[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5488 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 5488

 To amend the Federal Food, Drug, and Cosmetic Act to provide the Food 
 and Drug Administration with authority to recall food when there is a 
    reasonable basis for believing that the food is adulterated and 
        presents a risk to human health, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           September 26, 2002

 Mr. Pallone introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Food, Drug, and Cosmetic Act to provide the Food 
 and Drug Administration with authority to recall food when there is a 
    reasonable basis for believing that the food is adulterated and 
        presents a risk to human health, and for other purposes.

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

SECTION 1. FOOD RECALL AUTHORITY FOR FOOD AND DRUG ADMINISTRATION.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following section:

                           ``recall authority

    ``Sec. 416. (a) Order to Cease Distribution.--
            ``(1) In general.--If the Secretary determines that there 
        is a reasonable basis for believing that food is adulterated 
        and presents a risk to human health, the Secretary shall issue 
        an order requiring the appropriate persons (including 
        manufacturers, importers, distributors, or retailers) to 
        immediately cease distribution of the food.
            ``(2) Informal hearing.--An order under paragraph (1) shall 
        provide the person subject to the order with an opportunity for 
        an informal hearing, to be held not later than 10 days after 
        the date of the issuance of the order, on the actions required 
        by the order and on whether the order should be amended to 
        require a recall of the food involved. If, after providing an 
        opportunity for such a hearing, the Secretary determines that 
        inadequate grounds exist to support the actions required by the 
        order, the Secretary shall vacate the order.
    ``(b) Recall Order.--If, after providing an opportunity for an 
informal hearing under subsection (a)(2), the Secretary determines that 
the order involved should be amended to include a recall of the food 
with respect to which the order was issued, the Secretary shall amend 
the order to require a recall. The Secretary shall specify a timetable 
in which the food recall will occur and shall require periodic reports 
to the Secretary describing the progress of the recall.
    ``(c) Infant Formula.--With respect to the recall of infant 
formula, section 412(e) applies in lieu of subsections (a) and (b).''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(gg) The failure to comply with an order under section 416.''.
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