Document ID: EPA-HQ-OAR-2006-0159-0001
Agency: epa
Document Type: Proposed Rule
Title: Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2007
Posted Date: 2006-11-03T12:49:10Z

[Federal Register: November 3, 2006 (Volume 71, Number 213)]
[Proposed Rules]               
[Page 64668-64674]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no06-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2006-0159; FRL-8239-6]
RIN 2060-AN81

 
Protection of Stratospheric Ozone: Allocation of Essential Use 
Allowances for Calendar Year 2007

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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[[Page 64669]]

SUMMARY: EPA is proposing to allocate essential use allowances for 
import and production of class I stratospheric ozone depleting 
substances (ODSs) for calendar year 2007. 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 proposed allocations total 125.3 metric tons (MT) of 
chlorofluorocarbons (CFCs) for use in metered dose inhalers (MDIs) for 
2007.

DATES: Written comments on this proposed rule must be received by the 
EPA Docket on or before December 4, 2006, 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 November 7, 2006. If a 
hearing is held, it will take place on November 20, 2006 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-2006-0159, 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: 202-343-2338, attn: Kirsten M. Cappel.
     Mail: Air Docket, Environmental Protection Agency, 
Mailcode 6102T, 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 B108, Mail 
Code 6102T, 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-
2006-0159. EPA's policy is that all comments received 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 that you consider to 
be CBI or otherwise protected through http://www.regulations.gov or e-mail. 

The http://www.regulations.gov Web site is an ``anonymous access'' system, 

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

your e-mail address will be automatically captured and included as part 
of the comment that is placed in the public docket and made available 
on the Internet. If you submit an electronic comment, EPA recommends 
that you include your name and other contact information in the body of 
your comment and with any disk or CD-ROM you submit. If EPA cannot read 
your comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of 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 B102, 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 827J, 
Washington, DC 20005, by telephone: 202-343-9556; or by e-mail: 
cappel.kirsten@epa.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. What should I consider when preparing my comments?
II. Basis for Allocating Essential Use Allowances
    A. What are essential use allowances?
    B. Under what authority does EPA allocate essential use 
allowances?
    C. What is the process for allocating essential use allowances?
III. Essential Use Allowances for Medical Devices
IV. Proposed Allocation of Essential Use Allowances for Calendar 
Year 2007
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

A. What should I consider when preparing my comments?

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

the part or all of the information that you claim to be CBI. For CBI 
information in a disk or CD ROM that you mail to EPA, mark the outside 
of the disk or CD ROM as CBI and then identify electronically within 
the disk or CD ROM the specific information that is claimed as CBI. In 
addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments, 
remember to:
     Identify the rulemaking by docket number and other 
identifying information (subject heading, Federal Register date and 
page number).
     Follow directions--The agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives 
and substitute language for your requested changes.

[[Page 64670]]

     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 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 (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 phase out 
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 diseases.
    (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 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.

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 Protocol Parties. The Parties 
make the final decisions on whether to approve a Party's essential use 
nomination at their annual meeting. This nomination cycle occurs 
approximately two years before the year in which the allowances would 
be in effect. The allowances allocated through today's action were 
first nominated by the United States in January 2005.
    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

[[Page 64671]]

the Act and the 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 2007, the 
Parties authorized the United States to allocate up to 1,000 MT of CFCs 
for essential uses.

III. Essential Use Allowances for Medical Devices

    The following is a step-by-step list of actions EPA and FDA have 
taken thus far to implement the exemption for medical devices found at 
section 604(d)(2) of the Act for the 2007 control period.
    1. On January 25, 2006, 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 1/1/05 
to 12/31/05.
    c. The number of units anticipated to be produced in 2006.
    d. The gross target fill weight per unit (grams).
    e. Total amount of CFCs to be contained in the MDI product for 
2007.
    f. The additional amount of CFCs necessary for production.
    g. The total CFC request per MDI product for 2007.

