Document ID: EPA-HQ-OPP-2003-0059-0001
Agency: epa
Document Type: Rule
Title: Bacillus subtilis var. amyloliquefaciens strain FZB24; Exemption from the Requirement of a Tolerance
Posted Date: 2003-07-30T04:00Z

44635
Federal
Register
/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Rules
and
Regulations
Dated:
July
17,
2003.
Lawrence
Starfield,
Acting
Regional
Administrator,
Region
6.
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
SS
 
Texas
2.
In
§
52.2270
the
table
in
paragraph
(
c)
is
amended
under
Chapter
117,
Subchapter
B,
by
adding
a
new
entry
heading
as
``
Division
4
 
Cement
Kilns'',
adding
new
individual
entries
for
sections
``
117.260,
117.261,
117.265,
117.273,
117.279,
and
117.283'';
Subchapter
E,
by
adding
a
new
individual
entry
for
section
117.524
and
revising
the
entry
for
section
117.570.

§
52.2270
Identification
of
plan.

*
*
*
*
*
(
c)
*
*
*

EPA
APPROVED
REGULATIONS
IN
THE
TEXAS
SIP
State
citation
Title/
subject
State
approval/
submittal
date
EPA
approval
date
Explanation
*
*
*
*
*
*
*

Chapter
117
(
Reg
7)
 
Control
of
Air
Pollution
From
Nitrogen
Compounds
*
*
*
*
*
*
*

Section
117.223
.................
Source
Cap
.......................
04/
19/
00
............................
03/
16/
01,66
FR
15200
......
(
b)(
1)
Requires
EPA's
approval

Subchapter
B
 
Division
4
 
Cement
Kilns
Section
117.260
.................
Cement
Kiln
Definitions
....
04/
30/
00,
04/
02/
03
............
July
30,
2003
and
[
FR
page
number].
Section
117.261
.................
Applicability
.......................
04/
30/
00
............................
July
30,
2003
and
[
FR
page
number].
Also
finalizes
65
FR
64914.
Section
117.265
.................
Emission
Specifications
....
04/
30/
00,
04/
02/
03
............
July
30,
2003
and
[
FR
page
number].
Section
117.273
.................
Continuous
Demonstration
of
Compliance.
04/
30/
00
............................
July
30,
2003
and
[
FR
page
number].
Also
finalizes
65
FR
64914
Section
117.279
.................
Notification,
Recordkeeping
and
Reporting
Requirements.
04/
30/
00,
04/
02/
03
............
July
30,
2003
and
[
FR
page
number].

Section
117.283
.................
Source
Cap
.......................
04/
30/
00,
04/
02/
03
............
July
30,
2003
and
[
FR
page
number].
*
*
*
*
*
*
*

Subchapter
E
 
Administrative
Provisions
*
*
*
*
*
*
*

Section
117.524
.................
Compliance
Schedule
for
Cement
Kilns.
04/
30/
00,
04/
02/
03
............
July
30,
2003
and
[
FR
page
number].
*
*
*
*
*
*
*

Section
117.570
.................
Use
of
Emissions
Credits
for
Compliance.
04/
02/
03
............................
July
30,
2003
and
[
FR
page
number].
*
*
*
*
*
*
*

[
FR
Doc.
03
 
19279
Filed
7
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0059;
FRL
 
7309
 
8]

Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24;
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
subtilis
var.
amyloliquefaciens
strain
FZB24
on
all
agricultural
commodities
when
applied/
used
in
accordance
with
good
agricultural
use
practices
for
plant
strengthening,
growth
enhancement,
and
plant
disease
suppression.
Earth
BioSciences
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
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Federal
Register
/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Rules
and
Regulations
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
DATES:
This
regulation
is
effective
July
30,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0059,
must
be
received
on
or
before
September
29,
2003.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
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:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
 
Antimicrobial
pesticides
(
NAICS
32561)
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
 
0059.
The
official
public
docket
is
intended
to
serve
as
a
repository
for
materials
(
i.
e.,
documents
and
other
information)
submitted
to
the
Agency
in
connection
with
this
action
and/
or
relied
upon
by
the
Agency
in
taking
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
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.
To
the
extent
that
a
particular
document
is
not
located
in
the
official
public
docket,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
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.
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
October
22,
2002
(
67
FR
32231)
(
FRL
 
7275
 
7),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
2F06453)
by
Earth
BioSciences,
451
Orange
St,
New
Haven,
CT
06511.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Earth
BioSciences.
There
were
no
comments
received
in
response
to
the
Notice
of
Filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
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
exemption
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
408(
b)(
2)(
C)
of
the
FFDCA
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.

