SEC. 601. DEFINITIONS.
  As used in this title- 
       (1)  Appliance.-   The term  "appliance" means  any device
     which contains and uses a class I or class II substance as a
     refrigerant and  which is  used for household  or commercial
     purposes,  including  any  air   conditioner,  refrigerator,
     chiller, or freezer.
       (2) Baseline year.-  The term "baseline year" means- 
            (A)  the calendar year 1986, in the case of any class
          I substance  listed  in Group  I  or II  under  section
          602(a),
            (B)  the calendar year 1989, in the case of any class
          I substance listed in Group III, IV, or V under section
          602(a), and
            (C) a representative  calendar year  selected by  the
          Administrator, in the case of- 
                 (i) any substance added  to the list of  class I
               substances  after the  publication of  the initial
               list under section 602(a), and
                 (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 Proto-
     col.  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 Commis-
          sioner; 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  (CFC0911). 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 "pro-
     duce",   "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 U.S.C. 7671]