55519
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

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

Dated:
September
10,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
part
180
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
180.553
is
amended
as
follows:
a.
By
revising
the
commodities
plum,
prune,
dried
and
plum,
prune,
fresh
in
the
table
in
paragraph
(
a).
b.
By
removing
the
commodity
fruit,
stone,
except
plum,
prune,
fresh
in
the
table
in
paragraph
(
a).
c.
By
alphabetically
adding
commodities
in
the
table
in
paragraph
(
a).

§
180.553
Fenhexamid;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*

Cucumber
2.0
Fruit,
stone,
group
12,
except
plum,
prune,
fresh,
postharvest
10.0
*
*
*
*
*

Kiwifruit,
postharvest
15.0
*
*
*
*
*

Leafy
greens,
subgroup
4A,
except
spinach
30.0
*
*
*
*
*

Plum,
prune,
dried
2.5
Plum,
prune,
fresh
1.5
*
*
*
*
*

Vegetable,
fruiting,
group
8,
except
nonbell
pepper
2.0
*
*
*
*
*

[
FR
Doc.
03
 
24013
Filed
9
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0146;
FRL
 
7320
 
8]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
chlorfenapyr
[
4­
bromo­
2­(
4­
chlorophenyl)­
1­
(
ethoxymethyl)­
5­(
trifluoromethyl)­
1Hpyrrole
3­
carbonitrile]
in
or
on
vegetables,
fruiting,
group
8.
BASF
Agro
Research,
now
BASF
Corporation
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
September
26,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0146,
must
be
received
on
or
before
November
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
VI.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Ann
Sibold,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6502;
e­
mail
address:
sibold.
ann@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
grow
fruiting
vegetables
in
commercial
greenhouses,
consume
vegetables
that
were
raised
in
commercial
greenhouses,
or
provide
pest
control
services
to
commercial
greenhouses.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Pesticide
manufacturing
(
NAICS
32532)
 
Other
food
crops
grown
under
cover
(
NAICS
111419)
 
Entomological
services,
agricultural;
insect
control
for
crops
(
NAICS
115112)
 
Agricultural
production
or
harvesting
crews
(
NAICS
115115)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
VerDate
jul<
14>
2003
14:
38
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00087
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
55520
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
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
 
0146.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
September
13,
2000
(
65
FR
55236)
(
FRL
 
6742
 
3),
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
an
amended
pesticide
petition
(
PP
6F4716)
by
BASF
Agro
Research,
now
BASF
Corporation,
P.
O.
Box
400,
Princeton,
NJ
08543
 
0400,
now
P.
O.
Box
13528,
Research
Triangle
Park,
NC
27709
 
3528.
(
The
original
pesticide
petition
PP
6F4716
was
filed
by
American
Cyanamid
(
now
BASF
Agro
Research)
in
1996).
The
2000
notice
included
a
summary
of
the
petition
prepared
by
BASF
Agro
Research,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.513
be
amended
by
establishing
a
tolerance
for
residues
of
the
insecticide
chlorfenapyr,
[
4­
bromo­
2­(
4­
chlorophenyl)­
1­(
ethoxymethyl)­
5­
(
trifluoromethyl)­
1H­
pyrrole­
3­
carbonitrile],
in
or
on
vegetables,
fruiting,
group
8
at
1.0
parts
per
million
(
ppm).
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
tolerance
for
residues
of
chlorfenapyr
on
vegetables,
fruiting,
group
8
at
1.0
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
chlorfenapyr
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

VerDate
jul<
14>
2003
14:
38
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00088
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
55521
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
MRID
No.
(
year)/
Classification
Doses
Results
870.3100
90
 
Day
oral
toxicity
rats
42770219
(
1993)
Acceptable/
guideline
0,
150,
300,
600,
900,
1,200
ppm
0,
11.7,
24.1,
48.4,
72.5,
94.5
mg/
kg/
day
NOAEL
=
24.1
mg/
kg/
day
LOAEL
=
48.4,
based
on
spongiform
myelopathy
in
the
brain
and
spinal
cord
of
male
rats,
decreased
body
weight
gain
and
increased
relative
liver
weight
in
males
and
females,
increased
absolute
liver
weight
in
females,
and
decreased
hemoglobin
in
females
870.3100
90
 