III.
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.
Earth
BioSciences,
formerly
Taensa,
Inc.,
conducted
the
toxicology
studies
required
under
section
408(
d)(
2)(
A)
of
the
FFDCA
to
support
its
petition
for
an
exemption
from
the
requirement
of
tolerance
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
As
illustrated
below,
the
studies
conducted
indicate
a
low
mammalian
toxicity
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
In
addition,
no
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
All
toxicology
data
generated
by
Earth
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/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Rules
and
Regulations
BioSciences
have
been
reviewed
by
the
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
 
i.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
Spores
(
Technical):
 
Acute
oral
toxicity/
pathogenicity
in
rats.
``.
.
.
does
not
appear
to
be
toxic
and/
or
pathogenic
in
rats
when
dosed
at
1.3
x
108
cfu.''
BPPD
Review
of
Product
Chemistry
and
Toxicity/
Pathogenicity
Data
Submitted
by
Taensa,
Inc.,
for
the
Registration
of
TAE
 
022
and
TAE
 
022
WDG,
which
contains
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
(
Submission
No.:
S559221;
DP
Barcode:
254584;
Master
Record
Identification
(
MRID)
No's.:
447581
 
01
through
447581
 
20)
(
hereinafter
referred
to
as
``
BPPD
Review
­
December
20,
1999'').
 
Acute
dermal
toxicity/
pathogenicity
in
rabbits.
``
The
severity
of
irritation
persisted
72
hours,
and
slight
irritation
persisted
for
10
days,
and
all
resolved
by
day
11.
No
deaths
observed.
The
acute
lethal
dose
(
LD50)
is
greater
than
2,000
mg/
kg
.
.
.
Dermal
Toxicity
=
Toxicity
III.''
(
BPPD
Review
­
December
20,
1999).
 
Acute
inhalation
toxicity
in
rats.
``
The
inhalation
LC50
for
males,
females,
and
combined
was
>
0.93
mg/
L.
Toxicity
Category
III.''
(
Submission
No.:
S616797;
DP
Barcode:
283473;
MRID
No's.:
456725
 
01
and
456725
 
02)
(
hereinafter
referred
to
as
``
BPPD
Review
­
April
25,
2002'')
 
Acute
pulmonary
toxicity/
pathogenicity
in
rats.
``.
.
.
does
not
appear
to
be
toxic
and/
or
pathogenic
in
rats,
when
dosed
at
1.3
x
108
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
108
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
1010
cfu/
right
eye/
animal.''
(
BPPD
Review
­
December
20,
1999.)
The
December
20,
1999
BPPD
review
indicated
Toxicity
Category
I,
but
was
amended
in
a
March
7,
2000
review
to
Toxicity
Category
II
based
on
a
comparison
of
test
animals
showing
similar
recovery
trends
and
leading
to
reversibility
within
21
days.
Addendum
to
Toxicity
Category
for
TAE
 
022,
which
contains
Bacillus
subtilis
var.
amyloliquefaciens
Strain
FZB24
(
Submission
No.:
S559221;
DP
Barcode:
254584;
MRID
No.:
447581
 
14).
 
Primary
dermal
irritation.
``.
.
.
severity
of
irritations
persisted
>
72
hours,
but
resolved
by
day
11.
Dermal
irritation
=
Toxicity
II.''
(
BPPD
Review
­
December
20,
1999).
 
Hypersensitivity
testing.
``
Based
on
the
submitted
data
.
.
.
does
not
appear
to
be
a
sensitizer
when
dosed
at
3.6
x
1010
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).
 
Immune
response.
``
There
is
no
information
to
suggest
that
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
has
an
effect
on
the
immune
system.
The
submitted
toxicity/
pathogenicity
studies
in
rodents
indicated
that
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.''
(
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
°
C).
The
enumeration
shows
a
low
4.2
x
1011
cfu/
g
at
37
°
C
to
a
high
6.0
x
1011
cfu/
g
at
34
°
C.''
(
BPPD
Review
­
December
20,
1999).
ii.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
WDG
(
Formulation):
 
Acute
oral
LD50
toxicity
in
rats.
``
Toxic/
limit
dose
.
.
.
is
greater
than
2.8
g/
kg
body
weight
(
6.7
x
1010
cfu/
kg).
.
.
Toxicity
Category
III.''
(
BPPD
Review
­
December
20,
1999).
 
