[Federal Register Volume 68, Number 208 (Tuesday, October 28, 2003)]
[Proposed Rules]
[Pages 61382-61389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27160]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-7579-7]


Protection of Stratospheric Ozone: Allocation of Essential Use 
Allowances for Calendar Year 2004

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to allocate essential use allowances for 
import and production of class I stratospheric ozone depleting 
substances (ODSs) for calendar year 2004. Essential use allowances 
enable a person to obtain controlled class I ODSs as an exemption to 
the regulatory ban of production and import of these chemicals, which 
became effective on January 1, 1996. EPA allocates essential use 
allowances for exempted production or import of a specific quantity of 
class I ODS solely for the designated essential purpose. The proposed 
allocations total 2077.91 metric tons of chlorofluorocarbons for use in 
metered dose inhalers. EPA is also proposing to allocate the remaining 
allowances for methyl chloroform (141.877 metric tons) to the U.S. 
Space Shuttle Program.

DATES: Written comments on this proposed rule must be received by the 
EPA Docket on or before November 28, 2003, 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 November 7, 2003. If a 
hearing is held, EPA will publish a document in the Federal Register 
announcing the hearing information.

ADDRESSES: Comments on this proposed rulemaking should be submitted to 
Air and Radiation Docket, Environmental

[[Page 61383]]

Protection Agency, Mailcode 6102T, 1200 Pennsylvania Ave., NW., 
Washington, DC, 20460, Attention: Docket ID No. OAR-2003-0202. Comments 
also may be submitted electronically, by facsimile, or through hand 
deliver or courier service, as described in SUPPLEMENTARY INFORMATION 
below. Comments will be filed in EPA Air Docket ID No. OAR-2003-0202. 
Written comments or other materials also may be submitted in duplicate 
to the Essential Use Program Manager as identified in FOR FURTHER 
INFORMATION CONTACT below.
    Materials related to previous EPA actions on the essential use 
program are contained in EPA Air Docket No. A-93-39. Docket A-93-39 is 
located at EPA West Building, Room B102, 1301 Constitution Avenue, NW., 
Washington, DC, 20460. The Air Docket is open from 8:30 a.m. until 4:30 
p.m. Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Scott Monroe, Essential Use Program 
Manager, by regular mail: U.S. Environmental Protection Agency, Global 
Programs Division (6205J), 1200 Pennsylvania Avenue, NW., Washington, 
DC, 20460; by courier service or overnight express: 1301 L Street, NW., 
Washington DC, 20005, by telephone: 202-564-9712; or by email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. How can I get copies of related information?
    B. How and to whom do I submit comments?
    C. How should I submit confidential business information to EPA?
II. Basis for Allocating Essential Use Allowances
    A. What are essential use allowances?
    B. Under what authority does EPA allocate essential use 
allowances?
    C. What is the process for allocating essential use allowances?
III. Essential Use Allowances for Medical Devices
IV. Exemption for Methyl Chloroform for Use in the Space Shuttle and 
Titan Rockets
V. Proposed Allocation of Essential Use Allowances for Calendar Year 
2004
VI. Correction to 40 CFR Part 82, Sections 3 and 4(k)
VII. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions that Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act

I. General Information

A. How Can I Get Copies of Related Information?

1. Docket
    EPA has established an official public docket for this action at 
Air Docket ID No. OAR-2003-0202. The official public docket consists of 
the documents specifically referenced in this action and other 
information related to this action. Hard copies of documents related to 
previous essential use allocation rulemakings and other actions may be 
found in EPA Air Docket ID No. A-93-39. The public docket does not 
include Confidential Business Information (CBI) or other information 
whose disclosure is restricted by statute, although this information is 
part of EPA's official docket. The public docket is available for 
viewing at the Air and Radiation Docket in the EPA Docket Center, (EPA/
DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. 
The EPA Docket Center 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 Reading Room is (202) 566-1742, and the 
telephone number for the Air and Radiation Docket is (202) 566-1742. 
EPA may charge a reasonable fee for copying docket materials.
2. Electronic Access
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, ``EPA Dockets.'' You 
may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view 
public comments, access the index listing of the contents of the 
official public docket, and to access those documents in the public 
docket that are available electronically. Once in the system, select 
``search,'' then key in the appropriate docket identification number.
    Certain types of information will not be placed in EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. Although not all 
docket materials may be available electronically, you may still access 
any of the publicly available docket materials through the docket 
facility identified in section I.A.1 above.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the Docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

B. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, by facsimile, or 
through hand delivery/courier. To ensure proper receipt by EPA, 
identify the appropriate docket identification number in the subject 
line on the first page of your comment. Please ensure that your 
comments are submitted within the specified comment period. Comments 
received after the close of the comment period will be marked ``late.'' 
EPA is not required to consider these late comments. If you wish to 
submit CBI or information that is otherwise protected by statute, 
please follow the instructions in section I.C below. Do not use EPA 
Dockets or e-mail to submit CBI or information protected by statute.
1. Electronically
    Your use of EPA's electronic public docket to submit comments to 
EPA electronically is EPA's preferred method for receiving comments. Go 
directly to EPA Dockets at http://www.epa.gov/edocket, and follow the 
online instructions for submitting comments.

[[Page 61384]]

To access EPA's electronic public docket from the EPA Internet Home 
Page, select ``Information Sources,'' ``Dockets,'' and ``EPA Dockets.'' 
Once in the system, select ``search,'' and then key in Docket ID No. 
OAR-2003-0202. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    If you submit a comment electronically, EPA recommends that you 
include your name, mailing address, and an e-mail address or other 
contact information in the body of your comment. Also include this 
contact information on the outside of any disk or CD ROM you submit, 
and in any cover letter accompanying the disk or CD ROM. This ensures 
that you can be identified as the submitter of the comment and allows 
EPA to contact you in case EPA cannot read your comment due to 
technical difficulties or needs further information on the substance of 
your comment. EPA's policy is that EPA will not edit your comment. Any 
identifying or contact information provided in the body of a comment 
will be included as part of the comment that is placed in the official 
public docket and made available in EPA's electronic public docket. 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.
    Comments also may be sent by electronic mail (e-mail) to [email protected], Attention Docket ID No. OAR-2003-0202. In contrast to 
EPA's electronic public docket, EPA's e-mail system is not an 
``anonymous access'' system. If you send an e-mail comment directly to 
the Docket without going through EPA's electronic public docket, EPA's 
e-mail system automatically captures your e-mail address. E-mail 
addresses that are automatically captured by EPA's e-mail system are 
included as part of the comment that is placed in the official public 
docket, and made available in EPA's electronic public docket.
    You may submit comments on a disk or CD ROM that you mail to the 
mailing address identified below. These electronic submissions will be 
accepted in WordPerfect or ASCII file format. Avoid the use of special 
characters and any form of encryption.
2. By Mail
    Send two copies of your comments to: Air and Radiation Docket, 
Environmental Protection Agency, Mailcode 6102T, 1200 Pennsylvania 
Ave., NW., Washington, DC, 20460, Attention: Docket ID No. OAR-2003-
0202.
3. By Hand Delivery or Courier
    Deliver your comments to: EPA Docket Center, (EPA/DC) EPA West, 
Room B102, 1301 Constitution Ave., NW., Washington, DC, Attention 
Docket ID No. OAR-2003-0202. Such deliveries are only accepted during 
the Docket's normal hours of operation as identified in section I.A.1.
4. By Facsimile
    Fax your comments to: 202-566-1741, Attention: Docket ID No. OAR-
2003-0202.

C. How Should I Submit Confidential Business Information to EPA?

    Comments that contain confidential business information should be 
submitted in two versions, one clearly marked ``Public'', to be filed 
in the public docket, and the other clearly marked ``Confidential'' to 
be reviewed by authorized government personnel only. If the comments 
are not marked, EPA will assume they do not contain confidential 
business information and will docket them.
    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. 
Send or deliver information identified as CBI only to the Essential Use 
Program Manager. You may claim information that you submit to EPA as 
CBI by marking any part or all of that information as CBI (if you 
submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is CBI). Information so marked will not be 
disclosed except in accordance with procedures set forth in 40 CFR Part 
2.
    In addition to one complete version of the comment that includes 
any information claimed as CBI, a copy of the comment that does not 
contain the information claimed as CBI must be submitted for inclusion 
in the public docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket without prior notice. If you have any 
questions about CBI or the procedures for claiming CBI, please consult 
the person identified in the FOR FURTHER INFORMATION CONTACT section.

