
(
50+
years
old)
2.5
0.000287
2.499
1,700
81
87,000
1maximum
water
exposure
(
mg/
kg/
day)
=
cPAD
(
mg/
kg/
day)
­
food
exposure
(
mg/
kg/
day)
2The
crop
producing
the
highest
level
was
used.
3DWLOC
calculated
as
follows:
DWLOC
=
(
maximum
water
exposure
(
mg/
kg/
day))
*
(
body
weight
(
kg))
*
(
1,000
µ
g/
mg)/
water
consumption
(
liter/
day)

3.
Short­
term
risk.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Imazapyr
is
currently
registered
for
use
that
could
result
in
short­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
term
exposures
for
imazapyr.
Short­
term
aggregate
risk
assessments
are
required
for
adults
as
there
is
potential
for
both
dermal
and
inhalation
handler
exposure,
and
dermal
postapplication
exposure
from
the
residential
and
recreational
uses
of
imazapyr
on
turf
and
swimmer
exposure.
In
addition,
short­
term
aggregate
risk
assessments
are
required
for
children
and
toddlers
because
there
is
a
potential
for
oral
and
dermal
postapplication
exposure
resulting
from
the
residential
uses
of
imazapyr
on
turf
and
from
swimming.
The
short­
term
residential
handler
scenario
results
in
the
highest
exposure
for
adults.
Therefore,
for
adults,
the
homeowner
handler
scenario
was
aggregated
with
the
chronic
dietaryfood
exposure
for
the
U.
S.
General
population.
The
swimmer
scenario
resulted
in
the
highest
exposure
for
toddlers
and
children.
Therefore,
the
swimmer
scenario
exposure
estimates
were
aggregated
with
the
chronic
dietary
(
food)
to
provide
a
worst­
case
estimate
of
shortterm
aggregate
risk
for
children
1­
2
years
old.
Using
the
exposure
assumptions
described
in
this
unit
for
short­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
75,000
for
the
United
States
population,
and
55,000
for
children
1­
2
years
old.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern,
an
MOE
of
100,
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
imazapyr
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
5
of
this
unit:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
IMAZAPYR
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential
1
Aggregate
Level
of
Concern
(
LOC)
2
Surface
Water
EEC3
(
µ
g/
L)
Ground
Water
EEC3
(
µ
g/
L)
Short­
Term
DWLOC4
(
ppb)

U.
S.
Population
75,000
100
81
1,700
87,000
Children
1­
2
years
old
55,000
100
81
1,700
25,000
1Aggregate
MOE
=
[
NOAEL
/
(
Avg
Food
Exposure
+
Residential
Exposure)]
2The
level
of
concern
(
target
MOE)
includes
10X
for
interspecies
extrapolation
and
10X
for
intraspecies
variation
(
MOE<
100)
3The
crop
producing
the
highest
level
was
used
4DWLOC
calculated
as
follows:
DWLOC
=
(
maximum
water
exposure
(
mg/
kg/
day))
*
(
body
weight
(
kg))
*
(
1,000
µ
g/
mg)/
water
consumption
(
liter/
day)

4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Though
residential
exposure
could
occur
with
the
use
of
imazapyr,
the
short­
term
and
intermediate­
term
endpoints
are
the
same
and
thus
the
short­
term
assessment
is
conservative
for
the
intermediate­
term.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Imazapyr
is
not
expected
to
pose
a
cancer
risk
because
no
evidence
of
carcinogenicity
was
found
in
at
least
2
adequate
animal
tests
in
different
species.
6.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
imazapyr
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Two
methods
are
currently
listed
in
the
Pesticide
Analytical
Manual
(
PAM)
Vol.
II
for
enforcing
tolerances
of
imazapyr
in
or
on
corn
commodities;
Method
M
2468
is
a
gas
chromatography/
mass
spectrometry
(
GC/
MS)
methods
with
a
limit
of
quantitation
(
LOQ)
of
­
0.01
ppm
for
imazapyr
in
or
on
corn
grain,
forage
and
fodder,
and
Method
M
2657
is
a
capillary
electrophoresis
(
CE)
method
with
ultraviolet
(
UV)
detection
that
has
a
LOQ
of
0.05
ppm
for
imazapyr
in
or
on
corn
grain,
forage
and
fodder.
CE/
UV
methods
were
proposed
for
determining
imazapyr
in
or
on
grass
forage
and
hay
(
M
3023),
in
livestock
tissues
(
M
3184),
in
milk
and
milk
fat
(
M
3075
and
M
3223),
and
in
fish
and
shellfish
tissues
(
M
3066).
These
methods
are
similar
to
the
current
enforcement
method
M
2657,
and
based
on
the
concurrent
method
recovery
data
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/
Rules
and
Regulations
submitted,
are
adequate
for
collecting
data
on
residues
of
imazapyr
in
grass
forage
and
hay,
cattle
tissues
and
milk,
and
fish
and
shellfish.
The
CE/
UV
Methods
M
3023,
M
3184,
M
3075,
and
M
3066
have
been
forwarded
to
the
Analytical
Chemistry
(
ACB)
for
petition
method
validation
(
PMV)
trials.
Conclusions
regarding
the
suitability
of
the
proposed
enforcement
methods
will
be
deferred
until
completion
of
the
PMV
trials.

B.
International
Residue
Limits
There
are
no
Codex,
Canadian,
or
Mexican
maximum
residue
limits
(
MRLs)
for
residues
of
imazapyr
in
or
on
any
of
the
crops
involved
in
the
proposed
new
uses.

