Protection of Stratospheric Ozone: Request for Applications for Essential Use Allowances for 2012 and 2013, 42747-42749 [2010-17964]

Download as PDF Federal Register / Vol. 75, No. 140 / Thursday, July 22, 2010 / Notices Issued in Golden, CO on July 15, 2010. Jamie Harris, Director, Office of Acquisition and Financial Assistance, Golden Field Office. [FR Doc. 2010–17987 Filed 7–21–10; 8:45 am] BILLING CODE 6450–01–P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD10–15–000] Smart Grid Update; Notice of Commissioner and Staff Attendance at FERC/NARUC Collaborative on Smart Response Meeting July 15, 2010. The Federal Energy Regulatory Commission hereby gives notice that members of the Commission and/or Commission staff may attend the following meeting: FERC/NARUC Collaborative on Smart Response: Sacramento Convention Center, 1400 J Street, Sacramento, CA 95814. July 18, 2010 (8:15 a.m.–12:30 p.m.) Further information may be found at https://summer.narucmeetings.org/ program.cfm. Kimberly D. Bose, Secretary. [FR Doc. 2010–17888 Filed 7–21–10; 8:45 am] BILLING CODE 6717–01–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9178–4] Protection of Stratospheric Ozone: Request for Applications for Essential Use Allowances for 2012 and 2013 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: sroberts on DSKD5P82C1PROD with NOTICES Table of Contents The Environmental Protection Agency is requesting applications for essential use allowances for calendar years 2012 and 2013. 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 23rd Meeting of the Parties to the Protocol, to be held in 2011. SUMMARY: VerDate Mar<15>2010 18:46 Jul 21, 2010 Jkt 220001 Applications for essential use allowances must be submitted to EPA no later than August 23, 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 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 arling.jeremy@epa.gov. Information about essential uses may be obtained from EPA’s stratospheric protection Web site at https://www.epa.gov/ozone/ title6/exemptions/essential.html. SUPPLEMENTARY INFORMATION: DATES: I. Background on the Essential Use Nomination Process II. Information Required for Essential Use Applications for Production or Import of Class I Substances in 2012 and 2013 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, PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 42747 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). E:\FR\FM\22JYN1.SGM 22JYN1 sroberts on DSKD5P82C1PROD with NOTICES 42748 Federal Register / Vol. 75, No. 140 / Thursday, July 22, 2010 / Notices Users requesting essential use allowances for calendar years 2012 and 2013 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 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 2012 VerDate Mar<15>2010 18:46 Jul 21, 2010 Jkt 220001 and 2013 will be considered by the Parties in 2011 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 2012 and 2013 Through this action, EPA requests applications for essential use exemptions for all class I substances, except methyl bromide, for calendar years 2012 and 2013. This notice is the last opportunity to submit new or revised applications for 2012. This notice is also the first opportunity to submit requests for 2013. Companies will have an opportunity in 2011 to submit new, supplemental, or amended applications for 2013. 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 https://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 2012 and 2013. 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 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 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 2010 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 2010, 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 2010. Because all data necessary for applicants to complete Table IV will not be available until after the control period ends on December 31, 2010, 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.’’ E:\FR\FM\22JYN1.SGM 22JYN1 Federal Register / Vol. 75, No. 140 / Thursday, July 22, 2010 / Notices This form may be found on EPA’s Web site at https://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 2011. 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: July 14, 2010. Jackie Krieger, Acting Director, Office of Atmospheric Programs. bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at www.ffiec.gov/nic/. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 16, 2010. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414: 1. C-B-G, Inc., West Liberty, Iowa, to acquire additional shares for a total of up to 50.01 percent, of Washington Bancorp, Washington, Iowa, and thereby acquire shares of Federation Bank, Washington, Iowa. Board of Governors of the Federal Reserve System, July 19, 2010. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 2010–17900 Filed 7–21–10; 8:45 am] BILLING CODE 6210–01–S [FR Doc. 2010–17964 Filed 7–21–10; 8:45 am] FEDERAL TRADE COMMISSION BILLING CODE 6560–50–P [File No. 091 0032] FEDERAL RESERVE SYSTEM sroberts on DSKD5P82C1PROD with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or VerDate Mar<15>2010 18:46 Jul 21, 2010 Jkt 220001 Fidelity National Financial, Inc.; Analysis of the Agreement Containing Consent Order to Aid Public Comment Federal Trade Commission. Proposed Consent Agreement. AGENCY: ACTION: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the SUMMARY: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 42749 consent order — embodied in the consent agreement — that would settle these allegations. DATES: Comments must be received on or before August 16, 2010. ADDRESSES: Interested parties are invited to submit written comments electronically or in paper form. Comments should refer to ‘‘Fidelity National Financial, File No. 091 0032’’ to facilitate the organization of comments. Please note that your comment — including your name and your state — will be placed on the public record of this proceeding, including on the publicly accessible FTC website, at (https://www.ftc.gov/os/ publiccomments.shtm). Because comments will be made public, they should not include any sensitive personal information, such as an individual’s Social Security Number; date of birth; driver’s license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. Comments also should not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, comments should not include any ‘‘[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential. . . .,’’ as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and Commission Rule 4.10(a)(2), 16 CFR 4.10(a)(2). Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled ‘‘Confidential,’’ and must comply with FTC Rule 4.9(c), 16 CFR 4.9(c).1 Because paper mail addressed to the FTC is subject to delay due to heightened security screening, please consider submitting your comments in electronic form. Comments filed in electronic form should be submitted by using the following weblink: (https:// public.commentworks.com/ftc/ fidelitynationalfinancial) and following the instructions on the web-based form. To ensure that the Commission considers an electronic comment, you must file it on the web-based form at the weblink: (https:// public.commentworks.com/ftc/ fidelitynationalfinancial). If this Notice 1 The comment must be accompanied by an explicit request for confidential treatment, including the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. The request will be granted or denied by the Commission’s General Counsel, consistent with applicable law and the public interest. See FTC Rule 4.9(c), 16 CFR 4.9(c). E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[Federal Register Volume 75, Number 140 (Thursday, July 22, 2010)]
[Notices]
[Pages 42747-42749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17964]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9178-4]


