[Federal Register Volume 71, Number 233 (Tuesday, December 5, 2006)]
[Notices]
[Pages 70512-70514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20541]


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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 [email protected]. 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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