51471
Federal
Register
/
Vol.
68,
No.
166
/
Wednesday,
August
27,
2003
/
Rules
and
Regulations
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
FIFRA
section
18
exemption
under
section
408
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.

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

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

Dated:
August
19,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]

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

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.568
is
amended
by
adding
text
to
paragraph
(
b)
to
read
as
follows:
§
180.568
Flumioxazin;
tolerances
for
residues.

*
*
*
*
*
(
b)
Section
18
emergency
exemptions.
Time­
limited
tolerances
are
established
for
residues
of
the
herbicide
flumioxazin
in
connection
with
the
use
of
the
pesticides
under
section
18
emergency
exemptions
granted
by
EPA.
The
tolerances
will
expire
and
are
revoked
on
the
dates
specified
in
the
following
table.

Commodity
Parts
per
million
Expiration/
Revocation
date
Sweet
potato,
roots
..............
0.02
06/
30/
05
*
*
*
*
*

[
FR
Doc.
03
 
21662
Filed
8
 
26
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0254;
FRL
 
7320
 
2]

Thiamethoxam;
Pesticide
Tolerances
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
time­
limited
tolerances
for
the
combined
residues
of
thiamethoxam
and
CGA
 
322704
on
hops
at
0.10
parts
per
million
(
ppm);
bean,
succulent
at
0.02
ppm;
and
bean,
dried
at
0.02
ppm.
This
action
is
in
response
to
EPA's
granting
of
emergency
exemptions
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
the
pesticide
on
hops,
succulent
bean
seed
and
dry
bean
seed.
This
regulation
establishes
maximum
permissible
levels
for
residues
of
thiamethoxam
in
these
food
commodities.
The
tolerances
will
expire
and
are
revoked
on
December
31,
2006.
DATES:
This
regulation
is
effective
August
27,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0254,
must
be
received
on
or
before
October
27,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.

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Federal
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/
Vol.
68,
No.
166
/
Wednesday,
August
27,
2003
/
Rules
and
Regulations
FOR
FURTHER
INFORMATION
CONTACT:
Andrew
Ertman,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9367;
e­
mail
address:
Sec­
18­
Mailbox@
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
a
Federal
or
State
Government
Agency
involved
in
administration
of
environmental
quality
programs
(
i.
e.,
United
States
Departments
of
Agriculture,
Environment,
etc).
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Federal
or
State
Government
Entity
(
NAICS
9241).
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
ID
number
OPP
 
2003
 
0254.
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/
cfrhtm_
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
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408
(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346(
a),
is
establishing
tolerances
for
the
combined
residues
of
thiamethoxam
and
CGA
 
322704
on
hops
at
0.10
ppm;
bean,
succulent
at
0.02
ppm;
and
bean,
dried
at
0.02
ppm.
These
tolerances
will
expire
and
are
revoked
on
December
31,
2006.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerances
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18­
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
of
the
FFDCA
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
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.
.
.
.''
Section
18
of
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
Agency
from
any
provision
of
FIFRA,
if
EPA
determines
that
``
emergency
conditions
exist
which
require
such
exemption.''
This
provision
was
not
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
EPA
has
established
regulations
governing
such
emergency
exemptions
in
40
CFR
part
166.

