[Federal Register Volume 64, Number 178 (Wednesday, September 15, 1999)]
[Notices]
[Pages 50083-50086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24046]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6439-4]


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 Twelfth Meeting of 
the Parties to the Montreal Protocol on Substances that Deplete the 
Ozone Layer (the Protocol) to be held in 2000, for exemptions to the 
production and import phaseout in 2001 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).


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DATES: Applications for essential use exemptions must be submitted to 
EPA no later than November 1, 1999 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: Erin 
Birgfeld, Stratospheric Protection Division (6205J), Environmental 
Protection Agency, 401 M Street, S.W., Washington, D.C. 20460. If 
submitting applications by courier, the office address is 501 3rd 
Street, NW, Washington, DC 20001. 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: Erin Birgfeld 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:

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 2001 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, 0 30, 1996, 62 FR 51655, October 2, 
1997; and 63 FR 42629, August 10, 1998), 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 that non-Article 5 Parties 
(developed countries) would phase out the production and consumption of 
halons by January 1, 1994, and the production and consumption 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.
    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. * * *''
    At the Eighth Meeting of the Parties in 1996, the Parties 
established a new timetable for nomination of essential uses. Pursuant 
to Decision VIII/9, Parties may nominate a controlled substance for an 
exemption from the production and consumption phaseout by January 31 of 
each year to the Ozone Secretariat. Further detail on the essential use 
process is provided later in this section.
    Each year, the Parties to the Protocol have approved an unlimited, 
global essential use exemption for the production and consumption of 
high purity ozone depleting substances for use in laboratory and 
analytical techniques. EPA has implemented this exemption domestically 
through regulation. However, beginning January 1, 2000 EPA will no 
longer be able to allow laboratory essential use exemptions for CFCs 
and carbon tetrachloride for the following reasons. The Clean Air Act 
(the Act) provides for specific exemptions to the phaseout of ozone-
depleting substances, while the Protocol does not specify exemptions 
but establishes a process for the parties to determine what are 
essential uses beyond the phaseout dates. Thus, a use that is permitted 
under the Protocol may or may not be permitted under the Act. The 
phaseout schedule for class I substances in section 604 of the Act is 
less stringent than the Protocol phaseout schedule. For the past 
several years, EPA has been able to modify its regulations to authorize 
production of ozone-depleting substances for essential uses allowed 
under the Protocol, without regard to whether the Act contains 
exceptions for those uses, as long as the total authorized production 
did not exceed the amount permitted under section 604 of the Act. 
However, January 1, 2000 is the phaseout date under section 604 of the 
Act for all class I substances with the exception of methyl chloroform 
and methyl bromide. The phaseout dates for methyl chloroform and methyl 
bromide are January 1, 2002 and January 1, 2005, respectively. After 
the phaseout date for a particular substance has passed, EPA will no 
longer be able to authorize production of that substance unless the Act 
specifically authorizes it do so.
    The Act's specific exemption provisions include the following. 
Section 604 (d)(2) of the Act states that notwithstanding the phaseout, 
EPA shall, to the extent consistent with the Montreal Protocol, 
authorize production of limited quantities of class I substances for 
use in medical devices, if FDA, in consultation with EPA, determines 
that such production is necessary. Section 604(d) (3) states that EPA 
may, to the extent consistent with the Montreal Protocol, authorize 
production of limited quantities of halon-1211, halon-1301, and halon-
2402 solely for the purpose of aviation safety, if the Federal Aviation 
Administration, in consultation with EPA, determines that no safe and 
effective substitute has been developed and that such authorization is 
necessary for aviation safety purposes. Section 604(d)(1) provides that 
during the period from January 1, 2002 to January 1, 2005, EPA may, to 
the extent consistent with the Montreal Protocol, authorize the 
production of limited quantities of methyl chloroform solely for use in 
essential applications for which no safe and effective substitute is 
available. EPA cannot use any of these three exemptions to authorize 
any person to

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produce a class I substance in annual quantities greater than 10 
percent of that person's baseline. Section 604(g)(3) of the Act 
provides that EPA may, to the extent consistent with the Montreal 
Protocol, authorize the production of limited quantities of halon-1211, 
halon-1301, and halon-2402 after December 31, 1999 and before December 
31, 2004 for use in fire suppression and explosion prevention in 
association with domestic production of crude oil and natural gas 
energy supplies on the North Slope of Alaska, if EPA, in consultation 
with the U.S. Fire Administration, determines that no safe and 
effective substitute has been developed and that such authorization is 
necessary for fire suppression or explosion prevention purposes. EPA 
cannot use this exemption to authorize any person to produce any of 
these halons in an amount greater than 3 percent of that person's 
baseline. Finally, section 604(f) states that the President may, to the 
extent consistent with the Montreal Protocol, provide an exemption for 
production of CFC-114, halon-1211, halon-1301, and halon-2402 as 
necessary to protect U.S. national security interests, if the President 
finds that adequate substitutes are not available and that the 
production and use of the substance are necessary to protect national 
security interests.
    Since the Act does not specifically list laboratory uses as an 
exemption to the ban on production and consumption of class I 
substances, EPA cannot exempt CFCs and carbon tetrachloride for 
laboratory use after January 1, 2000. The exemptions for laboratory use 
of methyl chloroform and methyl bromide will cease on January 1, 2002, 
and January 1, 2005 respectively.
    Applicants should be aware that essential use exemptions granted to 
the U.S. for the year 2000 under the Protocol were limited to 
chlorofluorocarbons (CFCs) for metered dose inhalers (MDIs) to treat 
asthma and chronic obstructive pulmonary disease, and methyl chloroform 
for use in manufacturing solid rocket motors.
    The first step in the process to qualify a use as essential under 
the Protocol is for the user to consider 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. A full description of 
the application process is given in section II.
    Upon receipt of the essential use exemption application, EPA 
reviews the information provided and works with other interested 
Federal agencies to determine whether it meets the essential use 
criteria and warrants being nominated by the United States for an 
exemption. 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 of 
requests for CFCs 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 Technical and Economic 
Assessment Panel (TEAP) and its Technical Options Committees (TOCs), 
which review the submissions and make recommendations to the Parties 
for essential use 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 exemption from the production phaseout, EPA may 
propose regulatory changes to reflect the decisions by the Parties, but 
only to the extent such action is 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 production in 2001 and beyond will be considered by the 
Parties in 2000 for final action.

II. Information Required for Essential Use Applications for 
Production or Importation of Class I Substances in 2001 and 
Subsequent Years

    Through this notice, EPA requests applications for essential use 
exemptions for all Class I substances, except methyl bromide, for 2001 
and subsequent years. This is the last opportunity to submit 
applications for 2001; applicants will have an opportunity to submit 
applications for 2002 and beyond next year. All requests for exemptions 
submitted to EPA must present the information relevant to the 
application as prescribed in the TEAP ``Handbook on Essential Use 
Nominations'' (Handbook) as last published in 1997. The Handbook is 
available electronically on the web at www.teap.org. 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 requires 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 2000 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

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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 9, 1999.

Robert D. Brenner,
Acting Assistant Administrator, Office of Air and Radiation.
[FR Doc. 99-24046 Filed 9-14-99; 8:45 am]
BILLING CODE 6560-50-P