96-25001. Request for Applications for Essential Use Exemptions to the Production and Import Phaseout of Ozone Depleting Substances Under the Montreal Protocol  

  • [Federal Register Volume 61, Number 190 (Monday, September 30, 1996)]
    [Notices]
    [Pages 51110-51112]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-25001]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    [FRL-5618-3]
    
    
    Request for Applications for Essential Use Exemptions to the 
    Production and Import Phaseout of Ozone Depleting Substances Under the 
    Montreal Protocol
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Notice.
    
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    SUMMARY: Through this notice, the U.S. Environmental Protection Agency 
    is requesting applications for consideration at the Ninth Meeting of 
    the Parties to the Montreal Protocol to be held in September 1997 for 
    exemptions to the production and import phaseout in 1998 and subsequent 
    years for ozone-depleting substances (including halons 1211 and
    
    [[Page 51111]]
    
    1301, CFC-11, CFC-12, CFC-113, CFC-114, CFC-115, CFC-13, CFC-111, CFC-
    112, CFC-211, CFC-212, CFC-213, CFC-214, CFC-215, CFC-216, CFC-217, 
    carbon tetrachloride, and methyl chloroform).
    
    DATES: Applications for essential use exemptions must be submitted to 
    EPA no later than October 30, 1996 in order for the U.S. government to 
    complete its review and to submit nominations to the United Nations 
    Environment Programme (UNEP) and the Protocol Parties in a timely 
    manner.
    
    ADDRESSES: Send eight copies of application materials to: Nina 
    Bonnelycke, Stratospheric Protection Division (6205J), U.S. 
    Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 
    20460. Send one copy of application materials to: Air Docket A-93-39, 
    401 M Street, S.W. (6102), Room M1500, Washington, D.C. 20460.
    
    CONFIDENTIALITY: Applications should not contain confidential or 
    proprietary information.
    
    FOR FURTHER INFORMATION CONTACT: Nina Bonnelycke at the above address 
    or at (202) 233-9079 ph, (202) 233-9637 fax, or 
    bonnelycke.nina@epamail.epa.gov. General information may be obtained 
    from the Stratospheric Ozone Hotline at 1-800-296-1996.
    
    SUPPLEMENTARY INFORMATION:
    
    Table of Contents
    
    I. Background--The Essential Use Nomination Process
    II. Information Required for Essential Use Applications for 
    Production or Importation of Class I Substances in 1998 and 
    Subsequent Years
    