II. Basis for Allocating Essential Use Allowances

A. What Are Essential Use Allowances?

    Essential use allowances are allowances to produce or import 
certain ozone-depleting chemicals in the U.S. for purposes that have 
been deemed ``essential'' by the Parties to the Montreal Protocol and 
the U.S. Government.
    The Montreal Protocol on Substances that Deplete the Ozone Layer 
(Protocol) is the international agreement to reduce and eventually 
eliminate the production and consumption \1\ of all stratospheric ozone 
depleting substances (ODSs). The elimination of production and 
consumption of class I ODSs is accomplished through adherence to phase-
out schedules for specific class I ODSs,\2\ including: 
chlorofluorocarbons (CFCs), halons, carbon tetrachloride, and methyl 
chloroform. As of January 1, 1996, production and import of most class 
I ODSs were phased out in developed countries, including the United 
States.
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    \1\ ``Consumption'' is defined as the amount of a substance 
produced in the United States, plus the amount imported into the 
United States, minus the amount exported to Parties to the Montreal 
Protocol (see Section 601(6) of the Clean Air Act). Stockpiles of 
class I ODSs produced or imported prior to the 1996 phase out may be 
used for purposes not expressly banned at 40 CFR part 82.
    \2\ Class I ozone depleting substances are listed at 40 CFR Part 
82 subpart A, appendix A.
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    However, the Protocol and the Clean Air Act (Act) provide 
exemptions that allow for the continued import and/or production of 
class I ODS for specific uses. Under the Protocol, exemptions may be 
granted for uses that are determined by the Parties to be 
``essential.'' Decision IV/25, taken by the Parties to the Protocol in 
1992, established criteria for determining whether a specific use 
should be approved as essential, and set forth the international 
process for making determinations of essentiality. The criteria for an 
essential use, as set forth in paragraph 1 of Decision IV/25, are the 
following:
    ``(a) that a use of a controlled substance should qualify as 
`essential' only if:
    (i) it is necessary for the health, safety or is critical for the 
functioning of society (encompassing cultural and intellectual 
aspects); and
    (ii) there are no available technically and economically feasible 
alternatives or substitutes that are acceptable from the standpoint of 
environment and health;
    (b) that production and consumption, if any, of a controlled 
substance for

[[Page 61385]]

essential uses should be permitted only if:
    (i) all economically feasible steps have been taken to minimize the 
essential use and any associated emission of the controlled substance; 
and
    (ii) the controlled substance is not available in sufficient 
quantity and quality from existing stocks of banked or recycled 
controlled substances, also bearing in mind the developing countries' 
need for controlled substances.''

B. Under What Authority Does EPA Allocate Essential Use Allowances?

    Title VI of the Act implements the Protocol for the United 
States.\3\ Section 604(d) of the Act authorizes EPA to allow the 
production of limited quantities of class I ODSs after the phaseout 
date for the following essential uses:
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    \3\ According to Section 614(b) of the Act, Title VI ``shall be 
construed, interpreted, and applied as a supplement to the terms and 
conditions of the Montreal Protocol * * * and shall not be 
construed, interpreted, or applied to abrogate the responsibilities 
or obligations of the United States to implement fully the 
provisions of the Montreal Protocol. In the case of conflict between 
any provision of this title and any provision of the Montreal 
Protocol, the more stringent provision shall govern.'' EPA's 
regulations implementing the essential use provisions of the Act and 
the Protocol are located in 40 CFR part 82.
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    (1) Methyl Chloroform, ``solely for use in essential applications 
(such as nondestructive testing for metal fatigue and corrosion of 
existing airplane engines and airplane parts susceptible to metal 
fatigue) for which no safe and effective substitute is available.'' EPA 
issues 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, which use CFCs as propellant 
for the treatment of asthma and chronic obstructive pulmonary diseases.
    (3) Aviation Safety, for which limited quantities of halon-1211, 
halon-1301, and halon 2402 may be produced ``if the Administrator of 
the Federal Aviation Administration, in consultation with the 
Administrator [of EPA] determines that no safe and effective substitute 
has been developed and that such authorization is necessary for 
aviation safety purposes.'' Neither EPA nor the Parties have ever 
granted a request for essential use allowances for halon, because 
alternatives are available or because existing quantities of this 
substance are large enough to provide for any needs for which 
alternatives have not yet been developed.
    The Protocol, under Decision X/19, additionally allows a general 
exemption for laboratory and analytical uses through December 31, 2005. 
This exemption is reflected in EPA's regulations at 40 CFR part 82, 
subpart A. While the Act does not specifically provide for this 
exemption, EPA has determined that an allowance for essential 
laboratory and analytical uses is allowable under the Act as a de 
minimis exemption. The de minimis exemption is addressed in EPA's final 
rule of March 13, 2001 (66 FR 14760-14770). The Parties to the Protocol 
subsequently agreed (Decision XI/15) that the general exemption does 
not apply to the following uses: testing of oil and grease, and total 
petroleum hydrocarbons in water; testing of tar in road-paving 
materials; and forensic finger-printing. EPA incorporated this 
exclusion at Appendix G to Subpart A of 40 CFR part 82 on February 11, 
2002 (67 FR 6352).