Day
oral
toxicity
mouse
43492830
(
1994)
Acceptable/
guideline
0,
40,
80,
160,
320
M:
0,
7.1,
14.8,
27.6,
62.6
mg/
kg/
day
F:
0,
9.2,
19.3,
40,
78
mg/
kg/
day
NOAEL
=
27.6/
40,
M/
F
LOAEL
=
62.6/
78,
M/
F,
based
on
reduced
body
weights/
body
weight
gains,
and
spongiform
encephalopathy
in
both
sexes
870.3150
90
 
Day
oral
toxicity
dog
42770220
(
1993)
Acceptable/
guideline
0,
60,
120, 
247*
ppm
M:
0,
2.1,
3.9,
6.7
mg/
kg/
day
F:
0,
2.2,
4.5,
6.8
mg/
kg/
day
*
High
dose
animals
received
300
ppm
during
days
1
 
15,
240
ppm
during
days
15
 
25,
and
200
ppm
during
days
25
 
93
NOAEL
=
3.9/
4.5
mg/
kg/
day,
M/
F
LOAEL
=
6.7/
6.8
mg/
kg/
day,
M/
F,
based
on
emaciation,
decreased
body
weight
gains,
and
decreased
food
efficiency
870.3200
21/
28
 
Day
dermal
toxicity
rabbit
43492831
(
1993)
Unacceptable/
guideline
due
to
incomplete
histopathological
examination
0,
100,
400,
1,000
mg/
kg/
day
NOAEL
=
100
mg/
kg/
day
LOAEL
=
400
mg/
kg/
day,
for
both
sexes,
based
on
changes
in
liver
chemistry
and
morphology
870.3700
Prenatal
developmental
rat
42884202
(
1993)
Acceptable/
guideline
0,
25,
75,
225
mg/
kg/
day
Maternal
NOAEL
=
25
mg/
kg/
day
Maternal
LOAEL
=
75
mg/
kg/
day,
based
on
decreased
body
weight
gain
and
relative
food
consumption
during
treatment
Developmental
NOAEL
 
225
mg/
kg/
day
Developmental
LOAEL
=
not
identified
870.3700
Prenatal
developmental
rabbit
42770222
(
1993)
Acceptable/
guideline
0,
5,
15,
30
mg/
kg/
day
Maternal
NOAEL
=
5
mg/
kg/
day
Maternal
LOAEL
=
15
mg/
kg/
day,
based
on
decreased
body
weight
gain
during
treatment
Developmental
NOAEL
=
15
mg/
kg/
day
Developmental
LOAEL
=
30
mg/
kg/
day,
based
on
increased
post
implantation
loss
870.3800
2
 
Generation
reproduction
and
fertility
effects
rat
43492836
(
1994)
Acceptable/
guideline
0,
60,
300,
600
ppm
Premating
doses
for
P1
males/
females:
0/
0,
4.5/
5.0,
22.2/
24.5,
44/
44.6
mg/
kg/
day
Premating
doses
for
F1
males/
females:
0/
0,
4.4/
5.1,
22.5/
25.6,
44.6/
50.7
mg/
kg/
day
Parental
systemic
NOAEL
=
4.4
 
4.5
mg/
kg/
day,
M
Parental
systemic
LOAEL
=
22.2
 
22.5
mg/
kg/
day,
M,
based
on
decreased
absolute
body
weight/
body
weight
gains
of
P1
males
during
premating
Offspring
systemic
NOAEL
=
4.4
 
