USA/1217
WTO/TBT
US Vereinigte Staaten von Amerika
2016-12-27
2016-11-07

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 exemption for anesthetic drugs fortopical use on accessible mucous membranes of humans where a cannula is used forapplication. FDA is proposing this action because these products are no longer beingmarketed in approved versions that contain ODSs and because alternative products thatdo not use ODSs are now available.

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