Document ID: EPA-HQ-OPP-2003-0006-0001
Agency: epa
Document Type: Notice
Title: Cymoxanil; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-02-28T05:00Z

9660
Federal
Register
/
Vol.
68,
No.
40
/
Friday,
February
28,
2003
/
Notices
intended
to
restate
its
commitment
to
cost
share
with
Task
Force
I
or
to
make
an
offer
to
cost
share
with
Task
Force
II.
In
any
case,
Prochimie's
letter
at
most
shows
that
Prochimie
made
an
offer
to
cost
share,
which
was
an
option
it
emphasized
that
it
had
not
selected.
Prochimie
did
not
provide
any
evidence
that
it
had
selected
the
option
of
offer
to
pay
or
that
any
such
offer
had
been
accepted.
In
order
to
support
the
option
Prochimie
selected
to
address
the
data
requirements,
it
must
provide
evidence
that
any
such
offer
had
been
accepted.
Prochimie
did
not
do
that.
Although
Prochimie
paid
Task
Force
II
for
the
use
of
several
specific
studies
which
are
not
involved
in
this
Notice,
those
payments
do
not
provide
any
evidence
that
a
cost
share
agreement
has
been
reached
with
respect
to
any
other
studies
required
by
the
1991
DCI
for
nonresidential
turf
use
that
Task
Force
II
submitted
or
has
committed
to
submit.
In
fact,
Mr.
Rockwell,
the
chairman
of
Task
Force
II,
stated
in
an
affidavit
dated
May
2,
2000,
that
``
No
written
offer­
to­
pay
or
any
offer
to
jointly
develop
any
data
as
required
by
and
identified
in
the
1991
DCI
has
ever
been
received
by
Thiram
Task
Force
II.
.
.
from
Prochimie.''
Since
Task
Force
II
does
not
believe
that
it
has
ever
received
an
offer
to
cost
share
from
Prochimie,
it
is
unlikely
that
a
cost
share
agreement
has
been
reached
between
Prochimie
and
Task
Force
II.
Without
adequate
proof
of
such
an
agreement,
Prochimie
may
not
claim
an
ownership
interest
in
Task
Force
II's
data
for
which
Prochimie
has
not
paid
and
hence
may
not
claim
that
such
data
satisfies
Prochimie's
obligations.
Consequently,
the
Agency
considers
that
Prochimie
is
in
noncompliance
with
certain
data
requirements
for
nonresidential
turf
use
imposed
by
the
1991
DCI
irrespective
of
Task
Force
II's
actions
to
address
those
data
requirements.
Those
data
requirements
are
identified
in
Appendix
II
to
this
Notice
and
are
as
follows:
EPA
Guideline
Nos.
71
 
4(
b),
83
 
4,
85
 
1,
and
122
 
2.
Moreover,
prior
to
its
dissolution,
Task
Force
I
failed
to
satisfy
certain
1984
DCI
data
requirements
for
nonresidential
turf
use
that
were
also
imposed
by
the
1991
DCI.
Because
Prochimie
was
a
member
of
Task
Force
I
and
has
not
independently
submitted
data
or
otherwise
addressed
these
requirements,
Prochimie
is
in
noncompliance
with
these
requirements.
These
data
requirements
are
identified
in
Appendix
II
to
this
Notice
and
are
as
follows:
EPA
Guideline
Nos.
161
 
1,
161
 
2,
162
 
1,
163
 
1,
and
164
 
1.
In
a
letter
dated
December
21,
1998,
EPA
informed
Prochimie
that
the
data
required
under
the
1991
DCI
were
long
overdue
and
that
Prochimie
had
satisfied
only
those
data
requirements
that
had
been
satisfied
by
Task
Force
I
prior
to
its
dissolution.
In
a
letter
dated
January
12,
1999,
Prochimie
informed
EPA
that
``
Prochimie
cost
shared/
co­
owned
several
studies
submitted
by
Task
Force
II.''
However,
Prochimie
did
not
provide
the
evidence
required
by
the
1991
DCI
that
Prochimie
and
Task
Force
II
have
agreed
to
cost
share
in
the
development
of
any
other
data
required
by
the
1991
DCI
for
nonresidential
turf
use.
Prochimie's
letter
also
restated
Prochimie's
commitment
to
satisfy
certain
data
requirements
that
neither
Task
Forces
committed
to
fulfill.
However,
Prochimie
did
not
submit
any
studies
or
proof
required
by
the
1991
DCI
of
a
cost
share
agreement
with
any
party
obligated
to
satisfy
these
data
requirements.
In
a
letter
dated
June
29,
1999,
Prochimie
requested
data
waivers
(
or
determination
of
nonapplicability
or
no
need
for
additional
data)
for,
among
others,
the
following
data
requirements:
Guideline
Nos.
82
 
