Document ID: EPA-HQ-OPP-2002-0216-0001
Agency: epa
Document Type: Rule
Title: Tolylfluanid; Pesticide Tolerance.
Posted Date: 2002-09-25T04:00Z

60130
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
paragraphs
(a)(
1)
and
(a)(
2)
to
read
as
follows:

§
1955.3
General
policy.

(a)
*
*
*
(1)
Whenever
the
Assistant
Secretary
determines
that
under
§
1902.2(
b)
of
this
chapter
a
State
has
not
substantially
completed
the
developmental
steps
of
its
plan
at
the
end
of
three
years
from
the
date
of
commencement
of
operations,
a
withdrawal
proceeding
shall
be
instituted.
Examples
of
a
lack
of
substantial
completion
of
developmental
steps
include
but
are
not
limited
to
the
following:
*
*
*
*
*
(2)
Whenever
the
Assistant
Secretary
determines
that
there
is
no
longer
a
reasonable
expectation
that
a
State
plan
will
meet
the
criteria
of
§
1902.3
of
this
chapter
involving
the
completion
of
developmental
steps
within
the
three
year
period
immediately
following
commencement
of
operations,
a
withdrawal
proceeding
shall
be
instituted.
Examples
of
a
lack
of
reasonable
expectation
include
but
are
not
limited
to
the
following:
*
*
*
*
*
[FR
Doc.
02–
24284
Filed
9–
24–
02;
8:
45
am]

BILLING
CODE
4510–
26–
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0216;
FRL–
7200–
5]

Tolylfluanid;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
import
tolerance
for
residues
of
tolylfluanid
in
or
on
imported
apple,
grape,
hop,
and
tomato.
Bayer
Corporation
requested
this
tolerance
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
25,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP–
2002–
0216,
must
be
received
on
or
before
November
25,
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–
0216
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Mary
Waller,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
308–
9354;
e­
mail
address:
waller.
mary@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

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

Categories
NAICS
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
person
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–
0216.
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
August
11,
1997
(62
FR
42980)
(FRL–
5736–
1),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(Public
Law
104–
170),
announcing
the
filing
of
a
pesticide
petition
(PP
7E4825)
by
Bayer
Corporation,
8400
Hawthorn
Rd.,
Kansas
City,
MO
64120.
This
notice
included
a
summary
of
the
petition
prepared
by
Bayer
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.584
be
amended
by
establishing
an
import
tolerance
for
residues
of
the
fungicide
tolylfluanid,
(1,1­
dichloro­
N
dimethylamino)­
sulfonyl]­
1­
fluoro­
N
4­
methylphenyl)
methanesulfenamide),
in
or
on
apple
at
5.0
parts
per
million
(ppm),
grape
at
5.0
ppm,
hop
at
30
ppm,
and
tomato
at
1.0
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
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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
tolylfluanid
in
or
on
apple
at
5.0
ppm,
grape
at
11
ppm,
hop
at
30
ppm,
and
tomato
at
2.0
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
tolylfluanid
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effect­
level
(NOAEL)
and
the
lowest­
observedadverse
effect­
level
(LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90­
Day
oral
toxicity
rodents
(rat)
NOAEL
=
20.1
milligram/
kilogram/
day
(mg/
kg/
day)
male
(M)
LOAEL
=
108
mg/
kg/
day,
based
on
changes
in
clinical
blood
chemistry
associated
with
the
liver
and
thyroid
(M)
NOAEL
=
131
mg/
kg/
day
female
(F)
LOAEL
=
736.1
mg/
kg/
day,
based
on
changes
in
clinical
blood
chemistry
associated
with
the
liver
and
thyroid
and
decreased
body
weights
(F)
Acceptable/
guideline
870.3150
90­
Day
oral
toxicity
in
nonrodents
(dog)
NOAEL
=
23.1/
25
mg/
kg/
day
(F/
M)
LOAEL
=
67.2/
69.4
(F/
M)
mg/
kg/
day,
based
on
decreased
body
weight
gains
and
changes
in
liver
structure
and
function
in
both
sexes
Unacceptable/
guideline
870.3700
Prenatal
developmental
in
rodents
(rat)
Maternal
NOAEL
=
not
determined
LOAEL
=
100
mg/
kg/
day,
based
on
decreased
body
weight
gains
and
food
consumption.
Developmental
NOAEL
=
1,000
mg/
kg/
day
highest
dose
tested
(HDT)
LOAEL
>
1,000
mg/
kg/
day
Acceptable/
guideline
870.3700
Prenatal
developmental
in
rodents
(rat)
Maternal
NOAEL
=
100
mg/
kg/
day
LOAEL
=
300
mg/
kg/
day,
based
on
dose­
related
decreased
body
weight
gains
during
the
dosing
interval.
Developmental
NOAEL
>
1,000
mg/
kg/
day
(HDT)
LOAEL
=
not
identified
Acceptable/
guideline
870.3700
Prenatal
developmental
in
nonrodents
(rabbit)
Maternal
NOAEL
=
25
mg/
kg/
day
LOAEL
=
70
mg/
kg/
day,
based
on
evidence
of
hepatotoxicity
increased
glutamate
dehydrogenase
(GLDH)
and
triglyceride
levels
and
gross
and
microscopic
liver
pathology)
and
decreased
food
consumption
and
equivocal
decreases
in
body
weight
gain.
Developmental
NOAEL
=
25
mg/
kg/
day
LOAEL=
70
mg/
kg/
day,
based
on
increased
malformations
(arthrogryposis
of
front
extremities
and
small
orbital
cavity/
folded
retina)
and
variations
(floating
rib
and
accelerated
ossification).
Acceptable/
guideline
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Vol.
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186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY—
Continued
Guideline
No.
Study
Type
Results
870.3800
2­
Generation
reproduction
and
fertility
effects
(rat)
Parental/
systemic
NOAEL
=
7.9–
10.5
mg/
kg/
day
LOAEL
=
57.5–
78.0
mg/
kg/
day,
based
on
decreased
body
weights,
body
weight
gains,
and
liver
weights
in
the
P
females
Reproductive
NOAEL
=
7.9–
10.5
mg/
kg/
day
LOAEL
=
57.5–
78.0
mg/
kg/
day,
based
on
reduced
litter
size
Offspring
NOAEL
=
7.9–
10.5
mg/
kg/
day
LOAEL
=
57.5–
78.0
mg/
kg/
day,
based
on
decreased
pup
weights,
increased
pup
deaths
and
related
pup
viability
indices
Acceptable/
guideline
870.3800
2­
Generation
reproduction
and
fertility
effects
(rat)
Parental/
systemic
NOAEL
not
established
LOAEL
=
15.9–
21.5
mg/
kg/
day,
based
on
hardened
crania
of
P
generation
animals
Reproductive
NOAEL
not
established
LOAEL
=
15.9–
21.5
mg/
kg/
day,
based
on
increased
clinical
signs
of
toxicity
Offspring
NOAEL
>
15.9–
21.5
mg/
kg/
day
(HDT)
LOAEL
not
established
Unacceptable/
guideline
870.3800
2­
Generation
reproduction
and
fertility
effects
(rat)
Parental/
Systemic
NOAEL
=
20.1–
26.3
mg/
kg/
day
LOAEL
=
83.4–
109.5
mg/
kg/
day,
based
on
decreased
body
weights
and
body
weight
gains
Reproductive
NOAEL
=
83.4
­
109.5
mg/
kg/
day
LOAEL
=
335.6–
492.4
mg/
kg/
day,
based
on
decreased
mean
litter
size
Offspring
NOAEL
=
20.1–
26.3
mg/
kg/
day
LOAEL
=
83.4–
109.5
mg/
kg/
day,
based
on
decreased
pup
weights
Acceptable/
guideline
870.3800
2­
Generation
reproduction
and
fertility
effects
(rat)
Parental/
Systemic
NOAEL
=
75
mg/
kg/
day
LOAEL
=
375
mg/
kg/
day,
based
on
decreased
body
weights
and
body
weight
gains
for
both
generations
Reproductive
NOAEL
>
375
mg/
kg/
day
(HDT)
LOAEL
not
established
Offspring
NOAEL
=
75
mg/
kg/
day
LOAEL
=
375
mg/
kg/
day,
based
on
decreased
survival
and
reduced
body
weights
during
lactation
Acceptable/
guideline
870.4300
Combined
chronic
toxicity/
carcinogenicity
rodents
(rat)
NOAEL
=
18.1/
21.1
mg/
kg/
day
(M/
F)
LOAEL
=
90.1/
105.2
mg/
kg/
day
(M/
F),
based
on
skeletal
changes
Evidence
of
thyroid
follicular
cell
adenomas
and/
or
carcinomas
in
high­
dose
males
and
females
Acceptable/
guideline
870.4300
Combined
chronic
toxicity/
carcinogenicity
rodents
(rat)
NOAEL
=
20/
20
mg/
kg/
day
(M/
F)
LOAEL
=
80/
110
mg/
kg/
day
(M/
F),
based
on
bone
hyperostosis
in
males
and
females
Evidence
of
thyroid
follicular
cell
adenomas
and/
or
carcinomas
in
high­
dose
males
and
females
Acceptable/
guideline
870.4200
Carcinogenicity
rodents
(mouse)
NOAEL
=
76.3/
123.9
mg/
kg/
day
(M/
F)
LOAEL
=
375.8/
610.8
mg/
kg/
day
(M/
F),
based
on
skeletal,
liver,
and
kidney
changes
No
evidence
of
carcinogenicity
Acceptable/
guideline
870.4100
Chronic
toxicity
(dog)
NOAEL
=
12.5
mg/
kg/
day
LOAEL
=
62.5
mg/
kg/
day
(M),
based
on
decreased
body
weight
gains
Acceptable/
guideline
870.5100
Technical
Bacterial
gene
mutation
assay
Tolylfluanid
was
cytotoxic
to
all
strains
at
 