C. What Is the Process for Allocating Essential Use Allowances?

    Before EPA may allocate essential use allowances, the Parties to 
the Protocol must first approve the United States' request to produce 
or import essential class I ODSs. The procedure set out by Decision IV/
25 calls for individual Parties to nominate essential uses and the 
total amount of ODSs needed for those essential uses on an annual 
basis. The Protocol's Technology and Economic Assessment Panel 
evaluates the nominated essential uses and makes recommendations to the 
Protocol Parties. The Parties make the final decisions on whether to 
approve a Party's essential use nomination at their annual meeting. 
This nomination cycle occurs approximately two years before the year in 
which the allowances would be in effect. The allowances allocated 
through today's action were first nominated by the United States in 
January 2001.
    Once the U.S. nomination is approved by the Parties, EPA allocates 
essential use exemptions to specific entities through notice-and-
comment rulemaking in a manner consistent with the Act. For medical 
devices, EPA requests information from manufacturers about the number 
and type of devices they plan to produce, as well as the amount of CFCs 
necessary for production. EPA then forwards the information to the Food 
and Drug Administration (FDA), which determines the amount of CFCs 
necessary for metered-dose inhalers in the coming calendar year. Based 
on FDA's assessment, EPA proposes allocations to each eligible entity. 
Under the Act and the Protocol, EPA may allocate essential use 
allowances in quantities that together are below or equal to the total 
amount approved by the Parties. EPA may not allocate essential use 
allowances in amounts higher than the total approved by the Parties. 
For 2004, the Parties authorized the United States to allocate up to 
2,975 metric tons of CFCs for essential uses.
    For methyl chloroform, Decision X/6 by the Parties to the Protocol 
established that ``* * * the remaining quantity of methyl chloroform 
authorized for the United States at previous meetings of the Parties 
[will] be made available for use in manufacturing solid rocket motors 
until such time as the 1999-2001 quantity of 176.4 tons (17.6 ODP-
weighted tons) allowance is depleted, or until such time as safe 
alternatives are implemented for remaining essential uses.'' Section 
604(d)(1) of the Act terminates the exemption period for methyl 
chloroform on January 1, 2005. Therefore, between 1999 and 2004 EPA may 
allow production or import up to a total of 176.4 metric tonnes of 
methyl chloroform for authorized 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 2004 control period.
    1. On March 10, 2003, 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 1/1/02 to 
12/31/02.
    c. The number of units anticipated to be produced in 2003.
    d. The gross target fill weight per unit (grams).
    e. Total amount of CFCs to be contained in the MDI product for 
2004.
    f. The additional amount of CFCs necessary for production.
    g. The total CFC request per MDI product for 2004. The 114 letters 
are available for review in the Air Docket ID No. OAR-2003-0202. The 
companies requested that their responses be treated as confidential 
business information; for

[[Page 61386]]

