Document ID: EPA-HQ-OAR-2007-0297-0029
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-06-12T04:00Z

SEQ CHAPTER \h \r 1 ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2007-0297; FRL-   ]

RIN A2060

Protection of Stratospheric Ozone:  Allocation of Essential Use
Allowances for Calendar Year 2008

AGENCY:	Environmental Protection Agency (EPA).

ACTION:	Proposed rule.

SUMMARY:  EPA is proposing to allocate essential use allowances for
import and production of Class I ozone-depleting substances (ODSs) for
calendar year 2008.  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 allocations total
27.0 metric tons (MT) of chlorofluorocarbons (CFCs) for use in metered
dose inhalers (MDIs) for 2008.

DATES:  Written comments on this proposed rule must be received by the
EPA Docket on or before [insert date 30 days after date of publication],
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 More
Information Contact” by 5:00 p.m. Eastern Standard Time on [insert
date 5 days after publication].  If a hearing is held, it will take
place on [insert date 15 days after publication] at EPA headquarters in
Washington D.C.  EPA will post a notice on our website
(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
-2007-0297, by one of the following methods:

	  HYPERLINK "http://www.regulations.gov"  www.regulations.gov :
Follow the on-line instructions for submitting comments.

     	•	Email:    HYPERLINK "mailto:A-and-R-docket@epa.gov" 
A-and-R-docket@epa.gov 

     	•	Fax:  202-343-2338, attn: Kirsten M. Cappel

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
-2007-0297.  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   HYPERLINK "http://www.regulations.gov" 
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 ADDRESSES
above.  The   HYPERLINK "http://www.regulations.gov" 
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 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   HYPERLINK
"http://www.regulations.gov"  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   HYPERLINK
"http://www.regulations.gov"  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:  Kirsten M. Cappel, 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 1047C,
Washington D.C., 20005;  by telephone:  (202) 343-9556; or by email:
cappel.kirsten@epa.gov.  

SUPPLEMENTARY INFORMATION:

Table of Contents

General Information

		What should I consider when preparing my comments?

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

Proposed Allocation of Essential Use Allowances for Calendar Year 2008

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

I.	General Information

    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
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.  The elimination
of production and consumption of Class I ODSs is accomplished through
adherence to phaseout schedules for specific Class I ODSs, 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.

	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 phase out
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 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.  EPA plans to update this exemption in accordance with
future Decisions from the Parties and its own regulations.  

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 Protocol 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 2008 were first
nominated by the United States in January 2006. 

	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 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 2008, the
Parties authorized the United States to allocate up to 

385 MT of CFCs for essential uses.  In the 2008 nomination for essential
use allowances, the United States did not request CFCs for use in MDIs
where the sole active ingredient is albuterol.    

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 2008 calendar year.  

	1.  On January 27, 2007, 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 1/1/06 to
12/31/06.

		c. The number of units anticipated to be produced in 2007.

		d. The number of units anticipated to be produced in 2008. 

		e. The gross target fill weight per unit (grams).

		f. Total amount of CFCs to be contained in the MDI product for 2008.

		g. The additional amount of CFCs necessary for production.

		h. The total CFC request per MDI product for 2008. 

The 114 letters are available for review in the Air Docket ID No.
EPA-HQ-OAR- 2007-0297.  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. On January 30, 2007, 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 in reports from each
MDI manufacturer is available for review in the Air Docket ID No.
EPA-HQ-OAR- 2007-0297.  The companies requested that their 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 28, 2007, 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 2008. 
This letter is available for review in Air Docket ID No. EPA-HQ-OAR-
2007-0297.

