Document ID: EPA-HQ-OAR-2007-0297-0022
Agency: epa
Document Type: Proposed Rule
Title: Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2008
Posted Date: 2007-06-12T04:00Z

[Federal Register: June 12, 2007 (Volume 72, Number 112)]
[Proposed Rules]               
[Page 32269-32275]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jn07-18]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2007-0297; FRL-8325-7]
RIN A2060-AO44

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to allocate essential use allowances for 
import and production of Class I ozone-depleting substances (ODSs) for 
calendar year 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 
substances solely for the designated essential purpose. The proposed 
allocations total 27.0 metric tons (MT) of chlorofluorocarbons (CFCs) 
for use in metered dose inhalers (MDIs) for 2008.

DATES: Written comments on this proposed rule must be received by the 
EPA Docket on or before July 12, 2007, unless a public hearing is 
requested. Comments must then be received on or before 30 days 
following the public hearing. Any party requesting a public hearing 
must notify the contact listed below under FOR FURTHER INFORMATION 
CONTACT by 5 p.m. Eastern Standard Time on June 18, 2007. If a hearing 
is held, it will take place on June 27, 2007 at EPA headquarters in 
Washington DC. EPA will post a notice on our Web site (http://www.epa.gov/ozone
) announcing further information on the hearing if it 

is requested.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2007-0297, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for 

submitting comments.
     E-mail: A-and-R-docket@epa.gov.
     Fax: 202-566-9744.
     Mail: Air Docket, Environmental Protection Agency, 
Mailcode 2822T,

[[Page 32270]]

1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery or Courier. Deliver your comments to: EPA 
Air Docket, EPA West 1301 Constitution Avenue, NW., Room 3334, Mail 
Code 2822T, Washington, DC 20460. Such deliveries are only accepted 
during the Docket's normal hours of operation, and special arrangements 
should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2007-0297. EPA's policy is that all comments received by the docket 
will be included in the public docket without change and may be made 
available online at http://www.regulations.gov, including any personal 

information provided, unless the comment includes information claimed 
to be Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute. Do not submit information 
through http://www.regulations.gov or e-mail that you consider to be CBI or 

otherwise protected. If you would like the Agency to consider comments 
that include CBI, EPA recommends that you submit the comments to the 
docket that exclude the CBI portion but that you provide a complete 
version of your comments, including the CBI, to the person listed under 
ADDRESSES above. The http://www.regulations.gov website is an ``anonymous 

access'' system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through 
http://www.regulations.gov your e-mail address will be automatically captured 

and included as part of the comment that is placed in the public docket 
and made available on the Internet. If you submit an electronic 
comment, EPA recommends that you include your name and other contact 
information in the body of your comment and with any disk or CD-ROM you 
submit. If EPA cannot read your comment due to technical difficulties 
and cannot contact you for clarification, EPA may not be able to 
consider your comment. Electronic files should avoid the use of special 
characters, any form of encryption, and be free of any defects or 
viruses. For additional information about EPA's public docket visit the 
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the 
http://www.regulations.gov index. Although listed in the index, some 

information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in http://www.regulations.gov or in hard copy at the Air Docket, EPA/DC, EPA 

West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. This 
Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the Air 
Docket is (202) 566-1742.

FOR FURTHER INFORMATION CONTACT: Kirsten M. Cappel, 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 1047C, 
Washington DC, 20005; by telephone: (202) 343-9556; or by e-mail: 
cappel.kirsten@epa.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    What should I consider when preparing my comments?
II. Basis for Allocating Essential Use Allowances
    A. What are essential use allowances?
    B. Under what authority does EPA allocate essential use 
allowances?
    C. What is the process for allocating essential use allowances?
III. Essential Use Allowances for Medical Devices
IV. Proposed Allocation of Essential Use Allowances for Calendar 
Year 2008
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

I. General Information

What should I consider when preparing my comments?

    1. Confidential Business Information. Do not submit this 
information to EPA through http://www.regulations.gov or e-mail. Clearly mark 

the part or all of the information that you claim to be CBI. For CBI 
information in a disk or CD ROM that you mail to EPA, mark the outside 
of the disk or CD ROM as CBI and then identify electronically within 
the disk or CD ROM the specific information that is claimed as CBI. In 
addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments, 
remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
     Follow directions--The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.
     Describe any assumptions and provide any technical 
information and/or data that you used.
     If you estimate potential costs or burdens, explain how 
you arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
     Provide specific examples to illustrate your concerns, and 
suggest alternatives.
     Explain your views as clearly as possible, avoiding the 
use of profanity or personal threats.
     Make sure to submit your comments by the comment period 
deadline identified.

II. Basis for Allocating Essential Use Allowances

A. What are essential use allowances?

    Essential use allowances are allowances to produce or import 
certain 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

[[Page 32271]]

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. EPA plans to update this exemption in accordance with 
future Decisions from the Parties and its own regulations.

