Document ID: EPA-HQ-OPP-2002-0356-0001
Agency: epa
Document Type: Notice
Title: Bifenazate; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain                Pesticide Chemical in or on Food
Posted Date: 2003-01-15T05:00Z

2032
Federal
Register
/
Vol.
68,
No.
10
/
Wednesday,
January
15,
2003
/
Notices
levels.
Additionally,
the
DWLOC
was
over
3,000­
fold
greater
than
potential
fluroxypyr
residue
in
drinking
water.
Chronic
dietary
exposure
to
residues
of
fluroxypyr
from
current
and
proposed
uses
was
estimated
to
occupy
1.3%
of
the
RfD
for
children
1
to
6
years
old,
the
population
subgroup
predicted
to
be
most
highly
exposed.
Additionally,
the
DWLOC
was
calculated
to
be
over
3,000
fold
greater
than
potential
fluroxypyr
residue
in
drinking
water
predicted
by
conservative
screening
level
models.
Thus,
based
on
the
completeness
and
reliability
of
the
toxicity
data
and
the
conservative
exposure
assessment,
it
is
concluded
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
acute
dietary,
short­
term
and
chronic
aggregate
exposures
to
fluroxypyr
residues
from
current
and
proposed
uses.

F.
International
Tolerances
There
are
no
Codex
maximum
residue
levels
established
for
residues
of
fluroxypyr
MHE
and
fluroxypyr
on
any
food
or
feed
crop.

[
FR
Doc.
03
 
848
Filed
1
 
14
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0356;
FRL
 
7286
 
4]

Bifenazate;
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
Bifenazate
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0356,
must
be
received
on
or
before
February
14,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Shaja
R.
Brothers,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
3194;
e­
mail
address:
brothers.
shaja@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
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
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
 
2002
 
0356.
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
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
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/
Vol.
68,
No.
10
/
Wednesday,
January
15,
2003
/
Notices
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
e­
mail
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
 
2002
 
0356.
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
 
2002
 
0356.
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
 
2002
 
0356.
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
 
2002
 
0356.
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:
December
20,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
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/
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January
15,
2003
/
Notices
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

Interregional
Research
Project
Number
(
IR
 
4)
and
Crompton
Manufacturing
Company,
Inc.

PP
3E6517
EPA
has
received
a
pesticide
petition
(
3E6517)
from
the
Interregional
Research
Project
Number
(
IR
 
4),
681
U.
S.
Hwy.
#
1
South,
North
Brunswick,
NJ
08902
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.572
by
establishing
tolerances
for
residues
of
bifenazate,
(
diazinecarboxylic
acid,
2­(
4­
methoxy­[
1,1 ­
biphenyl]­
3­
yl),
1­
methylethylester)
in
or
on
the
following
raw
agricultural
commodities
(
RACs):
Vegetable,
cucurbit,
group
at
0.6
part
per
million
(
ppm);
vegetable,
fruiting,
group
at
2.0
ppm;
peppermint,
tops
at
25
ppm;
spearmint,
tops
at
25
ppm;
nut,
tree,
group
at
0.2
ppm;
almond,
hulls
at
10
ppm;
okra
at
2.0
ppm;
and
pistachio
at
0.2
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.
This
notice
includes
a
summary
of
the
petition
prepared
by
Crompton
Manufacturing
Company,
Inc.
(
formerly
Uniroyal
Chemical
Company),
Middlebury,
CT
06749.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
nature
of
the
residues
of
bifenazate
in
plants
is
adequately
understood.
The
major
residue
in
all
plant
metabolism
studies
is
bifenazate.
A
minor,
but
significant
metabolite
is
the
diazene
D3598,
which
was
found
to
interconvert
readily
to/
from
bifenazate
in
the
plant
matrix
during
the
analytical
procedure.
2.
Analytical
method.
Crompton
has
developed
practical
analytical
methodology
for
detecting
and
measuring
residues
of
bifenazate
in
or
on
RACs.
As
D3598,
a
significant
metabolite,
was
found
to
interconvert
readily
to/
from
bifenazate,
the
analytical
method
was
designed
to
convert
all
residues
of
D3598
to
the
parent
compound
(
bifenazate)
for
analysis.
The
method
utilizes
reversed
phase
high
performance
liquid
chromotography
(
HPLC)
to
separate
the
bifenazate
from
matrix
derived
interferences,
and
oxidative
coulometric
electrochemical
detection
for
the
identification
and
quantification
of
this
analyte.

