[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).
------------------------------------------------------------------------
\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