Document ID: EPA-HQ-OAR-2008-0503-0037
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-06-24T04:00Z

SEQ CHAPTER \h \r 1 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2008-0503; FRL-   ]

RIN- 2060-AO77

Protection of Stratospheric Ozone:  Allocation of Essential Use
Allowances for Calendar Year 2009

AGENCY:	Environmental Protection Agency (EPA).

ACTION:	Final rule.

SUMMARY:  With this action, EPA is allocating essential use allowances
for import and production of Class I ozone-depleting substances for
calendar year 2009.  Essential use allowances enable a person to obtain
controlled Class I ozone depleting substances as part of an exemption to
the regulatory ban on the production and import of these chemicals,
which became effective January 1, 1996.  EPA allocates essential use
allowances for production and import of a specific quantity of Class I
substances solely for the designated essential purpose.  The allocation
in this action is 63.0 metric tons of chlorofluorocarbons for use in
metered dose inhalers for 2009.

DATES:  This final rule is effective [insert date of publication].

ADDRESSES:    EPA has established a docket for this action under Docket
ID No. EPA-HQ-OAR-2008-0503.  All documents in the docket are listed on
the www.regulations.gov website.  Although listed in the index, some
information is not publicly available, e.g., confidential business
information (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 through www.regulations.gov or in hard copy at the Air
Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., N.W.,
Washington, D.C. 20460.  This Docket Facility is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays.  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 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, N.W., Room 1047A,
Washington D.C., 20005;  by telephone:  (202) 343-9548; or by email:
bohman.jennifer@epa.gov.  

SUPPLEMENTARY INFORMATION:

Table of Contents

Basis for Allocating Essential Use Allowances

What are essential use allowances?

Under what authority does EPA allocate essential use allowances?

What is the process for allocating essential use allowances?

Essential Use Allowances for Medical Devices

Response to Comments

Allocation of Essential Use Allowances for Calendar Year 2009

Statutory and Executive Order Reviews

Executive Order 12866:  Regulatory Planning and Review

Paperwork Reduction Act

Regulatory Flexibility Act

Unfunded Mandates Reform Act

Executive Order 13132:  Federalism

Executive Order 13175:  Consultation and Coordination with Indian Tribal
Governments

Executive Order 13045:  Protection of Children from Environmental Health
Risks and Safety Risks

Executive Order 13211:  Actions that Significantly Affect Energy Supply,
Distribution, or Use

National Technology Transfer and Advancement Act

Executive Order 12898: Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations

Congressional Review Act

      Judicial Review

     Effective Date of this Final Rule

I.  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 production and consumption of ODSs.  Eliminating the
production and consumption of Class I ODSs is accomplished through
adherence to phaseout schedules for specific Class I ODSs which include
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.  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.  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:

	(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 metered dose inhalers (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
laboratory and analytical use 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 take the final
decisions on whether to approve a Party’s essential use nomination at
their annual Meeting of the Parties.  This nomination process occurs
approximately two years before the year in which the allowances would be
in effect.  The allowances allocated for 2009 in this final rule 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 less than 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 the United States to allocate up to
282 metric tons (MT) of CFCs for essential uses.  In a notice of
proposed rulemaking published in the Federal Register on January 16,
2009 (74 FR 2954), EPA proposed to allocate 63.0 MT of CFCs for the
production of MDIs for the calendar year 2009.  In this final rule, EPA
is allocating 63.0 MT of CFCs for the production of MDIs for calendar
year 2009.

II.  Essential Use Allowances for Medical Devices

	The following is a step-by-step list of actions EPA and FDA have taken
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 letters from EPA 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 annual reporting 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.  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. 
This letter is available for review in the Air Docket ID No.
EPA-HQ-OAR-2008-0503.

	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 that
“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.”   

	6.  In accordance with FDA’s determination, EPA proposed to allocate
63.0 MT of CFCs for the production of MDIs for the calendar year 2009 in
a proposed rulemaking published on January 16, 2009 (74 FR 2954).  

