Document ID: EPA-HQ-OPP-2002-0263-0001
Agency: epa
Document Type: Notice
Title: Notice of Filing a Pesticide Peititionto Establish a Tolerance for a Certain Pesticide Chemical in or on 
Food
Posted Date: 2002-10-22T04:00Z

64881
Federal
Register
/
Vol.
67,
No.
204
/
Tuesday,
October
22,
2002
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0263;
FRL–
7275–
7]

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
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
in
or
on
various
food
commodities.

DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0263,
must
be
received
on
or
before
November
21,
2002.

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:
Robyn
Rose,
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–
9581;
e­
mail
address:
rose.
robyn@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPP–
2002–
0263.
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
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
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
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64882
Federal
Register
/
Vol.
67,
No.
204
/
Tuesday,
October
22,
2002
/
Notices
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.
2.
EPA
Dockets—
i.
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–
0263.
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–
0263.
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),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency
(7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001,
Attention:
Docket
ID
Number
OPP–
2002–
0263.
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–
0263.
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:
October
7,
2002.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
PP
2F06453
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
Taensa,
Inc.
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.
EPA
has
received
a
pesticide
petition
2F06453
from
Taensa,
Inc.,
26
Sherman
Ct,
P.
O.
Box
764,
Fairfield,
CT
06430,
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
microbial
pesticide
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
Taensa,
Inc.
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
Taensa,
Inc.
EPA
has
not
fully
evaluated
the
merits
of
the
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SGM
22OCN1
64883
Federal
Register
/
Vol.
67,
No.
204
/
Tuesday,
October
22,
2002
/
Notices
pesticide
petition.
The
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
of
the
petitioner.

A.
Product
Name
and
Proposed
Use
Practices
TAEGRO
TM
is
currently
registered
with
EPA
for
use
on
ornamentals
in
greenhouses
and
indoors
(EPA
Registration
Number
72098–
5).
TAEGRO
TM
Technical
(EPA
Registration
Number
72098–
6)
is
also
registered
with
EPA.
Registration
of
TAEGRO
TM
is
being
proposed
for
the
following
sites
(including
those
previously
registered):
Herbs
and
spices;
ornamentals;
shrubs,
shade
and
forest
trees;
tree,
vine,
bush
and
other
crops;
turf;
and
vegetables.
Methods
of
application
of
TAEGRO
TM
will
include
seed
treatment,
incorporation
into
growth
substrate
as
a
dry
powder
or
as
an
aqueous
suspension,
drenching,
spraying,
dipping
(roots
or
cuttings),
spraying,
chemigation,
and
hydroponic
use.
As
a
plant
strengthening
agent,
TAEGRO
TM
increases
yield
of
many
crops,
improves
flowering
and
plant
quality,
stimulates
resistance
of
plants
to
disease,
plant
disease
suppressant
and
can
be
used
with
fungicides.
Directions
for
use
of
TAEGRO
TM
are
as
follows:
Apply
TAEGRO
TM
as
early
as
possible
in
the
life
cycle
of
the
plant
to
enhance
growth
and
disease
resistance.
TAEGRO
TM
should
be
applied
to
plants
every
few
weeks
for
up
to
three
to
four
applications
as
needed.
For
best
results,
apply
TAEGRO
TM
to
seedlings
or
to
newly
rooted
cuttings.
1.
Transplants,
including
plugs.
TAEGRO
TM
may
be
applied
to
transplants
by
dipping
or
by
drenching,
making
sure
the
root
system
is
thoroughly
soaked.
For
dipping,
follow
the
instructions
for
``
Cutting
and
Root
Dips''
before
planting
transplants
into
soil
medium.
For
drenching,
first
plant
the
transplants
into
soil
medium
and
then
follow
instructions
for
``
Drenching.
''
2.
Drenching.
Apply
TAEGRO
TM
to
seedlings
or
to
newly
rooted
cuttings.
Drench
plants
with
the
TAEGRO
TM
suspension
making
sure
the
root
system
is
thoroughly
soaked.
Allowing
TAEGRO
TM
to
work
into
the
root
zone.
Apply
TAEGRO
TM
as
follows:
 
Per
100
gallons
of
water
­
by
weight
use
75
grams
or
2.6
ounces;
by
volume
use
3.5
fluid
ounces
of
TAEGRO
TM
.
 
