40189
Federal
Register
/
Vol.
67,
No.
113
/
Wednesday,
June
12,
2002
/
Rules
and
Regulations
List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
May
20,
2002.
Marcia
E.
Mulkey,
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.[
380]
is
amended
by
removing
from
the
table
in
paragraph
(
a)
the
entries
for
``
cucumbres'',
``
peppers
(
bell)'',
``
stonefruits,
except
plums/
fresh
prunes''
and
``
strawberries'',
and
by
adding
paragraph
(
e)
to
read
as
follows:

§
180.380
Vinclozolin;
tolerances
for
residues.

*
*
*
*
*
(
e)
Revoked
tolerances
subject
to
the
channel
of
trade
provisions.
The
following
table
lists
commodities
with
residues
of
vinclozolin
resulting
from
lawful
use
are
subject
to
the
channels
of
trade
provisions
of
section
408(
l)(
5)
of
the
FFDCA:

Commodity
Parts
per
million
Cucumbers
1.0
Peppers
(
bell)
3.0
Stonefruits,
except
plums/
fresh
prunes
25.0
Strawberries
10.0
[
FR
Doc.
02
 
13520
Filed
6
 
11
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0082;
FRL
 
7180
 
8]

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

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
triflusulfuron
methyl
in
or
on
beet,
sugar,
roots;
beet,
sugar,
tops;
and
chicory,
roots.
Interregional
Research
Project
#
4
(
IR­
4)
and
E.
I.
Dupont
de
Nemours
&
Company
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).

DATES:
This
regulation
is
effective
June
12,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0082,
must
be
received
on
or
before
August
12,
2002.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP
 
2002
 
0082
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Tompkins
or
Hoyt
Jamerson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305
 
5697
or
(
703)
308
 
9368;
e­
mail
address:
tompkins.
jim@
epa.
gov
or
jamerson.
hoyt@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

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

TABLE
1.
 
EXAMPLES
OF
POTENTIALLY
AFFECTED
ENTITIES
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
persons
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,''
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
 
Environmental
Documents.''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP
 
2002
 
0082.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
 
5805.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
December
22,
1999
(
64
FR
71760)
(
FRL
 
6391
 
1)
and
August
8,
2001
(
66
FR
41593)
(
FRL
 
6795
 
4),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP)
by
IR­
4
and
E.
I.
Dupont
de
Nemours
&
Company,
681
US
Highway
#
1
South
North
Brunswick,
NJ
08902
 
3390,
and
E.
I.
DuPont
de
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Federal
Register
/
Vol.
67,
No.
113
/
Wednesday,
June
12,
2002
/
Rules
and
Regulations
Nemours
&
Company,
DuPont
Agricultural
Products,
Barley
Mill
Plaza,
Wilmington,
DE
19880
 
0038.
This
notice
included
a
summary
of
the
petition
prepared
by
E.
I.
DuPont
de
Nemours,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.492
be
amended
by
establishing
a
tolerance
for
residues
of
the
herbicide,
triflusulfuron
methyl,
methyl
2­[[[[[
4­
(
dimethylamino)­
6­(
2,2,2­
trifluoroethoxy)­
1,3,5­
triazin­
2­
yl]
amino]
carbonyl]
amino]
sulfonyl]­
3­
methylbenzoate,
in
or
on
chicory,
root
at
0.05
parts
per
million
(
ppm)
(
PP
0E6214).
PP
4F4278
proposed
that
the
currently
established
time­
limited
tolerances
for
sugar
beet,
root
at
0.05
ppm
and
sugar
beet,
top
at
0.05
ppm
be
converted
to
permanent
tolerances
and
to
revise
the
commodities
to
read
beet,
sugar,
roots
at
0.05
ppm
and
beet,
sugar,
tops
at
0.05
ppm.
Section
408(
b)(
2)(
A)(
i)
of
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
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
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
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
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
FFDCA,
for
tolerances
for
residues
of
triflusulfuron
methyl
on
chicory,
root
at
0.05
ppm;
and
to
convert
the
timelimited
tolerances
for
beet,
sugar,
root
at
0.05
ppm
and
beet,
sugar,
top
at
0.05
to
permanent
tolerances.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerances
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
triflusulfuron
methyl
are
discussed
in
Table
2
of
this
unit,
as
well
as
the
no­
observed­
adverseeffect
level
(
NOAEL)
and
the
lowestobserved
adverse­
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
type
Results
870.3100
90
 
