[Federal Register Volume 62, Number 191 (Thursday, October 2, 1997)]
[Notices]
[Pages 51655-51656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26183]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-5902-1]


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 Environmental Protection Agency (EPA) 
is requesting applications for consideration at the Tenth Meeting of 
the Parties to the Montreal Protocol on Substances that Deplete the 
Ozone Layer (the Protocol) to be held in September 1998, for exemptions 
to the production and import phaseout in 1999 and subsequent years for 
ozone-depleting substances (including halons 1211 and 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 November 17, 1997 in order for the United States 
(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 five copies of application materials to: Chris 
O'Donnell, Stratospheric Protection Division (6205J), 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: Chris O'Donnell at the above address 
or at (202) 233-9079 telephone, (202) 233-9665 fax, or 
[email protected]. 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 1999 and 
Subsequent Years

I. Background--The Essential Use Nomination Process

    As described in previous Federal Register (FR) notices (58 FR 
29410, May 20, 1993; 59 FR 52544, October 18, 1994; 60 FR 54349, 
October 23, 1995; and 61 FR 51110, September 30, 1996), the Parties to 
the Protocol 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 Parties details 
the specific criteria and review process for granting essential use 
exemptions.
    At the Eighth Meeting of the Parties in 1996, the Parties modified 
the timetable for nomination of essential uses. Pursuant to Decision 
VIII/9, Parties may nominate a controlled substance for an exemption 
from the production phaseout by January 31 of each year. The United 
Nations Environment Programme (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 
1998 will be considering nominations for the year 1999 and beyond, 
today's notice solicits requests for those years. Further detail on the 
essential use 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

[[Page 51656]]

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 * * *.''
    Section 614 (b) of the Clean Air Act Amendments of 1990 (the Act) 
provides: ``In the case of conflict between any provision of this title 
[Title VI of the Act] and any provision of the Protocol, the more 
stringent provision shall govern.'' Thus, to the extent that an 
accelerated phaseout schedule has been adopted under the Protocol, EPA 
can legally provide exemptions for uses authorized by the Protocol but 
not otherwise specified in the Act as long as any additional production 
does not exceed the production reduction schedule contained in section 
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 UNEP Technology and 
Economic Assessment Panel (TEAP) 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. Past applicants should note 
that the current TEAP handbook has been substantially revised to 
reflect Decision VIII/10 of the Parties.
    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 recent 
essential use exemptions granted to the U.S. for 1997 were limited to 
chlorofluoro-carbons (CFCs) for metered dose inhalers (MDIs) to treat 
asthma and chronic obstructive pulmonary disease.
    In the case of multiple exemption requests for a single use, 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 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 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 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 Act.
    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 1999 and beyond will be considered by the 
Parties in 1998 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 1999 and Subsequent Years

    Through this notice, EPA requests applications for essential use 
exemptions for all Class I substances for 1999 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. As noted earlier, the TEAP 
handbook has been substantially revised to incorporate Decision VIII/10 
adopted by the Parties at their Eighth Meeting, in November 1996. 
Decision VIII/10 will require applicants to expand on information 
provided in previous nominations as well as provide new information. 
Since the U.S. government does not forward incomplete or inadequate 
nominations to the Ozone Secretariat, it is important for applicants to 
provide all information requested in the Handbook, including the 
information specified in the supplemental research and development form 
(page 43) and the accounting framework matrix (page 41). Parties have 
been asked to request this information from companies, and these forms 
will assist the EPA in preparing a complete and comprehensive 
nomination. 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 1998 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 25, 1997.
Richard D. Wilson,
Acting Assistant Administrator, Office of Air and Radiation.
[FR Doc. 97-26183 Filed 10-1-97; 8:45 am]
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