Document ID: EPA-HQ-OPP-2003-0160-0001
Agency: epa
Document Type: Notice
Title: Pesticide Products; Registration Approvals
Posted Date: 2003-05-30T04:00Z

32493
Federal
Register
/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Notices
nominated
should
have
expertise
in
one
or
more
of
the
following
areas:
Toxicology,
in
vitro
test
methods,
biostatistics.
Nominees
should
be
scientists
who
have
sufficient
professional
qualifications,
including
training
and
experience,
to
be
capable
of
providing
expert
comments
on
the
issues
for
this
meeting.
Nominees
should
be
identified
by
name,
occupation,
position,
address,
and
telephone
number.
Nominations
should
be
provided
to
the
DFO
listed
under
FOR
FURTHER
INFORMATION
CONTACT
on
or
before
June
9,
2003.
The
criteria
for
selecting
scientists
to
serve
on
the
FIFRA
SAP
are
that
these
persons
be
recognized
scientists
 
experts
in
their
fields;
that
they
be
as
impartial
and
objective
as
possible;
that
they
represent
an
array
of
backgrounds
and
perspectives
(
within
their
disciplines);
have
no
financial
conflict
of
interest;
have
not
previously
been
involved
with
the
scientific
peer
review
of
the
issue(
s)
presented;
and
that
they
be
available
to
participate
fully
in
the
review,
which
will
be
conducted
over
a
relatively
short
time
frame.
Nominees
will
be
asked
to
attend
the
public
meetings
and
to
participate
in
the
discussion
of
key
issues
and
assumptions
at
these
meetings.
Finally,
they
will
be
asked
to
review
and
to
help
finalize
the
meeting
minutes.
If
a
FIFRA
SAP
nominee
is
considered
to
assist
in
a
review
by
the
FIFRA
SAP
for
a
particular
session,
the
nominee
is
subject
to
the
provisions
of
5
CFR
part
2634,
Executive
Branch
Financial
Disclosure,
as
supplemented
by
the
EPA
in
5
CFR
part
6401.
As
such,
the
FIFRA
SAP
nominee
is
required
to
submit
a
Confidential
Financial
Disclosure
Form
for
Special
Government
Employees
Serving
on
Federal
Advisory
Committees
at
the
Environmental
Protection
Agency
(
EPA
Form
3110
 
485
 
02)
which
shall
fully
disclose,
among
other
financial
interests,
the
nominee's
employment,
stocks,
and
bonds,
and
where
applicable,
sources
of
research
support.
The
EPA
will
evaluate
the
nominee's
financial
disclosure
form
to
assess
that
there
are
no
formal
conflicts
of
interest
before
the
nominee
is
considered
to
serve
on
the
FIFRA
SAP.
Selected
FIFRA
SAP
members
will
be
hired
as
Special
Government
Employees.
The
Agency
will
review
all
nominations.
FIFRA
SAP
members
participating
at
this
meeting
will
be
posted
on
the
FIFRA
SAP
web
site
or
may
be
obtained
by
contacting
the
PIRIB
at
the
address
or
telephone
number
listed
in
Unit
I.
II.
Background
A.
Purpose
of
the
FIFRA
SAP
Amendments
to
FIFRA
enacted
November
28,
1975
(
7
U.
S.
C.
136w(
d)),
include
a
requirement
under
section
25(
d)
of
FIFRA
that
notices
of
intent
to
cancel
or
reclassify
pesticide
regulations
pursuant
to
section
6(
b)(
2)
of
FIFRA,
as
well
as
proposed
and
final
forms
of
rulemaking
pursuant
to
section
25(
a)
of
FIFRA,
be
submitted
to
a
SAP
prior
to
being
made
public
or
issued
to
a
registrant.
In
accordance
with
section
25(
d)
of
FIFRA,
the
FIFRA
SAP
is
to
have
an
opportunity
to
comment
on
the
health
and
environmental
impact
of
such
actions.
The
FIFRA
SAP
also
shall
make
comments,
evaluations,
and
recommendations
for
operating
guidelines
to
improve
the
effectiveness
and
quality
of
analyses
made
by
Agency
scientists.
Members
are
scientists
who
have
sufficient
professional
qualifications,
including
training
and
experience,
to
be
capable
of
providing
expert
comments
as
to
the
impact
on
health
and
the
environment
of
regulatory
actions
under
sections
6(
b)
and
25(
a)
of
FIFRA.
The
Deputy
Administrator
appoints
seven
individuals
to
serve
on
the
FIFRA
SAP
for
staggered
terms
of
4
years,
based
on
recommendations
from
the
National
Institutes
of
Health
and
the
National
Science
Foundation.
Section
104
of
FQPA
(
Public
Law
104
 
170)
established
the
FQPA
Science
Review
Board
(
SRB).
These
scientists
shall
be
available
to
the
FIFRA
SAP
on
an
ad
hoc
basis
to
assist
in
reviews
conducted
by
the
FIFRA
SAP.

