32390
Federal
Register
/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Rules
and
Regulations
Commodity
Parts
per
million
Pea,
blackeyed,
seed
................................................................................................................................
4.0
Pea,
southern,
seed
..................................................................................................................................
4.0
*
*
*
*
*
Turnip,
greens
...........................................................................................................................................
30
*
*
*
*
*
Vegetable,
cucurbit,
group
9
.....................................................................................................................
0.3
*
*
*
*
*

[
FR
Doc.
03
 
13563
Filed
5
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0133;
FRL
 
7306
 
8]

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

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
clothianidin
in
or
on
canola,
corn,
and
milk.
In
addition,
tolerances
are
established
for
indirect
or
inadvertent
residues
of
clothianidin
in
or
on
nongrass
animal
feed;
cereal
grain
forage,
fodder
and
straw;
grass
forage,
fodder
and
hay;
and
soybean
forage
and
hay.
Bayer
Corporation
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
May
30,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0133,
must
be
received
on
or
before
July
29,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Daniel
Kenny,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7546;
e­
mail
address:
kenny.
dan@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

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

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0133.
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
November
14,
2001
(
66
FR
57079)
(
FRL
 
6809
 
7),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
1F6315)
by
Bayer
Corporation,
8400
Hawthorn
Road,
Kansas
City,
MO
64120.
That
notice
included
a
summary
of
the
petition
prepared
by
Bayer
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
tolerances
for
residues
of
the
insecticide
clothianidin,
(
E)­
1­(
2­
chloro­
1,3­
thiazol­
5­
ylmethyl)­
3­
methyl­
2­
nitroguanidine,
in
or
on
canola,
seed
at
0.01
parts
per
million
(
ppm);
corn,
field,
grain
at
0.01
ppm;
corn,
pop,
grain
at
0.01
ppm;
corn,
sweet,
kernel
plus
cob
with
husk
removed
at
0.01
ppm;
corn,
field,
forage
at
0.10
ppm;
corn,
sweet,
forage
at
0.10
ppm;
corn,
field,
stover
at
0.10
ppm;
corn,
sweet,
stover
at
0.10
ppm;
corn,
pop,
stover
at
0.10
ppm;
and
milk
at
0.01
ppm.
Following
the
review
of
all
the
data,
tolerances
are
also
required
on
the
following
rotational
crops,
which
are
used
only
for
livestock
feeds.
These
tolerances
do
not
impact
the
dietary
risk
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No.
104
/
Friday,
May
30,
2003
/
Rules
and
Regulations
assessment
since
these
residues
are
significantly
lower
than
those
in
feed
items
from
the
crops
which
are
treated
directly
with
clothianidin
and/
or
thiamethoxam.
Tolerances
are
established
on
animal
feed,
nongrass
at
0.02
ppm;
grain,
cereal,
forage,
fodder
and
straw
at
0.02
ppm;
grass,
forage,
fodder
and
hay
at
0.02
ppm;
soybean,
forage
at
0.02
ppm;
and
soybean,
hay
at
0.02
ppm.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.*
*
*''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
tolerances
for
residues
of
clothianidin
on
canola,
seed
at
0.01
ppm;
corn,
field,
grain
at
0.01
ppm;
corn,
pop,
grain
at
0.01
ppm;
corn,
sweet,
kernel
plus
cob
with
husk
removed
at
0.01
ppm;
corn,
field,
forage
at
0.10
ppm;
corn,
sweet,
forage
at
0.10
ppm;
corn,
field,
stover
at
0.10
ppm;
corn,
sweet,
stover
at
0.10
ppm;
corn,
pop,
stover
at
0.10
ppm;
and
milk
at
0.01
ppm,
animal
feed,
nongrass
at
0.02
ppm;
grain,
cereal,
forage,
fodder
and
straw
at
0.02
ppm;
grass,
forage,
fodder
and
hay
at
0.02
ppm;
soybean,
forage
at
0.02
ppm;
and
soybean,
hay
at
0.02
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
clothianidin
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
(
rats)
NOAEL:
27.9/
34.0
milligrams/
kilogram/
day
(
mg/
kg/
day)
(
male/
female)
LOAEL:
202.0/
254.2
mg/
kg/
day
(
male/
female:
decreased
body
weight
(
bwt)
and
bwt
gain)

870.3150
90
 
Day
oral
toxicity
in
nonrodents
(
dogs)
NOAEL:
19.3/
42.1
mg/
kg/
day
(
male/
female)
LOAEL:
40.9/
61.8
mg/
kg/
day
(
thinness,
decreased
bwt,
bwt
gain
and
anemia
(
one
male);
decreased
white
blood
cells,
albumin,
and
total
protein
(
female)