5.1
mg/
kg/
day
Offspring
systemic
LOAEL
=
22.2
 
25.6
mg/
kg/
day,
based
on
decreased
pup
weights
at
weaning
Reproductive
NOAEL
 
44
 
50.7
mg/
kg/
day
Reproductive
LOAEL:
not
identified
VerDate
jul<
14>
2003
14:
38
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00089
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
55522
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
MRID
No.
(
year)/
Classification
Doses
Results
870.4100
Chronic
toxicity
dog
43492834
(
1994)
Acceptable/
guideline
0,
60,
120,
240
ppm
M:
0,
2.1,
4.0,
8.7
mg/
kg/
day
F:
0,
2.3,
4.5,
10.1
mg/
kg/
day
NOAEL
=
4.0/
4.5
mg/
kg/
day,
M/
F
LOAEL
=
8.7/
10.1
mg/
kg/
day,
M/
F,
based
on
decreased
body
weight/
body
weight
gains
870.4200
Carcinogenicity
mouse
43492838
(
1994)
Acceptable/
guideline
0,
20,
120,
240
ppm
M:
0,
2.8,
16.6,
34.5
mg/
kg/
day
F:
0,
3.7,
21.9,
44.5
mg/
kg/
day
NOAEL
=
2.8/
3.7
mg/
kg/
day,
M/
F
LOAEL
=
16.6/
21.9
mg/
kg/
day,
M/
F,
based
on
decreased
body
weight
gains,
brain
vacuolation,
and
scabbing
of
the
skin
(
males)
No
evidence
of
carcinogenicity
870.4300
Combined
chronic/
carcinogenicity
in
rat
43492837
(
1994)
Acceptable/
guideline
0,
60,
300,
600
ppm
M:
0,
2.9,
15.0,
30.8
mg/
kg/
day
F:
0,
3.6,
18.6,
37
mg/
kg/
day
NOAEL
=
15
mg/
kg/
day,
males
LOAEL
=
30.8
mg/
kg/
day,
males,
based
on
anemia
NOAEL
=
3.6
mg/
kg/
day,
females
LOAEL
=
18.6
mg/
kg/
day,
females,
based
on
decreased
body
weight/
body
weight
gain
Classification:
``
Suggestive
Evidence
of
Carcinogenicity,
but
Not
Sufficient
to
Assess
Human
Carcinogenic
Potential
based
on
significant
trends
in
liver
tumors
(
adenomas
and
combined
adenomas/
carcinomas),
malignant
histiocytic
sarcomas,
and
testicular
cell
tumors
in
male
rats
and
uterine
polyps
in
female
rats
seen
at
the
highest
dose
870.5100
Bacterial
reverse
mutation
42770223
(
1993)
Acceptable/
Guideline
Negative
for
reverse
mutation
in
S.
typhimurium
strains
TA
98,
TA
100,
TA
1535,
TA
1537,
TA
1538
and
E.
coli
strain
WP2
uvrA­
exposed
up
to
cytotoxicity
(
50
µ
g/
plate,
+/­
S9)

870.5300
In
vitro
mammalian
cell
gene
mutation
in
Chinese
hamster
ovary
cells
(
CHO/
HGPRT)
42770224,
43187601
(
1993)
Acceptable/
Guideline
Independently
performed
tests
were
negative
up
to
a
cytotoxic
and
precipitating
concentration
(
500
µ
g/
ml)
in
the
presence
of
S9
activation
or
the
solubility
limit
(
250
µ
g/
ml)
without
S9
activation
870.5375
In
vitro
mammalian
chromosome
aberration
(
CHO)
43492843
(
1994)
Acceptable
The
test
was
negative
up
to
100
µ
g/
ml
­
S9
or
25
µ
g/
ml
+
S9;
higher
doses
with
or
without
S9
activation
were
cytotoxic
870.5385
In
vitro
chromosome
aberration
assay
in
Chinese
hamster
lung
(
CHL)
cells
43492839
(
1994)
Acceptable/
Guideline
The
test
was
negative
up
to
a
precipitating
level
without
S9
activation
(
225
µ
g/
ml)
or
a
concentration
range
of
3.5
 
14.1
µ
g/
ml
+
S9.
Higher
S9­
activated
doses
( 
28
µ
g/
ml)
were
cytotoxic
870.5395
Mammalian
micronucleus
(
mouse)
42770225,
43187602
(
1993,
1994)
Acceptable/
Guideline
The
test
was
negative
in
mice
administered
single
oral
gavage
doses
of
7.5
 