B.
Face­
to­
Face
Public
Meeting
The
FIFRA
SAP
will
meet
to
consider
and
review
issues
concerned
with
ensuring
data
quality
for
in
vitro
tests
used
as
alternatives
to
animal
studies
for
regulatory
purposes.
Many
in
vitro
methods
have
been
developed
or
are
under
development
to
replace
animal
tests.
Organizations
may
develop
in
vitro
methods
using
ex
vivo
tissues
or
biological
constructs
as
the
target
tissue
and
fully
disclose
their
test
design
and
the
scientific
principles
of
the
test.
In
other
cases,
in
vitro
methods
may
be
developed
by
commercial
sponsors
for
commercial
marketing
as
Proprietary
Test
Methods
(
PTM).
In
vitro
alternatives
to
animal
testing
pose
unique
issues
regarding
quality
and
performance.
Once
a
new
in
vitro
method
is
validated
and
accepted
for
regulatory
use
to
characterize
human
health
and
environmental
effects,
a
process
is
needed
to
provide
assurance
that
it
will
continue
to
perform
in
a
manner
consistent
with
the
test
system
as
it
was
originally
validated.
Consistency
of
the
in
vitro
assay
system
is
needed
with:
Time,
any
change
in
ingredients
or
manufacturing
process
in
the
test
system
to
be
marketed,
or
variations
in
interpretation
of
a
method
described
only
generically
in
a
test
guideline.
In
addition,
a
process
should
be
developed
to
allow
``
Me­
too''
methods
to
qualify
for
regulatory
use,
based
on
the
validation
originally
performed
for
the
PTM.
For
this
meeting,
the
FIFRA
SAP
will
consider
and
review
test
guideline
approaches
to
address
performance
and
quality
of
in
vitro
methods
when
used
as
alternatives
to
animal
studies.
In
addition,
the
panel
will
consider
core
guideline
elements,
and
minimum
performance
and
procedural
standards
for
three
new
in
vitro
corrosivity
assays.

C.
FIFRA
SAP
Meeting
Minutes
The
FIFRA
SAP
will
prepare
meeting
minutes
summarizing
its
recommendations
to
the
Agency
in
approximately
60
days.
The
meeting
minutes
will
be
posted
on
the
FIFRA
SAP
web
site
or
may
be
obtained
by
contacting
the
PIRIB
at
the
address
or
telephone
number
listed
in
Unit
I.

List
of
Subjects
Environmental
protection,
Pesticides
and
pests.

Dated:
May
22,
2003.
Joseph
J.
Merenda,
Director,
Office
of
Science
Coordination
and
Policy.
[
FR
Doc.
03
 
13434
Filed
5
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0160;
FRL
 
7307
 
1]

Pesticide
Products;
Registration
Approvals
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
Agency
approval
of
applications
to
register
the
following
four
pesticide
products
Nut
GuardV/
Fruit
GuardV,
Novozymes
Biofungicide
Green­
ReleafTM
710­
140,
GB34
Concentrate
Biological
Fungicide,
and
GB34
Technical
Biological
Fungicide
containing
active
ingredients
not
included
in
any
previously
registered
products
pursuant
to
the
provisions
of
section
3(
c)(
5)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
as
amended.

VerDate
Jan<
31>
2003
19:
12
May
29,
2003
Jkt
200001
PO
00000
Frm
00039
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
30MYN1.
SGM
30MYN1
32494
Federal
Register
/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Notices
FOR
FURTHER
INFORMATION
CONTACT:
Regulatory
Action
Leader,
listed
in
the
table
below:

Regulatory
Action
Leader
Telephone
number/
e­
mail
address
Mailing
address
EPA
Registration
No.

