Document ID: EPA-HQ-OPP-2003-0219-0001
Agency: epa
Document Type: Rule
Title: Cymoxanil; Pesticide Tolerances
Posted Date: 2003-07-16T04:00Z

41927
Federal
Register
/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Rules
and
Regulations
provided
by
the
CRA
if
the
agency
makes
a
good
cause
finding
that
notice
and
public
procedure
is
impracticable,
unnecessary
or
contrary
to
the
public
interest.
This
determination
must
be
supported
by
a
brief
statement
(
5
U.
S.
C.
808(
2)).
As
stated
previously,
EPA
has
made
such
a
good
cause
finding,
including
the
reasons
therefore,
and
established
an
effective
date
of
July
16,
2003.
The
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.
The
EPA's
compliance
with
these
Executive
Orders
and
statutes
fo
the
underlying
rule
is
discussed
in
the
January
21,
2003,
Federal
Register
notice
containing
the
Allowance
System
for
Controlling
HCFC
Production,
Import
and
Export
final
rule
(
68
FR
2820).

List
of
Subjects
in
40
CFR
Part
82
Environmental
protection,
Administrative
practice
and
procedure,
Air
pollution
control,
Chemicals,
Chlorofluorocarbons,
Exports,
Hydrochlorofluorocarbons,
Imports,
Reporting
and
recordkeeping
requirements.

Dated:
July
7,
2003.

Jeffrey
R.
Holmstead,

Assistant
Administrator
for
the
Office
of
Air
and
Radiation.


For
the
reasons
stated
in
the
preamble,
40
CFR
part
82
is
amended
as
follows:

PART
82
 
PROTECTION
OF
STRATOSPHERIC
OZONE

1.
The
authority
citation
for
part
82
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7414,
7601,
7671
 
7671q.


2.
In
§
82.4
paragraph
(
n)
introductory
text
is
amended
by
revising
the
reference
``(
t)(
2)
and
(
t)(
3)''
to
read
``(
n)(
2)
and
(
n)(
3)''
and
revising
the
reference
``(
t)(
1)(
i)
through
(
iii)''
to
read
``(
n)(
1)(
i)
through
(
iii).''


3.
In
§
82.4(
n)(
4),
revise
the
reference
``(
t)(
3)''
to
read
``(
n)(
3)''
and
the
reference
``(
t)(
1)''
to
read
``(
n)(
1).''

[
FR
Doc.
03
 
18000
Filed
7
 
15
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0219;
FRL
 
7313
 
6]

Cymoxanil;
Pesticide
Tolerances
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
cymoxanil
in
or
on
hop,
dried
cones;
lettuce,
head;
imported
lychee;
vegetable,
cucurbit,
group
9;
and
vegetable,
fruiting,
group
8.
The
Interregional
Research
Project
Number
4
(
IR­
4),
the
Taipai
Economic
and
Cultural
Representative
Office,
and
E.
I
du
Pont
Nemours
and
Company
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
EPA
is
also
deleting
the
time­
limited
tolerance
for
hop,
dried
cones
established
in
connection
with
use
of
the
pesticide
under
section
18
emergency
exemptions
and
the
tolerance
for
imported
tomato.
These
tolerances
are
no
longer
needed
since
this
rule
establishes
tolerances
in
support
of
the
U.
S.
registration
for
hops
and
tomato.
DATES:
This
regulation
is
effective
July
16,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0219,
must
be
received
on
or
before
September
15,
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:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja]@
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
 
0219.
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
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Federal
Register
/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Rules
and
Regulations
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
July
6,
2001
(
66
FR
130)
(
FRL
 
6784
 
9)
and
February
28,
2003
(
68
FR
9660)
(
FRL
 
7288
 
9),
EPA
issued
notices
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
(
1E6224)
by
IR­
4,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390;
PP
1E6233
from
the
Taipai
Economic
and
Cultural
Representative
Office,
4301
Connecticut
Ave.,
NW
Suite
420,
Washington,
DC
20008;
and
PP
0F6072
from
E.
I.
duPont
de
Nemours
and
Company,
DuPont
Agricultural
Products,
Barley
Mill
Plaza,
Wilmington,
DE
19880
 
