2954 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 

meet this commitment because the State 

has proposed RACT rules for all 13 

source categories and has recently 

adopted a rule for one of these source 

categories. 

EPA is proposing to conditionally 

approve the RACT analysis based on a 

commitment submitted by New Jersey. 

Under section 110(k)(4) of the Act, EPA 

may conditionally approve a plan based 

on a commitment from the State to 

adopt specific enforceable measures by 

a date certain, but not later than 1 year 

from the date of approval. If EPA 

conditionally approves the commitment 

in a final rulemaking action, the State 

must meet its commitment to adopt the 

identified regulations. If the State fails 

to do so, this action will become a 

disapproval upon the State’s failure to 

meet its commitment. EPA will notify 

the State by letter that this action has 

occurred. If the conditional approval 

converts to a disapproval, the 

commitment will no longer be a part of 

the approved New Jersey SIP. Upon 

notification of the State that the 

conditional approval has converted to a 

disapproval, EPA will publish a notice 

in the Federal Register notifying the 

public that the conditional approval 

automatically converted to a 

disapproval. If the State meets its 

commitment, within the applicable time 

frame, the conditionally approved 

submission will remain a part of the SIP 

until EPA takes final action approving 

or disapproving the new SIP revision. If 

EPA disapproves the RACT SIP 

submittal, such action will start a 

sanctions and FIP clock. If EPA 

approves the submittal, the RACT 

analysis will be fully approved in its 

entirety and will replace the RACT 

conditionally approved into the SIP. 

EPA is not taking action at this time 

on New Jersey’s attainment 

demonstrations for the New YorkNorthern New Jersey-Long Island, NYNJ-CT and the PhiladelphiaWilmington-Atlantic City, PA-NJ-MDDE 8-hour ozone moderate 

nonattainment areas, but will do so in 

a future rulemaking. 

VI. Statutory and Executive Order 

Reviews 

Under the Clean Air Act, the 

Administrator is required to approve a 

SIP submission that complies with the 

provisions of the Act and applicable 

Federal regulations. 42 U.S.C. 7410(k); 

40 CFR 52.02(a). Thus, in reviewing SIP 

submissions, EPA’s role is to approve 

state choices, provided that they meet 

the criteria of the Clean Air Act. 

Accordingly, this proposed action 

merely approves state law as meeting 

Federal requirements and does not 

impose additional requirements beyond 

those imposed by state law. For that 

reason, this proposed action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

application of those requirements would 

be inconsistent with the Clean Air Act; 

and 

• Does not provide EPA with the 

discretionary authority to address, as 

appropriate, disproportionate human 

health or environmental effects, using 

practicable and legally permissible 

methods, under Executive Order 12898 

(59 FR 7629, February 16, 1994). 

In addition, this rule does not have 

tribal implications as specified by 

Executive Order 13175 (65 FR 67249, 

November 9, 2000), because the SIP is 

not approved to apply in Indian country 

located in the state, and EPA notes that 

it will not impose substantial direct 

costs on tribal governments or preempt 

tribal law. 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Hydrocarbons, 

Incorporation by reference, 

Intergovernmental relations, Oxides of 

nitrogen, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

Dated: December 29, 2008. 

Alan J. Steinberg, 

Regional Administrator, Region 2. 

[FR Doc. E9–944 Filed 1–15–09; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 82 

[EPA–HQ–OAR–2008–0503; FRL–8763–2] 

RIN–2060–AO77 

Protection of Stratospheric Ozone: 

Allocation of Essential Use Allowances 

for Calendar Year 2009 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to allocate 

essential use allowances for import and 

production of Class I ozone-depleting 

substances (ODSs) for calendar year 

2009. Essential use allowances enable a 

person to obtain controlled Class I ODSs 

as part of an exemption to the regulatory 

ban on the production and import of 

these chemicals, which became effective 

as of January 1, 1996. EPA allocates 

essential use allowances for exempted 

production or import of a specific 

quantity of Class I substances solely for 

the designated essential purpose. The 

proposed allocation in this action is 

63.0 metric tons (MT) of 

chlorofluorocarbons (CFCs) for use in 

metered dose inhalers (MDIs) for 2009. 

