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Essential Uses of CFCs for Metered-Dose Inhalers

Under the Montreal Protocol on Substances that Deplete the Ozone Layer, the production and consumption of most Class I ozone depleting substances has been banned for decades. The Parties provided an exemption for “Essential Uses” in Decision IV/25. That decision states:    

Use of a controlled substance should qualify as ‘essential’ only if:
  1. it is necessary for the health, safety or is critical for the functioning of society (encompassing cultural and intellectual aspects); and
  2. there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.
In addition production and consumption, if any, of a controlled substance, for essential uses should be permitted only if:
  1. all economically feasible steps have been taken to minimize the essential use and any associated emission of the controlled substance; and
  2. the controlled substance is not available in sufficient quantity and quality from the existing stocks of banked or recycled controlled substances. . .
In the past, the United States received annual exemptions for chlorofluorocarbons (CFCs) for metered-dose inhalers (MDIs) for treatment of asthma and chronic obstructive pulmonary disease (COPD). Today, all former essential uses have transitioned to ozone-safe alternatives. Additional information on the transition to ozone-safe MDIs can be found here: The Clean Air Act still allows limited uses to qualify for the essential uses exemption if those uses meet the Montreal Protocol criteria above. Information on how to apply for an essential use exemption can be found in this Federal Register notice published June 6, 2014.


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