8
µ
g/
plate
±
S9
and
precipitated
from
solutions
in
all
strains
at
5,000
µ
g/
plate
±
S9.
There
were
no
reproducible,
dose­
related
differences
in
the
number
of
revertant
colonies
in
any
strain
or
dose
over
the
background
Positive
controls
induced
appropriate
response.
Acceptable/
guideline
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25,
2002
/
Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY—
Continued
Guideline
No.
Study
Type
Results
870.5100
Metabolite—
WAK
5815
Bacterial
gene
mutation
assay
There
was
no
evidence
of
toxicity
or
significant
increase
in
mutant
colonies
over
background
in
any
of
strains
tested
in
either
the
initial
or
repeat
mutagenicity
assays.
Positive
controls
induced
appropriate
response.
Acceptable/
guideline
870.5100
Metabolite—
WAK
6550
Bacterial
gene
mutation
assay
There
were
no
reproducible,
dose­
related
differences
in
the
number
of
revertant
colonies
in
any
strain
or
dose
over
the
background
Positive
controls
induced
appropriate
response.
Acceptable/
guideline
870.5100
Metabolite—
WAK
6676
Bacterial
gene
mutation
assay
There
was
no
evidence
of
toxicity
or
significant
increase
in
the
mutant
colonies
over
background
in
any
strain
tested.
Positive
controls
induced
the
appropriate
responses
in
the
corresponding
strains
and
in
the
solvent
controls
were
consistent
with
the
expected
ranges
of
revertant
colonies
for
the
strains
used.
Acceptable/
guideline
870.5100
Metabolite—
WAK
6698
Bacterial
gene
mutation
assay
Metabolite
was
cytotoxic
at
doses
 