III.
Emergency
Exemption
for
Thiamethoxam
on
Hops,
Succulent
Bean
Seed
and
Dry
Bean
Seed
and
FFDCA
Tolerances
The
States
of
Washington
and
Idaho
requested
the
use
of
thiamethoxam
on
succuelent
and
dry
bean
seed
to
control
leaf
hoppers.
EPA
has
authorized
under
FIFRA
section
18
the
use
of
thiamethoxam
on
succulent
and
dry
bean
seed
for
control
of
leaf
hoppers
in
Washington
and
Idaho.
After
having
reviewed
the
submissions,
EPA
concurs
that
emergency
conditions
exist
for
these
States.
The
State
of
Oregon
requested
the
use
of
thiamethoxam
on
hops
to
control
garden
symphylans.
EPA
has
authorized
under
FIFRA
section
18
the
use
of
thiamethoxam
on
hops
for
control
of
garden
symphylans
in
Oregon.
After
having
reviewed
the
submission,
EPA
concurs
that
an
emergency
condition
exists
for
this
State.
As
part
of
its
assessment
of
this
emergency
exemption,
EPA
assessed
the
potential
risks
presented
by
residues
of
thiamethoxam
in
or
on
hops,
succulent
bean
seed
and
dry
bean
seed.
In
doing
so,
EPA
considered
the
safety
standard
in
section
408(
b)(
2)
of
the
FFDCA,
and
EPA
decided
that
the
necessary
tolerances
under
section
408(
l)(
6)
of
the
FFDCA
would
be
consistent
with
the
safety
standard
and
with
FIFRA
section
18.
Consistent
with
the
need
to
move
quickly
on
the
emergency
exemption
in
order
to
address
an
urgent
non­
routine
situation
and
to
ensure
that
the
resulting
food
is
safe
and
lawful,
EPA
is
issuing
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166
/
Wednesday,
August
27,
2003
/
Rules
and
Regulations
these
tolerances
without
notice
and
opportunity
for
public
comment
as
provided
in
section
408(
l)(
6)
of
the
FFDCA.
Although
these
tolerances
will
expire
and
are
revoked
on
December
31,
2006,
under
section
408(
l)(
5)
of
the
FFDCA,
residues
of
the
pesticide
not
in
excess
of
the
amounts
specified
in
the
tolerances
remaining
in
or
on
hops,
succulent
beans
and
dry
beans
after
that
date
will
not
be
unlawful,
provided
the
pesticide
is
applied
in
a
manner
that
was
lawful
under
FIFRA,
and
the
residues
do
not
exceed
a
level
that
was
authorized
by
these
tolerances
at
the
time
of
that
application.
EPA
will
take
action
to
revoke
these
tolerances
earlier
if
any
experience
with,
scientific
data
on,
or
other
relevant
information
on
this
pesticide
indicate
that
the
residues
are
not
safe.
Because
these
tolerances
are
being
approved
under
emergency
conditions,
EPA
has
not
made
any
decisions
about
whether
thiamethoxam
meets
EPA's
registration
requirements
for
use
on
hops,
succulent
bean
seed
and
dry
bean
seed
or
whether
permanent
tolerances
for
these
uses
would
be
appropriate.
Under
these
circumstances,
EPA
does
not
believe
that
these
tolerances
serve
as
a
basis
for
registration
of
thiamethoxam
by
a
State
for
special
local
needs
under
FIFRA
section
24(
c).
Nor
do
these
tolerances
serve
as
the
basis
for
any
State
other
than
Washington
and
Idaho
(
succulent
and
dry
bean
seed)
and
Oregon
(
hops)
to
use
this
pesticide
on
these
crops
under
section
18
of
FIFRA
without
following
all
provisions
of
EPA's
regulations
implementing
FIFRA
section
18
as
identified
in
40
CFR
part
166.
For
additional
information
regarding
the
emergency
exemption
for
thiamethoxam,
contact
the
Agency's
Registration
Division
at
the
address
provided
under
FOR
FURTHER
INFORMATION
CONTACT.
IV.
Aggregate
Risk
Assessment
and
Determination
of
Safety
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
November
26,
1997
(
62
FR
62961)
(
FRL
 
5754
 
7).
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
thiamethoxam
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
time­
limited
tolerances
for
the
combined
residues
of
thiamethoxam
and
CGA
 
322704
on
hops
at
0.10
ppm;
bean,
succulent
at
0.02
ppm;
and
bean,
dried
at
0.02
ppm.
EPA's
assessment
of
the
dietary
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
Toxicological
Endpoints
The
dose
at
which
no
observed
adverse
effect
levels
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
endpoint.
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
(
aRfD
or
cRfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
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
level
of
concern
(
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
the
following
Table
1:

TABLE
1.
 
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
dietary
(
general
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).

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Rules
and
Regulations
TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
THIAMETHOXAM
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
scenario
Dose
used
in
risk
assessment
UF
FQPA
SF*
and
level
of
concern
for
risk
assessment
Study
and
toxicological
effects
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
=
5%)
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*
milligrams/
kilogram/
day
(
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.