B.
Toxicological
Profile
1.
Acute
toxicity.
Bifenazate
technical,
acramite­
50WS,
and
floramite
SC
have
low
acute
oral,
dermal,
and
inhalation
toxicity
in
laboratory
animals.
The
oral
lethal
dose
LD50
in
rats
and
mice
is
greater
than
5
grams/
kilogram
(
g/
kg)
for
acramite­
50WS
and
the
technical
material.
The
oral
LD50
of
floramite
SC
is
greater
than
5
g/
kg
in
males
and
greater
than
2
g/
kg
in
females.
The
dermal
LD50
in
rats
of
bifenazate
technical
and
both
formulations
is
greater
than
5
g/
kg.
The
inhalation
lethal
concentration
LC50
in
the
rats
of
bifenazate
technical,
acramite­
50WS
and
floramite
SC
was
found
to
be
greater
than
4.4,
5.2,
and
1.8
milligrams/
liter
(
mg/
L),
respectively.
In
eye
irritation
studies,
acramite­
50WS
was
a
slight
irritant,
and
bifenazate
technical
was
non­
irritating.
Floramite
SC
was
found
to
be
irritating
to
the
eyes.
All
3
products
were
found
to
be
non­
irritating
to
the
skin
of
rabbits
and
nonsensitizing
on
the
skin
of
guinea
pigs.
2.
Genotoxicity.
Bifenazate
was
evaluated
and
found
to
be
negative
in
the
Ames
Reverse
Mutation,
Mouse
Lymphoma,
chinese
hamster
ovary
(
CHO)
chromosome
aberration
and
mouse
micronucleus
assays.
3.
Reproductive
and
developmental
toxicity
 
i.
Rabbit
developmental
study.
A
range­
finding
study
conducted
in
pregnant
New
Zealand
white
rabbits
at
dosage
levels
of
125,
250,
500,
750,
and
1,000
milligrams/
kilogram/
day
(
mg/
kg/
day)
demonstrated
maternal
toxicity
at
dosage
levels
of
500
mg/
kg/
day
and
greater
and
abortions
at
dosage
levels
of
250
mg/
kg/
day
and
greater.
Bifenazate
was
then
administered
by
oral
gavage
to
pregnant
New
Zealand
white
rabbits
at
dosage
levels
of
10,
50,
and
200
mg/
kg/
day.
No
test
article
related
effects
were
seen
at
any
dose
level.
The
no
observable
adverse
effect
level
(
NOAEL)
for
maternal
and
developmental
toxicity
was
greater
than
200
mg/
kg/
day.
ii.
Rat
developmental
study.
Bifenazate
did
not
produce
developmental
toxicity
when
administered
by
oral
gavage
to
pregnant
Sprague­
Dawley
CD
rats
at
dosage
levels
of
10,
100,
and
500
mg/
kg/
day.
A
reduction
in
maternal
body
weight
gain
was
seen
at
dosage
levels
of
100
and
500
mg/
kg/
day.
Clinical
observations
at
500
mg/
kg/
day
included
red
material/
staining
on
body
surfaces,
pale
extremities,
and
brown
discharge.
No
developmental
or
teratogenic
effects
were
observed
at
any
dosage
level.
The
NOAEL
for
maternal
toxicity
was
10
mg/
kg/
day
and
the
NOAEL
for
developmental
toxicity
was
greater
than
500
mg/
kg/
day.
iii.
Rat
reproduction
study.
Bifenazate
showed
no
effects
on
reproduction
when
fed
to
2
 
