Document ID: EPA-HQ-OAR-2002-0095-0001
Agency: epa
Document Type: Rule
Title: Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2003; Final Rule
Posted Date: 2002-12-27T05:00Z

Friday,

December
27,
2002
Part
X
Environmental
Protection
Agency
40
CFR
Part
82
Protection
of
Stratospheric
Ozone:
Allocation
of
Essential
Use
Allowances
for
Calendar
Year
2003;
Final
Rule
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27,
2002
/
Rules
and
Regulations
1
``
Consumption''
is
defined
as
the
amount
of
a
substance
produced
in
the
United
States,
plus
the
amount
imported
into
the
United
States,
minus
the
amount
exported
to
Parties
to
the
Montreal
Protocol
(
see
section
601(
6)
of
the
Clean
Air
Act).
Stockpiles
of
class
I
ODSs
produced
or
imported
prior
to
the
1996
phase
out
may
be
used
for
purposes
not
expressly
banned
at
40
CFR
part
82.
2
Class
I
ozone
depleting
substances
are
listed
at
40
CFR
part
82,
subpart
A,
appendix
A.
3
According
to
section
614(
b)
of
the
Act,
Title
VI
``
shall
be
construed,
interpreted,
and
applied
as
a
supplement
to
the
terms
and
conditions
of
the
Montreal
Protocol
*
*
*
and
shall
not
be
construed,
interpreted,
or
applied
to
abrogate
the
responsibilities
or
obligations
of
the
United
States
to
implement
fully
the
provisions
of
the
Montreal
Protocol.
In
the
case
of
conflict
between
any
provision
of
this
title
and
any
provision
of
the
Montreal
Protocol,
the
more
stringent
provision
shall
govern.''
EPA's
regulations
implementing
the
essential
use
provisions
of
the
Act
and
the
Protocol
are
located
in
40
CFR
part
82.
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
82
[
FRL
 
7430
 
7]

RIN
2060
 
AK48
Protection
of
Stratospheric
Ozone:
Allocation
of
Essential
Use
Allowances
for
Calendar
Year
2003
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
With
this
action,
EPA
is
allocating
essential
use
allowances
for
import
and
production
of
class
I
stratospheric
ozone
depleting
substances
(
ODSs)
for
calendar
year
2003.
Essential
use
allowances
enable
a
person
to
obtain
controlled
class
I
ODSs
as
an
exemption
to
the
regulatory
ban
of
production
and
import
of
these
chemicals,
which
became
effective
on
January
1,
1996.
EPA
allocates
essential
use
allowances
for
exempted
production
or
import
of
a
specific
quantity
of
class
I
ODS
solely
for
the
designated
essential
purpose.
Today
EPA
is
finalizing
the
allocations
proposed
in
the
Federal
Register
on
November
6,
2002
(
67
FR
67581).
These
allocations
total
3,270
metric
tons
of
chlorofluorocarbons
for
use
in
metered
dose
inhalers,
and
13.2
metric
tons
of
methyl
chloroform
for
use
in
the
U.
S.
Space
Shuttle
and
Titan
Rocket
programs.
DATES:
This
final
rulemaking
is
effective
December
27,
2002.
ADDRESSES:
Materials
relevant
to
this
rulemaking
are
contained
in
EPA
Air
Docket
No.
A
 
93
 
39.
The
Air
Docket
is
located
at
EPA
West
Building,
Room
B102,
1301
Constitution
Avenue,
NW.,
Washington,
DC,
20460.
The
Air
Docket
is
open
from
8:
30
a.
m.
until
4:
30
p.
m.
Monday
through
Friday.
EPA
may
charge
a
reasonable
fee
for
copying
docket
materials.

