
[Federal Register: June 11, 2008 (Volume 73, Number 113)]
[Rules and Regulations]               
[Page 33007-33013]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jn08-12]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2007-0297; FRL-8577-9]
RIN 2060-AO44

 
Protection of Stratospheric Ozone: Allocation of Essential Use 
Allowances for Calendar Year 2008

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 stratospheric ozone-depleting 
substances (ODSs) for calendar year 2008. Essential use allowances 
enable a person to obtain controlled Class I ODSs as part of an 
exemption to the regulatory ban on the production and import of these 
chemicals, which became effective as of January 1, 1996. EPA allocates 
essential use allowances for exempted production or import of a 
specific quantity of Class I ODSs solely for the designated essential 
purpose. The allocation in this action is 27.0 metric tons (MT) of 
chlorofluorocarbons (CFCs) for use in metered dose inhalers (MDIs) for 
2008.

DATES: This final rule is effective June 11, 2008.

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-OAR-2007-0297. All documents in the docket are listed on the 
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.

[[Page 33008]]

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: Kirsten Cappel, by regular mail: U.S. 
Environmental Protection Agency, Stratospheric Protection Division 
(6205J), 1200 Pennsylvania Ave., NW., Washington, DC 20460; by courier 
service or overnight express: 1310 L Street, NW., Room 1047C, 
Washington, DC 20005; by telephone: (202) 343-9556; by fax: (202) 343-
2338; or by e-mail: cappel.kirsten@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. Response to Comments
III. Allocation of Essential Use Allowances for Calendar Year 2008
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility
    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
V. Judicial Review
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 ODSs in the United States 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 an international agreement aimed at 
reducing and eliminating the production and consumption \1\ of ODSs. 
The elimination of production and consumption of Class I ODSs has been 
accomplished through adherence to phase-out 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. Section 604(d) of the Act authorizes EPA to allow the 
production of limited quantities of Class I ODSs after the phaseout 
date for the following essential uses:
    (1) Methyl chloroform, ``solely for use in essential applications 
(such as nondestructive testing for metal fatigue and corrosion of 
existing airplane engines and airplane parts susceptible to metal 
fatigue) for which no safe and effective substitute is available.'' 
Under the Act, this exemption was available only until January 1, 2005. 
Prior to that date, EPA issued essential use allowances for methyl 
chloroform 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 essential use 
allowances to manufacturers of metered dose inhalers (MDIs) that use 
CFCs as propellant for the treatment of asthma and chronic obstructive 
pulmonary disease (COPD).
    (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 in 
most cases alternatives are available and 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

[[Page 33009]]

XV/8 of the Parties to the Protocol. In a notice of proposed rulemaking 
published in the Federal Register on September 13, 2007 (72 FR 52332), 
EPA proposed to extend the global laboratory and analytical use 
exemption beyond December 31, 2007 contingent upon and consistent with 
future anticipated action by the Parties to the Montreal 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 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?

    Before EPA will allocate an essential use allowance, the Parties to 
the Montreal Protocol must first authorize the United States' request 
to produce or import essential Class I ODSs. 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 Montreal 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 at their annual meeting on whether to authorize a Party's 
essential use nomination. This nomination-and-authorization cycle 
begins approximately two years before the year in which the allowances 
would be in effect. The allowances allocated through this action were 
nominated by the United States in January 2006.
    Once the Parties authorize the U.S. nomination, EPA allocates 
essential use allowances to specific entities through notice-and-
comment rulemaking in a manner consistent with the Act. 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 for MDIs in 
the coming calendar year that are necessary to protect public health. 
Based on FDA's determination, EPA proposes allocations for each 
eligible entity. Under the Act and the Montreal Protocol, EPA allocates 
essential use allowances in quantities that together are below or equal 
to the total amount authorized by the Parties. EPA will not allocate 
essential use allowances in amounts higher than the total authorized by 
the Parties. For 2008, the Parties authorized the United States to 
allocate up to 385 MT of CFCs for essential uses. In the nomination for 
2008 essential use allowances, the United States did not request CFCs 
for use in MDIs where the sole active ingredient is albuterol. In a 
notice of proposed rulemaking published in the Federal Register on June 
12, 2007 (72 FR 32269), EPA proposed to allocate 27.0 MT of CFC-114 for 
the production of epinephrine MDIs for the calendar year 2008. In this 
final rule, EPA is allocating 27.0 MT of CFC-114 for the production of 
epinephrine MDIs for 2008.