generations
of
male
and
female
Sprague­
Dawley
CD
rats
at
dietary
concentrations
of
20,
80,
and
200
ppm.
At
a
dosage
level
of
200
ppm
there
was
a
reduction
in
body
weight
gain
in
F0
males
and
females.
Food
consumption
was
unaffected.
There
was
a
reduction
in
body
weight
gain
in
F1
females
at
all
dosage
levels
and
in
F1
males
at
80
and
200
ppm
in
the
absence
of
effects
on
food
consumption.
Since
the
20
ppm
F1
males
did
not
have
a
significant
reduction
in
body
weight
gain,
this
dosage
level
can
be
considered
a
NOAEL
for
systemic
adult
toxicity.
The
reduction
in
body
weight
gain
in
the
F1
females
at
20
ppm
would
not
be
considered
biologically
significant
because
no
effects
were
observed
on
reproductive
parameters
or
in
the
F2
litter.
The
reproductive
and
developmental
NOAEL
was
greater
than
200
ppm
(
10
mg/
kg/
day).
4.
Subchronic
toxicity
 
i.
Thirteen
 
week
rat
feeding
study.
Bifenazate
was
fed
to
male
and
female
Sprague
Dawley
CD
rats
for
13
weeks
at
dietary
concentrations
of
40,
200,
and
400
ppm.
At
dosage
levels
of
200
and
400
ppm
there
was
a
reduction
in
red
blood
cell
(
RBC)
count
and
hemoglobin
(
Hgb).
Food
intake
was
reduced
for
200
ppm
females
and
200
and
400
ppm
males.
Histopathological
effects
were
seen
in
the
liver,
spleen,
and
adrenal
cortex
in
males
and
females
at
200
and/
or
400
pm.
The
maximum
tolerated
dose
(
MTD)
was
exceeded
in
females
at
200
ppm
and
in
males
and
females
at
400
ppm.
The
NOAEL
for
subchronic
toxicity
in
rats
was
40
ppm
(
2
mg/
kg/
day).
ii.
Neurotoxicity
assessment.
No
treatment
related
effects
were
seen
on
neuro­
behavior
in
a
Standard
Functional
Observation
Battery
conducted
at
weeks
8
and
13
of
the
rat
feeding
study.
No
overt
signs
of
anticholinergic
activity,
and
no
statistically
significant
effects
on
cholinesterase
(
ChE)
activity
were
seen
in
rats
in
a
2
 
week
feeding
study
at
dose
levels
up
to
400
ppm.
Plasma,
erythrocyte
and
brain
ChE
activity
were
evaluated
in
male
and
female
rats
fed
bifenazate­
treated
diet
at
0,
20,
200,
or
400
ppm
for
2
weeks.
All
animals
survived
until
study
termination
and
effects
were
only
seen
on
body
weight
gain
and
food
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Federal
Register
/
Vol.
68,
No.
10
/
Wednesday,
January
15,
2003
/
Notices
consumption.
The
NOAEL
for
cholinergic
inhibition
was
greater
than
400
ppm
(
20
mg/
kg/
day).
iii.
Thirteen
 
week
dog
feeding
study.
Bifenazate
was
fed
to
male
and
female
Beagle
dogs
for
13
weeks
at
dietary
concentrations
of
40,
400,
and
1,000
ppm.
At
dosage
levels
of
400
and
1,000
ppm
there
was
a
reduction
in
RBC
count,
Hgb
and
hematocrit
(
HCT).
Liver
weights
were
increased
at
400
and
1,000
ppm
and
centrilobular
hepatocellular
hypertrophy
was
seen
in
females
at
400
ppm
and
males
and
females
at
1,000
ppm.
The
NOAEL
for
subchronic
toxicity
in
dogs
was
40
ppm
(
1
mg/
kg/
day).
5.
Chronic
toxicity
 
i.
Dog
chronic
feeding
study.
Bifenazate
was
fed
to
male
and
female
Beagle
dogs
for
1
 
