[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Proposed Rules]
[Pages 2954-2959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-945]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[EPA-HQ-OAR-2008-0503; FRL-8763-2]
RIN-2060-AO77
Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2009
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to allocate essential use allowances for
import and production of Class I ozone-depleting substances (ODSs) for
calendar year 2009. Essential use allowances enable a person to obtain
controlled Class I ODSs as part of an exemption to the regulatory ban
on the production and import of these chemicals, which became effective
as of January 1, 1996. EPA allocates essential use allowances for
exempted production or import of a specific quantity of Class I
substances solely for the designated essential purpose. The proposed
allocation in this action is 63.0 metric tons (MT) of
chlorofluorocarbons (CFCs) for use in metered dose inhalers (MDIs) for
2009.
DATES: Written comments on this proposed rule must be received by the
EPA Docket on or before February 17, 2009, 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 21, 2009. If a
hearing is held, it will take place on February 2, 2009 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-2008-0503, by one of the following methods:
http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
E-mail: [email protected]
Fax: 202-566-9744
Mail: Air Docket, Environmental Protection Agency,
Mailcode 2822T,
[[Page 2955]]
1200 Pennsylvania Ave., NW., Washington, DC 20460.
Hand Delivery or Courier. Deliver your comments to: EPA
Air Docket, EPA West 1301 Constitution Avenue, NW., Room 3334, Mail
Code 2822T, Washington, DC 20460. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2008-0503. EPA's policy is that all comments received by the docket
will be included in the public docket without change and may be made
available online at www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
through www.regulations.gov or e-mail that you consider to be CBI or
otherwise protected. If you would like the Agency to consider comments
that include CBI, EPA recommends that you submit the comments to the
docket that exclude the CBI portion but that you provide a complete
version of your comments, including the CBI, to the person listed under
FOR FURTHER INFORMATION CONTACT below. The www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through 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
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 www.regulations.gov or in hard copy at the Air Docket, EPA/DC, EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. This
Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the Air
Docket is (202) 566-1742.
FOR FURTHER INFORMATION CONTACT: Jennifer Bohman, 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 1013K,
Washington, DC 20005; by telephone: (202) 343-9548; 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 2009
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
J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
I. General Information
A. What should I consider when preparing my comments?
1. Confidential Business Information. Do not submit this
information to EPA through 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 substances (ODSs) in the U.S. for purposes that
have been deemed ``essential'' by the U.S. Government and by the
Parties to the Montreal Protocol on Substances that Deplete the Ozone
Layer (Montreal Protocol).
The Montreal Protocol is the international agreement aimed at
reducing and eliminating the
[[Page 2956]]
production and consumption \1\ of ODSs. The elimination of production
and consumption of Class I ODSs is accomplished through adherence to
phaseout schedules for specific Class I ODSs,\2\ which include CFCs,
halons, carbon tetrachloride, and methyl chloroform. As of January 1,
1996, production and import of most Class I ODSs were phased out in
developed countries, including the United States.
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\1\ ``Consumption'' is defined as the amount of a substance
produced in the United States, plus the amount imported into the
United States, minus the amount exported to Parties to the Montreal
Protocol (see Section 601(6) of the Clean Air Act).
\2\ Class I ozone depleting substances are listed at 40 CFR part
82, subpart A, appendix A.
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However, the Montreal Protocol and the Clean Air Act (the Act)
provide exemptions that allow for the continued import and/or
production of Class I ODSs for specific uses. Under the Montreal
Protocol, exemptions may be granted for uses that are determined by the
Parties to be ``essential.'' Decision IV/25, taken by the Parties to
the Protocol in 1992, established criteria for determining whether a
specific use should be approved as essential, and set forth the
international process for making determinations of essentiality. The
criteria for an essential use, as set forth in paragraph 1 of Decision
IV/25, are the following:
``(a) That a use of a controlled substance should qualify as
`essential' only if:
(i) It is necessary for the health, safety or is critical for the
functioning of society (encompassing cultural and intellectual
aspects); and
(ii) There are no available technically and economically feasible
alternatives or substitutes that are acceptable from the standpoint of
environment and health;
(b) That production and consumption, if any, of a controlled
substance for essential uses should be permitted only if:
(i) All economically feasible steps have been taken to minimize the
essential use and any associated emission of the controlled substance;
and
(ii) The controlled substance is not available in sufficient
quantity and quality from existing stocks of banked or recycled
controlled substances, also bearing in mind the developing countries'
need for controlled substances.''