870.3200
21/
28
 
Day
dermal
toxicity
(
rats)
NOAEL:
1,000
mg/
kg/
day
(
highest
dose
tested)
LOAEL:
>
1,000
mg/
kg/
day
870.3700
Prenatal
developmental
in
rodents
(
rats)
Maternal
NOAEL:
10
mg/
kg/
day
Maternal
LOAEL:
40
mg/
kg/
day
(
decreased
bwt
gain
and
food
consumption)
Developmental
NOAEL:
125
mg/
kg/
day
Developmental
LOAEL:
cannot
be
established
870.3700
Prenatal
developmental
in
nonrodents
(
rabbit)
Maternal
NOAEL:
25
mg/
kg/
day
Maternal
LOAEL:
75
mg/
kg/
day
(
increased
incidences
of
clinical
signs
(
scant
feces
and
orange
urine),
mortalities,
decreased
food
consumption,
early
delivery,
abortion,
and
decreased
bwt
gain)
Developmental
NOAEL:
25
mg/
kg/
day
Developmental
LOAEL:
75
mg/
kg/
day
(
premature
deliveries,
decreased
gravid
uterine
weights,
an
increased
litter
incidence
of
a
missing
lobe
of
the
lung
and
decreased
litter
average
for
ossified
sternal
centra
per
fetus)

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Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3800
Reproduction
and
fertility
effects
(
rat)
Parental
systemic
NOAEL:
31.2/
36.8
mg/
kg/
day
(
male/
female)
Parental
systemic
LOAEL:
163.4/
188.8
mg/
kg/
day
(
male/
female)
(
decreased
bwt,
bwt
gain
and
absolute
and
relative
thymus
weights)
Offspring
systemic
NOAEL:
9.8/
11.5
mg/
kg/
day
(
male/
female)
Offspring
systemic
LOAEL:
31.2/
36.8
mg/
kg/
day
(
male/
female:
decreased
bwt
gains
and
delayed
sexual
maturation
(
male);
decreased
absolute
thymus
weights
in
F1
pups
of
both
sexes
and
an
increase
in
stillbirths
in
both
generations)
Reproductive
NOAEL:
31.2/
188.8
mg/
kg/
day
(
male/
female)
Reproductive
LOAEL:
163.4/
not
established
mg/
kg/
day
(
male/
female:
decreased
sperm
motility,
and
increased
number
of
sperm
with
detached
heads
in
both
generations)

870.4100
Chronic
toxicity
dogs
NOAEL:
46.4/
40.1
mg/
kg/
day
(
male/
female)
LOAEL:
Not
established/
52.9
mg/
kg/
day
(
male/
female:
clinical
evidence
of
anemia
in
females).
Note:
dose­
related
decreases
in
ALT
activity
observed
in
mid­
and
high­
dose
males
and
females
870.4200
Carcinogenicity
mice
NOAEL:
171.4/
65.1
mg/
kg/
day
(
male/
female)
LOAEL:
254.1/
215.9
mg/
kg/
day
(
male/
female:
decreased
bwt
and
bwt
gain;
decreased
food
consumption
and
food
efficiency
in
males
at
the
LOAEL).
No
evidence
of
carcinogenicity
870.4300
Chronic
feeding/
Carcinogenicity
rat
NOAEL:
82.0/
32.5
mg/
kg/
day
(
male/
female)
LOAEL:
156.5/
97.8
mg/
kg/
day
(
male/
female,
decreased
bwt
and
food
consumption
and
altered
hepatocellular
eosinophilic
focus
of
the
liver
in
both
sexes;
ovary
interstitial
gland
hyperplasia
and
increased
lymphohistiocytic
infiltrate
in
females;
and
slightly
increased
incidences
of
pelvic
mineralization
and
transitional
cell
hyperplasia
in
the
kidney,
mottled
livers
of
males.
No
evidence
of
carcinogenicity
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
Parent
Small,
but
significant
increase
in
frequency
of
histidine
revertants
in
TA1535
strain
treated
at
1,500
and
5,000
µ
g/
plate
+/­
S9;
still
present
but
weaker
in
its
absence.
The
positive
response
was
only
reproducible
at
5,000
µ
g/
plate
+/­
S9.
Clothianidin
considered
mutagenic
under
conditions
of
this
test
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
Parent
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium
and
Escherichia
coli)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
Parent
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
Parent
Only
TA
1535
tested.
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
BN0335E2
metabolite
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
TZMU
metabolite
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
methyl
guanidine
intermediate
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
TZNG
metabolite
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
TMG
metabolite
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
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104
/
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30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
BN0230M
metabolite
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
MAI
metabolite
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
bacterial
reverse
mutation
assay
N­
Methylnitroguanid
in
intermediate
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
­
bacterial
reverse
mutation
assay
TI
435­
Triazan
intermediate
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5100
Gene
Mutation
­
bacterial
reverse
mutation
assay
TI
435­
CCMT­
Adduct
No
mutagenic
activity
in
bacteria
(
Salmonella
typhimurium)
under
conditions
of
this
assay
870.5300
Gene
Mutation
­
in
vitro
mammalian
cell
gene
mutation
test
(
L5178Y
TK
+/­
mouse
lymphoma
cells)
Parent
Increases
in
mutant
frequency
with
and
without
S9
at
dose
levels
that
were
cytotoxic.
The
observed
response
was
primarily
due
to
small
colony
formation,
indicating
clastogenic
activity
870.5300
Gene
Mutation
­
in
vitro
mammalian
cell
gene
mutation
test
(
V79­
HPRT
Assay)
Parent
No
increase
in
mutant
frequency
under
the
conditions
of
the
study
870.5395
Cytogenetics
­
mammalian
erythrocyte
micronucleus
test
Parent
Clothianidin
is
considered
to
be
neither
clastogenic
nor
aneugenic
under
these
test
conditions
870.5375
Cytogenetics
­
in
vitro
mammalian
chromosome
aberration
test
(
CHL
Cells)
Parent
Significant
increases
in
frequency
of
cells
with
structural
aberrations.
Predominant
types
were
chromatid
breaks
and
exchanges.
There
was,
however,
no
clear
indication
of
a
dose­
related
response
in
either
the
presence
or
absence
of
S9
activation
870.5500
Other
Effects
­
DNA
Repair
Test
in
Bacillus
subtillis
Parent
No
potential
for
DNA
damage
under
these
conditions
870.5550
Other
Effects
­
(
UDS)
in
Mammalian
Cells
in
Culture
Parent
No
evidence
(
or
a
dose
related
positive
response)
that
UDS
was
induced
870.6200
Acute
neurotoxicity
screening
battery
(
rat)
NOAEL:
Not
established
LOAEL:
100
mg/
kg
(
FOB:
decreased
arousal
and
decreased
motor
and
locomotor
activity)