30
mg/
kg
(
males)
or
5
 
20
mg/
kg
(
females
Clinical
toxicity
(
deaths
in
males
and
diarrhea
in
females)
was
seen
at
the
HDT.
There
was,
however,
no
evidence
of
cytotoxicity
for
the
target
organ
870.5550
Unscheduled
DNA
synthesis
42770226
(
1993)
Acceptable/
Guideline
Negative
for
inducing
unscheduled
DNA
synthesis
in
primary
rat
hepatocyte
cultures
exposed
up
to
severely
toxic
concentrations
( 
30
µ
g/
ml)

870.6200
Acute
neurotoxicity
screening
battery
rat
43492829
(
1994)
Acceptable/
guideline
0,
45,
90,
180
mg/
kg
NOAEL
=
45
mg/
kg/
day
LOAEL
=
90
mg/
kg/
day,
based
on
lethargy
in
male
rats
on
the
day
of
treatment
870.6200
Chronic
neurotoxicity
rat
43492833
(
1994)
Acceptable/
Guideline
0,
60,
300,
600
ppm
M:
0,
2.6,
13.6,
28.2
mg/
kg/
day
F:
0,
3.4,
18,
37.4
mg/
kg/
day
NOAEL
=
2.6/
3.4
mg/
kg/
day,
M/
F
LOAEL
=
13.6/
18
mg/
kg/
day,
M/
F,
based
on
the
presence
of
myelinopathic
alterations
in
the
central
nervous
system
(
CNS)
in
male
rats
and
decreased
average
body
weights/
body
weight
gains,
food
efficiency,
absolute
food
consumption
(
females)
and
water
consumption
(
males)

VerDate
jul<
14>
2003
14:
38
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00090
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
55523
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
MRID
No.
(
year)/
Classification
Doses
Results
870.7485
Metabolism
and
pharmacokinetics
rat
43492844
(
1994)
Acceptable/
guideline
20,
200
mg/
kg/
day
Low
recoveries
of
the
radioactive
dose
in
urine
and
tissues
indicate
limited
absorption
of
CL
303,630
(
chlorfenapyr)
by
rats.
The
radioactivity
in
urine,
as
a
percent
of
administered
dose,
from
the
high
dosed
rats
was
about
half
that
from
the
single
and
multiple­
low
dosed
rats.
More
than
80%
of
the
doses
were
eliminated
in
the
feces.
Most
of
the
radioactivity
was
eliminated
in
the
feces
and
urine
within
48
hours
of
dosing.
After
7
days,
89
 
121%
of
the
dosed
radioactivity
was
recovered.
At
sacrifice,
female
rats
had
greater
(
about
twice)
recovery
of
radioactivity
in
the
carcass,
blood,
and
fat
at
all
doses
than
did
males.
The
highest
recovery
of
radioactivity
from
a
single
organ
was
from
the
liver
(
0.15
 
0.48%
of
dose)
Metabolite
and
parent
compound
accounted
for
72
 
91%
of
the
radioactive
doses.
Parent
compound
was
the
major
radioactive
component
found
in
excreta,
accounting
for
approximately
40
 
