[Federal Register Volume 63, Number 153 (Monday, August 10, 1998)]
[Notices]
[Pages 42629-42631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21346]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6140-9]


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 Eleventh Meeting of 
the Parties to the Montreal Protocol on Substances that Deplete the 
Ozone Layer (the Protocol) to be held in September 1999, for exemptions 
to the production and import phaseout in 2000 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 September 24, 1998 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 three 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. Such information should be submitted under 
separate cover and should be identified by placing on (or attaching to) 
the information, at the time it is submitted to EPA, a cover sheet, 
stamped or typed legend, or other suitable form of notice employing 
language such as ``trade secret,'' ``proprietary,'' or ``company 
confidential.'' Information covered by a claim of business 
confidentiality will be disclosed by EPA only to the extent, and by 
means of the procedures, set forth at 40 CFR Part 2, Subpart B (41 FR 
36902). If no claim of confidentiality accompanies the information when 
it is received by EPA, the information may be made available to the 
public by EPA without further notice to the company (40 CFR 2.203).

FOR FURTHER INFORMATION CONTACT: Chris O'Donnell at the above address 
or at (202) 564-9079 telephone, (202) 565-2095 fax, or 
[email protected]. General information may be obtained from the 
Stratospheric Ozone Hotline at 1-800-296-1996.

SUPPLEMENTARY INFORMATION:

I. Background--The Essential Use Nomination Process
II. Information Required for Essential Use Applications for 
Production or Importation of Class I Substances in 2000 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; 61 FR 51110, September 30, 1996; and 62 FR 51655, 
October 2, 1997), 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 
1999 will be considering

[[Page 42630]]

nominations for the year 2000 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 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,'' (the handbook) available 
from EPA, to guide applicants. Applicants should follow the guidelines 
in the handbook when preparing their exemption requests. Applicants 
should note that the current TEAP handbook was revised in 1997 to 
reflect Decision VIII/10 of the Parties. Therefore applicants should 
use the handbook dated August 1997 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 recent 
essential use exemptions granted to the U.S. for 1999 were limited to 
chlorofluorocarbons (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 2000 and beyond will be considered by the 
Parties in 1999 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 2000 and 
Subsequent Years

    Through this notice, EPA requests applications for essential use 
exemptions for all Class I substances for 2000 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 was 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). Applicants should also 
note that reformulation information is required from all drug sponsors, 
irrespective of whether they manufacture their own product or contract 
with a filler to produce their product.
    The accounting framework matrix in the Handbook is titled, ``IV. 
Reporting Accounting Framework for Essential Uses Other Than Laboratory 
and Analytical Applications.'' The data requested in column H, On Hand 
Start of Year, is the total quantity of each controlled substance that 
an applicant has on hand as of January 1st of the year in question, 
whether the material is held for the applicant under contract or is on-
site at the facility, and whether the material was produced prior to 
the phaseout or obtained after the phaseout. The data requested in 
column J, Used for Essential Use, is the gross total quantity of the 
controlled substance that was used in the essential-use process, 
including amounts emitted, used in cleaning equipment, recycled or 
destroyed. 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 1999 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.

[[Page 42631]]

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: August 3, 1998.
Robert Perciasepe,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 98-21346 Filed 8-7-98; 8:45 am]
BILLING CODE 6560-50-P