55503
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
Commodity
Parts
per
million
Almond,
hulls
................
15
*
*
*
*
*

Nut,
tree,
group
14
.......
0.20
Okra
..............................
2.0
*
*
*
*
*

Peppermint,
tops
...........
25
Pistachio
.......................
0.20
*
*
*
*
*

Spearmint,
tops
.............
25
*
*
*
*
*

Vegetable,
cucurbit,
group
9.
0.75
Vegetable,
fruiting,
group
8.
2.0
(
2)
Tolerances
are
established
for
combined
residues
of
bifenazate
(
1­
methylethyl
2­(
4­
methoxy[
1,1'­
biphenyl]­
3­
yl)
hydrazinecarboxylate);
diazinecarboxylic
acid,
2­(
4­
methoxy­
[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate);
1,1'­
biphenyl,
4­
ol;
and
1,1'­
biphenyl,
4­
oxysulfonic
acid
(
expressed
as
1,1'­
biphenyl,
4­
ol)
in
or
on
the
following
food
commodities:

Commodity
Parts
per
million
Cattle,
meat
..................
0.02
Cattle,
meat
byproducts
0.02
Goat,
meat
....................
0.02
Goat,
meat
byproducts
0.02
Hog,
meat
.....................
0.02
Hog,
meat
byproducts
...
0.02
Horse,
meat
..................
0.02
Horse,
meat
byproducts
0.02
Milk
................................
0.02
Sheep,
meat
.................
0.02
Sheep,
meat
byproducts
0.02
(
b)
Section
18
emergency
exemptions.
Time­
limited
tolerances
are
established
for
combined
residues
of
bifenazate
(
1­
methylethyl
2­(
4­
methoxy[
1,1'­
biphenyl]­
3­
yl)
hydrazinecarboxylate)
and
diazinecarboxylic
acid,
2­(
4­
methoxy­[
1,1'­
biphenyl]­
3­
yl),
1­
methylethyl
ester
(
expressed
as
bifenazate)
in
connection
with
use
of
the
pesticide
under
section
18
emergency
exemptions
granted
by
EPA.
The
tolerances
will
expire
and
are
revoked
on
the
dates
specified
in
the
following
table.
*
*
*
*
*

[
FR
Doc.
03
 
24370
Filed
9
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0304];
FRL
 
7325
 
8]

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

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
thiacloprid
([
3­[(
6­
chloro­
3­
pridinyl)
methyl]­
2­
thiazolidinylidene]
cyanamide)
and
metabolites
retaining
the
thiazolidine
ring
intact,
measured
and
expressed
in
terms
of
thiacloprid,
per
se,
in
or
on
apple,
wet
pomace;
cotton,
undelinted
seed;
cotton,
gin
by­
products;
fruit,
pome
group
11;
fat,
meat,
liver,
kidney
and
meat
by­
products
of
cattle,
sheep,
goat
and
horse;
and
milk.
Bayer
CropScience
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
September
26,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0304],
must
be
received
on
or
before
November
25,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
 
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Marilyn
Mautz,
Registration
Division,
7505C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
703
305
 
6785;
e­
mail
address:
mautz.
marilyn@
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
 
0304.
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
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/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
May
7,
2003
(
68
FR
24458)
(
FRL
 
7303
 
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
9F6060)
by
Bayer
CropScience,
P.
O.
Box
12014,
2
T.
W.
Alexander
Dr.,
Research
Triangle
Park,
NC
27709.
That
notice
included
a
summary
of
the
petition
prepared
by
Bayer
CropScience,
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,
thiacloprid,
in
or
on
apple,
wet
pomace;
cattle,
meat
and
meat
byproducts;
cotton,
gin
byproducts;
cotton,
undelinted
seed;
fruit,
pome,
group
11;
and
milk
at
0.6;
0.2;
11.0;
1.0;
0.3;
and
0.1
parts
per
million
(
ppm),
respectively.
Upon
review
and
evaluation
of
the
data
submitted
in
support
of
the
petition,
the
Agency
determined
that
the
residues
of
concern
are
thiacloprid
plus
metabolites
retaining
the
thiazolidine
ring
intact.
Excluded
from
the
residues
of
concern
are
metabolites
such
as
6­
nicotinic
acid
(
6­
CNA)
for
which
the
thiazolidine
ring
is
broken.
These
metabolites
are
excluded
based
on
the
finding
that
the
toxic
effects
of
thiacloprid
are
considered
to
be
associated
with
the
entire
thiacloprid
molecule
(
with
both
the
thiazolidine
ring
and
the
chloropyridine
ring
intact).
Because
metabolism
and
degradation
studies
have
shown
that
the
thiazolidine
ring
is
less
stable
than
the
chloropyridine
ring,
it
is
understood
that
metabolites
retaining
the
thiazolidine
ring
also
retain
the
chloropyridine
ring
intact.
Metabolites
retaining
the
thiazolidine
ring
generally
constitute
most
of
the
residue
in
foods
and
feeds.
The
petition
was
subsequently
revised
to:
1.
Request
that
40
CFR
part
180
be
amended
by
establishing
tolerances
for
the
insecticide
thiacloprid
in
or
on
the
commodities:
Meat,
meat
byproducts,
liver,
fat,
and
kidney
of
sheep,
goat
and
horse;
liver;
fat
and
kidney
of
cattle;
and
2.
Lowering
the
previously
proposed
tolerance
levels
for
the
food
commodities,
cattle,
meat
from
0.2
ppm
to
0.03
ppm;
cattle,
meat
byproducts
from
0.2
ppm
to
0.05
ppm;
cotton,
undelinted
seed
from
1.0
ppm
to
0.02
ppm
and
milk
from
0.1
ppm
to
0.03
ppm
based
on
measurement
of
thiacloprid
per
se
rather
than
measurement
of
the
common
moiety,
6­
nicotinic
acid
(
6­
CNA)
upon
which
the
original
proposed
tolerances
were
based;
as
summarized
in
Table
1
of
this
unit.

