[Federal Register Volume 69, Number 245 (Wednesday, December 22, 2004)]
[Proposed Rules]
[Pages 76655-76660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27994]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-7852-1]
RIN 2060-AM50


Protection of Stratospheric Ozone: Allocation of Essential Use 
Allowances for Calendar Year 2005

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing to allocate essential use allowances for 
import and production of class I stratospheric ozone depleting 
substances (ODSs) for calendar year 2005. Essential use allowances 
enable a person to obtain controlled class I ODSs as an exemption to 
the regulatory ban of production and import of these chemicals, which 
became effective on January 1, 1996. EPA allocates essential use 
allowances for exempted production or import of a specific quantity of 
class I ODS solely for the designated essential purpose. The proposed 
allocations total 1,524.58 metric tons of chlorofluorocarbons for use 
in metered dose inhalers.

DATES: Written comments on this proposed rule must be received by the 
EPA Docket on or before January 21, 2005, 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 January 23, 2005. If a 
hearing is held, EPA will publish a document in the Federal Register 
announcing the hearing information.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR-2004-
0063, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Agency Web site: http://www.epa.gov/edocket. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the on-line instructions for 
submitting comments.
     Mail: Air and Radiation Docket, Environmental Protection 
Agency, Mailcode 6102T, 1200 Pennsylvania Ave., NW., Washington, DC, 
20460, Attention: Docket ID No. OAR-2004-0063.
     Hand Delivery: EPA Docket Center, (EPA/DC) EPA West, Room 
B102, 1301 Constitution Ave., NW., Washington, DC, Attention Docket ID 
No. OAR-2004-0063. 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 Air Docket ID No. OAR-2004-
0063. 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.epa.gov/edocket, 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 EDOCKET, 
regulations.gov, or e-mail. For instructions on how to submit CBI, see 
``How do I submit confidential business information to EPA?'' under 
SUPPLEMENTARY INFORMATION.
    The EPA EDOCKET and the federal regulations.gov websites are 
``anonymous access'' systems, 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 EDOCKET or 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.
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket. Although listed in the index, some 
information is not publicly available, namely 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 in EDOCKET or in hard 
copy at the Air Docket, EPA/DC, EPA West, Room B102, 1301 Constitution 
Ave., NW., Washington, DC. 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 Docket ID No. OAR-2004-0063 is (202) 566-1742.
    Materials related to previous EPA actions on the essential use 
program are contained in EPA Air Docket No. A-93-39. Docket A-93-39 may 
be reviewed at the Public Reading Room.

FOR FURTHER INFORMATION CONTACT: Scott Monroe, Essential Use Program 
Manager, 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., Washington D.C., 20005, by telephone: 202-343-9712; 
or by e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. How should I submit confidential business information to EPA?
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 2005
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. How Should I Submit Confidential Business Information to EPA?

    Comments that contain confidential business information should be 
submitted in two versions, one clearly marked ``Public'', to be filed 
in the

[[Page 76656]]

public docket, and the other clearly marked ``Confidential'' to be 
reviewed by authorized government personnel only. If the comments are 
not marked, EPA will assume they do not contain confidential business 
information and will docket them.
    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. 
Send or deliver information identified as CBI only to the Essential Use 
Program Manager. You may claim information that you submit to EPA as 
CBI by marking any part or all of that information as CBI (if you 
submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR Part 
2.
    In addition to one complete version of the comment that includes 
any 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 and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person identified in the FOR FURTHER INFORMATION CONTACT section.

II. Basis for Allocating Essential Use Allowances

A. What Are Essential Use Allowances?

    Essential use allowances are allowances to produce or import 
certain ozone-depleting chemicals in the U.S. for purposes that have 
been deemed ``essential'' by the Parties to the Montreal Protocol and 
the U.S. Government.
    The Montreal Protocol on Substances that Deplete the Ozone Layer 
(Protocol) is the international agreement to reduce and eventually 
eliminate the production and consumption \1\ of all stratospheric ozone 
depleting substances (ODSs). The elimination of production and 
consumption of class I ODSs is accomplished through adherence to phase-
out schedules for specific class I ODSs\2\, including: 
chlorofluorocarbons (CFCs), halons, carbon tetrachloride, and methyl 
chloroform. As of January 1, 1996, production and import of most class 
I ODSs were phased out in developed countries, including the United 
States.
---------------------------------------------------------------------------

    \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). Stockpiles of 
class I ODSs produced or imported prior to the 1996 phase out may be 
used for purposes not expressly banned at 40 CFR part 82.
    \2\ Class I ozone depleting substances are listed at 40 CFR Part 
82 subpart A, appendix A.
---------------------------------------------------------------------------

