Document ID: EPA-HQ-OPP-2003-0181-0001
Agency: epa
Document Type: Rule
Title: Flufenacet (N-(4-fluorophenyl)-N-(1-methylethyl)-2-[[5-(trifluoromethyl)-1,3,4-thiadiazol-2-yl]oxy]acetamide; Pesticide Tolerance
Posted Date: 2003-06-25T04:00Z

37749
Federal
Register
/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Rules
and
Regulations
G.
Executive
Order
13045,
Protection
of
Children
From
Environmental
Health
Risks
and
Safety
Risks
Protection
of
Children
From
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997),
applies
to
any
rule
that:
(
1)
Is
determined
to
be
``
economically
significant''
as
defined
under
Executive
Order
12866,
and
(
2)
concerns
an
environmental
health
or
safety
risk
that
EPA
has
reason
to
believe
may
have
a
disproportionate
effect
on
children.
If
the
regulatory
action
meets
both
criteria,
the
Agency
must
evaluate
the
environmental
health
or
safety
effects
of
the
planned
rule
on
children,
and
explain
why
the
planned
regulation
is
preferable
to
other
potentially
effective
and
reasonably
feasible
alternatives
considered
by
the
Agency.
This
rule
is
not
subject
to
Executive
Order
13045
because
it
does
not
involve
decisions
intended
to
mitigate
environmental
health
or
safety
risks.

H.
Executive
Order
13211,
Actions
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
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)
because
it
is
not
a
significant
regulatory
action
under
Executive
Order
12866.

I.
National
Technology
Transfer
and
Advancement
Act
Section
12
of
the
National
Technology
Transfer
and
Advancement
Act
(
NTTAA)
of
1995
requires
Federal
agencies
to
evaluate
existing
technical
standards
when
developing
a
new
regulation.
To
comply
with
NTTAA,
EPA
must
consider
and
use
``
voluntary
consensus
standards''
(
VCS)
if
available
and
applicable
when
developing
programs
and
policies
unless
doing
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
The
EPA
believes
that
VCS
are
inapplicable
to
this
action.
Today's
action
does
not
require
the
public
to
perform
activities
conducive
to
the
use
of
VCS.

J.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
A
major
rule
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
This
rule
will
be
effective
July
25,
2003.

K.
Petitions
for
Judicial
Review
Under
section
307(
b)(
1)
of
the
Clean
Air
Act,
petitions
for
judicial
review
of
this
action
must
be
filed
in
the
United
States
Court
of
Appeals
for
the
appropriate
circuit
by
August
25,
2003.
Filing
a
petition
for
reconsideration
by
the
Administrator
of
this
final
rule
does
not
affect
the
finality
of
this
rule
for
the
purposes
of
judicial
review
nor
does
it
extend
the
time
within
which
a
petition
for
judicial
review
may
be
filed,
and
shall
not
postpone
the
effectiveness
of
such
rule
or
action.
This
action
may
not
be
challenged
later
in
proceedings
to
enforce
its
requirements.
(
See
section
307(
b)(
2).)

List
of
Subjects
in
40
CFR
Part
52
Environmental
protection,
Air
pollution
control,
Intergovernmental
relations,
New
source
review,
Nitrogen
dioxide,
Ozone,
Particulate
matter,
Reporting
and
recordkeeping
requirements,
Volatile
organic
compounds.

Dated:
July
16,
2003.
Alexis
Strauss,
Acting
Regional
Administrator,
Region
IX.
[
FR
Doc.
03
 
16028
Filed
6
 
24
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0181;
FRL
 
7313
 
9]

Flufenacet
(
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­[[
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.
SUMMARY:

This
regulation
establishes
a
tolerance
for
combined
residues
of
flufenacet
(
N­
(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­
[[
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety
in
or
on
corn,
field,
forage;
corn,
field,
grain;
corn,
field,
stover;
and
soybean,
seed;
and
for
indirect
or
inadvertent
residues
for
flufenacet
and
its
metabolites
in
or
on
alfalfa,
forage;
alfalfa,
hay;
alfalfa,
seed;
clover,
forage;
clover,
hay;
grain,
cereal,
group
15,
except
rice;
grain,
cereal,
forage,
fodder
and
straw,
group
16,
except
rice;
and
grass,
forage,
fodder,
and
hay,
group
17.
BayerCropScience
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
June
25,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0181,
must
be
received
on
or
before
August
25,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
James
A.
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5697;
email
address:
tompkins.
jim@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

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

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0181.
The
official
public
VerDate
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31>
2003
15:
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24,
2003
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Federal
Register
/
Vol.
68,
No.
122
/
Wednesday,
June
25,
2003
/
Rules
and
Regulations
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_(_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
March
20,
2003
(
68
FR
13703)
(
FRL
 
