Document ID: EPA-HQ-OPP-2003-0106-0001
Agency: epa
Document Type: Notice
Title: Azoxystrobin; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-26T05:00Z

14622
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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Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
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
 
0106.
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
electonic
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
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
 
0106.
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
 
0106.
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
 
0106.

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Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
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
 
0106.
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:
March
18,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
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
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
(
IR­
4)

PP
2E6375,
2E6488,
2E6489,
and
2E6495
EPA
has
received
pesticide
petitions
(
2E6375,
2E6488,
2E6489,
and
2E6495)
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
180.507
by
establishing
tolerances
for
residues
of
azoxystrobin,
methyl(
E)­
2­(
2­(
6­(
2­
cyanophenoxy)
pyrimidin­
4­
yloxy)
phenyl)­
3­
methoxyacrylate
and
the
Z­
isomer
of
azoxystrobin,
methyl(
Z)­
2­(
2­(
6­(
2­
cyanophenoxy)
pyrimidin­
4­
yloxy)
phenyl)­
3
methoxyacrylate
in
or
on
the
following
raw
agricultural
commodities:
asparagus
at
0.02
parts
per
million
(
ppm)
(
2E6375);
brassica,
head
and
stem,
subgroup
5a
at
3.0
ppm
(
2E6488);
artichoke,
globe
at
4.0
ppm
(
2E6489);
herb
subgroup
19A,
fresh,
except
chive
at
50
ppm
(
2E6495);
and
herb
subgroup
19A,
dried,
except
chive
at
260
ppm
(
2E6495).
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
these
petitions.
This
summary
has
been
prepared
by
Syngenta,
the
registrant.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
azoxystrobin
as
well
as
the
nature
of
the
residues
is
adequately
understood
for
purposes
of
the
tolerances.
2.
Analytical
method.
An
adequate
analytical
method,
gas
chromatography
with
nitrogen­
phosphorus
detection
(
GC­
NPD)
or
in
mobile
phase
by
high
performance
liquid
chromatography
with
ultra­
violet
detection
(
HPLC­
UV),
is
available
for
enforcement
purposes
with
a
limit
of
detection
that
allows
monitoring
of
food
with
residues
at
or
above
the
levels
set
in
these
tolerances.
The
Analytical
Chemistry
section
of
the
EPA
concluded
that
the
method(
s)
are
adequate
for
enforcement.
Analytical
methods
are
also
available
for
analyzing
meat,
milk,
poultry
and
eggs
which
also
underwent
successful
independent
laboratory
validations.
3.
Magnitude
of
residues.
Complete
residue
data
for
azoxystrobin
on
artichoke,
globe;
asparagus,
head
and
stem
brassica
and
herb
subgroup
19A
have
been
submitted.
The
requested
tolerances
are
adequately
supported.

B.
Toxicological
Profile
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26,
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/
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TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
AZOXYSTROBIN
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
(
general
population
including
infants
and
children)
NOAEL=<
200
mg/
kg/
day
UF=
300
Acute
RfD=
0.67
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
Acute
RfD
+
FQPA
SF
=
0.67
mg/
kg/
day
Acute
neurotoxicity
study
in
rates
LOAEL
=
200
mg/
kg/
day
based
on
diarrhea
and
2
hours
post
dose
at
all
dose
levels
up
to
and
including
20
mg/
kg/
day
(
the
LOAEL)

Chronic
dietary
(
all
populations)
NOAEL
=
18
mg/
kg/
day
UF=
100
Chronic
RfD
=
0.18
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD
+
FQPA
SF
=
0.18
mg/
kg/
day
Combined
chronic
toxicity
carcinogenicity
feeding
study
in
rates
LOAEL
=
34/
117
mg/
kg/
day
in
males/
females
based
on
reduced
body
weights
in
both
sexes
and
bile
duct
lesions
in
males.

Short­
term
(
1
 
7
days)
incidental
oral
(
residential)
NOAEL
=
25
mg/
kg/
day
UF
=
100
FQPA
SF
=
1X
Prenatal
developmental
oral
toxicity
study
in
rates
LOAEL
=
100
mg/
kg/
day
based
on
increased
maternal
diarrhea,
urinary
incontinence,
and
salivation.

Intermediate­
term
(
1
week
to
several
months)
incidental
oral
(
residential)
NOAEL
=
20
mg/
kg/
day
UF
=
100
FQPA
SF
=
1X
90
 
Day
feeding
study
in
rats
LOAEL
=
211/
223
mg/
kg/
day
in
males/
females
based
on
decreased
body
weight
gain
in
both
sexes
and
clinical
signs
indicative
of
reduced
nutrition

Short­
intermediate­,
and
long­
term
dermal
(
residential)
None
None
21
 
Day
repeated
dose
dermal
study
in
rats.
No
dermal
or
systemic
toxicity
was
seen
at
the
limit
does
(
1,000
mg/
kg/
day).
This
risk
assessment
is
not
required

Short­
term
inhalation
(
1­
7
days)
(
residential)
Oral
Study
NOAEL
=
25
mg/
kg/
day
(
inhalation
absorption
rate
­
100%)
LOC
for
MOE
=
100
(
residential)
Prenatal
developmental
oral
toxicity
study
in
rats.
LOAEL
=
100
mg/
kg/
day
based
on
increased
maternal
diarrhea,
urinary
incontinence
and
salivation.

