Document ID: EPA-HQ-OPPT-2002-0041-0001
Agency: epa
Document Type: Rule
Title: Burkholderia Cepacia Complex; Significant New Use Rule
Posted Date: 2003-06-13T04:00Z

35315
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
Commodity
Parts
per
million
Vegetable,
root
and
tuber,
group
1,
except
sugar
beet
...................
0.40
*
*
*
*
*

Watercress
......................
3.5
Wax
jambu
......................
1.0
*
*
*
*
*

1
There
are
no
U.
S.
registration
as
of
June
13,
2003
for
use
on
banana.

*
*
*
*
*
[
FR
Doc.
03
 
14880
Filed
6
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
725
[
OPPT
 
2002
 
0041;
FRL
 
7200
 
3]

RIN
2070
 
AD43
Burkholderia
Cepacia
Complex;
Significant
New
Use
Rule
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
EPA
is
issuing
a
significant
new
use
rule
(
SNUR)
under
section
5(
a)(
2)
of
the
Toxic
Substances
Control
Act
(
TSCA)
for
Burkholderia
cepacia
complex
(
Bcc),
a
group
of
naturallyoccurring
microorganisms.
Bcc
microorganisms,
when
encountered
in
sufficient
numbers
through
an
appropriate
route
of
exposure
by
a
member
of
a
sensitive
population,
such
as
a
cystic
fibrosis
(
CF)
patient,
have
the
potential
to
cause
a
severe
infection,
resulting
in
significantly
increased
rates
of
mortality.
This
rule
would
require
persons
who
intend
to
manufacture,
import,
or
process
any
individual
member
of
Bcc
for
a
significant
new
use
to
notify
EPA
at
least
90
days
before
commencing
the
manufacturing
(
including
import)
or
processing
of
Bcc
for
a
use
designated
by
this
SNUR
as
a
significant
new
use.
The
required
notice
would
provide
EPA
with
the
opportunity
to
evaluate
the
intended
new
use
and
associated
activities
and,
if
necessary,
to
prohibit
or
limit
that
activity
before
it
occurs.
DATES:
This
final
rule
is
effective
on
August
12,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
James
Alwood,
Chemical
Control
Division,
Office
of
Pollution
Prevention
and
Toxics
(
7405M),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8974;
e­
mail
address:
alwood.
jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
manufacture
(
including
import),
process,
or
use
products
that
contain
living
microorganisms
subject
to
jurisdiction
under
TSCA,
especially
if
you
know
that
your
products
contain
or
may
contain
members
of
Bcc.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Chemical
manufacturers
(
NAICS
325),
e.
g.,
Persons
manufacturing,
importing,
or
processing
products
for
commercial
purposes
containing
Bcc
for
biofertilizers;
biosensors;
biotechnology
reagents;
commodity
or
specialty
chemical
production;
energy
applications;
and
other
TSCA
uses.
 
Waste
management
and
remediation
(
NAICS
562),
e.
g.,
Waste
treatment
or
pollutant
degradation.
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
list
of
substances
excluded
by
TSCA
section
(
3)(
2)(
B),
and
the
applicability
provisions
in
40
CFR
725.105(
c)
for
SNUR
related
obligations.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPPT
 
2002
 
0041.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
Docket
Center,
Rm.
B102­
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(
202)
566
 
0280.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
The
OPPTS
harmonized
test
guideline
referenced
in
this
document
is
available
at
http:/
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
A
frequently
updated
electronic
version
of
40
CFR
part
725
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr725_
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.
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
identification
number.

II.
Background
A.
What
Action
is
the
Agency
Taking?

This
SNUR
will
require
persons
to
notify
EPA
at
least
90
days
before
commencing
the
manufacture,
import,
or
processing
of
any
member
of
Bcc,
a
group
of
naturally
occurring
microorganisms,
for
any
use
other
than
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater.

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35316
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
B.
What
is
the
Agency's
Authority
for
Taking
this
Action?

TSCA
section
5(
a)(
2)
authorizes
EPA
to
determine
that
a
use
of
a
chemical
substance
is
a
``
significant
new
use.''
See
also,
40
CFR
part
725,
subparts
L
 
M.
EPA
must
make
this
determination
by
rule
after
considering
all
relevant
factors,
including
those
listed
in
section
5(
a)(
2)
of
TSCA.
Section
5(
a)(
2)
of
TSCA
lists
the
following
as
potentially
relevant
factors
for
EPA
to
consider:
(
A)
the
projected
volume
of
manufacturing
and
processing
of
a
chemical
substance,
(
B)
the
extent
to
which
a
use
changes
the
type
or
form
of
exposure
to
human
beings
or
the
environment
to
a
chemical
substance,
(
C)
the
extent
to
which
a
use
increases
the
magnitude
and
duration
of
exposure
of
human
beings
or
the
environment
to
a
chemical
substance,
and
(
D)
the
reasonably
anticipated
manner
and
methods
of
manufacturing,
processing,
distribution
in
commerce,
and
disposal
of
a
chemical
substance.

