[Federal Register: December 3, 2007 (Volume 72, Number 231)]
[Notices]
[Page 67930-67932]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de07-60]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-8500-5]
Protection of Stratospheric Ozone: Request for Applications for
Essential Use Allowances for 2009 and 2010
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 2009 and
2010. 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 uses at the Twentieth Meeting of the
Parties to the Protocol, to be held in 2008.
DATES: Applications for essential use allowances must be submitted to
EPA no later than January 2, 2008 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/strathome.html
.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background on the Essential Use Nomination Process
[[Page 67931]]
II. Information Required for Essential Use Applications for
Production or Import of Class I Substances in 2009 and 2010
I. Background on 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
(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 import 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 doing so, the user should consult recent
and ongoing rulemakings by the Food and Drug Administration (FDA)
concerning the essential use determination of various moieties for
MDIs.
Users should send a completed application to EPA on the candidate
use including information for U.S. Government agencies and the Parties
to Protocol to evaluate the candidate use according to the criteria in
the Decisions noted above.
Upon receipt of the essential use allowance 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
Medical Technical Options Committee (MTOC), which review the
submissions and make recommendations to the 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. 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.
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 2009 and
2010 will be considered by the Parties in 2008 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
consistent with the Clean Air Act.
II. Information Required for Essential Use Applications for Production
or Import of Class I Substances in 2009 and 2010
Through this action, EPA requests applications for essential use
exemptions for all class I substances, except methyl bromide, for
calendar years 2009 and 2010. This notice is the last opportunity to
submit new or revised applications for 2009. This notice is also the
first opportunity to submit requests for 2010. Companies will have an
opportunity in 2008 to submit new, supplemental, or amended
applications for 2010. 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 entities that request CFCs for
multiple companies to make clear the amount of CFCs requested for each
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 allow EPA and FDA to make
informed decisions regarding the amount of CFC to be nominated by the
U.S. Government for the years 2009 and 2010. 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
[[Page 67932]]
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 comprehensive
information pertaining to the research and development of alternative
CFC MDI products per Decision VIII/10, para. 1 as specified in the
Supplement to Nomination Request (pg. 46). In addition, consistent with
Decision XIX/13 from the 19th Meeting of the Parties, for each MDI for
which an essential use allowance is requested, applications should
provide the following information to the U.S. Government: the company's
commitment to the reformulation of the concerned products; the
timetable in which each reformulation process may be completed;
evidence that the company is diligently seeking approval of any CFC-
free alternative(s) in its domestic and export markets and
transitioning those markets away from its CFC products. Please note
that this information will not be forwarded to the Ozone Secretariat.
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
2007 on the amount of ODSs 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 2007, 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 2007. Because all data necessary
for applicants to complete Table IV will not be available until after
the control period ends on December 31, 2008, companies should not
include this chart with their essential use applications in response to
this notice. Instead, companies should report their data as required by
40 CFR 82.13(u)(2) in Section 5 of the report entitled ``Essential Use
Allowance Holders and Laboratory Supplier Quarterly Report and
Essential Use Allowance Holder Annual Report.'' This form may be found
on EPA's Web site at http://www.epa.gov/ozone/record/downloads/EssentialUse_ClassI.doc.
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 2008. EPA may also request additional information from
companies to support the U.S. 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' 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. 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. In addition, EPA expects that Parties will be interested in
research and development activities being undertaken by MDI
manufacturers to develop and transition to alternative, CFC-free MDI
products. To this end, applicants are encouraged to provide detailed
information in this regard. Applicants should submit their exemption
requests to EPA as noted in the ADDRESSES section above.
Dated: November 21, 2007.
Brian J. McLean,
Director, Office of Atmospheric Programs.
[FR Doc. E7-23417 Filed 11-30-07; 8:45 am]
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