0038.
Those
notices
included
summaries
of
the
petitions
prepared
by
E.
I.
duPont
de
Nemours
and
Company,
DuPont
Agricultural
Products,
the
registrant.
The
petitions
requested
that
40
CFR
180.503
be
amended
by
establishing
tolerances
for
residues
of
the
fungicide
cymoxanil,
[
2­
cyano­
N­
[(
ethylamino)
carbonyl]­
2­
(
methoxyimino)
acetamide],
in
or
on
hop
at
1.0
part
per
million
(
ppm)
(
PP
1E6224);
lettuce,
head
at
4.0
ppm
(
PP
6F6072);
imported
lychee
at
1.0
ppm
(
PP
1E6233);
vegetable,
cucurbit,
group
at
0.05
ppm
(
PP
0F6072);
and
vegetable,
fruiting,
group
at
0.2
ppm
(
PP
0F6072).
The
World
Wildlife
Fund
(
WWF)
submitted
comments
on
August
7,
2001
in
response
to
the
notice
of
filing
for
hops
and
lychee.
WWF
urged
EPA
to
apply
the
full
10X
FQPA
safety
factor
to
cymoxanil
``
because
completed
studies
for
this
fungicide
are
inadequate
to
detect
endocrine
disruption
and
the
endocrine
disruptor
data
gap
is
of
critical
importance
when
determining
a
reasonable
certainty
of
no
harm
to
embryos,
fetus,
infants
and
children.''
In
addition,
WWF
stated
that
there
may
be
evidence
of
increased
developmental
susceptibility
for
cymoxanil.
EPA
reviewed
the
comments
submitted
by
WWF
and
has
addressed
them
in
Unit
III.
D.
of
this
document.
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
November
26,
1997
(
62
FR
62961)
(
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
cymoxanil
on
hop,
dried
cones
at
1.0
ppm;
lettuce,
head
at
4.0
ppm;
vegetable,
cucurbit,
group
9
at
0.05
ppm;
vegetable,
fruiting,
group
8
at
0.2
ppm;
and
imported
lychee
at
1.0
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
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
cymoxanil
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
(
rat)
Systemic
toxicity
NOAEL
=
47.6
milligrams/
kilogram/
day
(
mg/
kg/
day)
in
males
and
59.9
mg/
kg/
day
in
females
Systemic
toxicity
LOAEL
=
102
mg/
kg/
day
in
males
and
137
mg/
kg/
day
in
females
based
on
decreases
in
body
weights,
body
weight
gains
and
food
efficiency
in
the
females,
and
body
weight
decreases
and
testicular
and
epididymal
changes
in
males.

870.3150
90
 
Day
oral
toxicity
in
nonrodents
(
dog)
Systemic
toxicity
NOAEL
not
established
Systemic
toxicity
LOAEL
=
3
mg/
kg/
day,
based
on
decreased
body
weights
(
13%)
and
food
consumption
in
females.

870.3200
21/
28
 
Day
dermal
toxicity
(
rat)
Systemic
and
dermal
toxicity
NOAEL
=
1,000
mg/
kg/
day,
highest
dose
tested
(
HDT)
Systemic
and
dermal
toxicity
LOAEL
was
not
established.

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/
Vol.
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No.
136
/
Wednesday,
July
16,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3700
Prenatal
developmental
in
rodents
(
rat)
Maternal
NOAEL
=
25
mg/
kg/
day
Maternal
LOAEL
=
75
mg/
kg/
day,
based
upon
reduced
body
weight,
body
weight
change
and
food
consumption
Developmental
NOAEL
=
10
mg/
kg/
day
Developmental
LOAEL
=
25
mg/
kg/
day,
based
upon
significant
increase
in
overall
malformations,
and
generalized
dose­
related
delay
in
skeletal
ossification;
at
75
and
150
mg/
kg/
day
significant
decrease
in
fetal
body
weights;
at
150
mg/
kg/
day
increased
early
resorptions
resulting
in
reduced
litter
size.

870.3700
Prenatal
developmental
in
nonrodents
(
rabbit)
Maternal
NOAEL
32
mg/
kg/
day
Maternal
LOAEL
was
not
established
Developmental
NOAEL
=
4
mg/
kg/
day
Developmental
LOAEL
=
8
mg/
kg/
day,
based
upon
an
increase
in
skeletal
anomalies
of
the
cervical
and
thoracic
vertebrae
and
ribs;
at
32
mg/
kg/
day,
cleft
palate
was
also
observed.

870.3800
2­
Generation
reproduction
and
fertility
effects
(
rat)
Systemic
toxicity
NOAEL
=
6.5
males
and
7.9
females
mg/
kg/
day
Systemic
toxicity
LOAEL
=
32.1
males
and
40.6
females
mg/
kg/
day,
based
on
reduced
pre­
mating
body
weight,
body
weight
gain,
and
food
consumption
for
P
males;
and
decreased
gestation
and
lactation
body
weight
for
F1
females
Reproductive
toxicity
NOAEL
97.9
mg/
kg/
day
for
males
and
130
mg/
kg/
day
for
females.
Reproductive
toxicity
LOAEL
was
not
established
Offspring
toxicity
NOAEL
=
6.5
males
and
7.9
females
mg/
kg/
day
Offspring
toxicity
LOAEL
=
32.1
female
and
40.6
females
mg/
kg/
day,
based
upon
decreased
F1
pup
viability
on
postnatal
days
0
 
4
and
on
a
significant
reduction
in
F2b
pup
weight.

