Document ID: EPA-HQ-OPP-2003-0286-0001
Agency: epa
Document Type: Rule
Title: Trifloxysulfuron; Pesticide Tolerance
Posted Date: 2003-09-17T04:00Z

54377
Federal
Register
/
Vol.
68,
No.
180
/
Wednesday,
September
17,
2003
/
Rules
and
Regulations
Dated:
September
3,
2003.
Robert
E.
Roberts,
Regional
Administrator,
Region
8.


40
CFR
part
70,
chapter
I,
title
40
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
70
 
[
AMENDED]


1.
The
authority
citation
for
part
70
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7401,
et
seq.


2.
In
appendix
A
to
part
70
the
entry
for
North
Dakota
is
amended
by
adding
paragraph
(
c)
to
read
as
follows:

Appendix
A
to
Part
70
 
Approval
Status
of
State
and
Local
Operating
Permits
Programs
*
*
*
*
*
North
Dakota
*
*
*
*
*
(
c)
The
North
Dakota
Department
of
Health,
Environmental
Health
Section
submitted
the
following
program
revisions
on
May
1,
2003:
NDAC
33
 
15
 
14
 
06.1(
o)(
2)(
aa),
effective
November
17,
2003.

*
*
*
*
*
[
FR
Doc.
03
 
23751
Filed
9
 
16
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0286;
FRL
 
7325
 
1]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
trifloxysulfuron
in
or
on
almond;
almond,
hulls;
fruit,
citrus,
group
10;
cotton,
undelinted
seed;
cotton,
gin
byproducts;
sugarcane;
and
tomato.
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
September
17,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0286,
must
be
received
on
or
before
November
17,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Jim
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5697;
e­
mail
address:
tompkins.
jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

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

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0286.
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
March
21,
2003
(
68
FR
13924)
(
FRL
 
7296
 
6),
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
1F6280)
by
Syngenta
Crop
Protection,
Inc.,
Greensboro,
NC
27419.
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
be
amended
by
establishing
a
tolerance
for
residues
of
the
herbicide
trifloxysulfuron­
sodium,
[
N­[[(
4,6­
dimethoxy­
2­
pyrimidinyl)
amino)
carbonyl]­
3­(
2,2,2­
trifluoroethoxy)­
2­
pyridinesulfonamide),
in
or
on
sugarcane
at
0.01
part
per
million
(
ppm);
cottonseed
at
0.05
ppm;
cotton
byproducts
at
1.0
ppm;
citrus
at
0.01
ppm;
almond
hulls
at
0.01
ppm;
almond
nut
meat
at
0.01
ppm;
and
tomatoes
at
0.01
ppm.
During
the
course
of
the
review
The
Agency
determined
that
based
on
available
data
and
current
commodity
vocabulary
that
tolerances
should
be
established
for
residues
of
the
herbicide
trifloxysulfuron
N­[[
4,6­
dimethoxy­
2­
pyrimidinyl)
amino)
carbonyl]­
3­
2,2,2­
trifluoroethoxy)­
2­
pyridinesulfonamide
in
or
on
the
commodities
almond
at
0.02
ppm;
almond,
hulls
at
0.01
ppm;
fruit,
citrus,
group
10
at
0.03
ppm;
cotton,
undelinted
seed
at
0.05
ppm;
cotton,
gin
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byproducts
at
1.0
ppm;
sugarcane
at
0.01
ppm,
and
tomato
at
0.01
ppm.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
residues
of
trifloxysulfuron
on
almond
at
0.02
ppm;
almond,
hulls
at
0.01
ppm;
fruit,
citrus,
group
10
at
0.03
ppm;
cotton,
undelinted
seed
at
0.05
ppm;
cotton
gin
byproducts
at
1.0
ppm;
sugarcane
at
0.01
ppm;
and
tomato
at
0.01
ppm.
EPAs
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
trifloxysulfuron
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
(
rats)
NOAEL:
507/
549
milligrams/
kilogram/
day
(
mg/
kg/
day)
Male/
Female
(
M/
F)
LOAEL:
1052/
1128
mg/
kg/
day
(
M/
F):
M
=
decreased
body
weight,
decreased
body
weight
gain,
equivocal
increased
testicular
atrophy
at
end
of
recovery
phase;
F
=
decreased
body
weight,
decreased
body
weight
gain,
equivocal
slightly
increased
histopathology
in
liver
(
single
cell
necrosis
focal
necrosis,
inflammation,
hepatocellular
hypertrophy).

