Protection of Stratospheric Ozone: Request for Applications for Essential Use Allowances for 2009 and 2010, 67930-67932 [E7-23417]

Download as PDF mstockstill on PROD1PC66 with NOTICES 67930 Federal Register / Vol. 72, No. 231 / Monday, December 3, 2007 / Notices Accession Number: 20071126–0214. Comment Date: 5 p.m. Eastern Time on Friday, December 14, 2007. Docket Numbers: ER08–255–000. Applicants: Pacific Gas and Electric Company. Description: Offer of Settlement and Stipulation and Appendices re PacifiCorp, Pacific Gas and Electric Co et al. under ER07–882 et al. Filed Date: 11/21/2007. Accession Number: 20071121–0123. Comment Date: 5 p.m. Eastern Time on Friday, December 7, 2007. Take notice that the Commission received the following electric securities filings: Docket Numbers: ES07–52–001. Applicants: Northern Indiana Public Service Company. Description: Northern Indiana Public Service Company submit a supplement to Exhibit 1 and on 11/27/07 submit an additional supplement. Filed Date: 11/26/2007; 11/27/2007. Accession Number: 20071126–5013; 20071127–5011. Comment Date: 5 p.m. Eastern Time on Thursday, December 6, 2007. Docket Numbers: ES07–57–001. Applicants: Northeast Utilities Service Company. Description: Supplemental Filing of Northeast Utilities Service Company. Filed Date: 11/21/2007. Accession Number: 20071121–5146. Comment Date: 5 p.m. Eastern Time on Thursday, December 6, 2007. Docket Numbers: ES07–63–001. Applicants: ITC Midwest LLC. Description: ITC Midwest LLC Submission of Exhibit B. Filed Date: 10/04/2007. Accession Number: 20071004–5037. Comment Date: 5 p.m. Eastern Time on Thursday, November 29, 2007. Docket Numbers: ES08–6–000. Applicants: Southwestern Electric Power Company. Description: Form 523—Request for Permission to Issue Securities of Southwestern Electric Power Company. Filed Date: 11/26/2007. Accession Number: 20071126–5059. Comment Date: 5 p.m. Eastern Time on Monday, December 17, 2007. Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission’s Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests VerDate Aug<31>2005 16:17 Nov 30, 2007 Jkt 214001 will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant. The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http:// www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests. Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426. The filings in the above proceedings are accessible in the Commission’s eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission’s Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email FERCOnlineSupport@ferc.gov or call (866) 208–3676 (toll free). For TTY, call (202) 502–8659. Nathaniel J. Davis, Sr., Deputy Secretary. [FR Doc. E7–23329 Filed 11–30–07; 8:45 am] BILLING CODE 6717–01–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8500–5] Protection of Stratospheric Ozone: Request for Applications for Essential Use Allowances for 2009 and 2010 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) is requesting applications for essential use allowances for calendar years 2009 and 2010. Essential use SUMMARY: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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. 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. DATES: 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). ADDRESSES: 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 E:\FR\FM\03DEN1.SGM 03DEN1 Federal Register / Vol. 72, No. 231 / Monday, December 3, 2007 / Notices II. Information Required for Essential Use Applications for Production or Import of Class I Substances in 2009 and 2010 mstockstill on PROD1PC66 with NOTICES 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 VerDate Aug<31>2005 16:17 Nov 30, 2007 Jkt 214001 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 67931 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 E:\FR\FM\03DEN1.SGM 03DEN1 mstockstill on PROD1PC66 with NOTICES 67932 Federal Register / Vol. 72, No. 231 / Monday, December 3, 2007 / Notices 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 VerDate Aug<31>2005 16:17 Nov 30, 2007 Jkt 214001 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] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8500–4] Tentative Approval and Solicitation of Request for a Public Hearing for Public Water System Supervision Program Revision for the State of New York Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: Notice is hereby given that the New York State is revising its approved Public Water System Supervision Program. EPA has determined that these revisions are no less stringent than the corresponding Federal regulations. Therefore, EPA intends to approve these program PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 revisions. All interested parties may request a public hearing. DATES: This determination to approve New York State’s primacy program revision application is made pursuant to 40 CFR 142.12(d)(3). It shall become final and effective unless (1) a timely and appropriate request for a public hearing is received or (2) the Regional Administrator elects to hold a public hearing on his own motion. Any interested persons, other than Federal Agencies, may request a public hearing. A request for a public hearing must be submitted to the Regional Administrator at the address shown below by January 2, 2008. If substantial requests for a public hearing are made within the requested thirty day time frame, a public hearing will be held and a notice will be given in the Federal Register and a newspaper of general circulation. Frivolous or insubstantial requests for a hearing may be denied by the Regional Administrator. If no timely and appropriate requests for a hearing are received and the Regional Administrator does not elect to hold a hearing on his own motion, this determination shall become final and effective January 2, 2008. Any request for a public hearing shall include the following information: (1) Name, address and telephone number of the individual, organization or other entity requesting a hearing; (2) a brief statement of the requesting person’s interest in the Regional Administrator’s determination and a brief statement on information that the requesting person intends to submit at such hearing; (3) the signature of the individual making the request or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity. Requests for Public Hearing shall be addressed to: Regional Administrator, U.S. Environmental Protection Agency— Region 2, 290 Broadway, New York, New York 10007–1866. All documents relating to this determination are available for inspection between the hours of 9 a.m. and 4:30 p.m., Monday through Friday, at the following offices: New York State Department of Health, Bureau of Public Water Supply Protection, Flanagan Square, 547 River Street, Troy, New York 12180– 2216. U.S. Environmental Protection Agency—Region 2, 24th Floor Drinking Water Section, 290 Broadway, New York, New York 10007–1866. ADDRESSES: E:\FR\FM\03DEN1.SGM 03DEN1

Agencies

[Federal Register Volume 72, Number 231 (Monday, December 3, 2007)]
[Notices]
[Pages 67930-67932]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23417]


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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.

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

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]
BILLING CODE 6560-50-P