[Federal Register Volume 65, Number 212 (Wednesday, November 1, 2000)]
[Notices]
[Pages 65311-65313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28009]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-6894-7]


Request for Applications for Essential Use Exemptions to the 
Production and Import Phaseout of Ozone Depleting Substances Under the 
Montreal Protocol for the Years 2002 and 2003

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 Thirteenth Meeting 
of the Parties to the Montreal Protocol on Substances that Deplete the 
Ozone Layer (the Protocol) to be held in 2001, for exemptions to the 
production and import phaseout in 2002 and 2003 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 December 1, 2000 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 two copies of application materials to: Erin Birgfeld, 
Stratospheric Protection Division (6205J), Environmental Protection 
Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460. If 
submitting applications by courier, the office address is 501 3rd 
Street, NW, Washington, DC 20001. Send one copy of your application 
materials to: Air Docket A-93-39, 401 M Street, SW, (6102), Room M1500, 
Washington, DC 20460.
    Confidentiality: Applications should not contain confidential or 
proprietary information. Such confidential information should be 
submitted under separate cover and be clearly identified 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 2002 and 2003

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; 63 FR 42629, August 10, 1998; and 64 FR 50083 , September 15, 
1999), the Parties to the Protocol agreed during the Fourth Meeting in 
Copenhagen on November 23-25, 1992, to accelerate the phase-out 
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 (under 
40 CFR 82, Subpart A), except methyl bromide, by January 1, 1996.

[[Page 65312]]

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. 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. * * *''
    Applicants should be aware that essential use exemptions granted to 
the U.S. for the year 2001 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 obtaining essential use allowances 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. 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 
such as for MDIs, 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 for MDIs is to determine that the 
aggregate request for a particular future year adequately reflects the 
total market need for CFC MDIs and expected availability of CFC 
substitutes by that point in time. If the sum of individual requests 
does not account for such factors, 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 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 and consumption 
phaseout, EPA may propose regulatory changes to reflect the decisions 
by the Parties, but only to the extent such action is consistent with 
the Clean Air Act (CAA or Act).
    The timing of this process is such that in any given year the 
Parties review nominations for essential use exemptions from the 
production and consumption phaseout intended for the following year and 
subsequent years. This means that, if nominated, applications submitted 
in response to today's notice for an exemption in 2002 and 2003 will be 
considered by the Parties in 2001 for final action.
    The quantities of controlled ODSs that are requested in response to 
this notice, if approved by the Parties to the Montreal Protocol in 
2001, will then be allocated as essential-use allowances (EUAs) to the 
specific U.S. companies through notice and comment rulemaking. EUAs for 
the year 2002 will be allocated to U.S. companies at the end of 2001, 
and EUAs for the year 2003 will be made at the end of 2002.
    Each year the Parties to the Protocol have approved an unlimited, 
global essential use exemption for the production and consumption of 
high purity class I ODSs for laboratory and analytical uses. Prior to 
the year 2000, EPA implemented this exemption domestically through 
regulation. As discussed in last year's notice requesting applications 
for essential use allowances (64 FR 50083), in the year 2000 and 
beyond, the Clean Air Act does not specifically list an exemption for 
laboratory and analytical uses of class I ODSs. EPA is issuing a 
separate rulemaking later in the year which will clarify this issue 
further. Until then, current stocks of class I ODSs that are already in 
the U.S. can continue to be sold for laboratory and analytical uses.

II. Information Required for Essential Use Applications for 
Production or Importation of Class I Substances in 2002 and 2003

    Through this notice, EPA requests applications for essential use 
exemptions for all Class I substances, except methyl bromide, for 2002 
and 2003. This is the last opportunity to submit applications for 2002. 
Companies will have an opportunity to submit supplemental or amended 
applications for 2003 next year. All requests for exemptions submitted 
to EPA must present information as prescribed in the TEAP ``Handbook on 
Essential Use Nominations'' (Handbook) as last published in 1997. You 
can request a Handbook from the Stratospheric Protection Hotline at 
(301) 614-3990 or (800) 296-1996. It is also available electronically 
on the web at www.teap.org. 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.
    In order to gain more complete information from essential use 
applicants for CFC MDIs, EPA is requesting more detailed information in 
the EUA applications. First, we ask that in the case of EUA 
applications requesting CFCs for multiple pharmaceutical companies 
(e.g. International Pharmaceutical Aerosol Consortium), the application 
make clear the amount of CFCs requested for each member company. 
Second, all essential use application for CFCs for MDIs should provide 
a breakdown of the quantity of CFCs necessary for each drug to be 
produced using the EUA. This detailed breakdown of EUAs will allow EPA 
and FDA to make more informed decisions on the amount of CFC to be 
nominated by the U.S. government for the years 2002 and 2003.
    Third, we request that all New Drug Application holders (NDA 
holders or sponsors) be engaged in the essential use application 
process for the year 2003 and beyond. We know of sponsor companies 
whose CFC MDI is produced by another company (the contract filler). In 
the past, EPA has accepted essential use applications submitted by the 
contract filler, in the absence sufficient information on the NDA 
holder's reformulation efforts. Therefore, EPA is

[[Page 65313]]

requesting that for the year 2003 and beyond, all NDA holders for MDIs 
to be produced using EUAs, submit an application to EPA for EUAs as 
specified in this notice. Please note, EPA will also consider 
applications submitted jointly by contract fillers. In the case where a 
contract filler produces a portion of an NDA holder's CFC MDIs, the 
contract filler and the NDA holder should work together to determine 
the total amount of CFCs necessary to produce the NDA holder's entire 
product line of CFC MDIs. The NDA holder should also provide an 
estimate of how the CFCs would be split between the contract filler and 
the NDA holder in the allocation year. This estimate will be used only 
as a basis for determining the nomination amount, and may be adjusted 
prior to allocation of EUAs.
    Since the U.S. government can 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). The accounting framework matrix in the Handbook titled 
``Table IV: Reporting Accounting Framework for Essential Uses Other 
Than Laboratory and Analytical'' requests data for the year 2000 on the 
amount of ODS exempted for an essential use, the amount acquired by 
production, the amount acquired by import, the amount on hand at the 
start of the year, the amount available for use in 2000, the amount 
used for the essential use, the quantity contained in exported 
products, the amount destroyed, and the amount on hand at the end of 
the year. Because the data necessary to complete Table IV will not be 
available until after January 1, 2001, companies should not include 
this chart with their EUA applications in response to this notice. EPA 
plans to send letters to each essential use applicant requesting the 
information in Table IV in the first 2 weeks of January 2001. Companies 
will have only fourteen days in which to respond since EPA must compile 
companies' responses to complete the U.S. CFC Accounting Framework for 
submission to the Parties to the Montreal Protocol by the end of 
January.
    EPA anticipates that the 2001 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 health care providers of the CFC 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, 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: October 25, 2000.
Robert Perciasepe,
Assistant Administrator, Office of Air and Radiation.
[FR Doc. 00-28009 Filed 10-31-00; 8:45 am]
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