C.
Conditions
Prior
to
granting
unconditional
registration,
the
registrant
will
be
required
to
address
the
following
issues:
1.
Fish
metabolism
study
2.
Corn
or
grass
storage
stability
information
or
study
3.
Additional
spray
additive
information
supporting
the
grass
field
trials.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
imazapyr
in
or
on
grass,
forage
at
100
ppm;
grass,
hay
at
30
ppm;
fish
at
1.0
ppm;
shellfish
at
0.10
ppm;
fats
of
cattle,
sheep,
goats,
and
horses
0.05
ppm;
kidney
of
cattle,
sheep,
goats,
and
horses
at
0.20
ppm;
meat
byproducts
(
except
kidney)
of
cattle,
sheep,
goats,
and
horses
at
0.05
ppm;
meat
of
cattle,
sheep,
goats,
and
horses
at
0.05
ppm;
and
milk
at
0.01
ppm.

VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0264
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
November
25,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0264,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?

A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

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26,
2003
/
Rules
and
Regulations
VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

VIII.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
record
keeping
requirements.

Dated:
September
16,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]


1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.500
is
revised
to
read
as
follows:

§
180.500
Imazapyr;
tolerances
for
residues.
(
a)
General.
Tolerances
are
being
established
for
residues
of
the
herbicide
imazapyr,
[
2­[
4,5­
dihydro­
4­
methyl­
4­(
1­
methylethyl)­
5­
oxo­
1H­
imidazol­
2­
yl]­
3­
pyridinecarboxylic
acid],
applied
as
the
acid
or
ammonium
salt,
in
or
on
the
following
raw
agricultural
commodities:

Commodity
Parts
per
million
Cattle,
fat
..............
0.05
Cattle,
kidney
........
0.20
Cattle,
meat
..........
0.05
Cattle,
meat
byproducts
(
except
kidney)
...............
0.05
Corn,
field,
forage
0.05
Corn,
field,
grain
...
0.05
Corn,
field,
stover
0.05
Fish
.......................
1.0
Goats,
fat
..............
0.05
Goats,
kidney
........
0.20
Goats,
meat
..........
0.05
Goats,
meat
byproducts
(
except
kidney)
...............
0.05
Grass,
forage
........
100
Grass,
hay
............
30
Horses,
fat
............
0.05
Horses,
kidney
......
0.20
Horses,
meat
........
0.05
Horses,
meat
byproducts
(
except
kidney)
...............
0.05
Milk
.......................
0.01
Sheep,
fat
.............
0.05
Sheep,
kidney
.......
0.20
Sheep,
meat
.........
0.05
Sheep,
meat
byproducts
(
except
kidney)
...............
0.05
Shellfish
................
0.10
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Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]
[
FR
Doc.
03
 
24123
Filed
9
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0289;
FRL
 
7324
 
8]

Etoxazole;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
etoxazole
in
or
on
cotton,
pome
fruits,
strawberries,
and
imported
tangerines.
Valent
U.
S.
A.
Corporation
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
September
26,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0289,
must
be
received
on
or
before
November
25,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Daniel
C.
Kenny,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7546;
e­
mail
address:
kenny.
dan@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
Production
(
NAICS
111)
 
Animal
Production
(
NAICS
112)
 
Food
Manufacturing
(
NAICS
311)
 
Pesticide
Manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0289.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
August
13,
2003
(
68
FR
48377)
(
FRL
 
7322
 
6),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
2F6420)
by
Valent
U.
S.
A.
Corporation,
1333
North
California
Blvd.,
Suite
600,
Walnut
Creek,
CA
94596.
That
notice
included
a
summary
of
the
petition
prepared
by
Valent
U.
S.
A.
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
tolerances
for
residues
of
the
insecticide
etoxazole,
2­(
2,6­
difluorophenyl)­
4­[
4­
(
1,1­
dimethylethyl)­
2­
ethoxyphenyl]­
4,5­
dihydrooxazole,
in
or
on
cottonseed
at
0.05
parts
per
million
(
ppm);
cotton,
gin
byproducts
(
gin
trash)
at
1.0
ppm,
pome
fruit
(
Crop
Group
11)
at
0.2
ppm,
apple,
wet
pomace
at
1.0
ppm,
strawberry
at
0.5
ppm,
and
oranges
at
0.10
ppm
(
to
support
the
importation
of
mandarin
oranges
into
the
U.
S.).
As
residues
in
processed
commodities
fed
to
animals
may
be
transferred
to
milk
and
edible
tissue
of
ruminants,
tolerances
were
also
proposed
for
animal
fat
at
0.03
ppm
and
milk
fat
at
0.04
ppm.
Based
on
EPA's
review,
the
petition
was
revised
by
the
petitioner
to
propose
tolerances
for
residues
of
etoxazole
on
cotton,
undelinted
seed
at
0.05
ppm;
cotton,
gin
byproducts
at
1.0
ppm;
fruit,
pome,
group
11
at
0.20
ppm;
apple,
wet
pomace
at
0.50
ppm;
strawberry
at
0.50
ppm;
tangerine
at
0.10
ppm;
liver
of
cattle,
goat,
horse,
and
sheep
at
0.01
ppm;
fat
of
cattle,
goat,
horse,
and
sheep
at
0.02
ppm;
and
milk,
fat
at
0.01
ppm.
Although
EPA
requested
a
number
of
changes
to
the
initial
petition,
the
nature
of
the
changes
(
i.
e.,
clarification
and
correction
of
commodity
terms
and
adjustments
in
tolerance
levels)
are
not
considered
significant.
Therefore,
EPA
is
issuing
this
as
a
final
action.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
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