	4.  On May 1, 2007 FDA sent a letter to EPA stating the amount of CFCs
determined by the Commissioner to be necessary for each MDI company in
2008.  This letter is available for review in the Air Docket ID No.
EPA-HQ-OAR- 2007-0297.  FDA’s letter informed EPA that it had
determined that 27.0 MT of CFCs were medically necessary for use in MDIs
in 2008.  The letter stated “Our determination 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 propellant in 2006, their estimated production in
2007, their estimated production in 2008, their anticipated
essential-use allocations in 2007, and their current (as of December 31,
2006) stockpile levels.  Our determination took into account any
transferred CFCs as well as pre-1996 CFC amounts.  We also considered
the different types and blends of CFCs necessary to produce specific
MDIs.  Finally, we based our determination for 2008 on an estimate of
the quantity of CFCs that would allow manufacturers to have a 12-month
stockpile at the end of 2008 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 2007 (71 FR 64668, November 3, 2006);

All manufacturers will procure the full quantity of CFCs allocated to
them for calendar year 2007;

The number of albuterol CFC MDIs produced in 2008 will be no more than
half of the number produced in 2007, with albuterol HFA MDIs making up
the remainder; and

No bulk CFC currently held by, or allocated to, any manufacturer will be
exported from the United States.  

	FDA’s determination specified that the essential use allowances
allocated for 2008 should only be used to acquire CFC-114 for the
production of epinephrine MDIs.  In its letter to EPA, FDA stated, “In
recent years, we aggregated the amounts for CFC-11, -12, and -114 and
provided recommendations on the total amounts necessary to protect the
public health.  This year, as sponsors transition to non-CFC alternative
and require smaller amounts of CFCs to produce CFC MDIs, we considered
individual amounts of CFCs necessary to protect the public health and
recommend an allocation of 27.0 tonnes of CFC-114 to Armstrong for the
manufacturer of epinephrine CFC MDIs.”  Consistent with FDA’s
determination letter, EPA is allocating 22.4 MT of CFC-114 to Armstrong
for the production of epinephrine MDIs for 2008.

	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 that a one-year operational supply is maintained by
that manufacturer.”  In their analysis of a one-year operational
supply of CFCs for the production of CFC-albuterol MDIs, FDA informed
EPA that it calculates volumes to allow the manufacturer to end the
calendar year with the appropriate level stock of CFCs for essential
uses.  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.

	In accordance with the FDA determination, today’s action proposes to
allocate essential use allowances to Armstrong for a total of 27.0 MT of
CFC-114 for the production of epinephrine MDI’s only for calendar year
2008.

	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 allocations (along with
current stocks) – or an alternative level – 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 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
2008 

TABLE I. - ESSENTIAL USE ALLOWANCES FOR

CALENDAR YEAR 2008

Company	Chemical	2008 Quantity (metric tons)

(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
and Chronic Obstructive Pulmonary Disease

Armstrong Pharmaceuticals	CFC-114

(production of epinephrine MDIs only)	27.0

EPA proposes to allocate essential use allowances for calendar year 2008
to the 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   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 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, EPA ICR number 1432.25.  A copy of the OMB
approved Information Collection Request (ICR) may be obtained from Susan
Auby, Collection Strategies Division; U.S. Environmental Protection
Agency (2822T); 1200 Pennsylvania Ave., NW, Washington, DC 20460 or by
calling (202) 566-1672. 

	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
in 40 CFR are listed in 40 CFR part 9. 

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 proposed 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 its field.  

	  SEQ CHAPTER \h \r 1 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 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, once finalized, 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

	Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), P.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 proposed
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

	  SEQ CHAPTER \h \r 1 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 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 proposed rule is not subject to Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 Fed. Reg. 28355, May 22, 2001) because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy.  The rule affects only the
pharmaceutical companies that requested essential use allowances.

I.  National Technology Transfer and Advancement Act

	Section 12(d) of the National Technology Transfer and Advancement Act
of 1995 ("NTTAA), Public Law 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.

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 determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because any change in the
level of environmental protection for any affected populations will not
have any disproportionately high and adverse human health or
environmental effects on any population, including any minority or
low-income population.  Any impacts of this proposed rule will be
equally distributed among all populations.  

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:  ________________________________________

______________________________________________

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:

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

(a) ***

TABLE I. - ESSENTIAL USE ALLOWANCES FOR CALENDAR YEAR 2008

Company	Chemical	2008 Quantity (metric tons)

(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
and Chronic Obstructive Pulmonary Disease

Armstrong Pharmaceuticals	CFC-114

(production of epinephrine MDIs only)

	27.0

*******

BILLING CODE 6560-50-P

 “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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