FOR
FURTHER
INFORMATION
CONTACT:
Scott
Monroe,
by
regular
mail:
U.
S.
Environmental
Protection
Agency,
Global
Programs
Division
(
6205J),
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC,
20460;
by
telephone:
(
202)
564
 
9712;
or
by
email:
monroe.
scott@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

Table
of
Contents
I.
Basis
for
Allocating
Essential
Use
Allowances
A.
What
Are
Essential
Use
Allowances?
B.
Under
What
Authority
Does
EPA
Allocate
Essential
Use
Allowances?
C.
What
Is
the
Process
for
Allocating
Essential
Use
Allowances?
II.
Response
to
Comments
III.
Allocation
of
Essential
Use
Allowances
for
Calendar
Year
2003
IV.
Administrative
Requirements
A.
Executive
Order
12866:
Regulatory
Planning
and
Review
B.
Paperwork
Reduction
Act
C.
Regulatory
Flexibility
Act
D.
Unfunded
Mandates
Reform
Act
E.
Executive
Order
13132:
Federalism
F.
Executive
Order
13175:
Consultation
and
Coordination
with
Indian
Tribal
Governments
G.
Executive
Order
13045:
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
H.
Executive
Order
13211:
Actions
that
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
I.
National
Technology
Transfer
and
Advancement
Act
J.
Congressional
Review
Act
V.
Judicial
Review
I.
Basis
for
Allocating
Essential
use
Allowances
A.
What
Are
Essential
Use
Allowances?

Essential
use
allowances
are
allowances
to
produce
or
import
certain
ozone­
depleting
chemicals
in
the
U.
S.
for
purposes
that
have
been
deemed
``
essential''
by
the
Parties
to
the
Montreal
Protocol
and
the
U.
S.
Government.
The
Montreal
Protocol
on
Substances
that
Deplete
the
Ozone
Layer
(
Protocol)
is
the
international
agreement
to
reduce
and
eventually
eliminate
the
production
and
consumption
1
of
all
stratospheric
ozone
depleting
substances
(
ODSs).
The
elimination
of
production
and
consumption
of
class
I
ODSs
is
accomplished
through
adherence
to
phase­
out
schedules
for
specific
class
I
ODSs,
2
including:
chlorofluorocarbons
(
CFCs),
halons,
carbon
tetrachloride,
methyl
chloroform,
and
methyl
bromide.
As
of
January
1,
1996,
production
and
import
of
most
class
I
ODSs
were
phased
out
in
developed
countries,
including
the
United
States.
However,
the
Protocol
and
the
Clean
Air
Act
(
Act)
provide
exemptions
that
allow
for
the
continued
import
and/
or
production
of
class
I
ODS
for
specific
uses.
Under
the
Protocol,
exemptions
may
be
granted
for
uses
that
are
determined
by
the
Parties
to
be
``
essential.''
Decision
IV/
25,
taken
by
the
Parties
to
the
Protocol
in
1992,
established
criteria
for
determining
whether
a
specific
use
should
be
approved
as
essential,
and
set
forth
the
international
process
for
making
determinations
of
essentiality.
The
criteria
for
an
essential
use,
as
set
forth
in
paragraph
1
of
Decision
IV/
25,
are
the
following:

``(
a)
that
a
use
of
a
controlled
substance
should
qualify
as
``
essential''
only
if:
(
i)
it
is
necessary
for
the
health,
safety
or
is
critical
for
the
functioning
of
society
(
encompassing
cultural
and
intellectual
aspects);
and
(
ii)
there
are
no
available
technically
and
economically
feasible
alternatives
or
substitutes
that
are
acceptable
from
the
standpoint
of
environment
and
health;
(
b)
that
production
and
consumption,
if
any,
of
a
controlled
substance
for
essential
uses
should
be
permitted
only
if:
(
i)
all
economically
feasible
steps
have
been
taken
to
minimize
the
essential
use
and
any
associated
emission
of
the
controlled
substance;
and
(
ii)
the
controlled
substance
is
not
available
in
sufficient
quantity
and
quality
from
existing
stocks
of
banked
or
recycled
controlled
substances,
also
bearing
in
mind
the
developing
countries'
need
for
controlled
substances.''