Acute
dermal
LD50
toxicity
in
rats.
``
The
severity
of
irritation
persisted
>
72
hours,
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
lethal
concentration
(
LC50)
toxicity
in
rats
(
Formulation).
``.
.
.
an
acute
inhalation
medium
(
LC50)
in
male
and
female
rats
is
greater
than
0.93
mg/
L
.
.
.
Toxicity
Category
III.''
(
BPPD
Review
­
April
25,
2002)
 
Primary
eye
irritation.
``
No
corneal
opacity,
and
no
signs
of
irritation
by
day
7,
when
dosed
.
.
.
at
3.6
x
1010
cfu/
right
eye/
animal.
.
.
.
Toxicity
Category
III.''
(
BPPD
Review
­
December
20,
1999).
 
Hypersensitivity.
``
Not
a
sensitizer
when
dosed
at
3.6
x
1010
cfu.
No
hypersensitivity
incidents
have
been
reported.''
(
BPPD
Review
­
December
20,
1999).
Based
on
the
data
generated
in
accordance
with
the
Tier
I
data
requirements
set
forth
in
40
CFR
158.740(
c),
the
Tier
II
and
Tier
III
data
requirements
were
not
triggered
and,
therefore,
not
required
in
connection
with
this
action.

IV.
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
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally­
occurring
microorganism
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
in
this
action.
The
end­
use
(
formulated)
product
will
be
applied
to
all
agricultural
commodities
as
a
seed
treatment
and
via
incorporation,
drenching,
spraying,
dipping,
chemigation
and
hydroponics.
1.
Food.
While
the
proposed
use
pattern
may
result
in
dietary
exposure
with
possible
residues
on
all
agricultural
commodities,
negligible
risk
is
expected
for
the
general
population,
as
well
as
for
infants
and
children.
Submitted
acute
toxicology
tests
(
MRID
Numbers
447581
 
08,
447581
 
09,
447581
 
10,
447581
 
11,
447581
 
12,
447581
 
13,
447581
 
14,
447581
 
16,
and
456725
 
02)
demonstrate
that
based
upon
the
use
sites,
use
patterns,
application
method,
use
rates,
low
exposure,
and
minimal
risk
of
toxicity,
the
potential
risks
from
dietary
exposure
for
both
the
general
population
and
infants
and
children
are
considered
low.
2.
Drinking
water
exposure.
Although
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
spores
may
be
found
naturally
in
water,
it
is
not
known
as
an
aquatic
bacterium,
and
therefore
is
not
expected
to
proliferate
in
aquatic
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/
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/
Rules
and
Regulations
habitats.
(
Earth
BioSciences
petition
from
the
requirement
of
a
tolerance
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24,
dated
May
3,
2002.)
In
addition,
the
potential
for
transfer
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
to
surface
or
ground
water
during
run­
off
associated
with
intended
use
applications
is
considered
minimal
to
non­
existent,
due
in
part
to
its
percolation
through
and
resulting
capture
in
soil.
Most
importantly,
though,
the
risk
from
consumption
of
drinking
water
containing
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
considered
minimal
as
there
is
no
evidence
of
adverse
effects
from
oral,
dermal,
or
inhalation
exposure
to
this
microbial
agent.
(
See
Unit
III.)
Accordingly,
it
is
not
considered
to
be
a
risk
to
drinking
water.

B.
Other
Non­
Occupational
Exposure
Based
on
the
proposed
use
patterns,
the
potential
of
non­
dietary
exposures
to
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
pesticide
residues
for
the
general
population,
including
infants
and
children,
is
unlikely.
Accordingly,
the
Agency
believes
that
the
potential
aggregate
non­
occupational
exposure,
derived
from
dermal
and
inhalation
exposure
through
the
application
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24,
should
fall
well
below
the
currently
tested
microbial
safety
levels.
(
MRID
Numbers
447581
 
10,
447581
 
11,
447581
 
12,
and
456725
 
02).
1.
Dermal
exposure.
Dermal
exposure
via
the
skin
is
a
potential
route
of
exposure
resulting
from
applications
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
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.
Acute
dermal
toxicity/
pathogenicity
data
resulted
in
irritation
that
persisted
72
hours,
and
slight
irritation
persisted
for
10
days,
and
all
resolved
by
day
11.
No
deaths
were
observed.
The
acute
lethal
dose
(
LD50)
is
greater
than
2,000
mg/
kg.
(
BPPD
Review
­
December
20,
1999).
Accordingly,
the
risks
anticipated
for
this
route
of
exposure
are
considered
minimal.
2.
Inhalation
exposure.
Inhalation
would
be
an
additional
potential
route
of
exposure
resulting
from
applications
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
However,
because
the
pulmonary
study
showed
no
adverse
effects
(
MRID
Numbers
447581
 
12
and
456725
 
02)
the
risks
anticipated
for
this
route
of
exposure
are
considered
minimal.

