Request for Applications for Essential Use Exemptions to the
Production and Import Phaseout of Ozone Depleting Substances Under the
Montreal Protocol for the Years 2006 and 2007
[Federal Register: October 6, 2004 (Volume 69, Number 193)]
[Notices]
[Page 59918-59920]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc04-78]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7824-5]
Request for Applications for Essential Use Exemptions to the
Production and Import Phaseout of Ozone Depleting Substances Under the
Montreal Protocol for the Years 2006 and 2007
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Through this action, the Environmental Protection Agency (EPA)
is requesting applications for essential use allowances for calendar
years 2006 and 2007. 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
[[Page 59919]]
the applications received in response to this notice as the basis for
its nomination of essential use allowances at the Seventeenth Meeting
of the Parties to the Montreal Protocol on Substances that Deplete the
Ozone Layer (the Protocol), to be held in 2005.
DATES: Applications for essential use exemptions must be submitted to
EPA no later than November 5, 2004 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: Scott Monroe,
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.)
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: Scott Monroe at the above address, or
by telephone at (202) 343-9712, by fax at (202) 343-2363, or by e-mail
at monroe.scott@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 Applications for
Production or Importation of Class I Substances in 2006 and 2007
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; 58 FR 52544, October 18, 1994; 60
FR 54349, October 23, 1995; 61 FR 51110, 0 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, 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 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, that product must also meet the criteria of Decision XII/2.
The user should then send a completed application in order to notify
EPA of the candidate use and provide information for U.S. Government
agencies and the Protocol Parties to evaluate that use according to the
criteria under the Protocol.
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 pulmonary disease, and methyl chloroform
for use in manufacturing solid rocket motors. As of January 1, 2005,
methyl chloroform will no longer be eligible for essential use
allowances under section 604(d)(1) of the Act. EPA is consulting with
the Department of Defense to identify mission-critical uses for which
methyl
[[Page 59920]]
chloroform or other ozone-depleting substances may be needed in the
future.
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 2006 and
2007 will be considered by the Parties in 2005 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 in
2005, 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 Act. EUAs for the
year 2006 will be allocated to U.S. companies at the end of 2005, and
EUAs for the year 2007 will be allocated at the end of 2006.
II. Information Required for Essential Use Applications for Production
or Importation of Class I Substances in 2006 and 2007
Through this action, EPA requests applications for essential use
exemptions for all class I substances, except methyl bromide, for
calendar years 2006 and 2007. (EPA requests and considers applications
for critical use exemptions for methyl bromide through a separate
process.) This notice is the last opportunity to submit new or revised
applications for 2006. This notice is also the first opportunity to
submit requests for 2007. Companies will have an opportunity to submit
new, supplemental, or amended applications for 2007 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 any person who requests 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 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 2006
and 2007. 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 cannot 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 2004 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 2004, 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
2004. Because all data necessary for applicants to complete Table IV
will not be available until after January 1, 2005, companies should not
include this chart with their EUA applications in response to this
notice. Instead, companies should provide the required data as
specified in 40 CFR 82.13(u)(2). EPA must 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
phasing out CFC MDIs, including efforts by pharmaceutical companies to
research, develop, and market non-CFC products. Accordingly, applicants
are strongly advised to present detailed information on this subject.
Applicants should submit their exemption requests to EPA as noted in
the ADDRESSES section above.
Dated: September 28, 2004.
Jeffrey R. Holmstead,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 04-22487 Filed 10-5-04; 8:45 am]
BILLING CODE 6560-50-P