99-324. Protection of Stratospheric Ozone: Allocation of 1999 Essential- Use Allowances  

  • [Federal Register Volume 64, Number 4 (Thursday, January 7, 1999)]
    [Rules and Regulations]
    [Pages 1092-1096]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-324]
    
    
    
    [[Page 1091]]
    
    _______________________________________________________________________
    
    Part IV
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
    _______________________________________________________________________
    
    
    
    40 CFR Part 82
    
    
    
    Protection of Stratospheric Ozone: Allocation of 1999 Essential-Use 
    Allowances; Final Rule
    
    Federal Register / Vol. 64, No. 4 / Thursday, January 7, 1999 / Rules 
    and Regulations
    
    [[Page 1092]]
    
    
    
    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 82
    
    [FRL-6217-1]
    RIN 2060-AI26
    
    
    Protection of Stratospheric Ozone: Allocation of 1999 Essential-
    Use Allowances
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
    -----------------------------------------------------------------------
    
    SUMMARY: With this action, EPA is allocating 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: This rule is effective January 7, 1999.
    
    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. Response to Comments
    IV. 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. Submission to Congress and the General Accounting Office
    
    I. Background
    
        The Montreal Protocol on Substances that Deplete the Ozone Layer 
    (Protocol) 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.
        The initial cycle of implementing this Decision has been completed 
    in the context of halons which were phased out of production at the end 
    of 1993. This initial timetable separated nominations for halons from 
    those for other ozone-depleting substances. EPA issued a Federal 
    Register document requesting nominations for essential uses of halons 
    (February 2, 1993; 58 FR 6786). In response, the Agency received over 
    ten nominations, but was able to work with applicants to resolve their 
    near-term requirements. As a result, the U.S. did not nominate any uses 
    for continued halon production in 1994. About a dozen other nations put 
    forth nominations which were reviewed by the Technical and Economic 
    Assessment Panel. Because the Panel determined that in each case 
    alternatives existed or that the existing supply of banked halons was 
    adequate to meet near-term needs, it did not recommend approval of any 
    of the nominations. In November of 1993, at the Fifth Meeting, the 
    Parties unanimously adopted the recommendation of the Panel not to 
    approve any essential uses for the production or consumption of halons 
    in 1994.
        EPA issued a second document for essential-use nominations for 
    halons on October 18, 1993 (58 FR 53722). These nominations covered 
    possible production of halons in 1995 for essential uses. In response 
    to this inquiry, EPA received no nominations.
        Only one nomination (from France) was received by the TEAP for 
    production and consumption of halons for an essential use in 1995. The 
    TEAP did not recommend approval of this nomination.
        EPA also issued a Federal Register document requesting nominations 
    for essential-use applications which would need to continue beyond the 
    1996 phaseout of consumption and production allowances for CFCs, methyl 
    chloroform, carbon tetrachloride, and hydrobromofluorocarbons (May 20, 
    1993, 58 FR 29410). EPA received 20 applications in response to this 
    document. For several of these applications, EPA determined that the 
    criteria contained in Decision IV/25 had not been satisfied. For 
    example, two applications sought CFCs for servicing existing air-
    conditioning equipment. EPA rejected these applications on the basis 
    that if all economically feasible steps were taken prior to the 1996 
    phaseout, then adequate supplies of banked and recycled CFCs should be 
    available. However, in rejecting these nominations, the United States 
    noted that servicing existing air-conditioning and refrigeration 
    equipment remains a major challenge to the successful transition from 
    the use of CFCs and that a future nomination in this area might be 
    necessary if a combination of retrofits, replacements, recycling, 
    recovery at disposal, and banking do not adequately address these 
    needs.
    
