Document ID: EPA-HQ-OPP-2003-0070-0001
Agency: epa
Document Type: Notice
Title: Buprofezin; Notice of Filing Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-26T05:00Z

14619
Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
In
reviewing
delegation
requests,
EPA's
role
is
to
approve
state
capabilities,
provided
that
they
meet
the
criteria
of
the
Clean
Air
Act.
In
this
context,
in
the
absence
of
a
prior
existing
requirement
for
the
State
to
use
voluntary
consensus
standards
(
VCS),
EPA
has
no
authority
to
disapprove
a
delegation
request
for
failure
to
use
VCS.
It
would
thus
be
inconsistent
with
applicable
law
for
EPA,
when
it
reviews
a
delegation
request,
to
use
VCS
in
place
of
a
delegation
request
that
otherwise
satisfies
the
provisions
of
the
Clean
Air
Act.
Thus,
the
requirements
of
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
15
U.
S.
C.
272
note)
do
not
apply.
This
rule
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act
of
1995
(
44
U.
S.
C.
3501
et
seq.).
This
information
notice
granting
delegation
of
the
Federal
PSD
program
to
Allegheny
County
issued
under
the
authority
of
sections
101,
110,
and
301
of
the
Clean
Air
Act,
as
amended
(
42
U.
S.
C.
7401,
7410,
7601).

Dated:
March
18,
2003.
Thomas
C.
Voltaggio,
Acting
Regional
Administrator,
Region
III.
[
FR
Doc.
03
 
7241
Filed
3
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0070;
FRL
 
7295
 
8]

Buprofezin;
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
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
 
0070,
must
be
received
on
or
before
April
25,
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
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0070.
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
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/
Vol.
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No.
58
/
Wednesday,
March
26,
2003
/
Notices
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
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
 
0070.
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
 
0070.
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
 
0070.
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
 
0070.
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.

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Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
Dated:
March
13,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner
summary
of
the
pesticide
petitions
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
was
prepared
by
the
petitioner
and
represent
the
views
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
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
(
IR
 
4)

PP
2E6369,
2E6455,
and
2E6493
EPA
has
received
pesticide
petitions
(
2E6369,
2E6455,
and
2E6493)
from
the
Interregional
Research
Project
Number
(
IR
 
4),
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902,
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.511
by
establishing
tolerances
for
residues
of
buprofezin
in
or
on
the
following
raw
agricultural
commodities:
Lychee,
logan,
spanish
lime,
rambutan,
and
pulasan
at
0.3
parts
per
million
(
ppm)
(
2E6369);
bean,
snap,
succulent
at
0.02
ppm
(
2E6455);
and
pistachio
at
0.05
ppm
(
2E6493).
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
summary
has
been
prepared
by
Nichino
American,
Inc.,
Wilmington,
DE
19808,
the
registrant.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolic
profile
of
buprofezin
has
been
elucidated
in
a
wide
range
of
crops,
including
tomatoes,
lettuce,
cotton,
and
citrus.
In
tomatoes,
lettuce,
and
cotton
unchanged
buprofezin
was
the
only
significant
residue.
In
citrus,
besides
buprofezin,
the
principal
polar
residue
is
a
hexose
conjugate
of
BF4
(
buprofezin
hydroxylated
in
the
t­
butyl
group),
which
was
resistant
to
enzyme
hydrolysis.
With
acid
hydrolysis
of
the
polar
fraction,
BF26
was
released,
with
minor
amounts
of
BF9
and
BF12.
The
same
compounds
were
observed
following
acid
hydrolysis
of
a
standard
of
BF4,
which
clearly
indicates
that
BF4
is
the
conjugated
metabolite
existing
in
citrus.
Although
only
limited
metabolism
was
observed
in
lettuce
and
cotton,
trace
levels
of
BF4/
BF26,
BF9,
and
BF12
were
observed
indicating
that
the
metabolic
pathway
does
not
differ
with
plant
species.
2.
Analytical
method.
Metabolism
studies
on
lettuce
and
tomatoes
have
shown
that
the
only
significant
residue
in
these
crops
is
buprofezin.
Development
of
the
analytical
method
took
place
in
parallel
with
the
metabolism
studies
and
the
method
was
designed
to
quantify
two
metabolites
(
BF9
and
BF12)
in
addition
to
the
parent
compound.
This
method
was
used
for
analysis
of
samples
from
the
field
trials
on
all
crops
except
citrus,
but
for
tolerance
enforcement
only
the
parent
compound
is
considered.
3.
Magnitude
of
residues.
The
magnitude
of
residues
is
adequately
understood
and
supports
the
proposed
tolerances.