year
at
dietary
concentrations
of
40,
400,
and
1,000
ppm.
At
dose
levels
of
400
and
1,000
ppm,
there
was
a
reduction
in
food
consumption
in
males
and
reduced
body
weight
gain
in
males
and
females.
There
was
a
reduction
in
RBC
count,
Hgb,
and
HCT
and
an
increase
in
bilirubin
at
400
and
1,000
ppm.
Histopathological
effects
on
bone
marrow,
kidney,
and
liver
were
also
seen
at
these
dose
levels.
The
NOAEL
for
chronic
toxicity
in
dogs
was
40
ppm
(
1
mg/
kg/
day).
ii.
Rat
chronic
feeding/
carcinogenicity
study.
Bifenazate
was
not
carcinogenic
in
rats
when
fed
to
male
and
female
Sprague­
Dawley
CD
rats
for
2
years
at
dietary
concentrations
of
20,
80,
and
160
in
females
or
20,
80,
and
200
ppm
in
males.
Body
weight
gain
was
reduced
in
males
and
females
at
the
high
dosage
levels.
A
reduction
in
RBC
count
and
an
increase
in
splenic
pigment
were
seen
in
females
at
160
ppm,
while
high
dose
males
exhibited
a
reduction
in
total
cholesterol
and
an
increase
in
splenic
pigment.
At
a
dose
level
of
80
ppm
there
was
a
reduction
in
body
weight
gain,
a
decrease
in
RBC
count
and
an
increase
in
splenic
pigment
in
females.
There
was
no
increase
in
tumor
incidence
in
males
or
females
as
a
result
of
bifenazate
administration.
The
NOAEL
for
chronic
toxicity
in
rats
was
20
ppm
(
1
mg/
kg/
day).
iii.
Mouse
carcinogenicity
study.
Bifenazate
was
not
carcinogenic
when
fed
to
male
and
female
CD
 
1
mice
for
18
months
at
dietary
concentrations
of
10,
100,
and
175
ppm
in
females
and
10,
100,
and
225
ppm
in
males.
Body
weight
gain
was
reduced
in
males
and
females
at
the
high
dose
level.
A
reduction
in
RBC,
total
leukocyte
and
lymphocyte
counts
was
seen
in
males
at
225
ppm.
There
was
no
increase
in
tumor
incidence
in
males
or
females
as
a
result
of
bifenazate
administration.
6.
Animal
metabolism.
In
rat,
14Cbifenazate
14C­
phenyl
hydrazine
carboxylic
acid,
2­(
4­
methoxy­
1,1­
biphenyl­
3­
yl)­
1­
methylethyl
ester
was
extensively
metabolized
when
it
was
given
orally
in
2
dose
levels
low
(
10
mg/
kg),
and
high
(
1,000
mg/
kg).
Although
o
of
the
dosed
radioactivity
was
excreted
in
the
feces,
bifenazate
depicted
a
good
degree
of
absorption
as
indicated
from
the
level
of
radioactivity
in
the
bile.
In
the
bile
radioactivity
study,
about
70%
of
the
C
 