    However, the Protocol and the Clean Air Act (Act) provide 
exemptions that allow for the continued import and/or production of 
class I ODS for specific uses. Under the 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 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:
---------------------------------------------------------------------------

    \3\ According to Section 614(b) of the Act, Title VI ``shall be 
construed, interpreted, and applied as a supplement to the terms and 
conditions of the Montreal Protocol * * * and shall not be 
construed, interpreted, or applied to abrogate the responsibilities 
or obligations of the United States to implement fully the 
provisions of the Montreal Protocol. In the case of conflict between 
any provision of this title and any provision of the Montreal 
Protocol, the more stringent provision shall govern.'' EPA's 
regulations implementing the essential use provisions of the Act and 
the Protocol are located in 40 CFR part 82.
---------------------------------------------------------------------------

    (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.'' 
Decision X/6 by the Parties to the Protocol established that ``* * * 
the remaining quantity of methyl chloroform authorized for the United 
States at previous meetings of the Parties [will] be made available for 
use in manufacturing solid rocket motors until such time as the 1999-
2001 quantity of 176.4 tons (17.6 ODP-weighted tons) allowance is 
depleted, or until such time as safe alternatives are implemented for 
remaining essential uses.'' Prior to 2004, EPA issued allowances for 
production of approximately 34 metric tons of methyl chloroform out of 
the authorized balance of 176 metric tons. Under section 604(d)(1) of 
the Act, EPA may no longer allocate essential use allowances for 
production and import of methyl chloroform as of January 1, 2005. In 
light of this deadline, in the allocation rulemaking for calendar year 
2004 (69 FR 4059) EPA allocated the remaining authorized production 
allowances for methyl chloroform, approximately 142 metric tons, to the 
National Aeronautics and Space Administration.
    (2) Medical Devices (as defined in section 601(8) of the Act), ``if 
such authorization is determined by the Commissioner [of the Food and 
Drug Administration], in consultation with the Administrator [of EPA] 
to be necessary for use in medical devices.'' EPA issues allowances to 
manufacturers of metered-dose inhalers, which 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

[[Page 76657]]

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.
    The Protocol, under Decision X/19, additionally allows a 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 allowance 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 exclusion at Appendix G 
to Subpart A of 40 CFR part 82 on February 11, 2002 (67 FR 6352).

C. What Is the Process for Allocating Essential Use Allowances?

    Before EPA may allocate essential use allowances, the Parties to 
the Protocol must first approve 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 Protocol's Technology and Economic Assessment Panel 
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 2003.
    Once the U.S. nomination is approved by the Parties, EPA allocates 
essential use exemptions to specific entities through notice-and-
comment rulemaking in a manner consistent with the Act. For medical 
devices, EPA requests information from manufacturers about the number 
and type of devices 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 metered-dose inhalers in the coming calendar year. Based 
on FDA's assessment, EPA proposes allocations to each eligible entity. 
Under 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 may not allocate essential use 
allowances in amounts higher than the total approved by the Parties. 
For 2005, the Parties authorized the United States to allocate up to 
1,902 metric tons 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 2005 control period.
    1. On February 24, 2004, 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 1/1/03 to 
12/31/03.
    c. The number of units anticipated to be produced in 2004.
    d. The gross target fill weight per unit (grams).
    e. Total amount of CFCs to be contained in the MDI product for 
2005.
    f. The additional amount of CFCs necessary for production.
    g. The total CFC request per MDI product for 2005.
    The 114 letters are available for review in the Air Docket ID No. 
OAR-2004-0063. The companies requested that their responses be treated 
as confidential business information; for this reason, EPA has not 
placed the responses in the docket.
    2. On May 18, 2004, 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 2005. This letter is available for review in Air 
Docket ID No. OAR-2004-0063.
    3. On July 28, 2004, FDA sent a letter to EPA stating the amount of 
CFCs determined by the Commissioner to be necessary for each MDI 
company in 2005. This letter is available for review in the Air Docket 
ID No. OAR-2004-0063. In their letter, FDA informed EPA that they had 
determined that 1524.58 metric tons of CFCs were necessary for use in 
medical devices in 2005.
    In accordance with the determination made by FDA, today's action 
proposes to allocate essential use allowances for a total of 1524.58 
metric tons of CFCs for use in MDIs for calendar year 2005. The amounts 
listed in this proposal are subject to additional review by EPA and FDA 
if new information demonstrates that the proposed allocations are 
either too high or too low. Commentors 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 
2005

    EPA proposes to allocate essential use allowances for calendar year 
2005 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. As explained in 
Section II.C. above, the amount of each allocation is based on the 
request of the company, which was reviewed by FDA to determine the 
quantities necessary for use in medical devices.

