Use of Ozone-Depleting Substances; Essential-Use Determinations

The Food and Drug Administration (FDA) is amending its regulation on the use of chlorofluorocarbon (CFC) propellants in self- pressurized containers to make it consistent with other laws. FDA is setting the standard it will use to determine which FDA-regulated products that utilize an ozone-depleting substance (ODS) are essential under the Clean Air Act. Under the Clean Air Act, FDA, in consultation with the Environmental Protection Agency (EPA), is required to determine whether an FDA-regulated product that utilizes an ODS is essential. FDA is also removing current essential-use designations for products no longer marketed and for metered-dose steroid human drugs for nasal inhalation. FDA will add or remove specific essential-use designations for other products by engaging in separate notice-and-comment rulemaking.