Per
1
gallon
of
water
5
grams
­
by
weight
use
0.75
gram;
by
volume
use
0.2
teaspoon
of
TAEGRO
TM
.
3.
Cutting
and
root
dips.
Stir
suspension
for
several
minutes
to
ensure
complete
mixture
and
to
eliminate
clumps.
Place
rootstock
in
the
suspension
for
5
to
10
minutes
allowing
time
for
TAEGRO
TM
to
penetrate
the
root
zone.
Ornamentals
should
receive
at
least
one
follow­
up
drench
treatment
2
to
3
weeks
following
initial
treatment.
Apply
TAEGRO
TM
as
follows:
 
Per
10
gallons
of
water
­
by
weight,
use
40
grams;
by
volume,
1.8
fluid
ounces
of
TAEGRO
TM
.
 
Per
1
gallon
of
water
­
by
weight,
use
4
grams;
by
volume,
use
1
teaspoon
of
TAEGRO
TM
.
 
Per
1
Liter
of
water
­
by
weight,
use
1
gram
of
TAEGRO
TM
.
4.
Turf.
As
an
overhead
spray,
mix
75
grams
of
TAEGRO
TM
in
100
gallons
of
water.
Before
applying,
stir
product
for
several
minutes
to
ensure
complete
suspension.
Apply
solution
with
a
conventional
sprayer
using
at
least
50
gallons
of
water
per
acre.
Water­
in
TAEGRO
TM
immediately
after
application
with
a
minimum
of
1/
10
inch
of
water.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
5.
Row
crops.
Mix
75
grams
of
TAEGRO
TM
in
100
gallons
of
water.
Before
applying,
stir
product
for
several
minutes
to
ensure
complete
suspension.
At
time
of
(or
just
following)
planting,
apply
as
a
spray
over
furrow.
Water­
in
TAEGRO
TM
immediately
after
application
with
a
minimum
of
1/
10
inch
of
water.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
6.
Hydroponics.
Prepare
a
stock
solution
by
adding
1
gram
of
TAEGRO
TM
,
for
every
50
feet
of
irrigation
tubing,
in
1
gallon
of
water.
Stir
product
for
several
minutes
to
ensure
complete
suspension.
Add
solution
to
circulating
water
system
and
allow
to
go
through
three
to
five
watering
cycles
before
clearing
the
system.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
7.
Seed
treatments.
Prior
to
planting,
mix
4
grams
of
TAEGRO
TM
in
1
liter
of
water
(or
3
teaspoons
per
gallon
of
water).
Stir
solution
for
several
minutes
to
ensure
complete
suspension.
Pour
seeds
into
solution
and
allow
to
soak
for
10
to
30
minutes.
For
very
small
seeds,
soaking
seedlings
in
plug
trays
after
germination
might
be
easier.
8.
Tubers,
bulbs
and
corms.
Mix
4
grams
of
TAEGRO
TM
in
1
liter
of
water
(or
3
teaspoons
per
gallon
of
water).
Stir
solution
for
several
minutes
to
ensure
complete
suspension.
Dip
tubers
(or
bulbs,
etc.)
for
10
to
30
minutes
before
planting.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
9.
Soil
incorporation.
Mix
TAEGRO
TM
into
soil
or
soilless
growing
media
at
a
rate
of
250
grams
per
cubic
yard.
Thoroughly
mix
media,
using
mechanical
mixing
equipment,
to
ensure
a
uniform
distribution
of
product.
Incorporated
into
soil,
TAEGRO
TM
can
be
raked
into
growing
beds
prior
to
planting.
10.
Mushrooms.
Mix
TAEGRO
TM
into
spawn
medium
at
a
rate
of
10
grams
per
cubic
foot.
Thoroughly
mix,
using
mechanical
mixing
equipment,
to
ensure
a
uniform
distribution
of
product.
11.
Interiorscapes.
Before
application,
thoroughly
moisten
root
zone
with
water.
Mix
1
gram
of
TAEGRO
TM
per
1
liter
of
water
(or
3/
4
teaspoon
per
gallon
of
water).
Stir
solution
for
several
minutes
to
ensure
complete
suspension.
Drench
solution
onto
root
zone
to
ensure
coverage
to
all
roots.
TAEGRO
TM
performs
best
when
applied
to
seedlings
or
young
plants.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
12.
Orchids
and
ferns.
For
potted
orchids
and
ferns,
follow
directions
for
drenching.
For
orchids
and
ferns
with
exposed
roots,
prepare
4
grams
of
TAEGRO
TM
in
1
liter
of
water
(or
3
teaspoons
per
gallon
of
water).
Pour
solution
into
spray
container
(or
squirt
bottle)
and
spray
roots
to
point
of
drip.
TAEGRO
TM
performs
best
when
applied
to
seedlings
or
young
plants.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.