 	7.  In this final rule, EPA is allocating 63.0 MT of CFCs for the
production of MDIs for calendar year 2009.	 

III.  Response to Comments

EPA received comments from two entities on the proposed rule.

One commenter supported the proposed rule and opposed limiting the use
of ODSs in MDIs.  The commenter noted that lower cost CFC MDIs are a
benefit for low-income individuals.

EPA believes that only a limited amount of production or import of CFCs
for use in MDIs is necessary in 2009.  Section 604 of the Clean Air Act
directs EPA to authorize the production of CFCs for essential MDIs if
FDA, in consultation with EPA, determines such production to be
necessary.  FDA, in consultation with EPA, has determined that 63.0 MT
of CFCs are necessary to meet the demand for 2009 MDI manufacturing. 
Therefore, this action allocates 63.0 MT of CFCs for use in MDIs in
2009.

EPA and FDA understand that patients may incur additional costs to
purchase inhalers as the market transitions to CFC-free alternatives,
such as HFA MDIs.  For example, patients covered by medical insurance
may encounter higher co-payments to purchase HFA MDIs, which are brand
name products.  However, patient assistance programs exist to assist
patients with the increased costs.  For low-income patients, these
programs include free and/or discounted medicines.  To assist patients
facing higher co-pays associated with the increased costs of the HFA
MDIs, programs such as coupons and discounted HFA MDIs are being made
available through physicians’ offices, at pharmacies, and at
individual manufacturers’ websites.  

In a related rulemaking, FDA responded to a similar comment regarding
the cost of CFC-free alternatives, stating, “Considering the
availability of programs providing low-cost or free prescription drugs
that would allow low-income, elderly, and uninsured individuals to
purchase alternative MDIs, and the availability of physician samples, we
believe that patients will be adequately served by alternative MDIs”
(73 FR 69532).

A second commenter supported the proposed rule but believes that the US
Government should take actions to limit the amount of CFCs needed for
use in MDIs in the future.  The commenter believes that the U.S.
Government should set up procedures or guidelines to encourage MDI
manufacturers to develop CFC-free MDIs.  The commenter also asked
whether the global laboratory and analytical use exemption would extend
to the future use of MDIs.

EPA notes that the transition to ozone-safe alternatives is well
underway and that, for example, the allocation of essential use
allowances for CFC-based MDIs significantly decreased from over 3,000 MT
in 2000 to 63.0 MT in 2009.  In this action, EPA is only allocating
essential use allowances to one manufacturer of CFC-MDIs.  

FDA has found the use of ODSs to be essential in a limited number of
medical products, including certain metered dose inhalers for the
treatment of asthma and chronic obstructive pulmonary disease (see 21
CFR 2.125(e)(1) and (e)(2)).  When a specific medical product meets the
criteria for removal of the essential use designation, FDA initiates
rulemakings that remove the essential use designations for MDIs in a
manner that is protective of public health.  Specifically, FDA published
a final rule in 2008 that removes the essential use designation for
epinephrine used in MDIs as of December 31, 2011 (73 FR 69532). 
Further, FDA published a proposed rule in 2007 that proposes removing
the essential use designations for flunisolide, triamcinolone,
metaproterenol, pirbuterol, albuterol and ipratropium in combination,
cromolyn, and nedocromil used in MDIs as of December 31, 2009 (72 FR
32030).  

With respect to the comment that EPA should encourage MDI manufacturers
to develop CFC-free MDIs, EPA agrees that that companies that apply for
essential use allocations should demonstrate ongoing research and
development of alternatives to CFC MDIs.  Decision VIII/10, taken in
1997, provides for applicants to submit information on the status of
research and development into alternatives, and Decision XIX/13, taken
in September 2007, provides for applicants to submit related information
describing their progress in transitioning to CFC-free formulations. 
Since 1997, EPA has requested that applicants provide this information
with their applications for CFC essential use nominations.  The MDI
manufacturer that is receiving an essential use allocation has submitted
information to EPA pertaining to its research and development efforts.  

