55849
Federal
Register
/
Vol.
68,
No.
188
/
Monday,
September
29,
2003
/
Rules
and
Regulations
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.

IX.
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
recordkeeping
requirements.

Dated:
September
23,
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
180.473
is
revised
to
read
as
follows:

§
180.473
Glufosinate
ammonium;
tolerances
for
residues.

(
a)
General.
(
1)
Tolerances
are
established
for
residues
of
the
herbicide
glufosinate
ammonium
(
butanoic
acid,
2­
amino­
4­(
hydroxymethylphosphinyl)­,
monoammonium
salt)
and
its
metabolites,
2­
acetamido­
4­
methylphosphinico­
butanoic
acid
and
3­
methylphosphinico­
propionic
acid,
expressed
as
2­
amino­
4­
(
hydroxymethylphosphinyl)
butanoic
acid
equivalents,
in
or
on
the
following
food
commodities:

Commodity
Parts
per
million
Almond,
hulls
..................
0.50
Apple
...............................
0.05
Banana
...........................
0.30
Banana,
pulp
..................
0.20
Bushberry
subgroup
13B
0.15
Cattle,
fat
........................
0.40
Cattle,
meat
....................
0.15
Cattle,
meat
byproducts
6.0
Cotton,
gin
byproducts
...
15
Cotton,
undelinted
seed
4.0
Egg
.................................
0.15
Goat,
fat
..........................
0.40
Goat,
meat
......................
0.15
Goat,
meat
byproducts
...
6.0
Grape
..............................
0.05
Hog,
fat
...........................
0.40
Hog,
meat
.......................
0.15
Hog,
meat
byproducts
....
6.0
Horse,
fat
........................
0.40
Horse,
meat
....................
0.15
Horse,
meat
byproducts
6.0
Juneberry
........................
0.10
Lingonberry
.....................
0.10
Milk
.................................
0.15
Nut,
tree,
group
14
.........
0.10
Potato
.............................
0.80
Potato,
chips
...................
1.60
Commodity
Parts
per
million
Potato
granules
and
flakes
...........................
2.00
Poultry,
fat
......................
0.15
Poultry,
meat
..................
0.15
Poultry,
meat
byproducts
0.60
Salal
................................
0.10
Sheep,
fat
.......................
0.40
Sheep,
meat
...................
0.15
Sheep,
meat
byproducts
6.0
(
2)
Tolerances
are
established
for
residues
of
the
herbicide
glufosinate
ammonium
(
butanoic
acid,
2­
amino­
4­
(
hydroxymethylphosphinyl)­,
monoammonium
salt)
and
its
metabolites,
2­
acetamido­
4­
methylphosphinico­
butanoic
acid
and
3­
methylphosphinico­
propionic
acid,
expressed
as
2­
amino­
4­
(
hydroxymethylphosphinyl)
butanoic
acid
equivalents,
in
or
on
the
following
food
commodities
derived
from
transgenic
canola,
transgenic
cotton,
transgenic
field
corn,
transgenic
rice,
transgenic
soybean
and
transgenic
sugar
beet
that
are
tolerant
to
glufosinate
ammonium:

Commodity
Parts
per
million
Aspirated
grain
fractions
...........
25.0
Beet,
sugar,
molasses
..............
5.0
Beet,
sugar,
roots
.....................
0.9
Beet,
sugar,
tops
(
leaves)
........
1.5
Canola,
meal
............................
1.1
Canola,
seed
............................
0.4
Corn,
field,
forage
.....................
4.0
Corn,
field,
grain
.......................
0.2
Corn,
field,
stover
.....................
6.0
Cotton,
gin
byproducts
.............
15
Cotton,
undelinted
seed
...........
4.0
Rice,
grain
................................
1.0
Rice,
hull
...................................
2.0
Rice,
straw
................................
2.0
Soybean
....................................
2.0
Soybean,
hulls
..........................
5.0
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
restrictions.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]

[
FR
Doc.
03
 
24565
Filed
9
 
26
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0218;
FRL
 
7318
 
2]

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

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/
Vol.
68,
No.
188
/
Monday,
September
29,
2003
/
Rules
and
Regulations
SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
quinoxyfen
in
or
on
sweet
and
tart
cherry,
grape,
and
hop,
dried
cones.
Interregional
Research
Project
Number
(
IR­
4)
requested
these
tolerances
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
29,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0218,
must
be
received
on
or
before
November
28,
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:
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9368;
e­
mail
address:
Jamerson.
Hoyt@
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
 