2,
83
 
4,
122
 
2,
161
 
1,
161
 
2,
163
 
1,
and
164
 
1,
and
165
 
4.
After
careful
consideration
of
Prochimie's
requests,
EPA
denied
the
request
for
waiver
of
the
above
mentioned
data
requirements
in
letters
dated
May
21,
2001
and
August
31,
2001.
In
a
letter
dated
August
31,
2001,
EPA
informed
Prochimie
of
its
failure
to
demonstrate
that
it
had
taken
appropriate
steps
to
secure
data
required
by
the
1991
DCI.
In
an
attachment
to
the
letter,
EPA
identified
all
of
the
data
requirements
for
nonresidential
turf
use
under
the
1991
DCI
and
the
names
of
the
parties
who
submitted
studies
for
those
requirements.
As
shown
in
that
attachment,
UCB
Chemicals
Corporation,
Inc.
(``
UCB''),
not
Task
Force
I
or
II,
satisfied
a
number
of
data
requirements
under
the
1991
DCI
for
nonresidential
turf
use.
The
letter
notified
Prochimie
of
the
Agency's
intent
to
issue
a
Notice
of
Intent
to
Suspend
Prochimie's
technical
thiram
registration
unless,
within
30
calendar
days
of
its
receipt
of
the
letter,
EPA
received
from
Prochimie
certain
required
data
or
proof
of
an
agreement
or
offer
to
cost
share
with
UCB.
In
its
October
4,
2001
response,
Prochimie
did
not
provide
any
of
the
data/
information
that
the
Agency
required,
but
instead
requested
a
re
 
evaluation
of
the
Agency's
determination
not
to
waive
certain
environmental
fate
studies,
clarification
of
applicable
existing
data,
and
a
determination
of
data
requirements
applicable
to
the
nonresidential
turf
use.
To
date,
Prochimie
has
failed
to
take
appropriate
steps
to
secure
certain
data
required
by
the
1991
DCI
applicable
to
nonresidential
turf
use
and
remains
in
noncompliance
with
those
data
requirements,
which
are
set
forth
in
Appendix
II
to
this
Notice.
Accordingly,
the
Agency
is
issuing
this
Notice
of
Intent
to
Suspend.

V.
What
is
the
Agency's
Authority
for
Taking
this
Action?

The
Agency's
authority
for
taking
this
action
is
section
6(
f)(
2)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
7
U.
S.
C.
136
et
seq.

List
of
Subjects
Environmental
protection.

Dated:
February
4,
2003.
Richard
Colbert,
Director,
Agriculture
Division,
Office
of
Compliance,
Office
of
Enforcement
and
Compliance
Assurance.
[
FR
Doc.
03
 
4776
Filed
2
 
27
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0006;
FRL
 
7288
 
9]

Cymoxanil;
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
 
0006,
must
be
received
on
or
before
March
31,
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:
Mary
L.
Waller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9354;
e­
mail
address:
waller.
mary@
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
OPP
 
2003
 
0006.
If
you
have
any
questions
regarding
the
applicability
of
VerDate
Jan<
31>
2003
18:
05
Feb
27,
2003
Jkt
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9661
Federal
Register
/
Vol.
68,
No.
40
/
Friday,
February
28,
2003
/
Notices
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
 
0006.
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
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
 
0006.
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
 
0006.
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,

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DC
20460
 
0001,
Attention:
Docket
ID
number
OPP
 
2003
 
0006.
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
 
0006.
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:
February
10,
2003.
Debra
Edwards,
Acting
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
E.
I.
du
Pont
de
Nemours
and
Company
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.

E.
I.
du
Pont
de
Nemours
and
Company
PP
0F6072
EPA
has
received
a
pesticide
petition
(
0F6072)
from
E.
I.
du
Pont
de
Nemours
and
Company,
DuPont
Agricultural
Products,
Barley
Mill
Plaza,
Wilmington,
DE
19880
 
0038
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.503
by
establishing
tolerances
for
residues
of
the
fungicide,
cymoxanil;
2­
cyano­
N­(
ethylamino)
carbonyl
l­
2­
(
methoxyimino)
acetamide
in
or
on
the
raw
agricultural
commodities
cucurbit
vegetables
at
0.05
parts
per
million
(
ppm),
fruiting
vegetables
at
0.2
ppm,
and
head
lettuce
at
4.0
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
plant
metabolism
of
cymoxanil
is
adequately
understood
in
three
diverse
crops:
potatoes,
tomatoes,
and
lettuce.
The
results
of
these
plant
metabolism
studies
indicate
that
cymoxanil
degrades
extensively
to
primarily
the
amino
acid
glycine,
with
subsequent
reincorporation
into
other
naturallyoccurring
products,
such
as
glucose.
2.
Analytical
method.
An
analytical
enforcement
method
is
available
for
determining
these
plant
residues
by
high
performance
level
chromotography
(
HPLC)
with
ultraviolet
(
UV)
detection.
The
limit
of
quantitation
allows
monitoring
of
crops
with
cymoxanil
residues
at
or
above
the
levels
proposed
in
these
tolerances.
3.
Magnitude
of
residues
 
i.
Cucurbit
vegetables.
The
magnitude
and
decline
of
residues
of
cymoxanil
was
determined
on
cucumber,
cantaloupe
and
summer
squash,
the
representative
commodities
for
the
cucurbit
vegetable
crop
group
as
follows:
 
Cucumber.
DPX­
KP481
50DF,
containing
25%
cymoxanil
and
25%
famoxadone,
was
applied
as
a
water
dispersible
granule
to
six
test
sites
in
Florida,
Georgia,
Minnesota,
Ohio,
Virginia,
and
Texas.
DPX­
KP481
50DF
was
applied
as
seven
broadcast
applications
at
the
maximum
rate
of
0.1875
lb
cymoxanil
acre
for
a
maximum
seasonal
use
rate
of
1.31
lb
cymoxanil/
acre.
Applications
were
made
approximately
5
days
apart.
The
target
pre­
harvest
interval
(
PHI)
was
3
days.
Residues
of
cymoxanil
were
less
than
0.05
ppm.
 