Day
oral
toxicity
rodents
(
two
studies
submitted)
NOAEL
=
6.56/
7.71
(
m/
f)
mg/
kg/
day
(
milligram/
kilogram/
day)
LOAEL
=
133/
153
(
m/
f)
mg/
kg/
day
based
on
decreased
body
weight
gain
and
food
efficiency
in
males;
increased
incidence
of
histopathological
changes
(
kidney
and
spleen)
in
females.
NOAEL
=
6.20/
7.54
(
m/
f)
mg/
kg/
day
LOAEL
=
127/
150
(
m/
f)
mg/
kg/
day;
based
on
decreased
mean
body
weight
gain,
decreased
mean
food
consumption
(
f),
decreased
mean
food
efficiency,
alterations
in
hematology
parameters
(
m);
hemosiderin
in
kidneys
(
f)

870.3150
90
 
Day
oral
toxicity
in
nonrodents
NOAEL
=
3.9/
3.7
(
m/
f)
mg/
kg/
day
LOAEL
=
146.9/
159.9
(
m/
f)
mg/
kg/
day
based
on
decreased
mean
body
weight
and
body
weight
gain,
decreased
hematocrit,
hemoglobin,
RBC`
s,
SGOT,
SGPT,
ALP,
absolute
and
relative
liver
and
testes
weight;
microscopic
abnormalities
of
the
liver
and
testes.

870.3200
21/
28
 
Day
dermal
toxicity
NOAEL
=
1,000
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
limit
dose.

870.3700a
Pre­
natal
developmental
in
rodents
Maternal
NOAEL
=
120
mg/
kg/
day
LOAEL
=
350
mg/
kg/
day
based
on
decreased
body
weight
gain,
decreased
food
consumption
and
lower
food
efficiency.
Developmental
NOAEL
=
>
1,000
mg/
kg/
day
limit
dose
LOAEL
=
>
1,000
mg/
kg/
day.

870.3700b
Pre­
natal
developmental
in
nonrodents
Maternal
NOAEL
=
90
mg/
kg/
day
LOAEL
=
270
mg/
kg/
day
based
on
clinical
signs
including
absent/
reduced
stool
and
stained
fur,
maternal
death,
increased
abortions,
decreased
body
weight
gain,
and
lower­
food
efficiency.
Developmental
NOAEL
=
90
mg/
kg/
day
LOAEL
=
270
mg/
kg/
day
based
on
increased
abortions.

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Federal
Register
/
Vol.
67,
No.
113
/
Wednesday,
June
12,
2002
/
Rules
and
Regulations
TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
type
Results
870.3800
Reproduction
and
fertility
effects
Parental/
Systemic
NOAEL
=
5.81/
7.75
(
m/
f)
mg/
kg/
day
LOAEL
=
44/
58
mg/
kg/
day
based
on
decreased
body
weight,
decreased
body
weight
gain,
decreased
food
consumption,
and
decreased­
food
efficiency.
Reproductive
NOAEL
=
89.5/
115
(
m/
f)
mg/
kg/
day
based
on
the
absence
of
reproductive
effects
at
the
highest
dose
tested
(
HDT).
LOAEL
=
>
115
mg/
kg/
day.
Offspring
NOAEL
=
5.81/
7.75
(
m/
f)
mg/
kg/
day
LOAEL
=
44/
58
(
m/
f)
mg/
kg/
day
based
on
decreased
F1
pup
body
weight
on
days
14
and
21
due
to
exposure
via
milk
and
in
the
diet.

870.4100a
Chronic
toxicity
rodents
NOAEL
=
2.44
mg/
kg/
day
LOAEL
=
30.6
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gain,
alteration
in
hematology
(
mainly
males)
and
increased
incidences
of
interstitial
cell
hyperplasia
in
testes.

