[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44001-44003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18573]
[[Page 44001]]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-9442-9]
Protection of Stratospheric Ozone: Request for Applications for
Essential Use Allowances for 2013 and 2014
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency is requesting applications
for essential use allowances for calendar years 2013 and 2014.
Essential use allowances provide exemptions from the phaseout of
production and import of ozone-depleting substances. Essential use
allowances 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 nomination of essential uses at the 24th Meeting of the Parties
to the Protocol, to be held in 2012.
DATES: Applications for essential use allowances must be submitted to
EPA no later than September 20, 2011 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 application materials to: Jeremy Arling, 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 1047E.
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: Jeremy Arling at the above address, or
by telephone at (202) 343-9055, by fax at (202) 343-2338, or by e-mail
at [email protected]. Information about essential uses may be
obtained from EPA's stratospheric protection Web site at http://www.epa.gov/ozone/title6/exemptions/essential.html.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background on the Essential Use Nomination Process
II. Information Required for Essential Use Applications for
Production or Import of Class I Substances in 2013 and 2014
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 addition, the user should consult recent
and ongoing rulemakings by the Food and Drug Administration (FDA)
concerning the essential use determination of various MDI moieties. In
particular, users should consider FDA's November 19, 2008, final
rulemaking that removes the essential use designation for epinephrine
used in MDIs as of December 31, 2011 (73 FR 69532). Users should also
consider FDA's April 14, 2010, rulemaking that removes the essential
use designations for flunisolide, triamcinolone, metaproterenol,
pirbuterol, albuterol and ipratropium in combination, cromolyn, and
nedocromil used in MDIs at various dates depending upon the inhaler (75
FR 19213).
Users requesting essential use allowances for calendar years 2013
and 2014 should send a completed application to EPA on the candidate
use. The application should include information that U.S. Government
agencies and the Parties to the Protocol can use to evaluate the
candidate use according to the criteria in the Decisions described
above.
Upon receipt of applications, EPA reviews the information and works
with other interested Federal agencies to determine whether the
candidate use meets the essential use criteria and warrants nomination
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 is to ensure 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 by the United Nations Ozone Secretariat to the Montreal
Protocol's Technical and Economic Assessment Panel (TEAP) and its
Medical Technical Options Committee (MTOC), which reviews the
submissions and makes
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recommendations to the Parties for essential use exemptions. The
Parties then consider those recommendations at their annual meeting
before making a 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.
Applicants should also be aware that the Parties last authorized an
essential use exemption for United States in 2008 for the 2010 calendar
year.
The Parties review nominations for essential use exemptions for the
following year and subsequent years. This means that, if nominated,
applications submitted in response to today's notice for an exemption
in 2013 and 2014 will be considered by the Parties in 2012 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 Clean Air Act.
II. Information Required for Essential Use Applications for Production
or Import of Class I Substances in 2013 and 2014
Through this action, EPA requests applications for essential use
exemptions for all class I substances, except methyl bromide, for
calendar years 2013 and 2014. This notice is the last opportunity to
submit new or revised applications for 2013. This notice is also the
first opportunity to submit requests for 2014. Companies will have an
opportunity in 2012 to submit new, supplemental, or amended
applications for 2014. All requests for exemptions submitted to EPA
should present information as requested in the current version of the
TEAP Handbook on Essential Use Nominations, which was updated in 2009.
The handbook is available electronically on the Web at http://ozone.unep.org/teap/Reports/TEAP_Reports/EUN-Handbook2009.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).
In addition, entities should address the following points to ensure
that their applications are clear and complete. First, entities that
request CFCs for multiple companies should clearly state the amount of
CFCs requested for each company. Second, all essential use applications
for CFCs should 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 CFCs to
be nominated by the U.S. Government for the years 2013 and 2014. Third,
all new drug application (NDA) holders for CFC MDI products produced in
the United States should 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
should determine the total amount of CFCs necessary to produce the NDA
holder's entire product line of CFC MDIs. The NDA holder should 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).
Finally, consistent with Decision XIX/13 taken in September 2007 at
the 19th Meeting of the Parties, when requesting essential use CFCs for
MDIs, applicants should provide the following information: (1) The
company's commitment to the reformulation of the concerned products;
(2) the timetable in which each reformulation process may be completed;
and (3) 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.
The accounting framework matrix in the Handbook (Table IV) titled
``Reporting Accounting Framework for Essential Uses Other Than
Laboratory and Analytical Applications'' requests data for the year
2011 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 2011, 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 2011. Because all data necessary
for applicants to complete Table IV will not be available until after
the control period ends on December 31, 2011, 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 titled ``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 each company's
responses and complete the U.S. Accounting Framework for Essential Uses
for submission to the Parties to the Montreal Protocol by the end of
January 2012. 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 educational programs, 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 on these efforts. Applicants should submit their exemption
requests to EPA as noted in the ADDRESSES section above.
The Office of Management and Budget (OMB) has approved the
information
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collection requirements contained in this notice under the provisions
of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned
OMB control number 2060-0170.
Dated: July 18, 2011.
Elizabeth Craig,
Acting Director, Office of Atmospheric Programs.
[FR Doc. 2011-18573 Filed 7-21-11; 8:45 am]
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