70%
of
the
administered
doses.
Minor
amounts
of
eight
primary
and
conjugated
metabolites
and
four
unidentified
isolated
components
were
detected
each
at
less
than
10%
of
the
dosed
radioactivity.
Liver
and
kidney
contained
several
primary
and
conjugated
metabolites
and
only
minor
levels
of
the
parent
compound
( 
8.3%
of
the
radioactivity
in
the
sample).
Based
on
the
metabolites
identified,
the
major
deposition
route
of
orally
administered
chlorfenapyr
is
fecal
excretion
of
unaltered
parent
compound.
Other
pathways
include
cleavage
of
the
ethoxymethyl
side­
chain,
followed
by
de­
alkylation
and
ring
hydroxylation,
and
some
degree
of
conjugation
of
the
de­
alkylated,
ring­
hydroxylated
metabolite.
The
two
rings
of
the
molecule
are
not
cleaved.
Metabolites
are
excreted
primarily
in
urine;
accumulation
in
tissues
is
minimal
B.
Toxicological
Endpoints
The
dose
at
which
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
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.
An
additional
safety
factor
(
SF)
may
be
required
if
the
data
base
is
incomplete.
For
chlorfenapyr
EPA
concluded
that
a
developmental
neurotoxicity
(
DNT)
study
is
required
based
on
the
presence
of
neuropathology
(
CNS
lesions)
and
neurotoxic
signs
seen
in
adult
rats
(
males)
and
mice
(
both
sexes).
EPA
further
concluded
that
a
UF
of
10X
is
required
until
the
data
are
received
and
evaluated.
EPA
does
not
have
sufficient
reliable
data
justifying
the
selection
of
a
factor
lower
than
the
default
10X
value
for
the
additional
SF
for
the
protection
or
infants
and
children
for
this
data
gap.
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
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.
A
summary
of
the
toxicological
endpoints
for
chlorfenapyr
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:

TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CHLORFENAPYR
FOR
USE
IN
HUMAN
RISK
ASSESSMENT.

Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13
 
50
years
of
age)
NOAEL
=
15
mg/
kg
UF
=
1,000
aRfD
=
0.015
mg/
kg
Special
FQPA
SF
=
1X
aPAD
=
aRfD
÷
FQPA
SF
=
0.015
mg/
kg
Developmental
toxicity
study
­
rabbit
LOAEL
=
30
mg/
kg/
day
based
on
increased
post­
implantation
loss
VerDate
jul<
14>
2003
14:
38
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00091
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
55524
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CHLORFENAPYR
FOR
USE
IN
HUMAN
RISK
ASSESSMENT.
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
Special
FQPA
SF*
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
General
population
including
infants
and
children)
NOAEL
=
45
mg/
kg
UF
=
1,000
aRfD
=
0.045
mg/
kg
Special
FQPA
SF
=
1X
aPAD
=
aRfD
÷
FQPA
SF
=
0.045
mg/
kg
Acute
neurotoxicity
study
­
rat
LOAEL
=
90
mg/
kg/
day
based
on
lethargy
in
male
rats
Chronic
Dietary
(
All
populations
NOAEL=
2.6
mg/
kg/
day
UF
=
1,000
cRfD
=
0.003
mg/
kg/
day
Special
FQPA
SF
=
1X
cPAD
=
cRfD
÷
FQPA
SF
=
0.003
mg/
kg/
day
Chronic
neurotoxicity
study
­
rat
LOAEL
=
13.6/
18
mg/
kg/
day,
M/
F,
based
on
the
presence
of
myelinopathic
alterations
in
the
CNS
in
male
rats
and
decreased
average
body
weights,
body
weigh
gains,
food
efficiency,
absolute
food
consumption
(
F),
and
water
consumption
(
M)
Supporting
this
endpoint
are
similar
CNS
lesions
and
skin
lesions
observed
in
the
mouse
carcinogenicity
study
(
NOAEL
=
2.8)

*
The
reference
to
the
special
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
chlorfenapyr
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
 
day
or
single
exposure.
The
Dietary
Exposure
Evaluation
Model
(
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
acute
exposure
assessments:
Tolerance­
level
residues
(
not
anticipated
residues);
100%
crop
treated
for
all
registered
and
proposed
commodities;
and
default
DEEM
 
Version
7.76
processing
factors
for
all
commodities.
EPA
selected
separate
acute
dietary
endpoints
for
females
13
 
50
years
old
and
the
general
U.
S.
population
(
including
infants
and
children).
Therefore,
two
separate
acute
dietary
exposure
assessments
were
performed
for
females
13
 
49
years
old
and
for
the
general
U.
S.
population
and
various
population
subgroups.
These
assessments
conclude
that
the
acute
dietary
exposure
estimates
are
below
EPA's
LOC
(<
100%
aPAD)
at
the
95th
exposure
percentile
for
females
13
 
