1
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
82
[
FRL­]

RIN
[]

Protection
of
Stratospheric
Ozone:
Allocation
of
Essential
Use
Allowances
for
Calendar
Year
2005.

AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.

SUMMARY:
EPA
is
proposing
to
allocate
essential
use
allowances
for
import
and
production
of
class
I
stratospheric
ozone
depleting
substances
(
ODSs)
for
calendar
year
2005.
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.
The
proposed
allocations
total
1,524.58
metric
tons
of
chlorofluorocarbons
for
use
in
metered
dose
inhalers.

DATES:
Written
comments
on
this
proposed
rule
must
be
received
by
the
EPA
Docket
on
or
before
[
insert
date
30
days
after
date
of
publication],
unless
a
public
hearing
is
requested.
Comments
must
then
be
received
on
or
before
30
days
following
the
public
hearing.
Any
party
requesting
a
public
hearing
must
notify
the
contact
listed
below
under
"
For
More
Information
Contact"
by
5:
00
p.
m.
Eastern
Standard
Time
on
[
insert
date
10
days
after
publication].
If
a
hearing
is
held,
EPA
will
publish
a
document
in
the
Federal
Register
announcing
the
hearing
information.

ADDRESSES:
Submit
your
comments,
identified
by
Docket
ID
No.
OAR­
2004­
0063,
by
one
of
the
following
methods:


Federal
eRulemaking
Portal:
http://
www.
regulations.
gov.
Follow
the
on­
line
instructions
for
submitting
comments.


Agency
Website:
http://
www.
epa.
gov/
edocket.
EDOCKET,
EPA's
electronic
public
docket
and
comment
system,
is
EPA's
preferred
method
for
receiving
comments.
Follow
the
on­
line
instructions
for
submitting
comments.


Mail:
Air
and
Radiation
Docket,
Environmental
Protection
Agency,
Mailcode
6102T,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC,
20460,
Attention:
Docket
ID
No.
OAR­
2004­
2
0063.


Hand
Delivery:
EPA
Docket
Center,
(
EPA/
DC)
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
D.
C.,
Attention
Docket
ID
No.
OAR­
2004­
0063.
Deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation,
and
special
arrangements
should
be
made
for
deliveries
of
boxed
information.
Instructions:
Direct
your
comments
to
Air
Docket
ID
No.
OAR­
2004­
0063.
EPA's
policy
is
that
all
comments
received
will
be
included
in
the
public
docket
without
change
and
may
be
made
available
online
at
http://
www.
epa.
gov/
edocket,
including
any
personal
information
provided,
unless
the
comment
includes
information
claimed
to
be
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
Do
not
submit
information
that
you
consider
to
be
CBI
or
otherwise
protected
through
EDOCKET,
regulations.
gov,
or
e­
mail.
For
instructions
on
how
to
submit
CBI,
see
"
How
do
I
submit
confidential
business
information
to
EPA?"
under
SUPPLEMENTARY
INFORMATION.
The
EPA
EDOCKET
and
the
federal
regulations.
gov
websites
are
"
anonymous
access"
systems,
which
means
EPA
will
not
know
your
identity
or
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
If
you
send
an
e­
mail
comment
directly
to
EPA
without
going
through
EDOCKET
or
regulations.
gov,
your
e­
mail
address
will
be
automatically
captured
and
included
as
part
of
the
comment
that
is
placed
in
the
public
docket
and
made
available
on
the
Internet.
If
you
submit
an
electronic
comment,
EPA
recommends
that
you
include
your
name
and
other
contact
information
in
the
body
of
your
comment
and
with
any
disk
or
CD­
ROM
you
submit.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
Electronic
files
should
avoid
the
use
of
special
characters,
any
form
of
encryption,
and
be
free
of
any
defects
or
viruses.
Docket:
All
documents
in
the
docket
are
listed
in
the
EDOCKET
index
at
http://
www.
epa.
gov/
edocket.
Although
listed
in
the
index,
some
information
is
not
publicly
available,
namely
CBI
or
other
information
whose
disclosure
is
restricted
by
statute.
Certain
other
material,
such
as
copyrighted
material,
is
not
placed
on
the
Internet
and
will
be
publicly
available
only
in
hard
copy
form.
Publicly
available
docket
materials
are
available
either
electronically
in
EDOCKET
or
in
hard
copy
at
the
Air
Docket,
EPA/
DC,
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Public
Reading
Room
is
(
202)
566­
1744,
and
the
telephone
number
for
Docket
ID
No.
OAR­
3
2004­
0063
is
(
202)
566­
1742.
Materials
related
to
previous
EPA
actions
on
the
essential
use
program
are
contained
in
EPA
Air
Docket
No.
A­
93­
39.
Docket
A­
93­
39
may
be
reviewed
at
the
Public
Reading
Room.