158
µ
g/
plate
in
the
initial
assay
and
1,581
µ
g/
plate
in
the
repeat
assay.
There
was
no
evidence
of
a
significant
increase
in
mutant
colonies
over
background
in
any
strains
tested
in
the
initial
or
repeat
mutagenicity
assays.
Positive
controls
induced
appropriate
response.
Acceptable/
guideline
870.5100
Technical
Bacterial
gene
mutation
assay
Tolylfluanid
was
tested
to
cytotoxic
concentrations.
Tolylfluanid
showed
no
evidence
of
inducing
methionine
revertants
in
Saccharomyces
cerevisiae
strains
±
S9.
However,
one
of
the
tests
(S211
)
was
inadequate
or
inconsistent.
Further,
in
the
S9
activated
assays,
the
positive
controls
did
not
elicit
an
adequate
response
negating
the
test
with
S9
for
both
strains.
Unacceptable/
guideline
870.5300
Metabolite—
WAK
6698
In
vitro
mammalian
cell
gene
mutation
assay
The
compound
was
tested
up
to
cytotoxic
concentrations
in
two
independent
assays
(
S9).
In
the
initial
test
concentrations
ranged
from
50
to
1,000
µ
g/
mL
±
S9.
In
the
repeat
assay
concentrations
ranged
from
100
to
800
µ
g/
mL
­S9
and
200
to
700
µ
g/
mL
+
S9.
Tolylfluanid
metabolite
was
negative
for
inducing
forward
mutations
at
the
TK
locus
in
mouse
L5178Y
±
S9.
Positive
control
methyl
methanosulfonate
and
3­
methylcholanthrene
induced
appropriate
responses.
Acceptable/
guideline
870.5300
Technical
In
vitro
mammalian
cell
gene
mutation
assay
These
dose
levels
were
selected
based
on
a
preliminary
cytotoxicity
study
conducted
at
0.5
to
250
µ
g/
mL
±
S9.
Tolylfluanid
has
been
judged
to
be
non­
mutagenic
±
S9.
Positive
controls
induced
appropriate
response
±
S9.
Acceptable/
guideline
870.5300
Technical
In
vitro
mammalian
cell
gene
mutation
assay
Cultures
were
tested
to
cytotoxic
concentrations.
Tolylfluanid
has
been
judged
to
be
non­
mutagenic
±
S9.
Positive
controls
induced
appropriate
response
±
S9.
Acceptable/
guideline
870.5300
Technical
In
vitro
mammalian
cell
gene
mutation
assay
The
compound
was
tested
up
to
cytotoxic
concentrations
(
S9).
Tolylfluanid
was
positive
for
inducing
forward
mutations
at
the
TK
locus
in
mouse
L5178Y
±
S9.
Positive
control
ethylmethane
sulfonate
and
3­
methylcholanthrene
induced
appropriate
responses
Colony
sizing
was
not
performed.
Acceptable/
guideline
Non­
Guideline
Technical
Mouse
spot
test
F1
pups
from
female
C57B1/
6J
mice
exposed
by
oral
gavage
to
tolylfluanid
(98.4%)
at
concentration
of
0;
1,750;
3,500;
and
7,000
mg/
kg
did
not
show
difference
in
incidence
in
relative
spots
between
the
treated
and
controls.
Systemic
toxicity
was
observed
in
dams
at
all
doses.
Mortality
was
observed
at
all
doses;
however
treatment
did
not
affect
reproductive
parameters
nor
there
was
difference
in
litter
size.
Positive
controls
showed
a
clear
increase
in
spots
in
the
progeny.
Acceptable/
non­
guideline
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186
/
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25,
2002
/
Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY—
Continued
Guideline
No.
Study
Type
Results
870.5375
Technical
In
vitro
mammalian
cell
gene
mutation
assay
The
test
was
conducted
up
to
cytotoxic
levels
±
S9.
Tolylfluanid
was
weakly
clastogenic
in
Chinese
hamster
V79
cells
in
the
presence
of
S9
activation.
Positive
control
mitomycin
and
cyclophosphamide
induced
appropriate
responses.
Acceptable/
guideline
870.5375
Technical
In
vitro
mammalian
cell
gene
mutation
assay
Cytotoxicity
was
observed
at
concentrations
1
to
10
µ
g/
milliliter
(mL)
­S9
and
5
to
10
µ
g/
mL
+S9.
Over
the
ranges
tested
clastogenic
effects
included
increased
incidences
of
metaphases
with
aberrations
including
gaps,
metaphases
excluding
gaps,
metaphases
with
exchanges,
and
metaphases
with
polyploidy
were
observed.
Tolyfluanid
is
clastogenic
both
in
the
presence
and
in
the
absence
of
S9
activation.
Positive
control
mitomycin
and
endoxan
induced
appropriate
responses.
Acceptable/
guideline
870.5380
Technical
In
vitro
mammalian
spermatogonia
chromosomal
aberration
test
No
mortality
or
clinical
signs
were
observed
at
either
dose.
No
statistically
significant
increases
in
the
frequency
of
chromosomal
aberrations
in
spermatogonia
were
observed.
Unacceptable/
guideline
870.5380
Technical
In
vitro
mammalian
spermatogonia
chromosomal
aberration
test
Clinical
signs
of
toxicity
and
cytotoxicity
to
target
cells
were
seen
at
5,000
mg/
kg/
day.
Tolylfluanid
did
not
induce
chromosomal
aberrations
in
spermatogonia
at
any
dose.
Positive
controls
did
not
produce
strong
positive
results.
Therefore,
sensitivity
of
assay
is
questionable
and
the
findings
of
the
study
are
equivocal.
Unacceptable/
guideline
870.5385
Technical
Mammalian
bone
marrow
chromosomal
aberration
test
3/
10
animals
died
but
exhibited
no
clinical
signs.
No
cytotoxicity
was
observed
at
the
dose
tested.
Positive
controls
induced
appropriate
response.
Inadequate
sampling
time
and
no
indication
of
test
material
present
at
target
site;
therefore,
data
not
valid
for
regulatory
purposes.
Unacceptable/
guideline
870.5385
Technical
Mammalian
bone
marrow
chromosomal
aberration
test
3/
10
of
10
animals
died
but
no
clinical
signs
of
toxicity
were
observed
at
the
dose
tested.
Test
results
were
erratic.
Positive
controls
induced
appropriate
response.
Inadequate
study
since
test
samples
were
not
analyzed
and
doses
were
not
high
enough
to
produce
toxicity.
Unacceptable/
guideline
870.5395
Technical
Mammalian
erythrocyte
micronucleus
assay
No
clinical
signs
of
toxicity
was
observed
and
was
not
toxic
to
the
target
tissue.
Treatment
with
tolylfluanid
did
not
induce
micronucleated
polychromatic
erythrocytes.
Inadequate
methods
and
methodology.
Unacceptable/
guideline
870.5450
Technical
Dominant
lethal
assay
(mice)
Did
not
induce
variations
in
any
dominant
lethal
parameters
nor
any
reduced
fertility.
Inadequate
study.
No
positive
control
data
Unacceptable
but
upgradable
with
receipt
of
positive
control
data
870.5915
Technical
In
vivo
sister
chromatid
exchange
assay
Mortality
at
500
mg/
kg
and
above.
Tolylfluanid
did
not
induce
sister
chromatid
exchange
at
any
dose
level.
Positive
control
cyclophosphamide
responded
appropriately.
Acceptable/
guideline
870.5500
Technical
Other
genotoxic
effects
unscheduled
DNA
synthesis
(UDS)
in
mammalian
cells
Tolylfluanid
did
not
induce
UDS
up
to
15.0
µ
g/
mL.
The
17.5
and
20
µ
g/
mL
doses
were
highly
toxic.
The
positive
control
2­
acetylaminofluorene
responded
appropriately.
Acceptable/
guideline
870.6200
Acute
neurotoxicity
screening
battery
(rat)
NOAEL
=
50
mg/
kg
in
females
LOAEL
=
150
mg/
kg/
day
based
on
functional
observation
battery
(FOB)
effects
and
decreased
motor
and
locomotor
activity
in
females
NOAEL
=
2,000
mg/
kg/
day
(M)—
limit
dose
LOAEL
=
not
established
(M)
Acceptable/
guideline
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186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY—
Continued
Guideline
No.
Study
Type
Results
870.6200
Subchronic
neurotoxicity
screening
battery
(rat)
NOAEL
=
25
mg/
kg
(F)
LOAEL
=
134
mg/
kg
based
on
decreased
mean
body
weights
in
females.
No
treatment­
related
neurotoxicological
effects
were
observed
at
any
treatment
level.
Acceptable/
guideline
870.7485
Metabolism
and
pharmacokinetics
(rat)
In
a
metabolism
study
in
rats,
tolylfluanid
was
administered
in
single
doses
of
2
or
100
mg/
kg
of
body
weight,
was
readily
absorbed
and
rapidly
hydrolyzed
within
48
hours.
Absorption
and
excretion
were
independent
of
dose,
sex,
and
pretreatment.
About
86–
100%
of
the
dose
was
recovered
in
48
hours,
with
56–
80%
of
the
dose
being
excreted
in
urine,
12–
36%
in
the
feces,
and
 
