[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Rules and Regulations]
[Pages 29952-29957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14862]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2008-0503; FRL-8922-7]
RIN-2060-AO77


Protection of Stratospheric Ozone: Allocation of Essential Use 
Allowances for Calendar Year 2009

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: With this action, EPA is allocating essential use allowances 
for import and production of Class I ozone-depleting substances for 
calendar year 2009. Essential use allowances enable a person to obtain 
controlled Class I ozone depleting substances as part of an exemption 
to the regulatory ban on the production and import of these chemicals, 
which became effective January 1, 1996. EPA allocates essential use 
allowances for production and import of a specific quantity of Class I 
substances solely for the designated essential purpose. The allocation 
in this action is 63.0 metric tons of chlorofluorocarbons for use in 
metered dose inhalers for 2009.

DATES: This final rule is effective June 24, 2009.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OAR-2008-0503. All documents in the docket are listed on the 
http://www.regulations.gov Web site. Although listed in the index, some 
information is not publicly available, e.g., confidential business 
information (CBI) or other information whose disclosure is restricted 
by statute. Certain other material, such as copyrighted material, is 
not placed on the Internet and will be publicly available only in hard 
copy form. Publicly available docket materials are available either 
electronically through www.regulations.gov or in hard copy at the Air 
Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., 
Washington, DC 20460. This Docket Facility is open from 8:30 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The Public 
Reading Room 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: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. 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?
II. Essential Use Allowances for Medical Devices
III. Response to Comments
IV. 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
    K. Congressional Review Act
VI. Effective Date of This Final Rule

I. 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

[[Page 29953]]

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. 
Eliminating the production and consumption of Class I ODSs is 
accomplished through adherence to phaseout schedules for specific Class 
I ODSs \2\ which include chlorofluorocarbons (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:
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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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     ``(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 metered dose inhalers (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 laboratory and 
analytical use 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 take the 
final decisions on whether to approve a Party's essential use 
nomination at their annual Meeting of the Parties. This nomination 
process occurs approximately two years before the year in which the 
allowances would be in effect. The allowances allocated for 2009 in 
this final rule 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

[[Page 29954]]

may allocate essential use allowances in quantities that together are 
less than 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 the 
United States to allocate up to 282 metric tons (MT) of CFCs for 
essential uses. In a notice of proposed rulemaking published in the 
Federal Register on January 16, 2009 (74 FR 2954), EPA proposed to 
allocate 63.0 MT of CFCs for the production of MDIs for the calendar 
year 2009. In this final rule, EPA is allocating 63.0 MT of CFCs for 
the production of MDIs for calendar year 2009.

II. Essential Use Allowances for Medical Devices

    The following is a step-by-step list of actions EPA and FDA have 
taken 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 letters from EPA 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 annual reporting 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. 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. This letter is available for review in the Air Docket ID No. EPA-
HQ-OAR-2008-0503.
    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 that ``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.''
    6. In accordance with FDA's determination, EPA proposed to allocate 
63.0 MT of CFCs for the production of MDIs for the calendar year 2009 
in a proposed rulemaking published on January 16, 2009 (74 FR 2954).
    7. In this final rule, EPA is allocating 63.0 MT of CFCs for the 
production of MDIs for calendar year 2009.

III. Response to Comments

    EPA received comments from two entities on the proposed rule.
    One commenter supported the proposed rule and opposed limiting the 
use of ODSs in MDIs. The commenter noted that lower cost CFC MDIs are a 
benefit for low-income individuals.
    EPA believes that only a limited amount of production or import of 
CFCs for use in MDIs is necessary in 2009. Section 604 of the Clean Air 
Act directs EPA to authorize the production of CFCs for essential MDIs 
if FDA, in consultation with EPA, determines such production to be 
necessary. FDA, in consultation with EPA, has determined that 63.0 MT 
of CFCs are necessary to meet the demand for 2009 MDI manufacturing. 
Therefore, this action allocates 63.0 MT of CFCs for use in MDIs in 
2009.
    EPA and FDA understand that patients may incur additional costs to 
purchase inhalers as the market transitions to CFC-free alternatives, 
such

[[Page 29955]]

