Environmental Protection Agency (EPA).
Notice.
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
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.
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).
Jeremy Arling at the addresses above, by telephone at (202) 343–9055, or by email at
The Parties to the
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.
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.
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.
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
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