DATES: Written comments on this 

proposed rule must be received by the 

EPA Docket on or before February 17, 

2009, unless a public hearing is 

requested. Comments must then be 

received on or before 30 days following 

the public hearing. Any party requesting 

a public hearing must notify the contact 

listed below under FOR FURTHER

INFORMATION CONTACT by 5 p.m. Eastern 

Standard Time on January 21, 2009. If 

a hearing is held, it will take place on 

February 2, 2009 at EPA headquarters in 

Washington DC. EPA will post a notice 

on our Web site (http://www.epa.gov/ 

ozone) announcing further information 

on the hearing if it is requested. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OAR–2008–0503, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• E-mail: A-and-R-docket@epa.gov 

• Fax: 202–566–9744 

• Mail: Air Docket, Environmental 

Protection Agency, Mailcode 2822T, 


hsrobinson on PROD1PC76 with PROPOSALS
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1200 Pennsylvania Ave., NW., 

Washington, DC 20460. 

• Hand Delivery or Courier. Deliver 

your comments to: EPA Air Docket, EPA 

West 1301 Constitution Avenue, NW., 

Room 3334, Mail Code 2822T, 

Washington, DC 20460. Such deliveries 

are only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–OAR–2008– 

0503. EPA’s policy is that all comments 

received by the docket will be included 

in the public docket without change and 

may be made available online at 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information through 

www.regulations.gov or e-mail that you 

consider to be CBI or otherwise 

protected. If you would like the Agency 

to consider comments that include CBI, 

EPA recommends that you submit the 

comments to the docket that exclude the 

CBI portion but that you provide a 

complete version of your comments, 

including the CBI, to the person listed 

under FOR FURTHER INFORMATION

CONTACT below. The 

www.regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

www.regulations.gov your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. 

If you submit an electronic comment, 

EPA recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the Air Docket, EPA/DC, EPA West, 

Room 3334, 1301 Constitution Ave., 

NW., Washington, DC. This Docket 

Facility is open from 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number 

for the Public Reading Room is (202) 

566–1744, and the telephone number for 

the Air Docket is (202) 566–1742. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Bohman, by regular mail: U.S. 

Environmental Protection Agency, 

Stratospheric Protection Division 

(6205J), 1200 Pennsylvania Avenue, 

NW., Washington, DC 20460; by courier 

service or overnight express: 1301 L 

Street, NW., Room 1013K, Washington, 

DC 20005; by telephone: (202) 343– 

9548; or by e-mail: 

bohman.jennifer@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. General Information 

A. What should I consider when preparing 

my comments? 

II. Basis for Allocating Essential Use 

Allowances 

A. What are essential use allowances? 

B. Under what authority does EPA allocate 

essential use allowances? 

C. What is the process for allocating 

essential use allowances? 

III. Essential Use Allowances for Medical 

Devices 

IV. Proposed Allocation of Essential Use 

Allowances for Calendar Year 2009 

V. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer and 

Advancement Act 

J. Executive Order 12898: Federal Actions 

To Address Environmental Justice in 

Minority Populations and Low-Income 

Populations 

I. General Information 

A. What should I consider when 

preparing my comments? 

1. Confidential Business Information. 

Do not submit this information to EPA 

through www.regulations.gov or e-mail. 

Clearly mark the part or all of the 

information that you claim to be CBI. 

For CBI information in a disk or CD– 

ROM that you mail to EPA, mark the 

outside of the disk or CD–ROM as CBI 

and then identify electronically within 

the disk or CD–ROM the specific 

information that is claimed as CBI. In 

addition to one complete version of the 

comment that includes information 

claimed as CBI, a copy of the comment 

that does not contain the information 

claimed as CBI must be submitted for 

inclusion in the public docket. 

Information so marked will not be 

disclosed except in accordance with 

procedures set forth in 40 CFR part 2. 