V.
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
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24,
the
Agency
is
confident
that
there
will
not
be
cumulative
effects
from
the
residues
of
this
product
on
all
agricultural
commodities.
(
See
Unit
III.)

VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
1.
U.
S.
population.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism
and
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment.
Based
on
the
very
low
levels
of
mammalian
toxicity
associated
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24,
which
is
demonstrated
by
the
data
summarized
above,
and
the
history
of
safe
use
of
B.
subtilis,
the
Agency
has
concluded
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
to
the
U.
S.
population.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
Accordingly,
exempting
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
from
the
requirement
of
a
tolerance
should
be
considered
safe
and
pose
no
significant
risk.
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
data
base
on
toxicity
and
exposure
unless
EPA
determines
that
a
different
margin
of
exposure
(
safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(
safety)
are
incorporated
into
EPA
risk
assessments
either
directly
through
the
use
of
a
margin
of
exposure
analysis
or
by
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
Here,
EPA
concludes
that
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
and
that
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.
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
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
appropriate
and
adequate
to
protect
human
health,
including
that
of
infants
and
children.

VII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
is
required
under
section
408(
p)
of
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
scientific
basis
for
including,
as
part
of
the
screening
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
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
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
subtilis
var.
amyloliquefaciens
strain
FZB24
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
subtilis
var.
amyloliquefaciens
strain
FZB24.
It
is
a
naturally
occurring
bacteria
that
is
widespread
in
the
environment.
To
date,
there
is
no
evidence
to
suggest
that
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
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Vol.
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146
/
Wednesday,
July
30,
2003
/
Rules
and
Regulations
affects
the
immune
system,
functions
in
a
manner
similar
to
any
known
hormone,
or
that
it
acts
as
an
endocrine
disruptor.

B.
Analytical
Method
The
Agency
proposes
to
establish
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation
for
the
reasons
stated
above,
including
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24'
s
lack
of
mammalian
toxicity.
For
the
same
reasons,
the
Agency
has
concluded
that
an
analytical
method
is
not
required
for
enforcement
purpose
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.

C.
Codex
Maximum
Residue
Level
There
are
no
Codex
maximum
residue
levels
established
for
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.

VIII.
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
written
objections
and
hearing
requests
with
the
Hearing
Clerk
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
 
2003
 
0059
in
the
subject
line
on
the
first
page
of
your
submission.
All
objections
and
hearing
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
September
29,
2003.
1.
Filing
the
request.
Your
objections
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
phone
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
 
2003
 
0059,
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
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).

IX.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
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
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68,
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146
/
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July
30,
2003
/
Rules
and
Regulations
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
from
the
tolerance
requirement
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.

X.
Congressional
Review
Act
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:
June
20,
2003.

James
Jones,

Director,
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
371.


2.
Section
180.1243
is
added
to
subpart
D
to
read
as
follows:

§
180.1243
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24;
exemption
from
the
requirement
of
a
tolerance.

An
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
in
or
on
all
agricultural
commodities
when
applied/
used
in
accordance
with
label
directions.
[
FR
Doc.
03
 
19134
Filed
7
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0246;
FRL
 
7319
 
6]

Boscalid;
3­
pyridinecarboxamide,
2­
chloro­
N­(
4'­
chloro[
1,1'­
biphenyl]­
2­
yl);
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
boscalid,
3­
pyridinecarboxamide,
2­
chloro­
N­(
4'­
chloro[
1,1'­
biphenyl]­
2­
yl)
in
or
on
certain
commodities
and
establishes
a
tolerance
for
the
combined
residues
of
boscalid,
3­
pyridinecarboxamide,
2­
chloro­
N­(
4'­
chloro[
1,1'­
biphenyl]­
2­
yl)
and
its
metabolites
2­
chloro­
N­(
4'­
chloro­
5­
hydroxy­
biphenyl­
2­
yl)
nicotinamide
and
the
glucuronic
acid
conjugate
of
2­
chloro­
N­(
4'­
chloro­
5­
hydroxy­
biphenyl­
2­
yl)
nicotinamide
in
or
on
certain
commodities.
BASF
Corporation
requested
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
July
30,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0246,
must
be
received
on
or
before
September
29,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Cynthia
Giles­
Parker,
Registration
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