Document ID: EPA-HQ-OPP-2003-0156-0001
Agency: epa
Document Type: Notice
Title: Cyazofamid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-05-07T04:00Z

24463
Federal
Register
/
Vol.
68,
No.
88
/
Wednesday,
May
7,
2003
/
Notices
proposed
uses
will
utilize
at
most
15%
of
the
aRfD
and
1%
of
the
cRfD
even
for
the
most
highly
exposed
population
subgroups
(
non­
nursing
infants).
Therefore,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
the
currently
proposed
uses
of
thiacloprid.

F.
International
Tolerances
No
CODEX
Maximum
Residue
Levels
(
MRL's)
have
been
established
for
residues
of
thiacloprid
on
any
crops
at
this
time.

[
FR
Doc.
03
 
11200
Filed
5
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0156;
FRL
 
7305
 
7]

Cyazofamid;
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
 
0156,
must
be
received
on
or
before
June
6,
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:
Dennis
McNeilly,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
6742];
e­
mail
address:
mcneilly.
dennis@
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.
EPA
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0156.
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
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although,
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
EPA
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
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Register
/
Vol.
68,
No.
88
/
Wednesday,
May
7,
2003
/
Notices
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
 
0156.
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
 
0156.
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
 
0156.
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
 
0156.
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:
April
23,
2003.
Debra
Edwards,
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.

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Vol.
68,
No.
88
/
Wednesday,
May
7,
2003
/
Notices
ISK
Biosciences
Corporation
PP
1F6305
EPA
has
received
a
pesticide
petition
[
1F6305]
from
ISK
Biosciences
Corporation,
7470
Auburn
Road,
Suite
A,
Concord
OH
44077,
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
a
tolerance
for
residues
of
the
fungicide
cyazofamid,
4­
chloro­
2­
cyano­
N,
N­
dimethyl­
5­(
4­
methylphenyl)­
1H­
imidazole­
1­
sulfonamide
(
CA),
in
or
on
the
raw
agricultural
commodity
(
RAC)
potatoes
at
0.01
parts
per
million
(
ppm)
and
cucurbits
at
0.1
ppm
and
the
fungicide
cyazofamid
and
the
metabolite
CCIM,
4­
chloro­
5­(
4­
methylphenyl)­
1Himidazole
2­
carbonitrile
(
CA)
in
or
on
the
RAC
tomatoes
at
0.2
ppm
and
wine
grapes
at
1.0
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
studies
in
potatoes
and
tomatoes,
together
with
the
magnitude
of
the
residue
studies
in
potatoes,
tomatoes
and
cucurbits,
suggest
that
the
tolerance
for
potatoes,
tomatoes,
and
cucurbits
should
be
based
only
on
parent
cyazofamid.
However,
magnitude
of
the
residue
studies
on
processed
tomatoes
indicate
that
both
cyazofamid
and
CCIM
are
identifiable
residues
in
tomato
puree
and
paste.
The
nature
and
magnitude
of
the
residue
studies
for
potatoes
showed
that
there
were
no
detectable
residues
of
cyazofamid
or
any
of
its
metabolites
in
the
RACs
or
processed
commodities.
Similar
studies
on
fresh
tomatoes
indicated
that
the
major
identifiable
and
quantifiable
residue
is
cyazofamid.
Magnitude
of
the
residue
studies
conducted
on
cucurbits
(
cucumber,
summer
squash
and
melon)
also
confirmed
that
the
major
residue
is
cyazofamid.
Nature
of
the
residue
studies
showed
that
no
single
identifiable
residue
represents
more
than
about
7%
of
the
total
radioactive
residue.
The
nature
and
magnitude
of
the
residue
studies
on
grapes
showed
that
cyazofamid
was
the
major
identifiable
residue
with
low
levels
of
CCIM.
The
residue
in
wine
made
from
cyazofamid
treated
grapes
is
CCIM.
The
tolerance
expression
for
potatoes
and
cucurbits
will
include
parent
cyazofamid
only.
The
tolerance
expression
for
wine
grapes
and
tomatoes
will
include
parent,
cyazofamid,
and
the
metabolite
CCIM.
2.
Analytical
method.
An
analytical
enforcement
method
is
available
for
determining
cyazofamid
plant
residues
in
or
on
potatoes,
cucurbits,
tomatoes
and
wine
grapes.
Samples
are
chopped
in
a
food
chopper
and
a
20­
g
sub­
sample
is
removed
for
extraction
with
100
milliliter
(
mL)
of
acetonitrile
(
twice).
The
combined
extracts
are
partitioned
with
hexane
and
then
are
reduced
to
10
mL
with
a
rotary
evaporator.
The
sample
is
then
partitioned
between
100
mL
of
2%
aqueous
sodium
sulfate
solution
and
50
mL
of
methylene
chloride
(
twice).
The
residue
is
dissolved
and
passed
through
a
2
gram
(
g)
Florisil
column
followed
by
quantification
by
ultraviolet­
high
performance
liquid
chromatography
(
UV­
HPLC).
3.
Magnitude
of
residues.
Residue
data
from
31
field
trails
(
0
 