870.6200
Subchronic
neurotoxicity
screening
battery
(
rat)
NOAEL:
60.0/
71.0
mg/
kg/
day
(
male/
female)
LOAEL:
177.0/
200.1
mg/
kg/
day
(
male/
female:
Slightly
decreased
food
consumption,
bwt
and
bwt
gains)

870.6300
Developmental
neurotoxicity
(
rat)
Maternal
NOAEL:
42.9
mg/
kg/
day
Maternal
LOAEL:
142
mg/
kg/
day
(
decreased
bwt,
bwt
gains,
and
food
consumption)
Offspring
NOAEL:
12.9
mg/
kg/
day
Offspring
LOAEL:
42.9
mg/
kg/
day
(
decreased
bwt
and
bwt
gains)

870.7485
Metabolism
and
pharmacokinetics
(
rat)
Overall
recovery:
95
 
100%.
Readily
absorbed
and
excreted
within
96
hours
following
a
single
2.5
mg/
kg
bwt
or
repeated
oral
dose
of
25
mg/
kg
bwt,
but
at
a
dose
of
250
mg/
kg,
absorption
became
biphasic
and
was
saturated
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Vol.
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No.
104
/
Friday,
May
30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.7485
Metabolism
and
pharmacokinetics
(
mouse)
Of
the
administered
radioactivity,
98.7
 
99.2%
was
recovered.
Readily
absorbed
and
excreted
within
168
hours
following
a
single
oral
dose
of
5
mg/
kg
bwt
870.7600
Dermal
Penetration
­
monkey
Dermal
absorption
as
the
sum
of
urinary
and
fecal
excretion
and
Cage/
Pan/
Chair
Wash,
Debris
was
0.24
(+
0.11)
as
percent
of
dose.
Adjustment
of
the
direct
absorption
determination
was
not
necessary
because
recovery
from
the
dermal
dose
was
 
90%.
A
value
of
1%
dermal
absorption
was
considered
appropriate
for
use
in
risk
assessment.
This
estimation
takes
into
account
any
variability
that
would
have
likely
occurred
with
testing
several
dose
levels
Special
study:
Neurotoxicity
and
pharmacology
mouse
NOAEL:
25
mg/
kg/
day
(
male/
female)
LOAEL:
50
mg/
kg
bw
mg/
kg/
day
(
transient
signs
of
decreased
spontaneous
motor
activity,
tremors,
and
deep
respirations)

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
(
LOC).
However,
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
intraspecies
differences.
EPA
has
concluded
that
the
toxicology
database
for
clothianidin
is
not
complete.
Due
to
evidence
of
effects
on
the
immune
system
and
that
juvenile
rats
appear
to
be
more
susceptible
to
these
effects,
EPA
has
determined
that
testing
should
be
conducted
to
assess
immune
system
function
in
adults
and
in
young
animals
following
developmental
exposures.
Therefore,
a
10X
database
UF
is
to
be
applied
to
all
dietary
exposure
endpoints
for
the
lack
of
a
developmental
immunotoxicity
study.
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
factors
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
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
clothianidin
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CLOTHIANIDIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF1
Special
FQPA
SF2
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13
 