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 2008 were 
first nominated by the United States in January 2006.
    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 2008, the Parties authorized the United States to allocate up to 
385 MT of CFCs for essential uses. In the 2008 nomination for essential 
use allowances, the United States did not request CFCs for use in MDIs 
where the sole active ingredient is albuterol.

III. Essential Use Allowances for Medical Devices

    The following is a step-by-step list of actions EPA and FDA have 
taken thus far to implement the exemption for medical devices found at 
section 604(d)(2) of the Act for the 2008 calendar year.
    1. On January 17, 2007, 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 1/1/06 to 
12/31/06.

[[Page 32272]]

    c. The number of units anticipated to be produced in 2007.
    d. The number of units anticipated to be produced in 2008.
    e. The gross target fill weight per unit (grams).
    f. Total amount of CFCs to be contained in the MDI product for 
2008.
    g. The additional amount of CFCs necessary for production.
    h. The total CFC request per MDI product for 2008.

    The 114 letters are available for review in the Air Docket ID No. 
EPA-HQ-OAR-2007-0297. 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 2007, 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 in reports from 
each MDI manufacturer is available for review in the Air Docket ID No. 
EPA-HQ-OAR-2007-0297. The companies requested that their 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 28, 2007, 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 2008. This letter is available for review in Air Docket 
ID No. EPA-HQ-OAR-2007-0297.
    4. On May 1, 2007 FDA sent a letter to EPA stating the amount of 
CFCs determined by the Commissioner to be necessary for each MDI 
company in 2008. This letter is available for review in the Air Docket 
ID No. EPA-HQ-OAR-2007-0297. FDA's letter informed EPA that it had 
determined that 27.0 MT of CFCs were medically necessary for use in 
MDIs in 2008. The letter stated: ``Our determination for the allocation 
of CFCs is lower than the total amount requested by sponsors. In 
reaching this estimate, we took into account the sponsors' production 
of MDIs that used CFCs as propellant in 2006, their estimated 
production in 2007, their estimated production in 2008, their 
anticipated essential-use allocations in 2007, and their current (as of 
December 31, 2006) stockpile levels. Our determination took into 
account any transferred CFCs as well as pre-1996 CFC amounts. We also 
considered the different types and blends of CFCs necessary to produce 
specific MDIs. Finally, we based our determination for 2008 on an 
estimate of the quantity of CFCs that would allow manufacturers to have 
a 12-month stockpile at the end of 2008 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 2007 (71 FR 64668, 
November 3, 2006);
     All manufacturers will procure the full quantity of CFCs 
allocated to them for calendar year 2007;
     The number of albuterol CFC MDIs produced in 2008 will be 
no more than half of the number produced in 2007, with albuterol HFA 
MDIs making up the remainder; and
     No bulk CFC currently held by, or allocated to, any 
manufacturer will be exported from the United States.
    FDA's determination specified that the essential use allowances 
allocated for 2008 should only be used to acquire CFC-114 for the 
production of epinephrine MDIs. FDA's letter stated: ``In recent years, 
we aggregated the amounts for CFC-11, -12, and -114 and provided 
recommendations on the total amounts necessary to protect the public 
health. This year, as sponsors transition to non-CFC alternative and 
require smaller amounts of CFCs to produce CFC MDIs, we considered 
individual amounts of CFCs necessary to protect the public health and 
recommend an allocation of 27.0 tonnes of CFC-114 to Armstrong for the 
manufacture of epinephrine CFC MDIs.'' Consistent with FDA's 
determination letter, EPA is proposing to allocate 27.0 MT of CFC-114 
to Armstrong for the production of epinephrine MDIs for 2008.
    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.'' In its analysis of a one-year operational supply 
of CFCs for the production of CFC-albuterol MDIs, FDA informed EPA that 
it calculates volumes to allow the manufacturer to end the calendar 
year with the appropriate stock of CFCs for essential uses. Allowing 
manufacturers to maintain up to a one-year operational supply accounts 
for unexpected variability in the demand for MDI products or other 
unexpected occurrences in the market and therefore ensures that MDI 
manufacturers are able to produce their essential use MDIs.
    In accordance with the FDA determination, today's action proposes 
to allocate essential use allowances to Armstrong for a total of 27.0 
MT of CFC-114 for the production of epinephrine MDIs only for calendar 
year 2008.
    The amounts listed in this proposal are subject to additional 
review, and revision, by EPA and FDA if information demonstrates that 
the proposed allocations are either too high or too low. We 
specifically request comment on the extent to which the proposed 
allocation of CFCs is sufficient to protect public health and ensure 
the manufacture and continuous availability of CFCs necessary to meet 
the expected demand. We also request comment on whether the proposed 
allocation, when considered along with current stocks, will best 
protect consumers by providing a smooth transition to non-CFC 
alternatives. Commenters requesting increases or decreases of essential 
use allowances should provide detailed information supporting a claim 
for additional or fewer CFCs. Any company that needs less than the full 
amount listed in this proposal should notify EPA of the actual amount 
needed.