B.
Product
Identity/
Chemistry
1.
Identity
of
pesticide
and
corresponding
residues.
The
active
ingredient
in
TAEGRO
TM
is
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
The
mechanism
by
which
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
acts
as
a
plant
strengthening
agent,
increases
yield
of
many
crops,
improves
flowering
and
plant
quality,
stimulates
resistance
of
plants
to
disease,
plant
disease
suppressant
appears
to
be
primarily
via
secondary
exudates.
Suppression
of
plant
disease
by
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
may
also
be
competitive.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
not
known
to
produce
toxins
or
antibiotics.
Further,
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment
and
occurs
in
most
arable
soils
of
the
world.

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22OCN1.
SGM
22OCN1
64884
Federal
Register
/
Vol.
67,
No.
204
/
Tuesday,
October
22,
2002
/
Notices
2.
Magnitude
of
residue
anticipated
at
the
time
of
harvest
and
method
used
to
determine
the
residue.
No
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
are
anticipated
in
treated
crops
at
harvest.
Subdivision
M
­
Series
153A­
3(
a)
indicates
that
``
if
Tier
I
toxicology
tests
indicate
no
toxic
or
other
harmful
properties,
then
no
residue
data
would
be
indicated.
''
Studies
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
demonstrated
low
mammalian
toxicity.
No
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
Further,
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment.
3.
Statement
of
why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
Subdivision
M
­
Series
153A3
a)
indicates
that
``
if
Tier
I
toxicology
tests
indicate
no
toxic
or
other
harmful
properties,
then
no
residue
data
would
be
indicated
and
thus
a
recommendation
for
an
exemption
from
the
requirement
of
a
tolerance
can
be
made.
''
Studies
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
demonstrated
low
mammalian
toxicity.
No
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
Further,
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment.

C.
Mammalian
Toxicological
Profile
Taensa,
Inc.
conducted
the
required
toxicology
studies
to
support
its
petition
for
an
exemption
from
the
requirement
of
tolerance
and
associated
registrations
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
The
studies
conducted
indicate
a
low
mammalian
toxicity
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
No
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
With
the
exception
of
an
inhalation
study
for
the
end­
use
product
(TAEGRO
TM
),
which
is
being
submitted
in
support
of
this
application,
all
toxicology
data
generated
by
Taensa
have
been
reviewed
by
EPA's
Biopesticides
and
Pollution
Prevention
Division
(BPPD).
Toxicology
data
in
support
of
the
exemption
from
the
requirement
of
a
tolerance
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
included
studies
with
spores
(technical)
and
with
the
formulated
product
(water
dispersible
powder)
as
follows:
1.
Acute
toxicity
and/
or
pathogenicity—
a.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
Spores
(Technical):
 
Acute
oral
toxicity/
pathogenicity
in
rats
­
``
does
not
appear
to
be
toxic
and/
or
pathogenic
when
dosed
at
1.3
x
10
8
cfu.
''
BPPD
Review
December
20,
1999.
 
