[Federal Register Volume 70, Number 223 (Monday, November 21, 2005)]
[Notices]
[Pages 70071-70073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22890]


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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 [email protected]. 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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