2. Tips for Preparing Your Comments. 

When submitting comments, remember 

to: 

• Identify the rulemaking by docket 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

• Follow directions—The agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

• Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

• Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

• If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

• Provide specific examples to 

illustrate your concerns, and suggest 

alternatives. 

• Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

• Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Basis for Allocating Essential Use 

Allowances 

A. What are essential use allowances? 

Essential use allowances are 

allowances to produce or import certain 

ozone depleting substances (ODSs) in 

the U.S. for purposes that have been 

deemed ‘‘essential’’ by the U.S. 

Government and by the Parties to the 

Montreal Protocol on Substances that 

Deplete the Ozone Layer (Montreal 

Protocol). 

The Montreal Protocol is the 

international agreement aimed at 

reducing and eliminating the 


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1 ‘‘Consumption’’ is defined as the amount of a 

substance produced in the United States, plus the 

amount imported into the United States, minus the 

amount exported to Parties to the Montreal Protocol 

(see Section 601(6) of the Clean Air Act). 

2Class I ozone depleting substances are listed at 

40 CFR part 82, subpart A, appendix A. 

3See Section 614(b) of the Act. EPA’s regulations 

implementing the essential use provisions of the 

Act and the Protocol are located in 40 CFR part 82. 

production and consumption 1 of ODSs. 

The elimination of production and 

consumption of Class I ODSs is 

accomplished through adherence to 

phaseout schedules for specific Class I 

ODSs,2 which include CFCs, halons, 

carbon tetrachloride, and methyl 

chloroform. As of January 1, 1996, 

production and import of most Class I 

ODSs were phased out in developed 

countries, including the United States. 

However, the Montreal Protocol and 

the Clean Air Act (the Act) provide 

exemptions that allow for the continued 

import and/or production of Class I 

ODSs for specific uses. Under the 

Montreal Protocol, exemptions may be 

granted for uses that are determined by 

the Parties to be ‘‘essential.’’ Decision 

IV/25, taken by the Parties to the 

Protocol in 1992, established criteria for 

determining whether a specific use 

should be approved as essential, and set 

forth the international process for 

making determinations of essentiality. 

The criteria for an essential use, as set 

forth in paragraph 1 of Decision IV/25, 

are the following: 

‘‘(a) 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; 

(b) 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 existing stocks of banked or 

recycled controlled substances, also 

bearing in mind the developing 

countries’ need for controlled 

substances.’’ 

B. Under what authority does EPA 

allocate essential use allowances? 

Title VI of the Act implements the 

Montreal Protocol for the United 

States.3 Section 604(d) of the Act 

authorizes EPA to allow the production 

of limited quantities of Class I ODSs 

after the phaseout date for the following 

essential uses: 

(1) Methyl Chloroform, ‘‘solely for use 

in essential applications (such as 

nondestructive testing for metal fatigue 

and corrosion of existing airplane 

engines and airplane parts susceptible 

to metal fatigue) for which no safe and 

effective substitute is available.’’ Under 

section 604(d)(1) of the Act, this 

exemption was available only until 

January 1, 2005. Prior to that date, EPA 

issued methyl chloroform allowances to 

the U.S. Space Shuttle and Titan Rocket 

programs. 

(2) Medical devices (as defined in 

section 601(8) of the Act), ‘‘if such 

authorization is determined by the 

Commissioner [of the Food and Drug 

Administration], in consultation with 

the Administrator [of EPA] to be 

necessary for use in medical devices.’’ 

EPA issues allowances to manufacturers 

of MDIs that use CFCs as propellant for 

the treatment of asthma and chronic 

obstructive pulmonary disease. 

(3) Aviation safety, for which limited 

quantities of halon-1211, halon-1301, 

and halon-2402 may be produced ‘‘if the 

Administrator of the Federal Aviation 

Administration, in consultation with the 

Administrator [of EPA] determines that 

no safe and effective substitute has been 

developed and that such authorization 

is necessary for aviation safety 

purposes.’’ Neither EPA nor the Parties 

have ever granted a request for essential 

use allowances for halon, because 

alternatives are available or because 

existing quantities of this substance are 

large enough to provide for any needs 

for which alternatives have not yet been 

developed. 