FOR
FURTHER
INFORMATION
CONTACT:
Scott
Monroe,
Essential
Use
Program
Manager,
by
regular
mail:
U.
S.
Environmental
Protection
Agency,
Stratospheric
Protection
Division
(
6205J),
1200
Pennsylvania
Avenue,
NW,
Washington,
DC,
20460;
by
courier
service
or
overnight
express:
1301
L
Street,
N.
W.,
Washington
D.
C.,
20005,
by
telephone:
202­
343­
9712;
or
by
email:
monroe.
scott@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
Table
of
Contents
I.
General
Information
A.
How
should
I
submit
confidential
business
information
to
EPA?
II.
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?
III.
Essential
Use
Allowances
for
Medical
Devices
IV.
Proposed
Allocation
of
Essential
Use
Allowances
for
Calendar
Year
2005
V.
Statutory
and
Executive
Order
Reviews
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
I.
General
Information
A.
How
should
I
submit
confidential
business
information
to
EPA?
Comments
that
contain
confidential
business
information
should
be
submitted
in
two
versions,
one
clearly
marked
"
Public",
to
be
filed
in
the
public
docket,
and
the
other
clearly
marked
"
Confidential"
to
be
reviewed
by
authorized
government
personnel
only.
If
the
comments
are
not
marked,
EPA
will
assume
they
do
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.

4
not
contain
confidential
business
information
and
will
docket
them.
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
Send
or
deliver
information
identified
as
CBI
only
to
the
Essential
Use
Program
Manager.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
Part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
identified
in
the
FOR
FURTHER
INFORMATION
CONTACT
section.
II.
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
consumption1
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
ODSs2,
including:
chlorofluorocarbons
(
CFCs),
halons,
carbon
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.

