[Federal Register Volume 69, Number 18 (Wednesday, January 28, 2004)]
[Rules and Regulations]
[Pages 4059-4065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-1812]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-7615-3]
RIN 2060-AM01


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: With this action, EPA is allocating 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 
allocations total 2077.91 metric tons of chlorofluorocarbons for use in 
metered dose inhalers. EPA is also allocating the remaining allowances 
for methyl chloroform (141.877 metric tons) to the U.S. Space Shuttle 
Program.

DATES: This final rule is effective January 28, 2004.

ADDRESSES: Materials related to this rulemaking are contained in EPA 
Air Docket OAR-2003-0202. The EPA Air Docket 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. Materials related to previous EPA actions on the 
essential use program are contained in EPA Air Docket No. A-93-39.

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) 343-9712; or by e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information

[[Page 4060]]

    A. How can I get copies of related information?
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. Response to Comments
IV. Exemption for Methyl Chloroform for Use in the Space Shuttle and 
Titan Rockets
V. 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
    J. Congressional Review Act
VIII. Judicial Review

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. 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 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.

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 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 phase out 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

[[Page 4061]]

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. Response to Comments

    EPA received one comment on the proposed rule of October 28, 2003. 
The comment opposed exempting Class I substances for any purpose, 
including asthma medication and the Space Shuttle program, because 
alternatives have been developed. EPA disagrees with this comment. 
Section 604 of the Clean Air Act, as amended, permits production of 
methyl chloroform for essential applications where safe and effective 
alternatives are not available, as well as for medical devices 
determined to be essential by FDA.
    NASA has identified and is using alternative solvents in the Space 
Shuttle program in all but a few remaining applications, for which no 
satisfactory alternative to methyl chloroform has yet been found. The 
remaining applications for which there is no alternative are case 
insulation components cleaning, activation of rubber layers in case 
insulation, flex bearing cleaning, and field joint cleaning.
    Regarding medical devices, FDA has found the use of ozone depleting 
substances to be essential in metered dose inhalers for the treatment 
of asthma and chronic obstructive pulmonary disease (see 21 CFR 
2.125(e)). Consequently, there are still a number of medical devices 
eligible for essential use CFCs in 2004. As established by final rule 
on July 24, 2002 (67 FR 48370), FDA will determine through rulemaking 
when a medical device is no longer essential due to the availability of 
safe and effective alternatives.

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

    As discussed in Section II.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. In addition, USAF has notified EPA that they have no need for 
2004 allowances. Therefore, EPA finds that 141.877 tons of methyl 
chloroform allowances are available for 2004 and allocates that 
quantity to NASA.

V. Allocation of Essential Use Allowances for Calendar Year 2004

    With today's action, EPA is allocating 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.

[[Page 4062]]



        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 82.4 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 proposed 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 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). We did not receive 
comments on this matter. Therefore, we are adopting the corrected 
statement.

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

    EPA has determined that it is not necessary to prepare a regulatory 
flexibility analysis in connection with this final rule. EPA has also 
determined that this rule will not have a significant economic impact 
on a substantial number of small entities. For purposes of assessing 
the impact of today's rule on small entities, small entities are 
defined as: (1) Pharmaceutical

[[Page 4063]]

preparations manufacturing businesses (NAICS code 325412) that have 750 
employees or fewer; (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 that is independently owned and 
operated and is not dominant in its field.
    After considering the economic impacts of today's final rule on 
small entities, EPA has concluded 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 proposed rule on small entities.'' 5 U.S.C. 603 
and 604. Thus, an agency may conclude 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 
rule provides an otherwise unavailable benefit to those companies that 
are receiving essential use allowances. We have therefore concluded 
that today's final rule will relieve regulatory burden for all small 
entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
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 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 final 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 final 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 No. 104-113, section 12(d) (15 
U.S.C. 272 note) directs EPA to use voluntary

[[Page 4064]]

consensus standards in this 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 final rule does not 
involve technical standards. Therefore, EPA did not consider the use of 
any voluntary consensus standards.

J. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. Therefore, EPA will submit a report containing this rule 
and other required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. A major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 
804(2). This rule will be effective January 28, 2004.

VIII. Judicial Review

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

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: January 21, 2004.
Michael O. Leavitt,
Administrator.

0
40 CFR part 82 is amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
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

0
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.
* * * * *

0
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) * * *

        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.
------------------------------------------------------------------------


[[Page 4065]]

[FR Doc. 04-1812 Filed 1-27-04; 8:45 am]
BILLING CODE 6560-50-P