Cantaloupe.
DPX­
KP481
50DF,
containing
25%
cymoxanil
and
25%
famoxadone,
was
applied
as
a
water
dispersible
granule
to
six
test
sites
in
Florida,
Georgia,
Minnesota,
Ohio,
Virginia,
and
Texas.
DPX­
KP481
50DF
was
applied
as
seven
broadcast
applications
at
the
maximum
rate
of
0.1875
lb
cymoxanil/
acre
for
a
maximum
seasonal
use
rate
of
1.31
lb
cymoxanil/
acre.
Applications
were
made
approximately
5
days
apart.
The
target
PHI
was
3
days.
Residues
of
cymoxanil
were
less
than
0.05
ppm.
 
Summer
squash.
DPX­
KP481
50DF,
containing
25%
cymoxanil
and
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25%
famoxadone,
was
applied
as
a
water
dispersible
granule
to
five
test
sites
in
Florida,
Pennsylvania,
Minnesota,
North
Carolina
and
California.
DPX­
KP481
50DF
was
applied
as
seven
broadcast
applications
at
the
maximum
rate
of
0.1875
lb
cymoxanil/
acre
for
a
maximum
seasonal
use
rate
of
1.31
lb
cymoxanil/
acre.
Applications
were
made
approximately
5
days
apart.
The
target
PHI
was
3
days.
Residues
of
cymoxanil
were
less
than
0.05
ppm.
ii.
Fruiting
vegetables.
The
magnitude
and
decline
of
residues
of
cymoxanil
was
determined
on
tomato
and
pepper,
the
representative
commodities
for
the
fruiting
vegetable
crop
group
as
follows:
 
Pepper.
Bell
and
non­
bell
DPXKP481
50DF,
containing
25%
cymoxanil
and
25%
famoxadone,
was
applied
as
a
water
dispersible
granule
to
nine
test
sites
in
Georgia,
Florida,
Ohio,
Texas,
Arizona,
California,
and
New
Mexico.
DPX­
KP481
50DF
was
applied
as
nine
broadcast
applications
at
a
maximum
seasonal
use
rate
of
1.12
lb
cymoxanil/
acre.
Applications
were
made
approximately
5
days
apart.
The
target
PHI
was
3
days.
Residues
of
cymoxanil
at
the
target
PHI
of
3
days
ranged
from
less
than
0.05
 
0.12
ppm
in
peppers
(
bell
and
non­
bell).
 
Tomato.
DPX­
KP481
50DF,
containing
25%
cymoxanil
and
25%
famoxadone
was
applied
as
a
water
dispersible
granule
to
12
test
sites
in
Florida,
Maryland,
Pennsylvania,
California
and
Indiana.
DPX­
KP481
50DF
was
applied
as
nine
broadcast
applications
at
a
maximum
seasonal
use
rate
of
1.12
lb
cymoxanil/
acre.
Applications
were
made
approximately
5
days
apart.
The
target
PHI
was
3
days.
Residues
of
cymoxanil
at
the
target
PHI
of
3
days
were
less
than
0.05
ppm
in
tomatoes.
 
Tomato,
process
fractions.
DPXKP481
50DF,
containing
25%
cymoxanil
and
25%
famoxadone,
was
applied
as
a
water
dispersible
granule
to
one
site
in
California
to
determine
the
magnitude
of
residue
in
tomato
and
the
extent
to
which
the
residue
concentrated
in
tomato
processed
fractions.
DPX­
KP481
50DF
was
applied
in
nine
broadcast
applications
at
1X
and
5X
the
proposed
maximum
rate
of
1.12
lb
cymoxanil/
acre.
Applications
were
made
approximately
5
days
apart.
The
target
PHI
was
3
days.
When
applied
at
5X
the
maximum
use
rate
residues
did
not
concentrate
in
tomato
washed,
unwashed,
paste
or
puree.
iii.
Head
lettuce.
DPX­
KP481
50DF,
containing
25%
cymoxanil
and
25%
famoxadone,
was
applied
as
a
water
dispersible
granule
to
eight
test
sites
in
Arizona,
California,
Florida,
New
York,
and
New
Mexico.
DPX­
KP481
50DF
was
applied
as
seven
broadcast
applications
at
the
maximum
rate
of
0.1875
lb
cymoxanil/
acre
for
a
maximum
seasonal
use
rate
of
1.31
lb
cymoxanil/
acre.
Applications
were
made
approximately
5
days
apart.
The
target
PHI
was
3
days.
Residues
of
cymoxanil
in
head
lettuce
ranged
from
less
than
0.05
 
2.8
ppm
(
wrapper
leaves
attached)
and
less
than
0.05
 
1.1
ppm
(
wrapper
leaves
removed).

