[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Proposed Rules]
[Pages 2954-2959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-945]


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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.

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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:
    <bullet> http://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
    <bullet> E-mail: <a href="/cdn-cgi/l/email-protection#3a7b175b545e1768175e5559515f4e7a5f4a5b145d554c"><span class="__cf_email__" data-cfemail="054428646b61285728616a666e6071456075642b626a73">[email protected]</span></a>
    <bullet> Fax: 202-566-9744
    <bullet> Mail: Air Docket, Environmental Protection Agency, 
Mailcode 2822T,

[[Page 2955]]

1200 Pennsylvania Ave., NW., Washington, DC 20460.
    <bullet> 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: 
<a href="/cdn-cgi/l/email-protection#90f2fff8fdf1febefaf5fefef9f6f5e2d0f5e0f1bef7ffe6"><span class="__cf_email__" data-cfemail="01636e696c606f2f6b646f6f68676473416471602f666e77">[email protected]</span></a>.

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:
    <bullet> Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
    <bullet> 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.
    <bullet> Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
    <bullet> Describe any assumptions and provide any technical 
information and/or data that you used.
    <bullet> If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    <bullet> Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    <bullet> Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
    <bullet> 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

[[Page 2956]]

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.
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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).
    \2\ Class I ozone depleting substances are listed at 40 CFR part 
82, subpart A, appendix A.
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    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:
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    \3\ See 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.
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    (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

[[Page 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 pre-1996 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:
    <bullet> All manufacturers will receive the full essential-use 
allocation proposed by EPA for calendar year 2008 (72 FR 32269, June 
12, 2007);
    <bullet> All manufacturers will procure the full quantity of CFCs 
allocated to them for 2008; and
    <bullet> 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 non-CFC 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
------------------------------------------------------------------------
                                                          2009  Quantity
          Company                     Chemical            (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

[[Page 2958]]

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 ozone-depleting 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

[[Page 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:


Sec.  82.8  Grant of essential use allowances and critical use 
allowances.

    (a) * * *

        Table I.--Essential Use Allowances for Calendar Year 2009
------------------------------------------------------------------------
                                                          2009 Quantity
          Company                     Chemical            (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


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