    I. Background--The Essential Use Nomination Process
    
        As described in previous Federal Register notices (58 FR 29410, May 
    20, 1993; 59 FR 52544, October 18, 1994; and 60 FR 54349, October 23, 
    1995), the Parties to the Montreal Protocol on Substances that Deplete 
    the Ozone Layer (the Parties) agreed during the Fourth Meeting in 
    Copenhagen on November 23-25, 1992, to accelerate the phaseout 
    schedules for Class I ozone-depleting substances. Specifically, the 
    Parties agreed to phase out the production of halons by January 1, 
    1994, and the production of other Class I substances, except methyl 
    bromide, by January 1, 1996. The Parties also reached decisions and 
    adopted resolutions on a variety of other matters, including the 
    criteria to be used for allowing ``essential use'' exemptions from the 
    phaseout of production and importation of controlled substances. 
    Language regarding essential uses was added to the Protocol provisions 
    in Article 2 governing the control measures. Decision IV/25 of the 
    Fourth Meeting of the Protocol details the specific criteria and review 
    process for granting essential use exemptions.
        At the Fifth Meeting of the Parties in 1993, the Parties modified 
    the timetable for nomination of essential uses. Pursuant to Decision V/
    18, Parties may nominate a controlled substance for an exemption from 
    the production phaseout by January 1 of each year. The UNEP committees 
    then review the nominations at their spring meetings and forward their 
    recommendations for decision at the Meeting of the Parties later that 
    year. The Parties may choose to grant the exemption for one or more of 
    the nominated years, but each approved or pending application may be 
    reconsidered and modified by the Parties at their annual meetings. 
    Since the Parties in 1997 will be considering nominations for the year 
    1998 and beyond, today's notice solicits requests for those years. 
    Further detail on the essential uses process is provided later in this 
    section.
        Decision IV/25 states 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''. In 
    addition, the Parties agreed ``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 the existing stocks of banked or recycled 
    controlled substances.''
        Any essential use exemptions also have to comply with the 
    provisions of the Clean Air Act Amendments (CAAA). Sec. 604 authorizes 
    the granting of specific exemptions from the phaseout schedules 
    contained in the CAAA. With respect to halons, the CAAA allows 
    exemptions from the phaseout for aviation safety [Sec. 604(d)(3)], 
    national security [Sec. 604(f)], and fire suppression and explosion 
    prevention [Sec. 604(g)]. Other exemptions specified in Sec. 604 
    include essential uses of methyl chloroform [Sec. 604(d)(1)]; uses of 
    Class I substances in medical devices [Sec. 604(d)(2)]; and uses of 
    CFC-114 for national security [Sec. 604(f)]. To the extent that an 
    accelerated phaseout schedule has been adopted under the Montreal 
    Protocol, EPA can legally provide exemptions for uses authorized by the 
    Protocol but not otherwise specified in the CAAA as long as any 
    additional production does not exceed the production reduction schedule 
    contained in Sec. 604(a).
        The first step in the process to qualify a use as essential under 
    the Protocol is for the user to ascertain whether the use of the 
    controlled substance meets the Decision IV/25 criteria. The user should 
    then notify EPA of the candidate use and provide information for U.S. 
    government agencies and the Protocol Parties to evaluate that use 
    according to the criteria under Decision IV/25. The United Nations 
    Environment Programme (UNEP) Technology and Economic Assessment Panel 
    has issued a handbook entitled ``Handbook on Essential Use 
    Nominations,'' available from EPA, to guide applicants. Applicants 
    should follow the guidelines in the handbook when preparing their 
    exemption requests.
        Upon receipt of the exemption request, EPA reviews the application 
    and works with other interested federal agencies to determine whether 
    it meets the essential use criteria and as a result warrants being 
    nominated for an exemption. Applicants should be aware that, to date, 
    the Parties to the Montreal Protocol have only granted the U.S. 
    essential use exemptions for CFCs for metered dose inhalers (MDIs) for 
    asthma and chronic obstructive pulmonary disease and for methyl 
    chloroform for the Space Shuttle.
        In the case of multiple exemption requests for a single use, such 
    as CFCs for metered dose inhalers (MDIs), EPA aggregates exemption 
    requests received from individual entities into a single U.S. request. 
    An important part of the EPA review is to determine that the aggregate 
    request for a particular out-year adequately reflects the market 
    penetration potential and expected availability of non-CFC substitutes 
    by that point in time. If the sum of individual requests does not 
    incorporate such assumptions, the U.S. government may adjust the 
    aggregate request to better reflect true market needs.
        Nominations submitted to the Ozone Secretariat by the U.S. and 
    other Parties are then forwarded to the UNEP Technical and Economic 
    Assessment Panel (TEAP) and its Technical Options Committees (TOCs), 
    which review the submissions and make recommendations to the Parties 
    for exemptions. Those recommendations are then considered by the 
    Parties at
    
    [[Page 51112]]
    
    their annual meeting for final decision. If the Parties declare a 
    specified use of a controlled substance as essential and issue the 
    necessary exemptions from the production phaseout, EPA may propose 
    regulatory changes to reflect the decisions by the Parties consistent 
    with the CAAA.
        The timing of the reviews is such that in any given year the 
    Parties review nominations for exemption from the production phaseout 
    intended for the following year and any subsequent years. This means 
    that, if nominated, applications submitted in response to today's 
    notice for CFC production in 1998 and beyond will be considered by the 
    Parties in 1997 for final action at the Meeting of the Parties in 
    September of that year.
    