Once
EPA
promulgates
a
rule
designating
``
significant
new
uses''
for
a
given
chemical
substance,
section
5(
a)(
1)(
B)
of
TSCA
requires
persons
to
submit
a
notice
to
EPA
at
least
90
days
before
they
manufacture,
import,
or
process
the
substance
for
that
use.
The
mechanism
for
reporting
under
this
requirement
is
established
under
40
CFR
725.105(
c).
EPA
has
interpreted
the
TSCA
section
3(
2)
definition
of
``
chemical
substance
''
as
authorizing
EPA
to
regulate
microorganisms
under
TSCA.
See
the
Federal
Register
of
April
11,
1997
(
62
FR
17910
and
17913)
(
FRL
 
5577
 
2).
Microorganisms
that
are
not
intergeneric
are
implicitly
included
on
the
TSCA
Inventory,
which
would
include
naturally­
occurring
microorganisms
such
as
Bcc
(
40
CFR
725.8(
b)).
Thus,
such
microorganisms
are
only
subject
to
TSCA
section
5
notification
requirements
upon
promulgation
of
a
SNUR,
pursuant
to
TSCA
section
5(
a)(
2).

C.
Which
General
Provisions
Apply?

General
provisions
for
SNURs
appear
under
subpart
L
of
40
CFR
part
725.
These
provisions
describe
persons
subject
to
the
rule,
recordkeeping
requirements,
exemptions
to
reporting
requirements,
and
applicability
of
the
rule
to
uses
occurring
before
the
effective
date
of
the
final
rule.
Provisions
relating
to
user
fees
appear
at
40
CFR
part
700.
Persons
subject
to
this
SNUR
must
comply
with
the
same
notice
requirements
and
EPA
regulatory
procedures
as
submitters
of
Microbial
Commercial
Activity
Notices
(
MCANs)
or
TSCA
Experimental
Release
Applications(
TERAs)
under
section
5(
a)(
1)(
A)
of
TSCA.
In
particular,
these
requirements
include
the
information
submission
requirements
of
TSCA
section
5(
b)
and
5(
d)(
1),
the
conditions
necessary
to
qualify
for
the
exemptions
under
TSCA
section
5(
h)(
1),
(
h)(
2),
(
h)(
3),
and
(
h)(
5),
as
codified
in
the
regulations
at
40
CFR
part
725.
In
contrast
to
the
provisions
of
40
CFR
part
721,
under
40
CFR
part
725,
EPA
has
adopted
a
narrow
interpretation
of
the
TSCA
section
5(
h)(
3)
exemption
for
small
quantities
used
in
research.
Under
40
CFR
725.3,
EPA
has
defined
small
quantities
solely
for
research
and
development
as
``
quantities
of
a
microorganism
manufactured,
imported,
or
processed
or
proposed
to
be
manufactured,
imported,
or
processed
solely
for
research
and
development
that
meet
the
requirements
of
§
725.234.''
Any
other
research
and
development
activity
of
a
microorganism
subject
to
a
SNUR
must
comply
with
the
section
5(
a)(
1)(
A)
notification
requirements
unless
that
activity
has
been
excluded
from
coverage
under
the
SNUR.
See
40
CFR
725.3,
subparts
E
and
F
of
40
CFR
part
725,
and
the
Federal
Register
of
April
11,
1997
(
62
FR
17921
 
17926).
Once
EPA
receives
an
MCAN
or
TERA,
EPA
may
take
regulatory
action
under
TSCA
section
5(
e),
5(
f),
6,
or
7
to
control
the
activities
on
which
it
has
received
the
MCAN
or
TERA.
If
EPA
does
not
take
action,
EPA
is
required
under
TSCA
section
5(
g)
to
explain
in
the
Federal
Register
its
reasons
for
not
taking
action.
Persons
who
intend
to
export
a
substance
identified
in
a
proposed
or
final
SNUR
are
subject
to
the
export
notification
provisions
of
TSCA
section
12(
b).
The
regulations
that
interpret
TSCA
section
12(
b)
appear
at
40
CFR
part
707.
Persons
who
intend
to
import
a
chemical
substance
identified
in
a
final
SNUR
are
subject
to
the
TSCA
section
13
import
certification
requirements,
which
are
codified
at
19
CFR
12.118
through
12.127
and
127.28.
Such
persons
must
certify
that
they
are
in
compliance
with
SNUR
requirements.
The
EPA
policy
addressing
the
import
certification
appears
at
40
CFR
part
707.

III.
Summary
of
the
Final
Rule
A.
Final
Rule
On
July
31,
2001,
the
Cystic
Fibrosis
Foundation
(
CFF)
submitted
a
petition
under
section
21
of
TSCA
which
requested
EPA
to
``
establish
regulations
prohibiting
the
manufacture,
processing,
distribution
in
commerce,
use,
and
improper
disposal
of
bacterial
species
within
the
Burkholderia
cepacia
complex.''
On
November
6,
2001
(
66
FR
56105)
(
FRL
 
6808
 
7),
EPA
published
in
the
Federal
Register
a
notice
denying
that
petition.
EPA
also
stated
in
the
notice
that
it
intended
to
issue
a
SNUR
for
Bcc.
On
January
9,
2002
(
67
FR
1179)
(
FRL
 
6809
 
2)
EPA
proposed
a
SNUR
for
Bcc,
where
the
significant
new
use
for
Bcc
was
designated
as
any
use
other
than
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater.
EPA
received
comments
regarding
the
proposed
SNUR
only
from
CFF.
EPA's
response
to
those
comments
is
contained
in
the
next
paragraph.
No
one
identified
any
other
ongoing
commercial
uses
of
Bcc
other
than
those
identified
by
EPA.
In
addition,
no
new
data
were
submitted
or
identified
that
would
change
EPA's
findings
regarding
the
SNUR
for
Bcc.
Therefore,
EPA
is
issuing
the
SNUR
as
proposed.
This
final
rule
requires
persons
who
intend
to
manufacture,
import,
or
process
Bcc
for
any
use
other
than
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater
notify
EPA
at
least
90
days
before
commencing
such
activity.