49
years
old
(
15%
aPAD),
and
the
general
U.
S.
population
(
6%
of
the
aPAD)
and
all
other
population
subgroups.
The
most
highly
exposed
population
subgroup
(
other
than
females
13
 
49
years
old)
is
children
1
 
2
years
old,
at
12%
of
the
aPAD.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
DEEM
 
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996,
and
1998
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
Tolerance­
level
residues
(
not
anticipated
residues);
100%
crop
treated
for
all
registered
and
proposed
commodities;
and
default
DEEM
 
Version
7.76
processing
factors
for
all
commodities.
An
assessment
of
the
general
U.
S.
population
and
various
population
subgroups
was
conducted.
This
assessment
concludes
that
the
chronic
dietary
exposure
estimates
are
below
EPA's
LOC
(<
100%
cPAD)
for
the
general
U.
S.
population
(
24%
of
the
cPAD)
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
is
children
1
 
2
years
old,
at
47%
of
the
cPAD.
2.
Dietary
exposure
from
drinking
water.
The
registered
uses
of
chlorfenapyr
include:
Termiticide
use,
crack
and
crevice
use,
and
use
on
ornamental
plants
grown
in
greenhouses.
The
proposed
use
is
for
vegetable
crops
grown
in
greenhouses.
When
used
according
to
label
directions,
these
uses
are
not
expected
to
result
in
contamination
of
drinking
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).
Chlorfenapyr
is
registered
for
residential
crack
and
crevice
use
and
in­
ground
termite
use.
EPA
has
addressed
the
issues
of
possible
residential
exposures
to
chlorfenapyr
when
used
according
to
label
directions,
either
as
a
termiticide
or
as
a
crack
and
crevice
treatment.
EPA
concluded
that
there
is
essentially
no
incidental­
oral
or
dermal
exposures.
Further,
the
low
vapor
pressure
of
chlorfenapyr
makes
inhalation
exposure
negligible.
4.
Cumulative
effects
from
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
chlorfenapyr
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
chlorfenapyr
and
any
other
substances
and
chlorfenapyr
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
chlorfenapyr
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
VerDate
jul<
14>
2003
14:
38
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00092
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
55525
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
cumulative/.

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
There
is
no
evidence
(
qualitative
or
quantitative)
for
increased
susceptibility
following
in
utero
exposure
in
the
developmental
toxicity
studies
in
rats
and
rabbits
or
prenatal/
postnatal
exposure
in
the
2
 
generation
reproduction
study
in
rats.
In
both
the
rat
and
rabbit
developmental
toxicity
studies
maternal
toxicity
included
decreased
body
weight
gain.
No
developmental
toxicity
was
noted
in
rats
up
to
the
highest
dose
tested
of
225
mg/
kg/
day).
Developmental
toxicity
in
rabbits
(
increased
post
implantation
loss)
occurred
at
a
higher
dose
than
maternal
toxicity.
In
the
2
 
generation
reproduction
study
in
rats,
parental
and
offspring
toxicity
included
body
weight
decrements
at
similar
doses.
No
reproductive
effects
were
noted
up
to
the
highest
dose
tested.
3.
Conclusion.
EPA
evaluated
the
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
chlorfenapyr.
EPA
concluded
that
the
toxicology
data
base
was
incomplete
for
FQPA
purposes
because
a
required
DNT
has
not
been
submitted.
The
DNT
was
required
due
to
the
presence
of
neuropathology
(
central
nervous
system
lesions)
and
neurotoxic
signs
seen
in
adult
rats
(
males)
and
mice
(
both
sexes).
Other
than
lacking
the
DNT
study,
EPA
identified
no
residual
uncertainties
for
prenatal/
postnatal
toxicity.
This
decision
is
based
on
the
following:
 
There
is
no
evidence
(
qualitative
or
quantitative)
of
increased
susceptibility
of
rat
or
rabbit
fetuses
to
in
utero
exposure
in
developmental
toxicity
studies.
There
is
no
evidence
(
qualitative
or
quantitative)
of
increased
susceptibility
of
rat
offspring
in
the
multi­
generation
reproduction
toxicity
study.
 