An additional essential use exemption 

under the Montreal Protocol, as agreed 

in Decision X/19, is the general 

exemption for laboratory and analytical 

uses. This exemption is reflected in 

EPA’s regulations at 40 CFR part 82, 

subpart A. While the Act does not 

specifically provide for this exemption, 

EPA has determined that an exemption 

for essential laboratory and analytical 

uses is allowable under the Act as a de 

minimis exemption. The de minimis 

exemption is addressed in EPA’s final 

rule of March 13, 2001 (66 FR 14760– 

14770). The Parties to the Protocol 

subsequently agreed (Decision XI/15) 

that the general exemption does not 

apply to the following uses: testing of 

oil and grease, and total petroleum 

hydrocarbons in water; testing of tar in 

road-paving materials; and forensic 

finger-printing. EPA incorporated this 

exemption at Appendix G to Subpart A 

of 40 CFR part 82 on February 11, 2002 

(67 FR 6352). In a December 29, 2005 

final rule, EPA extended the general 

exemption for laboratory and analytical 

uses through December 31, 2007 (70 FR 

77048), in accordance with Decision 

XV/8 of the Parties to the Protocol. At 

the 19th Meeting of the Parties in 

September 2007, the Parties agreed to 

extend the global laboratory and 

analytical use exemption through 

December 31, 2011, in Decision XIX/18. 

In a December 27, 2007 final rulemaking 

EPA took action to (1) extend the 

laboratory and analytical use exemption 

from December 31, 2007 to December 

31, 2011 for specific laboratory uses, (2) 

apply the laboratory and analytical use 

exemption to the production and import 

of methyl bromide, and (3) eliminate the 

testing of organic matter in coal from the 

laboratory and analytical use exemption 

(72 FR 73264). 

C. What is the process for allocating 

essential use allowances? 

The procedure set out by Decision IV/ 

25 calls for individual Parties to 

nominate essential uses and the total 

amount of ODSs needed for those 

essential uses on an annual basis. The 

Protocol’s Technology and Economic 

Assessment Panel (TEAP) evaluates the 

nominated essential uses and makes 

recommendations to the Parties. The 

Parties make the final decisions on 

whether to approve a Party’s essential 

use nomination at their annual meeting. 

This nomination process occurs 

approximately two years before the year 

in which the allowances would be in 

effect. The allowances proposed for 

allocation for 2009 were first nominated 

by the United States in January 2007. 

For MDIs, EPA requests information 

from manufacturers about the number 

and type of MDIs they plan to produce, 

as well as the amount of CFCs necessary 

for production. EPA then forwards the 

information to the Food and Drug 

Administration (FDA), which 

determines the amount of CFCs 

necessary for MDIs in the coming 

calendar year. Based on FDA’s 

determination, EPA proposes 

allocations to each eligible entity. Under 

the Act and the Montreal Protocol, EPA 

may allocate essential use allowances in 

quantities that together are below or 

equal to the total amount approved by 

the Parties. EPA will not allocate 

essential use allowances in amounts 

higher than the total approved by the 

Parties. For 2009, the Parties authorized 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 2957 

the United States to allocate up to 282 

MT of CFCs for essential uses. 

III. Essential Use Allowances for 

Medical Devices 

The following is a step-by-step list of 

actions EPA and FDA have taken thus 

far to implement the exemption for 

medical devices found at section 

604(d)(2) of the Act for the 2009 

calendar year. 

1. On January 16, 2008, EPA sent 

letters to MDI manufacturers requesting 

the following information under section 

114 of the Act (‘‘114 letters’’): 

a. The MDI product where CFCs will 

be used. 

b. The number of units of each MDI 

product produced from 1/1/07 to 12/31/ 

07. 

c. The number of units anticipated to 

be produced in 2008. 

d. The number of units anticipated to 

be produced in 2009. 

e. The gross target fill weight per unit 

(grams). 

f. Total amount of CFCs to be 

contained in the MDI product for 2009. 

g. The additional amount of CFCs 

necessary for production. 

h. The total CFC request per MDI 

product for 2009. 