B.
Response
to
Comments
As
noted
earlier,
the
only
comments
submitted
on
the
proposed
SNUR
were
from
CFF.
CFF
did
not
challenge
or
object
to
any
of
the
provisions
proposed
by
the
Agency
in
the
proposed
SNUR,
but
instead
suggested
that
the
final
rule
should
be
expanded
beyond
what
was
proposed
in
two
ways.
First,
CFF
stated
that
EPA
should
designate
as
a
significant
new
use
all
research
and
development
activities
that
result
in
potential
environmental
release
of
Bcc.
Second,
CFF
stated
that
EPA
should
require
manufacturers
of
microoganisms
that
may
contain
Bcc
to
test
their
products
for
the
presence
of
Bcc.
Leaving
aside
the
fact
that
these
comments
go
beyond
the
scope
of
the
proposed
SNUR,
the
changes
proposed
by
CFF
are
not
appropriate
for
inclusion
in
a
Significant
New
Use
Rule
under
section
5
of
TSCA.
As
to
CFF's
first
comment,
CFF
asks
the
Agency
to
require
notification
even
for
``
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater.''
In
the
proposed
SNUR,
EPA
identified
``
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater''
as
an
existing
use.
CFF
did
not
present
any
information
to
suggest
that
this
particular
use
is
not
an
existing
use,
or
that
new
research
and
development
activities
would
be
significantly
different
in
kind
or
quantity
than
existing
activities.
Under
the
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Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
circumstances,
the
Agency
continues
to
believe
that
the
particular
research
and
development
activities
excluded
from
the
proposed
SNUR
constitute
an
ongoing
use
of
Bcc,
and
therefore
do
not
constitute
a
``
significant
new
use''
for
purposes
of
section
5(
a)(
2)
of
TSCA.
Only
significant
new
uses
may
be
included
in
a
Significant
New
Use
Rule.
As
to
CFF's
request
that
the
SNUR
require
manufacturers
of
microorganisms
to
test
their
products
to
determine
whether
they
contain
Bcc.
EPA
concurs
that
manufacturers
of
microorganisms
are
responsible
for
knowing
whether
their
products
contain
Bcc
and
EPA
encourages
manufacturers
to
test
their
products
if
they
are
uncertain
whether
the
products
contain
Bcc.
EPA's
regulations
exempt
``
chemical''
impurities
from
SNUR
reporting
requirements
(
40
CFR
721.45(
d)),
but
those
regulations
do
not
provide
a
similar
exemption
for
``
microorganisms''
produced
as
impurities
(
see
40
CFR
725.912).
When
this
SNUR
becomes
a
final
effective
rule,
all
commercial
uses
of
Bcc,
except
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater,
will
require
notification
to
EPA
at
least
90
days
before
commencing
the
manufacturing
(
including
import)
or
processing
of
Bcc.
Any
manufacturer,
importer,
or
processor
of
microorganisms
that
actually
contain
Bcc,
even
if
the
Bcc
is
present
unintentionally
as
an
impurity,
will
be
required
to
submit
a
notification
before
commencing
activities
subject
to
this
final
SNUR.
However,
the
Agency
does
not
believe
that
a
requirement
to
test
products
is
appropriate
for
inclusion
in
a
SNUR
under
section
5
of
TSCA.
If
a
manufacturer,
importer,
or
processor
does
decide
to
test
its
products,
the
Agency
encourages
conformity
with
OPPTS
Product
Analysis
Test
Guideline
885.1100
for
product
identity.
Because
identification
of
members
of
the
Bcc
may
be
difficult
due
to
complexities
of
the
taxonomy
of
this
group,
EPA
believes
it
advisable
to
consult
experts
in
this
matter
prior
to
testing.
EPA
encourages
any
manufacturer,
importer,
or
processor
considering
such
testing
to
consult
the
Agency
for
further
guidance
or
questions.

