66561
Federal
Register
/
Vol.
67,
No.
212
/
Friday,
November
1,
2002
/
Rules
and
Regulations
*
*
*
*
*
[
FR
Doc.
02
 
27833
Filed
10
 
31
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0298;
FRL
 
7279
 
6]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
combined
residues
of
thiamethoxam
and
its
metabolite
in
or
on
corn
forage,
corn
stover
and
popcorn,
corn
grain
and
sweet
corn
(
kernal
and
cob
with
husk
removed).
Syngenta
Crop
Protection,
Inc.
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
November
1,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0298,
must
be
received
on
or
before
December
31,
2002.
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:
Dani
Daniel,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
703
305
 
5409;
e­
mail
address:
daniel.
dani@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

Categories
NAICS
Examples
of
Potentially
Affected
Entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
 
2002
 
0298.
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
June
27,
2002
(
67
FR
43310
 
43314)
(
FRL
 
7183
 
2),
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
0F6142)
by
Syngenta
Crop
Protection,
Inc.,
P.
O.
Box
18300
Greensboro,
NC
27419
 
8300.
That
notice
included
a
summary
of
the
petition
prepared
by
Syngenta
Crop
Protection,
Inc.,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.565
be
amended
by
establishing
tolerances
for
combined
residues
of
the
insecticide
thiamethoxam,
3­[(
2­
chloro­
5­
thiazolyl)
methyl]
tetrahydro­
5­
methyl­
N­
nitro­
4H­
1,3,5­
oxadiazin­
4­
imine
and
its
metabolite
(
N­(
2­
chloro­
thiazol­
5­
ylmethyl)­
N ­
methyl­
N ­
nitro­
guanidine)
in
or
on
the
raw
agricultural
commodities:
field
corn
forage
at
0.10
parts
per
million
(
ppm),
sweet
corn
forage
at
0.10
ppm,
popcorn
forage
at
0.10
ppm,
field
corn
stover
at
0.05
ppm,
sweet
corn
stover
at
0.05
ppm,
field
corn
grain
at
0.07
ppm,
popcorn
grain
at
0.02
ppm,
and
sweet
corn
(
kernal
and
cob
with
husk
removed)
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
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/
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67,
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212
/
Friday,
November
1,
2002
/
Rules
and
Regulations
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
combined
residues
of
thiamethoxam
and
its
metabolite
on
field
corn
forage
at
0.10
parts
per
million
(
ppm),
sweet
corn
forage
at
0.10
ppm,
popcorn
forage
at
0.10
ppm,
field
corn
stover
at
0.05
ppm,
sweet
corn
stover
at
0.05
ppm,
field
corn
grain
at
0.07
ppm
popcorn
grain
at
0.02
ppm,
and
sweet
corn
(
kernal
and
cob
with
husk
removed)
at
0.02
parts
per
million
(
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
thiamethoxam
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effectlevel
(
NOAEL)
and
the
lowest­
observedadverse
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
­
rat
NOAEL
=
1.74
(
males),
92.5
(
females)
mg/
kg/
day
LOAEL
=
17.64
(
males),
182.1
(
females)
mg/
kg/
day
based
on
increased
incidence
of
hyaline
change
of
renal
tubular
epithelium
(
males),
fatty
change
in
adrenal
gland
of
females,
liver
changes
in
females,
all
at
the
LOAEL.

870.3100
90
 
Day
oral
toxicity­
mouse
NOAEL
=
1.41
(
males),
19.2
(
females)
mg/
kg/
day
LOAEL
=
14.3
(
males),
231
(
females)
mg/
kg/
day
based
on
increased
incidence
of
hepatocellular
hypertrophy.
At
higher
dose
levels:
decrease
in
bodyweight
and
bodyweight
gain,
necrosis
of
individual
hepatocytes,
pigmentation
of
Kupffer
cells,
and
lymphocytic
infiltration
of
the
liver
in
both
sexes;
slight
hematologic
effects
and
decreased
absolute
and
relative
kidney
weights
in
males;
and
ovarian
atrophy,
decreased
ovary
and
spleen
weights
and
increased
liver
weights
in
females.

870.3150
90
 
oral
toxicity
­
dog
NOAEL
=
8.23
(
males),
9.27
(
females)
mg/
kg/
day
LOAEL
=
32.0
(
males),
33.9
(
females)
mg/
kg/
day
based
on
slightly
prolonged
prothrombin
times
and
decreased
plasma
albumin
and
A/
G
ratio
(
both
sexes);
decreased
calcium
levels
and
ovary
weights
and
delayed
maturation
in
the
ovaries
(
females);
decreased
cholesterol
and
phospholipid
levels,
testis
weights,
spermatogenesis,
and
spermatic
giant
cells
in
testes
(
males).

870.3200
28
 
dermal
toxicity
­
rat
NOAEL
=
250
(
males),
60
(
females)
mg/
kg/
day
LOAEL
=
1,000
(
males),
250
(
females)
mg/
kg/
day
based
on
increased
plasma
glucose,
triglyceride
levels,
and
alkaline
phosphatase
activity
and
inflammatory
cell
infiltration
in
the
liver
and
necrosis
of
single
hepatocytes
in
females
and
hyaline
change
in
renal
tubules
and
a
very
slight
reduction
in
body
weight
in
males.
At
higher
dose
levels
in
females,
chronic
tubular
lesions
in
the
kidneys
and
inflammatory
cell
infiltration
in
the
adrenal
cortex
were
observed.