Acute
dermal
toxicity/
pathogenicity
in
rabbits
­
``
The
severity
of
irritation
persisted
72
h,
and
slight
irritation
persisted
for
10
d,
and
all
resolved
by
day
11.
No
deaths
observed.
The
acute
lethal
dose
(LD50)
is
greater
than
2,000
mg/
kg.
.
.Dermal
irritation
=
Toxicity
II;
Dermal
Toxicity
=
Toxicity
III.
''
BPPD
Review
December
20,
1999.
 
Acute
pulmonary
toxicity/
pathogenicity
in
rats
­
``
does
not
appear
to
be
toxic
and/
or
pathogenic
in
rats,
when
dosed
at
1.3
x
10
8
cfu/
animal.
No
total
clearance
is
seen
form
the
lungs
of
treated
test
animals
showed
a
distinct
pattern
of
clearance
from
kidney,
liver,
and
spleen.
''
BPPD
Review
December
20,
1999.
 
Acute
intravenous
toxicity/
pathogenicity
in
rats
­
``
does
not
appear
to
be
toxic
and/
or
pathogenic
in
rats,
when
dosed
at
1.7
x
10
8
cfu/
animal.
''
BPPD
Review
December
20,
1999.
 
Primary
eye
irritation
­
``
showed
no
signs
of
persistent
irritation
into
day
21,
when
dosed
at
4.7
x
10
10
cfu/
right
eye/
animal.
''
BPPD
Review
December
20,
1999
­
The
initial
review
indicated
Toxicity
Category
I,
but
was
amended
to
Toxicity
Category
II
(BPPD
Review
March
7,
2000).
 
Hypersensitivity
testing
­
``
Based
on
the
submitted
data
does
not
appear
to
be
a
sensitizer
when
dosed
at
3.6
x
10
10
cfu.
''
BPPD
Review
December
20,
1999.
 
Hypersensitivity
incident
reporting
­
``
No
recorded
or
reported
hypersensitivity
reaction
based
on
handling
MCPA
in
lab
control
setting,
equating
to
55
person
years.
''
BPPD
Review
December
20,
1999.
 
Potential
health
effects
­
``
Based
on
information
given,
there
are
no
apparent
negative
effects
­
cited
literature
on
B.
Subtilis
indicate
and/
or
support
the
development
as
a
biological
control.
''
BPPD
Review
December
20,
1999.
 
Growth
parameters
­
``
is
shown
to
grow
at
all
tested
temperatures
(e.
g.,
30,
34,
37,
and
50
o
C).
The
enumeration
shows
a
low
4.2
x
10
11
cfu/
g
at
37
o
C
to
a
high
6.0
x
10
11
cfu/
g
at
34
o
C.
''
BPPD
Review
December
20,
1999.
b.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
WDG
(formulation):
 
Acute
oral
LD50
toxicity
in
rats
­
``
Toxic/
limit
dose
greater
than
2.8
g/
kg
body
weight
(6.7
x
10
10
cfu/
kg)
Toxicity
Category
III.
''
BPPD
Review
December
20,
1999.
 
Acute
dermal
LD50
toxicity
in
rats
­
``
The
severity
of
irritation
persisted
>
72
h,
but
resolved
by
day
11.
No
deaths
observed.
The
acute
dose
(LD50)
is
greater
than
2,000
mg/
kg
Dermal
irritation
=
Toxicity
Category
II;
Dermal
Toxicity
=
Toxicity
Category
III.
''
BPPD
Review
December
20,
1999.
 