7296
 
5),
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
pesticide
petitions
(
PP
6F4631
and
0F6095)
by
BayerCropScience,
P.
O.
Box
12014,
2
T.
W.
Alexander
Drive,
Research
Triangle
Park,
NC
27709.
That
notice
included
a
summary
of
the
petitions
prepared
by
BayerCropScience,
the
registrant.
One
comment
was
received
in
response
to
this
notice
of
filing
by
B.
Sachau,
15
Elm
Str.,
Florham
Park,
NJ
07932.
Mr.
Sachau
objected
generally
to
the
presence
of
pesticides
in
food
and
specifically
to
the
presence
of
flufenacet.
Bayer
requested
in
petition
6F4631
that
40
CFR
180.527
(
a)
be
amended
by
making
the
currently
time­
limited
tolerances
for
combined
residues
of
the
herbicide
flufenacet,
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­[[
5­
(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety]
permanent
in
or
on
the
following
agricultural
commodities:
Corn,
field,
forage
at
0.4
ppm;
corn,
field,
grain
at
0.05
ppm;
corn,
field,
stover
at
0.4
ppm;
and
soybean,
seed
at
0.1
ppm.
Bayer
requested
in
petition
0F6095
that
the
section
18
tolerances
listed
below
in
40
CFR
180.527
(
b)
for
combined
residues
of
the
herbicide
flufenacet,
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­[[
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide
and
it's
metabolites
containing
4­
fluoro­
Nmethylethyl
benzenamine
moiety]
be
made
permanent
and
moved
to
40
CFR
180.527
(
a),
cattle,
fat
at
0.05
ppm;
cattle,
kidney
at
0.5
ppm;
cattle,
meat
at
0.05
ppm;
cattle,
meat
byproducts
at
0.1
ppm;
goat,
fat
at
0.05
ppm;
goat,
kidney
at
0.5
ppm;
goat,
meat
at
0.05
ppm;
goat,
meat
byproducts
at
0.1
ppm;
hog,
fat
at
0.05
ppm;
hog,
kidney
at
0.5
ppm;
hog,
meat
at
0.05
ppm;
hog,
meat,
byproducts
at
0.1
ppm;
horse,
fat
at
0.05
ppm;
horse,
kidney
at
0.5
ppm;
horse,
meat
at
0.05
ppm;
horse,
meat
byproducts
at
0.1
ppm;
sheep,
fat
at
0.05
ppm;
sheep,
kidney
at
0.5
ppm;
sheep,
meat
at
0.05
ppm;
sheep,
meat
byproducts
at
0.1
ppm;
wheat,
forage
at
10.0
ppm;
wheat,
grain
at
1.0
ppm;
wheat,
hay
at
2.0
ppm;
and
wheat,
straw
at
0.50
ppm.
Bayer
requested
in
petition
0F6095
that
the
currently
time
limited
tolerances
in
40
CFR
180.527
(
d)
be
amended
by
establishing
permanent
tolerances
for
indirect
or
inadvertent
residues
of
the
herbicide
flufenacet;
N­
(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­
[[
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety
in
or
on
the
following
raw
agricultural
commodities
from
the
application
of
this
herbicide
to
the
raw
agricultural
commodities
listed
in
40
CFR
180.527
(
a)
and
(
b)
at
the
levels
listed
below
Table
1:
TABLE
1.
 
TOLERANCE
LEVELS
Commodity
Current
level
in
Parts
per
Million
Level
in
Parts
per
Million
proposed
by
Bayer
Alfalfa,
forage
0.1
0.1
Alfalfa,
hay
0.1
0.1
Alfalfa,
seed
0.1
0.1
Clover,
forage
0.1
0.1
Clover,
hay
0.1
0.1
Grain,
cereal,
group
15,
except
rice
0.1
0.4
Grain,
cereal,
forage,
fodder
and
straw,
group
16,
except
rice
0.1
10.0
Grass,
forage,
fodder
and
hay,
group
17
0.1
0.1
The
Agency's
current
review
did
not
include
the
data
submitted
with
petition
0F6095.
Therefore,
the
Agency
is
leaving
the
section
18
time
limited
tolerances
listed
in
40
CFR
180.527
(
b)
unchanged.
The
time
limited
tolerances
listed
in
40
CFR
180.527
(
b)
were
issued
in
connection
with
a
section
18
and
were
extended
to
July,
2005
on
January
16,
2003
(
68
FR
2242)(
FRL
 
7284
 
8).
The
section
18
tolerances
are
not
being
modified
in
this
notice
but
are
included
in
the
risk
assessments
discussed
below.
In
addition,
since
the
Agency's
current
review
did
not
include
the
data
submitted
with
petition
0F6095
and
the
risk
assessment
outlined
below
indicated
that
the
risk
cup
was
full,
the
tolerances
for
indirect
or
inadvertent
residues
listed
in
40
CFR
180.527(
d)
will
be
made
permanent
but
the
levels
will
remain
unchanged.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information..''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
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Rules
and
Regulations
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
tolerances
for
combined
residues
of
flufenacet,
(
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­[[
5­
(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide)
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety
on
corn,
field,
forage
at
0.4
ppm;
corn,
field,
grain
at
0.05
ppm;
corn,
field,
stover
at
0.4
ppm;
soybean,
seed
at
0.1
ppm
by
establishing
permanent
tolerances
for
indirect
or
inadvertent
residues
of
the
herbicide
flufenacet,
(
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­[[
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide)
and
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety
in
or
on
the
following
raw
agricultural
commodities
from
the
application
of
this
herbicide
to
the
raw
agricultural
commodities,
listed
in
40
CFR
180.527
(
a)
and
(
b),
alfalfa,
forage
at
0.1
ppm;
alfalfa,
hay
at
0.1
ppm;
alfalfa,
seed
at
0.1
ppm;
clover,
forage
at
0.1
ppm;
clover,
hay
at
0.1
ppm;
grain,
cereal,
group
15,
except
rice
at
0.1
ppm;
grain,
cereal,
forage,
fodder,
and
straw,
group
16,
except
rice
at
0.1
ppm;
and
grass,
forage,
fodder,
and
hay,
group
17
at
0.1
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
flufenacet
are
discussed
in
Table
2
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
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
 
Day
oral
toxicity
rodents
­
rat
NOAEL
=
<
6.0
(
male
[
m],
7.2
(
female
[
f])
milligram/
kilogram/
day
(
mg/
kg/
day)
LOAEL
=
6.0(
m)
mg/
kg/
day
based
on
decreased
T4;
28.8
mg/
kg/
day
(
f)
and
on
hematology
and
clinical
chemistry
findings
870.3100
90
 
day
feeding
­
mouse
NOAEL(
mg/
kg/
day)=
18.2(
m),
24.5(
f),
LOAEL
(
mg/
kg/
day)=
64.2
(
m),
91.3(
f)
based
on
systemic
toxicity
and
histopathology
of
the
liver,
spleen,
and
thyroid.