TABLE
1
 
PROPOSED
TOLERANCE
LEVELS
FOR
FOOD
COMMODITIES.

Commodity
Original,
Measured
as
6­
CNA
(
ppm)
Revised,
Measured
as
Thiacloprid
(
ppm)

Apple,
wet
pomace
0.6
0.6
Cattle,
meat
0.2
0.03
Cattle,
meat
byproducts
0.2
0.05
Cotton,
gin
byproducts
11.0
11.0
Cotton,
undelinted
seed
1.0
0.02
Cattle,
sheep,
goat
and
horse
fat
0.02
Cattle,
sheep,
goat
and
horse
kidney
0.05
Cattle,
sheep,
goat
and
horse
liver
0.15
Fruit,
pome,
group
11
0.3
0.3
Milk
0.1
0.03
Sheep,
goat
and
horse
meat
0.03
Sheep,
goat
and
horse
meat
byproducts
0.05
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
combined
residues
of
thiacloprid
and
metabolites
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Federal
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/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
retaining
the
thiazolidine
ring
intact,
measured
and
expressed
in
terms
of
thiacloprid,
per
se
on
apple,
wet
pomace;
cattle,
sheep,
goat
and
horse
meat;
meat
byproducts;
liver;
kidney;
and
fat;
cotton,
undelinted
seed;
cotton,
gin
byproducts;
fruit,
pome,
group
11;
and
milk
at
0.6;
0.03;
0.05;
0.15;
0.05;
0.02;
0.02;
11.0;
0.3;
and
0.03
ppm,
respectively.
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
thiacloprid
are
discussed
in
Table
2
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90­
Day
oral
toxicity
rodents
NOAEL
=
rats:
males,
7.3
mg/
kg/
day
;
females,
7.6
mg/
kg/
day;
mice,
females,
27.3
mg/
kg/
day
;
males
102.6
milligram/
kilogram/
day
(
mg/
kg/
day)
LOAEL
=
rats:
males,
28.6
mg/
kg/
day;
females,
35.6
mg/
kg/
day;
mice:
females,
27.2
mg/
kg/
day;
males,
542.4
mg/
kg/
day
based
on
rats:
decreased
body
weight
throughout
treatment:
mice:
females
based
on
adrenal
X­
zone
changes.
males
based
on
liver
effects
(
weight
and
hypertrophy).

870.3150
90­
Day
oral
toxicity
in
nonrodents
NOAEL
=
males.
8.5,
females,
8.9
mg/
kg/
day
LOAEL
=
 
34.9
mg/
kg/
day
based
on
mainly
liver
enzyme
changes,
thyroid
hormone
level
(
T4)
and
binding
capacity
changes
and
prostatic
weight
change
and
prostatic
hypertrophy.

870.3200
21/
28­
Day
dermal
toxicity
NOAEL
=
females,
300
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
liver
and
thyroid
effects
and
clinical
signs.

