[Federal Register: October 28, 2003 (Volume 68, Number 208)]
[Proposed Rules]
[Page 61382-61389]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc03-23]
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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: monroe.scott@epa.gov.
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 A-And-R-Docket@epa.gov, 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
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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
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Quantity
Company Chemical (metric tons)
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(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma
and Chronic Obstructive Pulmonary Disease
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Armstrong Pharmaceuticals...... CFC-11 or CFC-12 or 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
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National Aeronautics and Space Methyl Chloroform..... 141.877
Administration (NASA)/Thiokol
Rocket.
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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]
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