Document ID: EPA-HQ-OAR-2008-0503-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-01-16T05:00Z

Dear xxxx:

I am writing in regard to the essential use exemption program, which
allows for the production and import of chlorofluorocarbons (CFCs) for
the manufacture of essential use metered dose inhalers (MDIs).  The
purpose of this letter is threefold: (1) to request the provision of
certain data from companies that wish to receive a 2009 allocation of
essential use allowances; (2) to remind companies that received
essential use allowances in 2007 of their reporting obligations; and (3)
to request essential use data from companies that manufactured essential
use MDIs in 2007 and/or that owned pre-January 1, 1996 CFCs or essential
use CFCs in 2007.  The following paragraphs will explain, in detail, the
information that EPA is seeking.

First, companies that are requesting a 2009 essential use exemption for
the production and import of CFCs for the manufacture of essential use
MDIs must provide information on the amount of CFCs necessary for the
year 2009 by completing the enclosed form, “Year 2009 Essential Use
Allocation: CFC Reporting Form.”  The information you provide will be
shared with the Food and Drug Administration (FDA) and will assist FDA,
in consultation with EPA, in determining the amount of CFCs necessary
for your company to manufacture essential use MDIs in the year 2009. 
Please note that FDA will compare the data that you provide in response
to this letter to data submitted to FDA in annual reports, where
available.  Please provide this information to EPA by January 30, 2008.

EPA is requiring this information under section 114(a) of the Clean Air
Act (Act).  Pursuant to section 114(a), for the purpose of carrying out
any provision of the Act, the Administrator 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, providing this information
is mandatory.

Second, as required by 40 CFR 82.13(u)(2), companies that received
essential use allowances in 2007 are to report end-of-the-year data to
EPA within 30 days of the end of the control period (January 30, 2008). 
EPA reminds you of this obligation and for your convenience is attaching
the fifth page from the Essential Use Allowance Report titled,
“Essential Use Allowance Holder Annual Report.”  This report, in its
entirely, is also available on the Stratospheric Ozone Protection
Program’s website at: http://www.epa.gov/ozone/record/classone.html. 
Completing this annual report allows you to fulfill two reporting
requirements: (1) the essential use accounting framework and (2) the
annual report for essential use allowance holders.  

Third, EPA is requesting essential use data from companies that did not
receive essential use allowances in 2007 but that manufactured essential
use MDIs in 2007 and/or owned pre-January 1, 1996 CFCs or essential use
CFCs in 2007.  EPA is requesting that you complete the attached
“Essential Use Allowance Holder Annual Report,” and that you submit
it to EPA by January 30, 2008.  EPA will use data provided to track the
type and quantity of essential use MDIs produced in the United States,
and the type and quantity of pre-January 1, 1996 CFCs and essential use
CFCs owned by pharmaceutical companies.  In addition, EPA will use data
provided, in aggregate, to complete the 2007 United States Accounting
Framework for Essential Uses.  

Please note that pursuant to regulations 40 CFR Part 2, Subpart B, you
are entitled to assert a business confidentiality claim covering any
part or all 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.  

An original signed copy of the requested information should be submitted
to: 

Kirsten M. Cappel

Stratospheric Protection Division (mail code: 6205J)

U.S. Environmental Protection Agency 

1200 Pennsylvania Avenue, NW

Washington, DC 20460

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

Kirsten M. Cappel

Office Number: 1047C

Stratospheric Protection Division 

U.S. Environmental Protection Agency 

1310 L Street, NW

Washington, DC 20005

Thank you for your assistance in this matter.  If you have any
questions, please contact Kirsten Cappel of my staff by telephone at
(202) 343-9556 or by email at cappel.kirsten@epa.gov.  

				Sincerely,

					Ross Brennan, Chief

					Stratospheric Program Implementation Branch 

Enclosures

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