[Federal Register Volume 67, Number 215 (Wednesday, November 6, 2002)]
[Proposed Rules]
[Pages 67581-67586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28212]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-7407-8]
RIN 2060-AK48


Protection of Stratospheric Ozone: Allocation of Essential Use 
Allowances for Calendar Year 2003

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed rulemaking.

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SUMMARY: With this action, EPA is proposing to allocate essential-use 
allowances for import and production of class I stratospheric ozone 
depleting substances (ODSs) for calendar year 2003. Essential use 
allowances permit a person to obtain controlled ODSs as an exemption to 
the January 1, 1996 regulatory phase-out of production and import of 
these chemicals. EPA allocates essential-use allowances for exempted 
production or import of a specific quantity of class I ODS solely for 
the designated essential purpose. EPA is proposing to allocate 
essential-use allowances for production and import of ODSs for use in 
medical devices and the Space Shuttle and Titan Rockets.

DATES: Written comments on this proposed rule must be received on or 
before December 6, 2002, unles 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 by 5 p.m. Eastern Standard Time on November 16, 2002. If a 
hearing is held, EPA will publish a document in the Federal Register 
announcing the hearing information.

ADDRESSES: Comments on this rulemaking should be submitted in duplicate 
to: Erin Birgfeld, Essential Use Program Manager, Global Programs 
Division, U.S. Environmental Protection Agency (6205J), 1200 
Pennsylvania Avenue, NW., Washington, DC 20460. If you send comments 
using courier services or overnight express, please address comments to 
501 3rd Street NW., Washington, DC 20001. Comments will be filed in EPA 
Air docket number A-93-39. 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 
are public and contain no confidential information.
    Materials relevant to this rulemaking are contained in Docket No. 
A-93-39. The Docket is located at 1301 Constitution Avenue, NW., Room 
B108; Mail Code: 6102T Washington, DC 20460. The materials may be 
inspected from 8 a.m. until 5:30 p.m. Monday through Friday. EPA may 
charge a reasonable fee for copying docket materials.

FOR FURTHER INFORMATION CONTACT: Erin Birgfeld, U.S. Environmental 
Protection Agency, Global Programs Division, Office of Atmospheric 
Programs, 6205J, 1200 Pennsylvania Avenue, Washington, DC, 20460; (202) 
564-9079; [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Essential Use Allowances for Medical Devices
    A. How were essential-use allowances for medical devices 
nominated and approved by the Parties to the Montreal Protocol?
    B. How does the Clean Air Act authorize essential-use 
allowances?
    C. What was the allocation process for essential-use allowances 
for medical devices?
    D. How were the decisions on the amounts of essential-use 
allowances for each company made?
    E. Will the amounts actually allocated in the final rule be the 
same as the amounts listed in this proposed rule?
III. Exemption for methyl chloroform for use in the Space Shuttle 
and Titan Rockets
IV. Allocation of essential-use allowances for medical devices and 
the Space Shuttle and Titan Rockets for calendar year 2003
V. Administrative requirements
    A. Unfunded Mandates Reform Act
    B. Executive Order 12866
    C. Paperwork Reduction Act (PRA)
    D. Executive Order 13175 (Consultation and Coordination with 
Indian Tribal Governments)
    E. Regulatory Flexibility Act (RFA) as amended by the Small 
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 
U.S.C. 601 et. seq.
    F. Applicability of Executive Order 13045: Protection of 
Children from Environmental Health Risks and Safety Risks
    G. National Technology Transfer and Advancement Act
    H. Executive Order 13132 (Federalism)
    I. Executive Order 13211 (Energy Effects)