870.3150
90
 
Day
oral
toxicity
in
nonrodents
NOAEL
(
mg/
kg/
day)=
1.67
(
m);
1.70
(
f).
LOAEL
(
mg/
kg/
day)=
7.20
(
m);
6.90
(
f)
based
on
increases
in
LDH,
globulin,
and
spleen
pigment
in
females,
decreased
T4
and
ALT
values
in
both
sexes,
decreased
albumin
in
males,
and
decreased
serum
glucose
in
females
870.3200
21/
28
 
Day
dermal
toxicity
Dermal
irritation
NOAEL(
mg/
kg/
day)=
1000
(
m
and
f)
Systemic
toxicity
NOAEL
mg/
kg/
day)
=
20(
m);
150(
f)
LOAEL(
mg/
kg/
day)=
150(
m);
1,000(
f)
based
on
decreased
T4
and
FT4
levels
in
both
sexes
and
histopathological
findings
in
females
870.3700
Prenatal
developmental
toxicity
in
rodents
(
rat)
Maternal
NOAEL
=
25
mg/
kg/
day
LOAEL
=
125
mg/
kg/
day
based
on
decreased
BWG
initially
Developmental
NOAEL
=
25
mg/
kg/
day
LOAEL
=
125
mg/
kg/
day
based
on
decreased
fetal
body
weight,
delayed
ossificaition
in
skull,
vertebrae,
sternebrae,
and
appendages,
and
increased
extra
ribs.

870.3700
Prenatal
developmental
toxicity
in
nonrodents
(
rabbits)
Maternal
NOAEL
=
5
mg/
kg/
day
LOAEL
=
25
mg/
kg/
day
based
on
histopathological
findings
in
liver.
Developmental
NOAEL
=
25
mg/
kg/
day
LOAEL
=
125
mg/
kg/
day
based
on
increased
skeletal
variations.

870.3800
Reproduction
and
fertility
effects
­
rat
Parental/
Systemic
NOAEL
=
1.4
(
m),
1.5(
f)
mg/
kg/
day
LOAEL
=
7.4
(
m),
(
8.2
(
f)
mg/
kg/
day
based
on
increased
liver
weight
in
F1
females
and
hepatocytomegaly
in
F1
males
Reproductive
NOAEL
=
1.3
mg/
kg/
day
LOAEL
=
6.9
mg/
kg/
day
based
on
increased
pup
death
in
early
lactation
(
including
cannibalism)
for
F1
liters
and
the
same
effects
in
F1
and
F2
pups
at
36
mg/
kg/
day.

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25,
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Rules
and
Regulations
TABLE
2.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.4100
Chronic
toxicity
dogs
NOAEL
=
1.29(
m),
1.14(
f)
mg/
kg/
day
LOAEL
=
27.75
(
m),
26.82(
f)
mg/
kg/
day
based
on
increased
alkaline
phosphatase,
kidney,
and
liver
weight
in
both
sexes,
increased
cholesterol
in
males,
decreased
T3,
T4,
and
ALT
values
in
both
sexes,
and
increased
incidences
of
microscopic
lesions
in
the
brain,
eye,
kidney,
spinal
cord,
sciatic
nerve,
and
liver.

870.4300
Chronic
toxicity/
oncogenicity
in
rodents
(
rat)
NOAEL
=
1.2
(
m),
1.5
(
f)
mg/
kg/
day
LOAEL
=
19.3
(
m),
24.4(
f)
mg/
kg/
day
based
on
methemoglobinemia
and
multi­
organ
effects
in
blood,
kidney,
spleen,
heart,
brain,
eye,
liver
and
uterus.
No
evidence
of
carcinogenicity
870.4300
Carcinogenicity
mice
NOAEL
=
<
7.4
((
m),
9.4
(
f)
mg/
kg/
day
LOAEL
=
7.4
(
m),
38.4
(
f)
mg/
kg/
day
based
on
increased
incidence
and
severity
of
cataracts.
No
evidence
of
carcinogenicity
870.5100
Gene
Mutation
Ames
Assay
S.
typhimurium
not
mutagenic
870.5395
Cytogenetics
In
vivo
mammalian
cytogenetics
 
micronucleus
assay
(
mouse)
not
mutagenic.
870.5375
In
vitro
mammalian
cytogenetics­
Chinese
hamster
lung
fibroblasts
(
V79)
cells
not
mutagenic.
870.5375
In
vitro
cytogenetics
chromosomal
analysis
of
cultured
CHO
cells­
not
mutagenic.
870.5550
Other
Effects
Unscheduled
DNA
synthesis
in
rat
hepatocytes
in
vitro­
not
mutagenic.

