Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2010, 25780-25784 [2010-10926]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 75, Number 89 (Monday, May 10, 2010)]
[Rules and Regulations]
[Pages 25780-25784]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10926]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2009-0566; FRL-9147-8]
RIN-2060-AP59


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

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 (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 allocation in this 
action is 30.0 metric tons (MT) of chlorofluorocarbons (CFCs) for use 
in metered dose inhalers (MDIs) for 2010.

DATES: This final rule is effective May 10, 2010.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OAR-2009-0566. All documents in the docket are listed on the 
https://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 https://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: Jeremy Arling, by regular mail: U.S.

[[Page 25781]]

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) 343-9055; or by e-mail: 
arling.jeremy@epa.gov.

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 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
    K. Congressional Review Act

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 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 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

[[Page 25782]]

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.

II. 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''):
     The MDI product in which CFCs will be used.
     The number of units of each MDI product produced from 1/1/
08 to 12/31/08.
     The number of units anticipated to be produced in 2009.
     The number of units anticipated to be produced in 2010.
     The gross target fill weight per unit (grams).
     Total amount of CFCs to be contained in the MDI product 
for 2010.
     The additional amount of CFCs necessary for production.
     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 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.
    5. In accordance with FDA's determination, EPA proposed to allocate 
30.0 MT of CFCs for the production of MDIs for the calendar year 2010 
in a proposed rulemaking published on December 11, 2009 (74 FR 65719).
    6. In this final rule, EPA is allocating 30.0 MT of CFCs for the 
production of MDIs for calendar year 2010.

III. Response to Comments

    EPA received one significant comment on the proposed rule. The 
commenter opposed exemptions from the regulatory phaseout of CFCs. The 
commenter stated that five years should be the maximum number of years 
for granting exemptions.
    Under section 604(d) of the Act, ``to the extent such action is 
consistent with the Montreal Protocol,'' EPA is authorized to allow the 
production of limited quantities of Class I ODSs for use in medical 
devices ``if such authorization is determined by the Commissioner [of 
the Food and Drug

[[Page 25783]]

Administration], in consultation with the Administrator [of EPA] to be 
necessary for use in medical devices.'' The Act does not specify or 
limit the number of years for which EPA might grant essential use 
allowances for the production or import of CFCs for use in medical 
devices. [Does the Protocol have a time limit on this point? Should 
address that here too.]
    EPA describes above the actions and decision factors used to 
allocate essential use allowances. EPA believes the research and 
analysis supporting this final action is sound and that the allocation 
of CFCs for the continued manufacture of MDIs is necessary. EPA notes 
that the Montreal Protocol's Medical Technical Options Committee also 
recognized the necessity of allocating essential use allowances for 
CFCs for use in MDIs in 2010 by supporting the U.S. nomination.

IV. Allocation of Essential Use Allowances for Calendar Year 2010

    With this action, EPA is allocating essential use allowances for 
calendar year 2010 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 2010
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
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                                                           2010 Quantity
              Company                     Chemical         (metric tons)
------------------------------------------------------------------------
Armstrong.........................  CFC-11 or...........            30.0
                                    CFC-12 or...........
                                    CFC-114.............
------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the 
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and 
is therefore not subject to review under the EO.
    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. 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 final 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 final 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 final 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. EPA 
therefore concluded that today's final 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 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.

[[Page 25784]]

    In the spirit of Executive Order 13132, and consistent with EPA 
policy to promote communications between EPA and State and local 
governments, EPA specifically solicited comment on the 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.

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 final 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 final 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 determined that this rule will not have disproportionately 
high and adverse human health or environmental effects on minority or 
low-income populations, because it 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. 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. A major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This action not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective May 10, 2010.

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: April 29, 2010.
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 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
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
-------------------------------------------------------------------------
                                                           2010 Quantity
              Company                     Chemical         (metric tons)
------------------------------------------------------------------------
Armstrong.........................  CFC-11 or CFC-12 or             30.0
                                     CFC-114..
------------------------------------------------------------------------

* * * * *
[FR Doc. 2010-10926 Filed 5-7-10; 8:45 am]
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