5
tetrachloride,
and
methyl
chloroform.
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
6
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."
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
ODP­
weighted
tons)
allowance
is
depleted,
or
until
such
time
as
safe
alternatives
are
implemented
for
remaining
essential
uses."
Prior
to
2004,
EPA
issued
allowances
for
production
of
approximately
34
metric
tons
of
methyl
chloroform
out
of
the
authorized
balance
of
176
metric
tons.
Under
section
604(
d)(
1)
of
the
Act,
EPA
may
no
longer
allocate
essential
use
allowances
for
production
and
import
of
methyl
chloroform
as
of
January
1,
2005.
Therefore,
In
light
of
this
deadline,
in
the
allocation
rulemaking
for
calendar
year
2004
(
69
FR
4059)
EPA
allocated
the
remaining
authorized
production
allowances
for
methyl
chloroform,
approximately
142
metric
tons,
to
the
National
Aeronautics
and
Space
Administration.
in
the
allocation
rulemaking
for
calendar
year
2004
(
69
FR
4059).
(
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
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.
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
7
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
2003.
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
2005,
the
Parties
authorized
the
United
States
to
allocate
up
to
1,902
metric
tons
of
CFCs
for
essential
uses.
III.
Essential
Use
Allowances
for
Medical
Devices
The
following
is
a
step­
by­
step
list
of
actions
EPA
and
FDA
have
taken
thus
far
to
implement
the
exemption
for
medical
devices
found
at
section
604(
d)(
2)
of
the
Act
for
the
2005
control
period.
1.
On
February
24,
2004,
EPA
sent
letters
to
MDI
manufacturers
requesting
the
following
information
under
section
114
of
the
Act
("
114
letters"):
a.
The
MDI
product
where
CFCs
will
be
used.
8
b.
The
number
of
units
of
each
MDI
product
produced
from
1/
1/
03
to
12/
31/
03.
c.
The
number
of
units
anticipated
to
be
produced
in
2004.
d.
The
gross
target
fill
weight
per
unit
(
grams).
e.
Total
amount
of
CFCs
to
be
contained
in
the
MDI
product
for
2005.
f.
The
additional
amount
of
CFCs
necessary
for
production.
g.
The
total
CFC
request
per
MDI
product
for
2005.
The
114
letters
are
available
for
review
in
the
Air
Docket
ID
No.
OAR­
2004­
0063.
The
companies
requested
that
their
responses
be
treated
as
confidential
business
information;
for
this
reason,
EPA
has
not
placed
the
responses
in
the
docket.
2.
On
May
18,
2004,
EPA
sent
FDA
the
information
MDI
manufacturers
provided
in
response
to
the
114
letters
with
a
letter
requesting
that
FDA
make
a
determination
regarding
the
amount
of
CFCs
necessary
for
MDIs
for
calendar
year
2005.
This
letter
is
available
for
review
in
Air
Docket
ID
No.
OAR­
2004­
0063.
3.
On
July
28,
2004,
FDA
sent
a
letter
to
EPA
stating
the
amount
of
CFCs
determined
by
the
Commissioner
to
be
necessary
for
each
MDI
company
in
2005.
This
letter
is
available
for
review
in
the
Air
Docket
ID
No.
OAR­
2004­
0063.
In
their
letter,
FDA
informed
EPA
that
they
had
determined
that
1524.58
metric
tons
of
CFCs
were
necessary
for
use
in
medical
devices
in
2005.
In
accordance
with
the
determination
made
by
FDA,
today's
action
proposes
to
allocate
essential
use
allowances
for
a
total
of
1524.58
metric
tons
of
CFCs
for
use
in
MDIs
for
calendar
year
2005.
The
amounts
listed
in
this
proposal
are
subject
to
additional
review
by
EPA
and
FDA
if
new
information
demonstrates
that
the
proposed
allocations
are
either
too
high
or
too
low.
Commentors
requesting
increases
or
decreases
of
essential
use
allowances
should
provide
detailed
information
supporting
their
claim
for
additional
or
fewer
CFCs.
Any
company
that
needs
less
than
the
full
amount
listed
in
this
proposal
should
notify
EPA
of
the
actual
amount
needed.
IV.
Proposed
Allocation
of
Essential
Use
Allowances
for
Calendar
Year
2005
EPA
proposes
to
allocate
essential
use
allowances
for
calendar
year
2005
to
the
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.
As
explained
in
Section
II.
C.
above,
the
amount
of
the
each
allocation
is
based
on
the
request
of
the
company,
which
was
reviewed
by
FDA
to
determine
the
quantities
necessary
for
use
in
medical
devices.
TABLE
I.
­
ESSENTIAL
USE
ALLOCATION
FOR
CALENDAR
YEAR
2005
9
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
29
Aventis
Pharmaceutical
Products
CFC­
11
or
CFC­
12
or
CFC­
114
57
Boehringer
Ingelheim
Pharmaceuticals
CFC­
11
or
CFC­
12
or
CFC­
114
480
Schering­
Plough
Corporation
CFC­
11
or
CFC­
12
or
CFC­
114
816
3M
Pharmaceuticals
CFC­
11
or
CFC­
12
or
CFC­
114
69.18
Wyeth
CFC­
11
or
CFC­
12
or
CFC­
114
73.40
V.
Statutory
and
Executive
Order
Reviews
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
10
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.
Pursuant
to
the
terms
of
Executive
Order
12866,
OMB
has
notified
EPA
that
it
considers
this
a
"
significant
regulatory
action"
within
the
meaning
of
the
Executive
Order.
EPA
has
submitted
this
action
to
OMB
for
review
and
incorporated
changes
as
a
result.
Changes
made
in
response
to
OMB
suggestions
or
recommendations
will
be
documented
in
the
public
record.
A
copy
of
the
rule
showing
changes
that
were
made
is
available
in
EPA
Docket
OAR­
2004­
0063.
Under
Section
6(
a)(
3)(
B)(
ii)
of
Executive
Order
12866,
the
Agency
must
provide
to
OMB's
Office
of
Information
and
Regulatory
Affairs
an
"
assessment
of
the
potential
costs
and
benefits
of
the
regulatory
action,
including