Acute
inhalation
LC50
toxicity
in
rats
(formulation)
­
``
an
acute
inhalation
medium
lethal
concentration
(LC50)
in
male
and
female
rats
is
greater
than
0.93
mg/
L
Toxicity
Category
II.
''
IIT
Research
Institute
(Document
2
of
this
submission)
 
Primary
eye
irritation
``
no
corneal
opacity,
and
no
signs
of
irritation
by
day
7,
when
dosed
at
3.6
x
10
10
cfu/
right
eye/
animal
Toxicity
Category
III.
''
BPPD
Review
December
20,
1999.
c.
The
inert
ingredients
contained
in
the
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
formulation,
TAEGRO
TM
are
all
minimal
risk
(List
4).
2.
Genotoxicity.
Subdivision
M
Guidelines
do
not
require
the
conduct
of
genotoxicity
studies
to
support
the
registration
of
a
microbial
pest
control
agent,
such
as
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
3.
Reproductive
and
developmental
toxicity.
Subdivision
M
Guidelines
do
not
require
the
conduct
of
reproductive
and
developmental
toxicity
studies
to
support
the
registration
of
a
microbial
pest
control
agent,
such
as
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
4.
Subchronic
toxicity.
Subdivision
M
Guidelines
do
not
require
the
conduct
of
subchronic
toxicity
studies
to
support
the
registration
of
a
microbial
pest
control
agent,
such
as
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
5.
Chronic
toxicity.
Subdivision
M
Guidelines
do
not
require
the
conduct
of
chronic
toxicity
studies
to
support
the
registration
of
a
microbial
pest
control
agent,
such
as
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
According
to
Taensa,
Inc.,
sufficient
data
exist
to
assess
the
hazards
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
c)(
2),
for
the
exemptions
from
the
requirement
of
a
tolerance.
The
exposures,
including
dietary
exposure,
and
risks
associated
with
establishing
the
requested
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Federal
Register
/
Vol.
67,
No.
204
/
Tuesday,
October
22,
2002
/
Notices
exemption
from
the
requirement
of
a
tolerance
follows.

D.
Aggregate
Exposure
Bacillus
subtilis
var.
amyloliquefaciens
is
naturally
occurring
and
widespread
in
the
environment.
The
low
toxicity
and
non­
pathogenicity/
infectivity
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
demonstrated
by
the
data
summarized
herein.
The
product
will
be
applied
as
a
seed
treatment
and
via
incorporation,
drenching,
spraying,
dipping,
chemigation
and
hydroponics.
1.
Dietary
exposure—
a.
Food.
It
is
not
anticipated
that
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
will
occur
in
treated
raw
agricultural
commodities.
b.
Drinking
water.
It
is
not
anticipated
that
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
will
occur
in
drinking
water.
2.
Non­
dietary
exposure.
The
potential
for
non­
occupational,
nondietary
exposure
to
the
general
population
is
not
expected
to
be
significant.

E.
Cumulative
Exposure
There
is
no
anticipated
potential
for
cumulative
effects
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
and
other
substances
that
have
a
common
mode
of
action.

F.
Safety
Determination
1.
U.
S.
population.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment.
The
low
toxicity
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
demonstrated
by
the
data
summarized
above.
Based
on
this
information,
the
aggregate
exposure
to
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
over
a
lifetime
should
not
pose
appreciable
risks
to
human
health.
There
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
residues.
Exempting
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
from
the
requirement
of
a
tolerance
should
be
considered
safe
and
pose
insignificant
risk.
2.
Infants
and
children.
The
toxicity
and
exposure
data
are
sufficiently
complete
to
adequately
address
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
There
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
residues.

G.
Effects
on
the
Immune
and
Endocrine
Systems
No
specific
tests
have
been
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
to
determine
whether
it
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
other
endocrine
effects.
However,
it
is
not
likely
that
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
would
have
estrogen
or
endocrine
effects
because:
 
It
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
is
widespread
in
the
environment
 
It
has
demonstrated
low
mammalian
toxicity.
No
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
The
mechanism
by
which
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
controls
diseases
appears
to
be
via
exudates
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
does
not
produce
toxins
or
antibiotics.

