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           "(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

   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.

"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

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