[Federal Register Volume 63, Number 224 (Friday, November 20, 1998)]
[Proposed Rules]
[Pages 64437-64441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-31078]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 82
[FRL-6191-5]
Protection of Stratospheric Ozone: Allocation of 1999 Essential-
Use Allowances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of proposed rulemaking.
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SUMMARY: With this action, EPA is proposing the allocation of
essential-use allowances for the 1999 control period. The United States
nominated specific uses of controlled ozone-depleting substances (ODS)
as essential for 1999 under the Montreal Protocol on Substances that
Deplete the Ozone Layer (Protocol). The Parties to the Protocol
subsequently authorized specific quantities of ODS for 1999 for the
uses nominated by the United States. Essential-use allowances permit a
person to obtain controlled ozone-depleting substances as an exemption
to the January 1, 1996 regulatory phaseout of production and import.
Essential-use allowances are allocated to a person for exempted
production or importation of a specific quantity of a controlled
substance solely for the designated essential purpose.
DATES: Written comments on this proposed rule must be received on or
before December 21, 1998, unless a public hearing is requested.
Comments must then be received on or before 30 days following the
public hearing. Any party requesting a public hearing must notify the
Stratospheric Ozone Protection Hotline listed below by 5 p.m. Eastern
Standard Time on November 30, 1998. 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
(two copies) to: Air Docket No. A-92-13, U.S. Environmental Protection
Agency, 401 M Street, SW, Room M-1500, Washington, DC, 20460. Inquiries
regarding a public hearing should be directed to the Stratospheric
Ozone Protection Hotline at 1-800-269-1996.
Materials relevant to this rulemaking are contained in Docket No.
A-92-13. The Docket is located in room M-1500, First Floor, Waterside
Mall at the address above. The materials may be inspected from 8 a.m.
until 4 p.m. Monday through Friday. A reasonable fee may be charged by
EPA for copying docket materials.
FOR FURTHER INFORMATION CONTACT: The Stratospheric Ozone Protection
Hotline at 1-800-296-1996 or Tom Land, U.S. Environmental Protection
Agency, Stratospheric Protection Division, Office of Atmospheric
Programs, 6205J, 401 M Street, SW., Washington, DC, 20460, 202-564-
9185.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Allocation of 1999 Essential-use Allowances
III. Summary of Supporting Analysis
A. Unfunded Mandates Reform Act
B. Executive Order 12875: Enhancing the Intergovernmental
Partnership
C. Executive Order 12866
D. Paperwork Reduction Act
E. Executive Order 13084: Consultation and Coordination with Indian
Tribal Governments
F. Regulatory Flexibility Act
G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
H. National Technology Transfer and Advancement Act
I. Background
The Montreal Protocol on Substances that Deplete the Ozone Layer
(Protocol)
[[Page 64438]]
sets specific deadlines for the phaseout of production and importation
of ozone depleting substances (ODS). At their Fourth Meeting in 1992,
the signatories to the Protocol (the Parties) amended the Protocol to
allow exemptions to the phaseout for uses agreed by the Parties to be
essential. At the same Meeting, the Parties also adopted Decision IV/
25, which established both criteria for determining whether a specific
use should be approved as essential and a process for the Parties to
use in making such a determination.
The criteria for an essential use as set forth in Decision IV/25
are the following: ``(1) 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;
(2) 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.''
Decision IV/25 also sets out the procedural steps for implementing
this process. It first calls for individual Parties to nominate
essential-uses. These nominations are then to be evaluated by the
Protocol's Technology and Economic Assessment Panel (TEAP or the Panel)
which makes recommendations to representatives of all Protocol Parties.
The final decision on which nominations to approve is to be taken by a
meeting of the Parties.
II. Allocation of 1999 Essential-Use Allowances
In today's action, EPA is proposing allocation of essential-use
allowances for the 1999 control period 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 Uses Agreed To by the Parties to the Protocol for 1999 and Essential-Use Allowances
----------------------------------------------------------------------------------------------------------------
Company/Entity Class I controlled substance Quantity (metric tonnes)
----------------------------------------------------------------------------------------------------------------
(i) Metered Dose Inhalers for Treatment of Asthma and Chronic Obstructive Pulmonary Disease
----------------------------------------------------------------------------------------------------------------
International Pharmaceutical Aerosol CFC-11............................... 899.5
Consortium (IPAC)--Armstrong
Laboratories, Boehringer Ingelheim
Pharmaceuticals, Glaxo Wellcome, Rhone-
Poulenc Rorer, Schering-Plough
Corporation, 3M.
