Document ID: EPA_FRDOC_0001-15771
Agency: epa
Document Type: Notice
Title: Draft Guidance for Industry and Staff: Protection of Stratospheric Ozone; Essential Use Exemption Applications
Posted Date: 2014-06-06T04:00Z

[Federal Register Volume 79, Number 109 (Friday, June 6, 2014)]
[Notices]
[Pages 32728-32729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13235]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9911-77-OAR]

Protection of Stratospheric Ozone: Request for Applications for 
Essential Use Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In this notice, the Environmental Protection Agency (EPA) is 
providing information about the process for submitting applications for 
essential use exemptions. Essential use exemptions are exceptions to 
the phaseout of production and import of controlled class I ozone-
depleting substances (ODS). Essential use exemptions must be authorized 
by the Parties to the Montreal Protocol on Substances That Deplete the 
Ozone Layer and must be in accordance with the Clean Air Act. 
Applications received in accordance with this notice will be considered 
as the basis for submitting potential nominations for essential use 
exemptions to future Meetings of the Parties to the Montreal Protocol.

DATES: Applications for essential use exemptions must be submitted to 
EPA no later than September 30 of each year, in order for the U.S. 
Government to complete its consideration for nomination to the United 
Nations Environment Programme and the Parties to the Montreal Protocol 
in a timely manner.

ADDRESSES: Send application materials to: Essential Use Exemption 
Coordinator, Stratospheric Protection Division (6205J), U.S. 
Environmental Protection Agency, 1200 Pennsylvania Avenue NW., 
Washington, DC 20460.
    Confidentiality: Application materials that are confidential should 
be submitted under separate cover and be clearly identified as 
``confidential business information.'' Information covered by a claim 
of business confidentiality will be treated in accordance with the 
procedures for handling information claimed as confidential under 40 
CFR part 2, subpart B, and will be disclosed only to the extent and by 
means of the procedures set forth in that subpart. 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: Jeremy Arling at the addresses above, 
by telephone at (202) 343-9055, or by email at arling.jeremy@epa.gov. 
Information about essential uses may be obtained from EPA's 
stratospheric protection Web site at www.epa.gov/ozone/title6/exemptions/essential.html.

SUPPLEMENTARY INFORMATION:

I. Background on the Essential Use Exemption

    The Parties to the Montreal Protocol on Substances that Deplete the 
Ozone Layer (Montreal Protocol) agreed during the Fourth Meeting in 
Copenhagen in 1992 that non-Article 5 Parties (developed countries) 
would phase out the production and consumption of halons by January 1, 
1994, and phase out the production and consumption of other substances 
referred to under the Clean Air Act as class I substances, except 
methyl bromide, by January 1, 1996. The control measures for many of 
these substances, however, allow exemptions from the phaseout ``to the 
extent the Parties decide to permit the level of production or 
consumption that is necessary to satisfy uses agreed by them to be 
essential.'' See, e.g. art. 2A para 4. The Parties also decided on the 
criteria to be used for allowing ``essential use'' exemptions from the 
phaseout of production and import 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.
    Paragraph 1(a) of Decision IV/25 states that ``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, Paragraph 1(b) of Decision IV/25 states 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 . . .''
    The Clean Air Act in section 604 contemplates exemptions from the 
phaseout of Class I controlled substances in the United States, 
including exemptions for essential uses.\1\ The Clean Air Act sets 
sunset dates for three of these uses that are now in the past: (1) 
Methyl chloroform use generally (ending January 1, 2005); (2) halons 
for fire suppression and explosion prevention generally (ending 
December 31, 1999); and (3) halons for fire suppression and explosion 
prevention for oil production on the North Slope of Alaska (ending 
December 31, 2004). Two other uses do not have statutory sunset dates: 
(1) Class I substances for medical devices (section 604(d)(2)), and (2) 
halons for aviation safety (section 604(d)(3)). Each of these

[[Page 32729]]

provisions has its own criteria and process that must be followed; no 
exceptions are automatic.
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    \1\ This notice does not address all exemptions in section 604 
such as the exemptions for critical uses, sanitation and food 
protection, or national security.
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    Prior essential use applications were typically for 
chlorofluorocarbons (CFCs) for metered dose inhalers (MDIs). The 
Parties last authorized an essential use exemption for the United 
States allowing the production of CFCs for MDIs in 2008 for the 2010 
calendar year. Effective December 31, 2013, all CFC-containing MDIs 
have been removed from the Food and Drug Administration's (FDA's) list 
of essential uses found at 21 CFR 2.125(e). The United States has not 
nominated halons for aviation safety as an essential use. If EPA were 
to receive an application for halons for aviation safety, EPA would 
work with other relevant Federal agencies to establish the process for 
reviewing applications for this use.