        TABLE I.--ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005
------------------------------------------------------------------------
                                                       Quantity  (metric
            Company                    Chemical              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                 29
                                 CFC-114.
Aventis Pharmaceutical          CFC-11, or CFC-12, or                 57
 Products.                       CFC-114.
Boehringer Ingelheim            CFC-11, or CFC-12, or                480
 Pharmaceuticals.                CFC-114.
Schering-Plough Corporation...  CFC-11, or CFC-12, or                816
                                 CFC-114.
3M Pharmaceuticals............  CFC-11, or CFC-12, or              69.18
                                 CFC-114.

[[Page 76658]]

 
Wyeth.........................  CFC-11, or CFC-12, or              73.40
                                 CFC-114.
------------------------------------------------------------------------

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether this regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. The Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may:
    (1) Have an annual effect on the economy of $100 million or more, 
or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    Pursuant to the terms of Executive Order 12866, OMB has notified 
EPA that it considers this a ``significant regulatory action'' within 
the meaning of the Executive Order. EPA submitted this action to OMB 
for review and incorporated changes as a result. A copy of the rule 
showing changes that were made is available in EPA Docket OAR-2004-
0063.
    Under Section 6(a)(3)(B)(ii) of Executive Order 12866, the Agency 
must provide to OMB's Office of Information and Regulatory Affairs an 
``assessment of the potential costs and benefits of the regulatory 
action, including an explanation of the manner in which the regulatory 
action is consistent with a statutory mandate and, to the extent 
permitted by law, promotes the President's priorities and avoids undue 
interference with State, local, and tribal governments in the exercise 
of their governmental functions.''
    EPA is undertaking today's proposed action under the mandate 
established by Section 604(d) of the Clean Air Act Amendments of 1990, 
which directs the Administrator to authorize the production of limited 
quantities of class I substances solely for use in medical devices, if 
the Commissioner of FDA determines that the authorization is necessary. 
The proposed allocations in today's rule are the amounts determined by 
FDA to be necessary for calendar year 2005.
    EPA has not assessed the costs and benefits specific to today's 
proposed action. The Agency examined the costs and benefits associated 
with a related regulation. The Agency's Regulatory Impact Analysis 
(RIA) for the entire Title VI phaseout program 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 (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).

B. Paperwork Reduction Act

    This action does not add any information collection requirements or 
increase burden under the provisions of the Paperwork Reduction Act, 44 
U.S.C. 3501 et. seq. MB previously approved the information collection 
requirements contained in the final rule promulgated on May 10, 1995, 
and assigned OMB control number 2060-0170 (EPA ICR No. 1432.21).
    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 instruction; 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 are 
listed in 40 CFR part 9 and 48 CFR Chapter 1.

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 in 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 rule provides an otherwise unavailable benefit to those 
companies

[[Page 76659]]

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, 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 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. Today's rule affects only the 
companies that requested essential use allowances. 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 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 E.O. 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 E.O. 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 rule is not subject to E.O. 13045 because it 
implements the phase-out 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 subject to Executive Order 13211, Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 Fed. Reg. 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.

List of Subjects in 40 CFR Part 82

    Administrative practice and procedure, Air pollution control, 
Chemicals, Chlorofluorocarbons, Environmental protection, Imports,

[[Page 76660]]

Methyl Chloroform, Ozone, Reporting and recordkeeping requirements.

    Dated: December 16, 2004.
Michael O. Leavitt,
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 82.4 is amended by revising the table in paragraph 
(n)(2) to read as follows:


Sec.  82.4  Prohibitions for class I controlled substances.

* * * * *
    (n) * * *
    (2) * * *

        Table I.--Essential Use Allocation For Calendar Year 2005
------------------------------------------------------------------------
                                                       Quantity  (metric
            Company                    Chemical              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                 29
                                 CFC-114.
Aventis Pharmaceutical          CFC-11, or CFC-12, or                 57
 Products.                       CFC-114.
Boehringer Ingelheim            CFC-11, or CFC-12, or                480
 Pharmaceuticals.                CFC-114.
Schering-Plough Corporation...  CFC-11, or CFC-12, or                816
                                 CFC-114.
3M Pharmaceuticals............  CFC-11, or CFC-12, or              69.18
                                 CFC-114.
Wyeth.........................  CFC-11, or CFC-12, or              73.40
                                 CFC-114.
------------------------------------------------------------------------

* * * * *
[FR Doc. 04-27994 Filed 12-21-04; 8:45 am]
BILLING CODE 6560-50-P