B.
Toxicological
Profile
1.
Acute
toxicity.
A
battery
of
acute
toxicity
tests
on
technical
cymoxanil
places
it
in
the
following
Toxicity
Categories:

TABLE
1.
 
ACUTE
TOXICITY
RESULTS
ON
TECHNICAL
CYMOXANIL
Oral
LD50
Rat
960
mg/
kg
Category
III
Dermal
LD50
Rabbit
>
2,000
mg/
kg
Category
III
Inhalation
LC50
Rat
>
5.06
mg/
L
Category
IV
Eye
irritation
Rabbit
Slight
irritant
Category
IV
Dermal
irritation
Rabbit
Not
an
irritant
Category
IV
Dermal
sensitization
Guinea
pig
Not
a
sensitizer
An
acute
neurotoxicity
study
was
not
required
with
cymoxanil
and
no
acute
neurotoxicity
has
been
observed
in
short­
term
or
subchronic
studies.
2.
Genotoxicty.
Cymoxanil
was
tested
in
a
battery
of
assays
to
evaluate
genotoxicity
and
chromosome
aberrations
with
the
following
results.
Based
on
the
weight­
of­
evidence,
cymoxanil
is
not
considered
to
be
genotoxic
or
clastogenic.

TABLE
2.
 
GENOTOXICITY
AND
CHROMOSOME
ABERRATIONS
ASSAY
RESULTS
Bacterial
gene
mutation
Salmonella
typhimurium
Negative
Mammalian
gene
mutation
in
vitro
CHO/
HGPRT
Negative
Mammalian
chromosome
aberrations
in
vitro
CHO
Positive
Mammalian
chromosome
aberrations
in
vitro
Mouse
micronucleus
Negative
Unscheduled
DNA
synthesis
in
vitro
Primary
rat
hepatocytes
Negative
Unscheduled
DNA
synthesis
in
vitro
Primary
rat
hepatocytes
and
Spermatocytes
Negative
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3.
Reproductive
and
developmental
toxicity.
The
results
of
a
series
of
studies
indicated
that
there
were
no
reproductive,
developmental,
or
teratogenic
hazards
associated
with
cymoxanil.
In
a
2­
generation
cymoxanil
rat
reproduction
study,
the
no
observed
effect
level
(
NOEL)
for
both
parents
and
offspring
was
approximately
7
milligrams/
kilogram/
day
(
mg/
kg/
day),
based
on
decreased
body
weight,
weight
gain
and
food
consumption
in
adults
and
decreased
pup
weight
in
offspring
at
32
mg/
kg/
day.
There
were
no
reproductive
or
fertility
effects.
Since
offspring
effects
occurred
only
in
the
presence
of
maternal
toxicity,
it
is
considered
a
secondary
effect
to
the
health
effects
on
the
dam.
With
cymoxanil,
developmental
studies
conducted
in
rats
demonstrated
a
NOEL
of
10
mg/
kg/
day
and
a
lowest
observed
effect
level
(
LOEL)
of
25
mg/
kg/
day
for
both
adult
and
developmental
effects.
Maternal
effects
in
rats
included
decreased
weight,
weight
gain,
and
food
consumption.
Developmental
effects
were
increases
in
fetal
variations,
which
were
the
result
of
generalized
delays
in
ossification,
and
overall
malformations,
although
malformations
detected
were
not
doserelated
In
rabbits,
several
developmental
toxicity
studies
were
conducted
with
cymoxanil.
Based
on
the
weight­
of­
evidence
of
all
three
studies,
EPA
considered
there
was
no
unique
sensitivity
of
perinatal
animals
to
the
effects
of
cymoxanil,
nor
any
anomalies
of
the
fetal
nervous
system
at
maternally
toxic
doses
up
to
and
including
32
mg/
kg/
day
(
Cymoxanil
Agency
Risk
Assessment,
February
18,
1998).
4.
Subchronic
toxicity.
Subchronic
(
90
 
day)
feeding
studies
were
conducted
with
rats,
mice,
and
dogs.
In
addition,
the
following
subchronic
feeding
studies
were
conducted:
A
90
 