B.
Under
What
Authority
Does
EPA
Allocate
Essential
Use
Allowances?
Title
VI
of
the
Act
implements
the
Protocol
for
the
United
States.
3
Section
604(
d)
of
the
Act
authorizes
EPA
to
allow
the
production
of
limited
quantities
of
class
I
ODSs
after
the
phase
out
date
for
the
following
essential
uses:
(
1)
Methyl
Chloroform,
``
solely
for
use
in
essential
applications
(
such
as
nondestructive
testing
for
metal
fatigue
and
corrosion
of
existing
airplane
engines
and
airplane
parts
susceptible
to
metal
fatigue)
for
which
no
safe
and
effective
substitute
is
available.''
EPA
issues
methyl
chloroform
allowances
to
the
U.
S.
Space
Shuttle
and
Titan
Rocket
programs.
(
2)
Medical
Devices
(
as
defined
in
section
601(
8)
of
the
Act),
``
if
such
authorization
is
determined
by
the
Commissioner
[
of
the
Food
and
Drug
Administration],
in
consultation
with
the
Administrator
[
of
EPA]
to
be
necessary
for
use
in
medical
devices.''
EPA
issues
allowances
to
manufacturers
of
metered­
dose
inhalers,
which
use
CFCs
as
propellant
for
the
treatment
of
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asthma
and
chronic
obstructive
pulmonary
diseases.
(
3)
Aviation
Safety,
for
which
limited
quantities
of
halon­
1211,
halon­
1301,
and
halon
2402
may
be
produced
``
if
the
Administrator
of
the
Federal
Aviation
Administration,
in
consultation
with
the
Administrator
[
of
EPA]
determines
that
no
safe
and
effective
substitute
has
been
developed
and
that
such
authorization
is
necessary
for
aviation
safety
purposes.''
Neither
EPA
nor
the
Parties
have
ever
granted
a
request
for
essential
use
allowances
for
halon,
because
alternatives
are
available,
or
because
existing
quantities
of
this
substance
are
large
enough
to
provide
for
any
needs
for
which
alternatives
have
not
yet
been
developed.
The
Protocol,
under
Decision
X/
19,
additionally
allows
a
general
exemption
for
laboratory
and
analytical
uses
through
December
31,
2005.
This
exemption
is
reflected
in
EPA's
regulations
at
40
CFR
part
82,
subpart
A.
While
the
Act
does
not
specifically
provide
for
this
exemption,
EPA
has
determined
that
an
allowance
for
essential
laboratory
and
analytical
uses
is
allowable
under
the
Act
as
a
de
minimis
exemption.
The
de
minimis
exemption
is
addressed
in
EPA's
final
rule
of
March
13,
2001
(
66
FR
14760
 
14770).
The
Parties
to
the
Protocol
subsequently
agreed
(
Decision
XI/
15)
that
the
general
exemption
does
not
apply
to
the
following
uses:
testing
of
oil
and
grease,
and
total
petroleum
hydrocarbons
in
water;
testing
of
tar
in
road­
paving
materials;
and
forensic
finger­
printing.
EPA
incorporated
this
exclusion
at
appendix
G
to
subpart
A
of
40
CFR
part
82
on
February
11,
2002
(
67
FR
6352).
C.
What
Is
the
Process
for
Allocating
Essential
Use
Allowances?
Before
EPA
may
allocate
essential
use
allowances,
the
Parties
to
the
Protocol
must
first
approve
the
United
States'
request
to
produce
or
import
essential
class
I
ODSs.
The
procedure
set
out
by
Decision
IV/
25
calls
for
individual
Parties
to
nominate
essential
uses
and
the
total
amount
of
ODSs
needed
for
those
essential
uses
on
an
annual
basis.
The
Protocol's
Technology
and
Economic
Assessment
Panel
evaluates
the
nominated
essential
uses
and
makes
recommendations
to
the
Protocol
Parties.
The
Parties
make
the
final
decisions
on
whether
to
approve
a
Party's
essential
use
nomination
at
their
annual
meeting.
This
nomination
cycle
occurs
approximately
two
years
before
the
year
in
which
the
allowances
would
be
in
effect.
The
allowances
allocated
through
today's
action
were
first
nominated
by
the
United
States
in
January
2001.
Once
the
U.
S.
nomination
is
approved
by
the
Parties,
EPA
allocates
essential
use
exemptions
to
specific
entities
through
notice­
and­
comment
rulemaking
in
a
manner
consistent
with
the
Act.
For
medical
devices,
EPA
requests
information
from
manufacturers
about
the
number
and
type
of
devices
they
plan
to
produce,
as
well
as
the
amount
of
CFCs
necessary
for
production.
EPA
then
forwards
the
information
to
the
Food
and
Drug
Administration
(
FDA),
which
determines
the
amount
of
CFCs
necessary
for
metered­
dose
inhalers
in
the
coming
calendar
year.
Based
on
FDA's
assessment,
EPA
proposes
allocations
to
each
eligible
entity.
Under
the
Act
and
the
Protocol,
EPA
may
allocate
essential
use
allowances
in
quantities
that
together
are
below
or
equal
to
the
total
amount
approved
by
the
Parties.
EPA
may
not
allocate
essential
use
allowances
in
amounts
higher
than
the
total
approved
by
the
Parties.
For
methyl
chloroform,
Decision
X/
6
by
the
Parties
to
the
Protocol
established
that
``*
*
*
the
remaining
quantity
of
methyl
chloroform
authorized
for
the
United
States
at
previous
meetings
of
the
Parties
[
will]
be
made
available
for
use
in
manufacturing
solid
rocket
motors
until
such
time
as
the
1999
 
