Federal Register / Vol. 70, No. 223 / Monday, November 21, 2005 / Notices 70071 

DEPARTMENT OF ENERGY 

Environmental Management SiteSpecific Advisory Board, Oak Ridge 

Reservation 

AGENCY: Department of Energy. 

ACTION: Notice of open meeting. 

SUMMARY: This notice announces a 

meeting of the Environmental 

Management Site-Specific Advisory 

Board (EMSSAB), Oak Ridge 

Reservation. The Federal Advisory 

Committee Act (Pub. L. 92–463, 86 Stat. 

770) requires that public notice of this 

meeting be announced in the Federal 

Register. 

DATES: Wednesday, December 14, 2005, 

6 p.m. 

ADDRESSES: DOE Information Center, 

475 Oak Ridge Turnpike, Oak Ridge, 

Tennessee. 

FOR FURTHER INFORMATION CONTACT: Pat 

Halsey, Federal Coordinator, 

Department of Energy Oak Ridge 

Operations Office, P.O. Box 2001, EM–

90, Oak Ridge, TN 37831. Phone (865) 

576–4025; Fax (865) 576–5333 or e-mail: 

halseypj@oro.doe.gov or check the Web 

site at www.oakridge.doe.gov/em/ssab. 

SUPPLEMENTARY INFORMATION: Purpose of 

the Board: The purpose of the Board is 

to make recommendations to DOE in the 

areas of environmental restoration, 

waste management, and related 

activities. 

Tentative Agenda: Oak Ridge 

Reservation Planning—Integrating 

Multiple Land Uses 

Public Participation: The meeting is 

open to the public. Written statements 

may be filed with the Board either 

before or after the meeting. Individuals 

who wish to make oral statements 

pertaining to the agenda item should 

contact Pat Halsey at the address or 

telephone number listed above. 

Requests must be received five days 

prior to the meeting and reasonable 

provision will be made to include the 

presentation in the agenda. The Deputy 

Designated Federal Officer is 

empowered to conduct the meeting in a 

fashion that will facilitate the orderly 

conduct of business. Individuals 

wishing to make public comment will 

be provided a maximum of five minutes 

to present their comments. 

Minutes: Minutes of this meeting will 

be available for public review and 

copying at the Department of Energy’s 

Information Center at 475 Oak Ridge 

Turnpike, Oak Ridge, TN between 8 

a.m. and 5 p.m., Monday through 

Friday, or by writing to Pat Halsey, 

Department of Energy Oak Ridge 

Operations Office, P.O. Box 2001, EM–

90, Oak Ridge, TN 37831, or by calling 

her at (865) 576–4025. 

Issued at Washington, DC, on November 

15, 2005. 

Carol Matthews, 

Acting Advisory Committee Management 

Officer. 

[FR Doc. 05–23005 Filed 11–18–05; 8:45 am] 

BILLING CODE 6450–01–P 

DEPARTMENT OF ENERGY 

Office of Energy Efficiency and 

Renewable Energy 

Biomass Research and Development 

Technical Advisory Committee 

AGENCY: Department of Energy. 

ACTION: Notice of open meeting. 

SUMMARY: This notice announces an 

open meeting of the Biomass Research 

and Development Technical Advisory 

Committee under the Biomass Research 

and Development Act of 2000. The 

Federal Advisory Committee Act (Pub. 

L. 92–463, 86 Stat. 770) requires that 

agencies publish these notices in the 

Federal Register to allow for public 

participation. 

DATES: November 29th, 2005 at 8 a.m., 

November 30th, 2005 at 9:30 a.m. 

ADDRESSES: Washington Marriott Hotel, 

Ballrooms A&B, 1221 22nd Street, NW., 

Washington, DC 20037. 

FOR FURTHER INFORMATION CONTACT: Neil 

Rossmeissl, Designated Federal Officer 

for the Committee, Office of Energy 

Efficiency and Renewable Energy, U.S. 

Department of Energy, 1000 

Independence Avenue, SW., 

Washington, DC 20585; (202) 586–8668 

or Harriet Foster at (202) 586–4541; Email: harriet.foster@ee.doe.gov 

SUPPLEMENTARY INFORMATION: Purpose of 

Meeting: To provide advice and 

guidance that promotes research and 

development leading to promoting the 

use of bio-based fuels and bio-based 

products. 

Tentative Agenda: Agenda will 

include discussions on the following: 

• Discussion of recommendations 

towards updating the Biomass Vision 

and Roadmap. 