870.4100
Chronic
toxicity
(
dog)
Systemic
toxicity
NOAEL
=
3.0/
3.1
mg/
kg/
day
for
males/
and
females
Systemic
toxicity
LOAEL
=
5.7
mg/
kg/
day
(
HDT
in
males),
based
upon
depressed
weight
gains
through
week
12
and
changes
in
the
hematology
and
blood
chemistry
in
males
LOAEL
was
not
established
for
females.

870.4300
Combined
chronic
toxicity/
carcin
ogenicity
rodents
(
rat)
Systemic
toxicity
NOAEL
=
4.08
mg/
kg/
day
for
males
and
5.36
mg/
kg/
day
for
females
Systemic
toxicity
LOAEL
=
30.3
mg/
kg/
day
for
males
and
38.4
mg/
kg/
day
for
females
based
upon
decreased
body
weight,
body
weight
gain,
and
food
efficiency
increased
incidence
of
elongate
spermatid
degeneration
and
increased
aggressiveness
and/
or
hyperactivity
in
males
and
increased
incidence
of
nonneoplastic
lesions
of
the
lungs,
liver,
sciatic
nerve
and
retinal
atrophy
in
females
No
evidence
of
carcinogenicity.

870.4200
Carcinogenicity
mice
Systemic
toxicity
NOAEL
=
4.19
mg/
kg/
day
for
males
and
5.83
mg/
kg/
day
for
females
lowest
dose
tested
(
LDT)
Systemic
toxicity
LOAEL
=
42
mg/
kg/
day
for
males
and
58.1
mg/
kg/
day
for
females
HDT,
based
upon
increased
frequency
of
sperm
cyst/
cystic
dilatation,
tubular
dilatation
and
lymphoid
aggregates
in
males
and
hyperplastic
gastropathy
in
females
No
evidence
of
carcinogenicity.

870.5100
Gene
mutation
Cytotoxicity
in
all
strains
was
seen
at
750
µ
g/
plate
­
S9
and
1.000
µ
g/
plate
+
S9.
The
positive
controls
induced
the
expected
mutagenic
responses
in
the
appropriate
tester
strain.
There
was,
however,
no
evidence
that
the
test
material
induced
a
mutagenic
effect
under
any
test
condition.

870.5300
In
vitro
mammalian
cell
gene
mutation
assay
(
CHO)
Severe
cytotoxicity
was
seen
at
750
µ
g/
mL
­
S9
and
1,000
µ
g/
mL
+
S9.
The
positive
controls
induced
the
expected
mutagenic
responses.
There
was,
however,
no
evidence
that
the
test
material
was
mutagenic
at
the
Hypoxanthine
Guanine
Phophoribosyl
Transferase
locus
at
any
dose
under
any
assay
condition.

8
70.6200
Subchronic
neurotoxicity
screening
battery
(
rat)
No
effects
on
the
functional
observation
battery,
or
motor
activity
were
observed.
No
treatment­
related
gross
or
microscopic
findings
in
the
nervous
system
or
skeletal
muscles
of
the
male
and
female
rats
were
observed
The
neurotoxicity
NOAEL
3,000
ppm
(
224
mg/
kg/
day
in
males
and
333
mg/
kg/
day
in
females;
HDT).
Neurotoxicity
LOAEL
was
not
established.

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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.6300
Developmental
neurotoxicity
(
rat)
Maternal
toxicity
NOAEL
=
50
mg/
kg/
day
Maternal
toxicity
LOAEL
=
100
mg/
kg/
day,
based
on
slight
decrease
body
weight,
body
weight
gains
(
17%)
and
food
consumption.
Offspring
NOAEL
=
50
mg/
kg/
day
Offspring
LOAEL
=
100
mg/
kg/
day,
based
on
decreased
pup
survival,
decreased
pup
weight
and
body
weight
gain
during
early
lactation
(
less
than
6%),
increases
in
morphometric
measurements
(
anterior/
posterior
cerebrum
for
males,
cerebellar
height
for
females)
at
PND
79
 
83,
and
decreased
retention
in
the
water
maze
task
for
adult
females
(
latency
158%
of
control
levels)
seen
at
the
LOAEL
of
100
mg/
kg/
day.

