Document ID: EPA-HQ-OAR-2009-0566-0001
Agency: epa
Document Type: Proposed Rule
Title: Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2010
Posted Date: 2009-12-11T05:00Z

[Federal Register: December 11, 2009 (Volume 74, Number 237)]
[Proposed Rules]               
[Page 65719-65724]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de09-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2009-0566; FRL-9091-6]
RIN-2060-AP59

 
Protection of Stratospheric Ozone: Allocation of Essential Use 
Allowances for Calendar Year 2010

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 2010. Essential use allowances enable a person to obtain 
controlled Class I ODSs through 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 
production or import of a specific quantity of Class I substances 
solely for the designated essential purpose. The proposed allocation in 
this action is 30.0 metric tons (MT) of chlorofluorocarbons (CFCs) for 
use in metered dose inhalers (MDIs) for 2010.

DATES: Written comments on this proposed rule must be received by the 
EPA Docket on or before January 11, 2010, 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 December 16, 2009. If a 
hearing is held, it will take place on December 28, 2009 at EPA 
headquarters in Washington, DC. EPA will post a notice on our Web site 
(http://www.epa.gov/ozone/strathome.html) announcing further 
information on the hearing if it is requested.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2009-0566, 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, 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-
2009-0566. 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 http://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 http://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 http://
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 http://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

[[Page 65720]]

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 http://
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 http://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 1047A, 
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 2010
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 http://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 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

[[Page 65721]]

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 2010 were 
first nominated by the United States in January 2008.
    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 2010, the Parties authorized the United States to allocate up to 92 
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 2010 calendar year.
    1. On January 7, 2009, 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 1/1/08 to 
12/31/08.
    c. The number of units anticipated to be produced in 2009.
    d. The number of units anticipated to be produced in 2010.
    e. The gross target fill weight per unit (grams).
    f. Total amount of CFCs to be contained in the MDI product for 
2010.
    g. The additional amount of CFCs necessary for production.
    h. The total CFC request per MDI product for 2010.

The 114 letters are available for review in the Air Docket ID No. EPA-
HQ-OAR-2009-0566. 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 2009, 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-2009-0566. 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 April 1, 2009, EPA sent FDA the information MDI manufacturers 
provided in response to the 114 letters and information required by 40 
CFR

[[Page 65722]]

82.13(u) with a letter requesting that FDA make a determination 
regarding the amount of CFCs necessary for MDIs for calendar year 2010. 
This letter is available for review in Air Docket ID No. EPA-HQ-OAR-
2009-0566.
    4. On July 10, 2009, FDA sent a letter to EPA stating the amount of 
CFCs determined by the Commissioner to be necessary for each MDI 
company in 2010. This letter is available for review in the Air Docket 
ID No. EPA-HQ-OAR-2009-0566. FDA's letter informed EPA that it had 
determined that 30.0 MT of CFCs were necessary for use in medical 
devices in the year 2010.
    With respect to the 2010 determination, FDA stated, ``Our 
determination for the allocation of CFCs is lower than the total amount 
requested by manufacturers. In reaching this estimate, we took into 
account the sponsors' production of MDIs that used CFCs as a propellant 
in 2008, their estimated production in 2009, their estimated production 
in 2010, their anticipated essential-use allocations in 2009, and their 
current (as of December 31, 2008) stockpile levels. Our determination 
took into account any transferred CFCs as well as pre-1996 CFC amounts. 
Finally, we based our determination for 2010 on an estimate of the 
quantity of CFCs that would allow manufacturers to have adequate 
stockpiles at the end of 2010 consistent with the principles in 
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 2009 (74 FR 2954, January 
16, 2009);
     All manufacturers will procure the full quantity of CFCs 
allocated to them for 2009; 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.
    In accordance with the FDA determination, today's action proposes 
to allocate essential use allowances for a total of 30.0 MT of CFCs for 
use in MDIs for calendar year 2010.
    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 
2010

        Table I--Essential Use Allowances for Calendar Year 2010
------------------------------------------------------------------------
                                                           2010 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-           30.0
                                  114.
------------------------------------------------------------------------

    EPA proposes to allocate essential use allowances for calendar year 
2010 to the 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. 
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

[[Page 65723]]

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 USC 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 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 allowances to entities under an exemption to the ban on 
production and import of Class I ODSs.

E. Executive Order 13132: Federalism

    This action 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. This action merely allocates 
essential use allowances to entities under an exemption to the ban on 
production and import of Class I ODSs. Thus, Executive Order 13132 does 
not apply to this rule.
    In the spirit of Executive Order 13132, and consistent with EPA 
policy to promote communications between EPA and State and local 
governments, EPA specifically solicits comment on this proposed action 
from State and local officials.

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 
merely allocates essential use allowances to entities under an 
exemption to the ban on production and import of Class I ODSs. 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 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 a ``significant energy action'' as defined in 
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not 
likely to have a significant adverse effect on the supply, 
distribution, or use of energy. This action merely allocates essential 
use allowances to entities under an exemption to the ban on production 
and import of Class I ODSs.

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

[[Page 65724]]

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: December 7, 2009.
Lisa P. Jackson,
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 2010
------------------------------------------------------------------------
                                                           2010 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             30.0
                                     CFC-114.
------------------------------------------------------------------------

* * * * *

[FR Doc. E9-29556 Filed 12-10-09; 8:45 am]

BILLING CODE 6560-50-P