870.6200
Acute
neurotoxicity
screening
battery
NOAEL
=
<
75
(
m
and
f)
mg/
kg/
day
LOAEL
=
75
(
m
and
f)
mg/
kg/
day
based
on
clinical
signs
in
females
(
uncoordinated
gait
and
decreased
activity)
and
decreased
motor
activity
in
males.

870.6200
Subchronic
neurotoxicity
screening
battery
NOAEL
=
7.30
(
m),
8.40
(
f)
mg/
kg/
day
LOAEL
=
38.1
(
m),
42.6
(
f)
mg/
kg/
day
based
on
microscopic
lesions
(
including
axonal
swelling
in
brain
and
spinal
cord).

870.6300
Developmental
neurotoxicity
Maternal
NOAEL
=
40.8
mg/
kg/
day
LOAEL
=
not
determined
(
no
adverse
effects
seen).
Offspring
NOAEL
=
<
1.7
mg/
kg/
day
LOAEL
=
1.7
mg/
kg/
day
based
on
decreased
pre­
weaning
body
weight
and
body
weight
gain.

870.7485
Metabolism
and
pharmacokinetics
Rapidly
absorbed
and
metabolized
following
oral
exposure
to
either
single
or
multiple
doses.
The
urine
was
the
major
route
of
excretion
with
small
amount
excreted
via
feces.
Significant
amounts
of
radiolabel
were
eliminated
as
CO2
and
CH4.
A
maximum
of
7%
of
the
total
recovered
radiolabel
was
found
in
the
tissues
and
residual
carcass.
Twenty­
five
metabolites
arising
from
the
fluorophenyl
portion
of
the
molecule
were
detected
in
excreta,
and
17
of
these
were
identified.
The
total
amount
of
radiolabel
identified
ranged
from
[
Fluorophenyl­
UL­
14C]
FOE
5043
67%­
86%;
[
Thiadiazole­
2­
14C]
FOE
5043
84%­
92%;
and
[
Thiadiazole­
5­
14C]
FOE
5043
53%­
69%.
All
unidentified
residues
in
excreta
were
characterized
.

n/
a
Metabolism/
Mechanism
Hypothesis
of
an
extrathyroidal
mechanism
of
action
for
FOE
5043
(
flufenacet)
Hypothesis
of
an
extrathyroidal
mechanism
of
action
for
FOE
5043­
supplement
to
above.

n/
a
Metabolism/
Metabolite
Evaluated
a
hypothesis
that
the
neurotoxicity
observed
in
dogs
dosed
with
high
levels
of
FOE
5043
was
caused
by
metabolic
limitations.

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.
The
Agency
imposed
an
additional
10X
safety
factor
to
account
for
uncertainties
arising
because
available
data
support
the
possibility
of
decreases
in
thyroid
hormones
at
dose
levels
similar
to
those
used
in
the
submitted
rat
developmental
neurotoxicity
study
(
DNT)
as
well
as
the
lack
of
a
NOAEL
in
the
rat
developmental
neurotoxicity
study.
To
address
these
concerns
the
Agency
will
require
a
special
comparative
assay
on
thyroid
hormone
levels
in
neonatal
and
adult
rats
as
a
condition
of
registration.
The
Agency
also
had
a
concern
for
a
lack
of
a
NOAEL
in
the
rat
developmental
neurotoxicity
study
and
for
the
decrease
in
morphometric
measurements
in
adult
females
which
were
not
measured
at
the
lowest
dose.
The
doses
and
endpoints
for
various
risk
assessments
and
the
uncertainty
factors
applied
are
expected
to
adequately
address
uncertainties
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25,
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/
Rules
and
Regulations
arising
from
the
missing
data
and
a
lack
of
a
NOEL
in
the
DNT
study.
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
flufenacet,
the
Agency
concluded
that
the
Special
FQPA
Safety
Factor
could
be
reduced
to
1X,
based
on
the
low
degree
of
concern
and
lack
of
residual
uncertainties
for
pre­
and
postnatal
toxicity
as
outlined
in
Unit
III.
D.
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
carcinogenicity
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
flufenacet
used
for
human
risk
assessment
is
shown
in
Table
3
of
this
unit:

TABLE
3.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
FLUFENACET
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
General
population
including
infants
and
children)
LOAEL
=
1.7
mg/
kg/
day
UF
=
1,000X
Acute
RfD
=
LOAEL/
UF
=
0.0017
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD/
FQPA
SF
=
0.0017
mg/
kg/
day
Developmental
Neurotoxicity
study
in
rats.
LOAEL
=
1.7
mg/
kg/
day
based
on
decreased
body
weight/
body
weight
gain,
and
missing
morphometric
measurements
in
caudate/
putamen,
in
pups.

Chronic
Dietary
(
All
populations)
LOAEL=
1.7
mg/
kg/
day
UF
=
1,000
Chronic
RfD
=
LOAEL/
UF
=
0.0017
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD/
FQPA
SF
=
0.0017
mg/
kg/
day
Developmental
Neurotoxicity
study
in
rats.
LOAEL
=
1.7
mg/
kg/
day
based
on
decreased
body
weight/
body
weight
gain
in
pups.

Cancer
(
oral,
dermal,
inhalation)
Classifed
as
'
Not
Likely'
to
be
a
carcinogen.