870.3100
90
 
Day
oral
toxicity
rodents
(
mice)
NOAEL:
1,023/
1,507
mg/
kg/
day
(
M/
F)
LOAEL:
>
1,023/>
1,507
mg/
kg/
day
(
M/
F):
M
=
not
attained;
F
=
not
attained

870.3150
90
 
Day
oral
toxicity
in
nonrodents
(
dogs)
NOAEL:
19.8/
19.6
mg/
kg/
day
(
M/
F)
LOAEL:
164.2/
167.3
mg/
kg/
day
(
M/
F):
M
=
decreased
body
weight
gain
(
20%),
slight
hematological
effects,
clinical
chemistry
changes
suggesting
hepatotoxicity,
decreased
thymus
weight,
thymic
atrophy,
increased
glycogen
in
liver,
hemorrhage
in
mesenteric
lymph
nodes;
F
=
decreased
body
weight
gain
(
44%),
anemia
with
extramedullary
hematopoiesis
in
liver/
spleen
and
myeloidhyperplasia
in
bone
marrow,
clinical
chemistry
changes
suggesting
hepatotoxicity,
decrease
thymus
weight,
thymic
atrophy
and
hyaline
tubular
change
in
kidney.

870.3200
21/
28
 
Day
dermal
toxicity
(
rats)
NOAEL:
1,000/
100
mg/
kg/
day
(
M/
F)
LOAEL:
>
1,000/
1,000
mg/
kg/
day(
M/
F):
M
=
not
attained;
F
=
decreased
body
weight
gain.
No
dermal
irritation
M/
F.

870.3700
Prenatal
developmental
in
rodents
(
rats)
Maternal
NOAEL:
300
mg/
kg/
day
Maternal
LOAEL:
1,000
mg/
kg/
day
based
on
decreased
food
consumption
during
treatment,
decreased
body
weight
gain
during
post­
treatment.
Developmental
NOAEL:
300
mg/
kg/
day
Developmental
LOAEL:
1,000
mg/
kg/
day
based
on
slight
decrease
in
fetal
weight,
increased
skeletal
anomalies,
increased
poor/
absent
skeletal
ossification

870.3700
Prenatal
developmental
in
nonrodents
(
rabbit)
Maternal
NOAEL:
100
mg/
kg/
day
Maternal
LOAEL:
250
mg/
kg/
day
based
on
increased
mortality,
increased
vaginal/
anal
bleeding.
Developmental
NOAEL:
50
mg/
kg/
day
Developmental
LOAEL:
100
mg/
kg/
day
based
on
abnormally
shaped
heart
(
one
fetus
at
100
mg/
kg/
day
and
3
fetuses
from
2
litters
at
250
mg/
kg/
day).

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180
/
Wednesday,
September
17,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3800
Reproduction
and
fertility
effects
(
rat)
Parental
systemic
NOAEL:
78.8/
83.5
mg/
kg/
day
(
M/
F)
Parental
systemic
LOAEL:
631/
676
mg/
kg/
day
(
M/
F)
based
on
decreased
body
weight
and
gain
as
well
as
decreased
food
consumption.
Offspring
systemic
NOAEL:
78.8/
83.5
mg/
kg/
day
(
M/
F)
Offspring
systemic
LOAEL:
631/
676
mg/
kg/
day
(
M/
F):
decreased
pup
weight
and
weight
gain,
decreased
spleen
weight,
thymus
weight
and
increased
vaginal
patency.
Reproductive
NOAEL:
968/
1,030
mg/
kg/
day
(
M/
F)
Reproductive
LOAEL:
>
968/
1,030
(
M/
F)

870.4100
Chronic
toxicity
rodents
(
rat)
See
870.4300
870.4100
Chronic
toxicity
dogs
NOAEL:
51.1/
45.3
mg/
kg/
day
(
M/
F)
LOAEL:
123/
121
mg/
kg/
day
(
M/
F):
M
=
gray­
white
foci
in
lungs,
fibrous
thickening
of
lung
pleura,
equivocal
decreased
body
weight
gain;
F
=
equivocal
increased
incidence
and
severity
of
chronic
urinary
bladder
inflammation

870.4200
Carcinogenicity
rats
See
870.4300
870.4200
Carcinogenicity
mice
NOAEL:
854/
112
mg/
kg/
day
(
M/
F)
LOAEL:
>
854/
818
mg/
kg/
day
(
M/
F):
M
=
not
determined;
F
=
decreased
body
weight,
body
weight
gain
and
food
consumption.
Negative
for
carcinogenicity
in
M
and
F.