The 114 letters are available for 

review in the Air Docket ID No. EPA– 

HQ–OAR–2008–0503. The companies 

requested that their responses be treated 

as confidential business information; for 

this reason, EPA has placed the 

responses in the confidential portion of 

the docket. 

2. At the end of January 2008, as 

required by 40 CFR 82.13(u), EPA 

received information from MDI 

manufacturers that included such data 

as the type and quantity of CFCs held 

at the end of the year (i.e. stocks of pre1996 and post-1996 CFCs). The data 

submitted from the MDI manufacturers 

is available for review in the Air Docket 

ID No. EPA–HQ–OAR–2008–0503. The 

companies requested that their 

individual responses be treated as 

confidential business information; for 

this reason, EPA has placed the 

individual responses in the confidential 

portion of the docket. 

3. On February 13, 2008, EPA sent 

FDA the information MDI 

manufacturers provided in response to 

the 114 letters and information required 

by 40 CFR 82.13(u) with a letter 

requesting that FDA make a 

determination regarding the amount of 

CFCs necessary for MDIs for calendar 

year 2009. This letter is available for 

review in Air Docket ID No. EPA–HQ– 

OAR–2008–0503. 

4. On April 28, 2008, FDA sent a letter 

to EPA stating the amount of CFCs 

determined by the Commissioner to be 

necessary for each MDI company in 

2009. This letter is available for review 

in the Air Docket ID No. EPA–HQ– 

OAR–2008–0503. FDA’s letter informed 

EPA that it had determined that 88.0 

MT of CFCs were necessary for use in 

medical devices in the year 2009. 

5. On August 12, 2008, FDA sent a 

letter to EPA revising its April 28, 2008 

essential use determination. FDA’s 

revised letter informed EPA that it had 

determined that 63.0 MT of CFCs were 

necessary for use in medical devices for 

the year 2009. In its letter FDA stated, 

‘‘This letter revises our 

recommendations for the amount of 

CFCs necessary for use in medical 

devices in the year 2009. The amount of 

CFCs recommended in our April 28, 

2008 letter was based on information 

available then, that led to assumptions 

that are now outdated.’’ This letter is 

available for review in the Air Docket ID 

No. EPA–HQ–OAR–2008–0503. 

With respect to the 2009 

determination, FDA stated, ‘‘FDA’s 

determination for the allocation of CFCs 

is lower than the total amount requested 

by sponsors. In reaching this 

determination, we took into account the 

sponsors’ production of MDIs that used 

CFCs as a propellant in 2007, their 

estimated production in 2008, their 

estimated production in 2009, their 

anticipated essential-use allocations in 

2008, their current (as of December 31, 

2007) stockpile levels, and any 

intercompany transfers of CFCs. Finally, 

FDA based its determination for 2009 on 

an estimate of the quantity of CFCs that 

would allow manufacturers to have a 

12-month stockpile at the end of 2009, 

in accordance with paragraph 3 of 

Decision XVI/12 and paragraph 2 of 

Decision XVII/5.’’ 

The letter stated that in making its 

determination, FDA made the following 

assumptions: 

• All manufacturers will receive the 

full essential-use allocation proposed by 

EPA for calendar year 2008 (72 FR 

32269, June 12, 2007); 

• All manufacturers will procure the 

full quantity of CFCs allocated to them 

for 2008; and 

• No bulk CFCs currently held by, or 

allocated to, any manufacturer will be 

exported from the United States. 

EPA has confirmed with FDA that this 

determination is consistent with 

Decision XVII/5, including language on 

stocks that states that Parties ‘‘shall take 

into account pre- and post-1996 stocks 

of controlled substances as described in 

paragraph 1(b) of Decision IV/25, such 

that no more than a one-year operational 

supply is maintained by that 

manufacturer.’’ Allowing manufacturers 

to maintain up to a one-year operational 

supply accounts for unexpected 

variability in the demand for MDI 

products or other unexpected 

occurrences in the market and therefore 

ensures that MDI manufacturers are able 

to produce their essential use MDIs. 

