[Federal Register: December 5, 2006 (Volume 71, Number 233)]
[Notices]
[Page 70512-70514]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de06-31]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-8251-3]
Protection of Stratospheric Ozone: Request for Applications for
Essential Use Exemptions for 2008 and 2009
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is requesting
applications for essential use allowances for calendar years 2008 and
2009. Essential use allowances provide exemptions from the production
and import phaseout of ozone-depleting substances (ODSs) and must be
authorized by the Parties to the Montreal Protocol on Substances that
Deplete the Ozone Layer (the Protocol). The U.S. Government will use
the applications received in response to this notice as the basis for
its nomination of essential use allowances at the Nineteenth Meeting of
the Parties to the Protocol, to be held in 2007.
DATES: Applications for essential use exemptions must be submitted to
EPA no later than January 4, 2007 in order for the U.S. Government to
complete its review and to submit nominations to the United Nations
Environment Programme and the Protocol Parties in a timely manner.
ADDRESSES: Send two copies of application materials to: Kirsten Cappel,
Stratospheric Protection Division (6205J), U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460.
For applications sent via courier service, use the following direct
mailing address: 1310 L Street, NW., Washington, DC, 20005, room 1047C.
Confidentiality: Application materials that are confidential should
be submitted under separate cover and be clearly identified as ``trade
secret,'' ``proprietary,'' or ``company confidential.'' Information
covered by a claim of business confidentiality will be treated in
accordance with the procedures for handling information claimed as
confidential under 40 CFR part 2, subpart B, and will be disclosed only
to the extent and by means of the procedures set forth in that subpart.
Please note that data will be presented in aggregate form by the United
States as part of the nomination to the Parties. If no claim of
confidentiality accompanies the information when it is received by EPA,
the information may be made available to the public by EPA without
further notice to the company (40 CFR 2.203).
FOR FURTHER INFORMATION CONTACT: Kirsten Cappel at the above address,
or by telephone at (202) 343-9556, by fax at (202) 343-2363, or by e-
mail at cappel.kirsten@epa.gov. General information may be obtained
from EPA's stratospheric protection Web site at http://www.epa.gov/ozone
.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background on the Essential Use Nomination Process
II. Information Required for Essential Use
[[Page 70513]]
Applications for Production or Importation of Class I Substances in
2008 and 2009
I. Background--The Essential Use Nomination Process
The Parties to the Protocol agreed during the Fourth Meeting in
Copenhagen on November 23-25, 1992, that non-Article 5 Parties (that
is, developed countries) would phase out the production and consumption
of halons by January 1, 1994, and the production and consumption of
other class I substances (under 40 CFR part 82, subpart A), except
methyl bromide, by January 1, 1996. The Parties also reached decisions
and adopted resolutions on a variety of other matters, including the
criteria to be used for allowing ``essential use'' exemptions from the
phaseout of production and importation of controlled substances.
Decision IV/25 of the Fourth Meeting of the Parties details the
specific criteria and review process for granting essential use
exemptions.
Decision IV/25, paragraph 1(a), states that ``* * * a use of a
controlled substance should qualify as ``essential'' only if: (i) It is
necessary for the health, safety or is critical for the functioning of
society (encompassing cultural and intellectual aspects); and (ii)
there are no available technically and economically feasible
alternatives or substitutes that are acceptable from the standpoint of
environment and health.'' In addition, the Parties agreed ``that
production and consumption, if any, of a controlled substance, for
essential uses should be permitted only if: (i) All economically
feasible steps have been taken to minimize the essential use and any
associated emission of the controlled substance; and (ii) the
controlled substance is not available in sufficient quantity and
quality from the existing stocks of banked or recycled controlled
substances * * *.'' Decision XII/2 of the Twelfth Meeting of the
Parties states that any CFC metered dose inhaler (MDI) product approved
after December 31, 2000, is nonessential unless the product meets the
criteria in Decision IV/25, paragraph 1(a).
The first step in obtaining essential use allowances is for the
user to consider whether the use of the controlled substance meets the
criteria of Decision IV/25. If the essential use request is for an MDI
product, the user should also consider whether the product meets the
criteria of Decision XII/2.
In addition, the user should consult the final rule promulgated by
the Food and Drug Administration (FDA) on April 4, 2005 (70 FR 17168),
which removed the essential use designation for albuterol MDIs
effective December 31, 2008. Albuterol MDIs containing ODSs may not be
marketed after that effective date. Users may wish to consider the
impact of that action on their need for essential use CFCs in 2008.
Users should send a completed application to EPA on the candidate
use and provide information for U.S. Government agencies and the
Protocol Parties to evaluate the candidate use according to the
criteria in the Decisions noted above.
Upon receipt of the essential use exemption application, EPA
reviews the information provided and works with other interested
Federal agencies to determine whether the use meets the essential use
criteria and warrants being nominated by the United States for an
exemption. In the case of multiple exemption requests for a single use,
such as for MDIs, EPA aggregates exemption requests received from
individual entities into a single U.S. request. An important part of
the EPA review of requests for CFCs for MDIs is to determine that the
aggregate request for a particular future year adequately reflects the
total market need for CFC MDIs and expected availability of CFC
substitutes by that point in time. If the sum of individual requests
does not account for such factors, the U.S. government may adjust the
aggregate request to better reflect true market needs.
