Document ID: EPA-HQ-OPP-2002-0291-0001
Agency: epa
Document Type: Rule
Title: Bacillus Cereus Strain BP01; Exemption from the Requirement of a Tolerance
Posted Date: 2002-11-20T05:00Z

70012
Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Rules
and
Regulations
If
the
EPA
receives
adverse
written
comment,
we
will
publish
a
final
rule
informing
the
public
that
this
rule
will
not
take
effect.
We
will
address
all
public
comments
in
a
subsequent
final
rule
based
on
the
proposed
rule.
The
EPA
does
not
intend
to
institute
a
second
comment
period
on
this
action.
Any
parties
interested
in
commenting
on
these
actions
must
do
so
at
this
time.

VI.
Administrative
Requirements
Under
Executive
Order
12866
(
58
FR
51735,
October
4,
1993),
this
action
is
not
a
``
significant
regulatory
action''
and
therefore
is
not
subject
to
review
by
the
Office
of
Management
and
Budget.
For
this
reason,
this
action
is
also
not
subject
to
Executive
Order
13211,
``
Actions
Concerning
Regulations
That
Significantly
Effect
Energy
Supply,
Distribution,
or
Use''
(
66
FR
28355,
May
22,
2001).
This
action
merely
approves
state
law
as
meeting
Federal
requirements
and
imposes
no
additional
requirements
beyond
those
imposed
by
state
law.
Accordingly,
the
Administrator
certifies
that
this
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities
under
the
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et
seq.).
Because
this
rule
approves
pre­
existing
requirements
under
state
law
and
does
not
impose
any
additional
enforceable
duty
beyond
that
required
by
state
law,
it
does
not
contain
any
unfunded
mandate
or
significantly
or
uniquely
affect
small
governments,
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
Pub.
L.
104
 
4).
This
rule
also
does
not
have
tribal
implications
because
it
will
not
have
a
substantial
direct
effect
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
by
Executive
Order
13175
(
65
FR
67249,
November
9,
2000).
This
action
also
does
not
have
Federalism
implications
because
it
does
not
have
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132
(
64
FR
43255,
August
10,
1999).
This
action
merely
approves
a
state
rule
implementing
a
Federal
standard,
and
does
not
alter
the
relationship
or
the
distribution
of
power
and
responsibilities
established
in
the
Clean
Air
Act.
This
rule
also
is
not
subject
to
Executive
Order
13045
``
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks''
(
62
FR
19885,
April
23,
1997),
because
it
is
not
economically
significant.
In
reviewing
SIP
submissions,
EPA's
role
is
to
approve
state
choices,
provided
that
they
meet
the
criteria
of
the
Clean
Air
Act.
In
this
context,
in
the
absence
of
a
prior
existing
requirement
for
the
State
to
use
voluntary
consensus
standards
(
VCS),
EPA
has
no
authority
to
disapprove
a
SIP
submission
for
failure
to
use
VCS.
It
would
thus
be
inconsistent
with
applicable
law
for
EPA,
when
it
reviews
a
SIP
submission,
to
use
VCS
in
place
of
a
SIP
submission
that
otherwise
satisfies
the
provisions
of
the
Clean
Air
Act.
Thus,
the
requirements
of
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
15
U.
S.
C.
272
note)
do
not
apply.
This
rule
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act
of
1995
(
44
U.
S.
C.
3501
et
seq.).
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
A
major
rule
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
Under
section
307(
b)(
1)
of
the
Clean
Air
Act,
petitions
for
judicial
review
of
this
action
must
be
filed
in
the
United
States
Court
of
Appeals
for
the
appropriate
circuit
by
January
21,
2003.
Filing
a
petition
for
reconsideration
by
the
Administrator
of
this
final
rule
does
not
affect
the
finality
of
this
rule
for
the
purposes
of
judicial
review
nor
does
it
extend
the
time
within
which
a
petition
for
judicial
review
may
be
filed,
and
shall
not
postpone
the
effectiveness
of
such
rule
or
action.
This
action
may
not
be
challenged
later
in
proceedings
to
enforce
its
requirements.
(
See
section
307(
b)(
2).)

List
of
Subjects
in
40
CFR
Part
52
Environmental
protection,
Air
pollution
control,
Incorporation
by
reference,
Intergovernmental
relations,
Particulate
matter,
Reporting
and
recordkeeping
requirements.
Dated:
October
15,
2002.
David
A.
Ullrich,
Acting
Regional
Administrator,
Region
5.