B.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
for
the
combined
residues
of
thiamethoxam,
in
or
on
a
variety
of
raw
agricultural
commodities
(
RAC).
The
following
RAC's
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,
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
1
 
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
United
States
Department
of
Agriculture
(
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
DEEMTM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
chronic
exposure
estimates
are
based
on
Tier
3
analyses
that
incorporate
anticipated
residues
and
percent
crop
treated
(
PCT)
for
most
commodities.
iii.
Cancer.
Cancer
dietary
exposure
has
been
estimated
using
the
DEEMFCID
version
1.3.
The
cancer
exposure
estimates
are
based
on
Tier
3
analyses
that
incorporate
anticipated
residues
and
PCT
for
most
commodities.
iv.
Anticipated
residue
and
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
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.
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Vol.
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27,
2003
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Rules
and
Regulations
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
as
follows:
Potatos,
19%;
fruiting
vegetables,
15%;
cucumbers,
5%;
melons,
13%;
casabas,
44%;
crenshaws,
44%;
squash,
44%;
pumpkins,
44%;
apples,
5%;
crabapples,
53%;
pears,
9%;
quinces,
53%;
loquat,
53%;
barley,
0.1%;
sorghum,
9%;
wheat,
2%;
canola,
55%;
cotton,
20%.
The
Agency
believes
that
the
three
conditions
listed
above
have
been
met.
With
respect
to
condition
1,
PCT
estimates
are
derived
from
Federal
and
private
market
survey
data,
which
are
reliable
and
have
a
valid
basis.
EPA
uses
a
weighted
average
PCT
for
chronic
dietary
exposure
estimates.
This
weighted
average
PCT
figure
is
derived
by
averaging
State­
level
data
for
a
period
of
up
to
10
years,
and
weighting
for
the
more
robust
and
recent
data.
A
weighted
average
of
the
PCT
reasonably
represents
a
person's
dietary
exposure
over
a
lifetime,
and
is
unlikely
to
underestimate
exposure
to
an
individual
because
of
the
fact
that
pesticide
use
patterns
(
both
regionally
and
nationally)
tend
to
change
continuously
over
time,
such
that
an
individual
is
unlikely
to
be
exposed
to
more
than
the
average
PCT
over
a
lifetime.
For
acute
dietary
exposure
estimates,
EPA
uses
an
estimated
maximum
PCT.
The
exposure
estimates
resulting
from
this
approach
reasonably
represent
the
highest
levels
to
which
an
individual
could
be
exposed,
and
are
unlikely
to
underestimate
an
individual's
acute
dietary
exposure.
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
thiamethoxam
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
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
(
SCI­
GROW),
which
predicts
pesticide
concentrations
in
ground
water.
In
general,
EPA
will
use
GENEEC
(
a
Tier
1
model)
before
using
PRZM/
EXAMS
(
a
Tier
2
model)
for
a
screening­
level
assessment
for
surface
water.
The
GENEEC
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
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
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
percent
reference
dose
(%
RfD)
or
percent
population
adjusted
dose
(%
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
EECs
of
thiamethoxam
for
acute
exposures
are
estimated
to
be
7.1
parts
per
billion
(
ppb)
for
surface
water
and
1.94
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.43
(
noncancer
and
0.13
ppb
(
cancer)
for
surface
water
and
1.94
ppb
for
ground
water
(
cancer
and
non­
cancer).
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.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
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).

C.
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
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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.
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.
3.
Conclusions.
Based
on:
i.
Effects
on
endocrine
organs
observed
across
species.
ii.
The
significant
decrease
in
alanine
amino
transferase
levels
in
the
companion
animal
studies
and
in
the
dog
studies.
iii.
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.
iv.
The
transient
clinical
signs
of
neurotoxicity
in
several
studies
across
species.
v.
The
suggestive
evidence
of
increased
quantitative
susceptibility
in
the
rat
reproduction
study,
the
Agency
is
retaining
the
FQPA
factor
which
is
l0X.