and
7
 
day
pre­
harvest
intervals
(
PHIs))
on
cucurbits
[
11
sites
for
cucumbers,
11
sites
for
muskmelons
and
9
sites
for
summer
squash]
conducted
from
1999
 
2001
showed
that
mean
cyazofamid
residues
were
0.02
ppm
for
0
 
day
PHI
and
<
0.01
ppm
for
7
 
day
PHI
on
the
RAC
commodities.
The
highest
mean
cyazofamid
residue
was
0.07
ppm
at
0
 
day
PHI
on
muskmelon.
The
highest
7
 
day
PHI
cyazofamid
residue
was
0.04
ppm
on
cucumbers.
At
both
PHI's
CCIM
residues
were
<
0.01
ppm
except
for
3
samples
(
2
sites,
both
0
 
day
PHI)
which
were
at
the
0.01
ppm
LOQ.
The
sample
with
the
highest
total
residue
had
0.08
ppm
(
0.07
ppm
cyazofamid
+
0.01
ppm
CCIM).
The
studies
had
a
target
of
6
applications
of
0.071
lb.
of
active
ingredient
per
acre
(
0.42
lb
acre
(
a.
i./
acre)
total)
of
the
Cyazofamid
400SC
formulation
each
at
7
 
day
intervals.
Data
from
18
field
trials
in
potatoes
conducted
in
1999
 
2000
showed
that
no
residues
of
cyazofamid
or
CCIM
were
observed
in
any
of
the
RAC
commodity
at
any
location
(
7
 
day
PHI).
There
were
up
to
10
applications
of
0.071
lb.
of
active
ingredient
per
acre
(
0.70
lb
a.
i./
acre
total)
of
the
Cyazofamid
400SC
formulation
at
7
 
day
intervals.
The
PHI
for
most
trials
was
7
 
days;
however,
residue
dissipation
studies
with
PHIs
of
0­,
1­,
3­
and
7
 
days
were
run
at
2
locations.
Maximum
residues
of
0.01
ppm
of
cyazofamid
were
seen
at
0­
and
1
 
day
PHIs
at
one
location
and
no
residues
were
found
at
the
other
location.
The
results
of
a
processing
study
in
which
the
final
application
was
at
a
3X
application
rate
showed
that
for
samples
taken
with
a
3
 
day
PHI
no
detectable
residues
of
cyazofamid
or
CCIM
were
found
in
potato
flakes,
chips
or
wet
peels.
Therefore,
no
concentration
of
residues
occurred
during
processing.
For
tomatoes,
residues
of
cyazofamid
were
determined
in
the
treated
samples
from
35
RAC
trials
(
0­
and
7
 
day
PHI)
conducted
from
1999
 
2001.
The
mean
per
site
residues
ranged
from
nondetected
(<
0.01
ppm)
to
0.15
ppm
cyazofamid.
CCIM
residues
of
0.01­
0.02
ppm
were
found
in
samples
from
four
of
the
sites.
The
sample
with
the
maximum
residue
had
0.16
ppm
cyazofamid
and
no
detectable
CCIM.
The
studies
had
a
target
of
six
applications
of
0.071
lb
of
active
ingredient
per
acre
(
0.42
lb
a.
i./
acre
total)
of
the
Cyazofamid
400SC
formulation
each
at
7
 