0.48%
found
in
the
carcass.
Urinary
metabolite
common
to
both
sexes
were
dimethylaminosulfonylamino­
benzoic
acid
(RNH
0166;
46–
78%),
and
4­
methylamino­
benzoic
acid
(RNH
0416;
3–
6%).
Fecal
compounds
identified
were
unchanged
tolylfluanid
(1–
19%),
dimethylaminosulfotoluidid
(DMST;
5–
8%),
RNH
0166
(3–
12%),
and
RNH
0416
(
1%).
The
data
indicate
that
tolylfluanid
hydrolyzed
to
DMST,
which
is
then
transformed
to
the
major
metabolite
RNH
0166,
which
can
be
further
demethylated
to
the
minor
metabolite,
RNH
0416
(MRID
No.
44285805).
Acceptable/
guideline
870.7485
Metabolism
and
pharmacokinetics
(rat)
Series
of
metabolism
studies
showed
that
metabolic
profile
dependent
upon
label
position.
With
[dichlorofluoromethyl­
14
C]
tolylfluanid
labeling
major
urinary
metabolite
was
thiazolidine­
2­
thione­
4carbonic
acid
resulting
from
cleavage
of
the
side
chain
and
accounted
for
73–
74%
and
50–
63%,
respectively
by
IV
and
oral
routes.
Benzene
ring
label
resulted
in
metabolite
4­
(dimethylamino­
sulfonylamino)
benzoic
acid
which
accounted
for
90%
of
urinary
metabolic
activity
and
70%
of
fecal
radioactivity.
The
study
with
single
oral
dose
of
2
or
20
mg/
kg/
day
also
supported
the
results
of
the
main
study
(MRID
No.
44285805).

Non­
guideline
Non­
guideline
(rat)
thyroid
function
Thyroid­
stimulating
hormone
levels
significantly
increased
(168–
425%)
in
high­
dose
males
and
females.
Slightly
increased
T3
levels
in
males
rats
above
119.3
mg/
kg/
day
Acceptable/
nonguideline
Metabolite
Non­
guideline
(mice)
In
vitro
investigation
of
TTCA
goitrogenic
properties
Tolylfluanid's
metabolite
TTCA
was
shown
to
reversibly
inhibit
thyroid
peroxidase
(TPO)­
mediated
reactions
involved
with
the
initial
stages
of
thyroid
hormone
synthesis.
This
was
shown
by
the
dose­
dependent
decrease
in
formation
of
reactive
iodine;
the
interference
of
the
nonenzymatic
and
TPO­
mediated
iodination
of
L­
tyrosine,
and
by
TPO­
mediated
metabolism
of
TTCA.
In
the
latter
reaction,
TTCA
did
not
interfere
with
tyrosine
iodination
when
the
concentration
in
the
reaction
mixture
fell
below
a
certain
concentration.
Therefore,
TTCA,
unlike
tolylfluanid,
behaves
as
a
goitrogenic
compound
with
a
potency
approximately
equal
to
propylthiouracil
(PTU),
a
known
thionamide
inhibitor
of
initial
thyroid
hormone
synthesis.
Acceptable/
nonguideline
Non­
guideline
Non­
guideline
(rat)
32
P—
post­
labelling
assay
In
a
32
P—
post­
labelling
assay
for
detection
of
adduct
formation
in
lung,
thyroid,
and
liver
DNA
in
rats
revealed
that
there
was
no
evidence
of
DNA
adduct
formation
in
the
liver,
lung,
or
thyroid
of
rats
exposed
to
tolylfluanid.
Positive
control
2­
acetylaminofluorene
(2­
AAF)
(liver,
lung,
and
thyroid
DNA
adducts),
benzidine
(lung
DNA
adducts),
2­
Thiourea
(lung
and
thyroid
DNA
adducts),
and
dibenz[
a,
h]
anthracene
(DBA)
(DNA
adducts
in
the
lungs)
produced
appropriate
results.
Acceptable/
nonguideline
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
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/
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25,
2002
/
Rules
and
Regulations
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
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
factor
(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.
In
this
case
because
it
is
an
import
tolerance
only,
there
is
only
dietary
risk.
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
tolylfluanid
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.—
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
TOLYLFLUANID
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
females
13–
50
years
of
age
NOAEL
=
25
UF
1
=
300
Acute
RfD
=
aPAD
=
0.083
mg/
kg/
day
1x
Prenatal
developmental
toxicity/
rabbit
LOAEL
=
70
mg/
kg/
day
based
on
increased
malformations
(arthrogryposis
of
front
extremities
and
small
orbital
cavity/
folded
retina)
and
variations
(floating
ribs
and
accelerated
ossification).