2001
quantity
of
176.4
tons
(
17.6
ODPweighted
tons)
allowance
is
depleted,
or
until
such
time
as
safe
alternatives
are
implemented
for
remaining
essential
uses.''
Section
604(
d)(
1)
of
the
Act
terminates
the
exemption
period
for
methyl
chloroform
on
January
1,
2005.
Therefore,
between
1999
and
2004
EPA
may
allow
production
or
import
up
to
a
total
of
176.4
metric
tons
of
methyl
chloroform
for
authorized
essential
uses.
According
to
EPA's
tracking
system,
the
total
amount
of
methyl
chloroform
produced
or
imported
by
essential
use
allowance
holders
in
the
years
1999
 
2001
was
28.3
metric
tons.
With
today's
allocation
totaling
13.2
tons,
the
U.
S.
remains
well
below
the
established
cap
on
allowances
for
methyl
choloroform.

II.
Response
to
Comments
EPA
received
one
comment
in
response
to
the
proposed
rule.
The
commenter
supported
the
proposed
allocations.

III.
Allocation
of
Essential
Use
Allowances
for
Calendar
Year
2003
With
today's
action,
EPA
is
allocating
essential
use
allowances
for
calendar
year
2003
to
entities
listed
in
Table
1.
These
allowances
are
for
the
production
or
import
of
the
specified
quantity
of
class
I
controlled
substances
solely
for
the
specified
essential
use.

TABLE
I.
 
ESSENTIAL
USE
ALLOCATION
FOR
CALENDAR
YEAR
2003
Company
Chemical
Quantity
(
metric
tons)

(
i)
Metered
Dose
Inhalers
(
for
oral
inhalation)
for
Treatment
of
Asthma
and
Chronic
Obstructive
Pulmonary
Disease
Armstrong
Pharmaceuticals
........................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
574
Aventis
........................................................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
48
Boehringer
Ingelheim
Pharmaceuticals
......................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
907
Glaxo
SmithKline
........................................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
535
Schering­
Plough
Corporation
......................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
937
Sidmak
Laboratories
4
.................................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
136
3M
Pharmaceuticals
...................................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
133
(
ii)
Cleaning,
Bonding
and
Surface
Activation
Applications
for
the
Space
Shuttle
Rockets
and
Titan
Rockets
National
Aeronautics
and
Space
Administration
(
NASA)/
Thiokol
Rocket.
Methyl
Chloroform
......................................................................
9.8
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TABLE
I.
 
ESSENTIAL
USE
ALLOCATION
FOR
CALENDAR
YEAR
2003
 
Continued
Company
Chemical
Quantity
(
metric
tons)

United
States
Air
Force/
Titan
Rocket
.........................................
Methyl
Chloroform
......................................................................
3.4
4
EPA
proposed
to
allocate
allowances
to
Sidmak
Laboratories,
Inc.
for
136
metric
tons
for
use
in
2003.
Following
publication
of
the
proposal,
Sidmak
was
purchased
by
the
pharmaceutical
firm
PLIVA
d.
d.
In
2003,
a
subsidiary
of
PLIVA
d.
d.
reportedly
will
replace
Sidmak
Laboratories,
thereby
acquiring
Sidmak's
essential
use
allowances.
A
letter
to
EPA
describing
the
purchase
and
PLIVA's
commitment
to
execute
essential
use
allowances
in
accordance
with
EPA
regulations
and
Sidmak's
application
for
allowances
has
been
filed
in
Air
Docket
A
 
93
 
39,
Category
XII
 
A.