870.3700
Prenatal
developmental
­
rat
Maternal
NOAEL
=
30
mg/
kg/
day
LOAEL
=
200
mg/
kg/
day
based
on
decreased
body
weight,
body
weight
gain,
and
food
consumption.
Developmental
NOAEL
=
200
mg/
kg/
day
LOAEL
=
750
mg/
kg/
day
based
on
decreased
fetal
body
weight
and
an
increased
incidence
of
skeletal
anomalies.

870.3700
Prenatal
developmental
­
rabbit
Maternal
NOAEL
=
50
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day
based
on
maternal
deaths,
hemorrhagic
uterine
contents
and
hemorrhagic
discharge,
decreased
body
weight
and
food
intake
during
the
dosing
period.
Developmental
NOAEL
=
50
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day
based
on
decreased
fetal
body
weights,
increased
incidence
of
post­
implantation
loss
and
a
slight
increase
in
the
incidence
of
a
few
skeletal
anomalies/
variations.

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67,
No.
212
/
Friday,
November
1,
2002
/
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
=
1.84
(
males),
202.06
(
females)
mg/
kg/
day
LOAEL
=
61.25
(
males),
not
determined
(
females)
mg/
kg/
day
based
on
increased
incidence
of
hyaline
change
in
renal
tubules
in
F0
and
F1
males.
Reproductive
NOAEL
=
0.61
(
males),
202.06
(
females)
mg/
kg/
day
LOAEL
=
1.84
(
males),
not
determined
(
females)
mg/
kg/
day
based
on
increased
incidence
and
severity
of
tubular
atrophy
observed
in
testes
of
the
F1
generation
males.
Offspring
NOAEL
=
61.25
(
males),
79.20
(
females)
mg/
kg/
day
LOAEL
=
158.32
(
males),
202.06
(
females)
mg/
kg/
day
based
on
reduced
body
weight
gain
during
the
lactation
period
in
all
litters
.

870.4100
Chronic
toxicity
­
dog
NOAEL
=
4.05
(
males),
4.49
(
females)
mg/
kg/
day
LOAEL
=
21.0
(
males),
24.6
(
females)
mg/
kg/
day
based
on
increase
in
creatinine
in
both
sexes,
transient
decrease
in
food
consumption
in
females,
and
occasional
increase
in
urea
levels,
decrease
in
ALT,
and
atrophy
of
seminiferous
tubules
in
males.

870.4200
Carcinogenicity
­
mouse
NOAEL
=
2.63
(
males),
3.68
(
females)
mg/
kg/
day
LOAEL
=
63.8
(
males),
87.6
(
females)
mg/
kg/
day
based
on
hepatocyte
hypertrophy,
single
cell
necrosis,
inflammatory
cell
infiltration
pigment
deposition,
foci
of
cellular
alteration,
hyperplasia
of
Kupffer
cells
and
increased
mitotic
activity;
also,
an
increase
in
the
incidence
of
hepatocellular
adenoma
(
both
sexes).
At
higher
doses,
there
was
an
increase
in
the
incidence
of
hepatocellular
adenocarcinoma
(
both
sexes)
and
the
number
of
animals
with
multiple
tumors
evidence
of
carcinogenicity
870.4300
Combined
chronic
carcinogenicity
­
rat
NOAEL
=
21.0
(
males),
50.3
(
females)
mg/
kg/
day
LOAEL
=
63.0
(
males),
155
(
females)
mg/
kg/
day
based
on
increased
incidence
of
lymphocytic
infiltration
of
the
renal
pelvis
and
chronic
nephropathy
in
males
and
decreased
body
weight
gain,
slight
increase
in
the
severity
of
hemosiderosis
of
the
spleen,
foci
of
cellular
alteration
in
liver
and
chronic
tubular
lesions
in
kidney
in
females
no
evidence
of
carcinogenicity
870.5100
870.5265
Gene
mutation
in
S.
typhimurium
and
E.
coli
No
evidence
of
gene
mutation
when
tested
up
to
5,000
µ
g/
plate.
There
was
no
evidence
of
cytotoxicity.

870.5265
Gene
mutation
in
S.
typhimurium
No
evidence
of
gene
mutation
when
tested
up
to
5,000
µ
g/
plate.
The
S9
fraction
was
from
non­
induced
mouse
liver,
Aroclor
1254
induced
mouse
liver,
or
thiamethoxam
induced
mouse
liver,
following
dietary
administration
of
thiamethoxam
for
14
days
at
concentrations
up
to
2,500
ppm.

870.5300
Gene
mutation
in
chinese
hamster
V79
cells
at
HGPRT
locus
No
evidence
of
gene
mutation
when
tested
up
to
solubility
limit.

870.5375
CHO
cell
cytogenetics
No
evidence
of
chromosomal
aberrations
when
tested
up
to
cytotoxic
or
solubility
limit
concentrations.

