Ozone-depleting substances. Medical equipment (ICS: 11.040), Air quality (ICS: 13.040), Aerosol containers (ICS: 55.130), Products of the chemical industry (ICS: 71.100)

Use of Ozone- Depleting Substances (5 pages, in English)

The Food and Drug Administration (FDA, the Agency, or we) isproposing to amend its regulation on uses of ozone-depleting substances (ODSs), includingchlorofluorocarbons (CFCs), to remove the designation for certain products as "essentialuses" under the Clean Air Act. Essential-use products are exempt from the ban by FDA onthe use of CFCs and other ODS propellants in FDA-regulated products and from the ban bythe Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers.This action, if finalized, will remove the essential-use exemptions for sterile aerosol talcadministered intrapleurally by thoracoscopy for human use and for metered-dose atropinesulfate aerosol human drugs administered by oral inhalation. FDA is proposing this actionbecause alternative products that do not use ODSs are now available and because theseproducts are no longer being marketed in versions that contain ODSs.