[Federal Register: December 27, 2002 (Volume 67, Number 249)]
[Rules and Regulations]
[Page 79507-79512]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de02-28]
[[Page 79507]]
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Part X
Environmental Protection Agency
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40 CFR Part 82
Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2003; Final Rule
[[Page 79508]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-7430-7]
RIN 2060-AK48
Protection of Stratospheric Ozone: Allocation of Essential Use
Allowances for Calendar Year 2003
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 2003. 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. Today EPA is
finalizing the allocations proposed in the Federal Register on November
6, 2002 (67 FR 67581). These allocations total 3,270 metric tons of
chlorofluorocarbons for use in metered dose inhalers, and 13.2 metric
tons of methyl chloroform for use in the U.S. Space Shuttle and Titan
Rocket programs.
DATES: This final rulemaking is effective December 27, 2002.
ADDRESSES: Materials relevant to this rulemaking are contained in EPA
Air Docket No. A-93-39. The 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. EPA may charge a reasonable fee for copying docket materials.
FOR FURTHER INFORMATION CONTACT: Scott Monroe, by regular mail: U.S.
Environmental Protection Agency, Global Programs Division (6205J), 1200
Pennsylvania Avenue, NW., Washington, DC, 20460; by telephone: (202)
564-9712; or by email: monroe.scott@epa.gov.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. 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?
II. Response to Comments
III. Allocation of Essential Use Allowances for Calendar Year 2003
IV. Administrative Requirements
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
V. Judicial Review
I. 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, methyl
chloroform, and methyl bromide. 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 79509]]
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 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 tons of methyl
chloroform for authorized essential uses. According to EPA's tracking
system, the total amount of methyl chloroform produced or imported by
essential use allowance holders in the years 1999-2001 was 28.3 metric
tons. With today's allocation totaling 13.2 tons, the U.S. remains well
below the established cap on allowances for methyl choloroform.
II. Response to Comments
EPA received one comment in response to the proposed rule. The
commenter supported the proposed allocations.
III. Allocation of Essential Use Allowances for Calendar Year 2003
With today's action, EPA is allocating essential use allowances for
calendar year 2003 to entities listed in Table 1. These allowances are
for the production or import of the specified quantity of class I
controlled substances solely for the specified essential use.
Table I.--Essential Use Allocation for Calendar Year 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 CFC- 574
114.
Aventis........................ CFC-11 or CFC-12 or CFC- 48
114.
Boehringer Ingelheim CFC-11 or CFC-12 or CFC- 907
Pharmaceuticals. 114.
Glaxo SmithKline............... CFC-11 or CFC-12 or CFC- 535
114.
Schering-Plough Corporation.... CFC-11 or CFC-12 or CFC- 937
114.
Sidmak Laboratories \4\........ CFC-11 or CFC-12 or CFC- 136
114.
3M Pharmaceuticals............. CFC-11 or CFC-12 or CFC- 133
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.
[[Page 79510]]
United States Air Force/Titan Methyl Chloroform...... 3.4
Rocket.
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\4\ EPA proposed to allocate allowances to Sidmak Laboratories, Inc. for
136 metric tons for use in 2003. Following publication of the
proposal, Sidmak was purchased by the pharmaceutical firm PLIVA d.d.
In 2003, a subsidiary of PLIVA d.d. reportedly will replace Sidmak
Laboratories, thereby acquiring Sidmak's essential use allowances. A
letter to EPA describing the purchase and PLIVA's commitment to
execute essential use allowances in accordance with EPA regulations
and Sidmak's application for allowances has been filed in Air Docket A-
93-39, Category XII-A.
IV. Administrative Requirements
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 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 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
[[Page 79511]]
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 Executive Order 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 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 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.
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), Pub. L. 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary 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. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2). This rule will be
effective December 27, 2002.
V. 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
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Exports,
Imports, Laboratory and Analytical Uses, Methyl Chloroform, Ozone
layer, Reporting and recordkeeping requirements.
Dated: December 19, 2002.
Christine Todd Whitman,
Administrator.
40 CFR Part 82 is 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:
[[Page 79512]]
Sec. 82.4 Prohibitions.
* * * * *
(t) * * *
(2) * * *
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 CFC- 574
114.
Aventis........................ CFC-11 or CFC-12 or CFC- 48
114.
Boehringer Ingelheim CFC-11 or CFC-12 or CFC- 907
Pharmaceuticals. 114.
GlaxoSmithKline................ CFC-11 or CFC-12 or CFC- 535
114.
Schering-Plough Corporation.... CFC-11 or CFC-12 or CFC- 937
114.
Sidmak Laboratories............ CFC-11 or CFC-12 or CFC- 136
114.
3M Pharmaceuticals............. CFC-11 or CFC-12 or CFC- 133
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 Methyl Chloroform...... 3.4
Rocket.
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-32719 Filed 12-26-02; 8:45 am]
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