day
intervals.
The
results
of
a
tomato
processing
study
in
which
the
final
application
was
at
a
3X
application
rate
showed
that
for
samples
taken
with
a
3
 
day
PHI,
cyazofamid
was
<
0.01
ppm
in
both
tomato
paste
and
puree.
Tomato
paste
had
0.02
ppm
CCIM
and
tomato
puree
had
0.01
ppm
CCIM.
Therefore,
there
is
no
concentration
of
residues
during
tomato
processing.
Data
from
15
field
trials
in
grapes
conducted
from
1999
 
2001
in
the
United
States,
Argentina,
Mexico
and
Europe
showed
that
mean
cyazofamid
residues
ranged
from
<
0.01
to
0.34
ppm
and
mean
CCIM
residues
ranged
from
<
0.01
to
0.02
ppm
in
the
RAC
commodity
(
21
 
day
PHI)
following
eight
applications
of
0.081
to
0.089
lb.
of
active
ingredient
per
acre
(
0.65
to
0.71
lb
a.
i./
acre
total)
of
the
Cyazofamid
25SC
formulation
each
at
10
 
to
16
 
day
intervals.
Grapes
from
six
of
the
sites
were
processed
into
must
and
wine.
Most
samples
had
cyazofamid
residues
ranging
from
0.01
to
0.09
ppm.
The
CCIM
residues
in
must
ranged
from
<
0.01
to
0.01
ppm.
Cyazofamid
residues
in
wine
were
all
<
0.01
ppm.
CCIM
residues
in
wine
ranged
from
<
0.01
ppm
to
0.02
ppm.

B.
Toxicological
Profile
1.
Acute
toxicity.
Results
from
a
battery
of
acute
toxicity
studies
place
technical
cyazofamid
in
Toxicity
Category
IV
for
oral
LD50,
inhalation
LC50
and
dermal
and
eye
irritation
,
and
Category
III
for
dermal
LD
50.
Technical
cyazofamid
is
not
a
dermal
sensitizer.
In
an
acute
neurotoxicity
study,
no
treatment
related
effects
were
observed
at
any
dose.
The
no
observed
effect
level
(
NOEL)
was
2,000
milligrams/
kilogram
(
mg/
kg)
bodyweight
(
bwt).
2.
Genotoxicity.
A
battery
of
five
tests
has
been
conducted
to
assess
the
genotoxic
potential
of
technical
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Federal
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/
Vol.
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No.
88
/
Wednesday,
May
7,
2003
/
Notices
cyazofamid.
Assays
conducted
included
in
vitro
reverse
gene
mutation
tests
in
bacteria
and
an
in
vitro
forward
gene
mutation
test
in
a
mammalian
cell
system,
a
chromosomal
damage
test
in
mammalian
cells,
a
DNA
repair
test
in
bacteria,
and
an
in
vivo
micronucleus
test
in
mice.
Cyazofamid
did
not
elicit
a
genotoxic
response
in
any
of
the
studies
conducted.
3.
Reproductive
and
developmental
toxicity.
In
a
two­
generation
reproductive
toxicity
study,
the
only
effects
observed
were
body
weight
effects
which
were
observed
at
20,000
ppm
in
dams
during
gestation
and
lactation
and
in
weanling
pups.
No
reproductive
effects
were
observed.
The
NOEL
for
reproductive
effects
was
20,000
ppm
(
1,338
mg/
kg
bwt/
day).
The
NOEL
for
parental
toxicity
was
2,000
ppm
(
134
mg/
kg
bwt/
day).
In
a
rat
developmental
study,
cyazofamid
was
dosed
by
gavage
from
Days
0
to
19
of
gestation.
There
were
no
treatmentrelated
effects
observed
in
the
study.
The
NOEL
for
maternal
and
developmental
effects
was
1,000
mg/
kg
bwt/
day.
In
a
rabbit
developmental
study,
pregnant
rabbits
were
dosed
with
cyazofamid
by
gavage
on
Days
4
to
28
of
gestation.
There
were
no
treatmentrelated
effects
observed
in
the
study.
The
NOEL
for
maternal
and
developmental
effects
was
1,000
mg/
kg
bwt/
day.
The
developmental
studies
(
prenatal
developmental
studies
in
rat
and
rabbit
and
the
two
generation
reproduction
study
in
rat)
provided
no
indication
of
increased
sensitivity
of
rats
or
rabbits
from
in
utero
or
postnatal
exposure
to
cyazofamid.
Cyazofamid
is
not
a
developmental
or
reproductive
toxicant.
4.
Subchronic
toxicity.
The
oral
toxicity
of
cyazofamid
was
investigated
in
rats
and
dogs
in
13
 