870.3465
28
Day
inhalation
toxicity
NOAEL
=
0.542
mg/
kg/
day
LOAEL
=
4.93
mg/
kg/
day
based
on
[
liver
effects
(
hypertrophy
and
increased
NDEM

870.3700
Prenatal
developmental
in
rodents
Maternal
NOAEL
=
10
mg/
kg/
day
LOAEL
=
50
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
food
consumption,
increased
urination,
and
changes
in
water
consumption.
Developmental
NOAEL
=
10
mg/
kg/
day
LOAEL
=
50
mg/
kg/
day
based
on
increased
resorptions
(
complete
and
late),
skeletal
retardations,
variations
(
wavy
ribs
and
asymmetrical
sternebrae),
and
malformations
(
dysplastic
humerus,
radius,
and
scapulae)
and
on
decreased
fetal
weights
870.3700
Prenatal
developmental
in
nonrodents
Maternal
NOAEL
=
2
mg/
kg/
day
LOAEL
=
10
mg/
kg/
day
based
on
decreased
body
weight
gains,
food
consumption,
and
fecal
output.
Developmental
NOAEL
=
2
mg/
kg/
day
LOAEL
=
10
mg/
kg/
day
based
on
decreased
fetal
weights
870.3800
Reproduction
and
fertility
effects
Parental/
Systemic
NOAEL
=
males,
3.5
mg/
kg/
day
LOAEL
=
21
mg/
kg/
day
based
on
increased
liver
and
thyroid
weights
and
on
hepatocytomegaly,
liver
necrosis,
and
thyroid
follicular
cell
hypertrophy.
Reproductive
NOAEL
=
females,
4
.2
mg/
kg/
day
LOAEL
=
26
mg/
kg/
day
based
on
dystocia
Offspring
NOAEL
=
females,
4.2
mg/
kg/
day
LOAEL
=
females,
21
mg/
kg/
day
based
on
decreased
pup
weight
during
lactation.

870.4100
Chronic
toxicity
dogs
No
firm
LOAEL
was
established
for
this
chronic
feeding
study
with
dogs;
1,000
ppm
highest
dose
tested
(
HDT).
There
were
no
effects
that
were
of
sufficient
magnitude
or
consistency
to
justify
that
they
were
definite
responses
to
treatment.
Certain
effects
noted
in
the
subchronic
dog
study
on
the
prostate
and
other
male
organs
and
an
apparent
effect
on
uterine
weight
in
the
subchronic
dog
study
were
not
seen
in
this
chronic
study.
This
may
be
because
the
dogs
in
this
study
had
reached
maturity
870.4300
Combined
chronic
feeding
cacinogenicity
rats
NOAEL
=
males,
1.2
mg/
kg/
day
;
females,
1.6
mg/
kg/
day
LOAEL
=
males,
2.5
mg/
kg/
day;
females,
3.3
mg/
kg/
day
based
on
[
liver
toxicity
(
hepatocellular
hypertrophy
and
cytoplasmic
change
and
increased
enzyme
activity
thyroid
follicular
epithelial
hypertrophy
in
males
and
oculotoxicity
(
retinal
atrophy
in
females
Evidence
of
carcinogenicity
based
on
increased
incidence
of
thyroid
follicular
cell
adenomas
in
males
and
possibly
also
in
females
and
increased
incidence
of
uterine
tumors
(
adenocarcinomas)

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Rules
and
Regulations
TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.4200
Carcinogenicity
mice
NOAEL
=
males,
5.7
mg/
kg/
day;
females:
10.9
mg/
kg/
day
LOAEL
=
males,
234.1mg/
kg/
day;
females,
475.3
mg/
kg/
day
based
on
liver
toxicity
and
microscopic
lymph
node
changes
in
both
sexes
and
increased
X­
zone
vacuolization
of
the
adrenal
glands
in
female
mice
Evidence
of
carcinogenicity
based
on
increased
incidence
of
ovarian
luteomas
870.5100
Gene
Mutation
Negative
in
a
battery
of
tests
870.5300
Gene
Mutation
Negative
in
a
battery
of
tests
870.5375
Cytogenetics
Negative
in
battery
of
tests
870.5395
Cytogenetics
Negative
in
battery
of
tests
870.5500
Cytogenetics
Negative
in
battery
of
tests
870.5550
Other
Effects
Negative
870.6200
Acute
neurotoxicity
screening
battery
NOAEL
=
males,
11
mg/
kg
bodyweight
(
bw);
females,
3.1
mg/
kg/
day
LOAEL
=
males,
22
mg/
kg
bw;
females,
11
mg/
kg/
day
In
females,
based
on
reductions
in
motor
and
locomotor
activity.;
in
males,
(
based
on
FOB
observations
of
slight
tremors
and
ptosis
of
the
eyelids
on
the
day
of
treatment)

870.6200
Subchronic
neurotoxicity
screening
battery
NOAEL
=
males
,
24.2
mg/
kg/
day;
females,
27.9
mg/
kg/
day
LOAEL
=
males,
101
mg/
kg/
day;
females,
115
mg/
kg/
day
based
on
decreased
body
weight
gains
and
food
consumption
in
both
sexes
and
decreased
hindlimb
grip
strength
in
males.