Protection of Stratospheric Ozone: Request for Applications for 
Essential Use Allowances for 2012 and 2013

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency is requesting applications 
for essential use allowances for calendar years 2012 and 2013. 
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 23rd Meeting of the Parties 
to the Protocol, to be held in 2011.

DATES: Applications for essential use allowances must be submitted to 
EPA no later than August 23, 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 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 arling.jeremy@epa.gov. Information about essential uses may be 
obtained from EPA's stratospheric protection Web site at https://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 2012 and 2013

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).

[[Page 42748]]

    Users requesting essential use allowances for calendar years 2012 
and 2013 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 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 2012 and 2013 will be considered by the Parties in 2011 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 2012 and 2013

    Through this action, EPA requests applications for essential use 
exemptions for all class I substances, except methyl bromide, for 
calendar years 2012 and 2013. This notice is the last opportunity to 
submit new or revised applications for 2012. This notice is also the 
first opportunity to submit requests for 2013. Companies will have an 
opportunity in 2011 to submit new, supplemental, or amended 
applications for 2013. 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 https://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 2012 and 2013. 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 
2010 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 2010, 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 2010. Because all data necessary 
for applicants to complete Table IV will not be available until after 
the control period ends on December 31, 2010, 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.''

[[Page 42749]]

This form may be found on EPA's Web site at https://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 2011. 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: July 14, 2010.
Jackie Krieger,
Acting Director, Office of Atmospheric Programs.
[FR Doc. 2010-17964 Filed 7-21-10; 8:45 am]
BILLING CODE 6560-50-P
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