870.4100b
Chronic
toxicity
dogs
NOAEL
=
26.9
mg/
kg/
day
LOAEL
=
116.6
mg/
kg/
day
based
on
increased
liver
weight,
alkaline
phosphatase,
and
hepatocellular
hypertrophy.

870.4200
Carcino­
genicity
rats
NOAEL
=
2.44
mg/
kg/
day
LOAEL
=
30.6
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gain,
alteration
in
hematology
(
mainly
males)
and
increased
incidences
of
interstitial
cell
hyperplasia
in
the
testes.
(
Possible)
evidence
of
carcinogenicity
870.4300
Carcino­
genicity
mice
NOAEL
=
14.6
mg/
kg/
day
LOAEL
=
349
mg/
kg/
day
based
on
increased
liver
weight
and
increased
hepatic
cell
tumors
(
adenomas
and/
or
carcinomas
combined.
(
Possible)
evidence
of
carcinogenicity
870.5100
Gene
Mutation
No
genotoxic
effect
in
Ames
assay
using
S.
typhimurium.
(
two
studies)

870.5375
Cytogenetics
No
genotoxic
effect
in
Chinese
hampster
ovary
(
CHO)
gene
mutation
assay
870.5375
870.5395
Other
Effects
Positive
effects
in
the
presence
of
metabolic
activation,
but
inconclusive
in
the
absence
of
metabolic
activation
in
a
chromosomal
aberration/
human
lymphocyte
study.
Mouse
micronucleus
assay
negative
for
genotoxic
effects.

870.6200a
Acute
neurotoxicity
screening
battery
NOAEL
=
>
2,000
mg/
kg/
day
HDT
LOAEL
=
Not
established
870.6200b
Subchronic
neurotoxicity
screening
battery
NOAEL
=
92.7/
7.1
(
m/
f)
mg/
kg/
day
LOAEL
=
186.2/
51.6
(
m/
f)
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gain.

870.7485
Metabolism
and
pharmacokinetics
Urine
major
route
of
excretion
at
low
doses
and
the
feces
at
high
doses.
Ndesmethyl
triflusulfuron
methyl,
the
upper
urinary
metabolite
composed
between
25
 
44%
of
the
dose
at
the
low
dose
level
(
single
and
repeated).
Parent
was
the
major
component
in
the
high
dose
feces
and
liver.

870.7600
Dermal
penetration
No
dermal
absorption
studies
were
available.
A
27%
absorption
was
calculated
from
a
ratio
of
the
LOAEL
from
a
developmental
and
21
 
day
dermal
toxicity
studies
in
rabbits.

Special
studies:
In
vivo
and
in
vitro
mechanic
studies
The
purpose
of
these
studies
was
to
investigate
the
mechanism
of
Leydig
cell
tumor
induction
in
the
testes
of
male
rats.
A
dose­
dependent
decrease
in
aromatase
enzyme
activity
was
seen
in
vitro,
but
was
inconclusive
in
vivo.

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/

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and
Regulations
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
safety
factor.
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
triflusulfuron
methyl
used
for
human
risk
assessment
is
shown
in
Table
3
of
this
unit:

TABLE
3.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
TRIFLUSULFURON
METHYL
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
scenario
Dose
used
in
risk
assessment
UF
FQPA
SF*
and
LOC
for
risk
assessment
Study
and
toxicological
effects
Acute
Dietary
(
all
population
subgroups)
N/
A
No
toxicological
effects
attributable
to
a
single
exposure
(
dose)
were
observed
in
oral
toxicity
studies.
Therefore,
an
acute
RfD
can
not
be
established
and
an
acute
dietary
risk
assessment
will
not
be
conducted
for
the
general
population.

Chronic
Dietary
(
all
populations)
NOAEL
=
2.44
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.024
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
chronic
RfD
÷
FQPA
SF
=
0.024
mg/
kg/
day
Chronic
Toxicity
in
Rats
LOAEL
=
30.6
mg/
kg/
day
based
on
decreased
body
weight
and
body
weight
gain,
alter.
In
hematology
(
mainly
males),
increased
incidence
of
interstitial
cell
hyperplasia
in
testes.