IV.
Objectives
and
Rationale
of
the
Rule
In
determining
what
would
constitute
a
significant
new
use
for
the
microorganisms
that
are
the
subject
of
this
SNUR,
EPA
considered
relevant
information
on
the
toxicity
of
the
microorganisms,
likely
exposures
associated
with
potential
uses,
information
provided
by
industry
sources,
and
the
relevant
factors
listed
in
TSCA
section
5(
a)(
2)
and
Unit
II.
B.
Based
on
these
considerations,
EPA
has
determined
that
all
uses
other
than
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater,
are
significant
new
uses.
EPA's
considerations
under
each
of
the
relevant
factors
are
discussed
below:
1.
Projected
volume
of
manufacturing
and
processing
of
a
chemical
substance.
At
present
there
is
little
manufacturing
and
processing
of
Bcc,
so
almost
all
exposure
to
Bcc
today
is
from
its
presence
in
the
natural
environment.
Any
new
use
of
Bcc
could
result
in
a
significant
increase
in
manufacturing
and
processing
of
the
compound,
and
of
exposure
to
it.
Microorganisms
may
reproduce
and
increase
beyond
the
number
initially
introduced
and
may
spread
beyond
the
site
of
manufacture
or
processing.
Thus,
what
begins
as
a
small
localized
population
of
microorganisms
may
become
a
large
widespread
population
which
could
contribute
to
increased
exposure
potential
for
Bcc
beyond
that
which
occurs
naturally.
These
facts
complicate
the
Agency's
ability
to
project
the
potential
volume
and
processing
of
Bcc.
However,
Bcc
is
typically
found
in
the
environment
in
soils
at
a
concentration
of
102
to
104
colony
forming
units
(
cfu)/
g.
Manufacture
of
Bcc
would
result
in
production
of
batches
of
1016
cfu
of
Bcc.
Depending
on
the
type
and
duration
of
use
these
batches
could
be
even
larger.
(
See
Reference
16,
67
FR
1185,
January
9,
2002
(
FRL
 
6809
 
2))
2.
Extent
to
which
a
use
changes
the
type
or
form
of
exposure
to
human
beings
or
the
environment
to
a
chemical
substance.
Currently,
human
beings
are
exposed
to
Bcc
because
of
its
presence
in
soil,
where
it
is
found
at
concentrations
significantly
lower
than
might
be
seen
if
it
is
cultivated
for
commercial
use.
In
addition
to
the
fact
that
these
uses
would
likely
involve
much
higher
concentrations
of
Bcc
than
are
naturally
found
in
the
environment,
some
of
the
potential
uses
identified
for
Bcc,
including
bioremediation
(
degradation
of
toxic
chemicals),
degradation
of
grease
in
drains,
turf
management,
and
specialty
chemicals
production,
could
also
significantly
increase
direct
dermal
and
inhalation
exposures
of
Bcc
to
human
beings
and
release
of
Bcc
to
the
environment.
(
See
Reference
16,
67
FR
1185,
January
9,
2002).
This
would
be
especially
true
for
individuals
involved
directly
in
or
near
the
manufacturing
or
application
of
formulations
containing
Bcc.
These
are
types
and
forms
of
exposures
to
which
human
beings
and
the
environment
are
exposed
on
a
limited
basis
during
field
studies
of
Bcc
in
the
biodegradation
of
chlorinated
solvents
in
groundwater.
3.
Extent
to
which
a
use
changes
the
magnitude
and
duration
of
exposure
to
human
beings
or
the
environment
to
a
chemical
substance.
Currently,
human
beings
are
exposed
to
Bcc
because
of
its
presence
in
soil,
where
it
is
found
at
concentrations
significantly
lower
than
might
be
seen
if
it
is
cultivated
for
commercial
use.
In
addition
to
the
fact
that
these
uses
would
likely
involve
much
higher
concentrations
of
Bcc
than
are
naturally
found
in
the
environment,
some
of
the
potential
uses
identified
for
Bcc,
including
bioremediation
(
degradation
of
toxic
chemicals),
degradation
of
grease
in
drains,
turf
management,
and
specialty
chemicals
production,
could
also
significantly
increase
direct
dermal
and
inhalation
exposures
of
Bcc
to
human
beings
and
release
of
Bcc
to
the
environment.
Releases
from
typical
manufacturing
could
result
in
releases
to
surface
waters
of
109
to
1013
cfu
in
water
and
105
cfu
in
the
air.
Inhalation
exposures
of
450
cfu
and
dermal
exposures
of
1011
cfu
to
exposed
workers
could
also
result
from
typical
manufacturing.
(
See
Reference
16,
67
FR
1185,
January
9,
2002)
Exposures
from
various
uses
would
be
the
same
or
higher
depending
on
the
method
of
application.
For
example,
if
spray­
applied,
the
potential
for
inhalation
exposure
would
be
higher
due
to
potential
inhalation
of
mist.
All
Bcc
produced
for
uses
such
as
bioremediation
(
degradation
of
toxic
chemicals),
degradation
of
grease
in
drains,
and
turf
management
would
eventually
be
released
to
the
environment.
New
uses
could
also
significantly
increase
the
duration
of
exposure.
Use
in
bioremediation
for
research
and
development
could
be
limited
to
a
few
days/
yr.
In
instances
where
manufacturing
and
application
of
formulations
containing
Bcc
are
repeated
or
continuous
this
increased
level
of
exposure
could
occur
on
a
daily
basis
throughout
the
year.
In
addition,
repeated
or
continuous
applications
of
formulations
containing
Bcc
at
the
same
location
would
increase
the
likelihood
that
a
small
localized
population
could
become
a
larger
and
more
widespread
population.
All
of
these
factors
would
contribute
to
a
change
in
the
magnitude
and
duration
of
exposure
to
which
human
beings
and
the
environment
are
not
currently
exposed.
4.
The
reasonably
anticipated
manner
and
methods
of
manufacturing,
processing,
distribution
in
commerce,
and
disposal
of
a
chemical
substance.
EPA
has
not
currently
identified
any
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13JNR1
35318
Federal
Register
/
Vol.
68,
No.
114
/
Friday,
June
13,
2003
/
Rules
and
Regulations
general
commercial
use
of
Bcc.
EPA
has
identified
field
studies
of
Bcc
in
the
biodegradation
of
chlorinated
solvents
in
groundwater.
(
See
Reference
15,
67
FR
1185,
January
9,
2002)
EPA
expects
only
limited
exposures
from
the
identified
field
studies
of
Bcc
as
only
technically
qualified
individuals
are
growing
and
injecting
Bcc
directly
into
groundwater.
Other
potential
uses
identified
for
Bcc
which
include
bioremediation
(
degradation
of
toxic
chemicals),
degradation
of
grease
in
drains,
turf
management,
and
specialty
chemicals
production,
could
significantly
increase
dermal
and
inhalation
exposures
of
Bcc
to
human
beings
as
well
as
releases
to
the
environment.
Currently,
there
are
no
exposures
to
human
beings
and
no
releases
to
the
environment
from
these
uses.
In
most
cases
these
exposures
would
be
higher
than
typically
found
in
nature
and
more
likely
to
be
encountered
by
a
member
of
a
sensitive
population.
EPA
wants
to
achieve
the
following
objectives
with
regard
to
the
significant
new
uses
that
are
designated
in
this
rule.
EPA
wants
to
ensure
that:
 