day
in
rats
to
evaluate
neurotoxicity
and
28
 
day
feeding
studies
in
rats
and
mice
to
evaluate
immunotoxicity.
A
28
 
day
dermal
study
was
conducted
in
rats.
In
a
subchronic
toxicity/
neurotoxicity
study
in
rats
with
cymoxanil,
the
NOEL
of
47.6
mg/
kg/
day
in
males
was
based
on
decreased
body
weights
and
minimal
to
mild
testicular
and
epididymal
effects
at
higher
concentrations.
In
females,
the
NOEL
of
59.9
mg/
kg/
day
was
based
on
effects
on
body
weight,
weight
gain,
and
food
efficiency
at
higher
levels.
The
subchronic
NOEL
for
male
mice
administered
cymoxanil
was
8.25
mg/
kg/
day
based
on
body
weight
and
weight
gain
effects
at
82.4
mg/
kg/
day
and
above.
The
NOEL
for
females
was
121
mg/
kg/
day
based
on
increases
in
spleen
and
liver
weights
at
433
mg/
kg/
day
and
above.
For
cymoxanil,
dogs
were
the
most
sensitive
species
in
subchronic
studies.
Reduced
body
weight
gain
and/
or
food
consumption
was
observed
at
3
mg/
kg/
day
or
greater
in
females
and
5
mg/
kg/
day
and
above
in
males.
Both
sexes
had
red
blood
cells
(
RBC)
changes
decreased
RBC
counts,
hemaglobin
(
Hb),
and/
or
hematocrit
(
Hct)
and
increased
incidence
of
ketonuria
at
the
intermediate
and
high
concentration,
and
changes
in
serum
chemistry
(
decreases
in
various
electrolytes
and
proteins)
at
the
high
dose.
Males
had
testicular
and
epididymal
effects
at
the
highest
concentration,
11
mg/
kg/
day
(
raised
from
5
mg/
kg/
day
at
week
3);
this
was
considered
to
be
retardation
of
development
due
to
markedly
reduced
body
weight
in
this
group.
The
NOEL
for
males
was
3
mg/
kg/
day.
There
was
no
NOEL
in
female
dogs
in
the
90
 
day
study.
Although,
a
NOEL
was
not
established
in
the
dog
subchronic
study,
3
mg/
kg/
day
was
found
to
be
a
NOEL
in
a
subsequent
chronic
study
in
dogs.
Subchronic
28
 
day
studies
were
conducted
in
rats
and
mice
to
evaluate
the
immunotoxicity
potential
of
cymoxanil.
Cymoxanil
was
not
immunotoxic
up
to
and
including
the
highest
dose
tested
which
was
1,600
ppm
in
rats
(
108
and
117
mg/
kg/
day
in
males
and
females,
respectively),
1,200
ppm
(
218
mg/
kg/
day)
in
male
mice,
and
2,400
ppm
(
552
mg/
kg/
day)
in
female
mice.
Cymoxanil
was
applied
to
the
skin
of
rats
6
 
hours/
day
for
28
days
at
doses
of
0,
50,
500,
and
1,000
mg/
kg/
day.
There
were
no
effects
at
any
dose
tested.
The
28
 
day
dermal
NOEL
was
1,000
mg/
kg/
day,
the
highest
dose
tested.
5.
Chronic
toxicity.
Chronic
studies
with
cymoxanil
were
conducted
on
rats,
mice,
and
dogs
to
determine
oncogenic
potential
and/
or
chronic
toxicity
of
the
compound.
Effects
generally
similar
to
those
observed
in
the
90
 
day
studies
were
seen
in
the
chronic
studies.
Cymoxanil
was
not
oncogenic.
The
chronic
NOEL
for
cymoxanil
in
male
rats
was
4.08
mg/
kg/
day
based
on
decreased
body
weight,
weight
gain,
food
efficiency,
and
non­
neoplastic
lesions
in
several
organs
including
lung
inflammation,
spermatid
degeneration,
and
retinal
atrophy
at
30.3
mg/
kg/
day
or
higher.
In
addition,
male
rats
in
the
two
highest
groups
displayed
increased
aggressiveness
and
hyperreactivity
consistent
with
the
compromised
general
health
status
(
i.
e.
systemic
toxicity)
of
those
groups.
In
females,
the
NOEL
of
5.36
mg/
kg/
day
was
based
on
decreased
body
weight,
weight
gain,
food
efficiency,
and
non­
neoplastic
lesions
in
several
organs
including
lungs,
liver,
intestines,
mesenteric
lymph
nodes,
sciatic
nerve,
and
retina
at
38.4
mg/
kg/
day
or
higher.
Retinal
atrophy
and
sciatic
lesions
are
common
spontaneous
lesions
associated
with
aging.
These
effects
observed
in
cymoxanil
test
animals
were
considered
aging­
related
effects.
Spermatid
degeneration
occurs
spontaneously
in
rats.
While
the
incidence
was
increased
in
cymoxanil­
treated
rats,
most
were
mild
or
minimal
and
none
were
more
than
moderate.
Thus,
the
effects
are
considered
a
mild
exacerbation
of
a
spontaneously
occurring
lesion.
In
mice,
the
chronic
NOELs
for
cymoxanil
were
4.19
and
5.83
mg/
kg/
day
for
males
and
females,
respectively,
based
on
changes
in
organ
weights,
gastrointestinal
effects
in
females
and
liver,
testes
and
epididymal
effects
in
males
at
the
LOEL.
Similar
to
the
rat,
the
testicular
effects
were
considered
an
exacerbation
of
a
spontaneous
lesion,
that
occurred
in
one­
quarter
of
the
control
mice.
The
LOELs
were
42.0
and
58.1
mg/
kg/
day
for
males
and
females,
respectively.
The
chronic
cymoxanil
NOEL
for
male
dogs
was
3.0
mg/
kg/
day
based
on
a
temporary
decrease
in
body
weight
and
food
consumption,
and
lower
RBC
count,
hemoglobin,
and
hematocrit
at
5.7
mg/
kg/
day.
In
female
dogs
the
only
finding
was
a
transient
effect
on
body
weight,
food
consumption,
and
food
efficiency
at
the
highest
dose
tested,
3.1
mg/
kg/
day,
only
during
the
first
week
of
the
study.
EPA
considered
the
NOEL
in
females
to
be
3.1
mg/
kg
(
Cymoxanil
Agency
Risk
Assessment,
February
18,
1998).
6.
Animal
metabolism.
When
administered
by
gavage
to
rats,
cymoxanil
was
readily
absorbed
and
eliminated.
Absorption
reached
maximum
concentrations
in
whole
blood
within
4
hours
post­
dosing.
A
rapid
and
almost
complete
elimination
was
observed
in
the
urine
and
feces.
The
majority
of
radioactivity
was
recovered
within
96
hours,
mainly
in
urine
but
also
in
feces.
Radioactivity
in
the
tissues
and
carcass
was
less
than
1%.
In
the
urine
and
feces,
the
majority
of
the
radioactivity
was
free
and/
or
conjugated
glycine.
2­
Cyano­
2­
methoxyimino­
acetic
acid
was
also
found
in
low
levels
in
the
urine
and
trace
levels
in
the
feces.
Intact
cymoxanil
was
less
than
1%
in
feces
and
not
detected
in
the
urine.
The
metabolite
profile
in
urine
and
feces
was
similar
between
sexes,
among
dose
groups,
and
between
dosing
regimens
(
single
vs.
multiple).

