[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[S. 2565 Introduced in Senate (IS)]







105th CONGRESS
  2d Session
                                S. 2565

   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
  circumstances in which a substance is considered to be a pesticide 
       chemical for purposes of such Act, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

              October 7 (legislative day, October 2), 1998

Mr. Durbin (for himself, Mr. Warner, Ms. Mikulski, Mr. Hutchinson, Mr. 
Robb, Mr. Kennedy, and Mr. DeWine) introduced the following bill; which 
was read twice and referred to the Committee on Agriculture, Nutrition, 
                              and Forestry

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to clarify the 
  circumstances in which a substance is considered to be a pesticide 
       chemical for purposes of such Act, 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. SHORT TITLE.

    This Act may be cited as the ``Antimicrobial Regulation Technical 
Corrections Act of 1998''.

SEC. 2. DEFINITION OF PESTICIDE CHEMICAL UNDER FEDERAL FOOD, DRUG, AND 
              COSMETIC ACT.

    (a) In General.--Section 201(q) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(q)) is amended by striking ``(q)(1)'' and 
all that follows through the end of subparagraph (1) and inserting the 
following:
    ``(q)(1)(A) Except as provided in clause (B), the term `pesticide 
chemical' means any substance that is a pesticide within the meaning of 
the Federal Insecticide, Fungicide, and Rodenticide Act, including all 
active and inert ingredients of such pesticide. Notwithstanding any 
other provision of law, the term `pesticide' within such meaning 
includes ethylene oxide and propylene oxide when such substances are 
applied on food.
    ``(B) In the case of the use, with respect to food, of a substance 
described in clause (A) to prevent, destroy, repel, or mitigate 
microorganisms (including bacteria, viruses, fungi, protozoa, algae, 
and slime), the following applies for purposes of clause (A):
            ``(i) The definition in such clause for the term `pesticide 
        chemical' does not include the substance if the substance is 
        applied for such use on food, or the substance is included for 
        such use in water that comes into contact with the food, in the 
        preparing, packing, or holding of the food for commercial 
        purposes. The substance is not excluded under this subclause 
        from such definition if the substance is ethylene oxide or 
        propylene oxide, and is applied for such use on food. The 
        substance is not so excluded if the substance is applied for 
        such use on a raw agricultural commodity, or the substance is 
        included for such use in water that comes into contact with the 
        commodity, as follows:
                    ``(I) The substance is applied in the field.
                    ``(II) The substance is applied at a treatment 
                facility where raw agricultural commodities are the 
                only food treated, and the treatment is in a manner 
                that does not change the status of the food as a raw 
                agricultural commodity (including treatment through 
                washing, waxing, fumigating, and packing such 
                commodities in such manner).
                    ``(III) The substance is applied during the 
                transportation of such commodity between the field and 
                such a treatment facility.
            ``(ii) The definition in such clause for the term 
        `pesticide chemical' does not include the substance if the 
        substance is a food contact substance as defined in section 
        409(h)(6), and any of the following circumstances exist: The 
        substance is included for such use in an object that has a food 
        contact surface but is not intended to have an ongoing effect 
        on any portion of the object; the substance is included for 
        such use in an object that has a food contact surface and is 
        intended to have an ongoing effect on a portion of the object 
        but not on the food contact surface; or the substance is 
        included for such use in or is applied for such use on food 
        packaging (without regard to whether the substance is intended 
        to have an ongoing effect on any portion of the packaging). The 
        food contact substance is not excluded under this subclause 
        from such definition if any of the following circumstances 
        exist: The substance is applied for such use on a semipermanent 
        or permanent food contact surface (other than being applied on 
        food packaging); or the substance is included for such use in 
        an object that has a semipermanent or permanent food contact 
        surface (other than being included in food packaging) and the 
        substance is intended to have an ongoing effect on the food 
        contact surface.
With respect to the definition of the term `pesticide' that is 
applicable to the Federal Insecticide, Fungicide, and Rodenticide Act, 
this clause does not exclude any substance from such definition.''.
    (b) Regulations.--Section 408(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 346a(j)) is amended by adding at the end the 
following paragraph:
            ``(4) Certain substances.--With respect to a substance that 
        is not included in the definition of the term `pesticide 
        chemical' under section 201(q)(1) but was so included on the 
        day before the date of the enactment of the Antimicrobial 
        Regulation Technical Corrections Act of 1998, the following 
        applies as of such date of enactment:
                    ``(A) Notwithstanding paragraph (2), any regulation 
                applying to the use of the substance that was in effect 
                on the day before such date, and was on such day deemed 
                in such paragraph to have been issued under this 
                section, shall be considered to have been issued under 
                section 409.
                    ``(B) Notwithstanding paragraph (3), any regulation 
                applying to the use of the substance that was in effect 
                on such day and was issued under this section 
                (including any such regulation issued before the date 
                of the enactment of the Food Quality Protection Act of 
                1996) is deemed to have been issued under section 
                409.''.
    (c) Technical Amendment.--Section 201(q)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(q)(3)) is amended in the matter 
preceding clause (A) by striking ``paragraphs (1) and (2)'' and 
inserting ``subparagraphs (1) and (2)''.
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