870.7485
Metabolism
and
pharmacokinetics
(
rat)
Cymoxanil
was
readily
absorbed
and
86
to
94%
of
the
administered
dose
was
excreted
in
96
hours.
The
majority
of
the
administered
dose
was
recovered
in
the
urine
(
64
­
57%)
with
smaller
amounts
excreted
in
the
feces
(
16
­
24%)
and
carcass
(<
1%).
There
were
no
sex­
related
differences
in
the
absorption,
distribution
and
metabolism
of
cymoxanil.
In
urine
about
37
­
55%
of
the
dose
was
free
and/
or
conjugated
[
14C]
glycine
and
2
cyano­
2­
methoxyiminoacetic
acid
(
IN­
W3595;
about
7
to
33%
of
the
dose).
Intact
cymoxanil
was
not
isolated
in
urine.
In
feces
intact
14C
cymoxanil
(<
1%)
and
IN
W3595
was
detected
but
the
majority
of
radioactivity
was
14C
glycine
(
about
9
­
13%).
Based
on
the
data,
the
metabolic
pathway
involves
hydrolysis
of
cymoxanil
to
IN
W3595,
which
is
then
degraded
to
glycine,
which
in
turn
is
incorporated
into
natural
constituents
or
further
metabolized.

B.
Toxicological
Endpoints
The
dose
at
which
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern.
However,
the
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
(
aRfD
or
cRfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factors
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
lever
of
concern.
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
lever
of
concern.
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
cymoxanil
used
for
human
risk
assessment
is
shown
in
the
following
Table
2.

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CYMOXANIL
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)
NOAEL
=
4
mg/
kg/
day
UF
=
100
aRfD
=
0.04
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
aRfD
FQPA
SF
=
0.04
mg/
kg/
day
Developmental
toxicity
study
­
rabbit
Developmental
LOAEL
=
8
mg/
kg/
day
based
on
increased
skeletal
anomalies
of
the
cervical
and
thoracic
vertebrae
(
hemivertebrae)
and
ribs;
at
32
mg/
kg/
day,
cleft
palate
was
also
observed.

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Vol.
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16,
2003
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Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CYMOXANIL
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
(
general
population
including
infants
and
children)
NA
NA
An
effect
attributable
to
a
single
exposure
was
not
observed
in
the
oral
toxicity
studies,
including
the
developmental
toxicity
studies
in
rats
and
rabbits
Therefore,
an
aRfD
was
not
established
for
this
population.

Chronic
dietary
(
all
populations)
NOAEL
=
4
mg/
kg/
day
UF
=
100
cRfD
=
0.04
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD
FQPA
SF
=
0.04
mg/
kg/
day
Combined
chronic
toxicity/
carcinogenicity
study
­
rat
Systemic
LOAEL
=
30.3
mg/
kg/
day
based
on
decreases
in
body
weight,
body
weight
gain,
reduced
food
efficiency
and
histopathological
lesions
in
the
eyes
and
testes
of
males.

Short­
term
dermal
(
1
to
30
days)
(
Residential)
Oral
study
NOAEL
=
4
mg/
kg/
day
(
Dermal
absorption
rate
=
2.5%)
LOC
for
MOE
=
100
(
Residential)
Developmental
toxicity
study
­
rabbit
Developmental
LOAEL
=
8
mg/
kg/
day
based
on
increased
skeletal
anomalies
of
the
cervical
and
thoracic
vertebrae
(
hemivertebrae)
and
ribs;
at
32
mg/
kg/
day,
cleft
palate
was
also
observed.

Intermediate­
term
dermal
(
1
to
6
months)
(
Residential)
Oral
study
NOAEL
=
4
mg/
kg/
day
(
Dermal
absorption
rate
=
2.5%
LOC
for
MOE
=
100
(
Residential)
Developmental
toxicity
study
­
rabbit
Developmental
LOAEL
=
8
mg/
kg/
day
based
on
increased
skeletal
anomalies
of
the
cervical
and
thoracic
vertebrae
(
hemivertebrae)
and
ribs;
at
32
mg/
kg/
day,
cleft
palate
was
also
observed.

Long­
term
dermal
(>
6
months)
(
Residential)
Oral
study
NOAEL=
4
mg/
kg/
day
(
Dermal
absorption
rate
=
2.5%
when
appropriate)
LOC
for
MOE
=
100
(
Residential)
Combined
chronic
toxicity/
carcinogenicity
study
­
rat
Systemic
LOAEL
=
30.3
mg/
kg/
day
based
on
decreases
in
body
weight,
body
weight
gain,
reduced
food
efficiency
and
histopathological
lesions
in
the
eyes
and
testes
of
males.

Short­
term
inhalation
(
1
to
30
days)
(
Residential)
Oral
study
NOAEL=
4
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Developmental
toxicity
study
­
rabbit
Developmental
LOAEL
=
8
mg/
kg/
day
based
on
increased
skeletal
anomalies
of
the
cervical
and
thoracic
vertebrae
and
ribs;
at
32
mg/
kg/
day,
cleft
palate
was
also
observed.