0218.
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
May
30,
2003
(
68
FR
32497)
(
FRL
 
7295
 
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
pesticide
petitions
(
PP
1E6302
and
2E6474)
by
the
Interregional
Research
Project
Number
(
IR­
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902.
That
notice
included
a
summary
of
the
petitions
prepared
by
Dow
AgroSciences
LCC,
the
registrant.
The
comment
period
ended
June
30,
2003.
The
petitions
requested
that
40
CFR
180
be
amended
by
establishing
tolerances
for
residues
of
the
fungicide
quinoxyfen,
5,7­
dichloro­
4­(
4­
fluorophenoxy)
quinoline,
in
or
on
grape
at
0.70
parts
per
million
(
ppm)
(
1E6302);
hop,
dried
cones
at
5
ppm
(
1E6302);
and
cherry
at
0.4
ppm
(
2E6474).
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
tolerances
for
residues
of
quinoxyfen,
5,7­
dichloro­
4­(
4­
fluorophenoxy)
quinoline
in
or
on
cherry,
sweet
at
0.30
ppm;
cherry,
tart
at
0.30
ppm;
grape
at
0.60
ppm;
and
hop,
dried
cones
at
3.0
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
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Federal
Register
/
Vol.
68,
No.
188
/
Monday,
September
29,
2003
/
Rules
and
Regulations
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
quinoxyfen
are
discussed
below
and
summarized
in
Table
1
of
this
unit
as
well
as
the
noobserved
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observed­
adverse­
effectlevel
(
LOAEL)
from
the
toxicity
studies
reviewed.
The
primary
target
organs
affected
by
quinoxyfen
are
the
liver
and
kidney.
Liver
effects
were
seen
in
rat
and
mouse
subchronic
and
dog
chronic
studies.
Subchronic
effects
in
rats
and
mice
included
increased
liver
weights,
hepatocellular
hypertrophy
and
individual
cell
hepatocellular
necrosis.
These
effects
were
noted
at
high
doses
and
not
observed
in
the
chronic
rat
and
mouse
studies
since
they
were
performed
at
lower
doses.
Chronic
effects
in
the
dog
included
increased
liver
weights,
increased
alkaline
phosphatase
levels
and
increased
incidences
of
slight
microscopic
hepatic
lesions
(
increased
bile
in
canaliculi
and
increased
hepatocyte
size).
Kidney
effects
were
noted
only
in
the
rat
combined
chronic/
carcinogenicity
study
which
resulted
in
an
increased
severity
of
chronic
progressive
glomerulonephropathy
in
the
males.
Rabbits
were
much
more
susceptible
to
the
effects
of
quinoxyfen
than
any
other
species.
Systemic
effects
observed
in
the
rabbit
developmental
study
included
inanition,
loss
of
body
weight,
perineal
soiling,
blood
in
the
cage
pan
associated
with
urine,
and
abortions.
Body
weight
decrements
were
noted
in
the
rat
and/
or
mouse
subchronic,
chronic
and
carcinogenicity
studies
and
the
rabbit
developmental
and
rat
reproduction
studies.
No
effects
were
noted
via
the
dermal
route.
No
evidence
of
neurotoxicity
or
neuropathology
was
seen
in
any
of
the
submitted
studies,
including
the
acute
and
subchronic
neurotoxicity
studies.
There
was
no
evidence
of
carcinogenic
potential
in
either
the
rat
chronic
toxicity/
carcinogenicity
or
mouse
carcinogenicity
studies
and
no
concern
for
mutagenicity.
There
was
no
evidence
of
increased
susceptibility
in
the
oral
rat
or
rabbit
developmental
studies.
There
was
an
increased
quantitative
susceptibility
of
young
animals
following
pre/
postnatal
exposure
to
rats
in
the
reproduction
study.
In
this
study,
no
maternal
effects
were
observed
up
to
the
highest
dose
tested
(
100
milligrams/
kilograms/
day
(
mg/
kg/
day));
however,
minimally
reduced
F1a
pup
weights
were
noted
at
100
mg/
kg/
day.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
(
rat)
NOAEL
=
10
mg/
kg/
day
LOAEL
=
100
mg/
kg/
day
based
on
decreased
body
weight
gain
in
females,
increased
liver
weights
in
males
and
slight
hepatocellular
hypertrophy
(
centrilobular
and
midzonal;
both
sexes)