week
studies.
The
exposure
was
by
dietary
administration
for
the
rats
and
by
capsule
for
the
dogs.
There
were
no
treatment­
related
effects
observed
in
dogs
up
to
1,000
mg/
kg
bwt/
day
which
was
the
highest
dose
tested.
In
rats,
treated
at
5,000
ppm
there
was
a
treatment
related
increase
in
kidney
and
liver
weights
and
increased
observation
of
basophilic
tubules.
The
latter
was
observed
only
in
males.
The
NOEL
was
500
ppm
which
was
equivalent
to
a
dosage
of
29.9
mg/
kg
bwt/
day
to
males
and
33.3
mg/
kg
bwt/
day
to
females.
5.
Chronic
toxicity.
A
combined
chronic
and
oncogenicity
study
was
conducted
in
rats.
Cyazofamid
was
administered
continuously
for
a
period
of
104
weeks
to
male
and
female
Fischer
rats.
Cyazofamid
was
not
carcinogenic
in
this
study.
The
NOEL
for
chronic
effects
was
500
ppm
(
17
mg/
kg
bwt/
day)
based
on
kidney
and
liver
weight
differences
and
increases
in
urine
volume
and
chloride
levels
at
5,000
ppm.
In
a
long­
term
feeding
study,
mice
were
dosed
with
cyazofamid
in
the
diet
for
78
weeks.
No
treatment
related
effects
were
observed
and
it
was
concluded,
that
cyazofamid
was
not
carcinogenic.
The
NOEL
was
7,000
ppm
(
985
and
1,203
mg/
kg
bwt/
day
for
males
and
females,
respectively).
In
a
chronic
dog
study,
four
groups
of
six
dogs/
sex/
group
received
the
test
material
via
capsule
for
52
weeks.
No
treatment
related
effects
were
observed.
The
NOEL
was
1,000
mg/
kg
bwt/
day.
6.
Animal
metabolism.
Studies
on
the
metabolism
of
cyazofamid
in
animals
using
radioactive
test
material
have
been
conducted
with
cyazofamid,
labeled
with
14C
in
two
positions,
the
benzene
[
14C­
Bz]­
or
imidazole
[
14C­
Im]
position.
Absorption
is
rapid,
but
the
percentage
of
cyazofamid
absorbed
after
an
oral
dosage
decreases
as
the
dosage
is
increased.
All
absorbed
radiocarbon
is
rapidly
eliminated
with
urinary
and
biliary
elimination
of
radiocarbon
nearly
complete
within
24
hours.
The
metabolic
pathway
of
cyazofamid
includes
the
rapid
hydrolysis
of
the
dimethylsulfonamide
group
and
the
oxidation
of
the
benzyl
methyl
group.
7.
Metabolite
toxicology.
Comparison
of
the
metabolism
of
cyazofamid
by
plants
and
in
animals
indicates
that
a
number
of
the
identified
metabolites
are
common
to
both
plants
and
animals
but
metabolism
in
plants
is
more
extensive
than
in
animals.
The
data
indicate
that
the
final
products
of
the
metabolism
of
cyazofamid
in
animals
and
plants
represent
differences
in
the
extent
of
metabolism.
Several
of
the
metabolites
resulting
from
cyazofamid
are
similar
in
plants
and
animals
and,
therefore,
have
already
been
evaluated
toxicologically.
8.
Endocrine
disruption.
An
evaluation
of
the
potential
effects
on
the
endocrine
systems
of
mammals
has
not
been
determined;
however,
no
evidence
of
such
effects
was
reported
in
subchronic,
chronic
or
reproductive
toxicology.
There
was
no
observed
pathological
finding
of
the
endocrine
organs
in
these
studies,
and
there
were
no
reproductive
effects
at
the
maximum
dose
tested
of
20,000
ppm.
There
is
no
evidence
at
this
time
that
cyazofamid
causes
endocrine
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure.
A
reference
dose
(
RfD)
of
0.17
mg/
kg
bwt/
day
is
proposed
for
humans,
based
on
the
NOEL
from
the
2
year
rat
study
(
17
mg/
kg
bwt/
day)
and
dividing
by
an
uncertainty
factor
of
100.
The
acute
NOEL
of
100
mg/
kg
bwt
is
from
the
acute
neurotoxicity
study
adjusted
for
oral
absorption
of
5%.
No
treatment
related
effects
were
observed
at
any
dose
level.
i.
Food.
Tier
1
chronic
and
acute
dietary
exposure
analyses
were
conducted
for
cyazofamid
in/
on
cucurbits,
potatoes,
tomatoes
and
wine
grapes
to
determine
the
exposure
contribution
of
these
commodities
to
the
diet
and
to
ascertain
the
chronic
and
acute
risk
potential.
The
estimates
were
based
on
proposed
tolerance
level
residues
for
all
crops,
potato
and
tomato
processing
studies,
market
share
assumptions
of
100%
crop
treated,
and
consumption
data
from
the
1994
through
1996
United
States
Department
of
Agriculture
(
USDA)
continuing
survey
of
food
intake.
Even
using
all
of
the
worst
case
exposure
scenarios
listed
above,
the
Tier
1
chronic
dietary
exposure
estimates
resulted
in
an
estimated
exposure
for
the
U.
S.
population
of
0.000594
mg/
kg
bwt/
day.
This
exposure
corresponds
to
0.3%
of
the
RfD
of
0.17
mg/
kg
bwt/
day.
The
highest
exposure
estimate
was
calculated
for
the
children
1
 