this reason, EPA has not placed the responses in the docket.
    2. On April 17, 2003, EPA sent FDA the information MDI 
manufacturers provided in response to the 114 letters with a letter 
requesting that FDA make a determination regarding the amount of CFCs 
necessary for MDIs for calendar year 2003. This letter is available for 
review in Air Docket ID No. OAR-2003-0202.
    3. On August 25, 2003, FDA sent a letter to EPA stating the amount 
of CFCs necessary for each MDI company in 2004. This letter is 
available for review in the Air Docket ID No. OAR-2003-0202.
    In their letter, FDA informed EPA that they had determined that 
2,077.91 metric tons of CFCs were necessary for use in medical devices 
in 2004. The letter stated, ``Our recommendation for the allocation for 
CFCs is lower than the total amount requested by sponsors. In the past, 
we have based our recommendations on estimates that 60 million 
albuterol MDIs using CFCs as a propellant would be necessary each year. 
However, we have based the recommendation for 2004 on an estimate that 
55 million will be necessary. In reaching this estimate, we took into 
account the sponsors' production of albuterol MDIs that used CFCs as a 
propellant in 2002, their estimates for production in 2003, and the 
presence on the market of two albuterol MDIs that do not use CFCs. 
Three firms have requested CFCs sufficient to manufacture a total of 
over 65 million albuterol MDIs. Our allocation decision is based on a 
need to limit CFC allocations to quantities needed for the manufacture 
of 55 million albuterol MDIs and ensure the public health.''
    In accordance with the determination made by FDA, today's action 
proposes to allocate essential use allowances for a total of 2,077.91 
metric tons of CFCs for use in MDIs for calendar year 2004. The amounts 
listed in this proposal are subject to additional review by EPA and FDA 
if new information demonstrates that the proposed allocations are 
either too high or too low. Commentors requesting increases or 
decreases of essential use allowances should provide detailed 
information supporting their claim for additional or fewer CFCs. Any 
company that needs less than the full amount listed in this proposal 
should notify EPA of the actual amount needed.

IV. Exemption for Methyl Chloroform for Use in the Space Shuttle and 
Titan Rockets

    As discussed in Section I.C above, before the start of calendar 
year 2005; EPA may allocate up to 176.4 tons of methyl chloroform for 
authorized essential uses. According to reporting submitted to the EPA 
tracking system for ozone-depleting substances, the total amount of 
methyl chloroform produced or imported by essential use allowance 
holders (the U.S. Air Force (USAF) for Titan Rockets, and the National 
Aeronautics and Space Administration (NASA) for the Space Shuttle) from 
1999 through the second quarter of 2003 was 34.523 metric tons. USAF 
and NASA have notified EPA that they do not intend to use their 2003 
allowances to obtain methyl chloroform during the last two quarters of 
2003. Therefore, EPA finds that 141.877 tons of methyl chloroform 
allowances are available for 2004. In addition, USAF has notified EPA 
that they have no need for 2004 allowances. For this reason, we propose 
to make the remaining balance of allowances (141.877 metric tons) 
available to NASA.

V. Proposed Allocation of Essential Use Allowances for Calendar Year 
2004

    EPA proposes to allocate essential use allowances for calendar year 
2004 to the entities listed in Table 1. These allowances are for the 
production or import of the specified quantity of class I controlled 
substances solely for the specified essential use.

        Table I.--Essential Use Allocation for Calendar Year 2004
------------------------------------------------------------------------
                                                             Quantity
            Company                     Chemical          (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals......  CFC-11 or CFC-12 or             390.60
                                  CFC-114.
Aventis Pharmaceutical Products  CFC-11 or CFC-12 or              48.40
                                  CFC-114.
Boehringer Ingelheim             CFC-11 or CFC-12 or             500.20
 Pharmaceuticals.                 CFC-114.
PLIVA Inc......................  CFC-11 or CFC-12 or             136.00
                                  CFC-114.
Schering-Plough Corporation....  CFC-11 or CFC-12 or             918.00
                                  CFC-114.
3M Pharmaceuticals.............  CFC-11 or CFC-12 or              84.71
                                  CFC-114.
--------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space
                    Shuttle Rockets and Titan Rockets
------------------------------------------------------------------------
National Aeronautics and Space   Methyl Chloroform.....          141.877
 Administration (NASA)/Thiokol
 Rocket.
------------------------------------------------------------------------