II. Response to Comments

    EPA received comments from four entities on the proposed rule.
    One commenter opposed EPA's proposed allocation and opposed 
allowing MDI manufacturers to produce any MDIs that damage the ozone 
layer. The commenter further stated that MDI manufacturers should 
research and adopt alternatives that are healthful for all.
    The Parties grant essential use exemptions contingent on a finding 
that the use for which an exemption is being requested is essential for 
health, safety, or the functioning of society, and that there are no 
available technically and economically feasible alternatives or 
substitutes that are acceptable from the standpoint of health or the 
environment. FDA regulations at 21 CFR 2.125 provide criteria for 
removing ODS-containing medical devices from the list of essential uses 
(see also FDA's July 24, 2002 final rule at 67 FR 48370). 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 decreased from 3,136.3 MT in 2000 to 167.0 MT in 2007. FDA, 
in consultation with EPA, has determined that 27.0 MT of CFC-114 is 
necessary in 2008 for the production of epinephrine MDIs. As 
therapeutic alternatives become available, FDA will, consistent with 
its regulations, continue to initiate rulemakings for removal of 
essential use designations for certain MDIs in a manner that is 
protective of public health.
    With respect to the comment that MDI manufacturers should research 
alternatives to replace CFC MDIs, EPA agrees that companies applying 
for essential use allocations to manufacture essential use MDIs should 
demonstrate ongoing research and development of alternatives to CFC 
MDIs. EPA honors commitments under the Montreal Protocol to demonstrate 
progress in the transition to alternatives by considering this 
information in the application and nomination phase of the essential 
use process. 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. EPA will continue to 
consider companies' progress in the transition to CFC-free inhalers as 
a factor in the essential use nomination process.
    A second commenter observed that for the 2008 proposed allocation 
EPA used a ``new criterion'' under which allowances would be made 
available only to companies that held less than one year's stockpile of 
essential use CFCs. The commenter observed that if its allocation for 
2009--as well as its allocation for 2008--were zero, it would most 
likely not have sufficient CFC supplies to meet anticipated patient 
demand for other moieties during 2009. (The commenter noted that FDA 
has proposed, and not yet finalized, a rule to remove the essential use 
designation for those moieties as of December 31, 2009, but that it 
would need an allocation for 2009 regardless.)
    The commenter also noted that it is a contract manufacturer that 
makes products for clients. As a result, according to the commenter, 
although it could purchase CFCs from the pre-1996 stockpile to 
supplement its CFC supply, such action is not reasonable. The commenter 
explained that the price of pre-1996 CFCs is not regulated and that as 
a result, the material is available, if at all, only at higher prices 
than CFCs manufactured with essential use allowances. The commenter 
stated that it cannot absorb the higher cost of the pre-1996 material 
because the prices of its finished products are fixed.
    With respect to the comment that EPA used a new approach for the 
2008 proposal, EPA responds that EPA and FDA used the same procedure 
for 2008 as for prior years to determine the essential use allocation 
for each requesting MDI company. That is, to assess the amount of new 
CFC production required to satisfy 2008 essential uses, EPA and FDA 
applied the terms of Decision XVII/5, including the provision that 
Parties should allocate such that manufacturers of

[[Page 33010]]

