[Federal Register Volume 74, Number 244 (Tuesday, December 22, 2009)]
[Notices]
[Pages 68060-68062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-30404]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9094-3]


Protection of Stratospheric Ozone: Request for Applications for 
Essential Use Allowances for 2011 and 2012

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 2011 and 
2012. Essential use allowances provide exemptions from the phaseout of 
production and import of ozone-depleting substances (ODSs). Essential 
use allowances 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 22nd 
Meeting of the Parties to the Protocol, to be held in 2010.

DATES: Applications for essential use allowances must be submitted to 
EPA no later than January 21, 2010 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: Jennifer 
Bohman, Stratospheric Protection

[[Page 68061]]

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 1047A.
    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: Jennifer Bohman at the above address, 
or by telephone at (202) 343-9548, 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/strathome.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 2010 and 2011

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) and FDA's June 11, 
2007 proposed rulemaking that proposes removing the essential use 
designations for flunisolide, triamcinolone, metaproterenol, 
pirbuterol, albuterol and ipratropium in combination, cromolyn, and 
nedocromil used in MDIs as of December 31, 2009 (72 FR 32030).
    Users requesting essential use allowances for calendar years 2011 
and 2012 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 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. 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 2011 and 2012 will be considered by the Parties in 2010 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.

[[Page 68062]]

II. Information Required for Essential Use Applications for Production 
or Import of Class I Substances in 2011 and 2012

    Through this action, EPA requests applications for essential use 
exemptions for all class I substances, except methyl bromide, for 
calendar years 2011 and 2012. This notice is the last opportunity to 
submit new or revised applications for 2011. This notice is also the 
first opportunity to submit requests for 2012. Companies will have an 
opportunity in 2010 to submit new, supplemental, or amended 
applications for 2012. 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 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).

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 2011 and 2012. 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) entitled 
``Reporting Accounting Framework for Essential Uses Other Than 
Laboratory and Analytical Applications'' requests data for the year 
2009 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 2009, 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 2009. Because all data necessary 
for applicants to complete Table IV will not be available until after 
the control period ends on December 31, 2009, 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 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 2010. 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 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: December 3, 2009.
Brian J. McLean,
Director, Office of Atmospheric Programs.
[FR Doc. E9-30404 Filed 12-21-09; 8:45 am]
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