Intermediate­
term
inhalation
(
1
to
6
months)
(
Residential)
Oral
study
NOAEL
=
4
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Developmental
toxicity
study
­
rabbit
Developmental
LOAEL
=
8
mg/
kg/
day
based
on
increased
skeletal
anomalies
of
the
cervical
and
thoracic
vertebrae
and
ribs;
at
32
mg/
kg/
day,
cleft
palate
was
also
observed.

Long­
term
inhalation
(>
6
months)

(
Residential)
Oral
study
NOAEL=
4
mg/
kg/
day
(
Inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
Combined
chronic
toxicity/
carcinogenicity
study
­
rat
Systemic
LOAEL
=
30.3
mg/
kg/
day
based
on
decreases
in
body
weight,
body
weight
gain,
reduced
food
efficiency
and
histopathological
lesions
in
the
eyes
and
testes
of
males.

Cancer
(
oral,
dermal,
inhalation)
NA
NA
Classification:
not
likely
human
carcinogen
Q1*
=
none.

*
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
180.503)
for
the
residues
of
cymoxanil,
in
or
on
a
variety
of
raw
agricultural
commodities.
A
permanent
tolerance
of
0.05
ppm
for
residues
of
cymoxanil
per
se
in/
on
potatoes
has
been
established
under
40
CFR
180.503(
a).
A
time­
limited
tolerance
of
1
ppm
for
residues
of
cymoxanil
per
se
in/
on
hops,
dried
has
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Rules
and
Regulations
also
been
established
under
40
CFR
180.503(
b)
in
connection
with
EPA's
granting
of
a
section
18
emergency
exemption.
The
time­
limited
tolerance
for
hops,
dried
cone
was
set
to
expire
December
31,
2003.
Tolerances
for
residues
of
cymoxanil
per
se
in/
on
imported
grapes
and
tomatoes
at
0.1
ppm
are
established
under
40
CFR
180.503(
e).
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
cymoxanil
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
 
day
or
single
exposure.
In
conducting
the
acute
dietary
exposure
assessment
EPA
used
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Data
base
(
FCDI
DEEMTM)
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
United
States
Department
of
Agriculture
(
USDA)
1994
 
1996,
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
acute
dietary
exposure
analyses
assumed
tolerance
level
residues,
100%
crop
treated
and
DEEMTM
(
ver.
7.76)
default
processing
factors
for
all
registered/
proposed
commodities.
ii.
Chronic
exposure.
In
conducting
the
chronic
dietary
exposure
assessments
EPA
used
the
DEEMTM
software
with
the
FCID
which
incorporates
food
consumption
data
as
reported
by
respondents
in
the
USDA
1994
 
l996,
and
1998
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
The
chronic
dietary
exposure
analyses
assumed
tolerance
level
residues,
100%
CT,
and
DEEMTM
(
ver.
7.76)
default
processing
factors
for
all
registered/
proposed
commodities.
iii.
Cancer.
In
accordance
with
the
EPA
Draft
Guidelines
for
Carcinogen
Risk
Assessment
(
July
1999),
the
Agency
classified
cymoxanil
as
a
``
not
likely''
human
carcinogen.
Therefore,
a
cancer
dietary
exposure
analysis
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
cymoxanil
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
cymoxanil.
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(
GENEEC)
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
Screening
Concentration
in
Ground
water
(
SCI­
GROW),
which
predicts
pesticide
concentrations
in
ground
water.
In
general,
EPA
will
use
GENEEC
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
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.
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
cymoxanil
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
II.
E.
Cymoxanil
appears
to
be
mobile
in
soils.
However,
the
rapid
dissipation
of
cymoxanil
in
the
environment
precludes
the
possibility
of
extensive
leaching.
No
detections
of
cymoxanil
were
observed
below
the
0
 