870.3100
90
 
Day
oral
toxicity
rodents
(
mouse)
NOAEL
=
100
mg/
kg/
day
LOAEL
=
500
mg/
kg/
day
based
on
increased
liver
weights,
individual
cell
hepatocellular
necrosis
and
hepatocellular
hypertrophy
in
both
sexes
870.3150
90
 
Day
oral
toxicity
in
nonrodents
(
dog)
NOAEL
=
100
mg/
kg/
day
LOAEL
=
Not
identified
870.3200
28
 
Day
dermal
toxicity
(
rat)
NOAEL
=
1,000
mg/
kg/
day
LOAEL
=
Not
identified
870.3700
Prenatal
developmental
in
rodents
(
rat)
Maternal
NOAEL
=
1,000
mg/
kg/
day
LOAEL
=
Not
identified
Developmental
NOAEL
=
1,000
mg/
kg/
day
LOAEL
=
Not
identified
870.3700
Prenatal
developmental
in
nonrodents
(
rabbit)
Maternal
NOAEL
=
80
mg/
kg/
day
LOAEL
=
200
mg/
kg/
day
based
on
inanition,
clinical
signs,
decreased
body
weights,
body
weight
gains,
and
food
consumption
and
on
increased
incidences
of
abortion
Developmental
NOAEL
=
80
mg/
kg/
day
LOAEL
=
200
mg/
kg/
day
based
on
increased
incidences
of
abortion
870.3800
Reproduction
and
fertility
effects
(
rat)
Parental/
Systemic
NOAEL
=
100
mg/
kg/
day
LOAEL
=
Not
identified
Reproductive
NOAEL
=
100
mg/
kg/
day
LOAEL
=
Not
identified
Offspring
NOAEL
=
20
mg/
kg/
day
LOAEL
=
100
mg/
kg/
day
based
on
a
minimal
decrease
in
F1a
pup
weights
870.4100
Chronic
toxicity
rodents
See
870.4300
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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.4100
Chronic
toxicity
dogs
NOAEL
=
20
mg/
kg/
day
LOAEL
=
200
mg/
kg/
day
based
on
increased
alkaline
phosphatase,
increased
absolute
and
relative
(
to
body)
liver
weights,
and
an
increased
incidence
of
very
slight
to
slight
microscopic
hepatic
lesions
870.4200
Carcinogenicity
rats
See
870.4300
870.4200
Carcinogenicity
mouse
NOAEL
=
80
mg/
kg/
day
LOAEL
=
250
mg/
kg/
day
based
on
decreased
body
weight
gain
in
both
sexes
No
evidence
of
carcinogenicity
870.4300
Combined
chronic/
carcinogenicity
(
rat)
NOAEL
=
20
mg/
kg/
day
LOAEL
=
80
mg/
kg/
day
based
on
increases
in
severity
of
chronic
progressive
glomerulonephropathy
in
the
males
and
minimal
decreases
in
body
weight
and
body
weight
gain
in
the
males
and
females
No
evidence
of
carcinogenicity
870.5100
Gene
mutation
(
bacterial
reverse
mutation)
Negative
for
inducing
reverse
mutation
in
bacteria
exposed
to
doses
up
to
5,000
µ
g/
plate
(­
S9)
and
1,000
µ
g/
plate
(+
S9)

870.5300
Gene
mutation
(
In
vitro
mammalian
cell
gene
mutation)
Negative
for
inducing
forward
mutation
in
CHO
(
mammalian)
cells
treated
up
to
20
µ
g/
ml
(­
S9)
and
80
µ
g/
ml
(+
S9)