870.4300
Chronic
feeding/
carcinogenicity
rats
NOAEL:
82.6/
23.7
mg/
kg/
day
(
M/
F)
LOAEL:
429/
99.3
mg/
kg/
day
(
M/
F):
M
=
decreased
body
weight
and
gains,
decreased
food
consumption
and
increased
Leydig
cell
hyperplasia
in
testes;
F
=
increased
tubular
atrophy
in
kidneys.
At
500
mg/
kg/
day
decreased
body
weight,
body
weight
gain,
food
consumption
and
increased
tubular
atrophy
in
kidneys.
Negative
for
carcinogenicity
in
M
and
F.

870.5100
Gene
mutation
bacterial
reverse
mutation
assay
(
S.
typhimurium/
E.
coli)
Negative
without
and
with
S­
9
activation.

870.5300
In
vitro
mammalian
cell
forward
gene
mutation
assay
(
CHO
cells/
HGPRT
locus)
Negative
without
and
with
S­
9
activation.

870.5375
In
vitro
mammalian
cytogenetics
assay
in
CHO
cells
Negative
without
and
with
S­
9
activation.

870.5395
Cytogenetics
­
mammalian
erythrocyte
micronucleus
test
in
the
mouse
Negative
at
single
oral
doses
up
to
5,000
mg/
kg.

870.5500
In
vitro
unscheduled
DNA
synthesis
(
primary
rat
hepatocytes)
Negative
response
up
to
250
µ
g/
mL.
Cytotoxicity
at
 
15.63
µ
g/
mL.

870.6200
Acute
neurotoxicity
screening
battery
(
rat)
NOAEL:
<
2,000
mg/
kg/
day
(
M/
F)
LOAEL:
2,000
mg/
kg/
day
(
M/
F):
M
and
F
=
decreased
motor
activity
on
day
1,
histopathological
lesions
in
nervous
system
tissues.

870.6200
Acute
neurotoxicity
screening
battery
(
rat)
NOAEL:
2,000/
600
mg/
kg/
day
(
M/
F)
LOAEL:
>
2,000/
2,000
mg/
kg/
day
(
M/
F):
M
=
not
attained;
F
=
decreased
motor
activity
on
day
1.

870.6200
Subchronic
neurotoxicity
screening
battery
(
rat)
NOAEL:
112/
553
mg/
kg/
day
(
M/
F)
LOAEL:
472/
1,128
mg/
kg/
day
(
M/
F):
M
=
decreased
body
weight,
body
weight
gain
and
food
consumption.;
F
=
decreased
body
weight.

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180
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Wednesday,
September
17,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.6300
Developmental
neurotoxicity
(
rat)
No
study
performed.
Not
Required.

870.7485
Metabolism
and
pharmacokinetics
(
rat)
Rapidly
absorbed
and
exceted.
Most
(>
87%)
of
the
administered
dose
(
AD)
was
excreted
within
24
hours.
After
7
days,
very
little
( 
0.3%
of
AD)
remained
in
the
tissues.
Urine
was
the
primary
route
of
excretion
in
males
(
50­
61%
of
AD)
and
in
females
(
70­
80%
of
AD).
Unchanged
parent
in
males
(
11­
20%
of
AD)
and
in
females
(
37­
47%
of
AD)
was
excreted
almost
entirely
in
the
urine
and
only
trace
amounts
were
found
in
the
feces.
With
the
exception
of
the
parent,
the
metabolite
profile
was
similar
between
the
urine
and
feces.
The
2
primary
metabolites
in
both
urine
and
feces
were
Metabolite
J
(
desmethyl
parent,
up
to
26%
of
AD)
and
Metabolite
K
(
5'
hydroxy­
pyrimidine
of
parent,
up
to
19%
of
AD).
Other
metabolites
were
Metabolites
X,
N,
F,
A
and
D,
each
up
to
8.2%
of
the
AD
in
males
and
up
to
4.7%
of
the
AD
in
females.
Several
minor
metabolites
were
also
identified
as
Metabolite
Q,
Metabolite
P,
guanidine
CGA­
382997
and
CGA­
368732
(
each
 
4.4%
of
the
AD).