50
years
of
age)
Developmental
NOAEL
=
25
UF
=
10001
Acute
RfD
=
0.025
mg/
kg
FQPA
SF
=
1
aPAD
=
acute
RfD
÷
FQPA
SF=
0.025
mg/
kg
Developmental
rabbit
study
Developmental
LOAEL
=
75
mg/
kg/
day
based
on
an
increased
litter
incidence
of
a
missing
lobe
of
the
lung
Acute
Dietary
(
General
population)
NOAEL
=
25
UF
=
10001
Acute
RfD
=
0.025
mg/
kg
FQPA
SF
=
1
aPAD
=
acute
RfD
÷
FQPA
SF
=
0.025
mg/
kg
Special
Neurotoxicity/
Pharmacology
Study
in
Mice
and
Rats
LOAEL
=
50
mg/
kg
based
on
transient
signs
of
decreased
spontaneous
motor
activity,
tremors
and
deep
respirations
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Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CLOTHIANIDIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF1
Special
FQPA
SF2
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Chronic
Dietary
(
All
populations)
Offspring
NOAEL=
9.8
UF
=
10001
Chronic
RfD
=
0.0098
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
÷
FQPA
SF
=
0.0098
mg/
kg/
day
2
 
Generation
Reproduction
Study
Offspring
LOAEL
=
31.2
mg/
kg/
day
based
on
decreased
mean
bwt
gain
and
delayed
sexual
maturation,
decreased
absolute
thymus
weights
in
F1
pups
and
an
increase
in
stillbirths
in
both
generations
Cancer
(
oral,
dermal,
inhalation)
Classification:
Not
likely
1
An
additional
10X
database
uncertainty
factor
for
lack
of
a
developmental
immunotoxicity
study.
2
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.
Currently
there
are
no
tolerances
established
for
clothianidin
alone
on
any
commodity.
However,
clothianidin
is
a
major
metabolite
of
thiamethoxam,
and
tolerances
for
the
combined
residues
of
thiamethoxam
and
its
metabolite
clothianidin
have
been
established
under
40
CFR
part
180.565
for
both
plant
and
livestock
commodities.
Tolerances
for
thiamethoxam
range
from
0.02
ppm
to
1.5
ppm.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
clothianidin
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.
The
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
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
following
assumptions
were
made
for
the
acute
exposure
assessments:
The
acute
analysis
was
a
conservative,
Tier
I
assessment
which
was
based
on
tolerance
level
residues
and
the
assumption
of
100%
crop
treated.
Although
the
only
proposed
uses
for
clothianidin
are
on
canola
and
corn,
clothianidin
is
a
major
metabolite
of
thiamethoxam
which
has
many
registered
uses
and
several
pending
uses.
As
a
result,
residues
of
clothianidin
which
would
theoretically
result
from
the
metabolism
of
thiamethoxam
were
included
in
the
analysis.
In
crop
field
trials
and
in
animal
feeding
studies,
the
quantities
of
both
clothianidin
and
thiamethoxam
were
measured.
The
ratio
of
clothianidin
to
thiamethoxam
in
each
commodity
was
multiplied
by
the
respective
thiamethoxam
tolerance
level
to
arrive
at
the
theoretical
maximum
clothianidin
residue
level
which
would
be
present.
These
maximum
clothianidin
residues
were
used
in
the
acute
analysis.
For
the
commodities
which
have
both
thiamethoxam
tolerances
and
proposed
clothianidin
tolerances
(
i.
e.,
sweet
corn,
field
corn,
pop
corn,
canola,
and
milk),
the
proposed
clothianidin
tolerances
were
added
to
the
residues
which
result
from
use
of
thiamethoxam.
As
this
is
a
Tier
I
assessment,
dietary
exposure
and
risk
at
the
95th
percentile
of
exposure
are
reported.
The
general
U.
S.
population
and
all
population
subgroups
have
exposure
and
risk
estimates
which
are
below
EPA's
LOC
(
i.
e.,
the
aPADs
are
all
below
100%).
The
most
highly
exposed
population
subgroup
is
children
1
to
2
years
of
age,
which
utilizes
16%
of
the
aPAD.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment,
the
DEEM
 