Acute
dietary
general
population
including
infants
and
children
NOAEL
=
50
UF
1
=
300
Acute
RfD
=
aPAD
=
0.17
mg/
kg/
day
1x
Acute
oral
neurotoxicity/
rat
LOAEL
=
150
mg/
kg/
day
based
on
FOB
effects
(pilorection,
decreased
activity,
gait
abnormalities,
decreased
body
temperature,
and/
or
decreased
rearing).

Chronic
dietary
all
populations
NOAEL=
7.9
UF
1
=
300
Chronic
RfD
=
cPAD
=
0.026
mg/
kg/
day
1x
2­
Generation
reproduction/
rat
LOAEL
=
57.5
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
and
liver
weights.

Cancer
Classification:
``
Likely
to
be
carcinogenic
to
humans''
by
the
oral
route,
based
on
thyroid
tumors
in
high­
dose
male
and
female
rats.
The
FQPA
SF
Committee
further
recommended
a
linear
low­
dose
extrapolation
approach
for
the
quantification
of
human
cancer
risk
based
on
the
thyroid
tumors
in
rats.
Q1*
=
1.59
x
10
­3
based
upon
male
rat
thyroid
adenomas
and/
or
carcinomas
combined.

1
UF
(uncertainty
factor),
FQPA
Safety
Factor
(SF),
no­
observed­
adverse­
effect­
level
(NOAEL),
lowest­
observed­
adverse­
effect­
level
(LOAEL),
acute
Population
Adjusted
Dose
(aPAD),
chronic
Population
Adjusted
Dose
(cPAD),
reference
dose
(RfD).
*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
This
activity
reflects
the
establishment
of
the
first
U.
S.
import
tolerance
for
tolylfluanid
on
apple,
grape,
hop,
and
tomato
without
a
U.
S.
registration.
Since
there
are
no
other
food
or
feed
uses
in
the
United
States,
the
only
exposure
to
occur
is
dietary.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
tolylfluanid
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(DEEM
TM
7.76)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
United
States
Department
of
Agriculture
(USDA)
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
acute
Tier
2
(partially
refined
analysis)
exposure
assessments:
An
aPAD
of
0.083
mg/
kg/
day
was
used
for
females
between
13
and
50
years
of
age
based
on
developmental
toxicity
in
rabbits.
An
aPAD
of
0.17
was
used
for
the
general
U.
S.
population
(including
infants
and
children)
based
on
acute
neurotoxicity
in
rats.
Anticipated
residues
were
calculated
based
upon
submitted
field
trial
and
livestock
metabolism
data
for
all
proposed
uses
of
tolylfluanid.
The
resulting
acute
dietary
exposure
estimates
do
not
exceed
EPA's
level
of
concern
(
100%
aPAD)
at
the
95
th
exposure
percentile
for
females
13–
50
years
old
(42%
aPAD),
the
general
U.
S.
population
(31%
of
the
aPAD)
and
all
other
population
subgroups.
The
most
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highly
exposed
population
subgroup
is
infants
(
1
year
old,
at
100%
of
the
aPAD).

TABLE
3.—
ACUTE
DIETARY
EXPOSURE
TO
TOLYLFLUANID
Population
Subgroup
Acute
Dietary
1
Dietary
Exposure
(mg/
kg/
day)
%
aPAD
U.
S.
Population
(total)
0.051973
31
All
Infants
(
1
year
old)
0.169772
100
Children
1–
6
years
old
0.159553
94
Children
7–
12
years
old
0.063237
37
Females
13–
50
years
old
0.034529
20
Males
13–
19
years
old
0.023476
14
Males
20+
years
old
0.030744
18
Seniors
55+
years
old
0.033375
20
1
Acute
dietary
endpoint
of
0.083
mg/
kg/
day
applies
to
females
13–
50
years
old
only;
acute
dietary
endpoint
of
0.17
mg/
kg/
day
applies
to
the
general
U.
S.
population
(including
infants
and
children).

The
assessment
of
acute
dietary
exposure
used
the
following
conservative
assumptions
likely
to
generate
upper­
end
estimates
of
the
quantity
of
tolylfluanid
and
tolylfluanid
residues
ingested:
 
No
import
consumption
data
were
used
in
the
assessment
(i.
e.,
the
assessment
assumes
that
all
acute
dietary
exposure
from
the
proposed
commodities
is
from
imported
commodities).
 
100%
crop
treated
(CT)
was
assumed
for
these
imported
commodities:
All
imported
grape,
apple,
hop,
and
tomato
were
assumed
to
have
been
treated
with
tolylfluanid
and
to
have
tolylfluanid
residues
at
the
level
of
the
tolerance.
Inclusion
of
additional
data,
such
as
%CT/
import
consumption
data
and/
or
monitoring
data
(including
metabolites
of
concern),
could
be
made
in
order
to
refine
the
acute
dietary
exposure
assessment.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
DEEM
TM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989–
1992
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
A
cPAD
of
0.026
mg/
kg/
day
was
used
based
on
the
2­
generation
rat
reproduction
study.
All
dietary
exposure
from
the
proposed
commodities
is
from
imported
commodities.
Import
share
data
generated
within
the
Agency
were
used
in
the
assessment
to
estimate
what
proportion
of
the
grape,
apple,
hop,
and
tomato
consumed
in
the
United
States
are
imported.
Modified
DEEM
TM
processing
factors
based
on
the
results
of
processing
studies
were
used
for
raisins
and
apple
and
grape
juice/
juice
concentrates.
Default
DEEM
TM
processing
factors
were
used
for
all
other
processed
commodities.
Anticipated
residues
calculations
were
used
based
upon
submitted
field
trial
and
livestock
metabolism
data.