870.7485
Biliary
metabolism
(
rat)
In
bile
duct
cannulated
rats,
absorption
was
84­
88%
of
the
Administered
Dose
(
AD)
at
48
hours.
Nearly
all
of
the
AD
was
excreted
within
48
hours.
Excretion
in
urine
ranged
from
58­
76%,
in
bile
from
5­
27%,
and
in
feces
was
about
6%
of
the
AD.
There
was
no
evidence
for
an
enterohepatic
circulation.
Biotransformation
was
similar
to
that
in
the
conventional
rat
metabolism
study.
The
metabolite
profiles
in
urine,
bile
fluid
and
feces
were
all
similar.

870.7600
Dermal
penetration
(
rat)
No
study
performed.
Not
Required.

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
trifloxysulfuron
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

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Vol.
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17,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
TRIFLOXYSULFURON
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
(
females
13­
49)
Developmental
NOAEL
=
50
mg/
kg/
dayUF
=
100
Acute
RfD
=
0.5
mg/
kg
Special
FQPA
SF
=
1
aPAD
=
acute
RfD/
Special
FQPA
SF
=
0.5
mg/
kg
Developmental
Toxicity
Study
in
Rabbits.
Developmental
LOAEL
=
100
mg/
kg/
day
based
on
increased
incidence
of
abnormal
shaped
hearts
in
fetuses.

Acute
dietary
(
general
population
NOAEL
=
600
mg/
kg
UF
=
100
Acute
RfD
=
6.0
mg/
kg
Special
FQPA
SF
=
1
aPAD
=
acute
RfD/
Special
FQPA
SF
=
6.0
mg/
kg
Acute
Neurotoxicity
Studies
in
Rats.
LOAEL
=
2,000
mg/
kg
based
on
decreased
motor
activity
on
day
1
and
histopathological
lesions
in
nervous
system
tissues
of
males
and
females.

Chronic
dietary
(
all
populations
NOAEL=
23.7
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.237
mg/
kg/
day
Special
FQPA
SF
=
1
cPAD
=
chronic
RfD/
Special
FQPA
SF
=
0.237
mg/
kg/
day
Combined
Chronic
Toxicity/
Carcinogenicity
Study
in
Rats.
LOAEL
=
99.3
mg/
kg/
day
based
on
increased
tubular
atrophy
in
the
kidneys
of
females
(
developing
after
12
months).

Incidental
oral
short­
term
(
1
­
30
days)
Offspring
NOAEL
=
78.8/
83.5
(
M/
F)
mg/
kg/
day
Residential
LOC
for
MOE
=
100
2
 
Generation
Reproduction
Study
in
Rats.
Offspring
LOAEL
=
631/
676
(
M/
F)
mg/
kg/
day
based
on
decreased
pup
body
weights
on
day
21.

Dermal
short­
term
(
1
­
30
days)
Dermal
study
Systemic
NOAEL=
100
mg/
kg/
day
Residential
LOC
for
MOE
=
100
28
 
Day
Dermal
Toxicity
Study
in
Rats.
Systemic
LOAEL
=
1,000
mg/
kg/
day
based
on
decreased
body
weight
gain
in
females.

Inhalation
short­
term
(
1
­
30
days)
Oral
study
NOAEL=
50
mg/
kg/
day
(
inhalation
absorption
factor
=
100%)
Residential
LOC
for
MOE
=
100
Developmental
Toxicity
Study
in
Rabbits.
LOAEL
=
100
mg/
kg/
day
based
on
increased
incidence
of
abnormal
shaped
hearts
in
fetuses.