For
the
reasons
stated
in
the
preamble,
part
52,
chapter
I,
title
40
of
the
Code
of
Federal
Regulations
is
amended
as
follows:

PART
52
 
[
AMENDED]

1.
The
authority
citation
for
part
52
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7401
et
seq.

Subpart
P
 
Indiana
2.
Section
52.770
is
amended
by
adding
paragraph
(
c)(
153)
to
read
as
follows:

§
52.770
Identification
of
plan.

*
*
*
*
*
(
c)
*
*
*
(
153)
On
April
30,
2002
and
September
6,
2002,
Indiana
submitted
revised
particulate
matter
regulations
for
Union
Tank
Car's
railcar
manufacturing
facility
in
Lake
County,
Indiana.
The
submittal
amends
326
IAC
6
 
1
 
10.1.
The
revisions
consist
of
relaxing
the
limits
for
the
grit
blaster.
The
new
limits
are
0.01
grains
per
dry
standard
cubic
foot
and
9.9
pounds
per
hour.
(
i)
Incorporation
by
reference.
Amendments
to
Indiana
Administrative
Code
Title
326:
Air
Pollution
Control
Board,
Article
6:
Particulate
Rules,
Rule
1:
Nonattainment
Area
Limitations,
Section
10.1:
Lake
County
PM10
emission
requirements.
Filed
with
the
Secretary
of
State
on
July
26,
2002
and
effective
on
August
25,
2002.
Published
in
25
Indiana
Register
4076
on
September
1,
2002.

[
FR
Doc.
02
 
29473
Filed
11
 
19
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2002
 
0291;
FRL
 
7277
 
3]

Bacillus
Cereus
Strain
BPO1;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Bacillus
cereus
strain
BPO1
on
raw
and
processed
food
when
applied/
used
as
a
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70013
Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Rules
and
Regulations
foliar
applied
biological
plant
growth
regulator
intended
to
promote
root
mass
growth,
earlier
fruit
initiation,
increased
fruit
retention,
and
increased
nutrient
utilization.
Micro
Flow
Company
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Bacillus
cereus
strain
BPO1.

DATES:
This
regulation
is
effective
November
20,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2002
 
0291,
must
be
received
on
or
before
January
21,
2003.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
IX.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Robyn
Rose,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
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
 
0291.
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/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
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.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
November
21,
2001
(
66
FR
58481)
(
FRL
 
6802
 
1),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a(
e),
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
1F6324)
by
Micro
Flow
Company,
P.
O.
Box
5948
Lakeland,
FL
33807
 
5948.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Micro
Flow
Company.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.1181
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Bacillus
cereus
strain
BPO1.

III.
Risk
Assessment
New
section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
c)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
of
the
FFDCA
(
b)(
2)(
C)
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
Additionally,
section
408(
b)(
2)(
D)
of
the
FFDCA
requires
that
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.

IV.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness,
and
reliability
and
the
relationship
of
this
information
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
Acute
mammalian
toxicity/
pathogenicity
studies
via
oral,
dermal,
inhalation,
eye,
intratracheal,
and
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Federal
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/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Rules
and
Regulations
intravenous
routes
were
conducted
with
Bacillus
cereus
strain
BPO1.
No
pathogenicity
was
observed.
BPO1
was
also
tested
for
entero
toxin
emetic­
toxin
production;
no
toxins
were
detected.
Bacillus
cereus
has
been
implicated
in
nosocomial
infections
in
rare
instances
and
in
food
poisoning
incidents.
In
the
ELISA
Analysis
of
Enterotoxin
data
submitted,
there
was
no
evidence
of
diarrhoeal
type
enterotoxin
production
in
the
culture
filtrates
of
Bacillus
cereus
strain
BOP1
or
the
end
use
product.
In
a
blood
agar
hemolysis
assay
conducted
with
BPO1,
weak
alpha
hemolysis
was
observed.
Based
on
the
results
of
the
studies
in
this
unit,
subchronic,
reproductive,
teratology,
chronic,
and
mutagenicity
studies
were
not
deemed
necessary.
1.
Acute
oral
toxicity/
pathogenicity
(
OPPTS
870.1100;
152A
 