H.
Existing
Tolerances
No
tolerances
or
exemptions
from
the
requirement
of
tolerance
have
been
established
or
applied
for
domestically
or
internationally
other
that
subject
petition.

I.
International
Tolerances
No
maximum
residue
levels
have
been
established
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
by
codex
Alimentarius
Commission.
[FR
Doc.
02–
26844
Filed
10–
21–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7396–
9]

Proposed
Modification
of
and
Request
for
Additional
Public
Comment
on
the
General
National
Pollutant
Discharge
Elimination
System
Permits
for
Log
Transfer
Facilities
in
Alaska:
AK–
G70–
0000
and
AK–
G70–
1000
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Notice
of
proposed
modification
of
and
request
for
additional
public
comments
on
general
NPDES
permits
for
log
transfer
facilities
in
Alaska.

SUMMARY:
The
Director,
Office
of
Water,
EPA
Region
10,
provides
notice
of
and
requests
public
comment
on
proposed
modifications
of
the
two
general
National
Pollutant
Discharge
Elimination
System
(NPDES)
permits
for
Alaskan
log
transfer
facilities
(LTFs),
which
include
log
storage
areas
(LSAs),
that
were
issued
on
March
7,
2000
(65
FR
11999):
NPDES
permit
no.
AK–
G70–
0000,
which
modifies
Clean
Water
Act
(CWA)
section
404
dredge­
and­
fill
permits
issued
to
LTFs
by
the
U.
S.
Army
Corps
of
Engineers
(ACoE)
prior
to
October
22,
1985,
by
adding
CWA
section
402
effluent
limitations
and
conditions
to
those
permits,
and
NPDES
permit
no.
AK–
G70–
1000,
which
may
cover
all
other
log
transfer
facilities
in
Alaska.
The
EPA
issued
two
general
permits
for
Alaskan
log
transfer
facilities
on
March
7,
2000.
In
response
to
petitions
to
review
the
permits
brought
by
the
Natural
Resources
Defense
Council
and
nine
other
petitioners,
the
United
States
Court
of
Appeals
for
the
Ninth
Circuit,
on
February
13,
2002,
ruled
that
the
EPA
did
not
provide
adequate
notice
of
and
opportunity
to
comment
on
the
general
NPDES
permits
AK–
G70–
0000
and
AK–
G70–
1000
and
remanded
the
permits
to
the
EPA
to
take
further
comment
on
the
project
area
Zone
of
Deposit
(ZOD)
authorized
by
the
Alaska
Department
of
Environmental
Conservation
(ADEC),
and
subsequently
included
in
the
final
permits
by
the
EPA.
To
comply
with
the
Ninth
Circuit's
order,
the
EPA
is
seeking
public
comment
on
the
authorization
of
a
``
project
area''
zone
of
deposit
for
trace,
discontinuous,
and
continuous
coverage
in
the
general
permits.
The
EPA
also
is
proposing
to
modify
these
permits.
The
most
significant
proposal
would
add
a
limit
on
continuous
coverage
within
the
project
area
zone
of
deposit,
but
would
retain
the
project
area
zone
of
deposit
limit
for
bark
and
woody
debris
for
trace,
discontinuous,
and
continuous
coverage
if
less
than
one
acre
and
less
than
10
centimeters
in
depth.
This
notice
seeks
comment
on
the
proposed
major
modifications.
Finally,
the
notice
describes
various
minor
modifications
the
EPA
is
making
to
correct
typographical
errors.
DATES:
Interested
persons
may
submit
written
comments
on
the
proposed
modifications
to
general
NPDES
permits
AK–
G70–
0000
and
AK–
G70–
1000
and
on
the
project
area
zone
of
deposit
on
or
before
December
23,
2002.
ADDRESSES:
Comments
must
be
sent
to
the
attention
of
Alaskan
LTF
Public
Comments,
EPA
Region
10
(OW–
130),
1200
Sixth
Avenue,
Seattle,
WA
98101.
All
comments
should
include
the
name
of
the
commenter,
a
concise
statement
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