TABLE
4.—
CHRONIC
EXPOSURE
TO
TOLYLFLUANID
Population
Subgroup
Chronic
Dietary
1
Dietary
Exposure
(mg/
kg/
day)
%
aPAD
U.
S.
Population
(total)
0.000780
3
All
Infants
(
1
year
old)
0.003397
13
Children
1–
6
years
old
0.003638
14
Children
7–
12
years
old
0.001029
4
Females
13–
50
years
old
0.000399
2
Males
13–
19
years
old
0.000342
1
Males
20+
years
old
0.000340
1
Seniors
55+
years
old
0.000333
1
1
Chronic
dietary
endpoint
of
0.026
mg/
kg/
day
applies
to
general
U.
S.
population
and
all
population
subgroups.

The
assessment
of
chronic
dietary
exposure
for
the
general
U.
S.
population
and
all
population
subgroups
(including
infants
and
children)
used
the
following
conservative
assumptions
to
generate
upper­
end
estimates
of
the
quantity
of
tolylfluanid
and
tolylfluanid
residues
ingested:
 
100%
CT
was
assumed
for
these
imported
commodities:
All
imported
grape,
apple,
hop,
and
tomato
were
assumed
to
have
been
treated
with
tolylfluanid
and
to
have
tolylfluanid
residues
at
the
level
of
the
tolerance.
 
The
calculated
ARs
(parent
and
additional
metabolites
of
concern
not
in
tolerance
expression)
are
based
on
field
trial
data,
submitted
by
the
registrant
to
support
tolerances.
Field
trial
residue
data
are
generally
considered
by
the
Agency
as
an
upper­
end
or
a
worst
case
scenario
of
possible
residues
and
are
more
suited
to
the
requirements
of
tolerance
setting,
because
it
requires
highest
rates
of
application
and
shortest
PHI,
than
to
the
requirements
of
dietary
exposure
assessment
(when
a
more
realistic
estimate
is
desired).
The
chronic
dietary
exposure
estimates
do
not
exceed
EPA's
level
of
concern
(
100%
cPAD)
for
the
general
U.
S.
population
(3%
cPAD)
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
is
children
1–
6
years
old
at
14%
of
the
cPAD.
iii.
Cancer.
A
partially
refined,
cancer
dietary
exposure
assessment
was
conducted
for
the
general
U.
S.
population
using
the
same
assumptions
as
were
used
in
the
chronic
risk
assessment
(listed
in
the
preceding
section).
Import
share
data
generated
within
the
Agency
were
used
in
the
assessment
to
estimate
what
proportion
of
the
grape,
apple,
hop,
and
tomato
consumed
in
the
United
States
are
imported.
Modified
DEEM
TM
processing
factors
based
on
the
results
of
processing
studies
were
used
for
raisins
and
apple
and
grape
juice/
juice
concentrates.
Default
DEEM
TM
processing
factors
were
used
for
all
other
processed
commodities
The
cancer
risk
estimate
is
1.2
x
10
­6
for
the
general
U.
S.
population.
For
cancer
dietary
risk
estimates,
the
Agency
is
generally
concerned
with
cancer
risks
that
exceed
the
range
of
1
x
10
­6
.
The
following
conservative
assumptions
were
used
in
the
cancer
dietary
exposure
assessment:
 
The
percent
import
consumption
information
used
for
apple,
grape
and
tomato
commodities
assume
that
100%
of
these
imported
commodities
are
treated
with
tolylfluanid.
 
The
calculated
ARs
are
based
on
field
trial
data,
submitted
by
the
registrant
to
support
tolerances.
Field
trial
residue
data
are
generally
considered
by
the
Agency
as
providing
an
upper­
end
scenario
of
possible
residues
and
are
more
suited
to
the
requirements
of
tolerance
setting,
because
it
requires
highest
rates
of
application
and
shortest
PHI,
than
to
the
requirements
of
dietary
exposure
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25,
2002
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Rules
and
Regulations
assessment
(when
a
more
realistic
estimate
is
desired).
With
additional
refinements
to
the
dietary
exposure
assessment
(i.
e.,
country­
specific
percent
import
consumption
data
and/
or
monitoring
data
(including
metabolites
of
concern)
the
Agency
expects
the
estimated
cancer
risk
to
be
significantly
lower.
iv.
Anticipated
residue
and
%CT.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
Adequate
reliable
information
was
not
available
on
the
fraction
of
imported
grape,
apple,
hop,
and
tomato
which
were
treated
with
tolylfluanid,
therefore
the
Agency
assumed
that
all
these
commodities
were
treated
(100%
CT).
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
As
required
by
section
408(
b)(
2)(
E)
of
the
FFDCA,
EPA
will
issue
a
data
call­
in
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
Section
408(
b)(
2)(
F)
of
the
FFDCA
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
%CT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
%CT.
The
Agency
used
%CT
information
as
follows:
Since
the
tolerances
being
established
are
for
imported
commodities
only
and
a
petition
for
domestic
use
of
tolyfluanid
is
not
currently
pending
with
EPA,
the
Agency
analyzed
the
amount
of
imported
apple,
grape,
hop,
and
tomato,
relative
to
domestic
production,
and
derived
a
``
percent
crop
imported''
figure
for
each
commodity.
The
Agency
based
this
analysis
on
import
and
domestic
production
data
available
from
the
USDA
for
the
years
1995
through
1999.
The
proportion
of
imports
relative
to
domestic
production
for
each
of
the
commodities
are
as
follows:
Fresh
apple—
5.6%;
apple
juice—
56.4%;
canned
apple—
0.1%;
fresh
grape—
0.2%,
grape
juice—
43.4%;
fresh
tomato—
16.4%;
and
processed
tomato—
4.1%.
The
Agency's
analysis
assumed
100%
for
hop.
Tolylfluanid
is
currently
only
registered
for
use
in
a
small
number
of
European
countries,
however,
the
estimates
stated
in
this
unit
reflect
total
imports
of
these
commodities
into
the
United
States,
not
just
imports
from
Europe.
Therefore,
the
values
used
in
the
Agency's
risk
assessment
assume
that
all
imported
commodities
contain
residues
of
tolyfluanid.
These
assumptions
fulfill
Condition
1
by
overestimating
the
portion
of
imported
apple,
grape,
hop,
and
tomato
with
tolylfluanid
residues.
As
to
Conditions
2
and
3,
regional
consumption
information
and
consumption
information
for
significant
subpopulations
is
taken
into
account
through
EPA's
computer­
based
model
for
evaluating
the
exposure
of
significant
subpopulations
including
several
regional
groups.
Use
of
this
consumption
information
in
EPA's
risk
assessment
process
ensures
that
EPA's
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group
and
allows
the
Agency
to
be
reasonably
certain
that
no
regional
population
is
exposed
to
residue
levels
higher
than
those
estimated
by
the
Agency.
2.
Dietary
exposure
from
drinking
water.
Residues
in
drinking
water
are
not
expected
to
result
as
a
consequence
of
establishing
an
import
tolerance
for
tolylfluanid
residues
in
or
on
apple,
grape,
hop,
and
tomato.
Tolylfluanid
is
not
registered
for
use
in
the
United
States.
Therefore,
exposure
through
drinking
water
is
unlikely.
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).
Tolylfluanid
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.
''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
tolylfluanid
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,
tolylfluanid
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
tolylfluanid
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
the
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
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
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
following
in
utero
exposure
in
the
prenatal
developmental
study
in
rats.
Although
there
is
qualitative
evidence
of
increased
susceptibility
in
the
prenatal
developmental
study
in
rabbits
and
in
the
2­
generation
reproduction
study
in
rats,
the
Agency
did
not
identify
any
residual
uncertainties
after
establishing
toxicity
endpoints
and
traditional
UFs
to
be
used
in
the
risk
assessment
of
tolylfluanid.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
tolylfluanid
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
RfDs
established
are
protective
of
pre­/
post­
natal
toxicity
following
acute
and
chronic
exposures.
The
Agency
therefore
concluded
that
no
Special
FQPA
FS
is
necessary
to
protect
the
safety
of
infants
and
children
in
assessing
tolylfluanid
exposure
and
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risks.
However,
a
FQPA
factor
in
the
form
of
data
base
UF
(UFDB)
of
3x
was
applied
to
the
acute
RfDs
and
chronic
RfDs
to
account
for
the
comparative
thyroid
assay
(adult
versus
young
animals)
data
requirement.
3X
is
adequate
in
this
case
since
the
observed
thyroid
hormone
changes
that
necessitated
the
additional
study
occurred
at
a
dose
level
more
than
three­
fold
higher
than
the
dose
levels
(based
on
developmental
and
reproductive
toxicity)
used
as
the
basis
for
endpoints
for
risk
assessment.
Thus,
use
of
an
additional
3X
FQPA
SF
will
provide
at
least
a
10X
margin
of
safety
regarding
the
effects
for
which
there
is
some
uncertainty
and
for
which
additional
data
is
required.