10
and
152B
 
10;
MRIDs
4417737
 
05
and
441773
 
06).
In
the
acute
oral
toxicity
test,
five
male
and
five
female
rats
were
treated
with
a
split
dose,
(
10
milliliters/
kilograms/
dose)
(
mL/
kg)
for
a
total
of
5,000
milligrams
(
mg)/
kg
of
Bacillus
cereus
strain
BP01;
the
second
dose
administered
1
hour
after
the
first
dose.
Rats
were
weighed
and
observed
for
mortality
or
abnormalities
for
14
days.
No
abnormalities
were
noted
in
body
weight
or
weight
gain
throughout
the
study
or
upon
necropsy.
The
oral
lethal
dose
(
LD)
50
Bacillus
cereus
strain
BP01
was
determined
to
be
greater
than
5,000
mg/
kg
body
weight.
In
the
acute
oral
toxicity/
pathogenicity
test,
15
males
and
15
females
received
a
dose
of
1.23
x
108
colony
forming
units
(
CFU)
of
the
test
substance
by
oral
gavage;
nine
males
and
nine
females
were
treated
with
1.23
x
108
CFU
killed
test
substance
(
by
steam
sterilization).
Rats
were
weighed
on
days
0,
3,
7,
14,
and
18
and
signs
of
toxicity
were
observed
daily.
Randomly
sampled
rats
from
each
sex
and
each
test
group
were
sacrificed
on
days
0,
3,
7,
14,
and
18
and
examined
for
any
macroscopic
abnormalities.
Samples
of
the
kidneys,
liver,
spleen,
and
stomach
as
well
as
feces
were
homogenized
and
plated
to
determine
the
number
of
typical
Bacillus
cereus
colonies
after
incubation
at
30
0C
for
at
least
18
hours.
No
clinical
sign
were
noted
throughout
the
study
and
no
abnormalities
were
noted
in
any
animal
at
necropsy.
Two
males
displayed
a
loss
in
body
weight
from
day
0
to
3
and
five
females
lost
weight
from
day
7
to
14.
No
other
abnormalities
were
noted
in
body
weights
or
weight
gain.
Bacillus
cereus
strain
BP01
is
not
toxic,
pathogenic
or
infective
when
1
x
108
CFU
was
administered
orally.
A
distinct
clearance
pattern
was
observed
throughout
the
study.
2.
Acute
dermal
toxicity
(
OPPTS
870.1200;
152A
 
11;
MRID
441773
 
07).
Five
male
and
five
female
rabbits
were
given
a
dose
of
4.4
x
1010
CFU
(
2
grams
(
g))
dermally
for
24
hours
and
observed
after
dosing
for
signs
of
toxicity
and
dermal
irritation
for
14
days.
No
clinical
signs,
except
dermal
irritation,
were
noted
during
the
study
and
no
abnormalities
were
noted
upon
necropsy.
Two
males
and
five
females
displayed
a
loss
in
body
weight
from
day
0
to
day
7.
All
animals
displayed
a
weight
gain
through
the
end
of
the
study.
All
males
and
females
showed
slight
to
well
defined
redness
through
day
4;
very
slight
erythema
was
present
in
up
to
three
males
and
three
females
through
day
11.
Dermal
irritation
was
no
longer
apparent
by
day
12.
Slight
signs
of
edema
were
apparent
in
two
males
on
day
3.
Edema
was
no
longer
present
by
day
4.
The
LD50
of
Bacillus
cereus
strain
BP01
is
greater
than
2
grams
per
animal.
Mild
to
moderate
dermal
irritation
was
noted
and
was
no
longer
present
by
day
13.
3.
Acute
intratracheal
toxicity/
pathogenicity
(
OPPTS
885.3150;
152A
 
