Document ID: EPA-HQ-OPP-2003-0205-0001
Agency: epa
Document Type: Notice
Title: Chlorfenapyr; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-16T04:00Z

42022
Federal
Register
/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Notices
after
adjournment
of
the
public
meeting
to
provide
written
comments
supporting
any
verbal
comments
stated
at
the
public
meeting
to
be
made
a
part
of
the
public
record.
Meeting
Access:
Individuals
requiring
special
accommodation
at
this
meeting,
including
wheelchair
access
to
the
conference
room,
should
contact
Ms.
Sandra
Friedman,
friedman.
sandra@
epa.
gov
or
by
telephone/
voice
mail
at
(
202)
564
 
2526
at
least
five
business
days
prior
to
the
meeting
date
so
that
appropriate
arrangements
can
be
made.

Dated:
July
9,
2003.
Vanessa
T.
Vu,
Director,
EPA
Science
Advisory
Board.
[
FR
Doc.
03
 
18004
Filed
7
 
15
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0205;
FRL
 
7312
 
7]

Chlorfenapyr;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0205,
must
be
received
on
or
before
August
15,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
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
are
a
commercial
processor
of
food,
or
use
pesticides
to
control
pests
in
food
processing
operations.
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.
EPA
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0205.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
on
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
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42023
Federal
Register
/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Notices
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also,
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0205.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
number
OPP
 
2003
 
0205.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
number
OPP
 
2003
 
0205.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
number
OPP
 
2003
 
0205.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
to
the
Agency?

Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
July
2,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
BASF
Corporation
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
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/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Notices
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

BASF
Corporation
PP
3F6560
EPA
has
received
a
pesticide
petition
(
PP
3F6560)
from
BASF
Corporation,
26
Davis
Drive,
Research
Triangle
Park,
NC
27709
 
3528
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180,
by
establishing
a
tolerance
for
residues
of
chlorfenapyr,
[
4­
bromo­
2­(
4­
chlorophenyl)­
1­(
ethoxymethyl)­
5­
(
trifluoromethyl)­
1H­
pyrrole­
3­
carbonitrile]
on
all
food
items
in
food
handling
establishments
where
food
products
are
held,
processed,
and/
or
prepared
at
0.01
parts
per
million
(
ppm).
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
nature
of
the
residues
of
chlorfenapyr
in
plants
(
tomato,
citrus,
potato
and
head
lettuce)
is
adequately
understood
and
the
residue
of
concern
consists
of
the
parent
molecule.
The
metabolic
pathway
of
chlorfenapyr
in
the
laying
hen
and
the
lactating
goat
was
also
similar
to
that
in
laboratory
rats.
2.
Analytical
method.
The
GC
analytical
method,
M
2398,
which
is
proposed
as
the
enforcement
method
for
the
residue
of
chlorfenapyr
in
or
on
food
commodities,
has
a
limit
of
quantitation
(
LOQ)
of
0.01
ppm.
3.
Magnitude
of
residues.
A
study,
based
on
protocol
recommendations
outlined
in
EPA's
Residue
Chemistry
Test
Guidelines,
(
OPPTS
Harmonized
Test
Guideline
860.1460:
Food
Handling),
was
conducted
with
chlorfenapyr
formulated
as
a
24%
wettable
powder.
Applications
were
made
to
all
potential
sites
within
a
commercial
kitchen,
including
the
perimeter
of
the
restaurant
kitchen,
areas
under
cabinets
and
overhead
cabinets,
behind
and
on
sides
of
cabinets
and
appliances,
within
the
ceiling
voids,
and
around
pipes,
cords,
cables,
counter
legs,
and
wheels.
The
areas
in
which
the
product
was
applied
are
typical
of
those
treated
in
a
professional
pest
control
operation
in
a
commercial
kitchen.
The
test
was
conducted
using
a
wettable
powder
(
WP)
formulation
at
the
maximum
label
rate
for
indoor
use
of
0.5%
active
ingredient
(
a.
i.)/
1,000
ft2,
which
is
also
the
approved
maximum
rate
for
indoor
use
in
non­
food/
feed
areas
for
the
SC
formulation
(
suspension
in
water),
EPA
Registration
No.
241
 
392.
The
WP
formulation
has
a
larger
particle
size
and
will
be
more
easily
dispersed
than
the
SC
formulation,
and
therefore
will
best
characterize
the
potential
for
exaggerated
exposures
to
food
items.
Results
from
this
study
were
that
magnitudes
of
residues
in
all
composite
meal
samples,
both
covered
and
uncovered,
were
below
the
LOQ
of
10
parts
per
billion
(
ppb).
Thus,
there
is
a
reasonable
expectation
that
no
finite
residues
of
chlorfenapyr
will
result
in
food
items
following
crack
and
crevice
or
spot
applications
of
either
the
25%
wettable
powder
or
the
21%
suspension
concentrate.