IV.
Administrative
Requirements
A.
Executive
Order
12866:
Regulatory
Planning
and
Review
Under
Executive
Order
12866
(
58
FR
51735,
October
4,
1993),
the
Agency
must
determine
whether
this
regulatory
action
is
``
significant''
and
therefore
subject
to
review
by
the
Office
of
Management
and
Budget
(
OMB)
and
the
requirements
of
the
Executive
Order.
The
Order
defines
``
significant
regulatory
action''
as
one
that
is
likely
to
result
in
a
rule
that
may:
(
1)
Have
an
annual
effect
on
the
economy
of
$
100
million
or
more,
or
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,
jobs,
the
environment,
public
health
or
safety,
or
State,
local,
or
tribal
governments
or
communities;
(
2)
Create
a
serious
inconsistency
or
otherwise
interfere
with
an
action
taken
or
planned
by
another
agency;
(
3)
Materially
alter
the
budgetary
impact
of
entitlements,
grants,
user
fees,
or
loan
programs
or
the
rights
and
obligations
of
recipients
thereof;
or
(
4)
Raise
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order.
It
has
been
determined
that
this
action
is
not
a
``
significant
regulatory
action''
under
the
terms
of
Executive
Order
12866
and
is
therefore
not
subject
to
OMB
review.

B.
Paperwork
Reduction
Act
This
action
does
not
add
any
information
collection
requirements
or
increase
burden
under
the
provisions
of
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.
OMB
previously
approved
the
information
collection
requirements
contained
in
the
final
rule
promulgated
on
May
10,
1995,
and
assigned
OMB
control
number
2060
 
0170
(
EPA
ICR
No.
1432.21).
Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instruction;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
An
Agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
1.

C.
Regulatory
Flexibility
Act
EPA
has
determined
that
it
is
not
necessary
to
prepare
a
regulatory
flexibility
analysis
in
connection
with
this
final
rule.
EPA
has
also
determined
that
this
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
For
purposes
of
assessing
the
impact
of
today's
rule
on
small
entities,
small
entities
are
defined
as:
(
1)
Pharmaceutical
preparations
manufacturing
businesses
(
NAICS
code
325412)
that
have
less
than
750
employees;
(
2)
a
small
governmental
jurisdiction
that
is
a
government
of
a
city,
county,
town,
school
district
or
special
district
with
a
population
of
less
than
50,000;
and
(
3)
a
small
organization
that
is
any
not­
forprofit
enterprise
that
is
independently
owned
and
operated
and
is
not
dominant
in
its
field.
After
considering
the
economic
impacts
of
today's
final
rule
on
small
entities,
EPA
has
concluded
that
this
action
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
In
determining
whether
a
rule
has
a
significant
economic
impact
on
a
substantial
number
of
small
entities,
the
impact
of
concern
is
any
significant
adverse
economic
impact
on
small
entities,
since
the
primary
purpose
of
the
regulatory
flexibility
analyses
is
to
identify
and
address
regulatory
alternatives
``
which
minimize
any
significant
economic
impact
of
the
proposed
rule
on
small
entities.''
5
U.
S.
C.
603
and
604.
Thus,
an
agency
may
conclude
that
a
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities
if
the
rule
relieves
regulatory
burden,
or
otherwise
has
a
positive
economic
effect
on
all
of
the
small
entities
subject
to
the
rule.
This
rule
provides
an
otherwise
unavailable
benefit
to
those
companies
that
are
receiving
essential
use
allowances.
We
have
therefore
concluded
that
today's
final
rule
will
relieve
regulatory
burden
for
all
small
entities.

