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Allocation of Essential Use Allowances for Calendar Year 2005


EPA is issuing a final rule to exempt the production and import of chlorofluorocarbons (CFCs) for the manufacture of metered dose inhalers (MDIs) and other essential uses. Each year the Parties to the Montreal Protocol authorize import and production of specific quantities of class I ozone depleting substances (ODSs) for essential uses. Based on the amount authorized by the Parties, EPA then allocates essential use allowances for class I substances to U.S. companies through a rulemaking. Consistent with the CAA and the Montreal Protocol, essential uses for the United States are CFCs for use as propellant MDIs for treatment of asthma and chronic obstructive pulmonary disease.

The Parties approved the U.S. request of 1,902 metric tons of CFCs for 2005 at their fifteenth meeting in November 2003. EPA is allocating essential use allowances to specified pharmaceutical companies in the amount of 1,820.48 metric tons of CFCs for use in metered dose inhalers for 2005. This allocation is less than the amount approved by the Parties because the companies indicated that fewer allowances are needed for 2005 than they originally nominated two years prior. This final rule will be effective upon publication in the Federal Register.


In the early 1970s, researchers began to investigate the effects of various chemicals on the ozone layer. At that time it was determined that certain industrial chemicals, particularly chlorofluorocarbons (CFCs), were depleting stratospheric ozone, leading to increased biologically active ultraviolet light (called UVB) reaching the earth. Increased UVB reaching the earth can result in serious health effects such as skin cancer, cataracts and suppression of the immune system as well as harm crops, plastics and other materials and certain types of marine life.

Under the terms of the Protocol, as of January 1, 1996, developed countries, including the United States, were required to eliminate the production and importation of CFCs and other ODS for nearly all uses. However, in recognition that alternatives might not be available by that date for certain important products, the Parties established a process for exempting certain "essential uses" from the Protocol’s production and import bans.

Approval of essential use exemptions is based upon substantive criteria established under Decision IV/25 of the Montreal Protocol. Under these criteria, a use of a controlled substance should qualify as "essential" only if it is necessary for the health, safety or is critical for the functioning of society (encompassing cultural and intellectual aspects) and there are no available technical and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.

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