870.5375
Cytogenetics
(
In
vitro
mammalian
chromosome
aberration
(
RL))
Negative
up
to
100
µ
g/
ml
(­
S9
and
+
S9)

870.5395
Cytogenetics
(
mammalian
micronucleus
(
mouse))
Negative
up
to
5,000
mg/
kg
870.6200
Acute
neurotoxicity
screening
battery
(
rat)
NOAEL
=
2,000
mg/
kg
LOAEL
=
Not
identified
870.6200
Subchronic
neurotoxicity
screening
battery
NOAEL
=
80
mg/
kg/
day
LOAEL
=
Not
identified
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29,
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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.7485
Metabolism
and
pharmacokinetics
(
rat)
Quinoline­
labeled
and
phenyl­
labeled
quinoxyfen
were
rapidly
absorbed
with
approximately
68­
85%
of
the
administered
dose
being
eliminated
within
24
hours.
Overall
recovery
of
the
dosed
radioactivity
ranged
from
83.5­
96.2%.
Sex,
dose,
and
multiple
dosing
had
little
or
no
effect
on
the
excretion
profile
at
48
hours
post­
dosing.
Changing
the
position
of
the
14C­
label
altered
the
pattern
of
excretion.
The
major
route
of
elimination
was
through
the
urine
in
the
phenyl­
labeled
test
substance
(
44.9­
48.7%
of
dose
in
urine
and
38.2­
39.8%
of
dose
in
feces)
and
through
the
feces
in
the
quinoline­
labeled
test
substance
(
65.8­
78.3%
of
dose
in
feces
and
13.4­
19.7%
of
dose
in
urine).
Biliary
excretion
increased
its
contribution
to
fecal
radioactivity
as
the
dose
increased.
Concentrations
of
radioactivity
in
the
tissues
were
generally
slightly
lower
in
the
males
than
females
and
in
the
low­
dose
compared
to
the
high­
dose
group.
The
highest
concentrations
of
radioactivity
were
found
in
the
kidney,
liver,
ovaries,
perirenal
fat,
GI
tract
and
carcass.
Maximum
plasma
concentration
occurred
between
0.5
and
1.5
hours,
and
elimination
half­
lives
were
<=
1
hour
and
15­
19
hours
(
10
mg/
kg
group)
and
2­
3
hours
and
18­
22
hours
(
500
mg/
kg
group).
The
presence
of
several
radioactive
components
was
determined
in
the
unhydrolyzed
urine
(
up
to
12),
fecal
extracts
(
up
to
8),
and
bile
(
up
to
6).
No
differences
in
the
metabolite
profile
were
observed
that
were
related
to
sex
or
multiple
dosing
Increasing
amounts
of
the
parent
compound
were
found
in
the
feces
with
increasing
dose.
No
other
dose­
related
differences
were
observed.
Identified
metabolites
accounted
for
41.0­
42.8%
dose
in
the
[
Phenyl­
U­
14C]
XDE­
795
treated
group,
and
only
17.0­
31.7%
dose
in
the
other
treated
groups.
The
[
Phenyl­
U­
14C]
XDE­
795
treated
group
had
no
urinary
metabolites
in
common
with
the
[
2­
Quinoline­
14C]
XDE­
795
treated
groups
suggesting
cleavage
of
the
parent
molecule
An
acid­
labile
conjugate
of
4­
fluorophenol
was
found
in
the
urine
of
the
[
Phenyl­
U­
14C]
XDE­
795
treated
group
(
28.7­
32.8%
dose).
5,7­
Dichloro­
4­
hydroxyquinoline
was
observed
in
the
urine
of
the
[
2­
Quinoline­
14C]
XDE­
795
treated
groups
in
small
quantities
(
0.7­
1.7%
dose).
Thus,
the
identified
metabolites
in
the
urine
followed
diaryl­
ether
cleavage
of
the
parent
compound.
Fluorophenyl­
ring­
OH­
XDE­
795
(
two
isomers)
were
found
in
the
feces
of
all
treated
groups
(
5.4­
10.6%
dose).
In
the
bile
of
the
treated
groups,
two
major
metabolites
were
identified,
a
glucuronide
and/
or
sulfate
conjugate(
s)
of
the
two
isomers
of
fluorophenyl
ring­
hydroxy­
XDE­
795
(
9­
19%
dose)
and
an
unidentified
metabolite
(
13­
21%
dose).