CFC-12............................... 2157.4
CFC-114.............................. 183.6
Medisol Laboratories, Inc............... CFC-11............................... 67.3
CFC-12............................... 115.3
CFC-114.............................. 9.6
Aeropharm Technology, Inc............... CFC-11............................... 80.1
CFC-12............................... 160.2
Sciarra Laboratories, Inc............... CFC-11............................... 0.5
CFC-12............................... 1.5
CFC-114.............................. 0.5
----------------------------------------------------------------------------------------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the Space Shuttle Rockets and Titan Rockets
----------------------------------------------------------------------------------------------------------------
National Aeronautics and Space Methyl Chloroform.................... 56.7
Administration (NASA)/Thiokol Rocket.
United States Air Force/Titan Rocket.... Methyl Chloroform.................... 3.4
----------------------------------------------------------------------------------------------------------------
(iii) Laboratory and Analytical Applications
----------------------------------------------------------------------------------------------------------------
Global Exemption (Restrictions in All Class I Controlled Substances No quantity specified
Appendix G Apply). (except Group VI).
----------------------------------------------------------------------------------------------------------------
The International Pharmaceutical Aerosol Consortium (IPAC)
consolidated requests for an essential-use exemption to be nominated to
the Protocol as an agent of its member companies for administrative
convenience. By means of a confidential letter to each of the companies
listed above, EPA will allocate essential-use allowances separately to
each company in the amount requested by it for the nomination.
Applications submitted by the entities in Table I requested class I
controlled substances for uses claimed to be essential during the 1999
control period. The applications provided information in accordance
with the criteria set forth in Decision IV/25 of the Protocol and the
procedures outlined in the ``Handbook on Essential-Use Nominations.''
The applications request exemptions for the production and import of
specific quantities of specific class I controlled substances after the
phaseout as set forth in 40 CFR 82.4. The applications were reviewed by
the U.S. government and nominated to the Protocol Secretariat for
analysis by the Technical and Economic Assessment Panel (TEAP) and its
Technical Option Committees (TOCs). The Parties to the Montreal
Protocol approved the U.S. nominations for essential-use exemptions
during the Ninth Meeting in 1997 (Decision IX/18). Today's action
proposes the allocation of essential-use allowances to United States
entities based on nominations decided upon by the Parties to the
Protocol.
[[Page 64439]]
The 1999 global essential-use exemption for analytical and
laboratory applications published in today's proposed rule does not
alter the strict requirements both in 40 CFR 82.13 and in Appendix G to
40 CFR part 82, subpart A. The restrictions for the global laboratory
and analytical essential-use exemption listed in Appendix G include
requirements regarding purity of the class I controlled substances and
the size of the containers. In addition, there are detailed reporting
requirements in Sec. 82.13 for persons that take advantage of the
global laboratory and analytical essential-use exemption for class I
controlled substances. The strict requirements are established because
the Parties to the Protocol, and today's proposed rule, do not specify
a quantity of essential-use allowances permitted for analytical and
laboratory applications, but establish a global essential-use
exemption, without a named recipient.
Any person obtaining class I controlled substances after the
phaseout under the essential-use exemptions proposed in today's action
would be subject to all the restrictions and requirements in other
sections of 40 CFR part 82, subpart A. Holders of essential-use
allowances or persons obtaining class I controlled substances under the
essential-use exemptions must comply with the record keeping and
reporting requirements in Sec. 82.13 and the restrictions in Appendix
G.
III. Summary of Supporting Analysis
A. 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 by
State, local, and tribal governments, in the aggregate, or by 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. Section 204 of the UMRA requires the
Agency to develop a process to allow elected state, local, and tribal
government officials to provide input in the development of any
proposal containing a significant Federal intergovernmental mandate.
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. Because this proposed rule imposes
no enforceable duty on any State, local or tribal government it is not
subject to the requirements of sections 202 and 205 of the UMRA. EPA
has also determined that this rule contains no regulatory requirements
that might significantly or uniquely affect small governments;
therefore, EPA is not required to develop a plan with regard to small
governments under section 203. Finally, because this proposal does not
contain a significant intergovernmental mandate, the Agency is not
required to develop a process to obtain input from elected state,
local, and tribal officials under section 204.
B. Executive Order 12875: Enhancing the Intergovernmental Partnership
Under Executive Order 12875, EPA may not issue a regulation that is
not required by statute and that creates a mandate upon a State, local
or tribal government, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by those
governments or EPA consults with those governments. If EPA complies by
consulting, Executive Order 12875 requires EPA to provide the Office of
Management and Budget a description of the extent of EPA's prior
consultation with representatives of affected State, local and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's proposed rule does not create a mandate on State, local or
tribal governments. The proposed rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this proposed rule.