Leonard
Cole
(
703)
305
 
5412;
cole.
leonard@
epa.
gov
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001
73176
 
1
Susanne
Cerrelli
(
703)
308
 
8077;
cerrelli.
susanne@
epa.
gov
Do.
70127
 
2
Anne
Ball
(
703)
308
 
8717;
ball.
anne@
epa.
gov
Do.
7501
 
191
7501
 
192
SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0160.
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.
In
accordance
with
section
3(
c)(
2)
of
FIFRA,
a
copy
of
the
approved
label,
the
list
of
data
references,
the
data
and
other
scientific
information
used
to
support
registration,
except
for
material
specifically
protected
by
section
10
of
FIFRA,
are
also
available
for
public
inspection.
Requests
for
data
must
be
made
in
accordance
with
the
provisions
of
the
Freedom
of
Information
Act
and
must
be
addressed
to
the
Freedom
of
Information
Office
(
A
 
101),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
The
request
should:
Identify
the
product
name
and
registration
number
and
specify
the
data
or
information
desired.
A
paper
copy
of
the
fact
sheet,
which
provides
more
detail
on
this
registration,
may
be
obtained
from
the
National
Technical
Information
Service
(
NTIS),
5285
Port
Royal
Rd.,
Springfield,
VA
22161.
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.
Did
EPA
Approve
the
Applications?
The
Agency
approved
the
applications
after
considering
all
required
data
on
risks
associated
with
the
proposed
uses
of
Indian
Meal
Moth
Granulosis
Virus;
Bacillus
licheniformis
strain
SB3086;
Bacillus
pumilus
strain
GB34,
and
information
on
social,
economic,
and
environmental
benefits
to
be
derived
from
use.
Specifically,
the
Agency
has
considered
the
nature
of
the
chemical
and
its
pattern
of
use,
application
methods
and
rates,
and
level
and
extent
of
potential
exposure.
Based
on
these
reviews,
the
Agency
was
able
to
make
basic
health
and
safety
determinations
which
show
that
use
of
Indian
Meal
Moth
Granulosis
Virus;
Bacillus
licheniformis
strain
SB3086;
Bacillus
pumilus
strain
GB34
when
used
in
accordance
with
widespread
and
commonly
recognized
practice,
will
not
generally
cause
unreasonable
adverse
effects
to
the
environment.

III.
Approved
Applications
1.
EPA
issued
a
notice,
published
in
the
Federal
Register
of
August
31,
2001
(
66
FR
45987)
(
FRL
 
6760
 
5),
which
announced
that
AgriVir
LLC,
1625
K
Street,
NW,
Suite
1000,
Washington,
DC
20006,
had
submitted
an
application
to
register
the
pesticide
product,
Nut
GuardV/
Fruit
GuardV,
as
a
moth
larvicide
(
EPA
File
Symbol
73176
 
R),
containing
96.4%
Indian
Meal
Moth
Granulosis
Virus
and
larval
parts
on
milled
wheat
bran
carrier.
This
product
was
not
previously
registered.
The
application
was
approved
on
December
21,
2001,
as
Nut
GuardV/
Fruit
GuardV
(
EPA
Registration
Number
73176
 
1)
for
controlling
Indian
Meal
moth
larvae
on
dried
fruit,
shelled
and
unshelled
nuts,
and
in
cracks
and
crevices
in
processing,
packing,
and
storage
areas.
2.
EPA
issued
a
notice,
published
in
the
Federal
Register
of
June
26,
2002
(
67
FR
43114)
(
FRL
 
7182
 
9),
which
announced
that
Novozymes
Biologicals,

VerDate
Jan<
31>
2003
19:
12
May
29,
2003
Jkt
200001
PO
00000
Frm
00040
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
30MYN1.
SGM
30MYN1
32495
Federal
Register
/
Vol.
68,
No.
104
/
Friday,
May
30,
2003
/
Notices
Inc.,
111
Kelser
Mill
Road,
Salem,
VA
24153,
had
submitted
an
application
to
register
the
pesticide
product,
Novozymes
Biofungicide
Green
Releaf
TM
710­
140,
a
biological
fungicide
(
EPA
File
Symbol
70127
 
E),
containing
Bacillus
licheniformis
Strain
SB3086
at
0.14%.
This
product
was
not
previously
registered.
The
application
was
approved
on
February
4,
2003,
as
Novozymes
Biofungicide
Green­
ReleafTM
710­
140
(
EPA
Registration
Number
70127
 