There
are
no
concerns
or
residual
uncertainties
for
prenatal
and
postnatal
toxicity
in
the
available
developmental
and
2
 
generation
reproduction
toxicity
studies.
 
The
conservative
residue
assumptions
used
in
the
dietary
exposure
risk
assessments,
and
the
completeness
of
the
residue
chemistry
database.
EPA
concluded
that
a
FQPA
SF
in
the
form
of
UFDB
of
10X
is
required
until
the
data
from
the
DNT
study
are
received
and
evaluated.
EPA
does
not
have
sufficient
reliable
data
justifying
the
selection
of
a
factor
lower
than
the
default
10X
value
for
this
data
gap.

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
chlorfenapyr
will
occupy
6%
of
the
aPAD
for
the
U.
S.
population,
15%
of
the
aPAD
for
females
13
years
and
older,
12%
of
the
aPAD
for
children
1
 
2
years
old
and
3%
of
the
aPAD
for
infants
<
1
year
old.
As
explained
in
Unit
III.
C.
2.,
there
is
no
potential
for
acute
dietary
exposure
to
chlorfenapyr
in
drinking
water.
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
chlorfenapyr
from
food
will
utilize
24%
of
the
cPAD
for
the
U.
S.
population,
10%
of
the
cPAD
for
infants
<
1
year
old
and
47%
of
the
cPAD
for
children
1
 
2
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
chlorfenapyr
is
not
expected.
There
is
no
potential
for
chronic
dietary
exposure
to
chlorfenapyr
in
drinking
water.
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD.
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).
Chlorfenapyr
is
registered
for
use
on
sites
that
would
result
in
negligible
residential
exposure
and
no
exposure
from
drinking
water.
Therefore,
the
aggregate
risk
is
equal
to
the
risk
from
food,
and
does
not
exceed
the
Agency's
LOC.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
1.
Residue
analytical
methods.
The
proposed
enforcement
method
is
M2427,
a
gas
chromatography/
electron
capture
detection
(
GC/
ECD)
method
with
an
limit
of
quantitation
(
LOQ)
of
0.05
ppm.
Method
M2427
has
been
subjected
to
a
successful
independent
laboratory
validation
(
ILV)
as
well
as
an
acceptable
radiovalidation
using
samples
obtained
from
lettuce
and
tomato
metabolism
studies.
A
version
of
this
method,
M2284
was
sent
to
EPA's
Analytical
Chemistry
Branch
(
ACB)
in
Beltsville,
MD
for
a
petition
method
validation
(
PMV)
on
oranges
and
citrus
oil.
Although
the
PMV
was
successful,
minor
revisions
were
required.
A
new
version
of
analytical
method
M2284
with
the
recommended
revisions
has
not
been
submitted.
The
Agency's
review
of
PP
6F4716
concluded
that
method
M2427
is
adequate
for
data
collection
and
tolerance
enforcement
purposes
pending
submission
of
the
rewritten
method
M2284.
Since
M2427
is
similar
to
M2284,
the
petitioner
was
directed
to
rewrite
Method
M2427
following
the
ACB
comments
regarding
M2284.
The
petitioner
has
submitted
Method
2427.02,
which
contains
the
requested
revisions.
2.
Multiresidue
method
(
MRM).
The
data
requirement
for
MRM
is
satisfied
pending
U.
S.
Food
and
Drug
Administration
(
FDA)
review
and
acceptance
of
the
MRM
results.
The
petitioner
previously
submitted
MRM
recovery
data
for
chlorfenapyr
through
FDA
Protocols
A
through
E.
Protocols
A
and
B
were
not
applicable
to
chlorfenapyr.
In
Protocol
C,
chlorfenapyr
gave
a
good
response
with
the
electron
capture
detector
on
three
different
GC
columns.
In
Protocol
D,
using
pears
as
a
non­
fatty
food
representative,
the
5%
OV­
101
column
gave
the
greatest
sensitivity
at
0.05
and
0.50
ppm.
In
Protocol
E,
chlorfenapyr
eluted
well
on
Florisil
in
both
the
ethyl
ether/
petroleum
ether
system
and
the
alternate
hexane/
acetonitrile/
methylene
chloride
system
and
gave
acceptable
recovery.
Adequate
enforcement
methodology
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.

