Document ID: EPA-HQ-OPP-2003-0025-0001
Agency: epa
Document Type: Notice
Title: Pyriproxyfen; Notice of Filing Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-07T05:00Z

11093
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
F.
International
Tolerances
There
are
no
established
codex,
Canadian
or
Mexican
maximum
residue
levels
for
spiroxamine.
[
FR
Doc.
03
 
5316
Filed
3
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0025;
FRL
 
7289
 
8]

Pyriproxyfen;
Notice
of
Filing
Pesticide
Petitions
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
pesticide
petitions
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
 
0025,
must
be
received
on
or
before
April
7,
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:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
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
producers
(
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions.
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
 
0025.
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
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
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
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
VerDate
Dec<
13>
2002
17:
55
Mar
06,
2003
Jkt
200001
PO
00000
Frm
00063
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
07MRN1.
SGM
07MRN1
11094
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
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
 
0025.
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
 
0025.
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
 
0025.
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
 
0025.
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:
January
30,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summaries
of
Petitions
The
petitioner
summaries
of
the
pesticide
petitions
are
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summaries
of
the
petitions
were
prepared
by
the
petitioners
and
represent
the
views
of
the
petitioners.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
IR­
4
2E6416,
2E6425,
2E6428,
and
2E6436
EPA
has
received
pesticide
petitions
(
2E6416,
2E6425,
2E6428,
and
2E6436)
from
the
Interregional
Research
Project
Number
IR­
4,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
VerDate
Dec<
13>
2002
17:
55
Mar
06,
2003
Jkt
200001
PO
00000
Frm
00064
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
07MRN1.
SGM
07MRN1
11095
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
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
180.510
by
establishing
tolerances
for
residues
of
pyriproxyfen,
2­[
1­
methyl­
2­
4­
phenoxyphenoxy)
ethoxypyridine]
in
or
on
the
following
raw
agricultural
commodities:
1.
PP
2E6416
proposes
the
establishment
of
tolerances
for
atemoya,
biriba,
cherimoya,
custard
apple,
ilama,
soursop,
and
sugar
apple
at
0.20
parts
per
million
ppm
(
ppm).
2.
PP
2E6425
proposes
the
establishment
of
tolerances
for
fig
at
0.30
ppm,
and
fig,
dried
at
.1
ppm.
3.
PP
2E6428
proposes
the
establishment
of
tolerances
for
avocado,
black
sapote,
canistel,
mamey
sapote,
mango,
papaya,
sapodilla,
and
star
apple
at
1.0
ppm.
4.
PP
2E6436
proposes
the
establishment
of
a
tolerance
for
okra
at
0.02
ppm.
EPA
has
determined
that
the
petitions
contain
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
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.
This
notice
includes
a
summary
of
the
petitions
prepared
by
Valent
USA
Corporation.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
major
metabolic
pathways
in
plants
is
aryl
hydroxylation
and
cleavage
of
the
ether
linkage,
followed
by
further
metabolism
into
more
polar
products
by
further
oxidation
and/
or
conjugation
reactions.
However,
the
bulk
of
the
radiochemical
residue
on
raw
agricultural
commodities
samples
remained
as
parent.
Comparing
metabolites
detected
and
quantified
from
cotton,
apple,
tomato,
goat,
hen,
and
rat
shows
that
there
are
no
significant
aglycones
in
plants
which
are
not
also
present
in
the
excreta
or
tissues
of
animals.
The
residue
of
concern
is
best
defined
as
the
parent,
pyriproxyfen.
2.
Analytical
method.
The
extraction
methodology
has
been
validated
using
aged
radiochemical
residue
samples
from
metabolism
studies.
The
methods
have
been
validated
in
cottonseed,
apples,
soil,
and
oranges
at
independent
laboratories.
EPA
has
successfully
validated
the
analytical
methods
for
analysis
of
cottonseed,
pome
fruit,
nutmeats,
almond
hulls,
and
fruiting
vegetables.
The
limit
of
detection
of
pyriproxyfen
in
the
methods
is
0.01
ppm
which
will
allow
monitoring
of
food
with
residues
at
the
levels
proposed
for
the
tolerances.
3.
Magnitude
of
residues.
The
magnitude
of
residues
for
pyriproxyfen
is
adequately
understood
for
the
proposed
commodities.

