Environmental Protection Agency (EPA).
Notice.
Through this notice, the Environmental Protection Agency (EPA) is requesting applications for consideration at the Thirteenth Meeting of the Parties to the
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.
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.
Erin Birgfeld at the above address or at (202) 564–9079 telephone, (202) 565–2095 fax, or
As described in previous
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.
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
• 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 (
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
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