    [[Page 1093]]
    
        Of the responses to the Federal Register request for essential-use 
    applications, the United States submitted essential-use nominations to 
    the Protocol Secretariat for the following uses of CFCs: metered dose 
    inhalers and other selected medical applications; rocket motor assembly 
    for the Space Shuttle; aerosol wasp killers; limited use in a specified 
    bonding agent and polymer application; and a generic application for 
    laboratory uses under specified limitations. (Letter from Pomerance to 
    UNEP, September 27, 1993).
        Nominations from the U.S. and other countries for over 200 specific 
    uses were submitted to the Montreal Protocol Secretariat and provided 
    to the Technical and Economic Assessment Panel for review. In March 
    1994, the Panel issued the ``1994 Report of the Technology and Economic 
    Assessment Panel.'' The Report includes the Panel's recommendations for 
    essential-use production and consumption exemptions. The Panel 
    recommended that essential-use exemptions be granted for nominations 
    of: methyl chloroform in solvent bonding for the Space Shuttle; CFCs 
    used in metered dose inhalers; and specific controlled substances 
    needed for laboratory and analytical applications. For each of the 
    other nominations submitted, the TEAP determined that one or more of 
    the criteria for evaluating an essential-use had not been satisfied. 
    For example, in the case of several of the U.S. nominations, the report 
    states that alternatives are available and therefore the essential-use 
    exemption is not warranted.
        In every year since 1994, the Parties have reviewed recommendations 
    by the Technology and Economic Assessment Panel and made final 
    decisions on essential-use authorizations. Today's action follows 
    decisions taken by the Parties after considering recommendations by the 
    TEAP in 1997 and 1998.
        In 1993, the Parties to the Protocol modified the timetable for 
    submission of essential-use nominations to combine both halons and all 
    the other class I controlled substances (except methyl bromide) and to 
    reduce the overall length of time between nomination and decision. 
    According to Decision V/18, essential-use nominations for halon 
    consumption and production for 1995 and beyond, and essential-use 
    nominations for all the other class I controlled substances (except 
    methyl bromide) for 1997 and beyond, must be submitted to the 
    Secretariat prior to January 1st of the year prior to the year for 
    which production and consumption is being sought. The Parties again 
    revised the timetable for essential-use nominations in Decision VIII/9 
    requiring submission by 31 January in the year in which decisions would 
    be taken for subsequent years. EPA revised the domestic schedule 
    accordingly so a Federal Register document calling for essential-use 
    applications for class I controlled substances for future years is 
    published prior to the Protocol deadline for submission to the Ozone 
    Secretariat.
        Decision V/18 directed the Technology and Economic Assessment Panel 
    to develop a ``handbook on essential-use nominations'' (Handbook). The 
    July 1994 Handbook contained forms and instructions for how to apply 
    for an essential-use exemption. Subsequent decisions by the Parties to 
    the Protocol created additional criteria for essential-use 
    authorizations now reflected in the August 1997 Handbook on Essential-
    use Nominations. The Handbook may be obtained from the Stratospheric 
    Protection Division, U.S. Environmental Protection Agency or the Ozone 
    Secretariat of the Montreal Protocol in Nairobi. The Handbook can also 
    be downloaded from the TEAP website at: http://www.teap.org/html/
    teap__reports.html.
    
    II. Allocation of 1999 Essential-Use Allowances
    
        In today's action, EPA is allocating 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
    ----------------------------------------------------------------------------------------------------------------
                                                                                                         Quantity
                          Company/entity                            Class I controlled substance          (metric
                                                                                                          tonnes)
    ----------------------------------------------------------------------------------------------------------------
              (i) Metered Dose Inhalers for Treatment of Asthma and Chronic Obstructive Pulmonary Disease
    ----------------------------------------------------------------------------------------------------------------
    International Pharmaceutical Aerosol Consortium (IPAC)--   CFC-11...............................           899.5
     Armstrong Laboratories, Boehringer Ingelheim              CFC-12...............................          2157.4
     Pharmaceuticals, Glaxo Wellcome, Rhone-Poulenc Rorer,     CFC-114..............................           183.6
     Schering Corporation, 3M.
    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 Administration (NASA)/      Methyl Chloroform....................            56.7
     Thiokol Rocket.
    United States Air Force/Titan Rocket.....................  Methyl Chloroform....................             3.4
    ----------------------------------------------------------------------------------------------------------------
                                      (iii) Laboratory and Analytical Applications
    ----------------------------------------------------------------------------------------------------------------
    Global Exemption (Restrictions in Appendix G Apply)......  All Class I Controlled Substances                 \1\
                                                                (except Group VI).
    ----------------------------------------------------------------------------------------------------------------
    \1\ No quantity specified.
    