Cancer
(
oral,
dermal,
inhalation
Classification:
Not
Likely
to
be
carcinogenic
to
humans
*
The
reference
to
the
Special
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.
No
tolerances
have
been
previously
established
for
trifloxysulfuron.
Tolerances
being
established
under
§
180.591
include
almond;
almond
hulls;
cotton,
undelinted
seed;
cotton,
gin
byproducts;
fruit,
citrus,
Group
10;
sugarcane,
and
tomato.
No
tolerances
are
required
for
meat,
milk,
poultry
or
eggs.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
trifloxysulfuron
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
and
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
100%
of
the
crops
from
registered
uses
are
treated
and
that
residues
of
trifloxysulfuron
are
at
tolerance
levels.
Anticipated
residues
were
not
used.
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
and
1998
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
100%
of
the
crops
from
registered
uses
are
treated
and
that
residues
of
trifloxysulfuron
are
at
tolerance
levels.
Anticipated
residues
were
not
used.
iii.
Cancer.
Trifloxysulfuron
has
been
classified
as
``
not
likely
to
be
carcinogenic
in
humans.''
Therefore
a
quantitative
assessment
of
aggregate
cancer
risk
was
not
performed.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
trifloxysulfuron
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
trifloxysulfuron.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
Screening
Concentrations
in
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and
Regulations
Ground
Water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST
(
a
Tier
1
model)
before
using
PRZM/
EXAMS
(
a
Tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
trfloxysulfuron
they
are
further
discussed
in
the
aggregate
risk
sections
Unit
E.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
EECs
of
trifloxysulfuron
and
its
metabolites
of
concern
for
acute
exposures
are
estimated
to
be
6.47
parts
per
billion
(
ppb)
for
surface
water
and
0.054
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.52
ppb
for
surface
water
and
0.054
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).
Trifloxysulfuron
will
be
registered
for
use
on
the
following
non­
dietary
sites:
Turf
 
golfcourses.
The
risk
assessment
was
conducted
using
the
following
exposure
assumptions:
The
Agency
has
examined
the
potential
postapplication
exposure
to
individuals
over
12
years
of
age
from
the
proposed
use
of
trifloxysulfuron
on
golf
courses.
Duration
of
such
exposure
is
anticipated
to
be
short­
term.
The
short­
term
dermal
post­
application
exposure
for
golfing
was
estimated
to
be
0.0005
mg/
kg/
day.
The
estimate
assumes
that
18
holes
of
golf
are
played
in
4
hours,
that
there
are
0.015
µ
g
ai/
cm2
of
turf,
that
the
transfer
coefficient
for
turf
is
500
cm2/
hour,
and
that
the
average
golfer
weighs
60
kg.
Transfer
coefficients
are
based
on
surrogate
data,
from
chlorothalonil
and
chlorpyrifos,
describing
actual,
medianvalue
exposures
to
golfers.
The
vapor
pressure
of
trifloxysulfuron
is
very
low
and,
therefore,
inhalation
exposure
to
trifloxysulfuron
vapor
is
not
expected
to
occur.
The
Agency
has
not
assessed
inhalation
exposure
to
trifloxysulfuron
due
to
residential
activities.
4.
Cumulative
effects
from
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
trifloxysulfuron
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
trifloxysulfuron
and
any
other
substances
and
trifloxysulfuron
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
trifloxysulfuron
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
epa.
gov/
pesticides/
cumulative/.
D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
There
was
no
evidence
of
increased
quantitative
or
qualitative
susceptibility
in
the
developmental
toxicity
study
in
rats
or
in
the
2
 
generation
reproduction
study
in
rats.
In
the
developmental
toxicity
study
in
rabbits,
there
was
an
increase
in
quantitative
susceptibility
based
upon
the
presence
of
abnormally
shaped
heart
in
one
fetus
at
100
mg/
kg/
day.
Three
additional
fetuses
from
two
litters
at
250
mg/
kg/
day
also
had
abnormally
shaped
hearts.
The
degree
of
concern
for
this
finding
was
low
because
there
was
a
clear
NOAEL
for
this
effect,
only
1
fetus
had
the
effect
at
the
LOAEL,
and
this
effect
was
used
as
a
toxicological
endpoint
in
appropriate
risk
assessments.
There
are
no
residual
uncertainties
for
prenatal
and/
or
postnatal
toxicity.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
trifloxysulfuron
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
SF
to
protect
infants
and
children
should
be
reduced
to
1X.
This
determination
was
based
on
the
following:
 
The
toxicological
data
base
is
complete
for
FQPA
assessment.
 