MDIs maintain no more than one-year operational supply of CFCs for 
essential uses. FDA articulated to EPA that in making its determination 
for 2008, FDA calculated the quantity of CFCs that a manufacturer 
needed to produce essential use MDIs for the year and subtracted from 
that quantity any CFC stocks owned by the MDI manufacturer exceeding a 
one-year operational supply. The remainder, if more than zero, was the 
quantity of newly produced or imported CFCs needed by that 
manufacturer. In addition, FDA informed EPA that consistent with the 
language of Decision XVII/5, FDA evaluated each company on an 
individual basis, rather than the aggregate CFC supplies owned by all 
entities. The use of this approach has been previously described in 
EPA's 2006 and 2007 final rulemakings for allocating essential use 
allowances, 71 FR 58504 and 72 FR 32212, respectively.
    With respect to the comment about not being able to meet patient 
demand in 2009 if its allocation in 2009 is zero, EPA and FDA will 
assess 2009 allocations beginning in 2008 once more current information 
is available regarding the medical need for CFCs in MDIs. However, EPA 
expects that it and FDA will follow an approach for 2009 that is 
similar to that used for 2008 and previous control periods.
    Under this approach, FDA, in close collaboration with EPA, will 
undertake a thorough and comprehensive analysis of a number of factors 
to determine the amount of CFCs necessary for the manufacture of 
essential use MDIs for the 2009 control period. First, FDA would 
evaluate the medical necessity by assessing the number of CFC MDIs 
necessary to protect public health in the U.S. (including the 
consideration of current data on the prevalence of asthma and COPD) and 
the quantity of CFCs necessary to ensure the manufacture and continuous 
availability of those MDIs. Second, FDA would analyze the most current 
data available regarding the existing inventory of CFCs held by each 
MDI manufacturer. Third, FDA would account for the implementation of 
the terms of Decision XVII/5, including the provision that FDA allocate 
such that manufacturers maintain no more than a one-year operational 
supply. Finally, FDA would consider how manufacturers' existing CFC 
supplies would be drawn down as they manufacture essential use MDIs 
throughout the year.
    In response to the comment regarding potential outcomes of the FDA 
rulemaking that is now in the proposal stage, EPA asserts that concerns 
about the potential need for additional allowances would be best 
addressed in its essential use rulemaking for the 2009 control period.
    With respect to the commenter's assertion that it cannot afford the 
cost of pre-January 1, 1996 CFCs, EPA and FDA do not regulate the price 
of CFCs, whether in the pre-January 1, 1996 stockpile or produced or 
imported post-January 1, 1996 with essential use allowances. Rather, 
market mechanisms determine the price of CFCs. As discussed above, if 
FDA determines that there is a medical need for new production of CFCs 
for the manufacture of essential use MDIs, then FDA will recommend 
allocation of the necessary amount to the requesting MDI manufacturer 
to make those MDIs. That MDI manufacturer is permitted to purchase 
newly produced and/or imported CFCs up to the amount that it has been 
allocated. EPA and FDA would not expect a MDI manufacturer to need pre-
January 1, 1996 CFCs when FDA has determined that that manufacturer 
should be allocated essential use allowances.
    To supplement its CFC allocation for a particular year, an MDI 
manufacturer may purchase any pre-January 1, 1996 CFCs that are 
available in the marketplace, or it may acquire essential use CFCs 
through a transfer with another manufacturer (subject to EPA 
regulations for such transfers). However, EPA notes that in making 
determinations for annual essential use allocations for MDI 
manufacturers, FDA takes into account the entirety of each MDI 
manufacturer's stocks of CFCs, including pre- and post-January 1, 1996 
stocks and CFCs acquired through transfers.
    A third commenter supported EPA's proposed allocation and stated 
that it is sufficient to protect human health and provide a smooth 
transition to non-CFC alternatives, consistent with the principles and 
obligations of the Montreal Protocol, and that it conforms with the 
Clean Air Act and other U.S. law. The commenter stated that according 
to publicly available information, the quantity of pharmaceutical-grade 
CFCs in the United States is sufficient to meet patient needs and that 
EPA's proposed amount will provide a smooth transition to CFC-free 
alternatives. In particular, the commenter stated that the zero 
allocation for CFC-albuterol, which started with the 2007 allocation, 
will allow for the gradual phase-down of CFC albuterol on the market, 
and is optimal for patient care. The commenter also noted that the 
proposal will foster a smooth transition by not allocating CFCs to 
other CFC MDI products where there are CFC-free therapeutic 
alternatives available.
    A fourth commenter, who submitted comments claimed as CBI, opposed 
EPA's proposed allocation as too low and requested additional essential 
use allowances for calendar year 2008. A redacted version of these 
comments has been placed in the docket. In the public version of the 
comments, the commenter stated that based on an internal assessment of 
its current stockpile, it would not be able to meet production needs of 
Primatene Mist[supreg] if EPA did not grant it essential use allowances 
for calendar year 2008. To further evaluate the needs of the commenter, 
on August 8, 2007, EPA sent a letter to the commenter requesting 
additional information about its current and projected stockpile of 
CFCs, as well as current and projected production of Primatene 
Mist[supreg]. A copy of this letter is available in the docket. On 
August 21, 2007, the commenter sent a letter to EPA withdrawing its 
comments on the 2008 proposed rulemaking. In that letter the commenter 
noted that its withdrawal of its 2008 comments on the proposed 
rulemaking should not affect its request for essential use allowances 
in future years. A copy of this letter is also available in the docket.