I. Background

    The Montreal Protocol on Substances that Deplete the Ozone Layer 
(Protocol) is the international agreement to reduce and eventually 
eliminate production and consumption \1\ of all stratospheric ozone 
depleting substances (ODSs). The elimination of production and 
consumption is accomplished through adherence to phase-out schedules 
for production and consumption of specific class I ODSs including 
chlorofluorocarbons (CFCs), halons, carbon tetrachloride, methyl 
chloroform, hydrochlorofluorocarbons, and methyl bromide. As of January 
1996, production and import of class I ODSs \2\ were phased out in all 
developed countries including the United States. However, the Protocol 
and the Clean Air Act (CAA or Act) provide exemptions which allow for 
the continued import and/or production of class I ODS for specific 
uses. Under the Montreal Protocol, exemptions are granted for uses that 
are determined by the Parties to be ``essential.'' Decision IV/25, 
taken by the Parties in 1992, established criteria for determining

[[Page 67582]]

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:
---------------------------------------------------------------------------

    \1\ ``Consumption'' is defined as the amount of a substance 
produced in the United States, plus the amount imported, 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 phaseout can continue to be used for 
purposes not expressly banned at 40 CFR part 82.
    \2\ Class I ozone depleting substances are defined at 40 CFR 
Part 82, subpart A, appendix A.
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    `` (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.''
    The procedure set out by Decision IV/25 first calls for individual 
Parties to nominate essential-uses, and the amount of ODS needed for 
that essential-use 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.
    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 CAA. Under the CAA 
and the Montreal Protocol, EPA is authorized to allocate essential-use 
allowances in quantities below or equal to the amounts approved by the 
Parties. EPA cannot allocate essential-use allowances in amounts higher 
than is approved by the Parties.

II. Essential Use Allowances for Medical Devices.

A. How Were Essential-Use Allowances for Medical Devices Nominated and 
Approved by the Parties to the Montreal Protocol?

    On November 1, 2000, EPA issued a Federal Register notice (65 FR 
65311) requesting applications for essential-use allowances for the 
year 2003. The applications EPA received requested exemptions for the 
production and import of specific quantities of CFCs (CFC-11, CFC-12, 
and CFC-114) for use in metered dose inhalers (MDIs), and provided 
information in accordance with the criteria set forth in Decision IV/25 
of the Protocol and the procedures outlined in the ``1997 Handbook on 
Essential Use Nominations.'' Based on the information provided in these 
applications, and after consultation with the Food and Drug 
Administration (FDA), the U.S. forwarded a request for 3,270 metric 
tons of CFCs for use in metered dose inhalers to the Ozone Secretariat 
for consideration by the Technical and Economic Assessment Panel (TEAP) 
and the Aerosol Technical Options Committees (ATOC). The Parties 
approved the U.S. request for 3,270 metric tons of CFCs for essential-
uses in Decision XIII/8 taken at the 2001 Meeting of the Parties.

B. How Does the Clean Air Act Authorize Essential-Use Allowances?

    The CAA provides exemptions under section 604(d) to the phase-out 
of class I ODSs. With today's action, EPA is proposing to implement the 
exemption at 604(d)(2) of the Act which states that ``notwithstanding 
the phase-out, EPA shall, to the extent consistent with the Montreal 
Protocol, authorize production of limited quantities of class I ODSs 
for use in medical devices, if FDA, in consultation with EPA, 
determines that such production is necessary for use in medical 
devices''. The term ``medical device'' is defined in section 601(8) of 
the Clean Air Act as follows:
    ``[A]ny device (as defined in the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321)), diagnostic product, drug (as defined in the 
Federal Food, Drug, and Cosmetic Act), and drug delivery system
    (A) If such device, product, drug, or drug delivery system utilizes 
a class I or class II substance for which no safe and effective 
alternative has been developed, and where necessary, approved by the 
Commissioner [of FDA]; and
    (B) if such device, product, drug, or drug delivery system, has, 
after notice and opportunity for public comment, been approved and 
determined to be essential by the Commissioner [of FDA] in consultation 
with the Administrator [of EPA].''
    With today's action, EPA is proposing to allocate essential-use 
allowances for use in MDIs that have previously been determined to fit 
the definition of medical device above. For a full discussion of the 
definition of ``medical device'', and how it has been interpreted and 
applied in today's rulemaking please, refer to the interim final rule 
for the year 2000 allocation of essential-use allowances (65 FR 716).

