Document ID: EPA-HQ-OPP-2003-0240-0001
Agency: epa
Document Type: Notice
Title: Cyromazine; Notice of Filing of Pesticide Petitions to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-08-06T04:00Z

46616
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
F.
Safety
Determination
1.
U.
S.
population.
The
use
of
products
containing
yeast
extract
hydrolysate,
which
lacks
toxicity
and
is
used
in
such
low
concentrations,
is
compatible
with
EPA's
objectives
to
register
reduced
risk
pesticides.
Based
on
its
lack
of
toxicity
and
the
fact
that
yeast
extracts
are
already
present
in
the
diet,
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
of
the
U.
S.
population,
including
infants
and
children,
to
residues
of
yeast
extract
hydrolysate.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
Yeast
extract
hydrolysate
is
applied
at
low
rates
and
with
its
lack
of
toxicity
and
its
history
of
safe
use,
it
does
not
pose
a
safety
concern.
2.
Infants
and
children.
Based
on
the
lack
of
toxicity
of
yeast
extract
hydrolysate,
there
is
a
reasonable
certainty
that
no
harm
to
children
or
adults
will
result
from
aggregate
exposure
to
yeast
hydrolysate.
Exempting
yeast
extract
hydrolysate
from
the
requirement
of
a
tolerance
should
pose
no
significant
risk
to
humans.

G.
Effects
on
the
Immune
and
Endocrine
Systems
Yeast
extract
hydrolysate
is
a
naturally
occurring
biochemical.
To
date
there
is
no
evidence
to
suggest
that
yeast
extract
hydrolysate
functions
in
a
manner
similar
to
any
known
hormone,
or
that
it
acts
as
an
endocrine
disruptor.

H.
Existing
Tolerances
There
are
no
existing
tolerances
for
yeast
extract
hydrolysate
in
the
United
States.

I.
International
Tolerances
There
are
no
known
approved
Codex
maximum
residue
levels
established
for
residues
of
yeast
extract
hydrolysate.
[
FR
Doc.
03
 
19916
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0240;
FRL
 
7319
 
3]

Cyromazine;
Notice
of
Filing
of
Pesticide
Petitions
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
pesticide
petitions
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0240,
must
be
received
on
or
before
September
5,
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:
 
Industry
(
NAICS
111,
112,
311,
32532),
e.
g.,
Crop
production,
Animal
production,
Food
manufacturing,
and
Pesticide
manufacturing.
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
 
0240.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
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46617
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
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
 
0240.
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
 
0240.
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
 
0240.
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
 
0240.
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);

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46618
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
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:
July
28,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner
summary
of
the
pesticide
petitions
are
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
were
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
4
(
IR­
4)

PP
2E6507
and
PP
2E6510
EPA
has
received
pesticide
petitions
(
PP
2E6507
and
PP
2E6510)
from
IR­
4,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
 
3390
proposing,
pursuant
to
section
408(
d)
of
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.414
by
establishing
tolerances
for
residues
of
cyromazine,
(
N­
cyclopropyl­
1,3,5­
triazine­
2,4,6­
triamine)
in
or
on
the
following
raw
agricultural
commodities:
Leek;
onion,
green;
onion,
potato;
onion,
tree;
onion,
welsh;
and
shallot,
fresh
leaves
at
3.0
parts
per
million
(
ppm)
(
2E6507),
garlic,
bulb;
garlic
great­
headed,
bulb;
onion,
dry
bulb;
rakkyo,
bulb;
and
shallot,
bulb
at
0.2
ppm
(
2E6507),
vegetable
brassica,
leafy,
group
5,
except
broccoli
at
10
ppm
(
2E6510),
broccoli
at
1.0
ppm,
turnip,
greens;
cabbage,
abyssinian;
cabbage,
seakale;
and
hanover
salad,
leaves
at
10
ppm,
and
kidney
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.2
ppm,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.05
ppm
(
2E6510).
IR­
4
also
proposed
that
tolerances
for
residues
of
cyromazine
in
or
on
dry
bulb
onion
at
2.0
ppm
and
green
onion
at
0.1
ppm
established
under
40
CFR
180.414(
a)
and
Chinese
cabbage
and
Chinese
mustard
at
3.0
ppm
established
under
40
CFR
180.414(
c)
be
deleted
when
the
proposed
tolerances
are
established.
Chinese
cabbage
and
Chinese
mustard
are
included
in
the
Brassica
leafy
vegetable
group.
EPA
has
determined
that
the
petitions
contain
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petitions.
Additional
data
may
be
needed
before
EPA
rules
on
the
petitions.
This
summary
has
been
prepared
by
the
Syngenta
Crop
Protection
Incorporated.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
cyromazine
in
plants
is
adequately
understood
for
the
purposes
of
these
tolerances.
2.
Analytical
method.
Methods
AG­
408
and
AG­
417
as
listed
in
the
Food
and
Drug
Administration's
Pesticide
Analytical
Manual
(
PAM),
Vol­
II
are
adequate
to
enforce
the
proposed
tolerances.
3.
Magnitude
of
residues.
Residue
field
tests
were
conducted
in
typical
growing
regions
for
Brassica
and
bulb
vegetables
and
turnip
tops.
The
data
collected
support
the
proposed
tolerances
of
10.0
ppm
for
Brassica
leafy
vegetables,
10.0
ppm
for
turnip
tops
and
3.0
ppm
for
bulb
vegetables.