15
cm
soil
depth
at
any
of
the
test
sites.
Though
the
degradates
of
cymoxanil
are
mobile,
the
aerobic
soil
metabolism
study
showed
that
the
degradates
are
short­
lived.
Cymoxanil
and
its
degradates
should
not
pose
a
threat
to
ground
water.
Therefore,
ground
water
EEC
values
were
not
included
in
the
risk
assessment.
Based
on
the
GENEEC
model
the
EECs
of
cymoxanil
for
surface
water
are
estimated
to
be
4.13
parts
per
billion
(
ppb)
for
acute
exposures
and
0.19
ppb
for
chronic
exposure.
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).
Cymoxanil
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
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
cymoxanil
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
cymoxanil
and
any
other
substances
and
cymoxanil
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
cymoxanil
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
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level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
There
is
an
indication
of
increased
susceptibility
(
qualitative
and
quantitative)
of
rats
and
rabbits
to
in
utero
exposure
to
cymoxanil.
In
the
rat
developmental
toxicity
study,
decreased
fetal
body
weights
and
skeletal
malformations
were
observed
at
25
mg/
kg/
day
LOAEL,
which
is
below
the
maternal
toxicity
of
75
mg/
kg/
day
LOAEL.
In
the
rabbit
developmental
study
increased
skeletal
malformations
were
observed
at
8
mg/
kg/
day
LOAEL,
also
below
the
maternal
NOAEL
of
32
mg/
kg/
day.
In
the
2­
generation
reproduction
study
there
was
an
indication
of
increased
qualitative
susceptibility
in
the
offspring,
since
there
was
decreased
pup
viability
at
a
maternally
toxic
dose.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
cymoxanil
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
reduced
to
1X.
The
FQPA
factor
is
reduced
to
1X
because
in
the
developmental
and
postnatal
studies
(
including
a
developmental
neurotoxicity
study
in
rats)
the
effects
are
well
characterized
and
conservative
NOAELs
were
established
for
all
developmental
and
offspring
effects.
In
addition,
the
doses
selected
for
risk
assessment
are
lower
than
the
NOAELs
from
these
studies
and
are
protective
of
any
potential
prenatal
and
post­
natal
effects.
Therefore,
there
are
low
levels
of
concern
and
no
residual
uncertainties
for
prenatal
and
postnatal
toxicity.
In
response
to
the
notice
of
filing
of
July
6,
2001,
WWF
urged
EPA
to
apply
the
full
10X
FQPA
safety
factor
to
cymoxanil.
According
to
WWF
the
data
for
cymoxanil
is
inadequate
to
address
potential
endocrine
disruption
and
there
is
evidence
of
increased
susceptibility
in
the
prenatal
developmental
rabbit
study.
WWF
claimed
the
multigeneration
reproduction
study
in
rats
is
inadequate
because
it
was
conducted
before
the
1996
guideline
changes
which
added
additional
endpoints
responsive
to
estrogenic
and/
or
androgenic
endocrine
disruption.
In
addition,
WWF
noted
that
inferences
about
endocrine
disruption
based
on
current
guidelines
are
still
not
fully
adequate
to
evaluate
endocrine
disruption.
In
particular,
the
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC)
recommended
the
inclusion
of
more
endpoints
relevant
to
thyroid
disruption
and
measurement
of
estradiol,
testerone,
luteinizing
hormone,
follicle
stimulating
hormone,
T4
and
thyroid
stimulating
hormone
levels
in
multigeneration
studies.
WWF
further
argued
for
the
inclusion
of
certain
adrenal
hormones
such
as
ACTH
and
corticosterone
(
the
primary
glucocorticoid
in
rodents)
to
fully
address
the
endocrine
disruption
issue.
In
addition,
WWF
believes
that
there
is
an
increased
developmental
susceptibility
to
rabbits
fetuses.
WWF
questioned
the
conclusions
reached
by
the
Office
of
Pesticide
Programs'
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
Jan
20,
1998
that
there
is
no
sensitivity
in
fetuses
compared
to
maternal
animals.
Developmental
malformations
were
observed
at
8
mg/
kg/
day,
which
is
below
the
maternal
NOAEL
of
16
mg/
kg/
day.
These
results
were
discounted
due
to
uncertainties
regarding
the
source
of
the
parental
rabbits.
In
another
rabbit
study,
developmental
malformations
were
observed
at
the
same
dose
(
8
mg/
kg/
day)
as
in
the
previous
study,
however,
HIARC
did
not
consider
this
to
show
increased
susceptibility
because
the
effects
were
observed
at
8
mg/
kg/
day,
which
is
also
a
maternal
toxic
dose.
On
June
18,
2002,
HIARC
reviewed
the
WWF
comments
and
concluded
that
possible
endocrine­
related
effects
on
testicular
and/
or
epididymal
tissues
are
fully
characterized
and
well
defined
in
mouse,
subchronic
and
chronic
rat
and
dog
studies
with
clear
NOAELs.
Further,
in
the
reproduction
toxicity
study
in
rats,
testicular
effects
were
seen,
however,
these
effects
did
not
affect
any
measured
reproductive
parameters,
indicating
no
adverse
effects
on
reproduction.
Additional
measurements
recommended
by
EDSTAC
and
WWF
are
unlikely
to
provide
any
significant
additional
information
for
cymoxanil
since
NOAELs
are
clearly
defined
for
the
testicular
and/
or
epididymal
effects
and
there
are
no
indications
of
endocrine
disruption
in
other
organs
e.
g.,
thyroid
(
thyroid
weight
changes
and
hyperplasia),
adrenal
toxicity.
Prior
to
receipt
of
WWF
letter,
the
HIARC
on
August
21,
2001,
reevaluated
the
toxicology
data
base
and
modified
certain
study
reviews
resulting
in
the
selection
of
new
endpoints.
The
reevaluations
resulted
in
the
qualitative
and
quantitative
evidence
of
increased
susceptibility
to
rabbit
fetuses
(
as
suggested
by
WWF)
and
rat
fetuses.
In
addition,
reevaluation
of
rat
reproduction
toxicity
study
resulted
in
the
qualitative
increased
susceptibility
to
offspring.
A
conservative
NOAEL
from
the
rabbit
developmental
study
was
used
for
establishing
the
aRfD.
Nonetheless,
it
was
concluded
that
reliable
data
supported
applying
no
additional
safety
factor
since
endpoints
chosen
for
risk
assessments
adequately
protect
infants
and
children
with
regard
to
the
prenatal
and/
or
postnatal
toxicity
that
has
been
identified.