12;
MRID
441773
 
08).
Fifty
female
and
fifty
male
rats
received
a
single
dose
of
7
x
107
(
males),
or
9.33
x
107
CFU
(
females)
of
the
test
substance
in
a
volume
of
0.5
mL
by
intratracheal
administration;
fifty
females
and
fifty
males
were
treated
with
the
same
concentration
of
killed
test
substance
(
by
steam
sterilization);
an
additional
fifty
males
and
fifty
females
served
as
controls.
Rats
were
weighed
weekly
and
observed
for
signs
of
toxicity
daily.
Ten
rats
of
each
sex
from
each
group
were
sacrificed
on
days
0,
7,
14,
21,
and
36.
Animals
were
examined
for
macroscopic
abnormalities
by
necropsy.
Lungs
were
evaluated
by
histopathological
examination.
Samples
of
the
kidneys,
liver,
spleen,
brain,
mesenteric
lymph
nodes,
blood,
lungs,
and
caecum
were
homogenized,
plated,
and
incubated
for
at
least
18
hours
then
examined
for
typical
Bacillus
cereus
colonies.
Body
weight
losses
were
noted
in
females
from
the
test
substance
group,
one
during
the
first,
second
and
third
weeks.
No
other
abnormalities
were
noted
in
body
weight
or
weight
gain
throughout
the
study.
In
the
group
treated
with
the
test
substance,
three
females
displayed
a
rough
hair
coat,
two
females
showed
signs
of
labored
respiration,
and
one
female
had
hunched
posture
on
day
0.
Clinical
signs
were
no
longer
apparent
by
day
2.
Each
treatment
group
had
three
males
and
females
displaying
mottled,
dark
red
lungs
on
day
0.
Red
to
tan
lesions
remained
on
the
majority
of
animals
through
day
21.
Bacillus
cereus
strain
BP01
is
not
toxic,
pathogenic
or
infective
to
rats
at
an
intratracheal
dose
of
either
7
x
108
or
9.33
x
108
CFU.
A
slow
but
typical
clearance
pattern
was
observed;
slow
clearance
in
the
lung
with
distinct
clearance
pattern
noted
in
the
liver
and
spleen.
The
lesions
present
in
the
histopathology
sections
in
both
the
killed
and
live
test
substance
animals
indicate
an
inflammatory
response
to
the
treatment
due
to
the
presence
of
particulate
material.
4.
Acute
intravenous
toxicity
(
OPPTS
885.3200;
152A
 
13;
MRID
441773
 
09).
Five
male
and
five
female
rates
were
intravenously
injected
with
either
0.5
mL
of
Bacillus
cereus,
0.5
mL
of
the
killed
test
substance,
or
kept
as
a
naive
control.
The
rats
were
weighed
before
initial
dosing
and
weekly
thereafter.
Animals
were
observed
for
clinical
signs
twice
daily
for
14
days.
All
rats
were
examined
by
necropsy
for
any
macroscopic
abnormalities
at
the
end
of
the
study.
One
female
displayed
a
loss
in
body
weight
from
day
0
to
day
17.
No
other
abnormalities
were
noted
in
body
weight
or
weight
gain
throughout
the
study.
No
clinical
signs
were
reported
by
the
testing
facilty
and
no
abnormalities
were
noted
upon
necropsy.
Although
Bacillus
cereus
strain
BP01
is
not
toxic
to
rats
at
an
intravenous
dose
of
2.0
x
107
CFU,
the
registrant
failed
to
submit
the
clearance
portion
of
the
study.
However,
this
study
does
not
need
to
be
repeated
because
the
oral
and
intratracheal
studies
demonstrated
distinct
clearance
patterns.
5.
Primary
eye
irritation
(
OPPTS;
870.2400;
152A
 
14;
MRID
441773
 
10).
Three
male
and
three
female,
young
adult,
New
Zealnad
White
rabbits
were
given
a
single
dose
of
0.1g
(
equivalent
to
2.2
x
109
CFU)
of
the
microbial
pest
control
agent
(
MPCA)
in
the
everted
lower
right
eyelid
of
each
animal.
The
eye
was
gently
held
together
for
2
seconds
to
prevent
a
loss
of
material.
The
left
eye
served
as
the
control
for
each
animal.
The
Draize
Method
was
used
to
score
ocular
irritation
and
lesions
at
1
hour,
and
1,
2,
3,
4,
and
7
days
post
dosing.
A
2%
fluorescein
solution
and
ultraviolet
light
was
used
after
24
hours
to
evaluate
corneal
epithelial
damage.
Slight
to
moderate
redness,
chemosis,
and
occasional
discharge
was
observed
in
all
6
animals
within
1
hour
post
dosing.
Clinical
signs
were
no
longer
apparent
by
day
3.
No
abnormalities
were
observed
in
any
control
eye
during
the
study.
The
primary
irritation
scores
at
24
hours
post
dosing
was
4.8
when
a
0.1g
(
2
x
109
CFU)
ocular
dose
was
administered.

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Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Rules
and
Regulations
Ocular
irritation
was
no
longer
present
by
day
3.
6.
Immunotoxicity
(
OPPTS
880.3800).
Immune
response,
teratogenicity,
virulence
enhancement,
and
mammalian
mutagenicity
(
40
CFR
158.740(
c)(
2)(
vi)
through
(
xv),
were
not
required
since
survival,
replication,
infectivity,
toxicity,
or
persistence
of
the
microbial
agent
was
not
observed
in
the
test
animals
treated
in
the
Tier
I
infectivity
tests.
7.
Hypersensitivity
(
OPPTS
870.2600;
152
 
15).
Incidents
of
hypersensitivity
must
be
reported
to
the
Agency
in
a
timely
manner.
There
have
been
no
reports
of
incidents
of
hypersensitivity
to
Bacillus
cereus
since
it
was
registered.