VI. Correction to 40 CFR Part 82, Sections 3 and 4(k)

    On January 2, 2003, EPA published a final rule (68 FR 237) 
regarding quarantine and preshipment applications of methyl bromide, 
which is an ozone-depleting substance. This final rule removed 
paragraphs (n) through (s) of 40 CFR Part 82, Section 4, and 
redesignated paragraphs (t) through (w) as (n) through (q). However, 
the final rule did not also change the definition of ``essential-use 
allowances'' in Sec.  82.3 to be consistent with the reordering of 
paragraphs in Sec.  82.4. The definition of essential use allowances in 
Sec.  82.3 reads, ``Essential-Use Allowances means the privileges 
granted by Sec.  82.4(t) to produce class I substances, as determined 
by allocation decisions made by the Parties to the Montreal Protocol 
and in accordance with the restrictions delineated in the Clean Air Act 
Amendments of 1990.'' Therefore, for consistency with the reordered 
regulations, we are correcting the definition of essential use 
allowances to refer to Sec.  82.4(n).
    In addition, the final rule revised section 4(k) of 40 CFR Part 82 
to include paragraph 4(k)(1), which states that ``* * * only essential-
use allowances or exemptions are required to import class I controlled 
substances, with the exception of transhipments, heels, and used 
controlled substances.'' In undertaking this revision, EPA 
inadvertently deleted a phrase that had appeared in the prior version 
of this statement. EPA proposes to restore the deleted phrase by 
correcting the statement in question to read, ``* * * only essential 
use allowances or exemptions are required to import class I controlled 
substances, with the

[[Page 61387]]

exception of transhipments, heels, used controlled substances, and 
essential use CFCs.'' This correction clarifies that the import 
restriction does not apply to CFCs produced by non-U.S. entities under 
the authority of privileges granted by the Parties and the national 
authority of another country for use in essential metered dose 
inhalers. See 67 FR 6351 (February 11, 2002).

VII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether this regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. The Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may:
    (1) Have an annual effect on the economy of $100 million or more, 
or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    It has been determined that this action is not a ``significant 
regulatory action'' under the terms of Executive Order 12866 and is 
therefore not subject to OMB review.

B. Paperwork Reduction Act

    This action does not add any information collection requirements or 
increase burden under the provisions of the Paperwork Reduction Act, 44 
U.S.C. 3501 et. seq. OMB previously approved the information collection 
requirements contained in the final rule promulgated on May 10, 1995, 
and assigned OMB control number 2060-0170 (EPA ICR No. 1432.21).
    Burden means the total time, effort, or financial resources 
expended by persons to generate, maintain, retain, or disclose or 
provide information to or for a Federal agency. This includes the time 
needed to review instruction; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information. An Agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information unless it displays a currently valid OMB 
control number. The OMB control numbers for EPA's regulations are 
listed in 40 CFR part 9 and 48 CFR Chapter 1.

C. Regulatory Flexibility Act

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small businesses, small organizations, and small 
governmental jurisdictions.
    For purposes of assessing the impact of today's rule on small 
entities, the term small entities 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.
    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. This rule 
provides an otherwise unavailable benefit to those companies that are 
receiving essential use allowances.
    Although this proposed rule will not have significant economic 
impact on a substantial number of small entities, we continue to be 
interested in the potential impact of the proposed rule on small 
entities and welcome comments related to these issues.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year.
    Before promulgating an EPA rule for which a written statement is 
needed, section 205 of the UMRA generally requires EPA to identify and 
consider a reasonable number of regulatory alternatives and adopt the 
least costly, most cost-effective, or least burdensome alternative that 
achieves the objectives of the rule. The provisions of section 205 do 
not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective, or least burdensome alternative, if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may 
significantly or uniquely affect small governments, including tribal 
governments, it must have developed a small government agency plan 
under section 203 of the UMRA. The plan must provide for notifying 
potentially affected small governments, enabling officials of affected 
small governments to have meaningful and timely input in the 
development of EPA regulatory proposals with significant Federal 
intergovernmental mandates, and informing, educating, and advising 
small governments on compliance with the regulatory requirements.
    Today's rule contains no Federal mandates (under the regulatory 
provisions of Title II of the UMRA) for State, local, or tribal 
governments or the private sector, since it merely provides exemptions 
from the 1996 phase out of class I ODSs. Similarly, EPA has determined 
that this rule contains no regulatory requirements that might 
significantly or uniquely affect small governments, because this rule 
merely allocates essential use exemptions to entities as an exemption 
to the ban on production and import of class I ODSs.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State

