SAMPLE 114 LETTER for CFC Stocks Owned

Dear Sir or Madam:

	  SEQ CHAPTER \h \r 1 I am writing in regard to the essential use
exemption program, which allows for the production and importation of
chlorofluorocarbons (CFCs) for certain medical devices.  Specifically,
the Environmental Protection Agency (EPA) is asking companies to provide
information to EPA on the stocks of CFCs currently owned by your
company.  This information will assist EPA and the Food and Drug
Administration (FDA) to determine the size of the 2007 essential use
allocation exemption.

	Each year since the phase-out of Class I ozone-depleting substances
(ODSs) in 1996, the U.S. has asked the Parties to the Montreal Protocol
to approve production and import of specified quantities of CFCs for use
in metered dose inhalers (MDIs).  Once the Parties have approved the
requested quantities, EPA then allocates “essential use allowances”
as rights to import or produce CFCs 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.  This
section requires that 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. 

	Therefore, EPA is requesting that you provide information on stocks of
pre-1996 CFCs and post 1996 CFCs owned by your company as of May 1,
2006.  Please make sure to provide separate sub-totals for pre- and post
1996 material.  EPA considers stocks to be owned by you even if they are
physically held by another company on your behalf and not in your
possession.   

	EPA is requiring this information under section 114(a) of the Clean Air
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), providing this information is
mandatory.

	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.  Please note, EPA
does not consider aggregate stocks data across all companies to be
confidential business information even if individual company data is
claimed confidential and treated as such.

	Please submit the requested information within 20 days of the date of
this letter.  An original signed copy of the form should be submitted
to:

	Hodayah Finman

	Stratospheric Protection 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:

	Hodayah Finman

	Stratospheric Protection Division

	U.S. Environmental Protection Agency

	1310 L Street, NW (827 M)

	Washington, DC  20005-4113.

							

	Thank you for your assistance.  If you have any questions, please
contact me by phone at (202) 343-9246 or by e-mail at
finman.hodayah@epa.gov.

						Sincerely,

						

						Hodayah Finman

						Team Leader

						Stratospheric Protection Division

						Office of Atmospheric Programs