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
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
analysis
was
a
conservative,
Tier
I
assessment
which
was
based
on
tolerance
level
residues
and
the
assumption
of
100%
crop
treated.
As
stated
previously,
although
the
only
proposed
uses
for
clothianidin
are
on
canola
and
corn,
clothianidin
is
a
major
metabolite
of
thiamethoxam
which
has
many
registered
uses
and
several
pending
uses.
As
a
result,
residues
of
clothianidin
which
would
theoretically
result
from
the
metabolism
of
thiamethoxam
were
included
in
the
analysis.
In
crop
field
trials
and
in
animal
feeding
studies,
the
quantities
of
both
clothianidin
and
thiamethoxam
were
measured.
The
ratio
of
clothianidin
to
thiamethoxam
in
each
commodity
was
multiplied
by
the
respective
thiamethoxam
tolerance
level
to
arrive
at
the
theoretical
maximum
clothianidin
residue
level
which
would
be
present.
These
maximum
clothianidin
residues
were
used
in
the
chronic
analysis.
For
the
commodities
which
have
both
thiamethoxam
tolerances
and
proposed
clothianidin
tolerances
(
i.
e.,
sweet
corn,
field
corn,
pop
corn,
canola,
and
milk),
the
proposed
clothianidin
tolerances
were
added
to
the
residues
which
result
from
use
of
thiamethoxam.
The
general
U.
S.
population
and
all
population
subgroups
have
exposure
and
risk
estimates
which
are
below
EPA's
LOC
(
i.
e.,
the
chronic
population
adjusted
doses
(
cPADs)
are
all
below
100%).
The
most
highly
exposed
population
subgroup
is
children
1
to
2
years
of
age,
which
utilizes
18%
of
the
cPAD.
iii.
Cancer.
EPA
has
determined
that
clothianidin
is
not
likely
to
be
a
human
carcinogen
and
EPA,
therefore,
does
not
expect
it
to
pose
a
cancer
risk.
As
a
result,
a
quantitive
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
clothianidin
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
clothianidin.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.

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2003
/
Rules
and
Regulations
The
screening
concentration
in
ground
water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
For
a
screeninglevel
assessment
for
surface
water
EPA
will
use
FIRST
(
a
Tier
I
model)
before
using
PRZM/
EXAMS
(
a
Tier
II
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
clothianidin,
they
are
further
discussed
in
the
aggregate
risk
sections.
Based
on
the
FIRST
and
SCI­
GROW
models,
the
EECs
of
clothianidin
for
acute
exposures
are
estimated
to
be
3.97
parts
per
billion
(
ppb)
for
surface
water
and
1.46
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
2.14
ppb
for
surface
water
and
1.46
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).
Clothianidin
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Clothianidin
is
a
major
metabolite
of
the
insecticide
thiamethoxam
in
plants
and
animals.
Since
there
are
also
no
residential
uses
of
thiamethoxam,
possible
residential
exposure
to
clothianidin
due
to
thiamethoxam
uses
is
not
expected.
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
clothianidin
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
clothianidin
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
clothianidin
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
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.
No
quantitative
or
qualitative
susceptibility
was
observed
in
either
of
the
developmental
rat
or
rabbit
studies.
Quantitative
susceptibility
was
observed
in
both
the
reproduction
and
developmental
neurotoxicity
studies;
however,
the
degree
of
concern
for
these
studies
is
low
because
the
observed
effects
are
well
characterized
and
there
are
clear
NOAELs/
LOAELs
in
each
case.
In
addition,
the
endpoint
of
concern
is
the
one
that
is
being
used
for
short­,
intermediate­
and
long­
term
dietary
and
non­
dietary
exposure
risk
assessments.
There
are
no
residual
uncertainties.
Therefore,
there
are
no
to
low
concerns
with
regard
to
prenatal
and/
or
postnatal
toxicity.
3.
Conclusion.
The
toxicology
database
for
clothianidin
is
not
complete
for
FQPA
purposes.
A
complete
complement
of
acceptable
developmental,
reproduction,
developmental
neurotoxicity,
mammalian
neurotoxicity
and
special
neurotoxicity
studies
are
available;
however,
due
to
evidence
of
decreased
absolute
and
adjusted
organ
weights
of
the
thymus
and
spleen
in
multiple
studies
in
the
clothianidin
data
base,
and
since
juvenile
rats
in
the
2
 