UF
=
uncertainty
factor,
FQPA
SF
=
Special
FQPA
safety
factor,
NOAEL
=
no­
observed­
adverse­
effect­
level,
LOAEL
=
lowest­
observed­
adverse
effect­
level,
PAD
=
population­
adjusted
dose
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern,
NA
=
Not
Applicable/
Not
Required.
*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.527)
for
the
combined
residues
of
flufenacet,
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­[[
5­
(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide]
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety,
in
or
on
a
variety
of
raw
agricultural
commodities.
Tolerances
have
been
established
on
meat,
fat,
kidney,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep,
wheat
grain,
forage,
hay,
and
straw
in
connection
with
a
section
18.
These
tolerances
expire
July,
2005
and
have
been
included
in
the
risk
assessments.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
flufenacet
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
one
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
DEEM
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
[
1994
 
1996
and
1998]
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
expoure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
acute
exposure
assessments:
a.
Anticipated­
residue
estimates
were
assumed
for
some
commodities
(
field
corn,
soybeans,
and
wheat);
b.
Tolerance­
level
residues
were
assumed
for
some
crops
(
cereal
grains);
and
c.
Percent
crop­
treated
estimates
were
utilized
for
all
crops.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEM
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
[
 
1994
 
­
1996
and
1998]
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
a.
Anticipated­
residue
estimates
were
assumed
for
some
commodities
(
field
corn,
soybeans,
and
wheat);
b.
Tolerance­
level
residues
were
assumed
for
some
crops
(
cereal
grains);
and
c.
Percent
crop­
treated
estimates
were
utilized
for
all
crops.
iii.
Cancer.
Flufenacet
is
not
carcinogenic,
therefore
a
quantitative
cancer
risk
assessment
was
not
performed.

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iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
As
required
by
section
408(
b)(
2)(
E)
of
the
FFDCA,
EPA
will
issue
a
data
call­
in
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
Section
408(
b)(
2)(
F)
of
the
FFDCA
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
PCT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
PCT.
The
Agency
used
PCT
information
as
follows.
Based
on
current
use,
the
Agency
used
the
following
percent
crop
treated
estimates:
Field
corn
2%,
soybeans1%,
and
wheat
1%,.
For
crops
planted
in
rotation
(
cereal
grains),
2%
crop
treated
was
assumed
as
this
is
the
highest
estimate
for
the
primary
crops.
For
livestock
commodities,
a
percent
crop
treated
estimate
of
1%,
corresponding
to
the
use
on
wheat,
was
utilized.
The
Agency
has
previously
concluded
that
secondary
residues
of
flufenacet
in
livestock
commodities
would
not
result
from
the
use
of
flufenacet
on
corn
or
soybeans
but
would
result
from
the
section
18
use
on
wheat.
The
Agency
believes
that
the
three
conditions
listed
above
have
been
met.
With
respect
to
Condition
1,
PCT
estimates
are
derived
from
Federal
and
private
market
survey
data,
which
are
reliable
and
have
a
valid
basis.
EPA
uses
a
weighted
average
PCT
for
chronic
dietary
exposure
estimates.
This
weighted
average
PCT
figure
is
derived
by
averaging
State­
level
data
for
a
period
of
up
to
10
years,
and
weighting
for
the
more
robust
and
recent
data.
A
weighted
average
of
the
PCT
reasonably
represents
a
person's
dietary
exposure
over
a
lifetime,
and
is
unlikely
to
underestimate
exposure
to
an
individual
because
of
the
fact
that
pesticide
use
patterns
(
both
regionally
and
nationally)
tend
to
change
continuously
over
time,
such
that
an
individual
is
unlikely
to
be
exposed
to
more
than
the
average
PCT
over
a
lifetime.
For
acute
dietary
exposure
estimates,
EPA
uses
an
estimated
maximum
PCT.
The
exposure
estimates
resulting
from
this
approach
reasonably
represent
the
highest
levels
to
which
an
individual
could
be
exposed,
and
are
unlikely
to
underestimate
an
individual's
acute
dietary
exposure.
The
Agency
is
reasonably
certain
that
the
percentage
of
the
food
treated
is
not
likely
to
be
an
underestimation.
As
to
Conditions
2
and
3,
regional
consumption
information
and
consumption
information
for
significant
subpopulations
is
taken
into
account
through
EPA's
computer­
based
model
for
evaluating
the
exposure
of
significant
subpopulations
including
several
regional
groups.
Use
of
this
consumption
information
in
EPA's
risk
assessment
process
ensures
that
EPA's
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group
and
allows
the
Agency
to
be
reasonably
certain
that
no
regional
population
is
exposed
to
residue
levels
higher
than
those
estimated
by
the
Agency.
Other
than
the
data
available
through
national
food
consumption
surveys,
EPA
does
not
have
available
information
on
the
regional
consumption
of
food
to
which
flufenacet
may
be
applied
in
a
particular
area.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
flufenacet
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
flufenacet.
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
groundwater.
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
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
flufenacet
they
are
further
discussed
in
the
aggregate
risk
section
in
Unit
III.
E.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
flufenacet
for
acute
exposures
are
estimated
to
be
9.9
parts
per
billion
(
ppb)
for
surface
water
and
0.21
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
1.3
ppb
for
surface
water
and
0.21
ppb
for
ground
water.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).