B. Under what authority does EPA allocate essential use allowances?
Title VI of the Act implements the Montreal Protocol for the United
States.\3\ Section 604(d) of the Act authorizes EPA to allow the
production of limited quantities of Class I ODSs after the phaseout
date for the following essential uses:
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\3\ See Section 614(b) of the Act. EPA's regulations
implementing the essential use provisions of the Act and the
Protocol are located in 40 CFR part 82.
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(1) Methyl Chloroform, ``solely for use in essential applications
(such as nondestructive testing for metal fatigue and corrosion of
existing airplane engines and airplane parts susceptible to metal
fatigue) for which no safe and effective substitute is available.''
Under section 604(d)(1) of the Act, this exemption was available only
until January 1, 2005. Prior to that date, EPA issued methyl chloroform
allowances to the U.S. Space Shuttle and Titan Rocket programs.
(2) Medical devices (as defined in section 601(8) of the Act), ``if
such authorization is determined by the Commissioner [of the Food and
Drug Administration], in consultation with the Administrator [of EPA]
to be necessary for use in medical devices.'' EPA issues allowances to
manufacturers of MDIs that use CFCs as propellant for the treatment of
asthma and chronic obstructive pulmonary disease.
(3) Aviation safety, for which limited quantities of halon-1211,
halon-1301, and halon-2402 may be produced ``if the Administrator of
the Federal Aviation Administration, in consultation with the
Administrator [of EPA] determines that no safe and effective substitute
has been developed and that such authorization is necessary for
aviation safety purposes.'' Neither EPA nor the Parties have ever
granted a request for essential use allowances for halon, because
alternatives are available or because existing quantities of this
substance are large enough to provide for any needs for which
alternatives have not yet been developed.
An additional essential use exemption under the Montreal Protocol,
as agreed in Decision X/19, is the general exemption for laboratory and
analytical uses. This exemption is reflected in EPA's regulations at 40
CFR part 82, subpart A. While the Act does not specifically provide for
this exemption, EPA has determined that an exemption for essential
laboratory and analytical uses is allowable under the Act as a de
minimis exemption. The de minimis exemption is addressed in EPA's final
rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol
subsequently agreed (Decision XI/15) that the general exemption does
not apply to the following uses: testing of oil and grease, and total
petroleum hydrocarbons in water; testing of tar in road-paving
materials; and forensic finger-printing. EPA incorporated this
exemption at Appendix G to Subpart A of 40 CFR part 82 on February 11,
2002 (67 FR 6352). In a December 29, 2005 final rule, EPA extended the
general exemption for laboratory and analytical uses through December
31, 2007 (70 FR 77048), in accordance with Decision XV/8 of the Parties
to the Protocol. At the 19th Meeting of the Parties in September 2007,
the Parties agreed to extend the global laboratory and analytical use
exemption through December 31, 2011, in Decision XIX/18. In a December
27, 2007 final rulemaking EPA took action to (1) extend the laboratory
and analytical use exemption from December 31, 2007 to December 31,
2011 for specific laboratory uses, (2) apply the laboratory and
analytical use exemption to the production and import of methyl
bromide, and (3) eliminate the testing of organic matter in coal from
the laboratory and analytical use exemption (72 FR 73264).