14
was
collected
from
the
cannulated
bile
ducts
of
low
dosed
rats
indicating
an
active
level
of
absorption
and
enterohepatic
circulation.
7.
Metabolite
toxicology.
In
a
single
dose
oral
toxicity
limit
test
in
rats,
the
oral
LD50
of
the
diazene
product
of
bifenazate
was
estimated
to
be
approximately
5,000
mg/
kg.
At
2
hours
and
at
7
days
post­
dosing,
no
effects
were
seen
on
erythrocyte
cholinesterase
inhibition
(
ChEI)
in
male
or
female
rats.
In
addition,
no
effect
on
plasma
ChEI
was
seen
in
male
rats
at
7
days
only.
Since
this
effect
was
seen
only
in
plasma
of
females
at
one
time
point,
it
is
most
likely
a
pseudo­
cholinesterase
effect
without
biological
significance.
In
a
dermal
toxicity
screen,
the
LD50
of
the
diazene
was
estimated
to
be
>
2,000
mg/
kg.
8.
Endocrine
disruption.
There
are
no
known
reported
adverse
reproductive
or
developmental
effects
in
domestic
animals
or
wildlife
as
a
result
of
exposure
to
this
chemical.
A
standard
battery
of
required
toxicity
tests
have
been
conducted
on
bifenazate.
No
effects
were
seen
in
the
reproduction
or
developmental
studies
to
indicate
that
bifenazate
has
an
effect
on
the
endocrine
system.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Based
on
dietary,
drinking
water,
and
non­
occupational
exposure
assessments,
there
is
reasonable
certainty
of
no
harm
to
the
U.
S.
population,
any
population
subgroup,
or
infants
and
children
from
chronic
exposure
to
bifenazate.
i.
Food.
Chronic
dietary
exposure
was
estimated
using
dietary
exposure
evaluation
model
DEEMTM
tolerance
levels,
and
100%
crop
treated.
Processing
factors
were
used
for
apple
and
grape
juice.
The
chronic
dietary
exposure
to
the
U.
S.
population
(
total)
was
estimated
as
0.003093
mg/
kg
bwt/
day,
and
was
30.9%
of
the
reference
dose
(
RfD).
Exposure
to
non­
nursing
infants,
the
highest
exposed
population
subgroup,
was
0.007238
mg/
kg
bwt/
day
(
72.4%
of
the
RfD),
and
exposure
to
children
was
0.006627
mg/
kg
bwt/
day
(
66.3%
of
the
RfD).
ii.
Drinking
water.
The
residue
of
concern
in
drinking
water
was
determined
to
be
D1989.
Chronic
estimated
environmental
concentrations
(
EECs)
of
D1989
in
surface
water
and
ground
water
were
generated
using
FIRST
and
the
screening
concentration
in
ground
water
(
SCI­
GROW)
(
1
application
at
0.75
lbs
active
ingredient/
acre).
The
FIRST
model
generated
an
EEC
of
0.114
part
per
billion
(
ppb),
whereas,
the
SCI­
GROW
model
generated
an
EEC
of
0.0119
ppb.
These
EEC
values
are
much
lower
than
the
drinking
water
levels
of
concern
(
LOC)
(
227
ppb
for
adults,
27.6
ppb
for
infants
and
children).
Therefore,
exposure
to
potential
residues
in
drinking
water
is
expected
to
be
negligible.
2.
Non­
dietary
exposure.
Food
uses
described
in
this
petition
are
strictly
agricultural,
and
will
not
add
to
any
residential
non­
dietary
exposure
that
may
exist.

D.
Cumulative
Effects
The
mechanism/
mode
of
action
of
bifenazate
on
the
mammalian
RBC,
which
is
the
target
organ
in
the
species
tested,
remains
to
be
elucidated.
The
lack
of
information
on
bifenazate
mode
of
action
precludes
an
assessment
of
cumulative
effects.

E.
Safety
Determination
1.
U.
S.
population.
Based
on
the
toxicology
data
base
and
available
information
on
anticipated
residues,
chronic
dietary
exposure
to
the
U.
S.
population
(
total)
was
30.9%
of
the
RfD.
Exposure
to
potential
residues
in
drinking
water
is
expected
to
be
negligible,
as
drinking
water
levels
of
concern
(
DWLOCs)
are
substantially
higher
than
modeled
acute
and
longterm
EECs.
The
margin
of
exposure
(
MOEs)
from
the
limited
potential
for
short­
term
exposure
from
residential
uses
was
>
1,000.
Based
on
these
assessments,
it
can
be
concluded
that
there
is
reasonable
certainty
of
no
harm
to
the
U.
S.
population
or
any
population
subgroup
from
exposure
to
bifenazate.
2.
Infants
and
children.
The
chronic
dietary
exposure
was
72.4%
of
the
RfD
for
infants,
and
66.3%
for
children.
Exposure
to
potential
residues
in
drinking
water
is
expected
to
be
negligible,
as
DWLOCs
are
substantially
higher
than
modeled
acute
and
longterm
EECs.
The
MOEs
from
the
limited
potential
for
short­
term
exposure
from
residential
uses
was
>
1,000.
Based
on
these
assessments,
it
can
be
concluded
that
there
is
reasonable
certainty
of
no
harm
to
infants
and
children
from
exposure
to
bifenazate.