EPA
will
receive
notice
of
any
company's
intent
to
manufacture,
import,
or
process
Bcc
for
a
significant
new
use
before
that
activity
begins.
 
EPA
will
have
an
opportunity
to
review
and
evaluate
data
submitted
in
an
MCAN
or
TERA
before
the
notice
submitter
begins
manufacturing,
importing,
or
processing
Bcc
for
a
significant
new
use.
 
EPA
would
be
able
to
regulate
prospective
manufacturers,
importers,
or
processors
of
Bcc
before
a
significant
new
use
occurs,
provided
such
regulation
is
warranted
pursuant
to
TSCA
section
5(
e)
or
section
(
5)(
f).

V.
Alternatives
Before
issuing
this
SNUR,
EPA
considered
the
following
alternative
regulatory
actions
for
Bcc.
In
addition,
EPA
determined
that
Bcc
is
currently
not
subject
to
Federal
notification
requirements.
1.
Promulgate
a
TSCA
section
8(
a)
reporting
rule
for
Bcc.
Under
a
TSCA
section
8(
a)
rule,
EPA
could
require
any
person
to
report
information
to
the
Agency
when
they
intend
to
manufacture
or
import
Bcc.
However,
the
use
of
TSCA
section
8(
a)
rather
than
the
SNUR
authority,
would
not
provide
the
opportunity
for
EPA
to
review
human
and
environmental
hazards
and
exposures
associated
with
the
new
uses
of
these
substances
and,
if
necessary,
to
take
immediate
regulatory
action
under
TSCA
section
5(
e)
or
section
5(
f)
to
prohibit
or
limit
the
activity
before
it
begins.
In
addition,
EPA
may
not
receive
important
information
from
small
businesses,
because
those
firms
generally
are
exempt
from
TSCA
section
8(
a)
reporting
requirements.
In
view
of
EPA's
concerns
about
Bcc
and
its
interest
in
having
the
opportunity
to
review
these
substances
and
regulate
them
as
appropriate,
pending
the
development
of
exposure
and/
or
hazard
information
should
a
significant
new
use
be
initiated,
the
Agency
believes
that
a
TSCA
section
8(
a)
rule
for
Bcc
would
not
meet
all
of
EPA's
regulatory
objectives.
2.
Regulate
Bcc
under
TSCA
section
6.
EPA
must
regulate
under
TSCA
section
6
if
there
is
a
reasonable
basis
to
conclude
that
the
manufacture,
import,
processing,
distribution
in
commerce,
use,
or
disposal
of
a
chemical
substance
or
mixture
``
presents
or
will
present''
an
unreasonable
risk
of
injury
to
human
health
or
the
environment.
Based
on
EPA's
findings
that
there
is
currently
no
general
commercial
use
of
Bcc,
EPA
concluded
that
risk
management
action
under
TSCA
section
6
is
not
necessary
at
this
time.
This
SNUR
will
allow
the
Agency
to
address
the
potential
risks
associated
with
any
intended
significant
new
use
of
Bcc.