Cancer
(
oral,
dermal,
inhalation)
Triflusulfuron
methyl
is
classified
as
a
Group
C
 
possible
human
carcinogen
chemical.

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

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.492)
for
the
residues
of
triflusulfuron
methyl
in
or
on
sugar
beet,
root
and
sugar
beet,
top.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
triflusulfuron
methyl
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.
There
are
no
effects
attributable
to
a
single,
oral
dose
of
triflusulfuron
methyl.
Therefore,
an
acute
dietary
risk
assessment
was
not
conducted.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment,
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
United
States
Department
of
Agriculture
1989
 
1992
Nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
Tolerance
level
residues
and
that
100%
of
the
crop
is
treated.
Because
suitable
data
depicting
residues
of
triflusulfuron
methyl
in
drinking
were
not
available
for
incorporation
into
the
dietary
exposure
model,
the
dietary
exposure
estimates
do
not
include
potential
exposure
from
drinking
water.
The
dietary
exposure
is
based
on
sugar
beets,
because
chicory
was
not
reported
as
being
consumed
in
the
1989
 
1992
CSFII.
Therefore,
inclusion
of
chicory
in
the
dietary
analysis
would
not
alter
the
exposure
or
risk
estimates
from
those
obtained
from
sugar
beets.
The
cRfD
or
0.024
mg/
kg/
day
was
determined
where
the
NOAEL
of
2.44
mg/
kg/
day
is
based
on
decreased
body
weight
gain,
alterations
in
hematology
(
mainly
in
males)
and
increases
in
the
incidence
of
interstitial
hyperplasia
in
the
testes
at
the
LOAEL
of
30.6
mg/
kg/
day.
A
100
 
fold
UF
for
interspecies
extrapolation
and
intraspecies
variability
was
applied.
iii.
Cancer.
Triflusulfuron
methyl
is
classified
as
a
Group
C
 
possible
human
carcinogen
chemical
and
for
the
purpose
of
risk
characterization
the
RfD
approach
should
be
used
for
quantification
of
human
risk.
This
decision
was
based
on
evidence
of
statistically
significant,
dose
related
increases
in
the
incidence
of
interstitial
cell
adenomas
of
the
testes
at
two
doses,
as
well
as
statistically
significant
positive
trend
for
these
tumors
in
male
rats.
The
testicular
interstitial
cell
adenomas
observed
in
the
rat
were
benign.
There
was
no
reported
increased
tumor
incidences
of
any
type
in
the
female
rat
and
the
dosing
was
adequate
for
assessing
the
carcinogenic
potential
of
triflusulfuron
methyl.
Evidence
of
a
hormonal
mechanism
for
development
of
these
benign
tumors
in
rats
does
exist,
however,
the
data
were
suggestive
but
not
conclusive.
Although
there
was
some
evidence
of
clastogenic
activity
for
triflusulfuron
methyl,
positive
results
were
only
seen
with
activation
in
human
lymphocytes/
chromosomal
aberration
assay.
Triflusulfuron
methyl
is
a
member
of
a
class
of
chemicals
known
as
sulfonylureas.
Of
the
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2002
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Rules
and
Regulations
analogs
structurally
related
to
triflusulfuron
methyl,
three
sulfonylureas
have
been
associated
with
carcinogenicity
in
rodents.
Primisulfuron
methyl
and
prosulfuron
are
classified
as
Group
D
carcinogens
(
not
classifiable
as
to
human
carcinogenicity).
Only
tribenuron
methyl
is
classified
as
a
Group
C
carcinogen
(
possible
human
carcinogen),
however,
a
Q*
for
cancer
risk
assessment
is
not
required
because
there
is
no
evidence
of
genotoxicity
and
the
increased
incidence
of
mammary
gland
tumors
is
observed
at
doses
which
exceed
the
maximum
tolerated
dose.
Therefore
the
RfD
approach
is
appropriate
for
quantification
of
human
cancer
risk.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
triflusulfuron
methyl
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
triflusulfuron
methyl.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
SCI­
GROW
model
is
used
to
predict
pesticide
concentrations
in
shallow
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
highend
runoff
scenario
for
pesticides.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
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
LOCs.
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
triflusulfuron
methyl
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
EECs
of
triflusulfuron
methyl
for
acute
exposures
are
estimated
to
be
0.42
parts
per
billion
(
ppb)
for
surface
water
and
0.5
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
0.005
ppb
for
surface
water
and
0.5
ug/
L
(
micrograms/
Liter)
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).
Triflusulfuron
methyl
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
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
triflusulfuron
methyl
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,
triflusulfuron
methyl
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
triflusulfuron
methyl
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
FFDCA
provides
that
EPA
shall
apply
an
additional
10
 