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Notices
7.
Metabolite
toxicology.
There
are
no
metabolites
of
toxicological
significance
to
mammals.
8.
Endocrine
disruption.
Chronic,
lifespan,
and
multi­
generational
bioassays
in
mammals
and
acute
and
subchronic
studies
on
aquatic
organisms
and
wildlife
did
not
reveal
endocrine
effects.
Any
endocrine­
related
effects
would
have
been
detected
in
this
definitive
array
of
required
tests.
The
probability
of
any
such
effect
due
to
agricultural
uses
of
cymoxanil
is
negligible.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Cymoxanil
is
a
fungicide
currently
registered
in
the
United
States
for
use
on
potatoes.
In
addition,
tolerances
have
been
for
cymoxanil
on
imported
tomatoes
and
grapes.
This
tolerance
petition
proposes
the
following
new
uses
in
the
United
States:
Cucurbit
vegetables,
fruiting
vegetables
and
head
lettuce.
There
are
no
residential
uses.
i.
Food
 
a.
Chronic
dietary
exposure
assessment.
The
chronic
RfD
of
0.041
mg/
kg/
day
is
based
on
a
NOEL
of
4.08
mg/
kg/
day
from
the
1
year
rat
feeding
study
and
an
uncertainty
factor
of
100.
The
acute
NOEL
of
4.0
mg/
kg/
day
is
based
upon
maternal
clinical
signs
and
weight
effects
at
higher
levels
in
a
rat
developmental
study.
Chronic
dietary
cymoxanil
exposure
risks
resulting
from
the
proposed
use
of
DPX­
KP481
50DF
on
cucurbits,
fruiting
vegetables,
head
lettuce,
potatoes
and
imported
grapes
were
estimated
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM,
Novigen
Sciences,
Inc.,
1999
Version
6.74).
The
analysis
conservatively
assumed
that
30%
of
the
crops
on
the
proposed
label
would
be
treated
with
DPX­
KP481
50DF
and
used
field
trial
residue
data.
The
chronic
dietary
risk
estimate
for
cymoxanil
shows
that
an
adequate
margin
of
safety
exists
for
all
population
subgroups
and
that
no
effects
would
result
from
dietary
exposure
to
cymoxanil.
The
following
table
presents
the
analysis
which
indicate
large
margins
of
safety
for
each
population
subgroup
and
very
low
probability
of
effects
resulting
from
chronic
exposure
to
cymoxanil
in
DPX­
KP481
50DF.
No
sensitive
subpopulations
were
identified.
For
the
general
populations
and
all
subpopulations
0.2%
or
less
of
the
chronic
RfD
used.

TABLE
3.
 
RESULTS
OF
CHRONIC
DIETARY
ANALYSIS
WITH
CYMOXANIL
Population
Group
Maximum
Dietary
Exposure
(
mg/
kg/
day)
%
RfD
U.
S.
population
0.000063
0.2
Non­
nursing
infants
(<
1
yr.)
0.000016
<
0.1
Children
(
1
 
6
yr.)
0.000074
0.2
Children
(
7
 
12
yr.)
0.000068
0.2
Females
(
13+)
0.000074
0.2
b.
Acute
dietary
exposure.
Results
of
the
Tier
3
acute
dietary
exposure
analysis
show
that
an
adequate
margin
of
safety
exists
for
all
population
subgroups
and
that
no
acute
effects
would
result
from
dietary
exposure
to
cymoxanil.
The
analysis
conservatively
assumed
that
30%
of
the
crops
on
the
proposed
label
would
be
treated
with
DPX­
KP481
50DF
and
used
field
trial
residue
data.
The
results
of
the
acute
dietary
exposure
analysis
for
cymoxanil
are
given
in
the
table
below.
The
percentages
of
acute
reference
dose
(
aRFD)
for
cymoxanil
were
calculated
based
on
an
acute
NOEL
of
4
mg/
kg/
day
from
the
rabbit
developmental
study
based
on
maternal
clinical
signs
and
weight
effects
at
the
higher
levels
and
an
uncertainty
factor
of
100.
The
results
of
the
acute
dietary
exposure
analysis
for
cymoxanil
indicate
that
the
predicted
exposures,
expressed
as
a
percentage
of
the
aRFD
are
well
below
100%,
showing
cymoxanil
clearly
meets
the
Food
Quality
Protection
Act
(
FQPA)
standard
of
reasonable
certainty
of
no
harm
and
presents
much
lower
acute
dietary
risk
than
many
of
its
competitors.
At
the
99.9th
percentile,
the
percentage
of
the
aRFD
was
4.47%
for
the
general
population
and
5.72%
for
the
most
sensitive
subpopulation,
nursing
females.