B.
Toxicological
Profile
The
toxicity
of
chlorfenapyr
has
been
studied
extensively
and
there
is
a
complete
data
base
to
address
the
acute
and
chronic
effects,
effects
on
genetic
material,
the
potential
for
carcinogenicity
or
teratogenicity,
and
effects
on
reproductive
performance
or
growth
of
offspring.
Toxicological
data
submitted
previously
that
support
this
petition
for
tolerances
of
chlorfenapyr
include:
1.
Acute
toxicity.
Based
on
EPA's
toxicity
category
criteria,
the
acute
toxicity
category
for
chlorfenapyr
technical,
EPA
Registration
No.
241
 
366,
is
Category
II
or
moderately
toxic
(
signal
word
WARNING)
and
the
acute
toxicity
category
for
the
2SC
formulation,
EPA
Registration
Nos.
241
 
374
and
241
 
392,
is
Category
III
or
slightly
toxic
(
signal
word
CAUTION).
Males
appear
to
be
more
sensitive
to
the
effects
of
chlorfenapyr
than
females.
The
acute
toxicity
profile
indicates
that
absorption
by
the
oral
route
appears
to
be
greater
than
by
the
dermal
route.
The
following
are
the
results
from
the
acute
toxicity
tests
conducted
on
the
technical
material.
i.
Rat
Oral,
LD50
of
441/
1,152
milligrams/
kilogram
body
weight
(
mg/
kg
bwt)
modifying
factor
(
M/
F)
­
Toxicology
Category
II.
ii.
Rabbit
Dermal
LD50:
>
2,000
mg/
kg
bwt
M/
F
Toxicology
Category
III.
iii.
Acute
Inhalation
LC50:
0.83/
>
2.7
milligrams
per
liter
(
mg/
L)
M/
F
Toxicology
Category
III.
iv.
Eye
irritation:
Moderately
irritating
­
Toxicology
Category
III.
v.
Dermal
irritation:
Non­
irritating
­
Toxicology
Category
IV.
vi.
Dermal
sensitization:
Nonsensitizer
­
Non
sensitizer.
vii.
Acute
neurotoxicity:
NOEL
45
mg/
kg
bwt.
Not
an
acute
neurotoxicant
2.
Genotoxicity.
Chlorfenapyr
technical
(
94.5%)
was
examined
in
a
battery
of
in
vitro
and
in
vivo
tests
to
assess
its
genotoxicity
and
its
potential
for
carcinogenicity.
These
tests
are
summarized
below.
i.
Microbial/
Microsome
Mutagenicity
Assay:
Non­
mutagenic.
ii.
Mammalian
Cell
CHO/
HGPRT
Mutagenicity
Assay:
Non­
mutagenic.
iii.
In
vivo
Micronucleus
Assay:
Nongenotoxic
iv.
In
vitro
Chromosome
Aberration
Assay
in
CHO:
Non­
clastogenic.
v.
In
vitro
Abberation
Assay
in
CHLC:
Non­
clastogenic.
vi.
Unscheduled
DNA
Synthesis
(
UDS)
Assay:
Non­
genotoxic.
3.
Reproductive
and
developmental
toxicity.
Reproductive
and
developmental
toxicity.
Chlorfenapyr
is
neither
a
reproductive
nor
developmental
toxicant
and
is
not
a
teratogenic
agent
in
the
Sprague­
Dawley
rat
or
the
New
Zealand
white
rabbit.
This
is
demonstrated
by
the
results
of
the
following
studies:
i.
Rat
oral
teratology.
No
observed
effect
level
(
NOEL)
for
maternal
toxicity
25
mg/
kg
bwt/
day
and
NOEL
for
fetal/
developmental
toxicity
at
225
mg/
kg
bwt/
day.
ii.
Rabbit
oral
teratology.
NOEL
for
maternal
5
mg/
kg
bwt/
day
and
NOEL
for
fetal/
developmental
toxicity
30
mg/
kg
bwt/
day.
iii.
Rat
2­
generation
reproduction.
NOEL
for
parental
toxicity/
growth
and
offspring
development
60
parts
per
million
(
ppm)
(
5
mg/
kg
bwt/
day)
and
NOEL
for
reproductive
performance
600
ppm
(
44
mg/
kg
bwt/
day)
4.
Subchronic
toxicity.
The
following
are
the
results
of
the
subchronic
toxicity
test
that
have
been
conducted
with
chlorfenapyr.
i.
28
 