D.
Unfunded
Mandates
Reform
Act
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA),
Pub.
L.
104
 
4,
establishes
requirements
for
Federal
agencies
to
assess
the
effects
of
their
regulatory
actions
on
State,
local,
and
tribal
governments
and
the
private
sector.
Under
section
202
of
the
UMRA,
EPA
generally
must
prepare
a
written
statement,
including
a
cost­
benefit
analysis,
for
proposed
and
final
rules
with
``
Federal
mandates''
that
may
result
in
expenditures
to
State,
local,
and
tribal
governments,
in
the
aggregate,
or
to
the
private
sector,
of
$
100
million
or
more
in
any
one
year.
Before
promulgating
an
EPA
rule
for
which
a
written
statement
is
needed,
section
205
of
the
UMRA
generally
requires
EPA
to
identify
and
consider
a
reasonable
number
of
regulatory
alternatives
and
adopt
the
least
costly,
most
cost­
effective,
or
least
burdensome
alternative
that
achieves
the
objectives
of
the
rule.
The
provisions
of
section
205
do
not
apply
when
they
are
inconsistent
with
applicable
law.
Moreover,
section
205
allows
EPA
to
adopt
an
alternative
other
than
the
least
costly,
most
cost­
effective,
or
least
burdensome
alternative,
if
the
Administrator
publishes
with
the
final
rule
an
explanation
why
that
alternative
was
not
adopted.
Before
EPA
establishes
any
regulatory
requirements
that
may
significantly
or
uniquely
affect
small
governments,
including
tribal
governments,
it
must
have
developed
a
small
government
agency
plan
under
section
203
of
the
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UMRA.
The
plan
must
provide
for
notifying
potentially
affected
small
governments,
enabling
officials
of
affected
small
governments
to
have
meaningful
and
timely
input
in
the
development
of
EPA
regulatory
proposals
with
significant
Federal
intergovernmental
mandates,
and
informing,
educating,
and
advising
small
governments
on
compliance
with
the
regulatory
requirements.
Today's
rule
contains
no
Federal
mandates
(
under
the
regulatory
provisions
of
Title
II
of
the
UMRA)
for
State,
local,
or
tribal
governments
or
the
private
sector,
since
it
merely
provides
exemptions
from
the
1996
phase
out
of
class
I
ODSs.
Similarly,
EPA
has
determined
that
this
rule
contains
no
regulatory
requirements
that
might
significantly
or
uniquely
affect
small
governments,
because
this
rule
merely
allocates
essential
use
exemptions
to
entities
as
an
exemption
to
the
ban
on
production
and
import
of
class
I
ODSs.

E.
Executive
Order
13132:
Federalism
Executive
Order
13132,
entitled
``
Federalism''
(
64
FR
43255,
August
10,
1999),
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
does
not
have
federalism
implications.
It
will
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.
Thus,
Executive
Order
13132
does
not
apply
to
this
rule.

F.
Executive
Order
13175:
Consultation
and
Coordination
With
Indian
Tribal
Governments
Executive
Order
13175,
entitled
``
Consultation
and
Coordination
with
Indian
Tribal
Governments''
(
65
FR
67249,
November
9,
2000),
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.''
This
final
rule
does
not
have
tribal
implications,
as
specified
in
Executive
Order
13175.
Today's
rule
affects
only
the
companies
that
requested
essential
use
allowances.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

G.
Executive
Order
13045:
Protection
of
Children
From
Environmental
Health
Risks
and
Safety
Risks
Executive
Order
13045,
``
Protection
of
Children
from
Environmental
Health
risks
and
Safety
Risks''
(
62
FR
19885,
April
23,
1997),
applies
to
any
rule
that
(
1)
is
determined
to
be
``
economically
significant''
as
defined
under
Executive
Order
12866,
and
(
2)
concerns
an
environmental
health
and
safety
risk
that
EPA
has
reason
to
believe
may
have
a
disproportionate
effect
on
children.
If
the
regulatory
action
meets
both
criteria,
the
Agency
must
evaluate
the
environmental
health
or
safety
effects
of
the
planned
rule
on
children,
and
explain
why
the
planned
regulation
is
preferable
to
other
potentially
effective
and
reasonably
feasible
alternatives
considered
by
the
Agency.
EPA
interprets
Executive
Order
13045
as
applying
only
to
those
regulatory
actions
that
are
based
on
health
or
safety
risks,
such
that
the
analysis
required
under
section
5
 
501
of
the
Order
has
the
potential
to
influence
the
regulation.
This
rule
is
not
subject
to
Executive
Order
13045
because
it
implements
the
phase­
out
schedule
and
exemptions
established
by
Congress
in
Title
VI
of
the
Clean
Air
Act.

