[Congressional Bills 105th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4679 Enrolled Bill (ENR)]

        H.R.4679

                       One Hundred Fifth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
the twenty-seventh day of January, one thousand nine hundred and ninety-
                                  eight


                                 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 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)''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.