Request for Applications for Essential Use Exemptions to the
Production and Import Phaseout of Ozone Depleting Substances Under the
Montreal Protocol for the Years 2007 and 2008
[Federal Register: November 21, 2005 (Volume 70, Number 223)]
[Notices]
[Page 70071-70073]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21no05-39]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7998-6]
Request for Applications for Essential Use Exemptions to the
Production and Import Phaseout of Ozone Depleting Substances Under the
Montreal Protocol for the Years 2007 and 2008
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Through this action, the Environmental Protection Agency is
requesting applications for essential use allowances for calendar years
2007 and 2008. Essential use allowances provide exemptions to the
production and import phaseout of ozone-depleting substances and must
be authorized by the Parties to the Montreal Protocol on Substances
that Deplete the Ozone Layer. The U.S. Government will use the
applications received in response to this notice as the basis for its
[[Page 70072]]
nomination of essential use allowances at the Eighteenth Meeting of the
Parties to the Montreal Protocol on substances that Deplete the Ozone
Layer (the Protocol), to be held in 2006.
DATES: Applications for essential use exemptions must be submitted to
EPA no later than December 21, 2005 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: Hodayah Finman,
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 827M.
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: Hodayah Finman at the above address,
or by telephone at (202) 343-9246, by fax at (202) 343-2337, or by e-
mail at finman.hodayah@epa.gov. General information may be obtained
from EPA's stratospheric protection Web site at http://www.epa.gov/ozone.
Table of Contents
I. Background on the Essential Use Nomination Process
II. Information Required for Essential Use Applications for
Production or Importation of Class I Substances in 2007 and 2008
I. Background--The Essential Use Nomination Process
As described in previous Federal Register (FR) documents,\1\ the
Parties to the Protocol agreed during the Fourth Meeting in Copenhagen
on November 23-25, 1992, to accelerate the phaseout schedules for Class
I ozone-depleting substances. Specifically, the Parties agreed 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.
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\1\ 58 FR 29410, May 20, 1993; 59 FR 52544, October 18, 1994; 60
FR 54349, October 23, 1995; 61 FR 51110, October 30, 1996, 62 FR
51655, October 2, 1997; 63 FR 42629, August 10, 1998; 64 FR 50083,
September 15, 1999; 65 FR 65377, November 1, 2000; and 2001 66 FR
56102, November 6, 2001.
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Decision IV/25 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
taken at 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 a recent final rule
promulgated by the Food and Drug Administration (FDA) (70 FR 17168).
That rule, published April 4, 2005, finalized action by FDA to remove
the essential use designation for albuterol metered-dose inhalers
(MDIs) effective December 31, 2008. Albuterol MDIs containing ozone
depleting substances (ODS) may not be marketed after that effective
date. Users may wish to consider the impact that action has on their
need for essential use CFCs in 2007 and 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 it 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 issue the
necessary exemption from the 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
(CAA or Act). Applicants should be aware that essential use exemptions
granted to the United States under the Protocol in recent years have
been limited to chlorofluorocarbons (CFCs) for metered dose inhalers
(MDIs) to treat asthma and chronic obstructive
[[Page 70073]]
pulmonary disease, and methyl chloroform for use in manufacturing solid
rocket motors.
The timing of this process is typically 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 2007 and 2008 may be
considered by the Parties in 2006 for final action. The quantities of
controlled ODSs 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 (EUAs) to the specific U.S.
companies through notice and comment rulemaking, to the extent that
such allocations are consistent with the CAA.
II. Information Required for Essential Use Applications for Production
or Importation of Class I Substances in 2007 and 2008
Through this action, EPA requests applications for essential use
exemptions for all class I substances, except methyl bromide, for
calendar years 2007 and 2008. This notice is the last opportunity to
submit new or revised applications for 2007. This notice is also the
first opportunity to submit requests for 2008. Companies will have an
opportunity to submit new, supplemental, or amended applications for
2008 next year. All requests for exemptions submitted to EPA must
present information as prescribed in the current version of the TEAP
``Handbook on Essential Use Nominations'' (or ``handbook''), which was
published in June 2001. The handbook is available electronically on the
Web at http://www.teap.org 
or at http://www.epa.gov/ozone.
In brief, the TEAP Handbook states that applicants must present
information on:
? Role of use in society;
? Alternatives to use;
? Steps to minimize use;
? Steps to minimize emissions;
? 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 pharmaceutical 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
of EUAs will allow EPA and the Food and Drug Administration to make
informed decisions on the amount of CFC to be nominated by the U.S.
Government for the years 2007 and 2008. 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 EUAs. 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 45).
The accounting framework matrix in the handbook entitled ``Table
IV: Reporting Accounting Framework for Essential Uses Other Than
Laboratory and Analytical'' requests data for the year 2005 on the
amount of ODS exempted for an essential use, the amount acquired by
production, the amount acquired by import, the amount on hand at the
start of the year, the amount available for use in 2005, 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
2005. Because all data necessary for applicants to complete Table IV
will not be available until after January 1, 2006, companies should not
include this chart with their EUA applications in response to this
action. Instead, companies should provide the required data as
specified in 40 CFR 82.13(u)(2). EPA will compile companies' responses
to complete the U.S. CFC Accounting Framework for submission to the
Parties to the Montreal Protocol by the end of January.
EPA anticipates that the Parties' review of MDI essential use
requests will focus extensively on the United States' progress in
developing alternatives to 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 the 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 at
the beginning of today's document.
Dated: November 14, 2005.
Edward Callahan,
Acting Director, Office of Air and Radiation.
[FR Doc. 05-22890 Filed 11-18-05; 8:45 am]
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