Finally, the global laboratory and analytical exemption allows the
continued production and import of small amounts of class I ODSs for use
in essential laboratory and analytical methods.  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.  The use of CFCs in MDIs is not a laboratory or
analytical use.  Therefore, the use of CFCs in MDIs would not qualify
under the global laboratory and analytical use exemption.

IV.  Allocation of Essential Use Allowances for Calendar Year 2009 

With this action, EPA is allocating essential use allowances for
calendar year 2009 to the entity 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.

TABLE I. - ESSENTIAL USE ALLOWANCES FOR

CALENDAR YEAR 2009

Company	Chemical	2009 Quantity (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

V.  Statutory and Executive Order Reviews

A.  Executive Order 12866:  Regulatory Planning and Review

	Under Executive Order (EO) 12866   SEQ CHAPTER \h \r 1 (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 make any changes that would affect the burden.  However,
the Office of Management and Budget (OMB) has previously approved the
information collection requirements contained in the existing
regulations at 40 CFR 82.8(a) under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control
number 2060-0170.  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 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.  

	  SEQ CHAPTER \h \r 1 After considering the economic impacts of
today’s 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 USC 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 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 rule will relieve regulatory burden for
all small entities. EPA solicited comments on the potential impact of
the proposed rule on small entities.  EPA did not receive comments
related to the potential impact of the proposed rule on small entities.

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 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 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 have tribal implications because it does not have substantial direct
effects on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes. 
Thus, Executive Order 13175 does not apply to this action.  EPA
solicited comment on the proposed rule from tribal officials.  EPA did
not receive any comments from tribal officials on the proposed rule.

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 rule is not 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 a “significant energy action” as defined in
Executive Order 13211 (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. This rule does not have any adverse energy effects
because it merely allocates essential use allowances to entities
manufacturing metered dose inhalers as an exemption to the ban on
production and import of Class I ODSs.

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, 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 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 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 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.

K.  Congressional Review Act

	The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating the
rule must submit a rule report, which includes a copy of the rule, to
each House of the Congress and to the Comptroller General of the United
States.  Therefore, EPA will submit a report containing this rule and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.  This rule is not a
“major rule” as defined by 5 U.S.C. 804(2).  This rule will be
effective [insert date of publication].

VI.  Judicial Review

	Under section 307(b)(1) of the Act, EPA finds that these regulations
are of national applicability.  Accordingly, judicial review of the
action is available only by the filing of a petition for review in the
United States Court of Appeals for the District of Columbia Circuit
within sixty days of publication of the action in the Federal Register. 
Under section 307(b)(2), the requirements of this rule may not be
challenged later in judicial proceedings brought to enforce those
requirements.

  Effective Date of this Final Rule

	Section 553(d) of the Administrative Procedures Act (APA) generally
provides that rules may not take effect earlier than 30 days after they
are published in the Federal Register.  This final rule is issued under
section 307(d) of the CAA, which does not include a 30-day
effective-date period requirement, and which precludes the application
of section 553(d).  CAA section 307(d)(1) (“The provisions of section
553 through 557...of Title 5 shall not, except as expressly provided in
this subsection, apply to actions to which this subsection applies.”) 
EPA is making this final rule effective [insert date of publication],
and believes that this is consistent with the policies underlying APA
section 553(d).  Specifically, APA section 553(d) provides an exception
for any action that grants or recognizes an exemption or relieves a
restriction.  Because this action grants an exemption to the phaseout of
production and consumption of CFCs, EPA is making this action effective
immediately to ensure continued availability of CFCs for medical
devices.

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:  ________________________________________

______________________________________________

Lisa P. Jackson,

Administrator.

40 CFR Part 82 is 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:

§ 82.8 Grant of essential use allowances and critical use allowances.

(a) ***

TABLE I. - ESSENTIAL USE ALLOWANCES FOR CALENDAR YEAR 2009

Company	Chemical	2009 Quantity (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

*****

 “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).

  Class I ozone-depleting substances are listed at 40 CFR part 82,
subpart A, appendix A.

 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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Protection of Stratospheric Ozone:  Allocation of Essential Use
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