870.5395
In
vivo
mouse
bone
marrow
micronucleus
Negative
when
tested
up
to
levels
of
toxicity
in
whole
animals;
however
no
evidence
of
target
cell
cytotoxicity.

870.
5550
UDS
assay
Negative
when
tested
up
to
precipitating
concentrations
870.6200
Acute
neurotoxicity
screening
battery
­
rat
NOAEL
=
100
mg/
kg/
day
LOAEL
=
500
mg/
kg/
day
based
on
drooped
palpebral
closure,
decrease
in
rectal
temperature
and
locomotor
activity
and
increase
in
forelimb
grip
strength
(
males
only).
At
higher
dose
levels,
mortality,
abnormal
body
tone,
ptosis,
impaired
respiration,
tremors,
longer
latency
to
first
step
in
the
open
field,
crouched­
over
posture,
gait
impairment,
hypo­
arousal,
decreased
number
of
rears,
uncoordinated
landing
during
the
righting
reflex
test,
slight
lacrimation
(
females
only)
and
higher
mean
average
input
stimulus
value
in
the
auditory
startle
response
test
(
males
only).

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Rules
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Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.6200
Subchronic
neurotoxicity
screening
battery
­
rat
NOAEL
=
95.4
(
males),
216.4
(
females)
mg/
kg/
day,
both
highest
dose
tested.
LOAEL
=
not
determined.
No
treatment­
related
observations
at
any
dose
level.
LOAEL
was
not
achieved.
May
not
have
been
tested
at
sufficiently
high
dose
levels;
however,
new
study
not
required
because
the
weight
of
the
evidence
from
the
other
toxicity
studies
indicates
no
evidence
of
concern.

870.7485
Metabolism
and
pharmacokinetics
­
rat
Absorbed
rapidly
and
extensively,
widely
distributed,
followed
by
very
rapid
elimination,
mostly
in
urine.
Highest
tissue
concentrations
in
skeletal
muscle:
10
 
15%
of
administered
dose.
Half
life
times
from
tissues
ranged
from
2
 
6
hours.
Tissue
residues
after
7
days
extremely
low.
Approximately
84
 
95%
of
administered
dose
excreted
in
urine
and
2.5
 
6%
excreted
in
feces
within
24
hours.
Greater
than
0.2%
detected
in
expired
air.
Most
excreted
as
unchanged
parent:
70
 
80%
of
dose.
The
major
biotransformation
reaction
is
cleavage
of
oxadiazine
ring
to
corresponding
nitroguanidine
compound
Minor
pathways:
(
1)
cleavage
of
nitroguanidine
group
yielding
guanidine
derivative,
(
2)
hydrolysis
of
guanidine
group
to
corresponding
urea,
(
3)
demethylation
of
guanidine
group,
and
(
4)
substitution
of
the
chlorine
of
the
thiazole
ring
by
glutathione.
Cleavage
between
thiazole­
and
oxadiazine
ring
occurs
to
a
small
extent.
Glutathione
derivatives
prone
to
further
degradation
of
the
glutathione
moiety
resulting
in
various
sulfur­
containing
metabolites
(
e.
g.
mercapturates,
sulfides,
and
sulfoxides).
Both
the
thiazole
and
oxadiazine
moiety
susceptible
to
oxidative
attack.
Small
but
measurable
amounts
exhaled,
most
probably
as
CO2.
Metabolites
eliminated
very
rapidly.
Enterohepatic
circulation
negligible.

870.7485
Metabolism
and
pharmacokinetics
­
mouse
Approximately
72%
of
administered
dose
excreted
in
the
urine;
19%
excreted
in
feces.
Small
but
measurable
amount
detected
in
expired
air
(
approximately
0.2%
of
dose).
Predominant
metabolites:
unchanged
parent
(
33
 
41%
of
administered
dose;
2
other
metabolites:
8
 
12%
and
9
 
18%
of
administered
dose.
These
are
the
same
structures
that
were
most
commonly
observed
in
rat
excreta,
however
the
proportions
are
quite
different
in
mouse
excreta.
One
additional
significant
metabolite
(
mouse
R6)
was
isolated
from
feces
samples.
Between
30
 
60%
of
the
administered
dose
was
excreted
as
metabolites.

870.7600
Dermal
penetration
­
rat
Estimates
of
dermal
absorption
were
based
on
the
sum
of
radioactivity
in
skin
test
site,
urine,
feces,
blood,
and
carcass.
Percentage
dermal
absorption
is
27.0,
highest
mean
dermal
absorption
value
across
all
groups.
This
value
is
considered
to
represent
the
potential
cumulative
dermal
absorption
of
test
material
that
might
occur
after
a
10
hour
dermal
exposure.
As
the
study
design
did
not
permit
analysis
of
the
fate
of
skin
bound
residues,
residues
at
skin
site
were
included
in
determination
of
dermal
absorption.