There
was
no
evidence
of
increased
quantitative
or
qualitative
susceptibility
in
the
developmental
toxicity
study
in
rats.
At
the
limit
dose,
maternal
effects
were
decreased
food
consumption
during
treatment
and
decreased
body
weight
gain
during
posttreatment
The
only
fetal
findings
noted
at
the
limit
dose
were
a
slight
decrease
in
fetal
body
weights,
and
an
increase
in
minimal
skeletal
findings
and
poor/
absent
skeletal
ossification.
 
There
was
evidence
of
increased
quantitative
susceptibility
in
the
developmental
toxicity
study
in
rabbits.
The
maternal
NOAEL
was
100
mg/
kg/
day
based
on
increased
mortality
and
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increased
vaginal/
anal
bleeding
at
the
LOAEL
of
250
mg/
kg/
day.
The
developmental
NOAEL
was
50
mg/
kg/
day
based
on
an
increased
incidence
of
abnormally
shaped
hearts
at
the
LOAEL
of
100
mg/
kg/
day
(
one
fetus
at
100
mg/
kg/
day).
Three
additional
fetuses
from
two
litters
at
250
mg/
kg/
day
also
had
abnormally
shaped
hearts.
In
historical
control
data
provided
by
the
registrant,
there
were
no
reported
instances
of
abnormally
shaped
hearts.
The
degree
of
concern
is
low
for
the
quantitative
evidence
of
susceptibility
seen
in
the
rabbit
developmental
study
because
there
was
a
clear
NOAEL
for
this
effect,
only
one
fetus
had
the
effect
at
the
LOAEL,
this
effect
was
used
as
a
toxicological
endpoint
in
appropriate
risk
assessments.
 
There
was
no
evidence
of
increased
quantitative
or
qualitative
susceptibility
in
the
2
 
generation
reproduction
study
in
rats.
 
There
are
no
residual
uncertainties
for
prenatal
and/
or
postnatal
toxicity.
 
A
developmental
neurotoxicity
study
in
rats
is
not
required.
 
The
acute
and
chronic
dietary
food
exposure
assessments
assumed
tolerance
level
residue
data
and
100%
crop
treated.
The
acute
and
chronic
risk
assessments
will
not
underestimate
exposure
or
risk
since
the
exposures
are
based
on
reliable
data
derived
from
studies
designed
to
produce
worst­
case
residues.
 
The
dietary
drinking
water
assessment
used
concentration
values
generated
by
model
and
associated
modeling
parameters
which
are
designed
to
provide
conservative,
health
protective,
high­
end
estimates
of
water
concentrations
which
will
not
likely
be
exceeded.
Furthermore,
EPA
used
a
highly
conservative
technique
to
estimate
concentrations
of
non­
parent
residues
of
concern.
 
The
non­
dietary
exposure
assessment
will
not
underestimate
postapplication
exposure
to
golfers
resulting
from
the
use
of
trifloxysulfuron­
sodium
on
golf
course
turf.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
EECs.
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
ground
water
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
trifloxysulfuron
will
occupy
<
1%
of
the
aPAD
for
the
U.
S.
population,
<
1%
of
the
aPAD
for
females
13­
49
years,
<
1%
of
the
aPAD
for
all
infants
>
1
year
old
and
<
1%
of
the
aPAD
for
children
1
 
12
year
old.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
trifloxysulfuron
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
Table
3
of
this
unit:

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

U.
S.
population
6.0
<
1
6.47
0.054
210,000
All
infants
<
1
year
old
6.0
<
1
6.47
0.054
60,000
Children
1­
2
year
old
6.0
<
1
6.47
0.054
60,000
Females
13­
49
years
old
0.05
<
1
6.47
0.054
15,000
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
trifloxysulfuron
from
food
will
utilize
<
1%
of
the
cPAD
for
the
U.
S.
population,
<
1%
of
the
cPAD
for
females
13
 
49
years,
<
1%
of
the
cPAD
for
all
infants
>
1
year
old
and
<
1%
of
the
cPAD
for
children
1
 
2
years
old.
Based
the
use
pattern,
chronic
residential
exposure
to
residues
of
trifloxysulfuron
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
trifloxysulfuron
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
4
of
this
unit:

