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.

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 birgfeld.erin@epa.gov. 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. 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 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.