Day
rabbit
dermal
­
NOEL
100
mg/
kg
bwt/
day.
ii.
28
 
Day
rat
feeding
­
NOEL
<
600
ppm
(<
71.6
mg/
kg
bwt/
day).
iii.
28
 
Day
mouse
feeding
­
NOEL
<
160
ppm
(<
32
mg/
kg
bwt/
day).
iv.
13
 
Week
rat
dietary
­
NOEL
150
ppm
(
11.7
mg/
kg
bwt/
day).
v.
13
 
Week
mouse
dietary
­
NOEL
40
ppm
(
8.2
mg/
kg
bwt/
day).
vi.
13
 
Week
dog
dietary
­
NOEL
120
ppm
(
4.2
mg/
kg
bwt/
day).
5.
Chronic
toxicity.
Chlorfenapyr
is
not
oncogenic
in
either
Sprague­
Dawley
rats
or
CD­
1
mice
and
is
not
likely
to
be
carcinogenic
in
humans.
The
following
are
the
results
of
the
chronic
toxicity
tests
that
have
been
conducted
with
chlorfenapyr:

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Federal
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/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Notices
i.
1
 
Year
neurotoxicity
in
rats.
No
observed
adverse
effect
level
(
NOAEL)
60
ppm
(
2.6/
3.4
mg/
kg
bwt/
day
M/
F).
ii.
1
 
Year
dog
dietary.
NOAEL
120
ppm
(
4.0/
4.5
mg/
kg
bwt/
day
M/
F).
iii.
24
 
Month
rat
dietary.
NOAEL
for
chronic
effects
60
ppm
(
2.9/
3.6
mg/
kg
bwt/
day
M/
F
and
NOAEL
for
oncogenic
effects
600
ppm
(
31/
37
mg/
kg
bwt/
day
M/
F).
iv.
18
 
Month
mouse
dietary
­
NOAEL
for
chronic
effects
20
ppm
(
2.8/
3.7
mg/
kg
bwt/
day
M/
F
and
NOEL
for
Oncogenic
Effects
240
ppm
(
34.5/
44.5
mg/
kg
bwt/
day
M/
F).
6.
Animal
metabolism.
A
metabolism
study
was
conducted
in
Sprague­
Dawley
rats
at
approximately
20
and
200
mg/
kg
bwt
using
radiolabeled
chlorfenapyr.
Approximately
65%
of
the
administered
dose
was
eliminated
during
the
first
24
hours
(
62%
in
feces
and
3%
in
urine)
and
by
48
hours
following
dosing,
approximately
85%
of
the
dose
had
been
excreted
(
80%
in
feces
and
5%
in
urine.)
The
absorbed
chlorfenapyr­
related
residues
were
distributed
throughout
the
body
and
detected
in
tissues
and
organs
of
all
treatment
groups.
The
principal
route
of
elimination
was
via
feces,
mainly
as
unchanged
parent
plus
minor
Ndealkylated
debrominated,
and
hydroxylated
oxidation
products.
The
metabolic
pathway
of
chlorfenapyr
in
the
laying
hen
and
the
lactating
goat
was
also
similar
to
that
in
laboratory
rats.
7.
Metabolite
toxicology.
The
parent
molecule
is
the
only
moiety
of
toxicological
significance
in
plant
and
animal
commodities.
8.
Endocrine
disruption.
Collective
organ
weights
and
histopathological
findings
from
the
2­
generation
rat
reproduction
study,
as
well
as
from
the
subchronic
and
chronic
toxicity
studies
in
two
or
more
animal
species,
demonstrate
no
apparent
estrogenic
effects
or
effects
on
the
endocrine
system.
There
is
no
information
available
which
suggests
that
chlorfenapyr
would
be
associated
with
endocrine
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Based
on
the
completeness
and
reliability
of
the
toxicity
data
and
the
exposure
assessment
conducted,
BASF
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
chlorfenapyr,
including
all
dietary
exposure.
i.
Food.
There
are
currently
no
established
U.
S.
permanent
food
tolerances
for
chlorfenapyr.
There
are
two
tolerance
petitions
pending
at
EPA;
0.5
ppm
tolerance
on
imported
citrus
and
1.5
ppm
tolerance
on
greenhouse
grown
vegetable,
fruiting,
crop
group
8.
A
dietary
exposure
estimate
based
on
theoretical
maximum
residue
contribution
(
TMRC)
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
The
TMRC
is
a
``
worst
case''
estimate
for
dietary
exposure
because
it
assumes
that
100%
of
crop
is
treated
and
residues
in
the
food
are
always
found
at
the
tolerance
level.
Additional
assumptions
used
were
all
consumption
of
tomatoes­
whole
is
from
treated
greenhouse
grown
tomatoes,
greenhouse
grown
tomatoes
are
not
processed,
and
all
citrus
juice
in
the
U.
S.
is
made
from
treated
imported
citrus
pulp.
Default
processing
factors
were
used
to
determine
concentrations
in
processed
fractions.
The
tolerance
levels
used
in
the
dietary
assessment
were
0.5
ppm
for
citrus
pulp,
1.5
ppm
for
vegetable,
fruiting,
group
8,
and
0.01
ppm
for
all
other
crops.
a.
Acute
exposure.
The
acute
RfD
used
for
this
evaluation
was
0.45
mg/
kg
bwt
calculated
by
applying
the
100
 