B.
Toxicological
Profile
1.
Acute.
A
rat
acute
oral
toxicity
study
with
a
lethal
dose
(
LD)
50
of
approximately
3,387
milligrams/
kilogram
(
mg/
kg)
(
toxicity
category
III;
moderately
toxic).
A
rat
acute
dermal
toxicity
study
with
a
LD50
greater
than
3,100
mg/
kg
(
toxicity
category
III;
moderately
toxic).
A
rat
acute
inhalation
study
with
a
lethal
concentration
(
LC)
50
greater
than
2.9
mg/
kg
(
toxicity
category
IV;
slightly
toxic).
A
primary
eye
irritation
study
in
the
rabbit
that
showed
no
eye
irritation.
A
primary
dermal
irritation
study
in
the
rabbit
that
showed
mild
irritation
(
toxicity
category;
IV).
A
dermal
sensitization
study
in
the
guinea
pig
that
showed
no
sensitization.
2.
Genotoxicity.
Studies
on
gene
mutation
and
other
genotoxic
effects
showed
no
evidence
of
point
mutation
in
an
Ames
test;
no
indication
of
mutagenic
effects
in
a
dominant
lethal
test;
and
no
evidence
of
mutagenic
effects
in
a
nucleus
anomaly
test
in
Chinese
hamsters.
3.
Reproductive
and
developmental
toxicity.
In
a
rat
developmental
toxicity
study,
the
maternal
no
observed
adverse
effect
level
(
NOAEL)
was
100
mg/
kg/
day.
The
maternal
lowest
observed
adverse
effect
level
(
LOAEL)
was
300
mg/
kg
based
on
decreased
body
weight
gain
and
clinical
observations.
The
developmental
NOAEL
was
300
ppm.
The
developmental
LOAEL
was
600
mg/
kg
based
upon
an
increase
of
minor
skeletal
variation.
In
a
rabbit
developmental
toxicity
study,
the
maternal
NOAEL
was
10
mg/
kg.
The
maternal
LOAEL
was
30
mg/
kg
based
upon
decreased
body
weight
gain
and
food
consumption.
The
developmental
NOAEL/
LOAEL
was
greater
than
or
equal
to
60
mg/
kg.
In
a
multi­
generation
study
in
rats,
the
systemic
NOAEL
was
30
ppm
(
1.5
mg/
kg).
The
systemic
LOAEL
was
1,000
ppm
(
50
mg/
kg)
based
upon
decreased
body
weights
associated
with
decreased
food
consumption.
The
developmental/
offspring
systemic
NOAEL
was
1,000
ppm.
The
developmental/
offspring
systemic
LOAEL
was
3,000
ppm
(
150
mg/
kg)
based
upon
decreased
body
weight
at
birth
through
weaning.
There
were
no
effects
on
reproductive
parameters
at
the
highest
dose
tested
(
HDT)
(
3,000
ppm).
4.
Subchronic
toxicity.
In
a
6
 
month
feeding
study
in
dogs,
the
NOAEL
was
30
ppm
(
0.75
mg/
kg).
The
LOAEL
was
300
ppm
(
7.5
mg/
kg)
based
upon
decreased
hematocrit
and
decreased
hemoglobin.
Groups
of
male
and
female
beagle
dogs
(
4/
sex/
dose)
were
fed
diets
containing
cyromazine
at
0,
30,
300,
or
3,000
ppm
(
0,
0.75,
7.5,
or
75
mg/
kg/
day,
respectively)
for
6
 
