Document ID: EPA-HQ-OAR-2007-0297-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-06-08T04:00Z

Dear Mr./Ms. xxxxxx:

	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 twofold: (1) to request the provision of
certain data from companies that wish to receive a 2008 allocation of
essential use allowances; and (2) to remind companies that received
essential use allowances in 2006 of their reporting obligations.  The
following paragraphs will explain, in detail, the information that EPA
is seeking.

First, companies that are requesting a 2008 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 2008 by completing the enclosed form, “Year 2008 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 2008. 
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, 2007.

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 2006 are to report end-of-the-year data to
EPA within 30 days of the end of the control period (January 30, 2007). 
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 2007
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.  

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:

Year 2008 Essential Use Allocation: CFC Reporting Form

2006 Annual Report- Essential Use Allowance Holder 

	Year 2008 Essential Use Allocation: CFC Reporting Form

Company Name______________________________								

A	B	C	D	E	F	G	H

Product	Number of Units produced from 1/1/06 to 12/31/06	Number of Units
anticipated to be produced in 2007	Number of Units anticipated to be
produced in 2008	Gross Target fill weight per unit (grams)	Total CFC to
be contained in product for 2008 (metric tons)	Additional amount
necessary for production (metric tons)	TOTAL request per product for
2008 (metric tons) 

	

  U.S. Environmental Protection Agency                  

          stratospheric ozone protection program 	class i controlled
substance

quarterly report- essential-use allowance holders and laboratory
supplier and 

annual report- essential-use allowance holder  

(Sec 82.13)

SECTION 5	ANNUAL REPORT: 2006

For 4th Quarter Reporting Only

      

	5.2 Company Totals

A	B	C	D	E	F	G	H	I

Chemical Name	Amount Acquired by Production (kg)	Amount Acquired for
Essential Uses by Import and Country(s) of Manufacture	Amounts On Hand
at the End of the Year (includes 

pre-1996 amounts) (kg)	

Pre-phaseout

 (pre-1996) Stockpiled Amounts Held at the End of Year

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	 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

	 Column F= (Column D)(Column E)

	 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.

	 Total request per product for 2008 (metric tons) = Column F+ Column G

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