B.
Toxicological
Profile
1.
Acute
toxicity.
An
assessment
of
toxic
effects
caused
by
pyriproxyfen
is
discussed
in
Unit
II.
B.
of
the
Federal
Register
dated
April
4,
2001
(
FRL
 
6772
 
4)
(
66
FR
17883).
2.
Animal
metabolism.
The
absorption,
tissue
distribution,
metabolism
and
excretion
of
14C­
labeled
pyriproxyfen
were
studied
in
rats
after
single
oral
doses
of
2
or
1,000
milligrams/
kilograms
body
weight
(
mg/
kg/
bwt)
(
phenoxyphenyl
and
pyridyl
label),
and
after
a
single
oral
dose
of
2
mg/
kg/
bwt,
phenoxyphenyl
label
only,
following
14
daily
oral
doses
at
2
mg/
kg/
bwt
of
unlabelled
material.
For
all
dose
groups,
most
88
 
96%)
of
the
administered
radiolabel
was
excreted
in
the
urine
and
feces
within
2
days
after
radiolabeled
test
material
dosing,
and
92
 
98%
of
the
administered
dose
was
excreted
within
7
days.
Seven
days
after
dosing,
tissue
residues
were
generally
low,
accounting
for
no
more
than
0.3%
of
the
dosed
14C.
Radiocarbon
concentrations
in
fat
were
the
higher
than
in
other
tissues
analyzed.
Recovery
in
tissues
over
time
indicates
that
the
potential
for
bioaccumulation
is
minimal.
There
were
no
significant
sex
or
dose­
related
differences
in
excretion
or
metabolism.
3.
Metabolite
toxicology.
The
potential
for
chronic
toxicity
is
adequately
tested
by
chronic
exposure
to
the
parent
at
the
maximum
tolerated
dose
and
consequent
chronic
exposure
to
the
internally
formed
metabolites.
Seven
metabolites
of
pyriproxyfen,
4 ­
OHpyriproxyfen
5 ­
OH­
pyriproxyfen,
desphenyl­
pyriproxyfen,
POPA,
PYPAC,
2­
OH­
pyridine
and
2,5­
diOH­
pyridine,
have
been
tested
for
mutagenicity,
via
Ames
assay,
and
acute
oral
toxicity
to
mice.
All
seven
metabolites
were
tested
in
the
Ames
assay
with
and
without
S9
at
doses
up
to
5,000
micrograms
per
plate
or
up
to
the
growth
inhibitory
dose.
The
metabolites
did
not
induce
any
significant
increases
in
revertible
colonies
in
any
of
the
test
strains.
Positive
control
chemicals
showed
marked
increases
in
reverting
colonies.
The
acute
toxicity
to
mice
of
4 ­
OHpyriproxyfen
5 ­
OH­
pyriproxyfen,
desphenyl­
pyriproxyfen,
POPA,
and
PYPAC
did
not
appear
to
markedly
differ
from
pyriproxyfen,
with
all
metabolites
having
acute
oral
lethal
dose
(
LD50)
values
greater
than
2,000
mg/
kg/
bwt.
The
two
pyridines,
2­
OHpyridine
and
2,5­
diOH­
pyridine,
gave
acute
oral
LD50
values
of
124
(
male)
and
166
(
female)
mg/
kg/
bwt,
and
1,105
(
male)
and
1,000
(
female)
mg/
kg/
bwt,
respectively.
4.
Endocrine
disruption.
While
specific
tests,
uniquely
designed
to
evaluate
the
potential
effects
of
pyriproxyfen
on
mammalian
endocrine
systems
have
not
been
conducted,
the
toxicology
of
pyriproxyfen
has
been
extensively
evaluated
in
acute,
subchronic
chronic,
developmental,
and
reproductive
toxicology
studies
including
detailed
histopathology
of
numerous
tissues.
The
results
of
these
studies
show
no
evidence
of
any
endocrine­
mediated
effects
and
no
pathology
of
the
endocrine
organs.
Consequently,
Valent
concludes
that
pyriproxyfen
does
not
possess
estrogenic
or
endocrine
disrupting
properties
applicable
to
mammals.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
An
evaluation
of
chronic
dietary
exposure
including
both
food
and
drinking
water
has
been
performed
for
the
U.
S.
population
and
various
sub­
populations
including
infants
and
children.
No
acute
dietary
endpoint
and
dose
was
identified
in
the
toxicology
data
base
for
pyriproxyfen,
therefore,
the
Valent
Corporation
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
acute
dietary
exposure.
Chronic
dietary
exposure
to
pyriproxyfen
residues
was
calculated
for
the
U.
S.
population
and
25
population
subgroups
assuming
tolerance
level
residues,
processing
factors
from
residue
studies,
and
100%
of
the
crop­
treated.
The
analyses
included
residue
data
for
all
existing
uses,
pending
uses,
and
proposed
new
uses.
ii.
Drinking
water.
Since
pyriproxyfen
is
applied
outdoors
to
growing
agricultural
crops,
the
potential
exists
for
pyriproxyfen
or
its
metabolites
to
reach
ground
water
or
surface
water
that
may
be
used
for
drinking
water.
Because
of
the
physical
properties
of
pyriproxyfen,
it
is
unlikely
that
pyriproxyfen
or
its
metabolites
can
leach
to
potable
ground
water.
To
quantify
potential
exposure
from
drinking
water,
surface
water
concentrations
for
pyriproxyfen
were
estimated
using
Generic
Expected
Environmental
Concentration
(
GENEEC)
1.3.
2.
Non­
dietary
exposure.
Pyriproxyfen
is
currently
registered
for
use
on
residential
non­
food
sites.
Pyriproxyfen
is
the
active
ingredient
in
numerous
registered
products
for
flea
and
tick
control.
Formulations
include
foggers,