fold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
pre­
natal
and
post­
natal
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.
Pre­
natal
and
post­
natal
sensitivity.
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
to
in
utero
exposure
in
the
developmental
studies.
No
developmental
toxicity
was
seen
at
the
limit
dose
(
1,000
mg/
kg/
day)
in
rats.
In
rabbits,
developmental
toxicity
manifested
as
abortions
in
the
presence
of
severe
maternal
toxicity
(
mortality,
abortions,
clinical
signs,
decreased
body
weight,
and
food
efficiency).
In
the
2
 
generation
reproductive
toxicity
study,
the
effects
in
the
offspring
(
decreased
pup
body
weight
in
F1
on
days
14
and
21;
late
lactation)
can
be
attributed
to
the
decreases
in
body
weights
seen
in
the
parental
animals.
In
addition,
this
decrease
was
seen
only
in
the
F1
generation
but
not
in
the
second
generation.
There
is
no
indication
for
a
developmental
neurotoxicity
study
since
no
neuropathological
or
neurobehavioral
effects
in
the
acute
or
subchronic
neurotoxicity
studies
were
observed;
no
alteration
of
the
fetal
nervous
system
was
observed;
and
no
evidence
of
neurotoxicity
was
found
in
other
studies
in
the
data
base.
3.
Conclusion.
The
toxicity
data
base
for
triflusulfuron
methyl
is
complete
except
for
a
28
 
day
inhalation
(
nose
only)
toxicity
study.
This
study
is
of
marginal
value
for
the
FFDCA
determination
because
there
are
no
residential
uses
of
triflusulfuron
methyl.
Exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
Based
on
these
reasons,
the
FQPA
Safety
Factor
for
the
protection
of
children
has
been
removed
(
i.
e.
reduced
to
1x.)

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,

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/
Rules
and
Regulations
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.
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
(
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
¥
(
average
food
+
residential
exposure)).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
EPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2L/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
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.
Because
there
are
no
effects
attributable
to
a
single,
oral
dose
of
triflusulfuron
methyl
is
not
expected
to
pose
an
acute
risk.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
triflusulfuron
methyl
from
food
will
utilize
<
1%
of
the
cPAD
for
the
U.
S.
population,
<
1%
of
the
cPAD
for
infants
<
1
year,
and
<
1%
of
the
cPAD
for
children
aged
1
 
6
years
and
children
aged
7
 
12
years.
There
are
no
residential
uses
for
triflusulfuron
methyl
that
result
in
chronic
residential
exposure
to
triflusulfuron
methyl.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
4
of
this
unit:

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

U.
S.
Population
0.000011
<
1
0.005
0.50
840
Female
(
13
 
50
years)
0.000009
<
1
0.005
0.50
720
All
infants
(<
1
year)
0.000040
<
1
0.005
0.50
240
Children
(
1
 
6
years)
0.000025
<
1
0.005
0.50
240
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).
Triflusulfuron
methyl
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
do
not
exceed
the
Agency's
LOC.
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).
Triflusulfuron
methyl
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
do
not
exceed
the
Agency's
LOC.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Triflusulfuron
methyl
has
been
designated
a
Category
C
``
possible
human
carcinogen''
and
does
not
require
a
separate
cancer
risk
assessment.
Because
the
RfD
approach
was
determined
appropriate
for
quanification
of
human
cancer
risk,
the
chronic
aggregate
risk
assessment
is
sufficiently
protective
of
human
health.
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
triflusulfuron
methyl
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
An
adequate
tolerance
enforcement
method
is
available
in
PAM
II.
The
method
extracts
residues
of
triflusulfuron
methyl
in
a
buffered
acetonitrile
solution,
cleans
the
extract
on
a
phenyl
solid­
phase
extraction
cartridge,
and
quantitates
residues
on
a
HPLC/
UV
system.
B.
International
Residue
Limits
There
are
no
Canadian
or
Codex
MRLs
established
for
triflusulfuron
methyl.