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Flufenacet
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
flufenacet
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,
flufenacet
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
flufenacet
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
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
No
increase
in
susceptibility
was
seen
in
rat
and
rabbit
developmental
studies,
but
qualitative
and/
or
quantitative
increases
in
susceptibility
were
seen
in
the
rat
reproduction
study
and
in
the
rat
developmental
neurotoxicity
studies.
3.
Conclusion.
The
toxicology
data
base
for
flufenacet
is
complete
except
for
a
special
comparative
assay
on
thyroid
hormone
levels
in
neonatal
and
adult
rats
and
a
28­
day
inhalation
toxicity
study
in
rats.
The
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
Agency
evaluated
the
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
flufenacet.
The
Agency
concluded
that
there
is
a
low
degree
of
concern
and
lack
of
residual
uncertainties
for
pre­
and
post­
natal
toxicity
in
the
rat
reproduction
study
and
the
rat
and
rabbit
developmental
toxicity
studies.
The
Agency
determined
that
the
concern
is
also
low
for
susceptibility
seen
in
the
developmental
neurotoxicity
(
DNT)
study.
Multiple
offspring
effects
were
seen
at
the
mid­
and
high
doses,
and
no
adverse
maternal
effects
were
seen
at
any
dose.
However,
the
only
effect
seen
at
the
lowest
dose
in
offspring
was
a
transient
decrease
in
body
weight.
The
concern
for
the
decrease
in
the
offspring
weights
was
reduced
because
no
decrease
in
body
weight
was
seen
in
the
offspring
in
the
reproduction
study
.
The
Agency
considered
the
lack
of
comparative
data
for
thyroid
hormone
levels
in
adult
and
neonatal
animals.
Available
data
support
the
possibility
of
decreases
in
thyroid
hormones
in
adult
animals
(
decreases
were
observed
in
several
studies
conducted
in
rats,
mice,
rabbits,
and
dogs)
at
dose
levels
similar
to
those
used
in
the
submitted
DNT
study.
Because
of
the
above
concern,
a
special
comparative
study
on
thyroid
hormone
levels
in
neonatal
and
adult
rats
is
being
requested
by
the
Agency
as
a
condition
of
registration.
The
Agency
also
noted
that
morphometric
measurements
could
be
incorporated
into
the
comparative
thyroid
assay
to
confirm
the
findings
observed
in
adult
female
offspring
in
the
DNT
(
data
for
this
endpoint
were
not
available
at
the
low
dose).
Due
to
the
concerns
regarding
the
possibility
of
decreases
in
thyroid
hormones
and
the
need
for
comparative
susceptibility
data
on
this
issue
as
well
as
the
lack
of
a
NOAEL
in
the
DNT,
EPA
found
no
basis
to
remove
the
10X
FQPA
safety
for
the
protection
of
infants
and
children.
EPA
considers
this
additional
10X
factor
to
be
an
uncertainty
factor
to
address
the
deficiencies
in
the
database.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
[
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)].
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
groundwater
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
flufenacet
will
occupy
23%
of
the
aPAD
for
the
U.
S.
population,
17
%
of
the
aPAD
for
females
13
years
and
older,
23%
of
the
aPAD
for
all
infants
and
48%
of
the
aPAD
for
children
1­
2
years.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
flufenacet
in
drinking
water.
Table
4
of
this
unit
presents
the
EECs
and
DWLOCs
for
the
major
populations
subgroups.

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TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
FLUFENACET
Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