months.
No
treatment­
related
effects
were
observed
in
survival,
clinical
signs
or
body
weight
parameters.
Pronounced
effects
on
hematologic
parameters
were
manifested
as
decreases
in
hematocrit
and
hemoglobin
levels
at
300
and
3,000
ppm.
5.
Chronic
toxicity.
In
a
24
 
month
feeding
study
in
rats
the
NOAEL
for
the
study
was
30
ppm
(
1.5
mg/
kg/
day).
The
LOAEL
was
300
ppm
(
15.0
mg/
kg)
based
on
decreased
body
weight.
In
a
24
 
month
mouse
chronic
feeding
carcinogenicity
study
the
NOAEL
was
50
ppm
(
7.5
mg/
kg/
day).
The
LOAEL
was
1,000
ppm
(
150.0
mg/
kg)
based
upon
decreased
body
weight.
There
was
no
evidence
of
carcinogenicity
at
3,000
ppm
(
450
mg/
kg).
In
a
24
 
month
rat
chronic
feeding
carcinogenicity
study
the
NOAEL
was
greater
than
3,000
ppm
(
150
mg/
kg)
(
HDT).
There
was
no
evidence
of
carcinogenicity
at
3,000
ppm.
Cancer
Peer
Review
Committee
determined
that
there
is
no
evidence
of
carcinogenicity
in
studies
in
either
the
mouse
or
rat.
Based
upon
this
determination
it
can
be
concluded
that
cyromazine
does
not
pose
a
cancer
risk.

VerDate
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14>
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19:
35
Aug
05,
2003
Jkt
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PO
00000
Frm
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Fmt
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E:\
FR\
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06AUN1.
SGM
06AUN1
46619
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
6.
Animal
metabolism.
The
metabolism
of
cyromazine
has
been
adequately
characterized
in
the
rat,
goat,
and
chicken.
7.
Metabolite
toxicology.
EPA
has
removed
melamine,
a
metabolite
of
cyromazine,
from
the
tolerance
expression
as
a
residue
of
toxicological
concern.
For
more
information
on
melamine,
see
the
Federal
Register
of
September
15,
1999
(
64
FR
50043)
(
FRL
 
6098
 
7).
8.
Endocrine
disruption.
Cyromazine
does
not
belong
to
a
class
of
chemicals
proven
to
have
adverse
effects
on
the
endocrine
system.
There
is
no
evidence
that
cyromazine
has
any
effect
on
endocrine
function
in
developmental
or
reproduction
studies.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
Food.
For
the
purposes
of
assessing
the
potential
dietary
exposure
under
the
proposed
tolerances,
Syngenta
Crop
Protection
has
estimated
aggregate
exposure
from
all
crops
for
which
tolerances
are
established.
i.
Acute.
There
were
no
toxicological
effects
attributed
to
a
single
exposure
(
dose)
observed
in
oral
toxicity
studies
including
the
developmental
toxicity
studies
in
rats
and
rabbits.
Therefore,
there
is
a
reasonable
certainty
of
no
harm
from
acute
dietary
exposure.
ii.
Chronic.
The
cyromazine
chronic
dietary
exposure
assessment
utilized
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
,
version
7.76
from
Exponent.
All
consumption
data
from
this
assessment
were
taken
from
the
USDA's
Continuing
Survey
of
Food
Intake
by
Individuals
(
CSFII)
with
the
1994
 
96
consumption
database
and
the
Supplemental
CSFII
children's
survey
(
1998)
consumption
database.
The
cyromazine
Tier
III
chronic
dietary
exposure
assessment
was
based
upon
residue
field
trial
results,
and
tolerance
residues
for
crops
when
no
field
trial
data
were
available.
Anticipated
residue
estimates
were
used
for
milk,
meat,
fat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep;
and
for
all
other
commodities
tolerance
level
residues
were
assumed.
The
maximum
percent
crop
treated
values
for
cyromazine
were
obtained
from
the
Doane's
Market
Survey
Database
(
1999
 