as HFA MDIs. For example, patients covered by medical insurance may 
encounter higher co-payments to purchase HFA MDIs, which are brand name 
products. However, patient assistance programs exist to assist patients 
with the increased costs. For low-income patients, these programs 
include free and/or discounted medicines. To assist patients facing 
higher co-pays associated with the increased costs of the HFA MDIs, 
programs such as coupons and discounted HFA MDIs are being made 
available through physicians' offices, at pharmacies, and at individual 
manufacturers' Web sites.
    In a related rulemaking, FDA responded to a similar comment 
regarding the cost of CFC-free alternatives, stating, ``Considering the 
availability of programs providing low-cost or free prescription drugs 
that would allow low-income, elderly, and uninsured individuals to 
purchase alternative MDIs, and the availability of physician samples, 
we believe that patients will be adequately served by alternative 
MDIs'' (73 FR 69532).
    A second commenter supported the proposed rule but believes that 
the US Government should take actions to limit the amount of CFCs 
needed for use in MDIs in the future. The commenter believes that the 
U.S. Government should set up procedures or guidelines to encourage MDI 
manufacturers to develop CFC-free MDIs. The commenter also asked 
whether the global laboratory and analytical use exemption would extend 
to the future use of MDIs.
    EPA notes that the transition to ozone-safe alternatives is well 
underway and that, for example, the allocation of essential use 
allowances for CFC-based MDIs significantly decreased from over 3,000 
MT in 2000 to 63.0 MT in 2009. In this action, EPA is only allocating 
essential use allowances to one manufacturer of CFC-MDIs.
    FDA has found the use of ODSs to be essential in a limited number 
of medical products, including certain metered dose inhalers for the 
treatment of asthma and chronic obstructive pulmonary disease (see 21 
CFR 2.125(e)(1) and (e)(2)). When a specific medical product meets the 
criteria for removal of the essential use designation, FDA initiates 
rulemakings that remove the essential use designations for MDIs in a 
manner that is protective of public health. Specifically, FDA published 
a final rule in 2008 that removes the essential use designation for 
epinephrine used in MDIs as of December 31, 2011 (73 FR 69532). 
Further, FDA published a proposed rule in 2007 that proposes removing 
the essential use designations for flunisolide, triamcinolone, 
metaproterenol, pirbuterol, albuterol and ipratropium in combination, 
cromolyn, and nedocromil used in MDIs as of December 31, 2009 (72 FR 
32030).
    With respect to the comment that EPA should encourage MDI 
manufacturers to develop CFC-free MDIs, EPA agrees that companies that 
apply for essential use allocations should demonstrate ongoing research 
and development of alternatives to CFC MDIs. Decision VIII/10, taken in 
1997, provides for applicants to submit information on the status of 
research and development into alternatives, and Decision XIX/13, taken 
in September 2007, provides for applicants to submit related 
information describing their progress in transitioning to CFC-free 
formulations. Since 1997, EPA has requested that applicants provide 
this information with their applications for CFC essential use 
nominations. The MDI manufacturer that is receiving an essential use 
allocation has submitted information to EPA pertaining to its research 
and development efforts.
    Finally, the global laboratory and analytical exemption allows the 
continued production and import of small amounts of class I ODSs for 
use in essential laboratory and analytical methods. 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. The use of CFCs in MDIs is not a laboratory 
or analytical use. Therefore, the use of CFCs in MDIs would not qualify 
under the global laboratory and analytical use exemption.

IV. Allocation of Essential Use Allowances for Calendar Year 2009

    With this action, EPA is allocating essential use allowances for 
calendar year 2009 to the entity listed in Table 1. These allowances 
are for the production or import of the specified quantity of Class I 
controlled substances solely for the specified essential use.

        TABLE I--Essential Use Allowances for Calendar Year 2009
------------------------------------------------------------------------
                                                           2009 quantity
            Company                      Chemical          (metric tons)
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 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
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Armstrong......................  CFC-11 or CFC-12 or CFC-           63.0
                                  114.
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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 make any changes that would affect the burden. 
However, the Office of Management and Budget (OMB) has previously 
approved the information collection requirements

[[Page 29956]]

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 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 in its field.
    After considering the economic impacts of today's 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 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 rule will relieve regulatory burden 
for all small entities. EPA solicited comments on the potential impact 
of the proposed rule on small entities. EPA did not receive comments 
related to the potential impact of the proposed rule on small entities.

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 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 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 have tribal implications because it does not have substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes. Thus, Executive Order 13175 does not 
apply to this action. EPA solicited comment on the proposed rule from 
tribal officials. EPA did not receive any comments from tribal 
officials on the proposed rule.

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 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 rule does not have any adverse 
energy effects because it merely allocates essential use allowances to 
entities manufacturing metered dose inhalers as 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 rule does 
not involve technical standards. Therefore, EPA did not consider the 
use of any voluntary consensus standards.

[[Page 29957]]

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 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 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.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. Therefore, EPA will submit a report containing this rule 
and other required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2). This rule will be 
effective June 24, 2009.

VI. Effective Date of This Final Rule

    Section 553(d) of the Administrative Procedures Act (APA) generally 
provides that rules may not take effect earlier than 30 days after they 
are published in the Federal Register. This final rule is issued under 
section 307(d) of the CAA, which does not include a 30-day effective-
date period requirement, and which precludes the application of section 
553(d). CAA section 307(d)(1) (``The provisions of section 553 through 
557 * * * of Title 5 shall not, except as expressly provided in this 
subsection, apply to actions to which this subsection applies.'') EPA 
is making this final rule effective June 24, 2009, and believes that 
this is consistent with the policies underlying APA section 553(d). 
Specifically, APA section 553(d) provides an exception for any action 
that grants or recognizes an exemption or relieves a restriction. 
Because this action grants an exemption to the phaseout of production 
and consumption of CFCs, EPA is making this action effective 
immediately to ensure continued availability of CFCs for medical 
devices.

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: June 18, 2009.
Lisa P. Jackson,
Administrator.

0
40 CFR part 82 is amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
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

0
2. Section 82.8 is amended by revising table I 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-           63.0
                                  114.
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-14862 Filed 6-23-09; 8:45 am]
BILLING CODE 6560-50-P