[Federal Register Volume 71, Number 69 (Tuesday, April 11, 2006)]
[Proposed Rules]
[Pages 18262-18267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5329]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[EPA-HQ-OAR-2006-0158; FRL-8157-3]
RIN 2060-AN29
Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2006
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 2006. 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 ODS solely for the designated essential
purpose. The proposed allocations total 1,002.40 metric tons of
chlorofluorocarbons (CFCs) for use in metered dose inhalers for 2006.
DATES: Written comments on this proposed rule must be received by the
EPA Docket on or before May 11, 2006, unless a public hearing is
requested. Comments must then be received on or before May 22, 2006.
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 April 17, 2006. If a hearing is held, it will take place on
April 21, 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-2006-0158, by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected]
Fax: 202-343-2337, attn: Hodayah Finman
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, D.C. 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-
2006-0158. 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 website
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air Docket, EPA/
DC, EPA West, Room 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: Hodayah Finman, Team Leader, 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 827M Washington DC 20005, by telephone: 202-343-9246; or by e-
mail: [email protected].
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 2006
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
[[Page 18263]]
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.
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 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 aimed at reducing and
eliminating the production and consumption of stratospheric ozone-
depleting substances. The elimination of production and consumption of
class I ODSs is accomplished through adherence to phase-out schedules
for specific class I ODSs \1\, 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\ 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.\2\ 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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\2\ 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.''
Under section 604(d)(1) of the Act, this exemption was available only
until January 1, 2005.
(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 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 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
[[Page 18264]]
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). 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?
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 2004.
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 2006, the Parties authorized the United States to allocate up to
1,100 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 2006 control period.
1. On March 24, 2005, 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 1/1/04 to
12/31/04.
c. The number of units anticipated to be produced in 2005.
d. The gross target fill weight per unit (grams).
e. Total amount of CFCs to be contained in the MDI product for
2006.
f. The additional amount of CFCs necessary for production.
g. The total CFC request per MDI product for 2006.
The 114 letters are available for review in the Air Docket ID No.
EPA-HQ-OAR-2006-0158. 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 July 5, 2005, 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 2006. This letter is available for review in Air
Docket ID No. EPA-HQ-OAR-2006-0158.
3. On October 12, 2005, FDA sent a letter to EPA stating the amount
of CFCs determined by the Commissioner to be necessary for each MDI
company in 2006. This letter is available for review in the Air Docket
ID No. EPA-HQ-OAR-2006-0158. In their letter, FDA informed EPA that
they had determined that 1,002.40 metric tons of CFCs were necessary
for use in medical devices in 2006. The letter stated: ``Our
recommendation for the allocation of CFCs is lower than the total
amount requested by sponsors. In reaching this estimate, we took into
account the sponsors' production of MDIs that used CFCs as a propellant
in 2004, their estimated production in 2005, their estimated production
in 2006, their current stockpile levels, and the presence on the market
of two albuterol MDIs that do not use CFCs. We have also based our
recommendation for 2006 on an estimate of the quantity of MDIs using
CFCs as a propellant that would be necessary for sponsors to maintain a
12-month stockpile, consistent with paragraph 3 of Decision XVI/12.''
EPA has confirmed with FDA that this determination is consistent with
Decision XVII/5, including new 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 accordance with the determination made by FDA, today's action
proposes to allocate essential use allowances for a total of 1,002.40
metric tons of CFCs for use in MDIs for calendar year 2006.
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
2006
Table I.--Essential Use Allocation for Calendar Year 2006
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2006 Quantity
Company Chemical (metric tons)
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(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
and Chronic Obstructive Pulmonary Disease
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Armstrong Pharmaceuticals........ CFC-11 or CFC-12 or 147.50
CFC-114.
Boehringer Ingelheim CFC-11 or CFC-12 or 116.50
Pharmaceuticals. CFC-114.
Inyx (Aventis)................... CFC-11 or CFC-12 or 106.40
CFC-114.
Schering-Plough Corporation...... CFC-11 or CFC-12 or 556.00
CFC-114.
3M Pharmaceuticals............... CFC-11 or CFC-12 or 0.0
CFC-114.
[[Page 18265]]
Wyeth............................ CFC-11 or CFC-12 or 76.0
CFC-114.
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EPA proposes to allocate essential use allowances for calendar year
2006 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
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.
It has been determined by OMB and EPA that this proposed action is
not a ``significant regulatory action'' under the terms of Executive
Order 12866, and is therefore not subject to OMB review under the
Executive Order.
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 2006. 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 proposed 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. OMB 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 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 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, EPA certifies 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
[[Page 18266]]
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, 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 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 a mandatory requirement as per Section
604(d)(2) of the Clean Air Act which compels the Agency to allocate
essential use exemptions should the Food and Drug Administration finds
that the exemption is 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.
[[Page 18267]]
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: April 5, 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.
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 Allocation for Calendar Year 2006
------------------------------------------------------------------------
2006 Quantity
Company Chemical (metric tons)
------------------------------------------------------------------------
Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and
Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals........ CFC-11 or CFC-12 or 147.50
CFC-114.
Boehringer Ingelheim CFC-11 or CFC-12 or 116.50
Pharmaceuticals. CFC-114.
Inyx (Aventis)................... CFC-11 or CFC-12 or 106.4
CFC-114.
Schering-Plough Corporation...... CFC-11 or CFC-12 or 556.00
CFC-114.
3M Pharmaceuticals............... CFC-11 or CFC-12 or 0.0
CFC-114.
Wyeth............................ CFC-11 or CFC-12 or 76.0
CFC-114.
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-5329 Filed 4-10-06; 8:45 am]
BILLING CODE 6560-50-P