U.
S.
Population
0.0017
23
9.9
0.21
46
All
Infants
0.0017
23
9.9
0.21
13
Children
(
1­
2
yrs)
0.0017
48
9.9
0.21
9
Children
(
3­
5
yrs)
0.0017
42
9.9
0.21
10
Children
(
6­
12
yrs)]
0.0017
29
9.9
0.21
12
Youth
(
13­
19
yrs)
0.0017
21
9.9
0.21
41
Adults
(
20­
49
years)
0.0017
20
9.9
0.21
47
Females
(
13­
19
years)
0.0017
17
9.9
0.21
42
The
EECs
are
less
than
calculated
DWLOCs
for
acute
exposure
to
flufenacet
in
drinking
water,
except
for
the
population
subgroup,
children
1­
2
years
old,
where
the
EEC
marginally
exceeds
the
DWLOC.
In
evaluating
the
acceptability
of
these
estimated
risks,
EPA
has
taken
into
account
that
the
risk
assessment
was
performed
by
estimating
exposure
at
the
99.9th
percentile
of
exposure.
As
EPA
has
explained
in
its
policy
regarding
use
of
population
percentiles
in
estimating
exposure,
EPA
generally
uses
the
95th
percentile
when
conducting
an
exposure
assessment
with
unrefined
residue
values
(
i.
e.
assuming
all
covered
food
contains
tolerance
level
residues)
and
the
99.9th
percentile
when
using
highly
refined
residue
values
(
i.
e.
monitoring
values).
See
U.
S.
EPA,
Office
of
Pesticide
Programs,
Choosing
A
Percentile
of
Acute
Dietary
Exposure
as
a
Threshold
of
Regulatory
Concern
17
(
March
16,
2000)
(
http://
www.
epa.
gov/
pesticides/
trac/
science/
trac2b054.
pdf).
The
residue
values
used
in
the
flufenacet
risk
assessment
fall
somewhere
between
highly
refined
and
unrefined.
Although
the
Agency
did
use
data
bearing
on
percent
crop
treated,
three
other
aspects
of
the
assessment
made
it
not
particularly
refined,
and
therefore,
somewhat
conservative
(
i.
e.
tending
to
overstate
exposure).
First,
EPA
assumed
tolerance
level
residues
for
all
crops
covered
by
tolerances
designed
to
address
the
possibility
of
flufenacet
residues
being
present
in
crops
grown
at
a
later
date
in
the
same
field
as
the
treated
crop.
These
rotational
crop
tolerances
include
rice
and
sorghum.
Further,
compounding
this
conservative
assumption,
EPA
assumed
that
two
percent
of
all
of
the
crops
covered
by
rotational
crop
tolerances
would
contain
flufenacet
residues
even
though
the
treatment
rate
for
wheat
and
soybeans
was
at
a
one
percent
level
(
only
corn
was
at
the
two
percent
level)
and
it
is
unlikely,
in
any
event,
that
the
crops
covered
by
the
rotational
crop
tolerances
would,
in
their
entirety,
be
grown
in
a
rotational
program.
Second,
and
probably
most
important,
for
those
crops
for
which
EPA
did
not
assume
tolerance
level
residues
(
corn,
wheat,
and
soybeans)
EPA
did
not
use
monitoring
data
(
i.
e.
data
collected
from
food
as
it
moves
in
the
channels
of
trade)
but
data
from
crop
field
trials.
Crop
field
trials
are
studies
conducted
to
determine
the
maximum
residue
levels
that
can
occur
under
the
limits
imposed
by
the
pesticide's
label.
Accordingly,
such
studies
involve
applying
the
pesticide,
pursuant
to
its
label,
the
maximum
number
of
times
at
the
maximum
application
rate
and
harvesting
the
crop
as
promptly
as
soon
as
permitted
following
the
last
pesticide
treatment.
These
studies
overstate
the
residue
levels
that
consumers
are
exposed
to
for
two
reasons.
First,
in
crop
field
studies,
residue
levels
are
measured
at
harvest
and
thus
do
not
reflect
the
degradation
that
generally
occurs
during
the
production,
shipping,
and
storage
of
food
prior
to
sale
to
the
consumer.
Second,
farmers
are
not
required
to
apply
pesticides
in
the
manner
used
in
crop
field
trials
but
generally
may
use
lower
amounts
than
those
specified
on
the
label,
apply
the
pesticide
less
frequently
than
the
number
of
applications
permitted
by
the
label,
and
wait
longer
to
harvest
the
crop
than
the
minimum
pre­
harvest
interval
prescribed
by
the
label.
See
7
U.
S.
C.
136a(
ee).
Such
practices
reduce
residue
values,
normally
by
significant
amounts.
With
flufenacet,
the
decrease
will
be
even
more
significant
than
usual
because
some
of
the
field
trial
data
are
based
upon
an
application
rate
of
0.9
lbs.
a.
i.
acre
per
season
v.
s.
the
label
rate
of
0.79
lbs.
a.
i.
acre
per
season
for
field
corn
and
0.9
lbs.
a.
i.
acre
per
season
v.
s.
the
label
rate
of
0.45
lbs.
a.
i.
per
acre
per
season
for
soybeans.
A
third
aspect
of
the
flufenacet
exposure
assessment
that
overstated
residue
levels
was
the
fact
that
EPA
did
not
use
processing
reduction
factors.
Processing
studies
are
performed
in
order
to
show
whether
or
not
residues
concentrate
in
processed
commodities
of
the
RAC.
For
example
wheat
grain,
may
be
processed
into
bran,
flour,
middlings,
shorts
and
germ.
Processing
studies
frequently
show
residues
decreasing
in
the
processed
commodities.
If
the
residues
decrease
in
the
processed
commodity,
we
may
be
able
to
determine
a
reduction
factor.
The
concentration
and/
or
reduction
factors
are
directly
applied
to
the
residue
level
used
in
the
dietary
exposure
assessment
for
that
commodity.
The
processing
studies
for
flufenacet
treated
corn
and
soybeans
showed
no
detectable
residues.
However,
the
Agency
for
this
risk
assessment
assumed
the
residues
in
the
raw
agricultural
commodity
were
carried
through
undiminished
to
the
processed
commodities.
As
EPA
has
made
clear,
even
when
an
exposure
assessment
is
based
on
highly
refined
data,
an
indication
that
exposure
at
the
99.9th
percentile
poses
a
risk
of
concern
is
merely
the
starting
point
for
assessing
the
ultimate
safety
of
the
pesticide.
EPA
has
detailed
a
number
of
steps
that
are
important
to
assess
the
accuracy
of
any
99.9th
percentile
estimate
including
sensitivity
analyses
and
scrutiny
of
data
inputs.
When
an
assessment
does
not
rely
on
highly
refined
exposure
data
there
is
an
even
greater
need
for
close
examination
of
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Regulations
any
risk
estimates.
As
outlined
above,
there
are
several
aspects
of
the
flufenacet
exposure
assessment
that
are
likely
to
significantly
inflate
exposure,
and
thus
risk,
estimates.
Taking
this
into
account
as
well
as
the
fact
that
a
risk
analysis
using
a
99.8th
population
percentile
raises
the
DWLOC
for
children
between
1
and
2
years
old
to
12
ppb
and
thus
above
the
EEC
of
9.9
ppb,
EPA
concludes
that
flufenacet
does
not
show
a
acute
risk
of
concern.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
flufenacet
from
food
will
utilize
<
1
%
of
the
cPAD
for
the
U.
S.
population,
<
1
%
of
the
cPAD
for
all
infants
and
1.0
%
of
the
cPAD
for
children
(
1­
2
yrs).
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
flufenacet
in
drinking
water.
There
are
no
residential
uses
for
flufenacet
and
therefore,
no
chronic
residential
exposure
to
flufenacet.
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
5
of
this
unit:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
FLUFENACET
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.0017
<
1.0
1.3
0.21
59
All
Infants
0.0017
<
1.0
1.3
0.21
17
Children
(
1­
2
yrs)
0.0017
1.0
1.3
0.21
17
Youth
(
13­
19
yrs)
0.0017
<
1.0
1.3
0.21
51
Adults
(
20­
49
yrs)
0.0017
<
1.0
1.3
0.21
59
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).
Flufenacet
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
level
of
concern.
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Flufenacet
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
level
of
concern.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Flufenacet
is
not
carcinogenic,
therefore
no
aggregate
cancer
risk
is
expected.
6.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
flufenacet
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
(
gas
chromotography
/
mass
spectrometry
with
selected
ion
monitoring)
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
There
are
no
Codex,
Canadian,
or
Mexican
tolerances
for
flufenacet
on
corn,
soybeans,
wheat
or
livestock
commodities.