IV. Proposed Allocation of Essential Use Allowances for Calendar Year 
2008

        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).
------------------------------------------------------------------------

[[Page 32273]]

    EPA proposes to allocate essential use allowances for calendar year 
2008 to the entity listed in Table I. These allowances are for the 
production or import of the specified quantity of Class I controlled 
substances solely for the specified essential use.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is a ``significant regulatory action'' because it raises novel 
legal or policy issues. Accordingly, EPA submitted this action to the 
Office of Management and Budget (OMB) for review under EO 12866 and any 
changes made in response to OMB recommendations have been documented in 
the docket for this action.
    EPA prepared an analysis of the potential costs and benefits 
related to this action. This analysis is contained in the Agency's 
Regulatory Impact Analysis (RIA) for the entire Title VI phaseout 
program (U.S. Environmental Protection Agency, ``Regulatory Impact 
Analysis: Compliance with Section 604 of the Clean Air Act for the 
Phaseout of Ozone Depleting Chemicals,'' July 1992). A copy of the 
analysis is available in the docket for this action and the analysis is 
briefly summarized here. The RIA examined the projected economic costs 
of a complete phaseout of consumption of ozone-depleting substances, as 
well as the projected benefits of phased reductions in total emissions 
of CFCs and other ozone-depleting substances, including essential use 
CFCs used for MDIs.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden. 
The recordkeeping and reporting requirements included in this action 
are already included in an existing information collection burden and 
this action does not propose any changes that would affect the burden. 
However, the Office of Management and Budget (OMB) has previously 
approved the information collection requirements contained in the 
existing regulations at 40 CFR 82.8(a) under the provisions of the 
Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB 
control number 2060-0170, EPA ICR number 1432.25. A copy of the OMB 
approved Information Collection Request (ICR) may be obtained from 
Susan Auby, Collection Strategies Division; U.S. Environmental 
Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC 
20460 or by calling (202) 566-1672.
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The 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 today's proposed rule on 
small entities, small entity is defined as: (1) Pharmaceutical 
preparations manufacturing businesses (NAICS code 325412) that have 
less than 750 employees; (2) a small governmental jurisdiction that is 
a government of a city, county, town, school district or special 
district with a population of less than 50,000; and (3) a small 
organization that is any not-for-profit enterprise which is 
independently owned and operated and is not dominant its field.
    After considering the economic impacts of today's proposed rule on 
small entities, I certify that this action will not have a significant 
economic impact on a substantial number of small entities. In 
determining whether a rule has a significant economic impact on a 
substantial number of small entities, the impact of concern is any 
significant adverse economic impact on small entities, since the 
primary purpose of the regulatory flexibility analyses is to identify 
and address regulatory alternatives ``which minimize any significant 
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604. 
Thus, an agency may certify that a rule will not have a significant 
economic impact on a substantial number of small entities if the rule 
relieves regulatory burden, or otherwise has a positive economic effect 
on all of the small entities subject to the rule.
    This action, once finalized, will provide an otherwise unavailable 
benefit to those companies that are receiving essential use allowances 
by creating an exemption to the regulatory phaseout of 
chlorofluorocarbons. We have therefore concluded that today's proposed 
rule will relieve regulatory burden for all small entities. We continue 
to be interested in the potential impact of the proposed rule on small 
entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    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

[[Page 32274]]

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.
    Today's proposed 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 phaseout 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 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    This proposed rule does not have federalism implications. It will 
not have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. Thus, Executive Order 13132 does 
not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    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 proposed rule does not 
have tribal implications, as specified in Executive Order 13175. 
Today's proposed 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'' 
under Executive Order 12866, and (2) concerns an environmental health 
or 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 as 
the analysis required under section 5-501 of the Order has the 
potential to influence the regulation. This proposed rule is not 
subject to Executive Order 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 proposed rule is not subject to 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.

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 its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards. This 
proposed rule does not involve technical standards. Therefore, EPA did 
not consider the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    Executive Order 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 proposed rule will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations because any change in the 
level of environmental protection for any affected populations will not 
have any disproportionately high and adverse human health or 
environmental effects on any population, including any minority or low-
income population. Any impacts of this proposed rule will be equally 
distributed among all populations.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure, 
Air pollution control, Chemicals, Imports, Ozone, Reporting and 
recordkeeping requirements.

    Dated: June 6, 2007.
Stephen L. Johnson,
Administrator.
    40 CFR part 82 is proposed to be amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

    1. The authority citation for part 82 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7601,7671-7671q.

Subpart A--Production and Consumption Controls

    2. Section 82.8 is amended by revising the table in paragraph (a) 
to read as follows:

[[Page 32275]]

Sec.  82.8  Grant 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. E7-11299 Filed 6-11-07; 8:45 am]

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