Hepatic
cell
proliferation
study
­
mouse
NOAEL
=
16
(
males),
20
(
females)
mg/
kg/
day
LOAEL
=
72
(
males),
87
(
females)
mg/
kg/
day
based
on
proliferative
activity
of
hepatocytes.
At
higher
dose
levels,
increases
in
absolute
and
relative
liver
wts,
speckled
liver,
hepatocellular
glycogenesis/
fatty
change,
hepatocellular
necrosis,
apoptosis
and
pigmentation
were
observed.

Replicative
DNA
synthesis
in
28
 
day
feeding
study
­
male
rat
NOAEL
=
711
mg/
kg/
day
(
highest
dose
tested)
LOAEL
=
not
established.
Immunohistochemical
staining
of
liver
sections
from
control
and
high­
dose
animals
for
proliferating
cell
nuclear
antigen
gave
no
indication
for
a
treatment­
related
increase
in
the
fraction
of
DNA
synthesizing
hepatocytes
in
S­
phase.
CGA
293343
did
not
stimulate
hepatocyte
cell
proliferation
in
male
rats.

Special
study
to
assess
liver
biochemistry
in
mouse
NOAEL
=
17
(
males),
20
(
females)
mg/
kg/
day
LOAEL
=
74
(
males),
92
(
females)
mg/
kg/
day
based
on
marginal
to
slight
increases
in
absolute
and
relative
liver
weights,
a
slight
increase
in
the
microsomal
protein
content
of
the
livers,
moderate
increases
in
the
cytochrome
P450
content,
slight
to
moderate
increases
in
the
activity
of
several
microsomal
enzymes,
slight
to
moderate
induction
of
cytosolic
glutathione
S­
transferase
activity.
Treatment
did
not
affect
peroxisomal
fatty
acid
boxidation.

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Rules
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Regulations
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
intraspecies
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
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
thiamethoxam
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
THIAMETHOXAM
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietarygeneral
population
including
infants
and
children
NOAEL
=
100
mg/
kg/
day
UF
=
100
Acute
RfD
=
1
mg/
kg/
day
FQPA
SF
=
10
aPAD
=
acute
RfD/
FQPA
SF
=
0.1
mg/
kg/
day
Acute
mammalian
neurotoxicity
study
in
the
rat
LOAEL
=
500
mg/
kg/
day
based
on
treatment­
related
neurobehavioral
effects
observed
in
the
FOB
and
LMA
testing
(
drooped
palpebral
closure,
decreased
rectal
temperature
and
locomotor
activity,
increased
forelimb
grip
strength)

Chronic
Dietary
all
populations
NOAEL=
0.6
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.006
mg/
kg/
day
FQPA
SF
=
10
cPAD
=
chronic
RfD/
FQPA
SF
=
0.0006
mg/
kg/
day
2­
Generation
reproduction
study
LOAEL
=
1.8
mg/
kg/
day
based
on
increased
incidence
and
severity
of
tubular
atrophy
in
testes
of
F1
generation
males.

Oral
Nondietary
(
all
durations
NOAEL=
0.6
mg/
kg/
day
LOC
for
MOE
=
1,000
(
Residential)
2­
Generation
reproduction
study
LOAEL
=
1.8
mg/
kg/
day
based
on
increased
incidence
and
severity
of
tubular
atrophy
in
testes
of
F1
generation
males.

Dermal
(
all
durations
Residential)
Oral
study
NOAEL=
0.6
mg/
kg/
day(
dermal
absorption
rate
=
27%)
LOC
for
MOE
=
1,000
(
Residential)
LOC
for
MOE
=
100
(
Occupational)
2­
Generation
reproduction
study
LOAEL
=
1.8
mg/
kg/
day
based
on
increased
incidence
and
severity
of
tubular
atrophy
in
testes
of
F1
generation
males.

Inhalation
(
all
durations
Residential)
Oral
study
NOAEL=
0.6
mg/
kg/
day
(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
1,000
(
Residential)
LOC
for
MOE
=
100
(
Occupational)
2­
Generation
reproduction
study
LOAEL
=
1.8
mg/
kg/
day
based
on
increased
incidence
and
severity
of
tubular
atrophy
in
testes
of
F1
generation
males.

Cancer
(
oral,
dermal,
inhalation
Likely
carcinogen
for
humans
based
on
increased
incidence
of
hepatocellular
adenomas
and
carcinomas
in
male
and
female
mice.
Quantification
of
risk
based
on
most
potent
unit
risk:
male
mouse
liver
adenoma
and/
or
carcinoma
combined
tumor
rate.
The
upper
bound
estimate
of
unit
risk,
Q1*
(
mg/
kg/
day)­
1
is
3.77
x
10­
2
in
human
equivalents.

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

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.565)
for
the
combined
residues
of
thiamethoxam
and
its
metabolite,
in
or
on
a
variety
of
raw
agricultural
commodities.
The
following
raw
agricultural
commodities
have
established
tolerances:
barley,
canola,
cotton,
sorghum,
wheat,
tuberous
and
corm
vegetables
crop
subgroup,
fruiting
vegetables,
crop
group,
tomato
paste,
cucurbit
vegetables
crop
group,
pome
fruits
crop
group,

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2002
/
Rules
and
Regulations
milk
and
the
meat
and
meat
by
products
of
cattle,
goats,
horses,
and
sheep.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
thiamethoxam
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
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
tolerence
level
residues
and
100%
crop
treated.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
percent
crop
treated
(
based
on
projected
market
shares)
and
anticipated
residues
(
tier
3).
iii.
Cancer.
The
dietary
exposure
for
determining
cancer
risk
is
based
on
the
chronic
exposure
explained
in
the
previous
paragraph
using
the
same
assumptions.
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
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
percent
crop
treated
(
PCT)
information
as
follows
in
Table
3.