D.
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
+
chronic
non­
dietary,
nonoccupational
exposure).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
EPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
thiamethoxam
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
thiamethoxam
on
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
thiamethoxam
will
occupy
3%
of
the
aPAD
for
the
U.
S.
population;
2%
of
the
aPAD
for
females
13
years
and
older;
7%
of
the
aPAD
for
all
infants
<
1
year
old;
and
9%
of
the
aPAD
for
children
1
 
2
years
old.
In
addition,
despite
the
potential
for
acute
dietary
exposure
to
thiamethoxam
in
drinking
water,
after
calculating
DWLOCs
and
comparing
them
to
conservative
EECs
of
thiamethoxam
in
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
the
following
Table
2:

TABLE
2.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
THIAMETHOXAM
Population
subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
water
EEC
(
ppb)
Ground
water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

General
U.
S.
population
0.1
3
7.1
1.94
3,400
All
Infants
(<
1
year
old)
0.1
7
7.1
1.94
930
Children
(
1
 
2
years
old)
0.1
9
7.1
1.94
910
Children
(
3
 
5
years
old)
0.1
6
7.1
1.94
940
Children
(
6
 
12
years
old)
0.1
4
7.1
1.94
960
Youth
(
13
 
19
years
old)
0.1
2
7.1
1.94
3,400
Adults
(
20
 
49
years
old)
0.1
2
7.1
1.94
3,400
Adults
(
50+
years
old)
0.1
2
7.1
1.94
3,400
Females
(
13
 
49
years
old)
0.1
2
7.1
1.94
3,000
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
4%
of
the
cPAD
for
the
U.
S.
population,
8%
of
the
cPAD
for
all
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infants
<
1
year
old
and
12%
of
the
cPAD
for
children
1
 
2
years
old.
There
are
no
residential
uses
for
thiamethoxam
that
result
in
chronic
residential
exposure
to
thiamethoxam.
In
addition,
despite
the
potential
for
chronic
dietary
exposure
to
thiamethoxam
in
drinking
water,
after
calculating
DWLOCs
and
comparing
them
to
conservative
model
estimated
environmental
concentrations
of
thiamethoxam
in
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
3:

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

General
U.
S.
population
0.0006
4
0.43
1.94
20
All
infants
(<
1
year
old)
0.0006
8
0.43
1.94
5.6
Children
(
1
 
2
years
old)
0.0006
12
0.43
1.94
5.3
Children
(
3
 
5
years
old)
0.0006
10
0.43
1.94
5.4
Children
(
6
 
12
years
old)
0.0006
6
0.43
1.94
5.6
Youth
(
13
 
19
years
old)
0.0006
4
0.43
1.94
20
Adults
(
20
 
49
years
old)
0.0006
3
0.43
1.94
20
Adults
(
50+
years
old)
0.0006
3
0.43
1.94
20
Females
(
13
 
49
years
old)
0.0006
3
0.43
1.94
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
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
the
aggregate
risk
is
the
sum
of
the
risk
from
food
and
water,
which
were
previously
addressed.
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
non­
dietary,
nonoccupational
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
were
previously
addressed.
5.
Aggregate
cancer
risk
for
U.
S.
population.
At
the
present
time,
there
are
no
uses
of
thiamethoxam
that
will
result
in
non­
dietary,
non­
occupational
(
i.
e.,
residential)
exposures.
Therefore,
aggregate
cancer
risk
estimates
for
thiamethoxam
address
only
the
food
and
drinking
water
pathways
of
exposure.
EECs
for
thiamethoxam
for
comparison
to
the
DWLOCs
are
1.94
µ
g/
L
for
cancer
scenarios.
The
Agency
does
not
have
aggregate
risk
concerns
when
the
estimated
residues
in
water
are
less
than
the
DWLOCs.
For
cancer
risk,
which
is
estimated
for
the
total
U.
S.
population
only,
the
DWLOC
is
2.15
µ
g/
L
and
assumes
a
negligible
risk
level
of
3
x
10­
6
rather
than
1
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,
however
the
Agency
has
generally
treated
cancer
risks
up
to
3
in
1
million
as
within
the
range
of
1
in
1
million.
The
DWLOC
value
indicates
that
aggregate
exposure
to
thiamethoxam
is
not
likely
to
exceed
the
Agency's
level
of
concern
as
shown
in
the
following
Table
4:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
CANCER)
EXPOSURE
TO
THIAMETHOXAM
Population
subgroup
Maximum
acceptable
exposure
(
mg/
kg/
day)
1
Food
exposure
(
mg/
kg/
day)
Maximum
water
exposure
(
mg/
kg/
day)
2
Surface
water
EEC
(
ppb)
Ground
water
EEC
(
ppb)
Cancer
DWLOC
(
ppb)
3
General
U.
S.
population
0.0000795
0.000018
0.000062
0.13
1.94
2.15
1
Maximum
acceptable
exposure
=
3
x
10­
6
÷
0.0377
(
mg/
kg/
day)­
1
=
7.95
x
10­
5
mg/
kg/
day.
2
Maximum
water
exposure
=
maximum
acceptable
exposure
­
food
exposure.
3
DWLOC
=
maximum
water
exposure
(
mg/
kg/
day)
1,000
µ
g/
mg
H
body
weight
(
70
kg
general
population)
÷
water
consumption
(
2
L/
day).
Value
has
been
rounded
to
three
significant
figures.