VI.
Test
Data
and
Other
Information
EPA
recognizes
that
section
5
of
TSCA
does
not
require
the
development
of
any
particular
test
data
before
submission
of
a
MCAN
or
TSCA
Experimental
Release
Application
(
TERA).
Persons
are
required
only
to
submit
test
data
in
their
possession
or
control
and
to
describe
any
other
data
known
to
or
reasonably
ascertainable
by
them
(
15
U.
S.
C.
2604(
d);
40
CFR
725.160).
However,
in
view
of
the
potential
health
risks
posed
by
the
significant
new
uses
of
Bcc,
EPA
requests
that
potential
MCAN
or
TERA
submitters
include
data
that
would
permit
a
reasoned
evaluation
of
risks
posed
by
Bcc
when
used
for
an
intended
significant
new
use.
EPA
also
requests
that
potential
MCAN
or
TERA
submitters
include
data
that
demonstrate
that
the
bacteria
which
would
be
the
subject
of
the
MCAN
or
TERA
are
in
fact
in
the
Bcc.
EPA
encourages
persons
to
consult
with
the
Agency
before
submitting
an
MCAN
or
TERA
for
Bcc.
As
part
of
this
optional
pre­
notice
consultation,
EPA
will
discuss
specific
data
it
believes
are
necessary
to
evaluate
a
significant
new
use
of
Bcc.
EPA
urges
MCAN
or
TERA
submitters
to
provide
detailed
information
on
human
and
environmental
exposures
that
would
result
or
could
reasonably
be
anticipated
to
result
from
the
significant
new
uses
of
Bcc.
In
addition,
EPA
encourages
persons
to
submit
information
on
risks
posed
by
Bcc
compared
to
risks
posed
by
possible
substitutes.
An
MCAN
or
TERA
submitted
without
sufficient
data
to
reasonably
evaluate
risks
posed
by
a
significant
new
use
of
Bcc
may
increase
the
likelihood
that
EPA
will
take
action
under
TSCA
section
5(
e).

VII.
Applicability
of
Rule
to
Uses
Occurring
Before
Effective
Date
of
the
Final
Rule
EPA
believes
that
the
intent
of
section
5(
a)(
1)(
B)
of
TSCA
is
best
served
by
designating
a
use
as
a
significant
new
use
as
of
the
proposal
date
of
the
SNUR,
rather
than
as
of
the
effective
date
of
the
final
rule.
If
uses
begun
after
publication
of
the
proposed
SNUR
were
considered
to
be
ongoing,
rather
than
new,
it
would
be
difficult
for
EPA
to
establish
notification
requirements,
because
any
person
could
defeat
the
SNUR
by
initiating
the
proposed
significant
new
use
before
the
proposed
rule
became
final,
and
then
argue
that
the
use
was
ongoing.
Any
person
who,
after
publication
of
the
proposed
SNUR,
began
commercial
manufacture,
import,
or
processing
of
Bcc,
for
the
significant
new
use
in
this
SNUR,
must
stop
such
activity
before
the
effective
date
of
the
final
rule.
To
resume
commercial
manufacture,
import
or
processing
of
Bcc,
those
persons
will
have
to
meet
all
applicable
MCAN
or
TERA
requirements
and
wait
until
the
notice
review
period,
including
all
extensions,
expires
before
engaging
in
any
commercial
manufacture,
import,
or
processing
of
Bcc
for
a
significant
new
use.
If,
however,
persons
who
began
commercial
manufacture
or
import
of
Bcc
for
a
significant
new
use
between
the
proposal
and
the
effective
date
of
the
final
SNUR
met
the
conditions
of
advance
compliance
as
codified
at
40
CFR
725.912,
those
persons
would
be
considered
to
have
met
the
requirements
of
the
final
SNUR
for
those
activities.

VIII.
Economic
Considerations
EPA
has
evaluated
the
potential
costs
of
establishing
a
SNUR
for
potential
manufacturers,
importers,
and
processors
of
Bcc.
These
potential
costs
are
related
to
the
submission
of
MCANs,
TERAs,
and
the
export
notification
requirements
of
TSCA
section
12(
b).
EPA
notes
that,
the
costs
of
submission
of
MCANs
or
TERAs
will
not
be
incurred
by
any
company
unless
that
company
decides
to
pursue
a
significant
new
use
as
defined
in
this
SNUR.
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114
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June
13,
2003
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Rules
and
Regulations
Agency's
economic
analysis
is
available
in
the
public
docket
for
this
rule.

A.
MCANs
and
TERAs
Because
of
uncertainties
related
to
predicting
the
number
of
MCANs
or
TERAs
that
will
be
submitted
as
a
result
of
this
SNUR,
EPA
is
unable
to
calculate
the
total
annual
cost
of
compliance
with
the
final
rule.
However,
EPA
estimates
that
the
cost
for
preparation
and
submission
of
an
MCAN
ranges
from
approximately
$
7,582
to
$
42,736,
which
includes
the
$
2,500
user
fee
required
by
the
Agency.
EPA
notes
that
small
businesses
with
annual
sales
of
less
than
$
40
million
are
subject
to
a
reduced
user
fee
of
$
100.
The
cost
of
a
TERA
is
estimated
to
range
from
$
6,905
to
$
73,562.
Based
on
past
experience
with
SNURs
and
the
low
number
of
Significant
New
Use
Notices
(
SNUNs)
which
are
submitted
on
an
annual
basis,
EPA
believes
that
there
would
be
few,
if
any,
MCANs
or
TERAs
submitted
as
a
result
of
this
SNUR.
Furthermore,
no
company
is
required
to
submit
an
MCAN
or
TERA
for
Bcc
unless
the
company
decides
to
begin
manufacture,
import,
or
processing
of
Bcc
for
any
use
other
than
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater.
As
a
result,
EPA
expects
that
companies
would
be
able
to
determine
if
the
burden
of
submitting
an
MCAN
or
TERA
would
be
likely
to
create
significant
adverse
economic
impacts
for
the
company
prior
to
incurring
MCAN/
TERA­
related
costs.