VerDate
jul<
14>
2003
14:
38
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00093
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
55526
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
B.
International
Residue
Limits
There
are
no
established
Codex,
Canadian,
or
Mexican
maximum
residue
levels
(
MRLs)
for
chlorfenapyr
on
fruiting
vegetables;
therefore,
harmonization
of
MRLs
and
U.
S.
tolerances
is
not
an
issue
at
this
time.

C.
Conditions
The
following
data
are
required
as
a
condition
of
registration:
A
developmental
neurotoxicity
study
to
determine
the
cause/
relationship
of
potential
central
nervous
system/
myelinopathic
alterations
to
neurotoxicity
in
the
developing
young.

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
chlorfenapyr,
4­
bromo­
2­
(
4­
chlorophenyl)­
1­(
ethoxymethyl)­
5­
(
trifluoromethyl)­
1H­
pyrrole­
3­
carbonitrile,
in
or
on
vegetables,
fruiting,
group
8
at
1.0
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
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
 
0146
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,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VI.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0146,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

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

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
VerDate
jul<
14>
2003
14:
38
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00094
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
55527
Federal
Register
/
Vol.
68,
No.
187
/
Friday,
September
26,
2003
/
Rules
and
Regulations
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
tolerance
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

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

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

Dated:
September
22,
2003.
James
Jones,
Director,
Office
of
Pesticide
Programs.

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

PART
180
 
[
AMENDED]

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

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.

2.
A
new
section
heading
and
text
are
added
to
§
180.513
to
read
as
follows:

§
180.513
Chlorfenapyr;
tolerances
for
residues.

(
a)
General.
Tolerances
are
established
for
residues
of
the
insecticide
chlorfenapyr
[
4­
bromo­
2­(
4­
chlorophenyl)­
1­(
ethoxymethyl)­
5­
(
trifluoromethyl)­
1H­
pyrrole­
3­
carbonitrile]
in
or
on
the
following
raw
agricultural
commodities:

Commodity
Parts
per
million
Vegetables,
fruiting,
group
8
....
1.0
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]

[
FR
Doc.
03
 
24405
Filed
9
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
HEALTH
AND
HUMAN
SERVICES
Centers
for
Medicare
&
Medicaid
Services
42
CFR
Part
447
[
CMS
 
2175
 
CN]

RIN
0938
 
AM20
Medicaid
Program;
Time
Limitation
on
Price
Recalculations
and
Recordkeeping
Requirements
Under
the
Drug
Rebate
Program;
Correction
AGENCY:
Centers
for
Medicare
&
Medicaid
Services
(
CMS),
HHS.
ACTION:
Final
rule;
correction.

SUMMARY:
This
document
corrects
the
effective
date
of
a
final
rule
with
comment
period
published
in
the
Federal
Register
on
August
29,
2003
(
68
FR
51912).
That
rule
finalizes
separately,
in
an
accelerated
timeframe,
two
specific
provisions
of
the
September
19,
1995
proposed
rule.
It
establishes
new
recordkeeping
requirements
for
drug
manufacturers
under
the
Medicaid
drug
rebate
program.
It
also
sets
forth
a
3­
year
time
limitation
during
which
manufacturers
must
report
changes
to
average
manufacturer
price
and
best
price
for
purposes
of
reporting
data
to
us.
In
addition,
it
announces
the
pressing
need
for
codification
of
fundamental
recordkeeping
requirements.
It
also
announces
our
intention
to
continue
to
work
on
finalizing
the
complete
drug
VerDate
jul<
14>
2003
15:
34
Sep
25,
2003
Jkt
200001
PO
00000
Frm
00095
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26SER1.
SGM
26SER1