TABLE
3.
 
THIAMETHOXAM
USES
AND
ESTIMATES
OF
PERCENT
CROP
TREATED
Crop
Percent
Crop
Treated
Tuberous
and
Corm
Vegetables
­
Crop
Subgroup
1
C
9
Fruiting
Vegetables
(
Except
Cucurbits
­
Crop
Group
8
15
Cucumbers
5
Melons
13
Casabas
44
Crenshaws
44
Squash
44
Pumpkin
44
Apples
5
Crabapples
53
Pears
9
Quinces
53
Loquats
53
Field,
corn
6
Pop,
sweet
corn
100
Since
the
May
23,
2001
Final
Rule
establishing
tolerances
for
thiamethoxam,
the
Agency
has
updated
the
percent
crop­
treated
value
for
apples.
The
registrant
is
voluntarily
restricting
use
of
thiamethoxam
on
apples
to
only
three
states,
Michigan,
New
York
and
Pennsylvania.
These
three
states
account
for
28%
of
the
U.
S.
apple
production
(
122,000
out
of
430,200
bearing
acres).
After
consultation
with
experts
in
the
field,
EPA
believes
that
no
more
than
10%
of
the
apple
acreage
in
these
states
will
be
treated
with
thiamethoxam.
Thus,
using
a
percent
crop­
treated
value
of
5%
for
the
U.
S.
apple
acreage
is
expected
to
be
an
over­
estimate
of
the
acres
which
will
actually
be
treated
with
thiamethoxam.
The
Agency
used
6%
CT
for
field
corn
since
this
is
the
percent
crop­
treated
value
for
the
market
leader.
Sweet
corn
exposure
estimates,
which
currently
make
up
the
bulk
of
the
exposure
for
the
cereal
grains,
assume
100%
crop
treated.
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
regional
populations.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
thiamethoxam
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
thiamethoxam.
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(
GENEEC)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCIGROW
which
predicts
pesticide
concentrations
in
groundwater.
In
general,
EPA
will
use
GENEEC
(
a
tier
1
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
highend
runoff
scenario
for
pesticides.
GENEEC
incorporates
a
farm
pond
scenario,
while
PRZM/
EXAMS
incorporate
an
index
reservoir
environment
in
place
of
the
previous
pond
scenario.
The
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
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Regulations
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
thiamethoxam
they
are
further
discussed
in
the
aggregate
risk
sections
below.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
thiamethoxam
for
acute
exposures
are
estimated
to
be
11.4
parts
per
billion
(
ppb)
for
surface
water
and
1.94
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.77
ppb
for
surface
water,
and
1.94
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).
Thiamethoxam
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Although
such
uses
have
been
requested,
they
are
not
being
assessed
at
this
time.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
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
thiamethoxam
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,
thiamethoxam
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
thiamethoxam
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.
Safety
factor
for
infants
and
children
 
i.
In
general.
FFDCA
section
408
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
database
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
margin
of
exposure
(
MOE)
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
ii.
Prenatal
and
postnatal
sensitivity.
The
developmental
toxicity
studies
indicated
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetus
to
in
utero
exposure
based
on
the
fact
that
the
developmental
NOAELs
are
either
higher
than
or
equal
to
the
maternal
NOAELs.
However,
the
reproductive
studies
indicate
effects
in
male
rats
in
the
form
of
increased
incidence
and
severity
of
testicular
tubular
atrophy.
These
data
are
considered
to
be
evidence
of
increased
quantitative
susceptibility
for
male
pups
when
compared
to
the
parents.
iii.
Conclusion.
Based
on:
a.
Effects
on
endocrine
organs
observed
across
species.
b.
The
significant
decrease
in
alanine
amino
transferase
levels
in
the
companion
animal
studies
and
in
the
dog
studies.
c.
The
mode
of
action
of
this
chemical
in
insects
(
interferes
with
the
nicotinic
acetyl
choline
receptors
of
the
insect's
nervous
system)
thus
a
developmental
neurotoxicity
study
is
required.
d.
The
transient
clinical
signs
of
neurotoxicity
in
several
studies
across
species.
e.
The
suggestive
evidence
of
increased
quantitative
susceptibility
in
the
rat
reproduction
study,
the
Agency
is
retaining
the
FQPA
factor
which
is
l0X.