870.6300
Developmental
neurotoxicity
Maternal
NOAEL
=
4.4
mg/
kg/
day
LOAEL
=
25.6
mg/
kg/
day
based
on
decreased
body
weight
gain
and
food
consumption
during
early
gestation
(
gestation
day
(
GD)
0­
6.
Offspring
NOAEL
=
Tentative
Offspring
,
4.4
mg/
kg/
day
LOAEL
=
Tentative
Offspring,
25.6
mg/
kg/
day
based
on
decreased
pre­
weaning
and
post­
weaning
body
weights
in
both
sexes
and
delayed
sexual
maturation
in
the
males,
and
altered
performance
in
passive
avoidance
testing.

870.7485
Metabolism
and
pharmacokinetics
Thiacloprid
is
rapidly
absorbed
and
is
rapidly
excreted
after
the
following
metabolic
processes,
with
little
remaining
in
the
tissues.
The
metabolic
processes
were
summarized
as:
1.
Hyroxylation
of
the
thiazolidine
ring
and
subsequent
glucuronidation
(
as
shown
by
metabolite
PIZ
1270),
2.
Hydroxylation
of
the
cyanamide
moiety
(
metabolite
KNO
1891),
3.
Opening
of
the
thiazolidine
ring
(
e.
g.,
metabolites
KNO2672,
PIZ1297F/
WAK
6935),
4.
Formation
of
an
oxazole
ring
(
metabolite
PIZ
1253),
5.
Oxidation
and
subsequent
methylation
of
the
thiazolidine
ring
(
e.
g.,
PIZ
1297E
and
PIZ
1269X),
and
6.
Oxidative
cleavage
of
the
methylene
bridge
(
PIZ
1243).
Only
minor
gender­
related
quantitative
differences
in
metabolite
profiles
were
observed.

870.7600
Dermal
penetration
A
5%
dermal
absorption
value
is
appropriate
for
estimating
the
risk
resulting
from
dermal
exposure
to
Thiacloprid
formulated
as
a
40.4%
liquid
formulation
(
SC
480).
This
5%
value
is
also
appropriate
for
other
liquid
thiacloprid
formulations
that
are
similar
to
the
SC
480
liquid
formulation
product
tested
and
for
aqueous
dilutions
of
most
thiacloprid
formulations.

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
As
explained
in
Unit
III.
D.
3.,
EPA
determined
that
the
FQPA
SF
be
reduced
to
3X.
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
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/
Rules
and
Regulations
(
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
thiacloprid
used
for
human
risk
assessment
is
shown
in
Table
3
of
this
unit:

TABLE
3.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
THIACLOPRID
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
All
population
groups)
NOAEL
=
3.1
mg/
kg
UF
=
300*
Acute
RfD
=
0.01
mg/
kg.
Special
FQPA
SF
=
1
aPAD
=
acute
RfD/
FQPA
SF
=
0.01
mg/
kg
Acute
Neurotoxicity
­
rats
LOAEL
=
11
mg/
kg/
day
based
on
decreased
motor
activity
in
females.

Chronic
Dietary
(
All
populations
NOAEL=
1.2
mg/
kg/
day
UF
=
300*
Chronic
RfD
=
0.004
mg/
kg/
day
Special
FQPA
SF
=
1
cPAD
=
chronic
RfD/
FQPA
SF
=
0.004
mg/
kg/
day
Chronic
feeding
in
rats.
LOAEL
=
2.5
mg/
kg/
day
based
on
hepatic
hypertrophy
and
cytoplasmic
change
and
thyroid
hypertrophy
and
retinal
degeneration.