• Discussion of Annual 

Recommendations to the Secretaries of 

Agriculture and Energy. 

• Joint meeting with Interagency 

Biomass R&D Board. 

• Discussion of 2005 and 2006 

Committee Work Plans. 

• Establishment of subcommittees. 

Public Participation: In keeping with 

procedures, members of the public are 

welcome to observe the business of the 

Biomass Research and Development 

Technical Advisory Committee. To 

attend the meeting and/or to make oral 

statements regarding any of the items on 

the agenda, you should contact Neil 

Rossmeissl at 202–586–8668 or the 

Biomass Initiative at 202–586–4541 or 

harriet.foster@ee.doe.gov (e-mail). You 

must make your request for an oral 

statement at least 5 business days before 

the meeting. Members of the public will 

be heard in the order in which they sign 

up at the beginning of the meeting. 

Reasonable provision will be made to 

include the scheduled oral statements 

on the agenda. The Chair of the 

Committee will make every effort to 

hear the views of all interested parties. 

If you would like to file a written 

statement with the Committee, you may 

do so either before or after the meeting. 

The Chair will conduct the meeting to 

facilitate the orderly conduct of 

business. 

Minutes: The minutes of the meeting 

will be available for public review and 

copying at the Freedom of Information 

Public Reading Room; Room 1E–190; 

Forrestal Building; 1000 Independence 

Avenue, SW., Washington, DC, between 

9 a.m. and 4 p.m., Monday through 

Friday, except Federal holidays. 

Issued at Washington, DC, on November 

15, 2005. 

Carol Matthews, 

Acting Advisory Committee Management 

Officer. 

[FR Doc. 05–23004 Filed 11–18–05; 8:45 am] 

BILLING CODE 6450–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–7998–6] 

Request for Applications for Essential 

Use Exemptions to the Production and 

Import Phaseout of Ozone Depleting 

Substances Under the Montreal 

Protocol for the Years 2007 and 2008 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: Through this action, the 

Environmental Protection Agency is 

requesting applications for essential use 

allowances for calendar years 2007 and 

2008. Essential use allowances provide 

exemptions to the production and 

import phaseout of ozone-depleting 

substances and 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 

70072 Federal Register / Vol. 70, No. 223 / Monday, November 21, 2005 / Notices 

1 58 FR 29410, May 20, 1993; 59 FR 52544, 

October 18, 1994; 60 FR 54349, October 23, 1995; 

61 FR 51110, October 30, 1996, 62 FR 51655, 

October 2, 1997; 63 FR 42629, August 10, 1998; 64 

FR 50083, September 15, 1999; 65 FR 65377, 

November 1, 2000; and 2001 66 FR 56102, 

November 6, 2001. 

nomination of essential use allowances 

at the Eighteenth Meeting of the Parties 

to the Montreal Protocol on substances 

that Deplete the Ozone Layer (the 

Protocol), to be held in 2006. 

DATES: Applications for essential use 

exemptions must be submitted to EPA 

no later than December 21, 2005 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: Hodayah 

Finman, 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 827M. 

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: 

Hodayah Finman at the above address, 

or by telephone at (202) 343–9246, by 

fax at (202) 343–2337, or by e-mail at 

finman.hodayah@epa.gov. General 

information may be obtained from 

EPA’s stratospheric protection Web site 

at http://www.epa.gov/ozone. 

Table of Contents 

I. Background on the Essential Use 

Nomination Process 

II. Information Required for Essential Use 

Applications for Production or 

Importation of Class I Substances in 2007 

and 2008 

I. Background—The Essential Use 

Nomination Process 

As described in previous Federal 

Register (FR) documents,1 the Parties to 

the Protocol agreed during the Fourth 

Meeting in Copenhagen on November 

23–25, 1992, to accelerate the phaseout 

schedules for Class I ozone-depleting 

substances. Specifically, the Parties 

agreed 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 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 taken 

at 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 a 

recent final rule promulgated by the 

Food and Drug Administration (FDA) 

(70 FR 17168). That rule, published 

April 4, 2005, finalized action by FDA 

to remove the essential use designation 

for albuterol metered-dose inhalers 

(MDIs) effective December 31, 2008. 

Albuterol MDIs containing ozone 

depleting substances (ODS) may not be 

marketed after that effective date. Users 

may wish to consider the impact that 

action has on their need for essential 

use CFCs in 2007 and 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 it 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 issue the necessary 

exemption from the 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 (CAA or Act). Applicants 

should be aware that essential use 

exemptions granted to the United States 

under the Protocol in recent years have 

been limited to chlorofluorocarbons 

(CFCs) for metered dose inhalers (MDIs) 

to treat asthma and chronic obstructive 

Federal Register / Vol. 70, No. 223 / Monday, November 21, 2005 / Notices 70073 

pulmonary disease, and methyl 

chloroform for use in manufacturing 

solid rocket motors. 