V.
Aggregate
Exposures
In
examining
aggregate
exposure,
section
408
of
the
FFDCA
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).

A.
Dietary
Exposure
1.
Food.
While
the
suggested
use
pattern
may
result
in
dietary
exposure
with
possible
residues
on
food
and
feed,
negligible
risk
is
expected
for
both
the
general
population,
infants
and
children.
Submitted
acute
toxicology
tests
confirm
that
based
upon
the
use
sites,
use
patterns,
application
method,
use
rates,
low
exposure,
and
lack
of
significant
toxicology
concerns,
the
potential
risks,
if
any,
to
humans
are
considered
negligible,
therefore
an
exemption
from
the
requirement
of
a
tolerance
is
warranted.
Acute
exposure
could
occur
from
the
proposed
outdoor
use
sites
but
would
be
very
low
because
of
the
low
application
rates
of
less
than
48
fluid
ounces
of
BP01/
acre/
year
in
cotton
and
less
than
32
fluid
ounces
of
BP01/
acre/
year
in
soybean.
Considering
the
low
application
rates,
lack
of
toxicity/
pathogenicity,
ubiquitous
nature
and
natural
occurrence
of
Bacillius
cereus,
no
residue
data
were
required.
2.
Drinking
water
exposure.
The
microorganism
Bacillus
cereus
is
ubiquitous
in
many
soils
throughout
the
world.
Bacillus
cereus
is
not
known
as
an
aquatic
bacterium
and
therefore
is
not
expected
to
proliferate
in
aquatic
habitats.
The
potential
exists
for
Bacillus
cereus
strain
BPO1
to
enter
ground
water
or
other
drinking
water
sources,
after
application.
Both
percolation
through
soil
and
municipal
treatment
of
drinking
water
would
reduce
the
possibility
of
exposure
to
Bacillus
cereus
through
drinking
water.
Moreover,
Bacillus
cereus
strain
BPO1
is
not
considered
to
be
a
risk
to
drinking
water.
The
Agency
has
no
drinking
water
exposure
concerns,
because
exposure
is
minimal
to
non­
existent
and
the
demonstrated
lack
of
toxicity
or
pathogenicity
for
the
Bacillus
cereus
Strain
BP01
microbe.

B.
Other
Non­
Occupational
Exposure
The
potential
of
non­
dietary
exposures
to
Bacillus
cereus
strain
BPO1
pesticide
residues
for
the
general
population,
including
infants
and
children,
is
unlikely
since
this
is
only
an
agricultural
use
pesticide.
The
Agency
believes
that
the
potential
aggregate
exposure,
derived
from
dermal
and
inhalation
exposure
via
mixing,
loading,
and
applying
Bacillus
cereus
strain
BPO1,
should
fall
well
below
the
currently
tested
microbial
safety
levels.
1.
Dermal
exposure.
Dermal
exposure
via
the
skin
would
be
the
primary
route
of
exposure
for
mixer/
loader
applications.
Unbroken
skin
is
a
natural
barrier
to
microbial
invasion
of
the
human
body.
Dermal
absorption
could
occur
only
if
the
skin
were
cut,
if
the
microbe
were
a
pathogen
equipped
with
mechanisms
for
entry
through
or
infection
of
the
skin,
or
if
metabolites
were
produced
that
could
be
dermally
absorbed.
Submitted
acute
dermal
toxicity
data
confirmed
a
lack
of
dermal
toxicity
and
mild
to
moderate
dermal
irritation
was
only
observed
until
day
13
of
the
study.
2.
Inhalation
exposure.
Inhalation
would
be
the
primary
route
of
exposure
for
mixer/
loader
applications.
Because
the
pulmonary
study
showed
no
adverse
effects,
the
risks
anticipated
for
the
route
of
exposure
are
considered
minimal.