Cancer
(
Oral,
dermal,
inhalation
Q1*
(
mg/
kg/
day)­
1
=
4.06
x
10­
2
Classified
as
a
likely
human
carcinogen
based
on
thyroid
tumors
and
uterine
tumors
in
rats
and
ovary
tumors
in
mice
UF
=
uncertainty
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose
*
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.
There
are
no
tolerances
established
for
residues
of
thiacloprid.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
thiacloprid
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
one
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
A
moderately
refined,
Tier
3
acute
dietary
exposure
assessment,
which
incorporated
field
trial
data,
estimates
of
%
market
share,
and
empirical
processing
factors,
was
conducted
for
the
general
U.
S.
population
and
various
population
subgroups.
Monitoring
data
are
not
available
for
thiacloprid
as
it
is
a
new
chemical.
EPA
estimated
exposure
at
the
99.9th
exposure
percentile.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
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
chronic
exposure
assessments:
A
partially
refined,
Tier
3
chronic
dietary
exposure
assessment,
which
incorporated
field
trial
data,
empirical
processing
factors,
and
projected
percent
crop
treated
estimates,
was
conducted
for
the
general
U.
S.
population
and
various
population
subgroups.
Monitoring
data
are
not
available
for
thiacloprid
as
it
is
a
new
chemical.
iii.
Cancer.
A
cancer
assessment
was
performed
using
the
same
assumptions
as
the
chronic
assessment
in
Unit
III.
C.
1.
ii.
The
cancer
dietary
exposure
estimate
for
the
general
U.
S.
population
is
1.3
x
10­
6.
iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
As
required
by
section
408(
b)(
2)(
E)
of
the
FFDCA,
EPA
will
issue
a
data
call­
in
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
Section
408(
b)(
2)(
F)
of
the
FFDCA
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
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Friday,
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26,
2003
/
Rules
and
Regulations
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
PCT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
PCT.
The
Agency
used
PCT
information
for
both
the
acute
and
chronic
dietary
risk
assessment
as
follows:
A
routine
acute
and
chronic
dietary
exposure
analysis
for
thiacloprid
was
based
on
61%
of
apple
crop
treated,
51%
of
pear
crop
treated
and
1%
of
cotton
crop
treated.
The
Agency
believes
that
the
three
conditions
previously
discussed
have
been
met.
With
respect
to
Condition
1,
EPA
finds
that
the
PCT
information
described
in
the
preceding
paragraph
for
thiacloprid
used
on
these
crops
is
reliable
and
has
a
valid
basis.
The
PCT
estimates
are
based
on
use
of
existing
alternate
insecticides
against
insects
that
thiacloprid
will
control.
As
per
Agency
practice,
the
PCT
estimates
are
what
the
Agency
expects
to
be
likely
upper
bound
market
penetrations
for
various
crop/
pest
niches.
Maximal
percent
crop
treated
estimates
were
projected
for
apples,
pears,
and
cotton.
The
Agency
is
reasonably
certain
that
the
percentage
of
the
food
treated
is
not
likely
to
be
an
underestimation.
As
to
Conditions
2
and
3,
regional
consumption
information
and
consumption
information
for
significant
subpopulations
is
taken
into
account
through
EPA's
computer­
based
model
for
evaluating
the
exposure
of
significant
subpopulations
including
several
regional
groups.
Use
of
this
consumption
information
in
EPA's
risk
assessment
process
ensures
that
EPA's
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group
and
allows
the
Agency
to
be
reasonably
certain
that
no
regional
population
is
exposed
to
residue
levels
higher
than
those
estimated
by
the
Agency.
Other
than
the
data
available
through
national
food
consumption
surveys,
EPA
does
not
have
available
information
on
the
regional
consumption
of
food
to
which
thiacloprid
may
be
applied
in
a
particular
area.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
thiacloprid
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
thiacloprid.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
SCI­
GROW
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
The
Tier
II
screening
model,
PRZM/
EXAMS,
was
used
to
estimate
residues
of
thiacloprid
and
one
of
its
major
degradates,
YRC
2984
amide
in
surface
water.
The
SCI­
GROW
model
was
used
to
estimate
the
ground
water
residues.
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
thiacloprid
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
thiacloprid
and
one
of
its
major
degratates,
YRC
2894
amide
for
acute
exposures
are
estimated
to
be
10.2
parts
per
billion
(
ppb)
for
surface
water
and
0.06
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
2.36
ppb
for
surface
water
and
0.06
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).
Thiacloprid
is
not
registered
or
proposed
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Cumulative
effects
from
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
thiacloprid
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
thiacloprid
and
any
other
substances
and
thiacloprid
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
Thiacloprid
does
produce
6­
CNA,
a
metabolite
also
produced
by
another
registered
chloronicotinoid
pesticide.
However,
the
limiting
toxic
endpoints
used
in
this
assessment
for
thiacloprid
are
not
based
upon
the
toxicity
of
6­
CNA.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
thiacloprid
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/.