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
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
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
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and
Regulations
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.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
quinoxyfen
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
QUINOXYFEN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
(
females
13­
50
years
of
age)
and
acute
dietary
(
general
population
including
infants
and
children)
Not
applicable
Not
applicable
There
were
no
toxic
effects
attributable
to
a
single
dose.
Therefore,
an
endpoint
of
concern
was
not
identified
to
quantitate
acute­
dietary
risk
to
the
general
population
or
to
the
subpopulation
females
13­
50
years
old
Chronic
dietary
(
all
populations
NOAEL=
20
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.20
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD/
FQPA
SF
=
0.20
mg/
kg/
day
Combined
chronic
toxicity/
carcinogenicity
study
in
rat
LOAEL
=
80
mg/
kg/
day,
based
upon
increases
in
severity
of
chronic
progressive
glomerulonephropathy
in
the
males
and
minimal
decreases
in
body
weight
and
body
weight
gain
in
both
sexes
Cancer
(
oral,
dermal,
inhalation
Classified
as
not
likely
to
be
carcinogenic
to
humans
Not
applicable
No
evidence
of
carcinogenicity
in
rats
and
mice
*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Quinoxyfen
is
a
new
chemical
and
therefore,
these
are
the
first
tolerances
to
be
established
for
the
residues
of
quinoxyfen.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
quinoxyfen
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.
There
were
no
toxic
effects
attributable
to
a
single
dose.
Therefore,
an
endpoint
of
concern
was
not
identified
to
quantitate
acute­
dietary
risk
to
the
general
population
or
to
the
subpopulation
females
13
 
50
years
old.
As
a
result,
no
acute
risk
is
expected
from
exposure
to
quinoxyfen
and
hence
no
quantitative
acute
dietary
risk
assessment
was
performed.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment,
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCIDTM
)
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
An
unrefined,
Tier
1
chronic­
dietary
exposure
assessment
using
tolerancelevel
residues
and
assuming
100%
CT
for
all
proposed
commodities,
and
default
DEEM
Version
7.76
processing
factors
for
all
commodities.
iii.
Cancer.
Quinoxyfen
has
been
classified
as
not
likely
to
be
carcinogenic
to
humans.
Therefore,
a
quantitative
risk
assessment
was
not
conducted
to
assess
cancer
risk.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
quinoxyfen
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
quinoxyfen.
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
Screening
Concentrations
in
Ground
Water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
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
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Rules
and
Regulations
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
Both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
and
both
models
include
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
quinoxyfen,
they
are
further
discussed
in
the
aggregate
risk
sections
see
Unit
E.
Based
on
the
FIRST
and
SCI­
GROW
models,
the
EECs
of
quinoxyfen
for
chronic
exposures
are
estimated
to
be
0.8
parts
per
billion
(
ppb)
for
surface
water
and
0.006
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).
Quinoxyfen
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
effects
from
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
quinoxyfen
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
quinoxyfen
and
any
other
substances
and
quinoxyfen
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
quinoxyfen
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
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
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.
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
and
rabbit
fetuses
to
in
utero
exposure
in
developmental
studies.
There
is
evidence
of
increased
quantitative
susceptibility
(
minimal
decrease
in
F1a
pup
weights)
in
the
rat
multi­
generation
reproduction
study,
but
the
concern
is
low
since:
(
1)
The
effects
in
pups
are
well­
characterized
with
a
clear
NOAEL;
(
2)
the
pup
effects
are
minimal
at
the
LOAEL
and
only
noted
in
the
first­
generation
offspring;
and
(
3)
the
doses
and
endpoints
selected
for
regulatory
purposes
would
address
the
concerns
of
the
pup
effects
noted
in
the
rat
reproduction
study.
Therefore,
there
are
no
residual
uncertainties
for
prenatal/
postnatal
toxicity
in
this
study.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
quinoxyfen
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
There
are
no
residual
uncertainties
for
prenatal/
postnatal
toxicity.
No
additional
safety
factor
is
needed
for
data
base
uncertainties.
No
clinical
sign
of
neurotoxicity
or
neuropathology
was
seen
in
the
data
base.
A
developmental
neurotoxicity
study
is
not
required.
Therefore,
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
reduced
to
1X.

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
youth),
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
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
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29,
2003
/
Rules
and
Regulations
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
EPA
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.
An
endpoint
of
concern
was
not
identified
to
quantitate
acutedietary
risk
to
the
general
population
or
to
the
subpopulation
females
13
 
50
years
old.
As
a
result,
no
acute
risk
is
expected
from
exposure
to
quinoxyfen.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
quinoxyfen
from
food
will
utilize
less
than
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
(
1
 