C.
Conditions
The
following
studies
are
required
as
a
condition
of
registration.
1.
A
special
comparative
sensitivity
study
on
thyroid
hormone
levels
in
neonatal
and
adult
rats.
2.
28­
day
inhalation
toxicity
study
in
rats.

V.
Comments
One
comment
was
received
in
response
to
the
notice
of
filing
from
B.
Sachau,
15
Elm
St.,
Florham
Park,
NJ
07932.
Mr.
Sachau
objected
generally
to
the
presence
of
pesticides
in
food
and
specifically
to
the
presence
of
flufenacet.
Mr.
Sachau
also
proposed
that
the
U.
S.
establish
testing
on
humans
instead
of
dogs
and
rats.
Mr.
Sachau
comment
contained
no
scientific
data
or
evidence
to
rebut
the
Agency's
conclusion
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
flufenacet,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
VI.
Conclusion
Therefore,
the
tolerance
is
established
for
combined
residues
of
flufenacet,
(
N­
(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­
[[
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide)
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety]
on
corn,
field,
forage
at
0.4
ppm;
corn,
field,
grain
at
0.05
ppm;
corn,
field,
stover
at
0.4
ppm;
soybean,
seed
at
0.1
ppm
by
establishing
permanent
tolerances
for
indirect
or
inadvertent
residues
of
the
herbicide
flufenacet,
(
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­
[[
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl]
oxy]
acetamide)
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety
in
or
on
the
following
raw
agricultural
commodities
from
the
application
of
this
herbicide
to
the
raw
agricultural
commodities,
listed
in
40
CFR
180.527
(
a)
and
(
b),
alfalfa,
forage
at
0.1
ppm;
alfalfa,
hay
at
0.1
ppm;
alfalfa,
seed
at
0.1
ppm;
clover,
forage
at
0.1
ppm;
clover,
hay
at
0.1
ppm;
grain,
cereal,
group
15,
except
rice
at
0.1
ppm;
grain,
cereal,
forage,
fodder,
and
straw,
group
16,
except
rice,
at
0.1
ppm;
and
grass,
forage,
fodder
and
hay,
group
17
at
0.1
ppm.
These
tolerances
replaced
currently
expiring
tolerances
in
§
180.527
(
a)
and
(
d).

VII.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
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Rules
and
Regulations
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
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0181
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
25,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VII.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0181,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.
B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?

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

VIII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
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25,
2003
/
Rules
and
Regulations
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.
IX.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

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

Dated:
June
12,
2003.
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
371.


2.
Section
180.527
is
amended
by
revising
paragraphs
(
a)
and
(
d)
to
read
as
follows:

§
180.527
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­[(
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl)
oxy]
acetamide;
tolerances
for
residues.

(
a)
General.
Tolerances
are
established
for
the
combined
residues
of
the
herbicide
N­(
4­
fluorophenyl)­
N­(
1­
methylethyl)­
2­[(
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl)
oxy]
acetamide
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety
in
or
on
the
following
raw
agricultural
commodities:

Commodity
Parts
per
million
Corn,
field,
forage
0.4
Corn,
field,
grain
...
0.05
Corn,
field,
stove
..
0.4
Soybean,
seed
......
0.1
*
*
*
*
*
(
d)
Indirect
or
inadvertent
residues.
Tolerances
are
established
for
indirect
or
inadvertent
residues
of
the
herbicide
N­(
4­
fluroophenyl)­
N­(
1­
methylethyl)­
2­
[(
5­(
trifluoromethyl)­
1,3,4­
thiadiazol­
2­
yl)
oxy]
acetamide
and
its
metabolites
containing
the
4­
fluoro­
N­
methylethyl
benzenamine
moiety
in
or
on
the
raw
agricultural
commodities
listed
in
paragraph
(
a)
of
this
section.

Commodity
Parts
per
million
Alfalfa,
forage
.......
0.1
Alfalfa,
hay
............
0.1
Alfalfa,
seed
..........
0.1
Clover,
forage
.......
0.1
Clover,
hay
...........
0.1
Grain,
cereal,
group
15,
except
rice
....................
0.1
Grain,
cereal,
forage
fodder,
and
straw,
group
16,
except
rice
.........
0.1
Grass,
forage,
fodder
and
hay,
group
17
............
0.1
[
FR
Doc.
03
 
15905
Filed
6
 
24
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0179;
FRL
 
7311
 
5]

Extension
of
Tolerances
for
Emergency
Exemptions
(
Multiple
Chemicals)

AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
extends
timelimited
tolerances
for
the
pesticides
listed
in
Unit
II.
of
the
SUPPLEMENTARY
INFORMATION.
These
actions
are
in
response
to
EPA's
granting
of
emergency
exemptions
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
these
pesticides.
Section
408(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
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.
DATES:
This
regulation
is
effective
June
25,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0179,
must
be
received
by
EPA
on
or
before
July
25,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
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