VerDate
Dec<
13>
2002
17:
55
Mar
06,
2003
Jkt
200001
PO
00000
Frm
00065
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
07MRN1.
SGM
07MRN1
11096
Federal
Register
/
Vol.
68,
No.
45
/
Friday,
March
7,
2003
/
Notices
aerosol
sprays,
emulsifiable
concentrates,
and
impregnated
materials
(
pet
collars).
With
the
exception
of
the
pet
collar
uses,
consumer
use
of
pyriproxyfen
typically
results
in
acute
and
short­
term
intermittent
exposures.

D.
Cumulative
Effects
There
are
no
other
pesticidal
compounds
that
are
structurally
related
to
pyriproxyfen
and
have
similar
effects
on
animals.
In
consideration
of
potential
cumulative
effects
of
pyriproxyfen
and
other
substances
that
may
have
a
common
mechanism
of
toxicity,
there
are
currently
no
available
data
or
other
reliable
information
indicating
that
any
toxic
effects
produced
by
pyriproxyfen
would
be
cumulative
with
those
of
other
chemical
compounds.
Thus,
only
the
potential
risks
of
pyriproxyfen
have
been
considered
in
this
assessment
of
aggregate
exposure
and
effects.
Valent
will
submit
information
for
EPA
to
consider
concerning
potential
cumulative
effects
of
pyriproxyfen
consistent
with
the
schedule
established
by
EPA
at
(
62
FR
42020
August
4,
1997)
and
other
subsequent
EPA
publications
pursuant
to
the
Food
Quality
Protection
Act.

E.
Safety
Determination
1.
U.
S.
population.
Chronic
exposure
to
the
overall
U.
S.
population
is
estimated
to
be
0.002984
mg/
kg/
bwt
day,
representing
0.9%
of
the
Reference
Dose
(
RfD).
The
results
of
the
chronic
dietary
exposure
assessment
demonstrate
that
estimates
of
chronic
dietary
exposure
for
all
existing,
pending
and
proposed
uses
of
pyriproxyfen
are
well
below
the
chronic
RfD
of
0.35
mg/
kg/
bwt
day.
The
estimated
chronic
dietary
exposure
from
food
for
the
overall
U.
S.
population
and
many
non­
child/
infant
subgroups
is
from
0.002123
to
0.003884
mg/
kg/
bwt
day,
0.607
to
1.100%
of
the
RfD.
Generally,
the
Agency
has
no
cause
for
concern
if
total
residue
contribution
is
less
than
100%
of
the
RfD.
Valent
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
overall
U.
S.
population
or
any
nonchild
infant
subgroups
from
aggregate,
chronic
dietary
exposure
to
pyriproxyfen
residues.
2.
Infants
and
children
 
