"(ii) any class II substance.
"(3) Class i substance.-The term `class I substance' means each
of the substances listed as provided in section 602(a).
"(4) Class ii substance.-The term `class II substance' means
each of the substances listed as provided in section 602(b).
"(5) Commissioner.-The term `Commissioner' means the
Commissioner of the Food and Drug Administration.
"(6) Consumption.-The term `consumption' means, with respect to
any substance, the amount of that substance produced in the
United States, plus the amount imported, minus the amount
exported to Parties to the Montreal Protocol. Such term shall be
construed in a manner consistent with the Montreal Protocol.
"(7) Import.-The term `import' means to land on, bring into, or
introduce into, or attempt to land on, bring into, or introduce
into, any place subject to the jurisdiction of the United States,
whether or not such landing, bringing, or introduction
constitutes 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 class 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
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.
"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