C. What is the process for allocating essential use allowances?
The procedure set out by Decision IV/25 calls for individual
Parties to nominate essential uses and the total amount of ODSs needed
for those essential uses on an annual basis. The Protocol's Technology
and Economic Assessment Panel (TEAP) evaluates the nominated essential
uses and makes recommendations to the Parties. The Parties make the
final decisions on whether to approve a Party's essential use
nomination at their annual meeting. This nomination process occurs
approximately two years before the year in which the allowances would
be in effect. The allowances proposed for allocation for 2009 were
first nominated by the United States in January 2007.
For MDIs, EPA requests information from manufacturers about the
number and type of MDIs they plan to produce, as well as the amount of
CFCs necessary for production. EPA then forwards the information to the
Food and Drug Administration (FDA), which determines the amount of CFCs
necessary for MDIs in the coming calendar year. Based on FDA's
determination, EPA proposes allocations to each eligible entity. Under
the Act and the Montreal Protocol, EPA may allocate essential use
allowances in quantities that together are below or equal to the total
amount approved by the Parties. EPA will not allocate essential use
allowances in amounts higher than the total approved by the Parties.
For 2009, the Parties authorized
[[Page 2957]]
the United States to allocate up to 282 MT of CFCs for essential uses.
III. Essential Use Allowances for Medical Devices
The following is a step-by-step list of actions EPA and FDA have
taken thus far to implement the exemption for medical devices found at
section 604(d)(2) of the Act for the 2009 calendar year.
1. On January 16, 2008, 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 1/1/07 to
12/31/07.
c. The number of units anticipated to be produced in 2008.
d. The number of units anticipated to be produced in 2009.
e. The gross target fill weight per unit (grams).
f. Total amount of CFCs to be contained in the MDI product for
2009.
g. The additional amount of CFCs necessary for production.
h. The total CFC request per MDI product for 2009.
The 114 letters are available for review in the Air Docket ID No.
EPA-HQ-OAR-2008-0503. The companies requested that their responses be
treated as confidential business information; for this reason, EPA has
placed the responses in the confidential portion of the docket.
2. At the end of January 2008, as required by 40 CFR 82.13(u), EPA
received information from MDI manufacturers that included such data as
the type and quantity of CFCs held at the end of the year (i.e. stocks
of pre-1996 and post-1996 CFCs). The data submitted from the MDI
manufacturers is available for review in the Air Docket ID No. EPA-HQ-
OAR-2008-0503. The companies requested that their individual responses
be treated as confidential business information; for this reason, EPA
has placed the individual responses in the confidential portion of the
docket.
3. On February 13, 2008, EPA sent FDA the information MDI
manufacturers provided in response to the 114 letters and information
required by 40 CFR 82.13(u) with a letter requesting that FDA make a
determination regarding the amount of CFCs necessary for MDIs for
calendar year 2009. This letter is available for review in Air Docket
ID No. EPA-HQ-OAR-2008-0503.
4. On April 28, 2008, FDA sent a letter to EPA stating the amount
of CFCs determined by the Commissioner to be necessary for each MDI
company in 2009. This letter is available for review in the Air Docket
ID No. EPA-HQ-OAR-2008-0503. FDA's letter informed EPA that it had
determined that 88.0 MT of CFCs were necessary for use in medical
devices in the year 2009.
5. On August 12, 2008, FDA sent a letter to EPA revising its April
28, 2008 essential use determination. FDA's revised letter informed EPA
that it had determined that 63.0 MT of CFCs were necessary for use in
medical devices for the year 2009. In its letter FDA stated, ``This
letter revises our recommendations for the amount of CFCs necessary for
use in medical devices in the year 2009. The amount of CFCs recommended
in our April 28, 2008 letter was based on information available then,
that led to assumptions that are now outdated.'' This letter is
available for review in the Air Docket ID No. EPA-HQ-OAR-2008-0503.