    II. Information Required for Essential Use Applications for Production 
    or Importation of Class I Substances in 1998 and Subsequent Years
    
        Through this notice, EPA requests applications for essential use 
    exemptions for all class I substances for 1998 and subsequent years. 
    All requests for exemptions submitted to EPA must present the 
    information relevant to the application as prescribed in the TEAP 
    Handbook mentioned in the previous section, since the U.S. government 
    does not forward incomplete or inadequate nominations to the Ozone 
    Secretariat. In brief, the TEAP Handbook states that applicants must 
    present information on:
         Role of use in society.
         Alternatives to use, including education programs on 
    alternatives.
         Steps to minimize use, including development of CFC-free 
    alternatives.
         Steps to minimize emissions.
         Amount of substance available through recycling and 
    stockpiling.
         Quantity of controlled substances requested by year.
        EPA anticipates that the 1997 review by the Parties of MDI 
    essential use requests will focus extensively on research efforts 
    underway to develop alternatives to CFC MDIs, on education programs to 
    inform patients and providers of the phaseout and the transition to 
    alternatives, and on steps taken to minimize CFC use and emissions 
    including efforts to recapture or reprocess the controlled substance. 
    Accordingly, applicants are strongly advised to present detailed 
    information on these points including the scope and cost of such 
    efforts and the medical and patient organizations involved in the work. 
    Applicants can strengthen their exemption requests by submitting a 
    complete set of education materials and including copies of printed, 
    electronic or audio-visual tools. Applicants are given notice that 
    exemption requests without adequate information on research and 
    education will not be considered complete.
        Applicants should submit their exemption requests to EPA as noted 
    in the Addresses section at the beginning of today's notice.
    
        Dated: September 23, 1996.
    Mary D. Nichols,
    Assistant Administrator, Office of Air and Radiation.
    [FR Doc. 96-25001 Filed 9-27-96; 8:45 am]
    BILLING CODE 6560-50-P
    
    
    

Document Information

Published:
09/30/1996
Department:
Environmental Protection Agency
Entry Type:
Notice
Action:
Notice.
Document Number:
96-25001
Dates:
Applications for essential use exemptions must be submitted to EPA no later than October 30, 1996 in order for the U.S. government to complete its review and to submit nominations to the United Nations Environment Programme (UNEP) and the Protocol Parties in a timely manner.
Pages:
51110-51112 (3 pages)
Docket Numbers:
FRL-5618-3
PDF File:
96-25001.pdf
Supporting Documents:
» International Pharmaceutical Aerosol Consortium (IPAC), Washington, DC. Request for Nomination of the MDI as an Essential Use. [A-93-39-II-A-4]
» J.H. McCord, Jr., Lab Manager, Davis & Floyd, Incorporated [A-93-39-XI-H-2]
» Letter from Terence Young, Western Farmers Electric Cooperative (WFEC), Anadarko, OK. [A-93-39-XI-H-7]
» Daniel M. Panek, Director, JLI Environmental Laboratories, Auburn, NY. [A-93-39-XI-H-9]
» Data Table: Annex I - Essential Use Nominations For 2002-2004 Authorized by the Thirteenth Meeting of the Parties (in metric tonnes). [A-93-39-XII-A-3]
» Letter from E. Allera and T. Halpern of Buchanan Ingersoll to S. Monroe of EPA re: Imminent Change in name of Sidmak Laboratories [A-93-39-XII-A-6]
» Nomination request for essential uses of halons - 1993 [A-93-39-I-1]
» J. E. Henney, M.D., Commissioner, Department of Health & Human Services, Food & Drug Administration, requesting supplemental of their letter on 01-21-00 [A-93-39-VII-H-5]
» C. Dabruzzi, National Account Manager, 3M Pharmaceuticals/ 3MDrug Delivery Systems, Minnesota Mining & Manufacturing Company (3M) [A-93-39-IX-A-8]
» Minutes of the Meeting with the Food & Drug Administration, Environmental Protection Agency, & 3M Pharmaceuticals on 03-02-00 [A-93-39-VII-E-1]