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
and
Advancement
Act
Section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(``
NTTAA),
Pub.
L.
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note)
directs
EPA
to
use
voluntary
consensus
standards
in
this
regulatory
activities
unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
Voluntary
consensus
standards
are
technical
standards
(
e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
and
business
practices)
that
are
developed
or
adopted
by
voluntary
consensus
standards
bodies.
The
NTTAA
directs
EPA
to
provide
Congress,
through
OMB,
explanations
when
the
Agency
decides
not
to
use
available
and
applicable
voluntary
consensus
standards.
This
final
rule
does
not
involve
technical
standards.
Therefore,
EPA
did
not
consider
the
use
of
any
voluntary
consensus
standards.

J.
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.
Therefore,
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).
This
rule
will
be
effective
December
27,
2002.

V.
Judicial
Review
Under
section
307(
b)(
1)
of
the
Act,
EPA
finds
that
these
regulations
are
of
national
applicability.
Accordingly,
judicial
review
of
the
action
is
available
only
by
the
filing
of
a
petition
for
review
in
the
United
States
Court
of
Appeals
for
the
District
of
Columbia
Circuit
within
sixty
days
of
publication
of
the
action
in
the
Federal
Register.
Under
section
307(
b)(
2),
the
requirements
of
this
rule
may
not
be
challenged
later
in
judicial
proceedings
brought
to
enforce
those
requirements.

List
of
Subjects
in
40
CFR
Part
82
Environmental
protection,
Administrative
practice
and
procedure,
Air
pollution
control,
Chemicals,
Chlorofluorocarbons,
Exports,
Imports,
Laboratory
and
Analytical
Uses,
Methyl
Chloroform,
Ozone
layer,
Reporting
and
recordkeeping
requirements.

Dated:
December
19,
2002.
Christine
Todd
Whitman,
Administrator.

40
CFR
Part
82
is
amended
as
follows:

PART
82
 
PROTECTION
OF
STRATOSPHERIC
OZONE
1.
The
authority
citation
for
part
82
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7414,
7601,
7671
 
7671q.

Subpart
A
 
Production
and
Consumption
Controls
2.
Section
82.4
is
amended
by
revising
the
table
in
paragraph
(
t)(
2)
to
read
as
follows:

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Regulations
§
82.4
Prohibitions.

*
*
*
*
*
(
t)
*
*
*
(
2)
*
*
*

TABLE
I.
 
ESSENTIAL
USE
ALLOCATION
FOR
CALENDAR
YEAR
2003
Company
Chemical
Quantity
(
metric
tons)

(
i)
Metered
Dose
Inhalers
(
for
oral
inhalation)
for
Treatment
of
Asthma
and
Chronic
Obstructive
Pulmonary
Disease
Armstrong
Pharmaceuticals
........................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
574
Aventis
........................................................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
48
Boehringer
Ingelheim
Pharmaceuticals
......................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
907
GlaxoSmithKline
..........................................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
535
Schering­
Plough
Corporation
......................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
937
Sidmak
Laboratories
...................................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
136
3M
Pharmaceuticals
...................................................................
CFC
 
11
or
CFC
 
12
or
CFC
 
114
..............................................
133
(
ii)
Cleaning,
Bonding
and
Surface
Activation
Applications
for
the
Space
Shuttle
Rockets
and
Titan
Rockets
National
Aeronautics
and
Space
Administration
(
NASA)/
Thiokol
Rocket.
Methyl
Chloroform
......................................................................
9.8
United
States
Air
Force/
Titan
Rocket
.........................................
Methyl
Chloroform
......................................................................
3.4
*
*
*
*
*

[
FR
Doc.
02
 
32719
Filed
12
 
26
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
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13>
2002
05:
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Dec
27,
2002
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Frm
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Fmt
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FR\
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27DER5.
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27DER5