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Federal
Register
/
Vol.
68,
No.
10
/
Wednesday,
January
15,
2003
/
Notices
F.
International
Tolerances
There
are
no
Codex
or
other
international
maxium
residue
levels
(
MRLs)
on
tolerances
for
the
requested
uses
with
the
exception
of
cherries
in
Japan.
In
Japan,
the
following
MRLs
have
been
established:
Citrus
0.2
and
1.0;
apple
2.0;
pear
2.0;
peach
0.2;
cherry
3.0;
strawberry
3.0;
watermelon
0.2;
and
tea
2.0.
There
are
no
other
current
MRLs
or
tolerances
for
bifenazate.
[
FR
Doc.
03
 
850
Filed
1
 
14
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0163;
FRL
 
7283
 
8]

Primisulfuron­
methyl;
Report
of
the
FQPA
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
TRED);
Notice
of
Availability
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
availability
of
the
``
Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
TRED)
for
Primisulfuron­
methyl.''
EPA
has
reassessed
the
24
tolerances,
or
legal
limits,
established
for
residues
of
primisulfuron­
methyl
in/
on
raw
agricultural
commodities.
These
tolerances
are
now
considered
safe
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
FQPA
of
1996.

FOR
FURTHER
INFORMATION
CONTACT:
Christina
Scheltema,
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
2201;
fax
number:
(
703)
308
 
8005;
e­
mail
address:
scheltema.
christina@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

This
action
is
directed
to
the
public
in
general,
but
will
be
of
interest
to
a
wide
range
of
stakeholders,
including
environmental,
human
health,
and
agricultural
advocates;
the
chemical
industry;
pesticide
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
The
Agency
has
not
attempted
to
describe
all
the
persons
or
entities
who
may
be
interested
in
or
affected
by
this
action.
If
you
have
questions
in
this
regard,
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
 
2002
 
0163.
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/.
To
access
the
TRED
document
and
fact
sheet
electronically,
go
directly
to
the
REDs
table
on
the
EPA
Office
of
Pesticide
Programs
web
site,
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.
For
a
complete
list
of
available
documents
supporting
the
TRED,
see
the
electronic
version
of
the
public
docket,
which
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
for
documents
that
are
open
to
public
comment,
to
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number
or
chemical
name.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket,
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.

II.
What
Action
is
the
Agency
Taking?
EPA
has
assessed
the
risks
associated
with
current
and
proposed
food
uses
of
primisulfuron­
methyl,
reassessed
24
existing
tolerances,
and
reached
a
tolerance
reassessment
and
risk
management
decision.
The
Agency
is
announcing
the
availability
of
the
resulting
report
of
the
FQPA
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
for
Primisulfuron­
methyl,
also
known
as
a
TRED.
EPA
must
review
tolerances
and
tolerance
exemptions
that
were
in
effect
when
FQPA
was
enacted
in
August
1996,
to
ensure
that
these
existing
pesticide
residue
limits
for
food
and
feed
commodities
meet
the
safety
standard
established
by
the
new
law.
Tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
tolerance
revocation
occurs.
EPA
has
reviewed
and
made
the
requisite
safety
finding
for
the
tolerances
established
for
residues
of
primisulfuron­
methyl
in/
on
raw
agricultural
commodities.
The
Agency
has
determined
that
there
are
no
dietary
(
food
or
drinking
water)
or
aggregate
risks
of
concern
from
the
use
of
primisulfuron­
methyl,
so
mitigation
of
these
risks
is
not
necessary.
EPA
is
able
to
make
the
FQPA
safety
finding
for
all
current
and
proposed
uses
of
primisulfuorn­
methyl.
Therefore,
23
existing
tolerances
for
primisulfuron­
methyl
have
been
reassessed
and
remain
unchanged,
and
1
tolerance
on
sweet
corn
will
be
revoked
because
current
labels
prohibit
use
on
sweet
corn.
Although
EPA
is
considering
a
petition
for
a
new
use
on
Kentucky
bluegrass
grown
for
seed,
the
Agency
has
not
yet
made
a
decision
to
register
this
new
use
or
establish
any
associated
tolerances.
EPA
works
extensively
with
affected
parties
to
reach
the
tolerance
reassessment
decisions
presented
in
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