B.
Toxicological
Profile
1.
Acute
toxicity.
An
assessment
of
toxic
effects
caused
by
buprofezin
is
discussed
in
Unit
III.
A.
and
Unit
III.
B.
of
the
Federal
Register
dated
September
5,
2001
(
66
FR
46382)
(
FRL
 
6796
 
6).
2.
Animal
metabolism.
The
metabolism
of
buprofezin
has
been
extensively
studied
in
various
species
of
animals
and
fish.
Buprofezin
has
several
groups
that
can
metabolize
in
a
variety
of
ways
thus
potentially
producing
a
very
large
number
of
metabolites.
Indeed
extensive
metabolism
to
many
minor
metabolites
was
observed
in
all
the
animal
species.
Metabolism
in
fish
was,
however,
much
more
limited
and
clearly
defined.
Although
not
all
metabolic
intermediates
have
been
detected
in
all
the
species,
the
major
routes
of
metabolism
have
been
identified
in
animals
and
fish
and
a
consistent
pattern
is
observed
throughout
these
species.
The
proposed
metabolic
pathway
was
provided
in
the
tolerance
petition,
PP
0F6087.
For
convenience,
degradates
are
referred
to
by
an
internal
code:
BF
1
through
13.
Corresponding
chemical
structures
were
provided
in
the
tolerance
petition,
PP
0F6087.
3.
Endocrine
disruption.
No
special
studies
have
been
conducted
to
investigate
the
potential
of
buprofezin
to
induce
estrogenic
or
other
endocrine
effects.
The
standard
battery
of
required
toxicity
studies
has
been
completed.
These
studies
include
an
evaluation
of
the
potential
effects
on
reproduction
and
development
and
an
evaluation
of
the
pathology
of
the
endocrine
organs
following
repeated
or
long­
term
exposure.
These
studies
are
generally
considered
to
be
sufficient
to
detect
any
endocrine
effects.
The
only
effect
noted
on
endocrine
organs
was
an
increased
incidence
of
follicular
cell
hypertrophy
and
C­
cell
hyperplasia
of
the
thyroid
gland
in
rats
administered
buprofezin
at
dietary
concentrations
of
2,000
ppm
for
24
months.
Buprofezin
also
caused
mild
to
moderate
hepatotoxic
effects
at
this
dietary
concentration.
Nichino
America,
Inc.
believes
that
the
effect
on
the
thyroid
most
likely
resulted
from
increased
turnover
of
T3/
T4
in
the
liver
with
a
resultant
rise
in
TSH
secretion
(
due
to
the
hepatotoxicity).
The
rat
is
known
to
be
much
more
susceptible
than
humans
to
these
effects
due
to
the
very
rapid
turnover
of
thyroxine
in
the
blood
in
rats
(
12
hours
versus
about
5
to
9
days
in
humans).
Therefore,
the
thyroid
pathological
changes
which
have
been
noted
following
administration
of
high
doses
of
buprofezin
are
considered
to
be
of
minimal
relevance
to
human
risk
assessment,
particularly
considering
the
low
levels
of
buprofezin
to
which
humans
are
likely
to
be
exposed.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
Chronic
dietary
exposure
was
estimated
using
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
tolerance
levels,
and
100%
crop
treated,
except
for
tomatoes
with
40%
of
the
crop
treated.
The
chronic
dietary
exposure
to
the
U.
S.
population
(
total)
was
estimated
as
0.001229
milligrams/
kilogram/
body
weight/
day
(
mg/
kg
bwt/
day),
and
was
37%
of
the
estimated
reference
dose
(
RfD).
Exposure
to
children
ages
1
to
6,
the
highest
exposed
population
subgroup,
was
0.002393
mg/
kg
bwt/
day
(
73%
of
the
estimated
RfD).
ii.
Drinking
water.
The
residue
of
concern
in
drinking
water
was
determined
to
be
buprofezin.
The
potential
exposure
of
buprofezin
in
drinking
water
abstracted
from
surface
water
was
assessed
using
a
Tier
2,
modeling
approach.
EPA's
Pesticide
Root
Zone
Model
(
PRZM)
was
used
to
generate
potential
runoff
loads
from
a
standardized
agricultural
field
(
10
 
hectare
(
ha))
to
a
standardized
aquatic
system
(
1
 
ha
2
 
meters
(
m)
deep
pond)
following
application
of
buprofezin
to
citrus
(
the
maximum
proposed
use
rate
for
all
crops).
Exposure
Analysis
Modeling
Systems
(
EXAMS)
was
used
to
estimate
the
exposure
concentration
in
surface
water.
The
``
once­
in­
10
 
year''
exceedance
probability
corresponded
to
a
concentration
at
0.52
part
per
billion
(
ppb).
This
value
refers
to
the
56
 
day
average
estimated
concentration
in
a
farm
pond
draining
agricultural
land
and
must
be
considered
a
gross
overestimate
of
concentrations
of
buprofezin
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Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
at
the
point
of
drinking
water
abstraction.
2.
Non­
dietary
exposure.
Food
uses
described
in
these
petitions
are
strictly
agricultural
and
will
not
add
to
any
residential
non­
dietary
exposure
that
may
exist.