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
EPA
are
used
to
calculate
DWLOCs:
2L/
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,
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
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Regulations
exposure
from
food
to
thiamethoxam
will
occupy
3%
of
the
aPAD
for
the
U.
S.
population,
2%
of
the
aPAD
for
females
13
 
49
years
old,
7%
of
the
aPAD
for
all
infants
less
than
1
year
old
and
9%
of
the
aPAD
for
children
1
 
2
years
old.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
thiamethoxam
in
drinking
water.
The
surface
water
EEC
is
11.4
µ
g/
L
and
the
ground
water
EEC
is
1.94
µ
g/
L.
Since
the
surface
water
value
is
greater
than
the
ground
water
value,
the
surface
water
value
will
be
used
for
comparison
purposes
and
will
protect
for
any
concerns
for
ground
water
concentrations.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD.

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
THIAMETHOXAM
Population
Subgroup
aPAD,
mg/
kg/
day
%
aPAD
(
Food)
Ground
Water
EEC,
µ
g/
L
Surface
Water
EEC,
µ
g/
L
DWLOC,
µ
g/
L
U.
S.
Population
0.1
3
1.94
11.4
3,400
All
Infants
(
0
 
1
yr)
0.1
7
1.94
11.4
930
Children
(
1
 
2
yr)
0.1
9
1.94
11.4
910
Children
(
3
 
5
yr)
0.1
7
1.94
11.4
940
Children
(
6
 
12
yr)
0.1
4
1.94
11.4
960
Youth
(
13
 
19
yr)
0.1
2
1.94
11.4
980
Adult
(
20
 
49
yr)
0.1
2
1.94
11.4
3,400
Adult
(
50+
yr)
0.1
2
1.94
11.4
3,400
Females
(
13
 
49
yr)
0.1
2
1.94
11.4
2,900
a
Population
subgroups
shown
include
the
U.
S.
general
population
and
the
maximally
exposed
subpopulation
of
adults,
infants
and
children,
and
women
of
child­
bearing
age
for
each
exposure
scenario.
b
DWLOC
=
Maximum
Water
Exposure
(
mg/
kg/
day)
H
1,000
µ
g/
mg
body
weight
(
70
kg
general
population/
males
13+,
60
kg
females
13+,
10
kg
infants
and
children)
Water
Consumption
(
2
L/
day
adults,
1
L/
day
infants
and
children).
Maximum
water
exposure
=
aPAD
­
dietary
exposure
(
mg/
kg/
day)

2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
thiamethoxam
from
food
will
utilize
5%
of
the
cPAD
for
the
U.
S.
population,
13%
of
the
cPAD
for
all
infants
<
1
year
old
and
19%
of
the
cPAD
for
children
1
 
2
years
old.
Proposed
residential
uses
are
not
being
addressed
in
this
risk
assessment.
In
addition
to
chronic
dietary
exposure,
there
is
potential
for
chronic
dietary
exposure
to
thiamethoxam
in
drinking
water.
The
surface
water
EEC
is
0.6
µ
g/
L
and
the
groundwater
EEC
is
1.94
µ
g/
L.
Since
the
groundwater
value
is
greater
than
the
surface
water
value,
the
groundwater
value
will
be
used
for
comparison
purposes
and
will
protect
for
any
concerns
for
surface
water
concentrations.
After
calculating
the
DWLOCs
and
comparing
them
to
the
EECs
for
groundwater,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD.

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
THIAMETHOXAM
Population
Subgroup
cPAD,
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC,
µ
g/
L
Ground
Water
EEC,
µ
g/
L
DWLOC
µ
g/
L
U.
S.
Population
0.0006
5
0.77
1.9
20
All
Infants
(
0
 
1
yr)
0.0006
13
0.77
1.9
5.3
Children
(
1
 
2
yr)
0.0006
19
0.77
1.9
4.9
Children
(
3
 
5
yr)
0.0006
14
0.77
1.9
5.2
Children
(
6
 
12
yr)
0.0006
7
0.77
1.9
5.6
Youth
(
13
 
19
yr)
0.0006
4
0.77
1.9
5.8
Adult
(
20
 
49
yr)
0.0006
4
0.77
1.9
20
Adult
(
50+
yr)
0.0006
4
0.77
1.9
20
Females
(
13
 
49
yr)
0.0006
4
0.77
1.9
17
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).
Thiamethoxam
is
not
registered
for
use
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1,
2002
/
Rules
and
Regulations
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
does
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).
Thiamethoxam
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
does
not
exceed
the
Agency's
level
of
concern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
The
cancer
aggregate
dietary
risk
estimate
was
calculated,
using
the
Agency's
6%
estimated
market
share
for
treatment
of
field
corn.
The
dietary
cancer
risk
from
residues
in
food
is
0.9
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.
The
DWLOC
for
cancer
aggregate
risk
(
no
residential
uses)
is
calculated
using
the
following
equations:
DWLOCcancer(
µ
g/
L)
=
[
chronic
water
exposure(
mg/
kg/
day)
x
(
body
weight
(
kg))]
÷
[
consumption
(
L)
x
10­
3
mg/
µ
g]

chronic
water
exposure
(
mg/
kg/
day)=
negligible
risk
÷
Q*
­
[(
chronic
food
exposure)(
mg/
kg/
day)]

Assuming
that
the
negligible
risk
value
could
be
as
high
as
3
x
10­
6
,
the
chronic
water
exposure
value
is
estimated
to
be:

3
x
10­
6
÷
3.77
x
10­
2
­
0.0000245
=
0.0000551
mg/
kg/
day
The
DWLOCcancer
=
0.0000551
mg/
kg/
day
x
70
kg
÷
2L
x
10­
3
mg/
µ
g
=
1.9
µ
g/
L
The
surface
water
EEC
is
0.6
µ
g/
L
and
the
ground
water
EEC
is
1.9
µ
g/
L.
Since
the
ground
water
value
is
greater
than,
the
surface
water
value
it
will
be
used
for
comparison
purposes
and
will
protect
for
any
concerns
for
surface
water
concentrations.
The
estimated
chronic
ground
water
value
for
thiamethoxam
(
1.9
µ
g/
L)
is
essentially
at
the
DWLOCcancer
level
for
the
general
population
using
the
6%
market
share
for
treated
field,
corn
seed.
The
Agency
used
a
screening
level
model
designed
to
estimate
pesticide
concentrations
in
shallow
ground
water.
A
number
of
factors
lead
EPA
to
believe
that
the
actual
lifetime
exposure
through
drinking
water
will
be
less
than
the
DWLOCcancer.
These
reasons
are
as
follows:
a.
Thiamethoxam
is
systemic.
EPA's
Tier
1
ground
water
model
assumes
that
all
of
the
product
that
is
applied
to
the
crop
is
available
for
runoff.
The
registrant
has
submitted
data
to
show
that
a
percentage
(
15
 
25%)
of
the
product
is
absorbed
by
the
plant,
resulting
in
that
much
less
product
available
to
leach
into
ground
water.
Although
the
registrant
has
submitted
data
on
only
2
crops,
beans
and
cucumbers,
it
is
likely
that
the
total
amount
of
thiamethoxam
that
is
available
to
leach
into
ground
water
is
less
than
the
amount
EPA
uses
as
an
input
into
its
model.
Due
to
limited
data
on
the
amount
absorbed,
EPA
is
unable
to
quantify
this.
b.
Although
the
Agency
model
is
based
on
aerobic
soil
half
lives,
EPA's
risk
assessment
for
cancer
estimate
is
for
lifetime
exposure.
Data
indicate
the
anaerobic
aquatic
half
life
for
thiamethoxam
is
shorter
than
the
aerobic
soil
half
life
and
longer
than
the
aerobic
aquatic
half
life.
Although
EPA
is
unable
to
predict
with
a
high
degree
of
certainty
about
what
happens
to
thiamethoxam
over
time
in
ground
water,
this
does
provide
some
support
for
an
expectation
that
concentrations
in
ground
water
will
decline
between
annual
applications.
c.
Shallow
ground
water
modeling
is
not
the
perfect
model
for
representing
all
drinking
water
from
ground
water
sources.
It
is
likely
to
be
an
overestimate
of
most
drinking
water,
which
tends
to
originate
from
deeper
sources.
EPA's
experience
is
that
the
model
is
reasonably
accurate
for
shallow
drinking
water,
but
the
Agency
believes
that
it
is
less
accurate
for
drinking
water
from
deeper
sources.
d.
The
Agency
has
established
conditions
of
registration
for
the
previous
uses
which
include
two
prospective
ground
water
studies
and
a
retrospective
monitoring
study,
so
that
the
reasonable
certainty
of
no
harm
finding
will
be
sustained.
Preliminary
results
have
indicated
no
detections
of
thiamethoxam
in
ground
water.
e.
The
cancer
risk
from
the
food
uses
alone
is
0.9
x
10­
6.
The
dietary
risk
is
based
on
residue
data
derived
from
the
average
of
field
trials,
which
were
performed
at
a
higher
applied­
on
rate
than
were
accepted
by
the
EPA.
It
is
not
unusual
in
the
Agency's
experience
for
field
trial
data
to
be
an
order
of
magnitude
above
actual
monitoring.
Since
thiamethoxam
has
only
recently
been
registered,
actual
monitoring
data
is
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.
EPA
expects
that
this
refined
DWLOCcancer
would
be
larger
than
the
EECs
for
the
proposed
uses.
It
should
be
noted
that
there
are
no
detectable
residues
in
the
subject
corn
commodities.
Thus,
EPA
does
not
expect
that
the
general
population
would
be
exposed
to
levels
exceeding
the
DWLOCcancer
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
population,
and
to
infants
and
children
from
aggregate
exposure
to
thiamethoxam
residues.

A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
High
Performance
Liquid
Chromatography
using
ultra
violet
or
mass
spectrometry
(
HPLC/
UV
or
MS)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Calvin
Furlow,
PIRIB,
IRSD
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460;
telephone
number:
(
703)
305
 
5229;
e­
mail
address:
furlow.
calvin@
epa.
gov.