6
years
population
subgroup.
This
exposure
was
determined
to
be
0.000939
mg/
kg
bwt/
day
(
0.6%
of
the
RfD).
The
Tier
1
acute
assessment
for
the
U.
S.
population
resulted
in
a
margin
of
exposure
(
MOE)
of
35,789
at
the
95th
percentile.
This
corresponded
to
an
estimated
exposure
of
0.002793
mg/
kg
bwt/
day.
The
highest
acute
exposure
estimate
(
95th
percentile)
was
observed
in
children
1
 
3
years
subpopulation:
0.004580
mg/
kg
bwt/
day.
This
correlates
to
an
MOE
of
21,833.
It
can
be
concluded
that
acute
or
long­
term
dietary
exposure
to
cyazofamid
through
residues
on
treated
cucurbits,
potatoes,
tomatoes
and
imported
wine
grapes
should
not
be
of
cause
for
concern.
ii.
Drinking
water.
Since
cyazofamid
is
intended
for
application
outdoors
to
field
grown
potato,
tomato
and
cucurbits
crops,
the
potential
exists
for
parent
and
or
metabolites
to
reach
ground
or
surface
water
that
may
be
used
for
drinking
water.
The
calculated
drinking
water
levels
of
comparison
(
DWLOCs)
for
chronic
exposure
for
adult
males,
adult
females
and
toddlers
were
estimated
to
be
5,929
parts
per
billion
(
ppb),
5,083
ppb,
and
1,691
ppb,
respectively.
The
calculated
DWLOCs
for
acute
exposure
for
all
adults,
adult
females
and
toddlers
were
estimated
to
be
34,902
ppb,
29,923
ppb,
and
9,954
ppb,
respectively.
The
chronic
and
acute
DWLOC
values
are
well
above
the
modeled
chronic
and
acute
drinking
water
estimated
concentrations
(
DWECs)
of
0.023
ppb
(
generic
expected
estimated
concentration
(
GENEEC)
56
 
