[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:
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\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