104 STAT. 2650 PUBLIC LAW 101-549—NOV. 15, 1990 stitutes an importation within the meaning of the customs laws of the United States. "(8) MEDICAL DEVICE. —The term 'medical device' means any device (as defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic product, drug (as defined in the Federal Food, Drug, and Cosmetic Act), and drug delivery system— "(A) if such device, product, drug, or drug delivery system utilizes a class I or clsiss II substance for which no safe and effective alternative has been developed, and where necessary, approved by the Commissioner; and "(B) if such device, product, drug, or drug delivery system, has, after notice and opportunity for public comment, been approved and determined to be essential by the Commissioner in consultation with the Administrator. "(9) MONTREAL PROTOCOL.— The terms 'Montreal Protocol' and 'the Protocol' mean the Montreal Protocol on Substances that Deplete the Ozone Layer, a protocol to the Vienna Convention for the Protection of the Ozone Layer, including adjustments adopted by Parties thereto and amendments that have entered into force. "(10) OZONE-DEPLETION POTENTIAL. —The term 'ozone-depletion potential' means a factor established by the Administrator to reflect the ozone-depletion potential of a substance, on a mass per kilogram basis, as compared to chlorofluorocarbon-11 (CFC-11). Such factor shall be based upon the substance's atmospheric lifetime, the molecular weight of bromine and chlorine, and the substance's ability to be photolytically disassociated, and upon other factors determined to be an accurate measure of relative ozone-depletion potential. "(11) PRODUCE, PRODUCED, AND PRODUCTION. — The terms 'produce', 'produced', and 'production', refer to the manufacture of a substance from any raw material or feedstock chemical, but such terms do not include— "(A) the manufacture of a substance that is used and entirely consumed (except for trace quantities) in the manufacture of other chemicals, or "(B) the reuse or recycling of a substance. 42 USC 7671a. "SEC. 602. LISTING OF CLASS I AND CLASS II SUBSTANCES. "(a) LIST OF CLASS I SUBSTANCES.— Within 60 days after enactment of the Clean Air Act Amendments of 1990, the Administrator shall publish an initial list of class I substances, which list shall contain the following substances: Group I chlorofluorocarbon-ll (CFC-11) chloronuorocarbon-12 (CFC-12) chlorofluorocarbon-113 (CFC-113) chlorofluorocarbon-114 (CFC-114) chlorofluorocarbon-115 (CFC-115) Group II halon-1211 halon-1301 halon-2402 Group III chlorofluorocarbon-13 (CFC-13) chlorofluorocarbon-lll (CFC-111) chlorofluorocarbon-112 {CFC-112)
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