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Statement of Need: Chlorofluorocarbons (CFCs) are organic compounds that contain carbon, chlorine, and fluorine atoms. CFCs were first used commercially in the early 1930's and were later found to be useful as propellants in self-pressurized aerosol products, such as MDIs. CFCs are very stable in the troposphere--the lowest part of the atmosphere. They move to the stratosphere, a region that begins about 10-16 kilometers (km) (6-10 miles) above Earth's surface and extends up to about 50 km (31 miles) altitude. Within the stratosphere there is a zone about 15-40 km (10-25 miles) above the Earth's surfaces in which ozone is relatively highly concentrated. The zone in the stratosphere is generally called the ozone layer. Once in the stratosphere, CFCs are broken down by strong ultraviolet light, where they release chlorine atoms that then deplete stratospheric ozone. Depletion of stratospheric ozone by CFCs and other ODS will lead to higher UVB levels, which in turn will cause increased skin cancers and cataracts and potential damage to some marine organisms, plants, and plastics. The link between CFCs and the depletion of stratospheric ozone was discovered in the mid-1970's. Since 1978, the U.S. government has pursued a consistent policy of limiting the production and use of ODS, including CFCs.

Summary of the Legal Basis: The Clean Air Act and EPA's implementing regulations contain general prohibitions on the use and manufacture of ODS, such as CFCs. Exceptions to these bans are provided for specific medical products that FDA, in consultation with EPA, has found to be essential. FDA's essential use determinations have been contained in 21 CFR section 2.125. FDA published a new 21 CFR section 2.125 in the Federal Register on July 24, 2002 (67 FR 48370), (corrected in the Federal Registers of July 30, 2002 (67 FR 49396), and September 17, 2002 (67 FR 58678)). Section 2.125 provides criteria for determining when a use is essential and when a use is no longer essential. The procedures to determine when a use is no longer essential were implemented to better carry out responsibilities under both the Clean Air Act and the Montreal Protocol on Substances that Deplete the Ozone Layer, (September 16, 1987, S. Treaty Doc. No. 10, 100th Cong., 1st sess., 26 I.L.M. 1541 (1987)). Fran Du Melle, Executive Vice President of the American Lung Association, submitted a citizen petition on behalf of the U.S. Stakeholders Group on MDI Transition on January 29, 2003 (Docket No. 03P-0029/CP1). The petition requested that FDA initiate rulemaking to remove the essential use designation of albuterol MDIs. After evaluating the petition, comments submitted in response to the petition, and other information, FDA has tentatively determined that albuterol MDIs meet the criteria in section 2.125, and proposed a rule to remove other essential-use designations.

Alternatives: In the proposed rule, FDA specifically requested comments on the best effective date for any final rule to remove the essential use status of albuterol MDIs. FDA is considering which dates will allow manufacturers to obtain the capacity to produce adequate numbers of non-ODS albuterol MDIs. FDA is also considering which dates might minimize any financial burden on patients who would have to switch to non-ODS albuterol MDIs.

Anticipated Costs and Benefits: The expected benefit from this rulemaking, as part of an overall policy to eliminate production and use of ODSs, is the preservation of the Earth's stratospheric ozone. Currently there are generic versions of ODS albuterol MDIs, while there are no generic non-ODS albuterol MDIs. This rulemaking could force patients to switch from lower-priced generic versions of ODS albuterol MDIs to higher-priced non-ODS albuterol MDIs.

Risks: FDA is concerned about the possibility that some patients might stop using needed drugs because the prices of non-ODS albuterol MDIs might be higher than those of ODS albuterol MDIs.