TABLE
4.
 
RESULTS
OF
ACUTE
DIETARY
ANALYSIS
WITH
CYMOXANIL
Population
Group
99th
Percentile
of
Exposure
99th
Percentile
of
Exposure
Exposure
(
mg/
kg/
day)
%
aRfD
Exposure
(
mg/
kg/
day)
%
aRfD
U.
S.
population
0.000475
1.19
0.001789
4.47
Non­
nursing
infants
(<
1
yr.)
0.000184
0.46
0.000599
1.50
Children
(
1
 
6
yr.)
0.000576
1.44
0.002096
5.24
Children
(
7
 
12
yr.)
0.000485
1.21
0.001936
4.84
Females
(
13+
nursing)
0.000635
1.59
0.002287
5.72
ii.
Drinking
water.
Surface
water
exposure
was
estimated
using
the
Generic
Expected
Environmental
Concentration
(
GENEEC)
model.
Ground
water
exposure
was
estimated
using
SCI­
GROW.
These
are
screening
level
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Notices
models
used
for
determining
upper
bound
concentrations
of
pesticides
in
surface
water
and
ground
water.
The
acute
drinking
water
levels
of
concern
(
DWLOCs)
are
1.3
parts
per
million
(
ppm)
for
the
U.
S.
population,
and
0.38
ppm
for
the
most
exposed
population
subgroup,
children
(
1
 
6
years).
The
estimated
maximum
concentration
of
cymoxanil
in
surface
water
(
8.15
ppb)
derived
from
GENEEC
is
much
lower
than
the
acute
DWLOC.
Therefore,
one
can
conclude
with
reasonable
certainty
that
residues
of
cymoxanil
in
drinking
water
will
not
contribute
significantly
to
the
aggregate
acute
human
health
risk.
The
chronic
DWLOCs
are
1.4
ppm
for
the
U.
S.
population
and
0.4
ppm
for
the
most
sensitive
subgroup,
children
(
1
 
6
years).
The
DWLOCs
are
substantially
higher
than
the
GENEEC
56
 
day
estimated
environmental
concentration
of
0.37
ppb
for
cymoxanil
in
surface
water.
Therefore,
one
can
conclude
with
reasonable
certainty
that
residues
of
cymoxanil
in
drinking
water
do
not
contribute
significantly
to
the
aggregate
chronic
human
health
risk.
2.
Non­
dietary
exposure.
Cymoxanil
products
are
not
labeled
for
residential
non­
food
uses,
thereby
eliminating
the
potential
for
residential
exposure.
Nonoccupational
non­
dietary
exposure
for
cymoxanil
has
not
been
estimated
because
the
proposed
products
are
limited
to
commercial
crop
production.
Therefore,
the
potential
for
nonoccupational
exposure
is
insignificant.

D.
Cumulative
Effects
EPA's
consideration
of
a
common
mechanism
of
toxicity
is
not
necessary
at
this
time
because
there
is
no
indication
that
toxic
effects
of
cymoxanil
should
be
cumulative
with
those
of
any
other
chemical
compounds
or
with
each
other.
Cymoxanil
is
a
unique
cyanoacetamide
and
is
chemically
unrelated
to
any
other
commercial
plant
disease
control
agent.
Its
biochemical
mode
of
action
on
fungi
appears
to
be
unique;
it
is
theorized
to
act
through
inhibition
of
multiple
cellular
processes,
but
a
definitive
mechanism
has
not
been
completely
elucidated.
Similarly,
the
mechanism
of
action
underlying
observed
toxicological
effects
in
mammals
is
not
fully
characterized
and
there
is
no
reliable
information
to
suggest
that
cymoxanil
has
a
mechanism
of
toxicity
in
common
with
any
other
compound.
Given
the
distinct
chemical
and
toxicological
profile
of
cymoxanil,
its
low
acute
toxicity,
absence
of
genotoxic,
oncogenic,
developmental,
or
reproductive
effects,
and
low
exposure
potential,
the
expression
of
cumulative
human
health
effects
with
any
other
natural
or
synthetic
pesticide
is
not
anticipated.

