Environmental Protection Agency (EPA).
The Environmental Protection Agency (EPA) is requesting applications for essential use allowances for calendar years 2008 and 2009. 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 use allowances at the Nineteenth Meeting of the Parties to the Protocol, to be held in 2007.
Applications for essential use exemptions must be submitted to EPA no later than January 4, 2007 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.
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).Start Further Info
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 firstname.lastname@example.org. General information may be obtained from EPA's stratospheric protection Web site at http://www.epa.gov/ozone.End Further Info End Preamble Start Supplemental Information
Table of Contents
I. Background on the Essential Use Nomination Process
II. Information Required for Essential Use Start Printed Page 70513Applications for Production or Importation of Class I Substances in 2008 and 2009
I. Background—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 (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.
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 the final rule promulgated by the Food and Drug Administration (FDA) on April 4, 2005 (70 FR 17168), which removed the essential use designation for albuterol MDIs effective December 31, 2008. Albuterol MDIs containing ODSs may not be marketed after that effective date. Users may wish to consider the impact of that action on their need for essential use CFCs in 2008.
Users should send a completed application to EPA on the candidate use and provide information for U.S. Government agencies and the Protocol Parties to evaluate the candidate use according to the criteria in the Decisions noted above.
Upon receipt of the essential use exemption 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 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 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 (the 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, and methyl chloroform for use in manufacturing solid rocket motors.
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 2008 and 2009 will be considered by the Parties in 2007 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 Act.
II. Information Required for Essential Use Applications for Production or Importation of Class I Substances in 2008 and 2009
Through this action, EPA requests applications for essential use exemptions for all class I substances, except methyl bromide, for calendar years 2008 and 2009. This notice is the last opportunity to submit new or revised applications for 2008. This notice is also the first opportunity to submit requests for 2009. Companies will have an opportunity to submit new, supplemental, or amended applications for 2009 next year. 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 that entities (such as the International Pharmaceutical Aerosol Consortium) who request 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 will Start Printed Page 70514allow EPA and FDA to make informed decisions on the amount of CFC to be nominated by the U.S. Government for the years 2008 and 2009. 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 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 the information specified in the supplemental research and development form (page 46).
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 2006 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 2006, 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 2006. Because all data necessary for applicants to complete Table IV will not be available until after January 1, 2007, companies should not include this chart with their essential use applications in response to this notice. Instead, companies should provide the required data as specified at 40 CFR 82.13(u)(2). To assist companies in reporting this data, EPA will provide MDI manufacturers with a template to use. 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 2007. EPA may also request additional information from companies to support its 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's 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, particularly in the case of albuterol MDIs where a phaseout date has been set by FDA. 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. Applicants should submit their exemption requests to EPA as noted in the Addresses section above.Start Signature
Dated: November 28, 2006.
Brian J. McLean,
Director, Office of Atmospheric Programs.
[FR Doc. E6-20541 Filed 12-4-06; 8:45 am]
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