Nominations submitted by the United States and other Parties are
forwarded from the United Nations Ozone Secretariat to the Montreal
Protocol's Technical and Economic Assessment Panel (TEAP) and its
Technical Options Committees (TOCs), which review the submissions and
make recommendations to the Protocol Parties for essential use
exemptions. Those recommendations are then considered by the Parties at
their annual meeting for final decision. If the Parties declare a
specified use of a controlled substance as essential, and authorize an
exemption from the Protocol's production and consumption phaseout, EPA
may propose regulatory changes to reflect the decisions by the Parties,
but only to the extent such action is consistent with the Clean Air Act
(the Act). Applicants should be aware that essential use exemptions
granted to the United States under the Protocol in recent years have
been limited to CFCs for MDIs to treat asthma and chronic obstructive
pulmonary disease, and methyl chloroform for use in manufacturing solid
rocket motors.
The timing of the process described above is such that in any given
year the Parties review nominations for essential use exemptions from
the production and consumption phaseout intended for the following year
and subsequent years. This means that, if nominated, applications
submitted in response to today's notice for an exemption in 2008 and
2009 will be considered by the Parties in 2007 for final action. The
quantities of controlled substances that are requested in response to
this notice, if approved by the Parties to the Montreal Protocol, will
then be allocated as essential use allowances to the specific U.S.
companies through notice and comment rulemaking, to the extent that
such allocations are consistent with the Act.
II. Information Required for Essential Use Applications for Production
or Importation of Class I Substances in 2008 and 2009
Through this action, EPA requests applications for essential use
exemptions for all class I substances, except methyl bromide, for
calendar years 2008 and 2009. This notice is the last opportunity to
submit new or revised applications for 2008. This notice is also the
first opportunity to submit requests for 2009. Companies will have an
opportunity to submit new, supplemental, or amended applications for
2009 next year. All requests for exemptions submitted to EPA must
present information as requested in the current version of the TEAP
Handbook on Essential Use Nominations, which was updated in 2005. The
handbook is available electronically on the web at http://ozone.unep.org/teap/Reports/TEAP_Reports/EUN-Handbook2005.pdf
.
In brief, the TEAP Handbook states that applicants should present
information on:
Role of use in society;
Alternatives to use;
Steps to minimize use;
Recycling and stockpiling;
Quantity of controlled substances requested; and
Approval date and indications (for MDIs).
First, in order to obtain complete information from essential use
applicants for CFC MDIs, EPA requires that entities (such as the
International Pharmaceutical Aerosol Consortium) who request CFCs for
multiple companies make clear the amount of CFCs requested for each
member company. Second, all essential use applications for CFCs must
provide a breakdown of the quantity of CFCs necessary for each MDI
product to be produced. This detailed breakdown will
[[Page 70514]]
allow EPA and FDA to make informed decisions on the amount of CFC to be
nominated by the U.S. Government for the years 2008 and 2009. Third,
all new drug application (NDA) holders for CFC MDI products produced in
the United States must submit a complete application for essential use
allowances either on their own or in conjunction with their contract
filler. In the case where a contract filler produces a portion of an
NDA holder's CFC MDIs, the contract filler and the NDA holder must
determine the total amount of CFCs necessary to produce the NDA
holder's entire product line of CFC MDIs. The NDA holder must provide
an estimate of how the CFCs would be split between the contract filler
and the NDA holder in the allocation year. This estimate will be used
only as a basis for determining the nomination amount, and may be
adjusted prior to allocation of essential use allowances. Since the
U.S. Government does not forward incomplete or inadequate nominations
to the Ozone Secretariat, it is important for applicants to provide all
information requested in the Handbook, including the information
specified in the supplemental research and development form (page 46).
The accounting framework matrix in the Handbook (Table IV)
entitled, ``Reporting Accounting Framework for Essential Uses Other
Than Laboratory and Analytical Applications'' requests data for the
year 2006 on the amount of ODS exempted for an essential use, the
amount acquired by production, the amount acquired by import and the
country(s) of manufacture, the amount on hand at the start of the year,
the amount available for use in 2006, the amount used for the essential
use, the quantity contained in exported products, the amount destroyed,
and the amount on hand at the end of 2006. Because all data necessary
for applicants to complete Table IV will not be available until after
January 1, 2007, companies should not include this chart with their
essential use applications in response to this notice. Instead,
companies should provide the required data as specified at 40 CFR
82.13(u)(2). To assist companies in reporting this data, EPA will
provide MDI manufacturers with a template to use. EPA will then compile
companies' responses to complete the U.S Accounting Framework for
Essential Uses for submission to the Parties to the Montreal Protocol
by the end of January 2007. EPA may also request additional information
from companies to support its nomination using its information
gathering authority under Section 114 of the Act.
EPA anticipates that the Parties' review of MDI essential use
requests will focus extensively on the United States's progress in
phasing out CFC MDIs, including education programs to inform patients
and health care providers of the CFC phaseout and the transition to
alternatives, particularly in the case of albuterol MDIs where a
phaseout date has been set by FDA. Accordingly, applicants are strongly
advised to present detailed information on these points, including the
scope and cost of such efforts and the medical and patient
organizations involved in the work. Applicants should submit their
exemption requests to EPA as noted in the Addresses section above.
Dated: November 28, 2006.
Brian J. McLean,
Director, Office of Atmospheric Programs.
[FR Doc. E6-20541 Filed 12-4-06; 8:45 am]
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