E.
Safety
Determination
1.
U.
S.
population.
Dietary
and
occupational
exposure
will
be
the
major
routes
of
exposure
to
the
U.
S.
population
for
cymoxanil,
and
ample
margins
of
safety
have
been
demonstrated
for
both.
For
cymoxanil,
assuming
30%
crop
treated
and
residues
estimated
based
on
field
trial
results,
the
chronic
dietary
exposure
for
the
overall
U.
S.
population
is
estimated
to
be
0.000063
mg/
kg/
day,
using
0.2
percent
of
the
RfD.
For
acute
dietary
exposure,
the
estimated
exposure
is
0.000475
and
0.001789
at
the
99th
and
99.9th
percentiles,
which
will
utilize
1.19
and
4.47%,
respectively,
of
the
RfD
for
the
overall
U.
S.
population.
The
ground
application
margin
of
exposure
(
MOE)
was
7,814
for
mixers/
loaders
and
1,430
for
applicators.
The
aerial
application
MOE
was
3,907
for
mixers/
loaders
and
38,763
for
applicators.
The
MOE
for
flaggers
was
10,916.
Based
on
the
completeness
and
reliability
of
the
toxicity
data
and
the
conservative
exposure
assessments,
there
is
reasonable
certainty
that
no
harm
will
result
from
the
aggregate
exposure
of
residues
of
cymoxanil
including
all
anticipated
dietary
exposure
and
all
other
non­
occupational
exposures.
2.
Infants
and
children.
Chronic
dietary
exposure
of
cymoxanil
for
the
most
highly
exposed
children's
subpopulations
are:
0.000074
mg/
kg/
day
for
children
1
 
6
years
and
0.000068
mg/
kg/
day
for
children
7
 
12
years,
representing
0.2%
of
the
chronic
reference
dose
(
cRfD)
for
each
subpopulation.
Exposure
for
all
infant
subpopulations
was
negligible.
For
acute
dietary
exposure
of
cymoxanil,
the
%
RfD
for
children
1
 
6
years
is
1.44
at
the
99th
percentile
and
5.24
at
the
99.9th
percentile.
For
non­
nursing
infants
(>
1
yr.),
the
%
RfD
is
0.46
at
the
99th
percentile
and
1.50
at
the
99.9th
percentile.
There
are
no
residential
uses
of
cymoxanil;
it
is
extremely
unlikely
that
drinking
water
will
be
contaminated.
Based
on
the
completeness
and
reliability
of
the
toxicity
data
base,
the
lack
of
toxicological
endpoints
of
special
concern,
the
lack
of
any
indication
that
children
are
more
sensitive
than
adults
to
cymoxanil,
and
the
conservative
exposure
assessment,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
the
aggregate
exposure
of
residues
of
cymoxanil,
including
all
anticipated
dietary
exposure
and
all
other
nonoccupational
exposures.
Accordingly,
there
is
no
need
to
apply
an
additional
safety
factor
for
infants
and
children.

F.
International
Tolerances
To
date,
no
international
tolerances
exist
for
cymoxanil.
[
FR
Doc.
03
 
4257
Filed
2
 
27
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
EMERGENCY
MANAGEMENT
AGENCY
[
FEMA
 
1445
 
DR]

Alaska;
Amendment
No.
3
to
Notice
of
a
Major
Disaster
Declaration
AGENCY:
Federal
Emergency
Management
Agency
(
FEMA).
ACTION:
Notice.

SUMMARY:
This
notice
amends
the
notice
of
a
major
disaster
declaration
for
the
State
of
Alaska,
(
FEMA
 
1445­
DR),
dated
December
4,
2002,
and
related
determinations.

EFFECTIVE
DATE:
February
12,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
Magda
Ruiz,
Response
and
Recovery
Directorate,
Federal
Emergency
Management
Agency,
Washington,
DC
20472,
(
202)
646
 
2705
or
Magda.
Ruiz@
fema.
gov.

SUPPLEMENTARY
INFORMATION:
The
notice
of
a
major
disaster
declaration
for
the
State
of
Alaska
is
hereby
amended
to
include
the
following
areas
among
those
areas
determined
to
have
been
adversely
affected
by
the
catastrophe
declared
a
major
disaster
by
the
President
in
his
declaration
of
December
4,
2002:

Kodiak
Island
Borough
for
Public
Assistance
(
already
designated
for
Individual
Assistance).
Alaska
Railroad
right­
of­
way
between
Milepost
79
and
Milepost
102
along
the
Turnagain
Arm
and
state
highway
Milepost
4
Power
Creek
Road
highway
in
the
Cordova
area
for
Public
Assistance.
(
The
following
Catalog
of
Federal
Domestic
Assistance
Numbers
(
CFDA)
are
to
be
used
for
reporting
and
drawing
funds:
83.537,
Community
Disaster
Loans;
83.538,
Cora
Brown
Fund
Program;
83.539,
Crisis
Counseling;
83.540,
Disaster
Legal
Services
Program;
83.541,
Disaster
Unemployment
Assistance
(
DUA);
83.556,
Fire
Management
Assistance;
83.558,
Individual
and
Household
Housing;
83.559,
Individual
and
Household
Disaster
Housing
Operations;
83.560
Individual
and
Household
Program
 
Other
Needs,
83.544,
Public
Assistance
Grants;
83.548,
Hazard
Mitigation
Grant
Program.)

Joe
M.
Allbaugh,
Director.
[
FR
Doc.
03
 
4723
Filed
2
 
27
 
03;
8:
45
am]

BILLING
CODE
6718
 
02
 
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2003
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