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International and Clean Air Act Information Regarding the U.S.
Elimination of the Use of Ozone-Depleting Substances, Including Chlorofluorocarbons
The United States has banned the general use of Chlorofluorocarbons (CFCs) in consumer aerosols for decades, and eliminated the manufacture of CFCs in
the United States as of January 1, 1996, except for certain limited uses. The Montreal
Protocol permits continued production or importation of CFCs for use in essential medical
products upon approval by the Parties (i.e., signatory countries) to the Montreal
Protocol. As required by the Clean Air Act (CAA), FDA makes determinations of essentiality
in consultation with the Environmental Protection Agency (EPA). Once a determination of
essentiality is made, the United States, through EPA, applies annually to the Parties to
the Montreal Protocol for a specific CFC production allowance. The United States has
secured essential-use exemptions for the use of CFCs in Metered-Dose Inhalers (MDIs) and
will continue to work to obtain these exemptions for the future.
The FDA will continue to support essential-use exemptions for the use of
CFCs in MDIs for the treatment of lung diseases until non-ODS products adequately serve
the needs of patients who depend on these products. As manufacturers develop new,
technologically feasible alternatives to ODS products and the non-ODS products prove to be
medically acceptable alternatives, ODS production and importation for these products will
be eliminated in accordance with the terms of the CAA and the Montreal Protocol. The
United States will then no longer request essential-use allowances from the Parties to the
Montreal Protocol for these non-essential uses.
Additional information about the Montreal Protocol, the Clean Air Act, and
EPA nominations is available through the links below.
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The Montreal Protocol and its amendments
The full text of the Montreal Protocol and its amendments can be
read here. The United States is a signatory to the Montreal Protocol and has agreed to
follow its terms. The Montreal Protocol requires the eventual elimination of the use of
CFCs.
- Technology and Economic
Assessment Panel (TEAP) from theUnited Nations
Environment Programme, Ozone Secretariat. TEAP provides, at the
request of Parties, technical information related to the
alternative technologies that have been investigated and employed
to make it possible to virtually eliminate use of Ozone Depleting
Substances (CFCs, Halons etc.), that harm the ozone layer.
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EPA Web site on CFC use EPA information regarding the move away from the use
of ozone-depleting substances. Specific information regarding MDIs is also available here.
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Date created: March 31, 2005 |
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