2001)
and
used
for
lima
beans
(
0.8%),
cantaloupe
(
3.9%),
peppers
(
8.6%),
tomatoes
(
2.9%),
celery
(
68.9%),
lettuce
(
9.7%),
spinach
(
19.5%),
and
onions
(
0.2%).
For
all
other
registered
or
proposed
crop
uses,
it
was
assumed
that
100%
of
these
crops
were
treated.
2.
Drinking
water.
EPA
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
to
estimate
pesticide
concentrations
in
surface
water
and
screening
concentration
in
ground
water
(
SCIGROW
to
estimate
pesticide
concentrations
in
ground
water.
FIRST
incorporates
an
index
reservoir
environment
and
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
None
of
these
models
include
consideration
of
the
impact
that
processing
(
mixing,
dilution,
or
treatment)
would
have
on
the
removal
of
pesticides
from
the
water
source.
The
primary
use
of
these
models
by
EPA
is
to
provide
a
Tier
I
assessment
to
estimate
the
concentration
of
pesticides
in
drinking
water.
Estimated
Environmental
Concentrations
(
EECs)
of
cyromazine
in
drinking
water
were
determined
for
the
highest
use
rate
of
cyromazine.
Based
on
the
model
outputs,
the
EECs
of
cyromazine
are
1.8
parts
per
billion
(
ppb)
for
chronic
exposure
to
ground
water
and
10
ppb
for
chronic
exposure
to
surface
water.
3.
Non­
dietary
exposure.
Cyromazine
is
currently
registered
for
commercial
outdoor
use
on
landscape
ornamentals
and
commercial
interiorscapes.
There
are
no
lawn
or
indoor
residential
uses
and
significant
residential
exposure
is
not
expected.

D.
Cumulative
Effects
When
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
section
408(
b)(
2)(
D)(
v)
requires
that
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residue
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
Neither
Syngenta
nor
EPA
has
at
this
time,
data
available
to
determine
whether
cyromazine
has
a
common
mechanism
of
toxicity
with
other
substances
or
the
methodology
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
cyromazine
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.

E.
Safety
Determination.
1.
Acute
risk.
There
were
no
toxicological
effects
observed
in
oral
toxicity
studies,
including
the
developmental
toxicity
studies
in
rats
and
rabbits,
that
could
be
attributed
to
a
single
exposure
(
dose).
Since
there
is
a
reasonable
certainty
of
no
harm
from
acute
dietary
exposure,
an
acute
aggregate
risk
assessment
was
not
performed
for
cyromazine.
2.
Chronic
risk.
The
chronic
dietary
exposure
risk
analysis
(
food
only)
showed
that
exposure
from
all
established
and
these
proposed
tolerances
would
be
2.9%
of
the
chronic
reference
dose
(
cRfD)
for
the
most
exposed
subpopulation,
children
1
to
2
years
old.
EPA
has
determined
that
reliable
data
support
using
the
standard
margin
of
exposure
and
uncertainty
factor
(
100
for
combined
interspecies
and
intraspecies
variability)
for
cyromazine
and
an
additional
safety
factor
of
10X
is
not
necessary
to
protect
infants
and
children.
3.
Drinking
water.
The
chronic
drinking
water
level
of
concern
(
DWLOC)
for
the
most
exposed
subpopulation
(
children
1
 
6
years)
is
728
ppb.
Based
upon
the
SCI­
GROW
and
FIRST
model
outputs,
the
EECs
of
cyromazine
in
surface
water
and
ground
water
are
below
the
chronic
DWLOC;
therefore,
EPA
should
not
have
a
concern
regarding
cyromazine
in
drinking
water.
4.
Non­
dietary
exposure.
Due
to
the
nature
of
the
non­
dietary
use,
the
commercial
use
of
cyromazine
on
landscape
ornamentals
will
not
result
in
any
significant
residential
exposure.
Syngenta
has
considered
the
potential
aggregate
exposure
from
food,
water,
and
non­
occupational
exposure
routes
and
concluded
that
aggregate
exposure
is
not
expected
to
exceed
100%
of
the
cRfD.
Therefore,
Syngenta
has
concluded
that
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
cyromazine
residues.

F.
International
Tolerances.

The
U.
S.
tolerances
and
Codex
Maximum
Residue
Levels
(
MRLs)
are
compatible
for
ruminant
tissue,
bell
pepper,
and
tomato.
Codex
MRLs
and
U.
S.
tolerances
are
incompatible
for
milk,
celery,
cucumber,
lettuce,
melon,
and
mushroom.
[
FR
Doc.
03
 
20014
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0234;
FRL
 
7317
 
6]

Benoxacor;
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.

VerDate
jul<
14>
2003
19:
35
Aug
05,
2003
Jkt
200001
PO
00000
Frm
00052
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
06AUN1.
SGM
06AUN1