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Vol.
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No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
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.
Developmental
studies
did
not
show
either
qualitative
or
quantitative
susceptibility.
There
is
no
increase
in
quantitative
susceptibility
demonstrated
in
the
rat
developmental
neurotoxicity,
rabbit
developmental
or
rat
reproduction
studies.
There
is
an
apparent
qualitative
increase
in
susceptibility
in
the
rat
developmental
toxicity
study
as
indicated
by
increases
in
resorptions,
increases
in
skeletal
variations
and
retardations
and
malformations,
and
decreases
in
fetal
body
weight
that
occurred
at
the
same
dose
showing
a
decrease
in
maternal
body
weight,
but
the
concern
is
low
since:
i.
There
is
a
well
characterized
dose
response
with
a
clear
NOAEL
and
LOAEL;
ii.
The
fetal
effects
were
noted
in
the
presence
of
maternal
toxicity;
and
iii.
There
are
no
residual
uncertainties.
3.
Conclusion.
In
evaluating
whether
to
retain
the
10X
SF
to
protect
infants
and
children
or
to
select
a
different
safety
factor,
EPA
considered
the
following
factors:
i.
There
are
no
special
concerns
regarding
pre­
or
post­
natal
toxicity
exposure;
ii.
The
exposure
databases
(
food
and
drinking
water)
are
complete
and/
or
employ
conservative
assumptions;
iii.
There
is
no
residential
exposure;
iv.
The
risk
assessments
cover
or
approximate
all
the
metabolites
and
degradates
of
concern;
v.
The
assessments
do
not
underestimate
the
potential
risk
for
infants
and
children;
and
vi.
The
toxicity
database
is
complete
except
that
there
is
a
lack
of
morphometric
assessments
for
the
low­
and
mid­
dose
group
animals
in
the
developmental
neurotoxicity
study
(
DNT).
Although
the
lack
of
morphometric
assessments
in
the
DNT
raised
some
uncertainty,
EPA
determined
that
there
were
sufficient
reliable
data
to
select
an
additional
safety
factor
of
3X
instead
of
10X.
The
FQPA
safety
factor
of
3X
is
in
the
form
of
a
database
uncertainty
factor
of
3X.
A
3X
factor
was
judged
to
be
adequate
because
the
dose
selected
for
overall
risk
assessments
is
already
based
on
the
most
sensitive
end
points
for
acute
(
i.
e.
clinical
signs
indicative
of
neurotoxicity)
and
chronic
(
i.
e.
liver
and
thyroid
effects)
dietary
and
non­
dietary
exposure
scenarios,
and
the
available
data
indicate
that
the
full
characterization
of
brain
morphometrics
from
the
DNT
study
would
not
be
expected
to
lower
the
dose
used
for
risk
assessments
by
more
than
3­
fold.
To
elaborate,
since
the
magnitude
(
4­
14%)
of
the
morphometric
histopathology
changes
seen
in
the
offspring
at
the
highest
dose
(
40.8
mg/
kg/
day)
in
the
developmental
neurotoxicity
study
were
considered
to
be
at
or
near
the
limit
of
detection
for
differences
in
morphometric
measurements,
it
is
unlikely
that
measurable
morphometric
changes
will
be
seen
at
lower
doses.
Any
possible
slight
effects
at
lower
doses
are
highly
unlikely
to
change
the
regulatory
level.
The
actual
doses
used
to
establish
the
acute
RfD
(
3.1
mg/
kg/
day)
and
the
chronic
RfD
(
1.2
mg/
kg/
day)
are
13
and
34
fold
lower,
respectively,
than
the
40.8
mg/
kg/
day
dose
where
the
effects
of
minimal
magnitude
were
seen.
Applying
the
3
X
factor
further
renders
the
adjusted
doses
39
and
102­
fold
lower
than
the
dose
level
where
the
effects
of
minimal
magnitude
were
seen.
Morever,
even
if
the
slight
morphometric
changes
are
seen
at
the
mid,
and
even
the
low,
dose
of
the
DNT,
a
RfD
calculated
on
such
findings
is
highly
unlikely
to
be
lower
than
current
acute
and
chronic
RfDs
adjusted
by
3X
given
that
the
effects
seen
at
the
high
dose
were
marginal.
Therefore
it
is
concluded
that
3X
is
adequate
to
account
for
any
possible
morphometric
effects
that
may
be
noted
in
the
lower
doses
for
which
the
additional
readings
are
being
sought.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
thiacloprid
will
occupy
20%
of
the
aPAD
for
the
U.
S.
population,
8.5
%
of
the
aPAD
for
females
13
years
and
older,
51
%
of
the
aPAD
for
all
infants
and
47
%
of
the
aPAD
for
children
1­
2
years
old.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
thiacloprid
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
Table
4
of
this
unit:

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TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
THIACLOPRID
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