C.
Conditions
Submission
of
a
28
 
day
inhalation
(
nose
only)
toxicity
study
is
required
as
condition
of
registration.

V.
Conclusion
Therefore,
the
tolerances
are
established
for
residues
of
triflusulfuron
methyl,
methyl
2­[[[[[
4­
(
dimethylamino)­
6­(
2,2,2­
trifluoroethoxy)­
1,3,5­
triazin­
2­
yl]
amino]
carbonyl]
amino]
sulfonyl]­
3­
methylbenzoate,
in
or
on
chicory,
roots
at
0.05
ppm;
and
time­
limited
tolerances
for
sugar
beet,
root
at
0.05
ppm
and
sugar
beet,
top
at
0.05
ppm
are
converted
to
permanent
tolerances
and
redefined
as
beet,
sugar,
roots
and
beet,
sugar,
tops.

VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
FFDCA,
as
amended
by
the
FQPA,
any
person
may
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12,
2002
/
Rules
and
Regulations
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
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
FFDCA
sections
408
and
409.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2002
 
0082
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
August
12,
2002.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
C400,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC
20460.
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
(
202)
260
 
4865.
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.
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.
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.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2002
 
0082,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.
B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?

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

VII.
Regulatory
Assessment
Requirements
This
final
rule
establishes
a
tolerance
under
FFDCA
section
408(
d)
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
FFDCA
section
408(
d),
such
as
the
tolerance
in
this
final
rule,
do
not
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Federal
Register
/
Vol.
67,
No.
113
/
Wednesday,
June
12,
2002
/
Rules
and
Regulations
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
FFDCA
section
408(
n)(
4).
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.
VIII.
Submission
to
Congress
and
the
Comptroller
General
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

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

Dated:
May
31,
2002.
Peter
Caulkins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]

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

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
374.

2.
Section
180.492
is
revised
to
read
as
follows:

§
180.492
Triflusulfuron
methyl;
tolerances
for
residues.

(
a)
General.
Tolerances
are
established
for
residues
of
the
herbicide,
triflusulfuron
methyl
2­[[[[[
4­
(
dimethylamino)­
6­(
2,2,2­
trifluoroethoxy)­
1,3,5­
triazin­
2­
yl]
amino]
carbonyl]
amino]
sulfonyl]­
3­
methylbenzoate
in
or
on
the
raw
agricultural
commodities:

Commodity
Parts
per
million
Beet,
sugar,
roots
.....
0.05
Beet,
sugar,
tops
.......
0.05
Chicory,
roots
............
0.05
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]

[
FR
Doc.
02
 
14501
Filed
6
 
11
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0099;
FRL
 
7182
 
1]

RIN
2070
 
AB78
Spinosad;
Time­
Limited
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
time­
limited
tolerance
for
residues/
combined
residues
of
spinosad
in
or
on
stored
grains
(
barley,
corn,
oats,
rice,
sorghum/
milo,
and
wheat).
Dow
AgroSciences
LLC
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
The
tolerance
will
expire
on
May
31,
2004.
This
timelimited
tolerance
is
to
permit
the
marketing
of
stored
grains
in
accordance
with
the
Experimental
Use
Permit
(
EUP)
62719­
EUP­
50
which
is
being
issued
concurrently.
DATES:
This
regulation
is
effective
June
12,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0099,
must
be
received
on
or
before
August
12,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP
 
2002
 
0099
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
William
G.
Sproat,
Jr.,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
703
 
308
 
8587;
e­
mail
address:
sproat.
william@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

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

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
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