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
ground
water
are
less
than
the
calculated
DWLOCs,
OPP
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
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.

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Vol.
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136
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16,
2003
/
Rules
and
Regulations
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
cymoxanil
will
occupy
<
71%
of
the
aPAD
for
females
13
to
49
years
old.
This
is
the
only
population
for
which
an
acute
toxicological
endpoint
has
been
determined.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
cymoxanil
in
drinking
water
derived
from
surface
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
aPAD,
as
shown
in
the
following
Table
3.

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
CYMOXANIL
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

Females
(
13
 
49
years
old)
0.04
<
71
4.13
350
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
cymoxanil
from
food
will
utilize
13%
of
the
cPAD
for
the
U.
S.
population,
and
all
population
subgroups.
Adults
20
 
49
years
old
and
females
13
 
49
years
old
were
the
most
highly
exposed
subpopulations.
There
are
no
residential
uses
for
cymoxanil
that
result
in
chronic
residential
exposure.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
cymoxanil
in
drinking
water
derived
from
surface
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
the
following
Table
4.

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
CYMOXANIL
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.04
<
13
0.19
1,200
5.
Aggregate
cancer
risk
for
U.
S.
population.
In
accordance
with
the
EPA
Draft
Guidelines
for
Carcinogen
Risk
Assessment
(
July,
1999),
the
Agency
classified
cymoxanil
as
a
``
not
likely''
human
carcinogen.
Cymoxanil
is
not
expected
to
pose
a
cancer
risk
to
humans.
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
cymoxanil
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Cymoxanil
was
shown
to
be
recoverable
using
Protocol
D
of
FDA's
Pesticide
Analytical
Manual
I
methodology.
The
residue
of
concern
in
plants
was
previously
determined
to
be
parent
only.
In
addition,
Method
AMR
3060
 
94
Revision
2,
a
High
Performance
Liquid
Chromotography
Ultraviolet
(
HPLC/
UV)
method,
should
be
adequate
for
lychee
tolerance
enforcement
purposes.

B.
International
Residue
Limits
There
are
no
CODEX,
Canadian
or
Mexican
Maximum
Residue
Levels
established
for
cymoxanil
on
hops,
lychee,
or
cucurbit
vegetables.
The
U.
S.
tolerance
for
fruiting
vegetables
is
compatible
with
Codex.
Therefore,
no
compatibility
problems
exist
for
the
tolerances
established
by
this
rule.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
cymoxanil,
[
2­
cyano­
N­
[(
ethylamino)
carbonyl]­
2­
(
methoxyimino)
acetamide],
in
or
on
hop,
dried
cones
at
1.0
ppm;
lettuce,
head
at
4.0
ppm;
vegetable,
cucurbit
group
9
at
0.05
ppm;
vegetable,
fruiting,
group
8
at
0.2
ppm;
and
lychee
at
1.0
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
 
0219
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
September
15,
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
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and
Regulations
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
 
0219,
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''
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
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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:
June
30,
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
180.503
is
amended
by
adding
alphabetically
the
following
commodities
and
a
footnote
to
the
table
in
paragraph
(
a)
and
removing
paragraph
(
e)
to
read
as
follows:

§
180.503
Cymoxanil,
tolerance
for
residues.
(
a)
*
*
*

Commodity
Parts
per
million
Grape1
....................
0.1
Hop,
dried
cones
....
1.0
Commodity
Parts
per
million
Lettuce,
head
.........
4.0
Lychee1
..................
1.0
*
*
*
*
*
Vegetable,
cucurbit,
group
9
...............
0.05
Vegetable,
fruiting,
group
8
...............
0.2
1There
are
no
U.
S.
registrations
for
grape
and
lychee.

