01-27839. 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.

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 [phone] telephone, [phone] fax, or [e-mail]. 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.

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 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 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.

Footnotes

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.