Document ID: EPA-HQ-OPP-2003-0234-0002
Agency: epa
Document Type: Notice
Title: Benoxacor; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-08-06T04:00Z

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.

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Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certainpesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
identification
(
ID)
number
OPP
 
2003
 
0234,
must
be
received
on
or
before
September
5,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
orthrough
hand
delivery/
courier.
Follow
the
detailed
instructions
asprovided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
EnvironmentalProtection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC20460
 
0001;
telephone
number:
(
703)
305
 
6304;
e­
mail
address:
boyle.
kathryn@
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
anagricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
providesa
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)
codeshave
been
provided
to
assist
you
and
others
in
determining
whetherthis
action
might
apply
to
certain
entities.
If
you
have
any
questionsregarding
the
applicability
of
this
action
to
a
particular
entity,
consultthe
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
 
0234.
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
officialpublic
docket,
and
to
access
those
documents
in
the
public
docket
thatare
available
electronically.
Although
not
all
docket
materials
may
beavailable
electronically,
you
may
still
access
any
of
the
publiclyavailable
docket
materials
through
the
docket
facility
identified
in
UnitI.
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's
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
inEPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publiclyavailable
docket
materials
will
be
made
available
in
EPA's
electronicpublic
docket.
When
a
document
is
selected
from
the
index
list
in
EPADockets,
the
system
will
identify
whether
the
document
is
available
forviewing
in
EPA's
electronic
public
docket.
Although
not
all
docketmaterials
may
be
available
electronically,
you
may
still
access
any
ofthe
publicly
available
docket
materials
through
the
docket
facilityidentified
in
Unit
I.
B.
1.
EPA
intends
to
work
towards
providingelectronic
access
to
all
of
the
publicly
available
docket
materialsthrough
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policyis
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
publicdocket
as
EPA
receives
them
and
without
change,
unless
the
commentcontains
copyrighted
material,
CBI,
or
other
information
whosedisclosure
is
restricted
by
statute.
When
EPA
identifies
a
commentcontaining
copyrighted
material,
EPA
will
provide
a
reference
to
thatmaterial
in
the
version
of
the
comment
that
is
placed
in
EPA'selectronic
public
docket.
The
entire
printed
comment,
including
thecopyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
ordelivered
to
the
docket
will
be
transferred
to
EPA's
electronic
publicdocket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
willbe
scanned
and
placed
in
EPA's
electronic
public
docket.
Wherepractical,
physical
objects
will
be
photographed,
and
the
photographwill
be
placed
in
EPA's
electronic
public
docket
along
with
a
briefdescription
written
by
the
docket
staff.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
handdelivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
theappropriate
docket
ID
number
in
the
subject
line
on
the
first
page
ofyour
comment.
Please
ensure
that
your
comments
are
submitted
withinthe
specified
comment
period.
Comments
received
after
the
close
of
thecomment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
isotherwise
protected
by
statute,
please
follow
the
instructions
in
UnitI.
D.
Do
not
use
EPA
dockets
or
e­
mail
to
submit
CBI
or
informationprotected
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
outsideof
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
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Federal
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/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Notices
provided
in
the
body
of
a
comment
will
beincluded
as
part
of
the
comment
that
is
placed
in
the
official
publicdocket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPAcannot
read
your
comment
due
to
technical
difficulties
and
cannotcontact
you
for
clarification,
EPA
may
not
be
able
to
consider
yourcomment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
forreceiving
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
 
0234.
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
 
0234.
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
addressesthat
are
automatically
captured
by
EPA's
e­
mail
system
are
includedas
part
of
the
comment
that
is
placed
in
the
official
public
docket,
andmade
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
fileformat.
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
 
0234.
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,
CrystalMall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
DocketID
Number
OPP
 
