Allocation of Essential Use Allowances for Calendar Year 2009
- In accordance with the Montreal Protocol on Substances that Deplete the Ozone Layer and the Clean Air Act, EPA is allocating essential use allowances to permit U.S. companies to obtain limited quantities of certain ozone-depleting substances (ODSs) that have been phased out of production.
- This action allocates essential use allowances for chlorofluorocarbons (CFCs) to U.S. pharmaceutical companies for the manufacture of metered-dose inhalers (MDIs) for the treatment of asthma and chronic obstructive pulmonary disease.
- Based on the Food and Drug Administration’s (FDA) determination of the quantity of CFC necessary for use in MDIs for 2009, EPA is allocating 63.0 Metric Tons of CFCs to Armstrong Pharmaceuticals, Inc.
- Essential use allowances enable a person to obtain a controlled class I ODS as part of an exemption to the regulatory ban on the production and import of these chemicals, which became effective on January 1, 1996.
- Under the Montreal Protocol, exemptions may be granted for uses that are determined by the Parties to be "essential." Decision IV/25, taken by the Parties to the Protocol in 1992, established criteria for determining whether a specific use should be approved as essential, and set forth the international process for making determinations of essentiality.
- EPA allocates essential use allowances for exempted production or import of a specific quantity of a class I ODS solely for the designated essential purpose.
For Further Information
to EPA's page on essential use of CFCs for metered dose inhalers.