III. Allocation of Essential Use Allowances for Calendar Year 2008

    With this action, EPA is allocating essential use allowances for 
calendar year 2008 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.

[[Page 33011]]



        Table 1.--Essential Use Allowances for Calendar Year 2008
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                                                          2008 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
------------------------------------------------------------------------
Armstrong Pharmaceuticals........  CFC-114 (production              27.0
                                    of epinephrine
                                    MDIs only).
------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 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.

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 Part 82, Subpart 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 
are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) 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 this rule on small 
entities, small entities are defined as: (1) A small business that is 
primarily engaged in pharmaceutical preparations manufacturing (NAICS 
code 325412) and that has fewer than 750 employees (based on Small 
Business Administration size standards); (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 that is 
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this 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 proposed rule on small entities.'' 5 U.S.C. 603 
and 604. Thus, an agency may conclude 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 
rule provides an otherwise unavailable benefit to those companies that 
are receiving essential use allowances. We have therefore concluded 
that this final rule will relieve regulatory burden for all small 
entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year.
    Before promulgating an EPA rule for which a written statement is 
needed, section 205 of the UMRA generally requires EPA to identify and 
consider a reasonable number of regulatory alternatives and adopt the 
least costly, most cost-effective, or least burdensome alternative that 
achieves the objectives of the rule. The provisions of section 205 do 
not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective, or least burdensome alternative, if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may 
significantly or uniquely affect small governments, including tribal 
governments, it must have developed a small government agency plan 
under section 203 of the UMRA. The plan must provide for notifying 
potentially affected small governments, enabling officials of affected 
small governments to have meaningful and timely input in the 
development of EPA regulatory proposals with significant Federal 
intergovernmental mandates, and informing, educating, and advising 
small governments on compliance with the regulatory requirements.
    This rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) for State, local, or tribal 
governments or the private sector, since it merely provides exemptions 
from the 1996 phase-out of Class I ODSs. Similarly, EPA has determined 
that this rule 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, entitled ``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

[[Page 33012]]

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 final 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

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' This final rule does not have 
tribal implications, as specified in Executive Order 13175. This rule 
affects only the companies that requested essential use allowances. 
Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045, ``Protection of Children from Environmental 
Health risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies 
to any rule that (1) is determined to be ``economically significant'' 
as defined under Executive Order 12866, and (2) concerns an 
environmental health and safety risk that EPA has reason to believe may 
have a disproportionate effect on children. If the regulatory action 
meets both criteria, the Agency must evaluate the environmental health 
or safety effects of the planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency.
    EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that are based on 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 Executive Order 13045 because it implements the phaseout schedule 
and exemptions established by Congress in Title VI of the Clean Air 
Act.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This rule is not a ``significant energy action'' as defined in 
Executive Order 13211, ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (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. The rule affects 
only the pharmaceutical companies that requested essential use 
allowances of CFCs.

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, section 12(d) (15 U.S.C. 272 
note) directs EPA to use voluntary consensus standards in 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 12898 (59 FR 7629 (February 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 final 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 stratospheric ozone depletion that results from 
this final 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 in the U.S.

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 11, 2008.

V. Judicial Review

    Under section 307(b)(1) of the Act, EPA finds that these 
regulations are of national applicability. Accordingly, judicial review 
of the action is available only by the filing of a petition for review 
in the United States Court of Appeals for the District of Columbia 
Circuit within sixty days of publication of the action in the Federal 
Register. Under section 307(b)(2), the requirements of this rule may 
not be challenged later in judicial proceedings brought to enforce 
those requirements.

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 states, ``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.'' 
Thus, section 553(d) of the APA does not apply to this rule. EPA 
nevertheless is acting consistently with the policies underlying APA 
section 553(d) in making this rule effective June 11, 2008. 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

[[Page 33013]]

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, Exports, Imports, Ozone, Reporting 
and recordkeeping requirements.

    Dated: June 5, 2008.
Stephen L. Johnson,
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  Grants of essential use allowances and critical use 
allowances.

    (a) * * *

        Table I.--Essential Use Allowances for Calendar Year 2008
------------------------------------------------------------------------
                                                          2008 Quantity
             Company                     Chemical         (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals........  CFC-114 (production              27.0
                                    of epinephrine
                                    MDIs only).
------------------------------------------------------------------------


* * * * *
 [FR Doc. E8-13088 Filed 6-10-08; 8:45 am]

BILLING CODE 6560-50-P