For calendar year 2009, FDA’s 

determination aggregates the amounts of 

CFC–11, –12, or –114 being allocated to 

the MDI manufacturer. In its letter FDA 

stated, ‘‘As has generally been our 

practice, FDA is aggregating the 

amounts for CFCs, and is providing 

recommendations on the total amounts 

of CFCs necessary to protect the public 

health. FDA expects manufacturers to 

maintain an appropriate balance of 

CFCs necessary to produce their CFC 

MDIs.’’ 

In accordance with the FDA 

determination, today’s action proposes 

to allocate essential use allowances for 

a total of 63.0 MT of CFCs for use in 

MDIs for calendar year 2009. 

The amounts listed in this proposal 

are subject to additional review and 

revision by EPA and FDA if information 

demonstrates that the proposed 

allocations are either too high or too 

low. We specifically request comment 

on the extent to which the proposed 

allocation of CFCs is sufficient to 

protect public health and ensure the 

manufacture and continuous availability 

of CFCs necessary to meet the expected 

demand. We also request comment on 

whether the proposed allocation, when 

considered along with current stocks, 

will best protect consumers by 

providing a smooth transition to nonCFC alternatives. Commenters 

requesting increases or decreases of 

essential use allowances should provide 

detailed information supporting a claim 

for additional or fewer CFCs. Any 

company that needs less than the full 

amount listed in this proposal should 

notify EPA of the actual amount needed. 

IV. Proposed Allocation of Essential 

Use Allowances for Calendar Year 2009 

TABLE I—ESSENTIAL USE ALLOWANCES FOR CALENDAR YEAR 2009 

Company Chemical 

2009 

Quantity 

(metric tons) 

(i) Metered Dose Inhalers (for oral inhalation) 

for Treatment of Asthma and Chronic Obstructive Pulmonary Disease 

Armstrong CFC–11 or 

CFC–12 or 

CFC–114.

63.0 

EPA proposes to allocate essential use 

allowances for calendar year 2009 to the 


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entity listed in Table I. These 

allowances are for the production or 

import of the specified quantity of Class 

I controlled substances solely for the 

specified essential use. 

V. Statutory and Executive Order 

Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

Under Executive Order (EO) 12866 

(58 FR 51735, October 4, 1993), this 

action is a ‘‘significant regulatory 

action’’ because it raises novel legal or 

policy issues. Accordingly, EPA 

submitted this action to the Office of 

Management and Budget (OMB) for 

review under EO 12866 and any 

changes made in response to OMB 

recommendations have been 

documented in the docket for this 

action. 

EPA prepared an analysis of the 

potential costs and benefits related to 

this action. This analysis is contained in 

the Agency’s Regulatory Impact 

Analysis (RIA) for the entire Title VI 

phaseout program (U.S. Environmental 

Protection Agency, ‘‘Regulatory Impact 

Analysis: Compliance with Section 604 

of the Clean Air Act for the Phaseout of 

Ozone Depleting Chemicals,’’ July 

1992). A copy of the analysis is 

available in the docket for this action 

and the analysis is briefly summarized 

here. The RIA examined the projected 

economic costs of a complete phaseout 

of consumption of ozone-depleting 

substances, as well as the projected 

benefits of phased reductions in total 

emissions of CFCs and other ozonedepleting substances, including 

essential use CFCs used for MDIs. 

B. Paperwork Reduction Act 

This action does not impose any new 

information collection burden. The 

recordkeeping and reporting 

requirements included in this action are 

already included in an existing 

information collection burden and this 

action does not propose any changes 

that would affect the burden. However, 

the Office of Management and Budget 

(OMB) has previously approved the 

information collection requirements 

contained in the existing regulations at 

40 CFR 82.8(a) under the provisions of 

the Paperwork Reduction Act, 44 U.S.C. 