VI.
Cumulative
Effects
The
Agency
has
considered
available
information
on
the
cumulative
effects
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
These
considerations
included
the
cumulative
effects
on
infants
and
children
of
such
residues
and
other
substances
with
a
common
mechanism
of
toxicity.
Because
there
is
no
indication
of
mammalian
toxicity
to
this,
the
Agency
is
confident
that
there
will
not
be
cumulative
effects
from
the
registration
of
this
product
VII.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
1.
U.
S.
population.
There
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
U.
S.
population
from
exposure
to
Bacillus
cereus.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
has
arrived
at
this
conclusion
based
on
the
very
low
levels
of
mammalian
toxicity
(
no
toxicity
at
the
maximum
doses
tested,
Toxicity
Categories
III
and
IV
for
irritation)
associated
with
Bacillus
cereus
strain
BP01
and
the
history
of
safe
use
of
Bacillus
cereus.
2.
Infants
and
children.
FFDCA
section
408(
b)(
2)(
C)
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
exposure
(
safety)
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
database
unless
EPA
determines
that
a
different
margin
of
exposure
(
safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(
safety)
are
often
referred
to
as
uncertainty
(
safety)
factors.
A
battery
of
acute
toxicity/
pathogenicity
studies
is
considered
sufficient
by
the
Agency
to
perform
a
risk
assessment
for
microbial
pesticides.
Other
strains
of
Bacillus
cereus
have
been
implicated
in
nosocomial
infections
in
rare
instances
and
in
food
poisoning
incidents.
In
the
ELISA
Analysis
of
Enterotoxin
test
data
submitted
there
was
no
evidence
of
diarrhoeal
type
enterotoxin
production
in
the
culture
filtration
of
Bacillus
cereus
strain
BPO1
or
the
end
use
product.
Data
relating
to
the
post
application
die
off
of
Bacillus
cereus
species
vs.
background
soil
population
counts
demonstrated
that
this
organism
is
very
stable
in
the
soil
and
rhizosphere.
Also,
for
food
use
of
microbial
pesticides,
the
acute
toxicity/
pathogenicity
studies
have
allowed
for
the
conclusion
that
an
exemption
from
the
requirement
of
a
tolerance
is
appropriate
and
adequate
to
protect
human
health,
including
that
of
infants
and
children.

VIII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally­
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate.''
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
is
no
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scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
Bacillus
cereus
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
Based
on
available
data,
no
endocrine
system­
related
effects
have
been
identified
with
consumption
of
Bacillus
cereus
strain
BP01.
It
is
a
naturally
occurring
bacteria.
To
date,
there
is
no
evidence
to
suggest
that
Bacillus
cereus
affects
the
immune
system,
functions
in
a
manner
similar
to
any
known
hormone,
or
that
it
acts
as
an
endocrine
disruptor.

B.
Analytical
Method(
s)
The
Agency
proposes
to
establish
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation
based
upon
the
lack
of
mammalian
toxicity
of
Bacillus
cereus
and
the
lack
of
exposure
with
the
plant
growth
regulator
use
pattern.
For
the
same
reasons,
the
Agency
has
concluded
that
an
analytical
method
is
not
required
for
enforcement
purpose
for
Bacillus
cereus.

C.
Codex
Maximum
Residue
Level
There
are
no
Codex
harmonization
consideration
since
there
is
currently
no
codex
tolerance
for
Bacillus
cereus
residues.

IX.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d)
of
the
FFDCA,
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2002
 
0291
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
January
21,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
telephone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
IX.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2002
 
0291,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?
A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
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the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

X.
Regulatory
Assessment
Requirements
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
exemption
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications
''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

XI.
Submission
to
Congress
and
the
Comptroller
General
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
October
31,
2002.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]

1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
374.

2.
Section
180.1181
is
revised
to
read
as
follows:

§
180.1181
Bacillus
cereus
strain
BPO1;
exemption
from
the
requirement
of
a
tolerance.

An
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Bacillus
cereus
strain
BPO1
in
or
on
all
raw
agricultural
commodities
when
applied/
used
in
accordance
with
label
directions.
[
FR
Doc.
02
 
29331
Filed
11
 
19
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
73
[
DA
02
 
2231,
MB
Docket
No.
02
 
223,
RM
 
10520]

Digital
Television
Broadcast
Service;
Avalon,
CA
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule.

SUMMARY:
The
Commission,
at
the
request
of
Pappas
Southern
California
License,
LLC.,
and
pursuant
to
Section
531
of
the
Public
Health,
Security
and
Bioterrorism
Preparedness
and
Reponse
Act
of
2002,
allots
DTV
channel
47c
at
Avalon,
California.
DTV
channel
47c
can
be
allotted
to
Avalon
at
the
VerDate
0ct<
31>
2002
14:
01
Nov
19,
2002
Jkt
200001
PO
00000
Frm
00031
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
20NOR1.
SGM
20NOR1