[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]
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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.
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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.
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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). 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.
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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:
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\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.
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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.''
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
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Quantity (metric
Company Chemical tons)
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(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
and Chronic Obstructive Pulmonary Disease
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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.
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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