B.
Export
Notification
As
noted
in
Unit
II.
C.,
persons
who
intend
to
export
a
microorganism
identified
in
a
proposed
or
final
SNUR
are
subject
to
the
export
notification
provisions
of
TSCA
section
12(
b)
(
15
U.
S.
C.
2611(
b)).
These
provisions
require
that
a
company
notify
EPA
of
the
first
shipment
to
a
particular
country
of
an
affected
microorganism.
The
estimated
cost
of
the
TSCA
section
12(
b)(
1)
export
notification,
which
would
be
required
for
the
first
export
to
a
particular
country
of
a
microorganism
subject
to
this
rule,
is
estimated
to
be
$
158.35
for
the
first
time
that
an
exporter
must
comply
with
TSCA
section
12(
b)(
1)
export
notification
requirements,
and
$
14.43
for
each
subsequent
export
notification
submitted
by
that
exporter.
EPA
is
unable
to
estimate
the
total
number
of
TSCA
section
12(
b)
notifications
that
will
be
received
as
a
result
of
this
SNUR,
or
the
total
number
of
companies
that
will
file
these
notices.
However,
EPA
expects
that
the
total
cost
of
complying
with
the
export
notification
provisions
of
TSCA
section
12(
b)
will
be
limited
based
on
historical
experience
with
TSCA
section
12(
b)
notifications
and
the
fact
that
no
companies
have
currently
been
identified
that
currently
market
Bcc
commercially.
If
companies
were
to
manufacture
the
microorganisms
covered
by
this
SNUR
for
export
only,
these
companies
would
incur
costs
associated
with
export
notification
even
if
these
companies
decided
to
forgo
any
domestic
significant
new
use.
EPA
is
not
aware
of
any
companies
in
this
situation,
and
expects
that
any
potential
impact
would
be
limited
to
the
small
burden
of
export
notification.

IX.
Statutory
and
Executive
Order
Reviews
A.
Executive
Order
12866:
Regulatory
Planning
and
Review
Under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
the
Office
of
Management
and
Budget
(
OMB)
has
determined
that
SNURs
are
not
a
``
significant
regulatory
action''
subject
to
review
by
OMB,
because
they
do
not
meet
the
criteria
in
section
3(
f)
of
the
Executive
Order.

B.
Paperwork
Reduction
Act
According
to
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
an
Agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
that
requires
OMB
approval
under
the
PRA,
unless
it
has
been
approved
by
OMB
and
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
preamble
of
the
final
rule
and
in
addition
to
its
display
on
any
related
collection
instrument,
are
listed
40
CFR
part
9.
The
information
collection
requirements
related
to
this
action
have
already
been
approved
by
OMB
pursuant
to
the
PRA
under
OMB
control
number
2070
 
0012
(
EPA
ICR
No.
1188.06).
This
action
does
not
impose
any
burden
requiring
additional
OMB
approval.
If
an
entity
were
to
submit
an
MCAN
or
TERA
to
the
Agency,
the
annual
burden
is
estimated
to
average
between
98.96
and
118.92
hours
per
response
at
an
estimated
reporting
cost
between
$
5,957
and
$
7,192
per
MCAN.
This
burden
estimate
includes
the
time
needed
to
review
instructions,
search
existing
data
sources,
gather
and
maintain
the
data
needed,
and
complete,
review
and
submit
the
required
MCAN
or
TERA.
This
burden
estimate
does
not
include
the
$
2,500
user
fee
submission
of
an
MCAN
($
100
for
businesses
with
less
than
$
40
million
in
annual
sales).
Send
any
comments
about
the
accuracy
of
the
burden
estimate,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques,
to
the
Director,
OP
Regulatory
Information
Division
(
2137),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
Please
remember
to
include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
any
completed
forms
to
this
address.

C.
Regulatory
Flexibility
Act
Pursuant
to
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.),
the
Agency
hereby
certifies
that
promulgation
of
this
SNUR
will
not
have
a
significant
adverse
economic
impact
on
a
substantial
number
of
small
entities.
The
rationale
supporting
this
conclusion
is
as
follows.
A
SNUR
applies
to
any
person
(
including
small
or
large
entities)
who
intends
to
engage
in
any
activity
described
in
the
rule
as
a
``
significant
new
use.''
By
definition
of
the
word
``
new,''
and
based
on
all
information
currently
available
to
EPA,
it
appears
that
no
small
or
large
entities
presently
engage
in
such
activity.
Since
a
SNUR
only
requires
that
any
person
who
intends
to
engage
in
such
activity
in
the
future
must
first
notify
EPA
by
submitting
an
MCAN
or
TERA,
no
economic
impact
will
even
occur
until
someone
decides
to
engage
in
those
activities.
Although
some
small
entities
may
decide
to
conduct
such
activities
in
the
future,
EPA
cannot
presently
determine
how
many,
if
any,
there
may
be.
However,
EPA's
experience
to
date
is
that,
in
response
to
the
promulgation
of
over
1000
SNURs,
the
Agency
receives
fewer
than
10
SNUNs
per
year.
Of
those
SNUNs
submitted,
none
appear
to
be
from
small
entities
in
response
to
any
SNUR.
In
addition,
the
estimated
reporting
cost
for
submission
of
an
MCAN
or
TERA
(
see
Unit
VIII.
A.)
are
minimal
regardless
of
the
size
of
the
firm.
Therefore,
EPA
believes
that
the
potential
economic
impact
of
complying
with
this
SNUR
is
not
expected
to
be
significant
or
adversely
impact
a
substantial
number
of
small
entities.
This
rationale
has
been
provided
to
the
Chief
Counsel
for
Advocacy
of
the
Small
Business
Administration.

