Document ID: EPA-HQ-OPP-2003-0042-0001
Agency: epa
Document Type: Notice
Title: Issuance of an Experimental Use Permit
Posted Date: 2003-02-26T05:00Z

8900
Federal
Register
/
Vol.
68,
No.
38
/
Wednesday,
February
26,
2003
/
Notices
accounted
for
31%
of
the
total.
Major
sources
of
acute
exposures
for
the
U.
S.
population
and
children
1
 
6
years
old
included
cottonseed
oil
and
meat
(
beef)
commodities.
The
%
RfD
for
all
populations
was
less
than
0.01%
of
the
reference
dose
(
RfD)
of
1.0
mg/
kg
bwt/
day.
ii.
Drinking
water
 
a.
Acute
drinking
water
exposure.
The
estimated
tier
1
maximum
concentrations
of
butafenacil
in
surface
water
and
ground
water
are
1.98
ppb
and
0.000038
ppb,
respectively.
The
acute
RfD
for
butafenacil
is
1.0
mg/
kg
bwt/
day.
From
the
acute
dietary
exposure
analysis,
acute
food
exposure
from
the
uses
of
butafenacil
were
neglegible
for
all
populations.
Using
this
information,
acute
drinking
water
levels
of
comparison
(
DWLOC)
were
calculated
for
butafenacil.
The
lowest
DWLOC
was
10,000
ppb.
Based
on
this
analysis,
butafenacil
estimated
environmental
concentrations
(
EECs)
do
not
exceed
the
calculated
acute
DWLOCs.
b.
Chronic
drinking
water
exposure.
The
estimated
maximum
concentrations
of
butafenacil
in
surface
water
and
ground
water
are
0.033
ppb
Day
56
EEC/
3
from
Generic
Expected
Environmental
Concentration
(
GENEEC)
and
0.000025
parts
per
billion
(
ppb)
(
SCI­
GROW,
maximum
at
0.16
lb
active
ingredient/
acre/
year,
respectively.
The
chronic
RfD
for
butafenacil
is
1.0
mg/
kg
bwt/
day.
From
the
chronic
dietary
exposure
analysis,
an
exposure
to
butafenacil
is
negligible
for
all
populations.
Based
on
EPA's
``
Interim
Guidance
for
Conducting
Drinking
Water
Exposure
and
Risk
Assessments''
document
(
December
2,
1997),
chronic
drinking
water
levels
of
comparison
were
calculated
for
butafenacil.
The
lowest
DWLOC
was
10,000
ppb.
Based
on
this
analysis,
butafenacil
EECs
do
not
exceed
the
calculated
chronic
DWLOCs.
2.
Non­
dietary
exposure.
There
are
no
residential
uses
and
therefore,
no
need
for
non­
dietary
exposure
assessment
for
this
use.

D.
Cumulative
Effects
The
potential
for
cumulative
effects
of
butafenacil
and
other
substances
that
have
a
common
mechanism
of
toxicity
has
been
considered.
Butafenacil
is
a
member
of
the
class
of
herbicides
designated
as
uracil­
derivatives.
There
is
no
reliable
information
to
indicate
that
toxic
effects
produced
by
butafenacil
would
be
cumulative
with
those
of
any
other
chemical
including
another
pesticide.
Therefore,
Syngenta
believes
it
is
appropriate
to
consider
only
the
potential
risks
of
butafenacil
in
an
aggregate
risk
assessment.
E.
Safety
Determination
1.
U.
S.
population.
Using
the
acute
and
chronic
exposure
assumptions
and
the
proposed
RfDs
described
above,
the
aggregate
exposure,
including
drinking
water
to
butafenacil
to
the
U.
S.
population
(
48
contiguous
states,
all
seasons)
was
calculated
to
be
less
than
0.01%
of
the
RfD
of
1.0
mg/
kg
bwt/
day.
Therefore,
Syngenta
concludes
that
there
is
reasonable
certainty
that
no
harm
will
result
from
the
aggregate
acute
or
chronic
exposure
to
butafenacil
residues.
2.
Infants
and
children.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
butafenacil,
data
from
developmental
toxicity
studies
in
the
rat
and
rabbit
and
a
multi­
generation
reproduction
study
in
the
rat
have
been
considered.
In
the
rat
and
rabbit
teratology
studies
there
was
no
evidence
of
teratogenicity.
Delayed
fetal
development
was
apparent
only
at
maternally
toxic
doses
of
butafenacil
technical
in
rabbits.
In
the
rabbit
study
1,000
mg/
kg/
day
caused
effects
indicative
of
maternal
toxicity.
There
was
no
indication
of
developmental
toxicity
in
rabbit
offspring
at
100
mg/
kg/
day.
The
NOAEL
for
both
maternal
and
developmental
toxicity
was
established
at
100
mg/
kg/
day
in
rabbits.
In
the
rat
teratogenicity
study
there
was
no
observation
of
maternal
toxicity.
Body
weight
and
food
consumption
were
comparable
in
all
groups.
Reproduction
and
fetal
parameters
were
not
impaired.
Butafenacil
was
not
teratogenic
and
not
toxic
to
the
progeny.
Maternal
parameters
were
not
affected.
The
NOAEL
for
both
maternal
and
developmental
toxicity
was
 