2)
for
fungicidal
treatment
of
ornamental
turf,
lawns,
golf
courses,
ornamental
plants,
conifers
and
tree
seedlings
in
outdoor,
greenhouse,
and
nursery
sites.
The
active
ingredients
registered
for
this
product
are
Bacillus
licheniformis
Strain
SB3086
at
0.14%
and
Indole­
3­
butyric
Acid
at
0.00096%.
3.
EPA
issued
a
notice,
published
in
the
Federal
Register
of
December
31,
2001
(
66
FR
67520)
(
FRL
 
6813
 
7),
which
announced
that
Gustafson
LLC,
1400
Preston
Road,
Suite
400,
Plano,
TX
75093,
had
submitted
applications
to
register
the
following
two
pesticide
products
GB34
Concentrate
Biological
Fungicide,
fungicide
(
EPA
File
Symbol
7501
 
ROR)
and
GB34
Technical
Biological
Fungicide
(
EPA
File
Symbol
7501
 
ROE),
containing
Bacillus
pumilus
GB34
at
0.28%
and
13.8%,
respectively.
These
products
were
not
previously
registered.
The
applications
were
approved
on
March
13,
2003,
as
GB34
Concentrate
Biological
Fungicide
(
EPA
Registration
Number
7501
 
191);
for
use
as
a
treatment
for
soybeans
for
suppression
of
root
diseases
caused
by
Rhizoctonia
and
Fusarium
and
GB34
Technical
Biological
Fungicide
(
EPA
Registration
Number
7501
 
192)
for
reformulating
into
end­
use
fungicide
products.

List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.

Dated:
May
15,
2003.

Phil
Hutton,

Acting
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
13437
Filed
5
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0122;
FRL
 
7304
 
6]

Fenthion;
Notice
of
Receipt
of
Request
to
Voluntarily
Cancel
Certain
Pesticide
Registrations
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
In
accordance
with
section
6(
f)(
1)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
as
amended,
EPA
is
issuing
a
notice
of
receipt
of
request
by
Bayer
Environmental
Science
to
voluntarily
cancel
the
registrations
for
all
of
their
products
containing
O,
O­
dimethyl
O­(
4­
methylthio)­
m­
tolyl)
phosphorothioate
(
fenthion).
EPA
intends
to
grant
this
request
by
issuing
a
cancellation
order
at
the
close
of
the
comment
period
for
this
announcement
unless
the
Agency
receives
substantive
comments
within
the
comment
period
that
would
merit
its
further
review
of
this
request.
It
is
EPA's
intent
that
the
effective
date
of
the
cancellation
order,
as
requested
by
Bayer,
will
be
June
30,
2004.
Upon
the
effective
date
of
the
cancellation
order,
any
distribution
or
sale
of
products
listed
in
this
notice
will
be
prohibited
as
of
June
30,
2004,
except
for
return
of
unused
portions
to
Bayer
or
for
proper
disposal.
EPA
expects
use
of
products
listed
in
this
notice
will
be
permitted
until
November
30,
2004.
Any
such
use
must
be
in
accordance
with
the
label.
Bayer
has
submitted,
and
EPA
intends
to
approve,
label
amendments
intended
to
further
mitigate
the
risks
of
fenthion.
Because
Bayer
has
requested
cancellation
of
the
registrations
of
all
of
its
fenthion
products,
Bayer
is
not
required
to
satisfy
the
data
requirements
in
any
of
the
Agency's
Data
Call­
Ins,
including
the
Developmental
Neurotoxicity
Data
Call­
In.
DATES:
Comments
on
the
requested
registration
cancellations
must
be
submitted
to
the
address
provided
below
and
identified
by
docket
ID
number
OPP
 
2003
 
0122.
Comments
must
be
received
on
or
before
July
29,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
by
hand
delivery
or
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP
 
2003
 
0122
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
Susan
Jennings,
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
706)
355
 
8574;
e­
mail
address:
jennings.
susan@
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
persons
who
produce
or
use
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
notice,
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
 
0122.
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.
EPA
also
established
two
dockets
containing
documents
in
support
of
the
fenthion
IRED.
They
are
dockets
OPP
 
34145
and
OPP
 
34145A.
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
VerDate
Jan<
31>
2003
19:
12
May
29,
2003
Jkt
200001
PO
00000
Frm
00041
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
30MYN1.
SGM
30MYN1