2003
 
0234.
Such
deliveries
are
only
accepted
duringthe
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
CBIelectronically
through
EPA's
electronic
public
docket
or
by
email
Youmay
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
anypart
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CDROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identifyelectronically
within
the
disk
or
CD
ROM
the
specific
information
thatis
CBI).
Information
so
marked
will
not
be
disclosed
except
inaccordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includesany
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
notcontain
the
information
claimed
as
CBI
must
be
submitted
for
inclusionin
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submitthe
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
theoutside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docketand
EPA's
electronic
public
docket
without
prior
notice.
If
you
haveany
questions
about
CBI
or
the
procedures
for
claiming
CBI,
pleaseconsult
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
yourcomments:
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
usedthat
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
youarrived
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
thisnotice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docketID
number
assigned
to
this
action
in
the
subject
line
on
the
first
pageof
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
theestablishment
and/
or
amendment
of
regulations
for
residues
of
a
certainpesticide
chemical
in
or
on
various
food
commodities
under
section
408of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
informationregarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
atthis
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,
Feedadditives,
Food
additives,
Pesticides
and
pests,
Reporting
andrecordkeeping
requirements.

Dated:
July
22,
2003.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
belowas
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
summary
may
have
been
edited
by
EPA
if
the
terminology
usedwas
unclear,
the
summary
contained
extraneous
material,
or
thesummary
unintentionally
made
the
reader
conclude
that
the
findingsreflected
EPA's
position
and
not
the
position
of
the
petitioner.
Thepetition
summary
announces
the
availability
of
a
description
of
theanalytical
methods
available
to
EPA
for
the
detection
and
measurementof
the
pesticide
chemical
residues
or
an
explanation
of
why
no
suchmethod
is
needed.

Syngenta
Crop
Protection
PP
7E3489
EPA
has
received
an
amendment
to
pesticide
petition
(
PP
7E3489)
from
Syngenta
Crop
Protection,
410
Swing
Road,
Greensboro,
NC27419,
proposing
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.460
to
establish
the
use
ofbenoxacor,
(
4­(
dichloroacetyl)­
3,4­
dihydro­
3­
methyl­
2H­
1,4­
benzoxazine)
as
an
inert
ingredient
(
safener)
in
pesticide
formulations
containing
S­
metolachlor
in
or
on
raw
agricultural
commodities
(
RACs)
for
whichtolerances
have
been
established
for
S­
metolachlor
or
that
support
Smetolachlor
uses.
The
petitioner
is
not
requesting
a
change
in
thelevel
or
the
numerical
tolerance,
but
is
requesting
that
benoxacor
only
be
used
with
Smetolachlor
not
metolachlor.
EPA
has
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Notices
determined
that
the
request
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
thepetition.
Additional
data
may
be
needed
before
EPA
rules
on
thepetition.
The
Notice
of
Filing
was
published
in
the
Federal
Register
on
November
21,
1997
(
62
FR
62304)(
FRL
 
5755
 
2).
The
petitioner
at
that
time
was
Novartis
Crop
Protection,
Inc.
In
the
Federal
Register
of
February
13,
1998
(
63
FR
7299)
(
FRL
 