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

U.
S.
population
0.237
<
1
0.52
0.054
8300
All
infants
<
1
year
old
0.237
<
1
0.52
0.054
2,400
Children
1
 
2
years
old
0.237
<
1
0.52
0.054
2,400
Females
13
 
49
years
old
0.237
<
1
0.52
0.054
7,100
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).
Trifloxysulfuron
is
proposed
for
a
use
that
could
result
in
short­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
term
exposures
for
trifloxysulfuron.
Using
the
exposure
assumptions
described
in
this
unit
for
short­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
20,000
for
all
affected
populations
including
the
general
U.
S.
population,
youth
13
 
19
years
old,
adults
20
 
49
years
old,
and
females
13
 
49
years
old.
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
trifloxysulfuron
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
Table
5
of
this
unit:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
TRIFLOXYSULFURON
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

U.
S.
population
170,000
100
0.52
0.054
28,000
Youth
13
 
19
years
old
170,000
100
0.52
0.054
24,000
Adults
20
 
49
years
old
180,000
100
0.52
0.054
28,000
Females
13
 
49
years
old
180,000
100
0.52
0.054
24,000
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).
Trifloxysulfuron
is
not
registered
for
use
any
sites
that
would
result
in
any
intermediate
residential
exposure.
Therefore,
the
aggregate
risk
has
not
been
assessed
for
intermediate
scenarios.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Trifloxysulfuron
has
been
classified
as
``
not
likely
to
be
carcinogenic
to
humans.''
Therefore,
no
cancer
risk
is
expected.
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
trifloxysulfuron
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
high
performance
liquid
chromatography/
ultravoilet
(
HPLC/
UV)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
There
are
no
Canadian,
Mexican,
or
Codex
maximum
residue
limits
(
MRLs)
established
for
trifloxysulfuron.
Therefore,
international
harmonization
is
not
an
issue
with
the
proposed
uses.

C.
Conditions
No
conditions
are
required
to
support
these
tolerances.
V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
trifloxysulfuron,
N­[[
4,6­
dimethoxy­
2­
pyrimidinyl)
amino]
carbonyl]­
3­(
2,2,2­
trifluoroethoxy)­
2­
pyridinesulfonamide,
in
or
on
almond
at
0.02
ppm;
almond,
hulls
at
0.01
ppm;
fruit,
citrus,
group
10
at
0.03
ppm;
cotton,
undelinted
seed
at
0.05
ppm;
cotton,
gin
byproducts
at
1.0
ppm;
sugarcane
at
0.01
ppm,
and
tomato
at
0.01
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
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/
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17,
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/
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and
Regulations
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0286
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
November
17,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0286.
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
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17,
2003
/
Rules
and
Regulations
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

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

Dated:
September
4,
2003.
James
Jones,
Director,
Office
of
Pesticide
Programs.

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

PART
180
 
[
AMENDED]

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

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


2.
Section
180.591
is
added
to
read
as
follows:

§
180.591
Trifloxysulfuron;
tolerances
for
residues
(
a)
General.
Tolerances
are
established
for
residues
of
the
herbicide
trifloxysulfuron,
N­[[(
4,6­
dimethoxy­
2­
pyrimidinyl)
amino]
carbonyl]­
3­(
2,2,2­
trifluoroethoxy)­
2­
pyridinesulfonamide
in
or
on
the
following
raw
agricultural
commodities.

Commodity
Parts
per
million
Almond
.....................................................................................................................
0.02
Almond,
hulls
...........................................................................................................
0.01
Fruit,
citrus,
Group
10
..............................................................................................
0.03
Cotton,
undelinted
seed
...........................................................................................
0.05
Cotton,
gin
byproducts
.............................................................................................
1.0
Sugarcane
................................................................................................................
0.01
Tomato
.....................................................................................................................
0.01
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]
[
FR
Doc.
03
 
23428
Filed
9
 
16
 
03;
8:
45am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0306;
FRL
 
7327
 
5]

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

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
thiamethoxam
and
its
metabolite
in
or
on
imported
coffee,
pecan,
stone
fruit,
succulent
bean,
and
sunflower.
Syngenta
Crop
Protection,
Inc.
and
the
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.

DATES:
This
regulation
is
effective
September
17,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0306,
must
be
received
on
or
before
November
17,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
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
potentially
affected
by
this
action
if
you
are
an
agricultural
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