D.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
requires
that
the
Agency
must
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residue
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
Available
information
in
this
context
include
not
only
toxicity,
chemistry,
and
exposure
data,
but
also
scientific
policies
and
methodologies
for
understanding
common
mechanisms
of
toxicity
and
conducting
cumulative
risk
assessments.
For
most
pesticides,
although
the
Agency
has
some
information
in
its
files
that
may
turn
out
to
be
helpful
in
eventually
determining
whether
a
pesticide
shares
a
common
mechanism
of
toxicity
with
any
other
substances,
EPA
does
not
at
this
time
have
the
methodologies
to
resolve
the
complex
scientific
issues
concerning
common
mechanism
of
toxicity
in
a
meaningful
way.
At
the
present
time,
there
are
insufficient
data
available
to
allow
Nichino
America,
Inc.
to
properly
evaluate
the
potential
for
cumulative
effects
with
other
pesticides
to
which
an
individual
may
be
exposed.
For
the
purposes
of
this
assessment,
therefore,
Nichino
America,
Inc.
has
assumed
that
buprofezin
does
not
have
a
common
mechanism
of
toxicity
with
any
other
registered
pesticides.
Therefore,
only
exposure
from
buprofezin
is
being
addressed
at
this
time.

E.
Safety
Determination
1.
U.
S.
population
 
i.
Acute
risk.
To
estimate
acute
aggregate
exposure
risk,
the
Agency
combined
the
high­
end
value
from
food
and
water
and
compared
it
to
the
acute
population
adjusted
dose
(
aPAD).
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
buprofezin
will
occupy
4%
of
the
aPAD
for
females
13
years
and
older
(
no
endpoint
was
identified
for
the
general
population
including
infants
and
children).
In
addition,
there
is
potential
for
acute
dietary
exposure
to
buprofezin
in
drinking
water.
After
calculating
drinking
water
levels
of
concern
(
DWLOCs)
and
comparing
them
to
the
estimated
environmental
concentrations
(
EECs)
for
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD.
ii.
Chronic
risk.
Based
on
the
toxicology
data
base
and
available
information
on
anticipated
residues,
chronic
dietary
exposure
to
the
U.
S.
population
(
total)
was
37%
of
the
RfD.
Exposure
to
potential
residues
in
drinking
water
is
expected
to
be
negligible,
as
DWLOCs
are
substantially
higher
than
modeled
acute
and
longterm
EECs.
The
margin
of
exposure
(
MOE)
from
the
limited
potential
for
short­
term
exposure
from
residential
uses
was
>
1,000.
Based
on
these
assessments,
it
can
be
concluded
that
there
is
reasonable
certainty
of
no
harm
to
the
U.
S.
population
or
any
population
subgroup
from
exposure
to
buprofezin.
iii.
Aggregate
cancer
risk
for
the
U.
S.
population.
In
accordance
with
EPA
Guidelines
for
Carcinogen
Risk
Assessment
(
proposed
July
1999),
the
Agency's
Cancer
Assessment
Review
Committee
has
classified
buprofezin
as
having
suggestive
evidence
of
carcinogenicity,
but
not
sufficient
to
assess
human
carcinogenic
potential,
and
further
recommended
that
no
quantification
of
cancer
risk
is
required.
2.
Infants
and
children.
The
chronic
dietary
exposure
was
29%
of
the
RfD
for
infants
and
72%
of
the
RfD
for
children
ages
1
to
6.
Exposure
to
potential
residues
in
drinking
water
is
expected
to
be
negligible,
as
DWLOCs
are
substantially
higher
than
modeled
acute
and
long­
term
EECs.
The
MOE
from
the
limited
potential
for
short­
term
exposure
from
residential
uses
was
>
1,000.
Based
on
these
assessments,
it
can
be
concluded
that
there
is
reasonable
certainty
of
no
harm
to
infants
and
children
from
exposure
to
buprofezin.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population
and
to
infants
and
children
from
aggregate
exposure
to
buprofezin
residues.

F.
International
Tolerances
Permanent
CODEX
maximum
residue
levels
have
been
established
for
residues
of
buprofezin
in
cucumbers
at
1.0
ppm,
tomatoes
at
1.0
ppm,
and
citrus
at
0.5
ppm.

[
FR
Doc.
03
 
6948
Filed
3
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0106;
FRL
 
7299
 
3]

Azoxystrobin;
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
 
0106,
must
be
received
on
or
before
April
25,
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
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.

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