5771
 
1),
EPA
published
a
final
rule
establishing
tolerances
for
residues
of
benoxacor
at
0.01
ppm
for
all
commodities
for
which
tolerances
have
been
established
for
metochlor.
No
benoxacor
risk
assessments
have
been
performed
by
the
Agency
since
that
time.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
benoxacor
in
plants
and
animals
is
adequately
understood
for
purposes
of
these
tolerances.
Identified
metabolic
pathways
are
similar
in
plants
and
animals
(
goat,
hen,
and
rat).
2.
Analytical
method.
Adequate
enforcement
methodology,
gaschromatography/
nitrogen
phosphorous
detection
(
GC/
NPD),
is
availableto
enforce
the
tolerance
expression.
An
analytical
methodology
for
thedetermination
of
benoxacor
and
its
metabolites
in
plant
and
animalcommodities
(
Syngenta
Analytical
Method
AG536(
C))
is
available
uponrequest
from
EPA.
Analytical
Method
AG536c
involves
extraction,
filtering,
dilution,
partitioning,
and
cleanup.
Samples
are
then
analyzedby
capillary
gas
chromatography
using
N/
P
detection.
The
limit
ofquantitation
(
LOQ)
is
0.01
ppm.
3.
Magnitude
of
residues.
The
magnitude
of
the
residue
in
plants
is
adequately
understood
for
the
purposes
of
these
tolerances.
Morethan
30
residue
trials
were
conducted
in
19
States
on
a
variety
ofagricultural
crops,
corn
(
field
and
sweet);
soybeans,
potatoes,
greenbeans,
radishes,
sorghum,
peanuts,
head
lettuce,
and
peas.
There
wereno
detectable
residues
of
benoxacor
at
the
LOQ
of
0.01
ppm
(
manysamples
were
analyzed
at
an
LOQ
of
0.005
ppm
and
no
residues
weredetected)
in
any
RAC
or
processed
commodity.
No
transfer
of
residueto
animals
is
expected
through
their
diet.

B.
Toxicological
Profile
The
toxicological
profile
of
benoxacor
and
the
end
points
for
usein
risk
assessments
are
discussed
in
the
final
rule
published
in
the
Federal
Register
of
February
13,
1998
(
63
FR
7299)
(
FRL
 
5771
 
1).

C.
Aggregate
Exposure
1.
Dietary
exposure.
 
i.
Food.
Tolerances
have
been
established
(
40
CFR
180.460)
for
the
residues
of
benoxacor
in
or
on
a
variety
of
RACs.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
and
risks
from
benoxacor.
In
this
action,
Syngenta
Crop
Protection
is
requesting
to
amend
only
the
tolerance
expression
and
therefore
believes
that
the
most
recent
Food
Quality
Protection
Act
(
FQPA)
dietary
assessment
completed
by
EPA
is
valid
in
the
consideration
of
this
amendmentrequest.
ii.
Acute
exposure
and
risk.
Since
there
are
no
acute
toxicological
concerns
for
benoxacor,
EPA
has
previously
determined
that
an
acute
dietary
risk
assessment
was
not
required.
iii.
Chronic
exposure
and
risk.
For
the
purpose
of
assessing
chronic
dietary
exposure
from
benoxacor,
EPA
has
previously
considered
the
established
benoxacor
tolerance
of
0.01
ppm
and
the
RACs
for
which
tolerances
have
been
established
for
metolachlor.
There
are
no
otherestablished
U.
S.
tolerances
for
benoxacor,
and
there
are
no
otherregistered
uses
for
benoxacor
on
food
or
feed
crops
in
the
United
States.
Benoxacor
is
used
currently
only
as
a
herbicide
safener
in
end­
useproduct
formulations
that
contain
S­
metolachlor.
There
are
no
longerany
registrations
of
other
active
ingredients
that
contain
benoxacor.
In
conducting
this
exposure
assessment,
EPA
previously
assumedtolerance
level
residues
and
100%
crop
treated,
resulting
in
a
largeoverestimation
of
dietary
exposure
and
protective
of
any
chronic
dietaryexposure
scenario.
The
chronic
reference
dose
(
cRfD)
is
0.004milligram/
kilogram/
day
(
mg/
kg/
day).
Based
on
the
chronic
dietaryexposure
of
0.000205
mg/
kg/
day
for
the
U.
S.
population
and
0.000828mg/
kg/
day
for
the
most
highly
exposed
population
subgroup
(
nonnursinginfants
less
than
1
 