i.
Safety
factor
for
infants
and
children.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
pyriproxyfen,
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
margin
of
safety,
up
to
10­
fold,
for
added
protection
for
infants
and
children
in
the
case
of
threshold
effects
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.
The
toxicological
data
base
for
evaluating
prenatal
and
postnatal
toxicity
for
pyriproxyfen
is
complete
with
respect
to
current
data
requirements.
There
are
no
special
prenatal
or
postnatal
toxicity
concerns
for
infants
and
children,
based
on
the
results
of
the
rat
and
rabbit
developmental
toxicity
studies
or
the
2­
generation
reproductive
toxicity
study
in
rats.
Valent
concludes
that
reliable
data
support
use
of
the
standard
100­
fold
uncertainty
factor
and
that
an
additional
uncertainty
factor
is
not
needed
for
pyriproxyfen
to
be
further
protective
of
infants
and
children.
ii.
Chronic
dietary
exposure
and
risk
infants
and
children.
For
the
most
highly
exposed
sub­
population,
children
1
to
6
years
of
age,
exposure
is
calculated
to
be
0.007438
mg/
kg/
bwt
day,
or
2.1%
of
the
RfD.
Using
the
conservative
exposure
assumptions,
the
percentage
of
the
RfD
that
will
be
utilized
by
chronic
dietary
(
food
only)
exposure
to
residues
of
pyriproxyfen
ranges
from
0.002601
mg/
kg/
bwt
day
for
nursing
infants,
up
to
0.007438
mg/
kg/
bwt
day
for
children
(
1
to
6
years
of
age),
0.743
to
2.125%
of
the
RfD,
respectively.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD
because
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Valent
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate,
chronic
dietary
exposure
to
pyriproxyfen
residues.
iii.
Drinking
water.
The
average
56
 
day
concentration
predicted
in
the
simulated
pond
water
was
0.16
parts
per
billion
(
ppb).
Using
standard
assumptions
about
body
weight
and
water
consumption,
the
chronic
exposure
to
pyriproxyfen
from
this
drinking
water
would
be
4.57
x
10­
6
and
1.6
x
10­
5
mg/
kg/
bwt
day
for
adults
and
children,
respectively;
0.0046%
of
the
RfD
0.35
mg/
kg/
day
for
children.
Based
on
this
worse
case
analysis,
the
contribution
of
water
to
the
dietary
risk
is
negligible.
iv.
Non­
dietary
exposure.
Chronic
residential
post­
application
exposure
and
risk
assessments
were
conducted
to
estimate
the
potential
risks
from
pet
collar
uses.
The
risk
assessment
was
conducted
using
the
following
assumptions:
Application
rate
of
0.58
mg
active
ingredient
day,
average
body
weight
for
a
1
 
6
year
old
child
of
10
kg,
the
active
ingredient
dissipates
uniformly
through
365
days
the
label
instruct
to
change
collar
(
once
a
year),
1%
of
the
active
ingredient
is
available
for
dermal
and
inhalation
exposure
per
day
assumption
from
Draft
EPA
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
December
18,
1997).
The
assessment
also
assumes
an
absorption
rate
of
100%.
This
is
a
conservative
assumption
since
the
dermal
absorption
was
estimated
to
be
10%.
The
estimated
chronic
term
margin
of
exposure
(
MOE)
was
61,000
for
children,
and
430,000
for
adults.
The
risk
estimates
indicate
that
potential
risks
from
pet
collar
uses
do
not
exceed
the
Agency's
level
of
concern.

F.
International
Tolerances
There
are
no
presently
existing
Codex
maximum
residue
levels
for
pyriproxyfen.
[
FR
Doc.
03
 
5315
Filed
3
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0011;
FRL
 
7290
 
1]

Sulfentrazone;
Notice
of
Filing
Pesticide
Petitions
to
Establish
Tolerances
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
 
0011,
must
be
received
on
or
before
April
7,
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:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
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
VerDate
Dec<
13>
2002
17:
55
Mar
06,
2003
Jkt
200001
PO
00000
Frm
00066
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
07MRN1.
SGM
07MRN1