3501 et seq., and has assigned OMB 

control number 2060–0170. The OMB 

control numbers for EPA’s regulations 

in 40 CFR are listed in 40 CFR part 9. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act 

generally requires an agency to prepare 

a regulatory flexibility analysis of any 

rule subject to notice and comment 

rulemaking requirements under the 

Administrative Procedure Act or any 

other statute unless the agency certifies 

that the rule will not have a significant 

economic impact on a substantial 

number of small entities. Small entities 

include small businesses, small 

organizations, and small governmental 

jurisdictions. 

For purposes of assessing the impact 

of today’s proposed rule on small 

entities, small entity is defined as: (1) A 

small business that is primarily engaged 

in pharmaceutical preparations 

manufacturing as defined by NAICS 

code 325412 with less than 750 

employees; (2) a small governmental 

jurisdiction that is a government of a 

city, county, town, school district or 

special district with a population of less 

than 50,000; and (3) a small 

organization that is any not-for-profit 

enterprise which is independently 

owned and operated and is not 

dominant its field. 

After considering the economic 

impacts of today’s proposed rule on 

small entities, I certify that this action 

will not have a significant economic 

impact on a substantial number of small 

entities. In determining whether a rule 

has a significant economic impact on a 

substantial number of small entities, the 

impact of concern is any significant 

adverse economic impact on small 

entities, since the primary purpose of 

the regulatory flexibility analyses is to 

identify and address regulatory 

alternatives ‘‘which minimize any 

significant economic impact of the rule 

on small entities.’’ 5 U.S.C. 603 and 604. 

Thus, an agency may certify that a rule 

will not have a significant economic 

impact on a substantial number of small 

entities if the rule relieves regulatory 

burden, or otherwise has a positive 

economic effect on all of the small 

entities subject to the rule. 

This proposed action will provide an 

otherwise unavailable benefit to those 

companies that are receiving essential 

use allowances by creating an 

exemption to the regulatory phaseout of 

chlorofluorocarbons. We have therefore 

concluded that today’s proposed rule 

will relieve regulatory burden for all 

small entities. We continue to be 

interested in the potential impact of the 

proposed rule on small entities and 

welcome comments on issues related to 

such impacts. 

D. Unfunded Mandates Reform Act 

This action contains no Federal 

mandates under the provisions of Title 

II of the Unfunded Mandates Reform 

Act of 1995 (UMRA), 2 U.S.C. 1531– 

1538 for State, local, or tribal 

governments or the private sector. The 

action imposes no enforceable duty on 

any State, local or tribal governments or 

the private sector. This action is 

deregulatory and does not impose any 

new requirements on any entities. 

Therefore, this action is not subject to 

the requirements of sections 202 and 

205 of the UMRA. This action is also not 

subject to the requirements of section 

203 of UMRA because it contains no 

regulatory requirements that might 

significantly or uniquely affect small 

governments because this rule merely 

allocates essential use exemptions to 

entities as an exemption to the ban on 

production and import of Class I ODSs. 

E. Executive Order 13132: Federalism 

Executive Order 13132, titled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999), requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive Order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

This proposed rule does not have 

federalism implications. It will not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132. Thus, Executive 

Order 13132 does not apply to this rule. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications, as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). This action does not impose 

substantial direct compliance costs on 

Indian tribal governments. Thus, 

Executive Order 13175 does not apply 

to this action. EPA specifically solicits 

additional comment on this proposed 

action from tribal officials. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

EPA interprets EO 13045 as applying 

to those regulatory actions that concern 

health or safety risks, such that the 

analysis required under section 5–501 of 

the Order has the potential to influence 

the regulation. This proposed rule is not 


hsrobinson on PROD1PC76 with PROPOSALS
Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Proposed Rules 2959 

subject to EO 13045 because it 

implements Section 604(d)(2) of the 

Clean Air Act which states that the 

Agency shall authorize essential use 

exemptions should the Food and Drug 

Administration determine that such 

exemptions are necessary. 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355 (May 22, 

2001)), because it is not a significant 

regulatory action under Executive Order 

12866. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (‘‘NTTAA’’), Public Law 

104–113, 12(d) (15 U.S.C. 272 note) 

directs EPA to use voluntary consensus 

standards in its regulatory activities 

unless to do so would be inconsistent 

with applicable law or otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. The NTTAA directs EPA to 

provide Congress, through OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. This 

proposed rule does not involve 

technical standards. Therefore, EPA did 

not consider the use of any voluntary 

consensus standards. 