year
old),
this
chronic
dietary
riskassessment
resulted
in
the
use
of
5.13%
of
the
RfD
for
the
U.
S.
population
and
20.7%
of
the
RfD
for
the
most
highly
exposedpopulation
subgroup.
A
cancer
dietary
margin
of
exposure
(
MOE)
wascalculated
to
be
1,950
using
0.4
mg/
kg/
day
as
the
point
of
departure.
iv.
Drinking
water.
For
the
purposes
of
assessing
chronic
exposure
in
drinking
water,
EPA
has
previously
considered
the
registered
usesand
the
available
data
on
persistence
and
mobility
for
benoxacor.
TheAgency
has
determined
through
a
qualitative
risk
assessment
that
thephysical
and
chemical
characteristics
of
benoxacor
are
such
that
it
isnot
expected
to
impact
water
resources.
While
benoxacor
has
thepotential
to
be
mobile,
it
is
not
persistent
(
half­
life
in
soil
of
49
daysunder
aerobic
conditions
and
70
days
anaerobically).
In
light
of
thesefindings,
EPA
has
previously
determined
that
benoxacor's
use
as
asafener
in
S­
metolachlor
formulations
will
not
impact
ground
water
orsurface
water
resources,
and
therefore,
is
not
expected
to
lead
toexposure
to
humans
through
drinking
water.
2.
Non­
dietary
exposure.
All
registered
S­
metolachlor
products
to
which
benoxacor
is
added
as
a
safener
are
commercial
agriculturalproducts
not
registered
for
residential
use.
The
potential
for
nonoccupationalexposure
to
benoxacor
by
the
general
population
is
therefore
unlikely
except
for
the
potential
residues
in
food
crops
discussed
above.

D.
Cumulative
Effects
EPA
has
previously
determined
that
a
cumulative
assessment
is
notrequired
for
benoxacor.
Benoxacor
does
not
share
a
common
mode
oftoxicity
with
any
other
moiety
regulated
by
EPA
further
supporting
thelack
of
a
need
for
conducting
a
cumulative
assessment
in
relation
tothis
requested
tolerance
amendment.

E.
Safety
Determination
1.
U.
S.
population
 
i.
Acute
risk.
Since
there
are
no
acute
toxicological
concerns
for
benoxacor,
EPA
has
no
cause
for
concern
for
acute
aggregate
exposure.
ii.
Chronic
risk.
EPA
has
previously
concluded
that
aggregate
chronic
exposure
to
benoxacor
from
food
and
water
will
utilize
5.13%
of
the
RfD
for
the
U.
S.
population.
The
major
identifiable
subgroup
withthe
highest
aggregate
exposure
is
non­
nursing
infants
less
than
1
 
yearold
(
utilizing
20.7%
of
the
RfD).
EPA
generally
has
no
concern
forexposures
below
100%
of
the
RfD
because
the
RfD
represents
the
levelat
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
willnot
pose
appreciable
risks
to
human
health.
EPA
does
not
expect
theaggregate
exposure
to
exceed
100%
of
the
RfD.
EPA
has
previouslyconcluded
that
there
is
a
reasonable
certainty
that
no
harm
will
resultfrom
aggregate
exposure
to
benoxacor
residues.
The
carcinogenic
risk
from
food
uses
of
benoxacor
for
the
general
U.
S.
population
was
calculated
previously
by
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EPA
by
comparing
the
dietary
exposure
from
benoxacor
to
the
no
observed
adverse
effect
level
(
NOAEL)
identified
for
use
with
the
cancer
risk
assessment.
Based
on
the
NOAEL
selected
by
EPA
for
cancer
risk
characterization
of
0.4
mg/
kg/
day,
the
cancer
risk
was
estimated
to
result
in
a
MOE
of
1,950
contributed
through
all
the
published
uses
for
benoxacor.
Based
upon
the
extreme
conservatism
of
the
dietary
exposure
estimates
and
the
fact
that
tumors
were
observed
only
at
dose
levels
far
in
excess
of
the
selected
NOAEL,
this
MOE
is
at
a
level
which
the
Agency
does
notconsider
raising
a
concern
for
excess
lifetime
cancer.
2.
Infants
and
children.
EPA
has
previously
determined
that
the
toxicological
data
base
for
evaluating
prenatal
and
postnatal
toxicity
for
benoxacor
is
complete
with
respect
to
current
data
requirements.
Because
both
developmental
and
reproductive
effects
occurred
in
the
presence
of
parental
(
systemic)
toxicity,
these
data
do
not
suggest
anincreased
prenatal
or
postnatal
sensitivity
of
children
and
infants
tobenoxacor
exposure.
Based
on
the
above,
EPA
has
previously
concludedthat
reliable
data
support
use
of
a
100­
fold
MOE/
uncertainty
factor
(
UF),
rather
than
the
standard
1,000­
fold
margin/
factor
to
protect
infants
andchildren.
EPA
concludes
that
there
is
a
reasonable
certainty
that
noharm
will
result
to
infants
and
children
from
aggregate
exposure
tobenoxacor
residues.
3.
Acute
risk.
Since
there
are
no
acute
toxicological
concerns
for
benoxacor,
EPA
has
no
cause
for
concern
for
acute
aggregate
exposure.
4.
Chronic
risk.
Using
the
conservative
exposure
assumptions
described
above,
EPA
has
previously
concluded
that
aggregate
exposure
to
benoxacor
from
food
will
range
from
3.69%
of
the
RfD
for
females13+
years,
to
20.7%
of
the
RfD
for
non­
nursing
infants
less
than
1
 