C. 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 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 rule is not a ``significant
regulatory action'' under the terms of Executive Order 12866 and is
therefore not subject to OMB review.
D. 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. 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. 1432.16).
Burden means the total time, effort, or financial resources
expended by persons
[[Page 64440]]
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 15.
E. Executive Order 13084: Consultation and Coordination With Indian
Tribal Governments
Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments, or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected officials and other
representatives of Indian tribal governments ``to provide meaningful
and timely input in the development of regulatory policies or matters
that significantly or uniquely affect their communities.''
Today's proposed rule does not significantly or uniquely affect the
communities of Indian tribal governments. The proposed rule does not
impose any enforceable duties on Indian tribal governments.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to this rule.
F. Regulatory Flexibility
The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements 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 not-for-profit enterprises, and small governmental
jurisdictions. This proposed rule would not have a significant impact
on a substantial number of small entities since essential-use
allocations are granted to large pharmaceutical manufacturing
corporations and not small entities such as small businesses, not-for-
profit enterprises or small governmental jurisdictions.
EPA concluded that this proposed rule would not have a significant
impact on a substantial number of small entities, therefore, I hereby
certify that this action will not have a significant economic impact on
a substantial number of small entities. This rule, therefore, does not
require a regulatory flexibility analysis.
G. E.O. 13045: Protection of Children from Environmental Health Risks
and Safety Risks
Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that (1) is determined to be ``economically significant''
as defined under E.O. 12866, and (2) concerns an environmental health
and safety risk that EPA has reason to believe may have a
disproportionate effect on children. If the regulatory action meets
both criteria, the Agency must evaluate the environmental health or
safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
This rule is not subject to E.O. 13045 because it does not involve
decisions intended to mitigate environmental health or safety risks.
H. 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 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 is not considering the use of any voluntary consensus standards.
List of Subjects in 40 CFR Part 82
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Exports,
Hydrochlorofluorocarbons, Imports, Ozone layer, Reporting and record
keeping requirements.
Dated: November 16, 1998.
Carol M. Browner,
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(r)(2) is amended by revising the table to read as
follows:
Sec. 82.4 Prohibitions.
* * * * *
(r) * * *
(2) * * *
[[Page 64441]]
Table I.--Essential Uses Agreed To by the Parties to the Protocol for
1999 and Essential-Use Allowances
------------------------------------------------------------------------
Quantity
Company/Entity Class I Controlled (metric
Substance tonnes)
------------------------------------------------------------------------
(i) Metered Dose Inhalers for Treatment of Asthma and Chronic
Obstructive Pulmonary Disease
------------------------------------------------------------------------
International Pharmaceutical CFC-11..................... 899.5
Aerosol Consortium (IPAC)\1\-
Armstrong Laboratories,
Boehringer Ingelheim
Pharmaceuticals, Glaxo
Wellcome, Rhone-Poulenc
Rorer, Schering-Plough
Corporation, 3M.
CFC-12..................... 2157.4
CFC-114.................... 183.6
Medisol Laboratories, Inc..... CFC-11..................... 67.3
CFC-12..................... 115.3
CFC-114.................... 9.6
Aeropharm Technology, Inc..... CFC-11..................... 80.1
CFC-12..................... 160.2
Sciarra Laboratories, Inc..... CFC-11..................... 0.5
CFC-12..................... 1.5
CFC-114.................... 0.5
------------------------------------------------------------------------
(ii) Cleaning, Bonding and Surface Activation Applications for the
Space Shuttle Rockets and Titan Rockets
------------------------------------------------------------------------
National Aeronautics and Space Methyl Chloroform.......... 56.7
Administration (NASA)/Thiokol
Rocket.
United States Air Force/Titan Methyl Chloroform.......... 3.4
Rocket.
------------------------------------------------------------------------
(iii) Laboratory and Analytical Applications
------------------------------------------------------------------------
Global Exemption (Restrictions All Class I Controlled (\2\)
in Appendix G Apply). Substances (except Group
VI).
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\1\ The International Pharmaceutical Aerosol Consortium (IPAC)
consolidated requests for an essential-use exemption to be nominated
to the Protocol as an agent of its member companies for administrative
convenience. By means of a confidential letter to each of the
companies listed above, EPA will allocate essential-use allowances
separately to each company in the amount requested by it for the
nomination.
\2\ No quantity specified.
[FR Doc. 98-31078 Filed 11-19-98; 8:45 am]
BILLING CODE 6560-50-P