C. What Was the Allocation Process for 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 2003 control period.
    1. On March 4, 2002, 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 
12/31/01;
    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 
2003;
    f. The additional amount of CFCs necessary for production;
    g. The total CFC request per MDI product for 2003.
    The letters requesting information that EPA sent each company are 
available for review in the Air Docket No. A-93-39. The company's 
responses, however, are considered confidential business information 
and are not publicly available.
    2. On May 24, 2002, EPA sent FDA the information MDI manufacturers 
provided in response to the 114 letters along with a letter requesting 
that FDA make a determination regarding the amount of CFCs necessary 
for MDIs for calendar year 2003.
    3. On July 3, 2002, FDA sent a letter to EPA stating the amount of 
CFCs necessary for each MDI company in 2003. This letter is available 
in the public docket. In accordance with the determination made by FDA, 
today's action proposes to allocate essential-use allowances for a 
total of 3,270 metric tons of CFCs for use in MDIs for the year 2003 
calendar year.

[[Page 67583]]

D. How Were the Decisions on the Amounts of Essential-Use Allowances 
for Each Company Made?

    In their July 3, 2003 determination letter, FDA describes how the 
amount of CFCs necessary for use in MDIs was determined. They state the 
following: ``Under our existing regulations and our proposed rule \3\, 
we have interpreted the CAA definition of medical device to refer to 
any product that contains an active moiety \4\ that appears on the 
essential-use list found at 21 CFR 2.125. We further understand that 
under the Montreal Protocol, and therefore under the CAA, only products 
for the treatment of asthma or chronic obstructive pulmonary disease 
(COPD) are eligible for essential-use nominations and allocations. 
Under this definition, the sponsor of any drug product produced under 
an approved new drug application, abbreviated new drug application, or 
valid investigational new drug application, approved for the treatment 
of asthma or COPD, and containing an active moiety on our essential use 
list may obtain CFCs. We also understand that under Decision XII/2 of 
the 12th Meeting of the Parties to the Montreal Protocol, any CFC 
metered-dose inhaler product (MDI) for the treatment of asthma and/or 
COPD approved after December 31, 2000, in a non-Article 5(1) Party is 
not an essential-use, unless the product meets the criteria set out in 
paragraph 1(a) of Decision IV/25.
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    \3\ Use of Ozone-Depleting Substances; Essential Use 
Determinations, September 1, 1999. (64 FR 47719). The final rule was 
published on July 24, 2002, and will take effect January 20, 2003 
(67 FR 48370).
    \4\ An FDA regulation at 21 CFR 314.108(a) defines active moiety 
as `` the molecule or ion excluding those appended portions of the 
molecule that cause the drug to be an ester, salt (including a salt 
with hydrogen or coordination bonds), or other noncovalent 
derivative (such as a complex, a chelate or clathrate) of the 
molecule, responsible for the physiological or pharmacological 
action of the drug substance.''
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    ``With these definitions in mind, we [FDA] have examined the 
information you [EPA] obtained from individual sponsors regarding their 
historical and intended use of CFCs in specific products. We compared 
this information to the number of CFC MDIS necessary to ensure the 
public health of the United States and the quantities of CFCs needed to 
ensure the manufacture and continuous availability of those necessary 
MDIs. In listing the amounts we believe to be necessary for use in 
medical devices, we referred to this information, eliminated any 
double-counting or redundancy we found, considered changes in the 
prevalence of asthma and COPD, and eliminated allocations for uses not 
considered essential by the Parties to the Montreal Protocol, even if 
those uses are currently listed in our regulations at 21 CFR 
2.125(e).''

E. Will the Amounts Actually Allocated in the Final Rule Be the Same as 
the Amounts Listed in This Proposed Rule?

    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 no longer needs the full amount listed in this 
proposal should notify EPA of the actual amount needed.

