What are the U.S. Government’s obligations under the Montreal Protocol?
The United States is a party to the treaty, and as such, has agreed to phase out production and importation of ODSs, including CFCs, according to the timetables agreed to by the participating countries, including the United States. Congress amends the Clean Air Act (CAA) in 1990 in response to the Montreal Protocol, and the CAA and its implementing regulations call on HHS/FDA to determine which uses of ODSs in medical products remains essential. HHS/FDA does that in 21 CFR 2.125(e). If there have been alternatives to albuterol MDIs containing ODSs for several years, why did HHS/FDA not act sooner? There are many reasons for this. One of the criteria for beginning the process of finding a drug to no longer be an essential use of CFCs is that there must be adequate post-marketing experience with the alternative(s). Ventolin HFA, the second product necessary for beginning this process for albuterol, only began marketing in 2002. HHS/FDA believed it needed to allow at least a year prior to