General
U.
S.
population
0.01
20
10.2
0.06
281
All
infants
<
1
year
old
0.01
51
10.2
0.06
49
Children
1­
2
years
old
0.01
47
10.2
0.06
53
Children
3­
5
years
old
0.01
33
10.2
0.06
67
Females
13­
49
years
old
0.01
8.5
10.2
0.06
274
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
thiacloprid
from
food
will
utilize
<
1.0
%
of
the
cPAD
for
the
U.
S.
population,
4.4
%
of
the
cPAD
for
all
infants
and
4.2%
of
the
cPAD
for
children
1­
2
years
old
.
There
are
no
residential
uses
for
thiacloprid
that
result
in
chronic
residential
exposure
to
thiacloprid.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
thiacloprid
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
5
of
this
unit:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
THIACLOPRID
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.004
<
1.0
2.36
0.06
139
All
Infants
<
1
year
old
0.004
4.4
2.36
0.06
38
Children
1­
2
years
old
0.004
4.2
2.36
0.06
38
Children
3­
5
years
old
0.004
2.9
2.36
0.06
38
Children
6­
12
years
old
0.004
1.3
2.36
0.06
39
Females
13­
49
years
old
0.004
<
1.0
2.36
0.06
120
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).
Thiacloprid
is
not
registered
or
proposed
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Thiacloprid
is
not
registered
or
proposed
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
do
not
exceed
the
Agency's
level
of
concern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
In
accordance
with
the
EPA
Draft
Guidelines
for
Carcinogen
Risk
Assessment:
(
July
1999),
thiacloprid
was
classified
into
the
category
Likely
to
be
Carcinogenic
to
Humans.
A
linear
lowdose
extrapolation
approach
is
applied
to
the
quantifications
of
risk
to
be
estimated,
based
upon
male
rat
thyroid,
rat
uterine,
and
mouse
ovarian
tumors.
The
data
did
not
support
a
mode
of
action.
The
Q1*
is
4.06
x
10­
2
in
human
equivalents
based
on
the
rat
uterine
adenoma,
adenocarcinoma
and/
or
adenosquamous
carcinoma
combined
tumor
rates.
The
dietary
cancer
risk
from
residues
in
food
is
1.3X
10­
6.
A
cancer
DWLOC
is
calculated
only
for
the
general
U.
S.
Population.
For
this
population
the
calculated
DWLOC
of
1.5ug/
L
is
the
same
as
the
calculated
EEC
of
1.5
ug/
L.
DWLOC
=
3
X
10­
6/
Q1*
­
average
food
exposure
(
mg/
kg/
day)]*
bwt*
1,000
ug/
mg
÷
Water
consumption
(
liter/
day)
DWLOC
(
US
Pop.)
=
1.5
ug/
L.
Since
the
surface
water
EEC
for
cancer
is
1.5
ug/
L
the
risk
cup
is
exactly
filled
to
3
X
10­
6.
For
risk
management
purposes,
EPA
considers
a
cancer
risk
to
be
greater
than
negligible
when
it
exceeds
the
range
of
1
in
1
million.
EPA
has
generally
treated
cancer
risks
up
to
3
in
1
million
as
within
the
range
of
1
in
1
million.
EPA
believes
that
the
lifetime
exposure
will
be
result
in
negligible
cancer
risk
for
the
following
reason:
The
cancer
risk
from
the
food
uses
alone
is
1.3
x
10­
6.
The
dietary
risk
is
based
on
residue
data
derived
from
the
average
of
field
trials.
It
is
not
unusual
in
the
Agency's
experience
for
field
trial
data
to
be
an
order
of
magnitude
above
actual
monitoring.
Since
thiacloprid
is
a
new
chemical,
actual
monitoring
data
are
not
yet
available.
It
is
likely
that
the
actual
risk
contribution
from
food
will
be
much
lower
than
current
data
indicate,
which
would
result
in
a
larger
DWLOCcancer.
Thus,
EPA
does
not
expect
that
the
general
population
would
be
exposed
to
levels
that
would
exceed
a
neglible
cancer
risk
over
a
lifetime.
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
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population,
and
to
infants
and
children
from
aggregate
exposure
to
thiacloprid
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
The
petitioner
proposed
a
high
performance
liquid
chromatography
mass
spectrometry
(
HPLC/
MS/
MS)
method
for
determining
thiacloprid,
YRC­
2894
amide
and
4­
hydroxy­
YRC2894
amide
in
plants
which
has
been
found
to
be
appropriate
for
use
in
the
enforcement
of
the
plant
tolerances
associated
with
this
petition.
The
available
radiovalidation
and
metabolism
data
supports
this
method.
An
adequate
Independent
Lab
Validation
(
ILV)
has
been
provided
for
the
method
and
adequate
confirmatory
ions
were
also
identified
in
the
ILV.
The
petitioner
has
proposed
a
HPLC/
MS/
MS
method
for
determining
thiacloprid
in
livestock
tissues
which
has
been
found
to
be
appropriate
for
use
in
the
enforcement
of
the
animal
tissue
tolerances
associated
with
this
petition.
Existing
radiovalidation
and
metabolism
data
supports
this
method
as
well
as
does
an
ILV.
Mass
spectrometry
provides
an
adequate
confirmatory
method.
This
conclusion
is
based
upon
the
successful
use
of
mass
spectrometry
as
a
confirmatory
method
for
thiacloprid
in
plants,
the
similarity
between
the
HPLC/
MS/
MS
methods
for
thiacloprid
in
plants
and
animals,
and
the
Agency's
familiarity
with
mass
spectrometry
in
general.
As
a
condition
of
registration,
the
registrant
will
be
required
to
submit
a
description
of
the
procedures
for
the
use
of
mass
spectrometry
for
thiacloprid
in
animals.
Thiacloprid,
parent
only,
has
been
tested
through
the
FDA
PAM
I
multiresidue
protocol.
Upon
request,
the
methods
will
be
available
prior
to
the
harvest
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
There
are
no
established
Codex,
Canadian
or
Mexican
maximum
residue
limits
(
MRLs)
for
thiacloprid.

