SAMPLE
114
LETTER
for
Allocation
of
Essential
Use
Allowances
for
Calendar
Year
2005
Dear
Sir
or
Madam:

I
am
writing
to
request
your
cooperation
in
determining
the
amount
of
chlorofluorocarbons
(
CFCs)
needed
to
manufacture
metered
dose
inhalers
(
MDIs)
in
the
United
States
in
the
year
2005.
Each
year
since
the
phase­
out
of
class
I
ozone
depleting
substances
in
1996,
the
U.
S.
Environmental
Protection
Agency
(
EPA)
has
asked
the
Parties
to
the
Montreal
Protocol
to
approve
production
and
import
of
specified
quantities
of
CFCs
for
use
in
MDIs.
Once
the
Parties
have
approved
the
requested
quantities,
EPA
then
allocates
rights
to
import
or
produce
CFCs
as
"
essential
use
allowances"
to
each
company
through
rulemaking
for
that
year.
EPA,
in
allocating
the
rights
to
import
or
produce
CFCs,
implements
the
exception
for
"
medical
devices"
at
section
604(
d)(
2)
of
the
Clean
Air
Act
(
the
Act).
This
section
requires
that
the
Food
and
Drug
Administration
(
FDA),
in
consultation
with
EPA,
determine
the
amount
of
CFCs
"
necessary"
for
medical
devices.
EPA
then
allocates
essential
use
allowances
to
companies
in
accordance
with
this
determination.

With
this
letter,
EPA
requests
that
[
company
name]
provide
information
on
the
amount
of
CFCs
necessary
for
the
year
2005
by
completing
the
enclosed
form.
The
information
you
provide
will
be
shared
with
FDA,
and
will
assist
FDA
in
consultation
with
EPA
in
determining
the
amount
of
CFCs
necessary
for
your
company
in
the
year
2005.
Please
note
that
FDA
will
compare
the
data
you
provide
in
response
to
this
letter
to
data
submitted
to
FDA
in
annual
reports,
where
available.

Pursuant
to
section
114(
a)
of
the
Act,
for
the
purposes
of
carrying
out
any
provision
of
the
Act,
the
Administrator
of
EPA
is
authorized
to
require
any
person
who
is
subject
to
any
requirement
of
the
Act
to
establish
and
maintain
such
records,
make
such
reports,
and
provide
such
other
information
as
the
Administrator
may
reasonably
require.
Therefore,
in
accordance
with
section
114(
a)(
1)
of
the
Act,
you
are
hereby
required
to
provide
the
information
requested
in
the
enclosed
form.
You
are
required
to
submit
the
completed
reporting
forms
within
twenty
(
20)
business
days
from
the
date
of
receipt
of
this
letter.
An
original
signed
copy
of
the
reporting
forms
should
be
submitted
to:

Scott
Monroe
Global
Programs
Division
(
6205J)
U.
S.
Environmental
Protection
Agency
1200
Pennsylvania
Avenue
N.
W.
Washington,
DC
20460.

If
sending
by
express
mail
or
delivery
service,
please
use
the
following
address:

Scott
Monroe
Global
Programs
Division
U.
S.
Environmental
Protection
Agency
1310
L
Street,
NW
Washington,
DC
20005­
4113.

Pursuant
to
the
regulations
at
40
CFR,
part
2,
subpart
B,
you
are
entitled
to
assert
a
business
confidentiality
claim
covering
all
or
any
part
of
the
submitted
business
information
as
defined
in
40
CFR
2.201(
c).
Asserting
a
business
confidentiality
claim
does
not
relieve
your
obligation
to
respond
fully
to
this
letter.
Failure
to
assert
such
a
claim
makes
the
submitted
information
subject
to
public
disclosure
upon
request
and
without
further
notice
to
you
pursuant
to
the
Freedom
of
Information
Act,
5
U.
S.
C.
section
552.
Information
subject
to
a
business
confidentiality
claim
may
be
available
to
the
public
only
to
the
extent
set
forth
in
the
above
cited
regulation.

Thank
you
in
advance
for
your
assistance.
Failure
to
comply
with
this
letter
may
result
in
the
delay
of
essential
use
allocations
for
the
year
2005.
If
you
have
any
questions,
please
contact
Scott
Monroe
by
phone
at
(
202)
343­
9712
or
by
email
at
monroe.
scott@
epa.
gov.

Sincerely,

Drusilla
Hufford,
Director
Global
Programs
Division
Enclosure
1
If
significant
numbers
of
different
canister
sizes
are
produced,
this
target
fill
number
should
either
be
the
weighted
average
for
that
product
(
i.
e.,
the
sum
of
the
gross
target
fill
times
the
percentage
of
canisters
produced
in
that
size
divided
by
the
total
number
of
canisters)
or
each
size
may
be
contained
in
a
separate
row
of
the
report
2
Column
F=
(
Column
D)(
Column
E)

3
Provide
details
regarding
your
additional
amount
needed,
e.
g.,
canisters
produced
but
not
distributed,
CFCs
lost
in
processing,
CFCs
remaining
at
end
of
batch
run,
CFCs
used
in
line
cleaning.

4
Total
request
per
product
for
2005
(
metric
tons)
=
Column
F+
Column
G
Year
2005
Essential
Use
Allocation:
CFC
Reporting
Form
Company
Name______________________________

A
B
C
D
E
F
G
H
Product
Number
of
Units
produced
from
1/
1/
03to
12/
31/
03
Number
of
Units
anticipated
to
be
produced
in
2004
Number
of
Units
anticipated
to
be
produced
in
2005
Gross
Target
fill
weight
per
unit
(
grams)
1
Total
CFC
to
be
contained
in
product
for
2005
(
metric
tons)
2
Additional
amount
necessary
for
production
(
metric
tons)
3
TOTAL
request
per
product
for
2005
(
metric
tons)
4
Example
Product
1,327,456
1,300,000
1,200,000
22
26.40
2.60
29.00