fold
safety
factor
to
the
NOEL
from
the
acute
neurotoxicity
evaluation
of
chlorfenapyr.
The
acute
exposure
was
evaluated
at
the
99.9th
percentile.
The
most
highly
exposure
sub­
population
was
non­
nursing
infants
(<
1
yr
old)
which
utilized
16.2%
of
the
acute
RfD.
Therefore,
based
on
the
exposure
assessment
discussed
above,
BASF
concludes
there
is
a
reasonable
certainty
that
no
harm
will
result
from
the
acute
dietary
exposure
to
chlorfenapyr
residues.
b.
Chronic
exposure.
The
chronic
RfD
used
for
this
evaluation
was
0.03
mg/
kg
bwt
calculated
by
applying
a
100
 
fold
safety
factor
to
the
NOAEL
from
1
 
year
rat
neurotoxicity
study
and
the
chronic
feeding
studies
in
the
rat
and
mouse.
The
most
highly
exposure
subpopulation
was
children
1
 
6
years
of
age
which
utilized
19.8%
of
the
chronic
RfD.
Therefore,
based
on
the
exposure
assessment
discussed
above,
BASF
concludes
there
is
a
reasonable
certainty
that
no
harm
will
result
from
the
chronic
dietary
exposure
to
chlorfenapyr
residues.
ii.
Drinking
water.
There
is
no
concern
for
exposure
to
residues
of
chlorfenapyr
in
drinking
water
based
on
the
approved,
pending
and
proposed
directions
for
use
and
its
physical
and
chemical
properties.
Approved
uses
in
the
U.
S.
include
applications
to
ornamental
plants
inside
greenhouses,
to
a
narrow
band
of
soil
adjacent
to
buildings
and
to
crack­
and­
crevice
and
spot
treatments
inside
structures.
A
pending
use
expands
greenhouse
applications
to
vegetable,
fruiting,
crop
group
8.
The
proposed
use
for
food
handling
areas
is
also
applied
as
a
crack­
and­
crevice
and
spot
treatment
inside
structures.
Chlorfenapyr
has
extremely
low
water
solubility
(
120
ppb
at
25
°
C)
and
is
also
immobile
in
soil
and
does
not
leach
because
it
is
strongly
adsorbed
to
all
common
soil
types.
2.
Non­
dietary
exposure.
Non­
dietary
exposure
to
chlorfenapyr
is
expected
to
be
negligible
based
on
assessments
made
by
EPA
for
the
approved
use
on
ornamentals
grown
in
greenhouses,
as
a
termiticide
and
for
indoor
applications
for
general
pest
control.
These
assessments
were
based
on
the
physicochemical
characteristics
of
the
compound,
the
intended
use
pattern,
and
available
information
concerning
its
environmental
fate.
The
vapor
pressure
of
chlorfenapyr
is
less
than
1
x
10
 
7
mm
of
mercury
(
Hg);
therefore,
the
potential
for
non­
occupational
exposure
by
inhalation
is
insignificant.
These
assessments
also
apply
to
the
pending
use
on
greenhouse
grown
vegetable,
fruiting,
crop
group
8
and
the
proposed
use
in
food
handling
areas.