2
years
old),
the
children
subpopulation
at
greatest
exposure.
There
are
no
residential
uses
for
quinoxyfen
that
result
in
chronic
residential
exposure
to
quinoxyfen.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
quinoxyfen
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
3
of
this
unit:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
QUINOXYFEN
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.20
<
1%
0.8
0.006
7,000
All
infants
(<
1
year
old)
0.20
1%
0.8
0.006
2,000
Children
(
1­
2
years
old)
0.20
1%
0.8
0.006
2,000
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).
Quinoxyfen
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
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).
Quinoxyfen
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
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.
Quinoxyfen
has
been
classified
as
not
likely
to
be
carcinogenic
to
humans.
Therefore,
quinoxyfen
is
not
expected
to
pose
a
cancer
risk.
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
quinoxyfen
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
IR­
4
has
proposed
a
gas
chromatography
(
GC)
method
with
mass­
selective
detection
(
MSD)
entitled
Determination
of
DE­
795
Residues
in
Grape
Wine,
Must,
and
Pomace
ERC95.26
(
and
its
supplement
S1)
for
the
enforcement
of
proposed
tolerances
for
residues
of
quinoxyfen
in/
on
grapes,
cherries,
and
hops.
Method
ERC
95.26
is
classified
as
acceptable
and
conforms
with
the
criteria
of
OPPTS
Harmonized
Guideline
860.1340.
The
petitioner
has
submitted
a
study
which
investigated
the
behavior
of
quinoxyfen
through
MRMs
outlined
in
FDA's
Pesticide
Analytical
Manual
(
PAM),
Volume
I,
Appendix
II.
The
study
summary
reported
that
depending
on
spike
levels,
certain
MRM
Protocols
(
D,
E,
and
F)
yielded
partial
(
incomplete)
to
complete
recoveries
of
quinoxyfen
in
grapes
(
nonfatty
matrix)
and
ground
beef
(
fatty
matrix).
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
email
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
There
are
no
Mexican,
Canadian
or
Codex
maximum
residue
limits
established
for
quinoxyfen
on
sweet
and
tart
cherries,
grapes,
or
hops.
Therefore,
no
compatibility
problems
exist
for
these
tolerances.

V.
Conclusion
Therefore,
tolerances
are
established
for
quinoxyfen,
5,7­
dichloro­
4­(
4­
fluorophenoxy)
quinoline
in
or
on
cherry,
sweet
at
0.30
ppm;
cherry,
tart
at
0.30
ppm;
grape
at
0.60
ppm;
and
hop,
dried
cone
at
3.0
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
 
0218
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
28,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
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Rules
and
Regulations
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
 
0218,
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).

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''

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29,
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/
Rules
and
Regulations
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
recordkeeping
requirements.

Dated:
September
23,
2003.
James
Jones,
Director,
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
180.588
is
added
to
subpart
C
to
read
as
follows:

§
180.588
Quinoxyfen;
tolerances
for
residues.

(
a)
General.
Tolerances
are
established
for
residues
of
the
fungicide
quinoxyfen,
5,7­
dichloro­
4­(
4­
fluorophenoxy)
quinoline
in
or
on
the
following
raw
agricultural
commodities:

Commodity
Parts
per
million
Cherry,
sweet
...............................................................................................................................
0.30
Cherry,
tart
...................................................................................................................................
0.30
Hop,
dried
cones
.........................................................................................................................
3.0
Grape
...........................................................................................................................................
0.60
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]

[
FR
Doc.
03
 
24561
Filed
9
 
26
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0315;
FRL
 
7328
 
6]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
combined
residues
of
sethoxydim
(
2­[
1­(
ethoxyimino)
butyl]­
5­
[
2­(
ethylthio)
propyl]­
3­
hydroxy­
2­
cyclohexen­
1­
one)
and
its
metabolites
containing
the
2­
cyclohexen­
1­
one
moiety
(
calculated
as
the
herbicide)
in
or
on
corn,
sweet,
forage;
corn,
sweet,
stover;
juneberry;
lingonberry;
pistachio;
salal;
and
safflower
and
increases
the
tolerance
on
cattle,
meat
by
products;
corn,
sweet,
kernels
plus
cob
with
husk
removed;
goat,
meat
byproducts;
hog,
meat
byproducts;
horse,
meat
byproducts;
milk;
and
sheep,
meat
byproducts.
BASF
Corporation
requested
the
tolerances
for
corn,
sweet,
forage;
corn,
sweet,
stover
and
the
increase
in
tolerance
for
corn,
sweet,
kernels
plus
cob
with
husk
removed;
milk;
and
meat
products
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
Interregional
Project
#
4
(
IR­
4)
requested
the
tolerances
on
juneberry,
lingonberry,
pistachio,
salal,
and
safflower
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
29,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0315,
must
be
received
on
or
before
November
28,
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)
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
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