B.
International
Residue
Limits
There
are
no
international
residue
limits
for
thiamethoxam.

V.
Conclusion
Therefore,
the
tolerances
are
established
for
combined
residues
of
thiamethoxam,
3­[(
2­
chloro­
5­
thiazolyl)
methyl]
tetrahydro­
5­
methyl­
Nnitro
4H­
1,3,5­
oxadiazin­
4­
imine
and
its
metabolite
N­(
2­
chloro­
thiazol­
5­
ylmethyl)­
N ­
methyl­
nitro­
guanidine,
in
or
on
field
corn
forage
at
0.10
ppm,
sweet
corn
forage
at
0.10
ppm,
popcorn
forage
at
0.10
ppm,
field
corn
stover
at
0.05
ppm,
sweet
corn
stover
at
0.05
ppm,
field
corn
grain
at
0.07
ppm,
popcorn
grain
at
0.02
ppm,
and
sweet
corn
(
kernal
and
cob
with
husk
removed)
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
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/
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November
1,
2002
/
Rules
and
Regulations
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
 
2002
 
0298
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
December
31,
2002.
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
 
2002
 
0298,
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.
Regulatory
Assessment
Requirements
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
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Register
/
Vol.
67,
No.
212
/
Friday,
November
1,
2002
/
Rules
and
Regulations
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.
Submission
to
Congress
and
the
Comptroller
General
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,
Pesticide
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
October
24,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]

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

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.
2.
Section
180.565
is
amended
by
alphabetically
adding
commodities
to
the
table
in
paragraph
(
a)
to
read
as
follows:

§
180.565
Thiamethoxam;
tolerances
for
residues.
(
a)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*
Corn,
field,
forage
.....................
0.10
Corn,
pop,
forage
.....................
0.10
Corn,
sweet,
forage
..................
0.10
Corn,
field,
grain
.......................
0.020
Corn,
pop,
grain
........................
0.02
Corn,
field,
stover
.....................
0.05
Corn
pop,
stover
.......................
0.05
Corn,
sweet,
stover
..................
0.05
Corn,
sweet,
kernal
plus
cob
with
husks
removed
..............
0.02
*
*
*
*
*

*
*
*
*
*
[
FR
Doc.
02
 
27830
Filed
10
 
31
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
TRANSPORTATION
Research
and
Special
Programs
Administration
49
CFR
Parts
172,
174,
175,
176,
and
177
[
Docket
No.
RSPA
 
01
 
10568
(
HM
 
207B)]

RIN
2137
 
AC64
Hazardous
Materials:
Retention
of
Shipping
Papers
AGENCY:
Research
and
Special
Programs
Administration
(
RSPA),
DOT.
ACTION:
Final
rule;
response
to
appeals.

SUMMARY:
In
this
final
rule,
RSPA
is
making
changes
to
a
final
rule
published
on
July
12,
2002,
in
which
RSPA
amended
the
Hazardous
Materials
Regulations
(
HMR)
to
require
shippers
and
carriers
to
retain
a
copy
of
each
hazardous
material
shipping
paper,
or
an
electronic
image
thereof,
for
a
period
of
375
days
after
the
date
the
hazardous
material
is
accepted
by
a
carrier.
This
final
rule
responds
to
five
appeals
of
the
July
12,
2002
final
rule.
EFFECTIVE
DATES:
This
final
rule
is
effective
on
November
1,
2002.
Voluntary
compliance
is
authorized
as
of
August
12,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
Deborah
Boothe
of
the
Office
of
Hazardous
Materials
Standards,
(
202)
366
 
8553,
Research
and
Special
Programs
Administration,
U.
S.
Department
of
Transportation,
400
Seventh
Street,
SW.,
Washington,
DC
20590.

SUPPLEMENTARY
INFORMATION:

I.
Background
On
July
12,
2002,
The
Research
and
Special
Programs
Administration
(
RSPA,
we)
published
a
final
rule
under
Docket
HM
 
207B
(
67
FR
46123)
amending
the
Hazardous
Materials
Regulations
(
HMR;
49
CFR
parts
171
 
180)
to
require
shippers
and
carriers
to
retain
a
copy
of
each
hazardous
material
shipping
paper,
or
an
electronic
image
thereof,
for
a
period
of
375
days
after
the
date
the
hazardous
material
is
accepted
by
a
carrier.
The
July
12,
2002
final
rule
incorporates
into
the
HMR
the
requirements
in
the
Federal
hazardous
material
transportation
law
(
Federal
hazmat
law)
to
require
that,
after
a
hazardous
material
``
is
no
longer
in
transportation,''
each
offeror
and
carrier
of
a
hazardous
material
must
retain
the
shipping
paper
``
or
electronic
image
thereof
for
a
period
of
1
year
to
be
accessible
through
their
respective
principal
places
of
business.''
49
U.
S.
C.
5110(
e),
added
by
Public
Law
103
 
311,
Title
I,
section
115,
108
Stat.
1678
(
Aug.
26,
1994).
That
section
also
provides
that
the
offeror
and
carrier
``
shall,
upon
request,
make
the
shipping
paper
available
to
a
Federal,
State,
or
local
government
agency
at
reasonable
times
and
locations.''
The
July
12,
2002
final
rule
requires
each
person
who
offers
or
transports
a
hazardous
material
in
commerce
to
retain
a
copy
of
the
shipping
paper
for
375
days
after
the
date
the
shipment
is
accepted
by
the
initial
carrier.
To
facilitate
enforcement
of
this
requirement,
the
final
rule
requires
each
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