D.
Cumulative
Effects
The
pyrrole
insecticides
represent
a
new
class
of
chemistry
with
a
unique
mechanism
of
action.
No
other
data
are
available
that
indicate
that
any
toxicological
effects
produced
by
chlorfenapyr
would
be
cumulative
with
those
of
any
other
compound.
The
parent
molecule,
chlorfenapyr
is
a
pro­
insecticide
that
is
converted
to
the
active
form,
CL
303,268,
via
rapid
metabolism
by
mixed
function
oxidases
(
MFOs).
The
active
form
uncouples
oxidative
phosphorylation
in
the
insect
mitochondria
by
disrupting
the
proton
gradient
across
the
mitochondrial
membrane.
The
production
of
ATP
is
inhibited
resulting
in
the
cessation
of
all
cellular
functions.
Because
of
this
unique
mechanism
of
action,
it
is
highly
unlikely,
that
toxic
effects
produced
by
chlorfenapyr
would
be
cumulative
with
those
of
any
other
pesticide
chemical.
In
mammals,
there
is
a
lower
titer
of
MFOs,
and
chlorfenapyr
is
metabolized
by
different
pathways
(
including
dehalogenation,
oxidation
and
ring
hydroxylation)
to
other
polar
metabolites
without
any
significant
accumulation
of
the
potent
uncoupler,
CL
303,268.
In
the
rat,
approximately
85%
of
the
administered
dose
is
excreted
in
the
feces
within
48
hours,
thereby
reducing
the
levels
of
chlorfenapyr
and
CL
303,268
that
are
capable
of
reaching
the
mitochondria.
This
differential
metabolism
of
chlorfenapyr
to
CL
303,268
in
insects
versus
to
other
polar
metabolites
in
mammals
is
responsible
for
the
selective
insect
toxicity
of
the
pyrroles.

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Federal
Register
/
Vol.
68,
No.
136
/
Wednesday,
July
16,
2003
/
Notices
E.
Safety
Determination
1.
U.
S.
population.
Using
the
exposure
assumptions
described
above,
BASF
has
estimated
that
chronic
dietary
aggregate
exposure
to
chlorfenapyr
for
the
U.
S.
population
was
0.002615
mg/
kg
bwt/
day
or
8.7%
of
the
chronic
RfD
of
0.03
mg/
kg
bwt/
day.
Other
than
children
less
than
12
years
of
age,
hispanics
are
the
U.
S.
population
subgroup
with
the
highest
chronic
exposure
of
0.003403
mg/
kg
bwt/
day,
or
11.3%
of
the
RfD.
EPA
has
no
concerns
about
exposure
that
are
less
than
100%
of
the
RfD
as
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
It
is
therefore,
safe
to
conclude
that
there
is
reasonable
certainty
that
no
harm
to
the
overall
U.
S.
population
will
result
from
chronic
exposure
to
chlorfenapyr
residues.
2.
Infants
and
children.
Using
the
exposure
assumption
described
above,
BASF
has
estimated
that
the
chronic
dietary
aggregate
exposure
to
chlorfenapyr
for
children
1
 
6
years
of
age
was
0.005936
mg/
kg
bwt/
day,
or
19.8%
of
the
chronic
RfD
of
0.03
mg/
kg
bwt/
day.
Children
1
 
6
years
of
age
were
the
sub­
population
that
utilized
the
largest
portion
of
the
chronic
RfD.
It
is
therefore,
safe
to
conclude
that
there
is
reasonable
certainty
that
no
harm
to
infants
and
children
will
result
from
chronic
exposure
to
chlorfenapyr
residues.

F.
International
Tolerances
No
Codex
or
Canadian
tolerances/
limits
for
residues
in
any
food
presently
exist
for
chlorfenapyr.
In
Mexico
there
is
a
MRL
of
0.3
ppm
for
cottonseed.
[
FR
Doc.
03
 
17900
Filed
7
 
15
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0235;
FRL
 
7317
 
4]

Gellan
Gum;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
identification
(
ID)
number
OPP
 
2003
 
0235,
must
be
received
on
or
before
August
15,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6304;
e­
mail
address:
boyle.
kathryn@
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
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
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
ID
number
OPP
 
2003
 
0235.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
EPA's
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
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