TABLE
5.—
ADDITIONAL
FQPA
SAFETY
FACTOR
LOAEL
to
NOAEL
(UFL)
Subchronic
to
Chronic
(UFS)
Incomplete
Data
base
(UFDB)
Special
FQPA
Safety
Factor
(Hazard
and
Exposure)

Magnitude
of
factor
1X
1X
3X
1X
Rationale
for
the
factor
No
LOAEL
to
NOAEL
extrapolations
performed
No
subchronic
to
chronic
extrapolations
performed
Lack
of
comparative
thyroid
assay
(adult
versus
young
animals
No
residual
uncertainties
regarding
pre­
or
post­
natal
toxicity
or
completeness
of
the
toxicity
or
exposure
data
bases
Endpoints
to
which
the
factor
is
applied
Not
applicable
(NA)
NA
All
dietary
exposure
scenarios
NA
E.
Aggregate
Risks
and
Determination
of
Safety
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
tolylfluanid
will
occupy
31%
of
the
aPAD
for
the
U.
S.
population,
20%
of
the
aPAD
for
females
13
years
and
older,
100%
of
the
aPAD
for
infants
<
1year
old,
and
94%
of
the
aPAD
for
children
between
7
and
12
years
old.
In
addition,
there
is
no
potential
for
acute
dietary
exposure
to
tolylfluanid
in
drinking
water.
Although
this
risk
assessment
projects
that
infants
under
1
year
of
age
will
receive
the
maximum
safe
exposure,
for
the
reasons
detailed
in
this
unit,
this
assessment
is
likely
to
substantially
overstate
risk.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
tolylfluanid
from
food
will
utilize
3%
of
the
cPAD
for
the
U.
S.
population,
13%
of
the
cPAD
for
infants
<
1
year
old,
and
14%
of
the
cPAD
for
children
between
1
and
6
years
old.
There
are
no
residential
uses
for
tolylfluanid
that
result
in
chronic
residential
exposure
to
tolylfluanid.
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).
Tolylfluanid
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
a
short­
term
aggregate
risk
was
not
performed.
4.
Intermediate­
term
risk.
Tolylfluanid
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
an
intermediateterm
aggregate
risk
was
not
performed.
5.
Aggregate
cancer
risk
for
U.
S.
population.
The
cancer
risk
estimate
for
the
general
U.
S.
population
from
tolylfluanid
is
1.2
x
10
­6
.
In
general,
the
Agency's
level
of
concern
for
cancer
exposure
is
for
risks
in
the
range
of
1
x
10
­6
and
this
risk
estimate
is
comfortably
with
this
range.
Moreover,
several
conservative
assumptions
were
included
in
the
assessment
(enumerated
in
Unit
III.
C.
1.,
Dietary
exposure
from
food
and
feed
uses).
With
additional
refinements
to
the
dietary
exposure
assessment
(i.
e.,
country­
specific
percent
import
consumption
data
and/
or
monitoring
data
(including
metabolites
of
concern),
the
Agency
expects
the
cancer
risk
to
be
substantially
lower.
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
tolylfluanid
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
For
tolylfluanid
in/
on
apple,
grape,
hop,
and
tomato,
the
submitted
independent
laboratory
validation
(ILV)
using
a
gas
chromatograph
(GC)/
thermal
ionization
detector
(TID)
procedure
designated
as
Method
00441
and
entitled
Determination
of
Tolylfluanid
in/
on
Various
Raw
Agricultural
and
Processed
Commodities
has
been
received
and
the
method
has
been
forwarded
to
the
Agency's
laboratory
for
validation.
The
petitioner
will
be
required
to
make
any
modifications
or
revisions
to
the
proposed
method
resulting
from
EPA's
validation.
The
petitioners
submitted
the
multiresidue
data
concerning
the
recovery
of
tolylfluanid
residues
using
the
Food
and
Drug
Administration
(FDA)
MRM
protocols
(PAM
Vol.
I)
and
following
modified
cleanup
procedures.
These
results
indicate
that
tolylfluanid
is
likely
to
be
recovered
through
FDA
MRM
Protocols
D
and
E.
The
results
have
been
forwarded
to
the
FDA
for
inclusion
in
the
Pesticide
Analytical
Method
Volume
I.
Prior
to
publication
and
upon
request,
the
method
will
be
available
from
the
Analytical
Chemistry
Branch
(ACB),
BEAD
(75053),
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
George
C.
Meade,
MD
20755–
5350.
Contact
Francis
D.
Griffith,
Jr.,
telephone
number:
(410)
305–
2905;
e­
mail
address:
griffith.
francis@
epa.
gov.
The
analytical
standards
are
also
available
from
the
EPA
National
Standard
Repository
at
the
same
location.
Based
on
the
proposed
uses,
a
residue
enforcement
method
for
livestock
commodities
is
not
necessary
at
this
time.

