Dear Stakeholder:

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 data from companies
that wish to receive an allocation of essential use allowances in 2010;
(2) to remind companies that received essential use allowances in 2008
of their reporting obligations; and (3) to request data from companies
that manufactured essential use MDIs in 2008 and/or that owned
pre-January 1, 1996 CFCs or essential use CFCs in 2008.  The following
paragraphs will explain, in detail, the information that EPA is seeking.

First, companies that are requesting an exemption for the production and
import of CFCs in 2010 for the manufacture of essential use MDIs must
provide information on the amount of CFCs necessary for the year 2010 by
completing the enclosed form, “Year 2010 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 2010.  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, 2009.

EPA is requiring this information under section 114(a) of the Clean Air
Act (Act).  Pursuant to section 114(a), 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 for the
purpose of carrying out any provision of the Act.  Therefore, in
accordance with section 114(a)(1) of the Act, it is mandatory for
companies to provide this information.

Second, as required by 40 CFR 82.13(u)(2), companies that received
essential use allowances in 2008 are to report end-of-the-year data to
EPA within 30 days of the end of the control period (January 30, 2009). 
EPA reminds you of this obligation and is attaching a template,
“Annual Report - Essential Use Allowance Holder” to assist you in
reporting your data.  The template is an excerpt from the annual
essential use allowance holder report that will be used for 2008
reporting.  This template 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 2008 but that manufactured essential
use MDIs in 2008 and/or owned pre-January 1, 1996 CFCs or essential use
CFCs in 2008.  EPA is requesting that you complete the attached
“Annual Report - Essential Use Allowance Holder,” and that you
submit it to EPA by January 30, 2009.  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 2008 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: 

Jennifer Bohman

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:

Jennifer Bohman

Office Number: 1047A

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 Jennifer Bohman of my staff by telephone at
(202) 343-9548 or by email at bohman.jennifer@epa.gov.  

				Sincerely,

					Ross Brennan, Chief

					Stratospheric Program Implementation Branch 

Enclosures

 

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