day)
and
1.38
ppb
(
GENEEC
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2003
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Notices
instantaneous
value),
respectively.
Therefore,
there
is
comfortable
certainty
that
no
harm
will
result
from
combined
dietary
food
and
water,
exposure
due
to
the
use
of
cyazofamid
on
cucurbits,
potatoes
and
tomatoes.
2.
Non­
dietary
exposure.
No
petition
for
registration
of
cyazofamid
is
being
made
for
either
indoor
or
outdoor
residential
use.
Non­
occupational
exposure
of
cyazofamid
to
the
general
population
is,
therefore,
not
expected
and
is
not
considered
in
aggregate
exposure
estimates.

D.
Cumulative
Effects
Cyazofamid
is
a
cyanoimidazole
fungicide.
Since
there
are
no
other
members
of
this
class
of
fungicides,
it
is
considered
unlikely
that
cyazofamid
would
have
a
common
mechanism
of
toxicity
with
any
other
pesticide
in
use
at
this
time.

E.
Safety
Determination
1.
U.
S.
population.
Dietary
and
occupational
exposure
will
be
the
major
routes
of
exposure
to
the
U.
S.
population.
Ample
margins
of
safety
have
been
demonstrated
for
both
situations.
For
the
U.
S.
population,
the
chronic
dietary
exposure
to
cyazofamid
is
0.000594
mg/
kg
bwt/
day,
which
utilizes
0.3%
of
the
RfD
for
the
overall
U.
S.
population,
assuming
100%
of
the
crops
are
treated.
The
acute
dietary
exposure
to
the
U.
S.
population
is
0.002793
mg/
kg
bwt/
day
(
95th
percentile)
resulting
in
a
MOE
of
35,789.
Using
only
pesticide
handlers
exposure
data
base
(
PHED)
data
levels
A
and
B
(
those
with
a
high
level
of
confidence),
MOE
for
occupational
exposure
is
5,195
for
mixer/
loaders,
and
5,884
for
aerial
applicators.
Based
on
the
completeness
and
reliability
of
the
toxicity
data
and
the
conservative
exposure
assessments,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
the
aggregate
exposure
of
residues
of
cyazofamid
including
all
anticipated
dietary
exposure
and
all
other
non­
occupational
exposures.
2.
Infants
and
children.
Chronic
dietary
exposure
of
the
most
highly
exposed
subgroup
in
the
population,
children
1
 
6,
is
0.000939
mg/
kg
bwt/
day
or
0.6%
of
the
RfD.
The
acute
dietary
exposure
of
the
most
exposed
subgroup,
children
1
 
3,
is
0.00458
mg/
kg
bwt/
day.
This
correlates
to
an
MOE
of
21,833.
There
are
no
residential
uses
of
cyazofamid.
Based
on
the
completeness
and
reliability
of
the
toxicity
data,
the
lack
of
toxicological
endpoints
of
special
concern,
the
lack
of
any
indication
of
greater
sensitivity
of
children,
and
the
conservative
exposure
assessment;
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
the
aggregate
exposure
to
residues
of
cyazofamid
from
all
anticipated
sources
of
dietary
and
non­
occupational
exposure.
Accordingly,
there
is
no
need
to
apply
an
additional
safety
factor
for
infants
and
children.

F.
International
Tolerances
There
are
presently
no
Codex
maximum
residue
limits
established
for
residues
of
cyazofamid
on
any
crop.
[
FR
Doc.
03
 
11198
Filed
5
 
6
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0111;
FRL
 
7305
 
1]

Folpet;
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
 
0111
must
be
received
on
or
before
June
6,
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:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7610;
e­
mail
address:
jackson.
sidney@
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.
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.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
EPA
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP
 
2003
 
0111.
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
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