With respect to the 2009 determination, FDA stated, ``FDA's
determination for the allocation of CFCs is lower than the total amount
requested by sponsors. In reaching this determination, we took into
account the sponsors' production of MDIs that used CFCs as a propellant
in 2007, their estimated production in 2008, their estimated production
in 2009, their anticipated essential-use allocations in 2008, their
current (as of December 31, 2007) stockpile levels, and any
intercompany transfers of CFCs. Finally, FDA based its determination
for 2009 on an estimate of the quantity of CFCs that would allow
manufacturers to have a 12-month stockpile at the end of 2009, in
accordance with paragraph 3 of Decision XVI/12 and paragraph 2 of
Decision XVII/5.''
The letter stated that in making its determination, FDA made the
following assumptions:
All manufacturers will receive the full essential-use
allocation proposed by EPA for calendar year 2008 (72 FR 32269, June
12, 2007);
All manufacturers will procure the full quantity of CFCs
allocated to them for 2008; and
No bulk CFCs currently held by, or allocated to, any
manufacturer will be exported from the United States.
EPA has confirmed with FDA that this determination is consistent
with Decision XVII/5, including language on stocks that states that
Parties ``shall take into account pre- and post-1996 stocks of
controlled substances as described in paragraph 1(b) of Decision IV/25,
such that no more than a one-year operational supply is maintained by
that manufacturer.'' Allowing manufacturers to maintain up to a one-
year operational supply accounts for unexpected variability in the
demand for MDI products or other unexpected occurrences in the market
and therefore ensures that MDI manufacturers are able to produce their
essential use MDIs.
For calendar year 2009, FDA's determination aggregates the amounts
of CFC-11, -12, or -114 being allocated to the MDI manufacturer. In its
letter FDA stated, ``As has generally been our practice, FDA is
aggregating the amounts for CFCs, and is providing recommendations on
the total amounts of CFCs necessary to protect the public health. FDA
expects manufacturers to maintain an appropriate balance of CFCs
necessary to produce their CFC MDIs.''
In accordance with the FDA determination, today's action proposes
to allocate essential use allowances for a total of 63.0 MT of CFCs for
use in MDIs for calendar year 2009.
The amounts listed in this proposal are subject to additional
review and revision by EPA and FDA if information demonstrates that the
proposed allocations are either too high or too low. We specifically
request comment on the extent to which the proposed allocation of CFCs
is sufficient to protect public health and ensure the manufacture and
continuous availability of CFCs necessary to meet the expected demand.
We also request comment on whether the proposed allocation, when
considered along with current stocks, will best protect consumers by
providing a smooth transition to non-CFC alternatives. Commenters
requesting increases or decreases of essential use allowances should
provide detailed information supporting a claim for additional or fewer
CFCs. Any company that needs less than the full amount listed in this
proposal should notify EPA of the actual amount needed.
IV. Proposed Allocation of Essential Use Allowances for Calendar Year
2009
Table I--Essential Use Allowances for Calendar Year 2009
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2009 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................. CFC-11 or CFC-12 or CFC-114 63.0
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EPA proposes to allocate essential use allowances for calendar year
2009 to the
[[Page 2958]]
entity listed in Table I. These allowances are for the production or
import of the specified quantity of Class I controlled substances
solely for the specified essential use.
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action'' because it raises
novel legal or policy issues. Accordingly, EPA submitted this action to
the Office of Management and Budget (OMB) for review under EO 12866 and
any changes made in response to OMB recommendations have been
documented in the docket for this action.
EPA prepared an analysis of the potential costs and benefits
related to this action. This analysis is contained in the Agency's
Regulatory Impact Analysis (RIA) for the entire Title VI phaseout
program (U.S. Environmental Protection Agency, ``Regulatory Impact
Analysis: Compliance with Section 604 of the Clean Air Act for the
Phaseout of Ozone Depleting Chemicals,'' July 1992). A copy of the
analysis is available in the docket for this action and the analysis is
briefly summarized here. The RIA examined the projected economic costs
of a complete phaseout of consumption of ozone-depleting substances, as
well as the projected benefits of phased reductions in total emissions
of CFCs and other ozone-depleting substances, including essential use
CFCs used for MDIs.