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

    EPA is proposing to allocate methyl chloroform (MCF) for use in 
solid rocket motor assemblies. The CAA exemption for continued 
production and import of methyl chloroform is found at 604(d)(1) and 
reads as follows:
    (1) Essential Uses of Methyl Chloroform.--Notwithstanding the 
termination of production required by subsection (b), during the period 
beginning on January 1, 2002, and ending on January 1, 2005, the 
Administrator [of EPA], after notice and opportunity for public 
comment, may, to the extent such action is consistent with the Montreal 
Protocol, authorize the production of limited quantities of 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. Notwithstanding 
this paragraph, the authority to produce methyl chloroform for use in 
medical devices shall be provided in accordance with paragraph (2).
    Decision X/6 states 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.'' According 
to the EPA tracking system, the total amount of MCF produced or 
imported by essential-use allowance holders from 1999 through 2001 was 
28.3 metric tons, well below the limit of 176.4 metric tons. Based on 
the need for MCF for the space shuttle and Titan Rocket, EPA is 
proposing to allocate 13.2 metric tons of MCF for 2003.
    Essential-use allowance holders should be aware that the exemption 
for MCF under section 604(d)(1) of the CAA expires in the year 2005. 
Thus, EPA will not have statutory authority to allocate essential-use 
allowances for MCF after that date.

IV. Allocation of Essential-Use Allowances for Medical Devices and the 
Space Shuttle and Titan Rockets for Calendar Year 2003

    EPA is proposing to allocate essential-use allowances for calendar 
year 2003 to entities listed in Table I for exempted production or 
import of the specific quantity of class I controlled substances solely 
for the specified essential-use.

        Table I.--Essential use Allocation for Calendar Year 2003
------------------------------------------------------------------------
                                                               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          574
                                       CFC-114.
Aventis.............................  CFC-11 or CFC-12 or           48
                                       CFC-114.
Boehringer Ingelheim Pharmaceuticals  CFC-11 or CFC-12 or          907
                                       CFC-114.
GlaxoSmithKline.....................  CFC-11 or CFC-12 or          535
                                       CFC-114.
Schering-Plough Corporation.........  CFC-11 or CFC-12 or          937
                                       CFC-114.

[[Page 67584]]

 
Sidmak Laboratories Inc.............  CFC-11 or CFC-12 or          136
                                       CFC-114.
3M Pharmaceuticals..................  CFC-11 or CFC-12 or          133
                                       CFC-114.
-------------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space
                    Shuttle Rockets and Titan Rockets
------------------------------------------------------------------------
National Aeronautics and Space        Methyl Chloroform.....         9.8
 Administration (NASA)/Thiokol
 Rocket.
United States Air Force/Titan Rocket  Methyl Chloroform.....         3.4
------------------------------------------------------------------------

VI. Administrative Requirements

A. 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 under 
section 203 of the UMRA a small government agency plan. 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 
the 1996 phaseout of class I ODSs. Similarly, EPA has determined that 
this rule contains no regulatory requirements that might significantly 
or uniquely affect small governments. Again, this is because this rule 
merely allocates essential use exemptions to entities as an exemption 
to the ban on production and import of class I ODSs.

B. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether this regulatory action is ``significant'' 
and therefore subject to OMB review 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 entitlement, 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 rule is not a 
``significant regulatory action'' under the terms of Executive Order 
12866 and is therefore not subject to OMB review.

C. Paperwork Reduction Act (PRA)

    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. The Office of Management and Budget (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 instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of information; 
and transmit or otherwise disclose the information. An Agency may not 
conduct or sponsor, and a person is not required to respond to a 
collection of information unless it displays a currently valid OMB 
control number. The OMB control numbers for EPA's regulations are 
listed in 40 CFR part 9 and 48 CFR Chapter 1.