D.
Unfunded
Mandates
Reform
Act
Based
on
EPA's
experience
with
SNURs,
State,
local,
and
tribal
governments
have
not
been
impacted
by
these
rulemakings,
and
EPA
does
not
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13,
2003
/
Rules
and
Regulations
have
any
reasons
to
believe
that
any
State,
local,
or
tribal
government
will
be
impacted
by
this
rulemaking.
As
such,
EPA
has
determined
that
this
regulatory
action
does
not
impose
any
enforceable
duty,
contain
any
unfunded
mandate,
or
otherwise
have
any
effect
on
small
governments
subject
to
the
requirements
of
sections
202,
203,
204,
or
205
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).

E.
Executive
Order
13132:
Federalism
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).

F.
Executive
Order
13175:
Consultation
and
Coordination
with
Indian
Tribal
Governments
This
rule
does
not
have
tribal
implications
because
it
is
not
expected
to
have
substantial
direct
effects
on
Indian
Tribes.
This
does
not
significantly
or
uniquely
affect
the
communities
of
Indian
tribal
governments,
nor
does
it
involve
or
impose
any
requirements
that
affect
Indian
Tribes.
Accordingly,
the
requirements
of
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000),
which
took
effect
on
January
6,
2001
do
not
apply
to
this
rule.

G.
Executive
Order
13045:
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
This
action
is
not
subject
to
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997),
because
this
is
not
an
economically
significant
regulatory
action
as
defined
by
Executive
Order
12866,
and
this
action
does
not
address
environmental
health
or
safety
risks
disproportionately
affecting
children.

H.
Executive
Order
13211:
Actions
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
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)
because
it
is
not
a
significant
regulatory
action
under
Executive
Order
12866.

I.
National
Technology
Transfer
Advancement
Act
In
addition,
since
this
action
does
not
involve
any
technical
standards,
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),
does
not
apply
to
this
action.

J.
Executive
Order
12898:
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
This
action
does
not
entail
special
considerations
of
environmental
justice
related
issues
as
delineated
by
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994).

K.
Executive
Order
12630:
Governmental
Actions
and
Interference
with
Constitutionally
Protected
Property
Rights
EPA
has
complied
with
Executive
Order
12630,
entitled
Governmental
Actions
and
Interference
with
Constitutionally
Protected
Property
Rights
(
53
FR
8859,
March
15,
1988),
by
examining
the
takings
implications
of
this
rule
in
accordance
with
the
``
Attorney
General's
Supplemental
Guidelines
for
the
Evaluation
of
Risk
and
Avoidance
of
Unanticipated
Takings''
issued
under
the
Executive
Order.

L.
Executive
Order
12988:
Civil
Justice
Reform
In
issuing
this
rule,
EPA
has
taken
the
necessary
steps
to
eliminate
drafting
errors
and
ambiguity,
minimize
potential
litigation,
and
provide
a
clear
legal
standard
for
affected
conduct,
as
required
by
section
3
of
Executive
Order
12988,
entitled
Civil
Justice
Reform
(
61
FR
4729,
February
7,
1996).

M.
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
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.
This
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
725
Environmental
protection,
Chemicals,
Hazardous
substances,
Reporting
and
recordkeeping
requirements.

Dated:
June
6,
2003.
Charles
M.
Auer,
Director,
Office
of
Pollution
Prevention
and
Toxics.


Therefore,
40
CFR
part
725
is
amended
as
follows:

PART
725
 
[
AMENDED]


1.
The
authority
citation
for
part
725
continues
to
read
as
follows:

Authority:
15
U.
S.
C.
2604,
2607,
2613,
and
2625.


2.
By
adding
new
§
725.1075
to
subpart
M
to
read
as
follows:

§
725.1075
Burkholderia
cepacia
complex.

(
a)
Microorganism
and
significant
new
uses
subject
to
reporting.
(
1)
The
microorganisms
identified
as
the
Burkholderia
cepacia
complex
defined
as
containing
the
following
nine
species,
Burkholderia
cepacia,
Burkholderia
multivorans,
Burkholderia
stabilis,
Burkholderia
vietnamiensis,
Burkholderia
ambifaria,
Burkholderia
pyrrocinia,
Burkholderia
cepacia
genomovar
VIII
(
Burkholderia
anthina),
and
Burkholderia
cepacia
genomovars
III
and
VI
are
subject
to
reporting
under
this
section
for
the
significant
new
uses
described
in
paragraph
(
a)(
2)
of
this
section.
(
2)
The
significant
new
use
is
any
use
other
than
research
and
development
in
the
degradation
of
chemicals
via
injection
into
subsurface
groundwater.
(
b)
[
Reserved]

[
FR
Doc.
03
 
15010
Filed
6
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
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