[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
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(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.''.
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(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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