D. 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 6, 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.'' ``Policies that have tribal 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal government and Indian tribes.''
    This proposed rule does not have tribal implications. It will not 
have substantial direct effects on tribal governments, on the 
relationship

[[Page 67585]]

between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes, as specified in Executive Order 13175. 
Today's rule does not affect the communities of Indian tribal 
governments since the only entities directly affected by this rule are 
the companies that requested essential-use allowances. Thus, Executive 
Order 13175 does not apply to this rule. In the spirit of Executive 
Order 13175, and consistent with EPA policy to promote communications 
between EPA and tribal governments, EPA specifically solicits 
additional comment on this proposed rule from tribal officials.

E. Regulatory Flexibility Act (RFA) as amended by the Small Business 
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et. 
seq.

    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, 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 is 
because 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.

F. Applicability of 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 Executive Order 12866, and (2) concerns an 
environmental health or safety risk that EPA has reason to believe may 
have a disproportionate effect on children. If the regulatory action 
meets both criteria, the Agency must evaluate the environmental health 
or safety effects of the planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency. EPA 
interprets Executive Order 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 proposed rule is not subject to 
Executive Order 13045 because it implements the phase-out schedule and 
exemptions established by Congress in Title VI of the Clean Air Act.

G. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (``NTTAA), Pub. L. No. 104-113, section 12(d) (15 U.S.C. 
272 note) directs EPA to use voluntary consensus standards in its 
regulatory activities unless to do so would be inconsistent with 
applicable law or otherwise impractical. Voluntary consensus standards 
are technical standards (e.g., materials specifications, test methods, 
sampling procedures, and business practices) that are developed or 
adopted by voluntary consensus standards bodies. The NTTAA directs EPA 
to provide Congress, through OMB, explanations when the Agency decides 
not to use available and applicable voluntary consensus standards. This 
proposed rule does not involve technical standards. Therefore, EPA did 
not consider the use of any voluntary consensus standards.

H. Executive Order 13132 (Federalism)

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 
10, 1999), requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''
    This proposed rule does not have federalism implications. It will 
not have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and responsibilities among the various levels of government, 
as specified in Executive Order 13132. Thus, Executive Order 13132 does 
not apply to this rule. In the spirit of Executive Order 13132, and 
consistent with EPA policy to promote communications between EPA and 
State and local governments, EPA specifically solicits comment on this 
proposed rule from State and local officials.

I. Executive Order 13211 (Energy Effects)

    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.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure, 
Air pollution control, Chemicals, Chlorofluorocarbons, Exports, 
Imports, Methyl chloroform, Ozone layer.

    Dated: October 30, 2002.
Christine Todd Whitman,
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 82.4 is amended by revising the table in paragraph 
(t)(2) to read as follows:


Sec.  82.4  Prohibitions.

* * * * *
    (t) * * *
    (2) * * *

[[Page 67586]]



        Table I.--Essential use Allocation for Calendar Year 2003
------------------------------------------------------------------------
                                                               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          574
                                       CFC-114.
Aventis.............................  CFC-11 or CFC-12 or           48
                                       CFC-114.
Boehringer Ingelheim Pharmaceuticals  CFC-11 or CFC-12 or          907
                                       CFC-114.
GlaxoSmithKline.....................  CFC-11 or CFC-12 or          535
                                       CFC-114.
Schering-Plough Corporation.........  CFC-11 or CFC-12 or          937
                                       CFC-114.
Sidmak Laboratories Inc.............  CFC-11 or CFC-12 or          136
                                       CFC-114.
3M Pharmaceuticals..................  CFC-11 or CFC-12 or          133
                                       CFC-114.
-------------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space
                    Shuttle Rockets and Titan Rockets
------------------------------------------------------------------------
National Aeronautics and Space        Methyl Chloroform.....         9.8
 Administration (NASA)/Thiokol
 Rocket.
United States Air Force/Titan Rocket  Methyl Chloroform.....         3.4
------------------------------------------------------------------------

* * * * *
[FR Doc. 02-28212 Filed 11-5-02; 8:45 am]
BILLING CODE 6560-50-P