    
    [[Page 1094]]
    
        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 
    allocates essential-use allowances to United States entities based on 
    nominations decided upon by the Parties to the Protocol.
        The 1999 global essential-use exemption for analytical and 
    laboratory applications published in today's 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 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 in today's action is 
    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. Response to Comments
    
        EPA received one comment pointing out that, in accordance with the 
    direct final rule published on August 4, 1998 (63 FR 41625) and the 
    related subsequent notice on October 5, 1998 (63 FR 53290), the 
    regulatory citation in the propose rule published on November 20, 1998 
    (63 FR 64437) should be changed from Sec. 82.4(r)(2) to 
    Sec. 82.4(t)(2). With this action, EPA makes this appropriate change to 
    the paragraph citation to be consistent with changes made in prior 
    rules.
    
    IV. Summary of Supporting Analysis
    
    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 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 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 rule 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 rule does not create a mandate on State, local or tribal 
    governments. The final rule does not impose any enforceable duties on 
    these
    
    [[Page 1095]]
    
    entities. Accordingly, the requirements of section 1(a) of Executive 
    Order 12875 do not apply to this 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 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 rule does not significantly or uniquely affect the 
    communities of Indian tribal governments. The final 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 Act
    
        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 final 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 final 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. 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 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''), Public Law 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 
    final rule does not involve technical standards. Therefore, EPA is not 
    considering the use of any voluntary consensus standards.
    
    [[Page 1096]]
    
    I. Submission to Congress and the General Accounting Office
    
        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. 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).
    
    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 
    recordkeeping requirements.
    
        Dated: December 31, 1998.
    Carol M. Browner,
    Administrator.
    
        Accordingly, 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(t)(2) is amended by revising the table to read as 
    follows:
    
    
    Sec. 82.4  Prohibitions.
    
    * * * * *
        (t) * * *
        (2) * * *
    
         Table I.--Essential-Uses Agreed To by the Parties to the Protocol for 1999 and Essential-Use Allowances
    ----------------------------------------------------------------------------------------------------------------
                                                                                                         Quantity
                          Company/entity                            Class I controlled substance          (metric
                                                                                                          tonnes)
    ----------------------------------------------------------------------------------------------------------------
              (i) Metered Dose Inhalers for Treatment of Asthma and Chronic Obstructive Pulmonary Disease
    ----------------------------------------------------------------------------------------------------------------
    International Pharmaceutical Aerosol Consortium (IPAC) 1-- CFC-11...............................           899.5
     Armstrong Laboratories, Boehringer Ingelheim              CFC-12...............................          2157.4
     Pharmaceuticals, Glaxo Wellcome, Rhone-Poulenc Rorer,     CFC-114..............................           183.6
     Schering Corporation, 3M.
    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 Administration (NASA)/      Methyl Chloroform....................            56.7
     Thiokol Rocket.
    United States Air Force/Titan Rocket.....................  Methyl Chloroform....................             3.4
    ----------------------------------------------------------------------------------------------------------------
                                      (iii) Laboratory and Analytical Applications
    ----------------------------------------------------------------------------------------------------------------
    Global Exemption (Restrictions in Appendix G Apply)......  All Class I Controlled Substances               (\2\)
                                                                (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. 99-324 Filed 1-6-99; 8:45 am]
    BILLING CODE 6560-50-P
    
    
    

Document Information

Effective Date:
1/7/1999
Published:
01/07/1999
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
99-324
Dates:
This rule is effective January 7, 1999.
Pages:
1092-1096 (5 pages)
Docket Numbers:
FRL-6217-1
RINs:
2060-AI26
PDF File:
99-324.pdf
CFR: (2)
40 CFR 82.4(t)(2)
40 CFR 82.4