yearold.
EPA
generally
has
no
concern
for
exposures
below
100%
of
theRfD
because
the
RfD
represents
the
level
at
or
below
which
dailyaggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciablerisks
to
human
health.
EPA
does
not
expect
the
aggregate
exposure
toexceed
100%
of
the
RfD.
EPA
has
previously
concluded
that
there
isa
reasonable
certainty
that
no
harm
will
result
to
infants
and
childrenfrom
aggregate
exposure
to
benoxacor
residues.
F.
International
Tolerances
No
Codex
maximum
residue
levels
have
been
established
forresidues
of
benoxacor.

[
FR
Doc.
03
 
19915
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2003
 
0037;
FRL
 
7322
 
4]

Certain
New
Chemicals;
Receipt
and
Status
Information
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
Section
5
of
the
Toxic
Substances
Control
Act
(
TSCA)
requires
any
person
who
intends
to
manufacture
(
defined
by
statute
to
include
import)
a
new
chemical
(
i.
e.,
a
chemical
not
on
the
TSCA
Inventory)
to
notify
EPA
and
comply
with
the
statutory
provisions
pertaining
to
the
manufacture
of
new
chemicals.
Under
sections
5(
d)(
2)
and
5(
d)(
3)
of
TSCA,
EPA
is
required
to
publish
a
notice
of
receipt
of
a
premanufacture
notice
(
PMN)
or
an
application
for
a
test
marketing
exemption
(
TME),
and
to
publish
periodic
status
reports
on
the
chemicals
under
review
and
the
receipt
of
notices
of
commencement
to
manufacture
those
chemicals.
This
status
report,
which
covers
the
period
from
June
3,
2003
to
July
11,
2003,
consists
of
the
PMNs
pending
or
expired,
and
the
notices
of
commencement
to
manufacture
a
new
chemical
that
the
Agency
has
received
under
TSCA
section
5
during
this
time
period.
DATES:
Comments
identified
by
the
docket
ID
number
OPPT
 
2003
 
0037
and
the
specific
PMN
number
or
TME
number,
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:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division,
Office
of
Pollution
Prevention
and
Toxics
(
7408M),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.

SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
As
such,
the
Agency
has
not
attempted
to
describe
the
specific
entities
that
this
action
may
apply
to.
Although
others
may
be
affected,
this
action
applies
directly
to
the
submitter
of
the
premanufacture
notices
addressed
in
the
action.
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
OPPT
 
2003
 
0037.
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
EPA
Docket
Center,
Rm.
B102­
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(
202)
566
 
0280.
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.

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19:
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