C.
Conditions
The
following
information
must
be
submitted
as
a
condition
for
product
registrations
related
to
these
tolerances:
The
registrant
will
be
required
to
submit
a
description
of
the
procedures
for
the
use
of
mass
spectrometry
for
thiacloprid
in
animals.
V.
Conclusion
Therefore,
tolerances
are
established
for
combined
residues
of
thiacloprid
and
metabolites
retaining
the
thiazolidine
ring
intact,
measured
and
expressed
as
thiacloprid,
per
se,
in
or
on
apple,
wet
pomace
at
0.6
ppm;
cattle,
sheep,
goat,
and
horse
meat
at
0.03
ppm;
cattle,
sheep,
goat
and
horse
meat
byproducts
at
0.05
ppm;
cattle,
sheep,
goat,
and
horse
liver
at
0.15
ppm;
cattle,
sheep,
goat,
and
horse
kidney
at
0.05
ppm;
and
cattle
sheep,
goat,
and
horse
fat
at
0.02
ppm;
cotton,
undelinted
seed
at
0.02
ppm;
cotton,
gin
byproducts
at
11.0
ppm;
fruit,
pome,
group
11
at
0.3
ppm;
and
milk
at
0.03
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
 
0304
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
November
25,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
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/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0304,
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
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

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

Dated:
September
16,
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
180.594
is
added
to
read
as
follows:

§
180.594
Thiacloprid;
tolerances
for
residues.
(
a)
General.
Tolerances
for
combined
residues
of
the
insecticide
thiacloprid
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Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
([
3­[(
6­
chloro­
3­
pyridinyl)
methyl]­
2­
thiazolidinylidene]
cyanamide)
and
metabolites
retaining
the
thiazolidine
ring
intact,
measured
and
expressed
in
terms
of
thiacloprid,
per
se,
in
or
on
the
following
commodities:

Commodity
Parts
per
million
Apple,
wet
pomace
0.60
Cattle,
fat
..............
0.020
Cattle,
kidney
........
0.050
Cattle,
liver
............
0.15
Cattle,
meat
..........
0.030
Cattle,
meat
byproducts
............
0.050
Cotton,
gin
byproducts
....................
11.0
Cotton,
undelinted
seed
..................
0.020
Fruit,
pome,
group
11
......................
0.30
Goat,
fat
................
0.020
Goat,
kidney
.........
0.050
Goat,
liver
.............
0.15
Goat,
meat
............
0.030
Goat,
meat
byproducts
....................
0.050
Horse,
fat
..............
0.020
Horse,
kidney
........
0.050
Horse,
liver
...........
0.15
Horse,
meat
..........
0.030
Horse,
meat
byproducts
............
0.050
Milk
.......................
0.030
Sheep,
fat
.............
0.020
Sheep,
kidney
.......
0.050
Sheep,
liver
...........
0.15
Sheep,
meat
.........
0.030
Sheep,
meat
byproducts
............
0.050
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]
[
FR
Doc.
03
 
24371
Filed
9
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0301;
FRL
 
7326
 
7]

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

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
fenhexamid
in
or
on
cucumber;
fruit,
stone,
group
12,
except
plum,
prune,
fresh,
postharvest;
kiwifruit,
postharvest;
leafy
greens
subgroup
4A,
except
spinach;
plum,
prune,
dried;
plum,
prune,
fresh;
vegetable,
fruiting,
group
8,
except
nonbell
pepper.
Interregional
Research
Project
Number
4
(
IR
 
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
EPA
is
also
deleting
certain
fenhexamid
tolerances
that
are
no
longer
needed
as
a
result
of
this
action.
DATES:
This
regulation
is
effective
September
26,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0301,
must
be
received
on
or
before
November
25,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9368;
e­
mail
address:
jamerson.
hoyt@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Industry
(
NAICS
111),
e.
g.,
Crop
production.
 
Industry
(
NAICS
112),
e.
g.,
Animal
production.
 
Industry
(
NAICS
311),
e.
g.,
Food
manufacturing.
 
Industry
(
NAICS
32532),
e.
g.,
Pesticide
manufacturing.
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
 
0301.
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.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
May
21,
2003
(
68
FR
27799)
(
FRL
 
7308
 
4),
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
2E6463,
2E6496,
3E6532,
and
3E6541)
by
IR
 
4,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390.
That
notice
included
a
summary
of
the
petitions
prepared
by
Arvesta
Corporation,
100
First
Street,
Suite
1700,
San
Francisco,
CA
94105,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petitions
requested
that
40
CFR
180.553
be
amended
by
establishing
tolerances
for
residues
of
the
fungicide
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