The 114 letters are available for review in the Air Docket ID No. EPA-
HQ-OAR-2006-0159. 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. On March 23, 2006, EPA sent FDA the information MDI 
manufacturers provided in response to the 114 letters with a letter 
requesting that FDA make a determination regarding the amount of CFCs 
necessary for MDIs for calendar year 2007. This letter is available for 
review in Air Docket ID No. EPA-HQ-OAR-2006-0159.
    3. On May 10, 2006, under section 114 of the Act, EPA sent letters 
to MDI manufacturers requesting information on the amount and type of 
CFC stocks owned by the company. EPA requested CFC stock information 
pertaining to amounts and types of CFCs, pre-1996 CFCs and post-1996 
CFCs, held by each company as of May 1, 2006. The purpose of this 
request was to gather additional data to assist EPA and FDA to 
determine the size of the 2007 essential use allocation exemption. The 
114 letters are available for review in the Air Docket ID No. EPA-HQ-
OAR-2006-0159. 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.
    4. On September 28, 2006, FDA sent a letter to EPA stating the 
amount of CFCs determined by the Commissioner to be necessary for each 
MDI company in 2007. This letter is available for review in the Air 
Docket ID No. EPA-HQ-OAR-2006-0159. In their letter, FDA informed EPA 
that they had determined that 125.3 MT of CFCs were necessary for use 
in MDIs in 2007. The letter 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 
manufacturers' production of MDIs that used CFCs as a propellant in 
2005, their estimated production in 2006, their estimated production in 
2007, and their current (as of May 1, 2006) stockpile levels. We have 
also taken into account that roughly 40 percent of the albuterol MDIs 
currently being produced use HFA-134a as their propellant. We have also 
based our determination for 2007 on an estimate of the quantity of CFCs 
that would allow manufacturers to maintain as much as a 12-month 
stockpile in accordance with paragraph 3 of Decision XVI/12 and 
paragraph 2 of Decision XVII/5.''
    The letter stated that the following assumptions were made in 
reaching the determination for 2007:
     All manufacturers will procure the full quantity of CFCs 
allocated to them for the year 2007.
     The number of albuterol CFC MDIs produced in the remainder 
of 2006 and in 2007 will be 40 percent of the total number of albuterol 
MDIs produced in those periods, and 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.
     No bulk CFCs currently held by, or allocated to, any 
manufacturer will be exported from the United States.
    FDA informed EPA that the second assumption was based on an average 
for the period of May 1, 2006, through December 31, 2006, and the full 
2007 control period. Thus, CFC MDIs are expected to decline from 60% of 
the total number of albuterol MDIs, as estimated currently, to less 
than 40% by the end of 2007, which is the end of the averaging period.
    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 their analysis of a one-year operational 
supply of CFCs for the production of CFC albuterol MDIs, FDA and EPA 
took into account that the production of these MDIs would continue to 
decrease as December 31, 2008, nears, thus requiring a reduced amount 
of CFCs.
    In accordance with the FDA determination, today's action proposes 
to allocate essential use allowances for a total of 125.3 MT of CFCs 
for use in MDIs for calendar year 2007.
    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 the 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 allocations (along with current stocks)--or an alternative 
level--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 
their 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 
2007

[[Page 64672]]

        Table I.--Essential Use Allowances for Calendar Year 2007
------------------------------------------------------------------------
                                                          2007 Quantity
            Company                    Chemical           (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for Oral Inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals.....  CFC-11 or CFC-12 or                  0.0
                                 CFC-114.
Boehringer Ingelheim            CFC-11 or CFC-12 or                  0.0
 Pharmaceuticals.                CFC-114.
Inyx (Aventis)................  CFC-11 or CFC-12 or                 39.6
                                 CFC-114.
Schering-Plough Corporation...  CFC-11 or CFC-12 or                  0.0
                                 CFC-114.
3M Pharmaceuticals............  CFC-11 or CFC-12 or                 45.7
                                 CFC-114.
Wyeth.........................  CFC-11 or CFC-12 or                 40.0
                                 CFC-114.
------------------------------------------------------------------------

EPA proposes to allocate essential use allowances for calendar year 
2007 to the entities 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.

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 metered-dose inhalers.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden. 
The recordkeeping and reporting requirements included in this action 
are already included in an existing information collection burden and 
this action does not make any changes that would affect the burden. 
However, the Office of Management and Budget (OMB) has previously 
approved the information collection requirements 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 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 proposed rule provides 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), Pub L. 
104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local,

[[Page 64673]]

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.
    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 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 
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 E.O. 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 E.O. 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 E.O. 
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 No. 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.

List of Subjects in 40 CFR Part 82

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

    Dated: October 30, 2006.
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.

[[Page 64674]]

Subpart A--Production and Consumption Controls

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

Sec.  82.8  Grants of essential use allowances and critical use 
allowances.

    (a) * * *

        Table I.--Essential Use Allowances for Calendar Year 2007
------------------------------------------------------------------------
                                                          2007 Quantity
            Company                    Chemical           (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for Oral Inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals.....  CFC-11 or CFC-12 or                  0.0
                                 CFC-114.
Boehringer Ingelheim            CFC-11 or CFC-12 or                 00.0
 Pharmaceuticals.                CFC-114.
Inyx (Aventis)................  CFC-11 or CFC-12 or                 39.6
                                 CFC-114.
Schering-Plough Corporation...  CFC-11 or CFC-12 or                  0.0
                                 CFC-114.
3M Pharmaceuticals............  CFC-11 or CFC-12 or                 45.7
                                 CFC-114.
Wyeth.........................  CFC-11 or CFC-12 or                 40.0
                                 CFC-114.
------------------------------------------------------------------------

[FR Doc. E6-18581 Filed 11-2-06; 8:45 am]

BILLING CODE 6560-50-P