1,000
mg/
kg/
day,
the
highest
dose
level
tested.
In
a
rat
multi­
generation
study
the
NOAEL
for
systemic
toxicity
in
both
sexes
and
both
generations
of
rats
was
2.48
mg/
kg/
day.
There
were
no
effects
on
the
reproductive
parameters
and
the
NOAEL
for
reproductive
toxicity
was
 
1,000
ppm.
Offspring
effects
were
observed
only
at
dose
levels
that
also
produced
parental
toxicity.
There
is
no
evidence
that
developing
offsprings
are
more
sensitive
than
adults
to
the
effects
of
butafenacil.
FFDCA
section
408
provides
that
EPA
may
apply
an
additional
safety
factor
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base.
Based
on
the
current
toxicological
requirements,
the
data
base
for
butafenacil
relative
to
prenatal
and
postnatal
effects
for
children
is
complete.
Further,
for
butafenacil,
the
developmental
studies
showed
no
increased
sensitivity
in
fetuses
as
compared
to
maternal
animals
following
in­
utero
exposures
in
rats
and
rabbits,
and
no
increased
sensitivity
in
pups
as
compared
to
the
adults
in
the
multi­
generation
reproductive
toxicity
study.
Therefore,
it
is
concluded,
that
an
additional
uncertainty
factor
is
not
warranted
to
protect
the
health
of
infants
and
children
and
that
a
RfD
of
1.0
mg/
kg
bwt/
day
is
appropriated
for
assessing
aggregate
risk
to
infants
and
children
from
butafenacil.

F.
International
Tolerances
There
are
no
codex
established
for
residues
of
butafenacil
on
cotton,
undelinted
seed
or
cotton,
gin
byproducts.
[
FR
Doc.
03
 
4386
Filed
2
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0042;
FRL
 
7293
 
4]

Issuance
of
an
Experimental
Use
Permit
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Notice.

SUMMARY:
EPA
has
granted
an
experimental
use
permit
(
EUP)
to
the
following
pesticide
applicant.
An
EUP
permits
use
of
a
pesticide
for
experimental
or
research
purposes
only
in
accordance
with
the
limitations
in
the
permit.

FOR
FURTHER
INFORMATION
CONTACT:
Denise
Greenway,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8263;
e­
mail
address:
greenway.
denise@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

This
action
is
directed
to
the
public
in
general.
Although
this
action
may
be
of
particular
interest
to
those
persons
who
conduct
or
sponsor
research
on
pesticides,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
information
in
this
action,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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8901
Federal
Register
/
Vol.
68,
No.
38
/
Wednesday,
February
26,
2003
/
Notices
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
 
0042.
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.

II.
EUP
EPA
has
issued
the
following
EUP:
73049
 
EUP
 
2.
Issuance.
Valent
BioSciences
Corporation,
870
Technology
Way,
Libertyville,
IL
60048.
This
EUP
allows
the
use
of
3,924
pounds
of
the
biochemical
plant
regulator
6­
benzyladenine
on
9,680
acres
of
apple
and
on
300
acres
of
pistachio
to
evaluate
its
efficacy
for
fruit
thinning
and
sizing
for
apple
and
its
mitigation
of
alternate­
year
bearing
for
pistachio.
The
program
is
authorized
only
in
the
States
of
California,
Idaho,
Maine,
Maryland,
Massachusetts,
Michigan,
New
Jersey,
New
York,
North
Carolina,
Ohio,
Oregon,
Pennsylvania,
Utah,
Vermont,
Virginia,
Washington,
West
Virginia,
and
Wisconsin.
The
EUP
is
effective
from
January
22,
2003
to
January
31,
2005.
A
temporary
tolerance
exemption
to
expire
on
January
31,
2005
has
been
established
for
residues
of
the
active
ingredient
in
or
on
apple
and
pistachio.

Authority:
7
U.
S.
C.
136c.

List
of
Subjects
Environmental
protection,
Experimental
use
permits.

Dated:
February
13,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
4525
Filed
2
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2002
 
0066;
FRL
 
7293
 
5]

Endocrine
Disruptor
Screening
Program,
Proposed
Chemical
Selection
Approach
for
Initial
Round
of
Screening;
Extension
of
Comment
Period
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice;
extension
of
comment
period.

SUMMARY:
In
a
Federal
Register
Notice
that
published
on
December
30,
2002,
EPA
sets
forth
for
public
comment
the
approach
EPA
plans
to
use
for
selecting
the
first
group
of
chemicals
to
be
screened
in
the
Agency's
Endocrine
Disruptor
Screening
Program
(
EDSP).
EPA
requested
that
comments
be
submitted
on
or
before
March
1,
2003.
In
response
to
several
requests
to
extend
the
deadline
for
submitting
comments,
EPA
is
hereby
extending
the
comment
period
to
April
1,
2003.
DATES:
Comments,
identified
by
docket
ID
number
OPPT
 
2002
 
0066,
must
be
received
on
or
before
April
1,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
December
30,
2002
Federal
Register
document.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCA­
Hotline@
epa.
gov.
For
technical
information
contact:
Greg
Schweer,
Exposure
Assessment
Coordination
and
Policy
Division
(
7203M),
Office
of
Science
Coordination
and
Policy,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8469;
e­
mail
address:
schweer.
greg@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

This
action
is
directed
to
the
public
in
general,
and
may
be
of
particular
interest
to
those
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Toxic
Substances
Control
Act
(
TSCA),
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
the
Safe
Drinking
Water
Act
(
SDWA),
or
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
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
 
2002
 
0066.
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
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