[105th Congress Public Law 324]
[From the U.S. Government Printing Office]


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[DOCID: f:publ324.105]


[[Page 112 STAT. 3035]]

Public Law 105-324
105th Congress

                                 An Act


 
    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 <<NOTE: Oct. 30, 
                     1998 -  [H.R. 4679]>> purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Antimicrobial 
Regulation Technical Corrections Act of 1998.>> 

SECTION 1. SHORT TITLE. <<NOTE: 21 USC 301 note.>> 

    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

[[Page 112 STAT. 3036]]

                (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.''.

[[Page 112 STAT. 3037]]

    (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)''.

    Approved October 30, 1998.

LEGISLATIVE HISTORY--H.R. 4679:
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CONGRESSIONAL RECORD, Vol. 144 (1998):
            Oct. 7, considered and passed House.
            Oct. 9, considered and passed Senate.

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