EPA
recognizes
that
the
active
ingredient
clothianidin
is
identical
to
the
thiamethoxam
metabolite­
of­
concern
CGA
 
322704;
however,
clothianidin
has
not
been
classified
as
a
carcinogen
and
therefore,
it
has
been
removed
from
the
cancer
assessment.
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.
V.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
High
Performance
Liquid
Chromatography
using
Ultra
Violet
or
Mass
Spectrometry
(
HPLC/
UV
or
MS)
is
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Rules
and
Regulations
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
CODEX,
Canadian,
or
Mexican
maximum
residue
limits
that
impact
this
action.

C.
Conditions
The
thiamethoxam
label
currently
contains
the
following
rotational
crop
restriction:
Immediate
rotation
to
any
crop
on
the
label
or
to
cucurbit
vegetables,
fruiting
vegetables,
cotton,
sorghum,
corn,
wheat,
barley,
canola,
tuberous
and
corm
vegetables,
and
tobacco.
For
all
other
crops,
a
120
 
day
plant
back
interval
must
be
observed.
That
restriction
is
adequate
to
cover
the
requested
section
18
use
as
a
seed
treatment
for
succulent
and
dried
beans.
Hops
is
not
rotated
and,
therefore,
does
not
raise
any
potential
rotational
crop
issues.

VI.
Conclusion
Therefore,
the
tolerances
are
established
for
the
combined
residues
of
thiamethoxam
and
CGA
 
322704
on
hops
at
0.10
ppm;
bean,
succulent
at
0.02
ppm;
and
bean,
dried
at
0.02
ppm.

VII.
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
the
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
 
0254
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
October
27,
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
VII.
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
the
docket
ID
number
OPP
 
2003
 
0254,
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:
opp­
docket@
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).

VIII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
timelimited
tolerances
under
section
408
of
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27,
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/
Rules
and
Regulations
the
FFDCA.
The
Office
of
Management
and
Budget
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
FIFRA
section
18
exemption
under
section
408
of
the
FFDCA,
such
as
the
[
tolerances]
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.

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

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

Dated:
August
14,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

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

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.565
is
amended
by
adding
text
to
paragraph
(
b)
to
read
as
follows:

§
180.565
Thiamethoxam;
tolerances
for
residues.

*
*
*
*
*
(
b)
Section
18
emergency
exemptions.
Time­
limited
tolerances
are
established
for
the
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
CGA­
322704
in
connection
with
use
of
the
pesticide
under
section
18
emergency
exemptions
granted
by
EPA.
These
tolerances
will
expire
and
are
revoked
on
the
dates
specified
in
the
following
table:

Commodity
Parts
per
million
Expiration/
revocation
date
Bean,
dried
.......
0.02
12/
31/
06
Bean,
succulent
0.02
12/
31/
06
Hops
.................
0.10
12/
31/
06
*
*
*
*
*

[
FR
Doc.
03
 
21783
Filed
8
 
26
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0279;
FRL
 
7323
 
1]

Diflubenzuron;
Pesticide
Tolerances
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
time­
limited
tolerances
for
combined
residues
of
diflubenzuron
in
or
on
wheat
and
barley
commodities.
This
action
is
in
response
to
treatment
of
these
crops
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
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