The timing of this process is typically 

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 2007 

and 2008 may be considered by the 

Parties in 2006 for final action. The 

quantities of controlled ODSs 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 (EUAs) to the 

specific U.S. companies through notice 

and comment rulemaking, to the extent 

that such allocations are consistent with 

the CAA. 

II. Information Required for Essential 

Use Applications for Production or 

Importation of Class I Substances in 

2007 and 2008 

Through this action, EPA requests 

applications for essential use 

exemptions for all class I substances, 

except methyl bromide, for calendar 

years 2007 and 2008. This notice is the 

last opportunity to submit new or 

revised applications for 2007. This 

notice is also the first opportunity to 

submit requests for 2008. Companies 

will have an opportunity to submit new, 

supplemental, or amended applications 

for 2008 next year. All requests for 

exemptions submitted to EPA must 

present information as prescribed in the 

current version of the TEAP ‘‘Handbook 

on Essential Use Nominations’’ (or 

‘‘handbook’’), which was published in 

June 2001. The handbook is available 

electronically on the Web at http:// 

www.teap.org or at http://www.epa.gov/ 

ozone. 

In brief, the TEAP Handbook states 

that applicants must present 

information on: 

• Role of use in society; 

• Alternatives to use; 

• Steps to minimize use; 

• Steps to minimize emissions; 

• 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 

pharmaceutical 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 of 

EUAs will allow EPA and the Food and 

Drug Administration to make informed 

decisions on the amount of CFC to be 

nominated by the U.S. Government for 

the years 2007 and 2008. 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 EUAs. 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 45). 

The accounting framework matrix in 

the handbook entitled ‘‘Table IV: 

Reporting Accounting Framework for 

Essential Uses Other Than Laboratory 

and Analytical’’ requests data for the 

year 2005 on the amount of ODS 

exempted for an essential use, the 

amount acquired by production, the 

amount acquired by import, the amount 

on hand at the start of the year, the 

amount available for use in 2005, 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 2005. 

Because all data necessary for 

applicants to complete Table IV will not 

be available until after January 1, 2006, 

companies should not include this chart 

with their EUA applications in response 

to this action. Instead, companies 

should provide the required data as 

specified in 40 CFR 82.13(u)(2). EPA 

will compile companies’ responses to 

complete the U.S. CFC Accounting 

Framework for submission to the Parties 

to the Montreal Protocol by the end of 

January. 

EPA anticipates that the Parties’

review of MDI essential use requests 

will focus extensively on the United 

States’ progress in developing 

alternatives to 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 the 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 at the beginning 

of today’s document. 

Dated: November 14, 2005. 

Edward Callahan, 

Acting Director, Office of Air and Radiation. 

[FR Doc. 05–22890 Filed 11–18–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[AMS–FRL–7998–9] 

California State Motor Vehicle 

Pollution Control Standards; Within 

the Scope Requests; Opportunity for 

Public Hearing and Comment 

AGENCY: Environmental Protection 

Agency, (EPA). 

ACTION: Notice of opportunity for public 

hearing and public comment. 

SUMMARY: The California Air Resources 

Board (CARB) has notified EPA that it 

has approved amendments to its onhighway motorcycle and motorcycle 

engine for 2004 and subsequent model 

years. CARB requests that EPA confirm 

CARB’s findings that its amendments 

are within-the-scope of previous 

waivers issued by EPA under section 

209(b) of the Clean Air Act (Act), 42 

U.S.C. 7543(b). 

DATES: EPA has tentatively scheduled a 

public hearing for December 27, 2005, 

2005 beginning at 10 a.m. EPA will hold 

a hearing only if a party notifies EPA by 

December 12, 2005, expressing its 

interest in presenting oral testimony 

regarding CARB’s requests or other 

issues noted in this notice. By December 

16, 2005, any person who plans to 

attend the hearing should call David 

Dickinson of EPA’s Compliance and 

Innovative Strategies Division at (202) 

343–9256 to learn if a hearing will be 

held. Any party may submit written 

comments by January 30, 2006. 

ADDRESSES: EPA will make available for 

public inspection at the Air and 

Radiation Docket written comments 

received from interested parties, in