Federal Register - "Use of Ozone-Depleting Substances"

Title: Use of Ozone-Depleting Substances Source: Federal Register Data/Action: Health and Human Services Department (Final Rule) Date: 10/26/2016 Text Preview: ...propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers... ...EPA for applications for exemptions (60 FR 54349, October 23, 1995). Firms that wish to use ODSs manufactured after the phase-out date in medical devices (as defined in section 601(8) of the Clean Air Act) (42 U.S.C. 7671(8)) covered under section 610 of the Clean Air Act (42 U.S.CC. 7671i) must receive exemptions for essential uses under the Montreal Protocol. EPA regulations implementing the provisions of section 610 of the Clean Air Act contain a general ban on the use of ODSs in pressurized dispensers, such as metered-dose inhalers (MDIs) (40 CFR 82.64(c) and 82.66(d)). These EPA... ...to be essential by the Commissioner in consultation with the Administrator of EPA. Class I substances include CFCs, halons, carbon tetrachloride, methyl chloroform...