generation
reproduction
study
appear
to
be
more
susceptible
to
these
effects,
EPA
has
determined
that
testing
should
be
conducted
to
assess
immune
system
function
in
adults
and
in
young
animals
following
developmental
exposures.
As
noted
previously,
a
10X
database
UF
was
applied
because
of
the
lack
of
this
study.
The
FQPA
factor
is
removed
because
there
are
no
to
low
concerns
and
no
residual
uncertainties
with
regard
to
prenatal
and/
or
postnatal
toxicity.
As
stated
above,
no
quantitative
or
qualitative
susceptibility
was
observed
in
either
of
the
development
rat
or
rabbit
studies,
and
the
observed
effects
are
well
characterized
and
there
are
clear
NOAELs/
LOAELs
in
the
reproduction
and
developmental
neurotoxicity
studies.
In
addition,
the
acute
and
chronic
dietary
food
exposure
assessment
utilizes
existing
and
proposed
tolerance
level
residues
and
100%
crop
treated
information
for
all
commodities.
By
using
these
screeninglevel
assessments,
acute
and
chronic
exposures/
risks
will
not
be
underestimated.
Furthermore,
the
dietary
drinking
water
assessment
(
Tier
I
estimates)
uses
values
generated
by
model
and
associated
modeling
parameters
which
are
designed
to
provide
conservative,
health
protective,
high­
end
estimates
of
water
concentrations.
Finally,
there
are
no
residential
uses
for
either
clothianidin
or
thiamethoxam.

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
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Vol.
68,
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104
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Friday,
May
30,
2003
/
Rules
and
Regulations
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
EPA's
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,
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
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.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
clothianidin
will
occupy
7.3%
of
the
aPAD
for
the
U.
S.
population,
5.4%
of
the
aPAD
for
females
13
years
and
older,
11%
of
the
aPAD
for
all
infants
(
less
than
1
year
old)
and
16%
of
the
aPAD
for
children
1
to
2
years
old.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
clothianidin
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
aPAD,
as
shown
in
Table
3
of
this
unit:

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

General
U.
S.
population
0.025
7.3
3.97
1.46
810
All
infants
(<
1
year
old)
0.025
11
3.97
1.46
220
Children
(
1
 
2
years
old)
0.025
16
3.97
1.46
210
Females
(
13
 
49
years
old)
0.025
5.4
3.97
1.46
710
Adults
(
50+
years
old)
0.025
6.0
3.97
1.46
820
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
clothianidin
from
food
will
utilize
5.9%
of
the
cPAD
for
the
U.
S.
population,
9.8%
of
the
cPAD
for
all
infants
(
less
than
1
year
old)
and
18%
of
the
cPAD
for
children
1
to
2
years
old.
There
are
no
residential
uses
for
clothianidin
that
result
in
chronic
residential
exposure
to
clothianidin.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
clothianidin
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
4
of
this
unit:

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

General
U.
S.
Population
0.0098
5.9
2.14
1.46
320
All
Infants
(<
1
year
old)
0.0098
9.8
2.14
1.46
88
Children
(
1
 
2
years
old)
0.0098
18
2.14
1.46
80
Females
(
13
 
49
years
old)
0.0098
4.6
2.14
1.46
280
Adults
(
50+
years
old)
0.0098
4.9
2.14
1.46
320
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).
Clothianidin
and
thiamethoxam
are
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
LOC.
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
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Rules
and
Regulations
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Clothianidin
and
thiamethoxam
are
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
LOC.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Clothianidin
has
been
classified
as
a
``
not
likely
human
carcinogen.''
Therefore,
it
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
clothianidin
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
(
example
­
liquid
chromotography)
is
available
to
enforce
the
tolerance
expression.
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;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
No
Codex,
Canadian,
or
Mexican
maximum
residue
levels
(
MRLs)
have
been
established
for
residues
of
clothianidin.

C.
Conditions
A
developmental
immunotoxicity
study
with
comparative
measures
between
the
pups
and
the
parents
is
required.

V.
Conclusion
Therefore,
tolerances
are
established
for
residues
of
clothianidin,
(
E)­
1­(
2­
chloro­
1,3­
thiazol­
5­
ylmethyl)­
3­
methyl­
2­
nitroguanidine,
in
or
on
canola,
seed
at
0.01
ppm
;
corn,
field,
grain
at
0.01
ppm;
corn,
pop,
grain
at
0.01
ppm;
corn,
sweet,
kernel
plus
cob
with
husk
removed
at
0.01
ppm;
corn,
field,
forage
at
0.10
ppm;
corn,
sweet,
forage
at
0.10
ppm;
corn,
field,
stover
at
0.10
ppm;
corn,
sweet,
stover
at
0.10
ppm;
corn,
pop,
stover
at
0.10
ppm;
and
milk
at
0.01
ppm,
animal
feed,
nongrass
at
0.02
ppm;
grain,
cereal,
forage,
fodder
and
straw
at
0.02
ppm;
grass,
forage,
fodder
and
hay
at
0.02
ppm;
soybean,
forage
at
0.02
ppm;
and
soybean,
hay
at
0.02
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
 
0133
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
July
29,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0133,
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
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30,
2003
/
Rules
and
Regulations
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
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:
May
19,
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
180.586
is
added
to
read
as
follows:

§
180.586
Clothianidin;
tolerances
for
residues.