J. Executive Order 12898: Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes federal 

executive policy on environmental 

justice. Its main provision directs 

federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has concluded that it is not 

practicable to determine whether there 

would be disproportionately high and 

adverse human health or environmental 

effects on minority and/or low income 

populations from this proposed rule. 

EPA believes, however, that this action 

affects the level of environmental 

protection equally for all affected 

populations without having any 

disproportionately high and adverse 

human health or environmental effects 

on any population, including any 

minority or low-income population. 

Any ozone depletion that results from 

this proposed rule will impact all 

affected populations equally because 

ozone depletion is a global 

environmental problem with 

environmental and human effects that 

are, in general, equally distributed 

across geographical regions. 

List of Subjects in 40 CFR Part 82 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Chemicals, 

Chlorofluorocarbons, Imports, Methyl 

Chloroform, Ozone, Reporting and 

recordkeeping requirements. 

Dated: January 12, 2009. 

Stephen L. Johnson, 

Administrator. 

40 CFR Part 82 is proposed to be 

amended as follows: 

PART 82–PROTECTION OF 

STRATOSPHERIC OZONE 

1. The authority citation for part 82 

continues to read as follows: 

Authority: 42 U.S.C. 7414, 7601, 7671– 

7671q. 

Subpart A—Production and 

Consumption Controls 

2. Section 82.8 is amended by revising 

the table in paragraph (a) to read as 

follows: 

§ 82.8 Grant of essential use allowances 

and critical use allowances. 

(a) * * * 

TABLE I.—ESSENTIAL USE ALLOWANCES FOR CALENDAR YEAR 2009 

Company Chemical 2009 Quantity 

(metric tons) 

(i) Metered Dose Inhalers (for oral inhalation) 

for Treatment of Asthma and Chronic Obstructive Pulmonary Disease 

Armstrong CFC–11 or 

CFC–12 or 

CFC–114.

63.0 

* * * * * 

[FR Doc. E9–945 Filed 1–15–09; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 080521698–8699–01] 

RIN 0648–AW87 

Fisheries of the Northeastern United 

States; Northeast Multispecies 

Fishery; Secretarial Interim Action 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Proposed rule; request for 

comment. 

SUMMARY: NMFS proposes a temporary 

Secretarial interim action under the 

Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act) to implement 

measures intended to immediately 

reduce overfishing in the Northeast (NE) 

multispecies fishery, while addressing 

the need to help sustain fishing 

communities, without compromising 

rebuilding objectives. Measures 

proposed for the commercial fishery 

include the following: A differential 

days-at-sea (DAS) area north of 41°30′ N. 

lat., whereby a vessel would be charged 

2 days for every day fished; a large 

Southern New England (SNE) Closure 

Area; and modified groundfish trip 

limits. This action does not change the 

scheduled DAS reduction in the NE 

Multispecies Fishery Management Plan 

(FMP), which would result in an 

approximate 18–percent reduction in 

DAS. For private recreational vessels 

fishing in the Exclusive Economic Zone 

(EEZ) and for federally permitted 

charter/party vessels, this action would 

extend in time a seasonal prohibition on 

the possession of Gulf of Maine (GOM) 

cod, and prohibit the possession of SNE 

winter flounder. For federally permitted 

charter/party vessels, this action would 

implement a trip limit for Georges Bank 

(GB) cod. In addition, this action 

proposes to mitigate some of the 

negative short-term economic impacts of 

the FMP by making modifications to the 

DAS Leasing Program, the Regular B 

DAS Program, and the DAS Transfer 

Program; continuing the Eastern U.S./ 

Canada Haddock Special Access 

Program (SAP); and implementing a 

reduction in the haddock minimum size 

to 18 inches (45 cm). Finally, this action 

would specify management measures 

for the U.S./Canada Management Area 

for fishing year (FY) 2009. 


hsrobinson on PROD1PC76 with PROPOSALS