B.
International
Residue
Limits
There
are
no
Canadian
or
Mexican
MRLs
established
for
tolylfluanid
residues
in/
on
crop
commodities.
The
Codex
Alimentarius
Commission
has
established
MRLs
for
tolylfluanid
residues
in/
on
various
commodities,
including
currant
at
5
ppm,
gherkin
at
2
ppm,
lettuce
head
at
1
ppm,
pome
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fruits
at
5
ppm,
strawberry
at
3
ppm,
and
tomato
at
2
ppm.
The
Codex
MRLs
are
expressed
in
terms
of
tolylfluanid
per
se.
Although
the
submitted
residue
data
support
the
proposed
tolerance
of
1.0
ppm
on
tomato,
the
Agency
is
establishing
this
tolerance
at
2.0
ppm
in
order
to
harmonize
with
the
current
Codex
MRL.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
tolylfluanid,
(1,1­
dichloro­
N­[(
dimethylamino)­
sulfonyl]
1
fluoro­
N­(
4­
methylphenyl)
methanesulfenamide),
in
or
on
apple
at
5
ppm,
grape
at
11
ppm,
hop
at
30
ppm,
and
tomato
at
2
ppm.

VI.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
the
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP–
2002–
0216
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
November
25,
2002.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(703)
603–
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.
''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.
''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(703)
305–
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP–
2002–
0216,
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.
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
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
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and
Regulations
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(NTTAA),
Public
Law
104–
113,
section
12(
d)
(15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(RFA)
(5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.
''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.
''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers,
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.
''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.
''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

VIII.
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:
September
13,
2002.
James
Jones,
Acting
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
180.584
is
added
to
subpart
C
to
read
as
follows:

§
180.584
Tolylfluanid,
tolerances
for
residues.

(a)
General.
Tolerances
are
established
for
residues
of
tolylfluanid,
1,1­
dichloro­
N­[(
dimethylamino)
sulfonyl
1­
fluoro­
N­(
4­
methylphenyl)
methanesulfenamide
in
or
on
the
following
commodities.

Commodity
Parts
per
million
Apple
1
..................................................................................................................
5.0
Grape
1
.................................................................................................................
11
Hop
1
.....................................................................................................................
30
Tomato
1
...............................................................................................................
2.0
1
No
U.
S.
registration
as
of
August
31,
2002.

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and
Regulations
(b)
Section
18
emergency
exemptions.
[Reserved]
(c)
Tolerances
with
regional
registrations.
[Reserved]
(d)
Indirect
or
inadvertent
residues.
[Reserved]

[FR
Doc.
02–
24094
Filed
9–
24–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0234;
FRL–
7198–
3]

Fluroxypyr
1­
methylheptyl
ester;
Pesticide
Tolerances
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
time­
limited
tolerances
for
combined
residues
of
fluroxypyr
[1­
methylheptyl
ester
1­
methylheptyl
((
4­
amino­
3,5­
dichloro­
6­
fluoro­
2­
pyridinyl)
oxy)
acetate]
and
its
metabolite
fluroxypyr
[((
4­
amino­
3,5­
dichloro­
6­
fluoro­
2­
pyridinyl)
oxy)
acetic
acid]
in
or
on
sorghum,
grain
at
0.035
parts
per
million
(ppm);
sorghum,
forage
at
2.0
ppm;
and
sorghum,
grain,
stover
at
4.0
ppm.
This
action
is
in
connection
with
a
crisis
exemption
declared
by
the
state
of
Kansas
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
authorizing
use
of
the
pesticide
on
sorghum.
This
regulation
establishes
maximum
permissible
levels
for
residues
of
fluroxypyr
1­
methylheptyl
ester
and
its
metabolite,
all
expressed
as
fluroxypyr
in
these
food
commodities.
The
tolerances
will
expire
and
are
revoked
on
December
31,
2005.
DATES:
This
regulation
is
effective
September
25,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP–
2002–
0234,
must
be
received
on
or
before
November
25,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP–
2002–
0234
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Libby
Pemberton,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
308–
9364;
e­
mail
address:
sec–
18–
Mailbox@
epamail.
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
categories
and
entities
may
include,
but
are
not
limited
to:

Categories
NAICS
Codes
Examples
of
Potentially
Affected
Entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0234.
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,
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
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a,
is
establishing
tolerances
for
combined
residues
of
the
herbicide
fluroxypyr
1­
methylheptyl
ester,
[1­
methylheptyl
((
4­
amino­
3,5­
dichloro­
6­
fluoro­
2­
pyridinyl)
oxy)
acetate]
and
its
metabolite
fluroxypyr
[((
4­
amino­
3,5­
dichloro­
6­
fluoro­
2­
pyridinyl)
oxy)
acetic
acid],
in
or
on
sorghum,
grain
at
0.035
ppm;
sorghum,
forage
at
2.0
ppm;
and
sorghum,
grain,
stover
at
4.0
ppm.
These
tolerances
will
expire
and
are
revoked
on
December
31,
2005.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerances
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(the
legal
limit
for
a
pesticide
chemical
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