II. Essential Use Nomination Process

    Entities requesting essential use exemptions should send a 
completed application to EPA on the candidate use by September 30, 
three years prior to the year of the intended use. Upon receipt of 
applications, EPA will review the information and work with other 
interested Federal agencies as required in section 604 of the Clean Air 
Act to determine whether the candidate use satisfies Clean Air Act 
requirements, as well as whether it meets the essential use criteria 
adopted by the Parties to the Montreal Protocol and warrants nomination 
by the United States for an exemption.
    All Parties, including the United States, must transmit nominations 
to the UNEP Ozone Secretariat by January 31 to be considered by the 
Parties at their annual meeting at the end of that year. The UNEP Ozone 
Secretariat forwards nominations to the Montreal Protocol's Technical 
and Economic Assessment Panel (TEAP) and its relevant Technical Options 
Committee (TOC). The TOC and the TEAP review the nomination to 
determine whether it meets the criteria for an essential use 
established by Decisions IV/25, XII/2, XV/5, and XVI/12, and to make 
recommendations to the Parties for essential use exemptions. The 
Parties then consider those recommendations at their annual meeting 
before making a final decision.
    An essential use exemption is granted to the nominating Party for a 
specific quantity of a specified ODS for a specific time period. If the 
Parties determine that a specified use of a controlled substance is 
essential and authorize an exemption from the Protocol's production and 
consumption phaseout, EPA may then take domestic action to allow the 
production and consumption to the extent consistent with the Clean Air 
Act.

III. Information Required for Essential Use Applications

    In the past, EPA had annually issued a notice requesting 
applications for essential use exemptions. Through this action, EPA 
provides the opportunity to submit applications for essential use 
exemptions for class I substances for all future control periods 
(calendar years). Applications requesting essential use allowances 
should include information that U.S. Government agencies and the 
Parties to the Protocol can use to evaluate the candidate use according 
to the criteria in the Decisions described above. Applications that 
fail to include sufficient information may not be nominated.
    Specifically, all applications submitted to EPA should include the 
information requested in the current version of the TEAP Handbook on 
Essential Use Nominations, which as of the date of this notice was last 
updated in 2009. The handbook is available electronically on the 
internet at http://ozone.unep.org/teap/Reports/TEAP_Reports/EUN-Handbook2009.pdf. EPA requests that applications contain the following 
information, as described in the handbook, in order for the U.S. to 
provide sufficient information to the Montreal Protocol's technical 
review bodies within the nomination:
    1. A detailed description of the use that is the subject of the 
nomination;
    2. Details of the type, quantity, and quality of the controlled 
substance that is requested to satisfy the use;
    3. The period of time and the annual quantities of the controlled 
substances that are requested;
    4. An explanation of why the nominated volumes and the intended use 
of these quantities are necessary for health and/or safety, or critical 
for the functioning of society;
    5. An explanation of what other alternatives and substitutes are 
currently available and what steps are being taken to implement those 
alternatives and substitutes;
    6. An explanation of why alternatives and substitutes are not 
sufficient or appropriate to eliminate the proposed use;
    7. A description of the measures that are proposed to eliminate all 
unnecessary emissions, including design considerations and maintenance 
procedures;
    8. An explanation of what efforts are being undertaken to employ 
other measures for this application in the future;
    9. A description of the efforts that have been made to acquire 
stockpiled or recycled controlled substance for this application both 
domestically and internationally as well as an explanation of what 
efforts have been made to establish banks for the controlled substance; 
and
    10. A description of any other barriers encountered in attempts to 
eliminate the use of the controlled substance for this application.
    In addition, applicants should specify which exemption in CAA 
section 604 they are seeking: the exemption for medical devices at 
section 604(d)(2) or the exemption for aviation safety at section 
604(d)(3). Each of these statutory exemptions has its own process and 
criteria that would need to be satisfied prior to any regulatory action 
authorizing the exemption.
    The Office of Management and Budget (OMB) has approved the 
information collection requirements contained in this notice under the 
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and 
has assigned OMB control number 2060-0170.

    Dated: May 30, 2014.
Paul Gunning,
Acting Director, Office of Atmospheric Programs.
[FR Doc. 2014-13235 Filed 6-5-14; 8:45 am]
BILLING CODE 6560-50-P