(
a)
General.
Tolerances
are
established
for
residues
of
the
insecticide
clothianidin,
(
E)­
1­(
2­
chloro­
1,3­
thiazol­
5­
ylmethyl)­
3­
methyl­
2­
nitroguanidine,
in
or
on
the
following
raw
agricultural
commodities:

Commodity
Parts
per
million
Canola,
seed
..................
0.01
Corn,
field,
forage
...........
0.10
Corn,
field,
grain
.............
0.01
Corn,
field,
stover
...........
0.10
Corn,
pop,
grain
..............
0.01
Corn,
pop,
stover
............
0.10
Corn,
sweet,
forage
........
0.10
Corn,
sweet,
kernel
plus
cob
with
husk
removed
0.01
Corn,
sweet,
stover
........
0.10
Milk
.................................
0.01
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30MYR1.
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30MYR1
32400
Federal
Register
/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Rules
and
Regulations
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
and
inadvertant
residues.
Tolerances
are
established
for
the
indirect
or
inadvertent
residues
of
the
insecticide
clothianidin,
(
E)­
1­(
2­
chloro­
1,3­
thiazol­
5­
ylmethyl)­
3­
methyl­
2­
nitroguanidine,
in
or
on
the
following
raw
agricultural
commodities
when
present
therein
as
a
result
of
the
application
of
clothianidin
to
crops
listed
in
paragraph
(
a)
of
this
section:

Commodity
Parts
per
million
Animal
feed,
nongrass
....
0.02
Grain,
cereal,
forage,
fodder
and
straw
.........
0.02
Grass,
forage,
fodder
and
hay
.......................
0.02
Soybean,
forage
.............
0.02
Soybean,
hay
..................
0.02
[
FR
Doc.
03
 
13564
Filed
5
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
Centers
for
Medicare
&
Medicaid
Services
42
CFR
Parts
410,
414,
and
485
[
CMS
 
1204
 
CN]

RIN
0938
 
AL21
Medicare
Program;
Revisions
to
Payment
Policies
Under
the
Physician
Fee
Schedule
for
Calendar
Year
2003
and
Inclusion
of
Registered
Nurses
in
the
Personnel
Provision
of
the
Critical
Access
Hospital
Emergency
Services
Requirement
for
Frontier
Areas
and
Remote
Locations
AGENCY:
Centers
for
Medicare
&
Medicaid
Services
(
CMS),
HHS.
ACTION:
Correction
of
final
rule
with
comment
period.

SUMMARY:
This
document
corrects
technical
errors
that
appeared
in
the
final
rule
with
comment
period
published
in
the
Federal
Register
on
December
31,
2002,
entitled,
``
Revisions
to
Payment
Policies
Under
the
Physician
Fee
Schedule
for
Calendar
Year
2003
and
Inclusion
of
Registered
Nurses
in
the
Personnel
Provision
of
the
Critical
Access
Hospital
Emergency
Services
Requirement
for
Frontier
Areas
and
Remote
Locations''.
EFFECTIVE
DATE:
This
rule
is
effective
March
1,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
Diane
Milstead,
(
410)
786
 
3355.
SUPPLEMENTARY
INFORMATION:

I.
Background
In
FR
Doc.
02
 
32503
of
December
31,
2002
(
67
FR
79966),
there
were
a
number
of
technical
errors
that
are
identified
and
corrected
in
the
Correction
of
Errors
section
below.
Additionally
there
are
various
revisions
to
Addenda
B,
C,
D
and
E.
The
provisions
in
this
correction
notice
are
effective
as
if
they
had
been
included
in
the
document
published
December
31,
2002.

Discussion
of
Addenda
B,
C,
D
and
E
1.
In
Addendum
B,
we
assigned
incorrect
status
indicators
for
the
following
CPT
codes:
Page
80111
for
CPT
code
67221;
page
80143
for
CPT
codes
90723,
90740,
90743,
90744,
90746,
90747
and
90748;
page
80158
for
CPT
codes
99026
and
99027;
and
page
80166
for
HCPCS
code
J3370.
We
assigned
incorrect
status
indicators
and
RVUS
for
the
following
CPT
and
HCPCS
codes:
Page
80147
for
CPT
code
92597;
page
80149
for
CPT
codes
93315,
99315
 
TC,
99317
and
93317
 
TC;
page
80156
for
95951
and
95951
 
TC,
page
80158
for
CPT
code
99026
and
99027
and
page
80163
for
G0125
and
G0125
 
TC.
We
also
erroneously
assigned
RVUs
to
the
following
HCPCS
codes
that
are
not
used
for
Medicare
payment:
Page
80164
for
G0219
and
G0219
 