*
*
*
*
*
[
FR
Doc.
03
 
17731
Filed
7
 
15
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
54
[
CC
Docket
No.
96
 
45;
FCC
03
 
115]

Federal­
State
Joint
Board
on
Universal
Service;
Promoting
Deployment
and
Subscribership
in
Unserved
and
Underserved
Areas,
Including
Tribal
and
Insular
Areas
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule;
petitions
for
reconsideration.

SUMMARY:
In
this
document,
the
Commission
addresses
the
requests
of
several
petitioners
to
reconsider
portions
of
the
Twelfth
Report
and
Order
and
Further
Notice
of
Proposed
Rulemaking,
adopting
rules
to
provide
additional,
targeted
universal
service
support
to
low­
income
consumers
on
tribal
lands
and
establishing
a
framework
for
the
resolution
of
eligible
telecommunications
carrier
(
ETC)
designations.
The
Commission
also
concludes
that
the
definition
of
``
reservation''
for
purposes
of
the
universal
service
programs
remains
the
same
as
that
adopted
in
the
Twelfth
Report
and
Order
and
Further
Notice
of
Proposed
Rulemaking.
The
Commission
addresses
several
requests
for
reconsideration
relating
to
the
rule
amendments
to
the
universal
service
low­
income
programs
adopted
in
the
Twelfth
Report
and
Order
and
Further
Notice
of
Proposed
Rulemaking.
The
Commission
also
clarifies,
on
its
own
motion,
the
Commission's
rules
regarding
the
qualification
criteria
for
enhanced
Lifeline
and
Link­
Up
service.
In
addition,
the
Commission
declines
to
adopt
a
rule
that
would
require
resolution
of
the
merits
of
any
request
for
ETC
designation
within
six
months
of
the
filing
date.
The
Commission
also
declines
to
extend
the
enhanced
lowincome
programs
to
the
Northern
Mariana
Islands.
DATES:
Effective
August
15,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
Shannon
Lipp,
Attorney,
Telecommunications
Access
Policy
Division,
Wireline
Competition
Bureau,
(
202)
418
 
7400.

SUPPLEMENTARY
INFORMATION:
This
is
a
summary
of
the
Commission's
Twenty­
Fifth
Order
on
Reconsideration
and
Report
and
Order
(
Order)
in
CC
Docket
No.
96
 
45
released
on
May
21,
2003.
This
Order
was
also
released
with
a
companion
Further
Notice
of
Proposed
Rulemaking.
The
full
text
of
this
document
is
available
for
public
inspection
during
regular
business
hours
in
the
FCC
Reference
Center,
Room
CY
 
A257,
445
Twelfth
Street,
SW.,
Washington,
DC
20554.

I.
Introduction
1.
In
this
Order,
we
address
the
requests
of
several
petitioners
to
reconsider
portions
of
the
Twelfth
Report
and
Order
and
Further
Notice
of
Proposed
Rulemaking,
65
FR
47941,
August
4,
2003,
adopting
rules
to
provide
additional,
targeted
universal
service
support
to
low­
income
consumers
on
tribal
lands
and
establishing
a
framework
for
the
resolution
of
Eligible
Telecommunications
Carrier
(
ETC)
designations
under
section
214(
e)(
6)
of
the
Communications
Act
of
1934,
as
amended
(
the
Act).
The
advancement
of
universal
service
on
tribal
lands
remains
a
major
policy
goal
of
this
Commission.
Through
our
on­
going
dialogue
with
the
tribes,
as
most
recently
exemplified
by
the
Commission's
launch
of
the
Indian
Telecommunications
Initiatives
in
Phoenix,
Arizona
on
September
19,
2002,
the
Commission
continues
in
its
efforts
to
promote
telecommunications
subscribership
within
American
Indian
and
Alaskan
Native
tribal
communities.
2.
We
affirm
that
the
framework
adopted
by
the
Commission
for
resolution
of
ETC
designations
on
tribal
lands
provides
a
reasonable
means
to
facilitate
the
expeditious
resolution
of
such
requests,
while
balancing
the
respective
federal,
state,
and
tribal
interests.
We
also
conclude
that
the
definition
of
``
reservation''
for
purposes
of
the
universal
service
programs
remains
the
same
as
that
adopted
in
the
Twelfth
Report
and
Order
and
Further
Notice
of
Proposed
Rulemaking
despite
the
Bureau
of
Indian
Affairs'
(
BIA)
subsequent
modification
of
that
definition
for
purposes
of
its
direct
assistance
programs.
We
address
several
requests
for
reconsideration
relating
to
the
rule
amendments
to
the
universal
service
low­
income
programs
adopted
in
the
Twelfth
Report
and
Order
and
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