an
explanation
of
the
manner
in
which
the
regulatory
action
is
consistent
with
a
statutory
mandate
and,
to
the
extent
permitted
by
law,
promotes
the
President's
priorities
and
avoids
undue
interference
with
State,
local,
and
tribal
governments
in
the
exercise
of
their
governmental
functions."
EPA
is
undertaking
today's
proposed
action
under
the
mandate
established
by
Section
604(
d)
of
the
Clean
Air
Act
Amendments
of
1990,
which
directs
the
Administrator
to
authorize
the
production
of
limited
quantities
of
class
I
substances
solely
for
use
in
medical
devices,
if
the
Commissioner
of
FDA
determines
that
the
authorization
is
necessary.
The
proposed
allocations
in
today's
rule
are
the
amounts
determined
by
FDA
to
be
necessary
for
calendar
year
2005.
EPA
has
not
assessed
the
costs
and
benefits
specific
to
today's
proposed
action.
The
Agency
examined
the
costs
and
benefits
associated
with
a
related
regulation.
The
Agency's
Regulatory
Impact
Analysis
(
RIA)
for
the
entire
Title
VI
phaseout
program
examined
the
projected
economic
costs
of
a
complete
phaseout
of
consumption
of
ozone­
depleting
substances,
as
well
as
the
projected
benefits
of
phased
reductions
in
total
emissions
of
CFCs
and
other
ozone­
depleting
substances,
including
essentialuse
CFCs
used
for
metered­
dose
inhalers
(
U.
S.
Environmental
Protection
Agency,
"
Regulatory
Impact
Analysis:
Compliance
with
Section
604
of
the
Clean
Air
Act
for
the
Phaseout
of
Ozone
Depleting
Chemicals,"
July
1992).
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).
11
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
The
RFA
generally
requires
an
agency
to
prepare
a
regulatory
flexibility
analysis
of
any
rule
subject
to
notice
and
comment
rulemaking
requirements
under
the
Administrative
Procedure
Act
or
any
other
statute
unless
the
agency
certifies
that
the
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
Small
entities
include
small
businesses,
small
organizations,
and
small
governmental
jurisdictions.
For
purposes
of
assessing
the
impact
of
today's
rule
on
small
entities,
small
entity
is
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
for­
profit
enterprise
which
is
independently
owned
and
operated
and
is
not
dominant
its
field.
After
considering
the
economic
impacts
of
today's
proposed
rule
on
small
entities,
I
certify
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
rule
on
small
entities."
5
USC
603
and
604.
Thus,
an
agency
may
certify
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.
12
This
rule
provides
an
otherwise
unavailable
benefit
to
those
companies
that
are
receiving
essential
use
allowances
by
creating
an
exemption
to
the
regulatory
phaseout
of
chlorofluorocarbons.
We
have
therefore
concluded
that
today's
proposed
rule
will
relieve
regulatory
burden
for
all
small
entities.
We
continue
to
be
interested
in
the
potential
impact
of
the
proposed
rule
on
small
entities
and
welcome
comments
on
issues
related
to
such
impacts.
D.
Unfunded
Mandates
Reform
Act
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA),
P.
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
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.
13
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
proposed
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
proposed
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
E.
O.
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
E.
O.
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
E.
O.
13045
because
it
implements
the
phase­
out
schedule
and
exemptions
established
by
Congress
in
Title
VI
of
the
Clean
Air
Act.
14
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
Fed.
Reg.
28355,
May
22,
2001)
because
it
is
not
likely
to
have
a
significant
adverse
effect
on
the
supply,
distribution,
or
use
of
energy.
The
rule
affects
only
the
pharmaceutical
companies
that
requested
essential
use
allowances.
I.
National
Technology
Transfer
and
Advancement
Act
Section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
("
NTTAA),
Public
Law
No.
104­
113,
section
12(
d)
(
15
U.
S.
C.
272
note)
directs
EPA
to
use
voluntary
consensus
standards
in
its
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
proposed
rule
does
not
involve
technical
standards.
Therefore,
EPA
did
not
consider
the
use
of
any
voluntary
consensus
standards.
List
of
Subjects
in
40
CFR
Part
82
Administrative
practice
and
procedure,
Air
pollution
control,
Chemicals,
Chlorofluorocarbons,
Environmental
protection,
Imports,
Methyl
Chloroform,
Ozone,
Reporting
and
recordkeeping
requirements.

Dated:
_______________________________________

______________________________________________

Michael
O.
Leavitt,
Administrator
40
CFR
Part
82
is
proposed
to
be
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.
15
Subpart
A
 
Production
and
Consumption
Controls
2.
Section
82.4
is
amended
by
revising
the
table
in
paragraph
(
n)(
2)
to
read
as
follows:

§
82.4
Prohibitions
for
class
I
controlled
substances.

*
*
*
*
*

(
n)
*
*
*

(
2)
*
*
*

TABLE
I.
­
ESSENTIAL
USE
ALLOCATION
FOR
CALENDAR
YEAR
2005
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
29
Aventis
Pharmaceutical
Products
CFC­
11
or
CFC­
12
or
CFC­
114
57
Boehringer
Ingelheim
Pharmaceuticals
CFC­
11
or
CFC­
12
or
CFC­
114
480
Schering­
Plough
Corporation
CFC­
11
or
CFC­
12
or
CFC­
114
816
3M
Pharmaceuticals
CFC­
11
or
CFC­
12
or
CFC­
114
69.18
Wyeth
CFC­
11
or
CFC­
12
or
CFC­
114
73.40
16
BILLING
CODE
6560­
50­
P