26;
page
80165
for
G0255
and
G0255
 
26.
These
corrections
are
reflected
in
correction
number
12
to
follow.
2.
We
indicated
the
incorrect
global
period
in
Addenda
B
and
C
for
the
following
CPT
codes:
Page
80100
for
CPT
code
58550;
pages
80074
and
80167
for
CPT
codes
33224;
and
page
80134
for
CPT
codes
77789,
77789
 
26
and
77789
 
TC.
The
corrected
global
period
is
in
correction
number
13
to
follow.
3.
In
Addenda
B
and
C,
on
pages
80044,
80165
and
80170,
we
erroneously
assigned
RVUs
to
a
CPT
code
0020T
which
is
an
emerging
technology
code
and
also
created
two
new
HCPCS
codes
(
G0279
and
G0280)
with
payments
based
on
our
valuation
of
this
CPT
code.
However,
assignment
of
RVUs
for
this
CPT
code
is
contrary
to
national
policy
established
in
the
November
1,
2001
(
66
FR
55269),
final
rule
which
stated
that
we
would
provide
payment
for
emerging
technology
codes
as
determined
by
the
carrier.
In
addition,
based
on
the
creation
of
these
two
G
codes,
we
are
not
recognizing
CPT
code
0019T
for
Medicare
purposes.
Corrections
for
these
services
are
in
correction
number
14.
4.
In
Addenda
B
on
page
80097,
incorrect
work
and
practice
expense
RVUS
were
assigned
to
CPT
code
53853.
In
addition,
on
page
80110
the
RVUs
listed
under
non­
facility
total
and
facility
total
were
incorrect
for
the
following
codes:
66710,
66720,
66761
66762
and
66770.
These
corrections
are
reflected
in
correction
number
15.
5.
In
Addenda
B
and
C,
incorrect
practice
expense
RVUs
were
assigned
for
the
following
CPT
codes:
Page
80044
for
CPT
codes
10021
and
10022;
page
80060
for
CPT
26587;
page
80084
for
CPT
code
42820;
page
80092
for
CPT
codes
50080,
50081,
50236,
50240;
page
80093
for
CPT
codes
50553,
50555,
50557,
50561,
50684
and
50690;
page
80094
for
CPT
codes
50953,
50955,
50957,
50961,
51010,
51605,
51610,
51710,
51726
and
51726
 
TC;
page
80095
and
80168
for
CPT
codes
51772,
51772
 
TC,
51784,
51784
 
TC,
51785,
51785
 
TC,
51792,
51792
 
TC,
51795,
51795
 
TC,
51798,
52000,
52005,
52010,
52204,
52214,
52224,
52265,
52270,
52275,
52276,
52281,
52282,
52283,
52285,
52310,
52315,
52317,
52330
and
52332;
page
80096
for
CPT
codes
52647,
53025,
53040,
53080,
53085,
53200,
53265
and
53270;
page
80093
for
CPT
codes
53850,
53852,
54000,
54001,
54015,
54055,
54060,
54105,
54111,
54115,
54120,
54125,
54130,
54135,
54160,
54205,
54300,
54304,
54308,
54312,
54324,
54328,
54332,
54360
and
54430;
page
80098
for
CPT
codes
54500,
54700,
55100,
55250,
55450,
and
55700;
page
80099
for
CPT
code
55873;
page
80100
for
CPT
code
58340;
page
80109
for
CPT
code
65220;
page
80110
for
CPT
code
66740;
page
80110
for
CPT
codes
66821
and
66984;
page
80111
for
CPT
codes
67820
and
67825;
page
80117
for
CPT
codes
71275
and
71275
 
TC;
page
80119
for
CPT
codes
72191
and
72191
 
TC;
page
80120
for
CPT
codes
73206
and
73206
 
TC;
page
80121
for
CPT
codes
73706
and
73706
 
TC;
page
80122
for
CPT
codes
74175
and
74175
 
TC;
page
80130
for
CPT
codes
76519
and
76519
 
TC;
page
80141
for
CPT
code
88141;
page
80145
for
CPT
codes
91122,
91122
 
TC,
92014,
92081,
92081
 
TC,
92083,
92083
 
TC,
92135
,
92135
 
TC,
92235;
page
80146
for
CPT
codes
92235
 
TC,
92250
and
92250
 
TC;
page
80148
for
CPT
code
93012;
page
80153
for
CPT
codes
94014
and
94015;
page
80163
for
HCPCS
codes
G0124
and
G0141;
page
80165
and
80170
for
HCPCS
codes
G0275,
G0278
and
G0281;
page
80166
and
80170
for
HCPCS
codes
G0283,
G0289
and
P3001.
The
corrected
RVUs
are
in
item
number
16.
6.
In
Addendum
D,
on
page
80171,
the
carrier
numbers
listed
for
Ohio
and
West
Virginia
are
incorrect.
The
corrected
numbers
are
reflected
in
number
17
to
follow.

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16:
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2003
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