[Federal Register Volume 66, Number 215 (Tuesday, November 6, 2001)]
[Notices]
[Pages 56102-56104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27839]
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ENVIRONMENTAL PROTECTION AGENCY
[FRL-7098-4]
Request for Applications for Essential Use Exemptions to the
Production and Import Phaseout of Ozone Depleting Substances under the
Montreal Protocol for the years 2003 and 2004
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: Through this notice, the Environmental Protection Agency (EPA)
is requesting applications for essential use allowances for calendar
years 2003 and 2004. Essential-use allowances provide exemptions to the
production and import phaseout of ozone-depleting substances and must
be authorized by the Parties to the Montreal Protocol on Substances
that Deplete the Ozone Layer (the Protocol). The U.S. government will
use the applications received in response to this notice as the basis
for its nomination of essential use allowances at the Fourteenth
Meeting of the Parties to the Protocol to be held in 2002.
DATES: Applications for essential use exemptions must be submitted to
EPA no later than December 6, 2001 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,
Global Programs Division (6205J), Environmental Protection Agency, 1200
Pennsylvania Avenue, NW., Washington, DC 20460. For applications sent
via courier service, use the direct mailing address at 501 3rd Street,
NW., Washington, DC 20001. Send one copy of the non-confidential
application materials to: Air Docket A-93-39, 401 M Street, SW. (6102),
Room M1500, Washington, DC 20460.
Confidentiality: Applications that are sent to the Air Docket
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 protection website at www.epa.gov/ozone.
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 2003 and 2004
I. Background--The Essential Use Nomination Process
As described in previous Federal Register (FR) notices,\1\ the
Parties to the Protocol agreed during the Fourth Meeting in Copenhagen
in 1992 on 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.
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\1\ 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; 64 FR 50083,
September 15, 1999; and 65 FR 65377, November 1, 2000.
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Paragraph 1(a) of 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 * * *'' Decision XII/2 taken at the twelfth meeting of the
Parties states that any CFC MDI product approved after December 31,
2000 is non-essential unless the product meets the criteria in Decision
IV/25 paragraph 1(a).
The first step in obtaining essential use allowances is for the
user to
[[Page 56103]]
consider whether the use of the controlled substance meets the criteria
of Decisions IV/25 and XII/2. 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 the Protocol. 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). Applicants should be aware that
essential use exemptions granted to the U.S. for the year 2002 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 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 2003 and 2004 will be
considered by the Parties in 2002 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
2002, will then be allocated as essential-use allowances (EUAs) to the
specific U.S. companies through notice and comment rulemaking. EUAs for
the year 2003 will be allocated to U.S. companies at the end of 2002,
and EUAs for the year 2004 will be allocated at the end of 2003.
With Decision X/19 the Parties approved an unlimited, global
essential use exemption for the production and consumption of high
purity class I ODSs for essential laboratory and analytical uses
through the year 2005. More recently, with Decision XI/15, the Parties
eliminated three laboratory methods from the global exemption by
declaring them to be non-essential beginning January 1, 2002. These
methods are: testing of oil and grease and total petroleum hydrocarbons
in water, testing of road-paving materials, and forensic finger
printing. EPA will be proposing a regulation to implement Decision XI/
15 in the near future.
II. Information Required for Essential Use Applications for
Production or Importation of Class I Substances in 2003 and 2004
Through this notice, EPA requests applications for essential use
exemptions for all class I substances, except methyl bromide, for
calendar years 2003 and 2004. This is the last opportunity to submit
new or revised applications for 2003. Companies will have an
opportunity to submit supplemental or amended applications for 2004
next year. All requests for exemptions submitted to EPA must present
information as prescribed in the updated version of the TEAP ``Handbook
on Essential Use Nominations'' (Handbook) published in June 2001. The
handbook is available electronically on the web at www.teap.org, or at
www.epa.gov/ozone.
In brief, the TEAP Handbook states that applicants must present
information on:
role of use in society;
alternatives to use;
steps to minimize use;
steps to minimize emissions;
recycling and stockpiling;
quantity of controlled substances requested; and
approval date and indications (for MDIs)
In submitting request for EUAs, EPA requires that applicants
requesting EUAs for multiple pharmaceutical companies (e.g.,
International Pharmaceutical Aerosol Consortium), make clear the amount
of CFCs requested for each member company. Also, all essential use
applications for CFCs must provide a breakdown of the quantity of CFCs
necessary for each MDI product to be produced. This detailed
information will allow EPA and FDA to make informed decisions on the
amount of CFC to be nominated by the U.S. government for the years 2003
and 2004.
There are some companies that hold New Drug Applications for CFC
MDIs but whose MDI products are manufactured by another company (the
contract filler). Beginning with this application cycle, all NDA
holders for CFC MDI products produced in the U.S. must submit a
complete application for essential use allowances either on their own
or in conjunction with their contract filler. In the case where a
contract filler produces a portion of an NDA holder's CFC MDIs, the
contract filler and the NDA holder must determine the total amount of
CFCs necessary to produce the NDA holder's entire product line of CFC
MDIs. The NDA holder should 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 cannot 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 45).
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 2001 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 2001, 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 2001. Because the data necessary
to complete Table IV will not be available until after January 1, 2002,
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 2002. Companies will have only fourteen days in which
to respond since EPA must compile
[[Page 56104]]
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 2002 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 should submit their exemption requests to EPA as noted
in the Addresses section at the beginning of today's notice.
Dated: October 29, 2001.
Robert D. Brenner,
Acting Assistant Administrator, Office of Air and Radiation.
[FR Doc. 01-27839 Filed 11-5-01; 8:45 am]
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