B. Paperwork Reduction Act
This action does not impose any new information collection burden.
The recordkeeping and reporting requirements included in this action
are already included in an existing information collection burden and
this action does not propose any changes that would affect the burden.
However, the Office of Management and Budget (OMB) has previously
approved the information collection requirements contained in the
existing regulations at 40 CFR 82.8(a) under the provisions of the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and has assigned OMB
control number 2060-0170. The OMB control numbers for EPA's regulations
in 40 CFR are listed in 40 CFR part 9.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act generally requires an agency to
prepare a regulatory flexibility analysis of any rule subject to notice
and comment rulemaking requirements under the Administrative Procedure
Act or any other statute unless the agency certifies that the rule will
not have a significant economic impact on a substantial number of small
entities. Small entities include small businesses, small organizations,
and small governmental jurisdictions.
For purposes of assessing the impact of today's proposed rule on
small entities, small entity is defined as: (1) A small business that
is primarily engaged in pharmaceutical preparations manufacturing as
defined by NAICS code 325412 with less than 750 employees; (2) a small
governmental jurisdiction that is a government of a city, county, town,
school district or special district with a population of less than
50,000; and (3) a small organization that is any not-for-profit
enterprise which is independently owned and operated and is not
dominant its field.
After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the rule on small entities.'' 5 U.S.C. 603 and 604.
Thus, an agency may certify that a rule will not have a significant
economic impact on a substantial number of small entities if the rule
relieves regulatory burden, or otherwise has a positive economic effect
on all of the small entities subject to the rule.
This proposed action will provide an otherwise unavailable benefit
to those companies that are receiving essential use allowances by
creating an exemption to the regulatory phaseout of
chlorofluorocarbons. We have therefore concluded that today's proposed
rule will relieve regulatory burden for all small entities. We continue
to be interested in the potential impact of the proposed rule on small
entities and welcome comments on issues related to such impacts.
D. Unfunded Mandates Reform Act
This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. This action is deregulatory
and does not impose any new requirements on any entities. Therefore,
this action is not subject to the requirements of sections 202 and 205
of the UMRA. This action is also not subject to the requirements of
section 203 of UMRA because it 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, titled ``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
This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action does
not impose substantial direct compliance costs on Indian tribal
governments. Thus, Executive Order 13175 does not apply to this action.
EPA specifically solicits additional comment on this proposed action
from tribal officials.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets EO 13045 as applying to those regulatory actions
that concern health or safety risks, such that the analysis required
under section 5-501 of the Order has the potential to influence the
regulation. This proposed rule is not
[[Page 2959]]
subject to EO 13045 because it implements Section 604(d)(2) of the
Clean Air Act which states that the Agency shall authorize essential
use exemptions should the Food and Drug Administration determine that
such exemptions are necessary.
H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.
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, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. The NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards. This proposed
rule does not involve technical standards. Therefore, EPA did not
consider the use of any voluntary consensus standards.
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
EPA has concluded that it is not practicable to determine whether
there would be disproportionately high and adverse human health or
environmental effects on minority and/or low income populations from
this proposed rule. EPA believes, however, that this action affects the
level of environmental protection equally for all affected populations
without having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. Any ozone depletion that results from this proposed
rule will impact all affected populations equally because ozone
depletion is a global environmental problem with environmental and
human effects that are, in general, equally distributed across
geographical regions.
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Imports, Methyl
Chloroform, Ozone, Reporting and recordkeeping requirements.
Dated: January 12, 2009.
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 Grant of essential use allowances and critical use
allowances.
(a) * * *
Table I.--Essential Use Allowances for Calendar Year 2009
------------------------------------------------------------------------
2009 Quantity
Company Chemical (metric tons)
------------------------------------------------------------------------
(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong................. CFC-11 or CFC-12 or CFC-114 63.0
------------------------------------------------------------------------
* * * * *
[FR Doc. E9-945 Filed 1-15-09; 8:45 am]
BILLING CODE 6560-50-P