[[Page 61388]]

and local officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.''
    This proposed rule does not have federalism implications. It will 
not have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. Thus, Executive Order 13132 does 
not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' This proposed rule does not 
have tribal implications, as specified in Executive Order 13175. 
Today's rule affects only the companies that requested essential use 
allowances. Thus, Executive Order 13175 does not apply to this rule.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045, ``Protection of Children From Environmental 
Health risks and Safety Risks'' (62 FR 19885, April 23, 1997), applies 
to any rule that (1) is determined to be 'economically significant'' as 
defined under E.O. 12866, and (2) concerns an environmental health and 
safety risk that EPA has reason to believe may have a disproportionate 
effect on children. If the regulatory action meets both criteria, the 
Agency must evaluate the environmental health or safety effects of the 
planned rule on children, and explain why the planned regulation is 
preferable to other potentially effective and reasonably feasible 
alternatives considered by the Agency. EPA interprets E.O. 13045 as 
applying only to those regulatory actions that are based on health or 
safety risks, such that the analysis required under section 5-501 of 
the Order has the potential to influence the regulation. This rule is 
not subject to E.O. 13045 because it implements the phase-out schedule 
and exemptions established by Congress in Title VI of the Clean Air 
Act.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211, Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 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, section 12(d) (15 U.S.C. 272 
note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards. This 
proposed rule does not involve technical standards.
    Therefore, EPA did not consider the use of any voluntary consensus 
standards.

List of Subjects in 40 CFR Part 82

    Administrative practice and procedure, Air pollution control, 
Chemicals, Chlorofluorocarbons, Exports, Environmental protection, 
Imports, Methyl Chloroform, Ozone, Reporting and recordkeeping 
requirements.

    Dated: October 22, 2003.
Marianne L. Horinko,
Acting 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 82.3 is amended by revising the definition of Essential 
Use Allowances to read as follows:


Sec.  82.3  Definitions for class I and class II controlled substances.

* * * * *
    Essential-Use Allowances means the privileges granted by Sec.  
82.4(n) to produce class I substances, as determined by allocation 
decisions made by the Parties to the Montreal Protocol and in 
accordance with the restrictions delineated in the Clean Air Act 
Amendments of 1990.
* * * * *
    3. Section 82.4 is amended by revising paragraph (k)(1) and the 
table in paragraph (n)(2) to read as follows:


Sec.  82.4  Prohibitions for class I controlled substances.

* * * * *
    (k)(1) Prior to January 1, 1996, for all Groups of class I 
controlled substances, and prior to January 1, 2005, for class I, Group 
VI controlled substances, a person may not use production allowances to 
produce a quantity of a class I controlled substance unless that person 
holds under the authority of this subpart at the same time consumption 
allowances sufficient to cover that quantity of class I controlled 
substances nor may a person use consumption allowances to produce a 
quantity of class I controlled substances unless the person holds under 
authority of this subpart at the same time production allowances 
sufficient to cover that quantity of class I controlled substances. 
However, prior to January 1, 1996, for all class I controlled 
substances, and prior to January 1, 2005, for class I, Group VI 
controlled substances, only consumption allowances are required to 
import, with the exception of transhipments, heels, and used controlled 
substances. Effective January 1, 1996, for all Groups of class I 
controlled substances, except Group VI, only essential use allowances 
or exemptions are required to import class I controlled substances, 
with the exception of transhipments, heels, used controlled substances, 
and essential use CFCs.
* * * * *
    (n) * * *
    (2) * * *

[[Page 61389]]



        Table I.--Essential Use Allocation for Calendar Year 2004
------------------------------------------------------------------------
                                                             Quantity
            Company                     Chemical          (metric tons)
------------------------------------------------------------------------
 (i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
                and Chronic Obstructive Pulmonary Disease
------------------------------------------------------------------------
Armstrong Pharmaceuticals......  CFC-11 or CFC-12 or             390.60
                                  CFC-114.
Aventis Pharmaceutical Products  CFC-11 or CFC-12 or              48.40
                                  CFC-114.
Boehringer Ingelheim             CFC-11 or CFC-12 or             500.20
 Pharmaceuticals.                 CFC-114.
PLIVA Inc......................  CFC-11 or CFC-12 or             136.00
                                  CFC-114.
Schering-Plough Corporation....  CFC-11 or CFC-12 or             918.00
                                  CFC-114.
3M Pharmaceuticals.............  CFC-11 or CFC-12 or              84.71
                                  CFC-114.
--------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space
                             Shuttle Rockets
------------------------------------------------------------------------
National Aeronautics and Space   Methyl Chloroform.....          141.877
 Administration (NASA)/Thiokol
 Rocket.
------------------------------------------------------------------------

[FR Doc. 03-27160 Filed 10-27-03; 8:45 am]
BILLING CODE 6560-50-P