Intermediate­
term
inhalation
(
1
week
to
several
months)
(
residential)
Oral
Study
NOAEL
=
20
mg/
kg/
day
(
inhalation
absorption
rate
­
100%)
LOC
for
MOE
=
100
(
residential)
90
 
Day
feeding
study
in
rats
LOAEL
=
211/
223
mg/
kg/
day
in
males/
females
based
on
decreased
body
weight
gain
in
both
sexes
and
clinical
signs
indicative
of
reduced
nutrition

Long­
term
inhalation
(>
180
days)
(
residential)
None
None
This
risk
assessment
is
not
applicable
to
the
use
of
azoxystrobin
Cancer
(
oral,
dermal,
inhalation)
None
None
Azoxystrobin
is
classified
as
not
likely
to
be
carcinogenic
in
humans
2.
Metabolite
toxicology.
There
are
no
metabolites
of
concern
based
on
a
differential
metabolism
between
plants
and
animals.
3.
Endocrine
disruption.
There
is
no
evidence
that
azoxystrobin
is
an
endocrine
disrupter.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Tolerance
values
have
been
established
(
40
CFR
180.507(
a))
for
the
combined
residues
of
both
azoxystrobin
and
its
Z
isomer,
in
or
on
a
variety
of
raw
agricultural
commodities
including
meat,
milk
and
eggs.
These
established
tolerances
range
from
0.02
ppm
on
tree
nuts
to
55
ppm
on
soybean
hay.
i.
Food.
Tier
I
acute
and
chronic
dietary
exposure
evaluations
were
made
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
,
version
7.76
from
Exponent.
All
processing
factors
used
DEEM
 
defaults
values.
All
consumption
data
for
these
assessments
were
taken
from
the
USDA's
Continuing
Survey
of
Food
Intake
by
individuals
(
CSFII)
with
the
1994
 
1996
consumption
data
base
and
the
Supplemental
CSFII
children's
survey
(
1998)
consumption
data
base.
These
dietary
exposure
assessments
included
all
registered
uses
and
proposed
uses
on
asparagus
(
0.02
ppm),
brassica,
head
and
stem
subgroup
5A
(
3
ppm),
herb
subgroup
19A
(
250
ppm)
and
artichoke
globe
(
4
ppm).
ii.
Drinking
water.
There
is
no
established
maximum
concentration
level
(
MCL)
for
residues
of
azoxystrobin
in
drinking
water.
No
health
advisory
levels
for
azoxystrobin
in
drinking
water
have
been
established.
The
concentration
of
azoxystrobin
in
surface
water
is
based
on
generic
estimated
environmental
concentration
(
GENEEC)
modeling
and
in
ground
water
based
on
screening
concentration
in
ground
water
(
SCI­
GROW)
modeling.
2.
Non­
dietary
exposure.
Azoxystrobin
is
registered
for
residential
use
on
ornamentals
and
turf.
The
Agency
evaluated
the
existing
toxicological
data
base
for
azoxystrobin
and
assessed
both
the
appropriate
toxicological
endpoints
and
the
dose
levels
of
concern.
Dermal
absorption
data
indicate
that
absorption
is
less
than
or
equal
to
4%.

D.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,

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modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
Azoxystrobin
is
related
to
the
naturally
occurring
strobilurins.
Syngenta
concluded
that
further
consideration
of
a
common
mechanism
of
toxicity
is
not
appropriate
at
this
time
since
there
are
no
data
to
establish
whether
a
common
mechanism
exists
with
any
other
substances.

E.
Safety
Determination
1.
Infants
and
Children.
The
chronic
dietary
exposure
(
food
only)
resulting
from
all
established
and
proposed
azoxystrobin
uses
was
27.6%
of
the
reference
dose
(
RfD)
for
the
most
sensitive
subpopulation,
children
1
and
2
years
old.
Additionally,
for
this
same
subpopulation,
the
acute
dietary
exposure
(
food
only)
resulting
from
all
established
and
proposed
azoxystrobin
uses
was
22.3%
of
the
acute
reference
dose
(
aRfD).
The
EPA
has
determined
that
there
is
reliable
data
support
using
the
standard
MOE
and
uncertainty
factor
(
100X
for
chronic
and
300X
for
acute)
for
azoxystrobin
and
that
an
additional
safety
factor
of
10
is
not
necessary
to
be
protective
of
infants
and
children.
Syngenta
has
considered
the
potential
aggregate
exposure
from
food,
water
and
non­
occupational
exposure
routes
and
concludes
that
aggregate
exposure
is
not
expected
to
exceed
100%
of
the
chronic
reference
dose
and
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
the
aggregate
exposure
to
azoxystrobin.

[
FR
Doc.
03
 
7056
Filed
3
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0053;
FRL
 
7294
 
6]

Quinoxyfen;
Receipt
of
Application
for
Emergency
Exemption;
Solicitation
of
Public
Comment
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
EPA
has
received
specific
exemption
requests
from
the
Idaho
Department
of
Agriculture,
the
Oregon
Department
of
Agriculture,
and
the
Washington
State
Department
of
Agriculture
to
use
the
pesticide
quinoxyfen
(
CAS
No.
124495
 
18
 
7)
to
treat
up
to
a
total
of
19,500
acres
of
hops
to
control
powdery
mildew;
3,000
acres
in
Idaho,
3,500
acres
in
Oregon,
and
13,000
acres
in
Washington.
The
Applicants
propose
the
use
of
a
new
chemical
which
has
not
been
registered
by
EPA.
EPA
is
soliciting
public
comment
before
making
the
decision
whether
or
not
to
grant
the
exemptions.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0053,
must
be
received
on
or
before
April
10,
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:
Barbara
Madden,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6463;
fax
number:
(
703)
308
 
5433;
e­
mail
address:
Sec­
18­
Mailbox@
epamail.
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
Federal
or
State
government
agency
involved
in
administration
of
environmental
quality
programs.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Federal
or
State
Government
entity,
(
NAICS
9241),
e.
g.,
Department
of
Agriculture,
Environment,
etc.
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
 
0053.
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.
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.
1.
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
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