[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 1299 Introduced in Senate (IS)]







105th CONGRESS
  1st Session
                                S. 1299

   To limit the authority of the Administrator of the Environmental 
 Protection Agency and the Food and Drug Administration to ban metered-
                             dose inhalers.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 21, 1997

 Mr. Hutchinson (for himself and Mr. Inhofe) introduced the following 
 bill; which was read twice and referred to the Committee on Labor and 
                            Human Resources

_______________________________________________________________________

                                 A BILL


 
   To limit the authority of the Administrator of the Environmental 
 Protection Agency and the Food and Drug Administration to ban metered-
                             dose inhalers.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Asthma Inhaler Regulatory Relief 
Act''.

SEC. 2. LIMITATION ON AUTHORITY TO BAN METERED-DOSE INHALERS.

    Neither the Administrator of the Environmental Protection Agency 
nor the Commissioner of the Food and Drug Administration may prohibit 
the manufacture, distribution, or sale of metered-dose inhalers that 
use chlorofluorocarbons unless the Administrator of the Environmental 
Protection Agency and the Commissioner of the Food and Drug 
Administration jointly certify to the Congress that alternatives to 
such inhalers are available that, for all populations of users of such 
inhalers, are comparable in terms of safety and effectiveness, 
therapeutic indications, dosage strength, costs, and retail 
availability.

SEC. 3. MORATORIUM ON FURTHER RULEMAKING.

    The Commissioner of the Food and Drug Administration shall withdraw 
the March 6, 1997, advance notice of proposed rulemaking concerning 
chlorofluorocarbons in metered-dose inhalers and shall not issue any 
other proposal until after the 10th Meeting of the Parties to the 
Montreal Protocol on Substances That Deplete the Ozone Layer. Any 
subsequent proposal shall be in the form of an advance notice of 
proposed rulemaking and shall be initiated only after extensive 
consultations with patients, physicians, other health care providers, 
manufacturers of metered-dose inhalers, and other stakeholders.

SEC. 4. DEVELOPMENT OF STRATEGY.

    (a) In General.--Following the 10th meeting of Parties to the 
Montreal Protocol on Substances That Deplete the Ozone Layer, but not 
later than January 30, 1999, the Commissioner of the Food and Drug 
Administration shall publish a new advance notice of proposed 
rulemaking, setting forth the initial strategy for facilitating the 
transition in the United States to metered-dose inhalers that do not 
use chlorofluorocarbons.
    (b) Obligations Under Montreal Protocol.--The initial strategy 
developed under subsection (a) shall be submitted by the Secretary of 
State to the Montreal Protocol Secretariat by January 31, 1999, to 
fulfill United States obligations under the Montreal Protocol decision 
IX/14.
                                 <all>