II
105TH CONGRESS
2D SESSION
H. R. 4679
IN THE SENATE OF THE UNITED STATES
OCTOBER 8 (legislative day, OCTOBER 2), 1998
Received
AN ACT
To amend the Federal Food, Drug, and Cosmetic Act to
clarify the circumstances in which a substance is consid-
ered to be a pesticide chemical for purposes of such
Act, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Antimicrobial Regula-
tion Technical Corrections Act of 1998’’.
SEC. 2. DEFINITION OF PESTICIDE CHEMICAL UNDER FED-
ERAL 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 pes-
ticide within the meaning of the Federal Insecticide, Fun-
gicide, 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, vi-
ruses, fungi, protozoa, algae, and slime), the following ap-
plies 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
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comes into contact with the food, in the preparing,
packing, or holding of the food for commercial pur-
poses. The substance is not excluded under this sub-
clause from such definition if the substance is ethyl-
ene 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 agricul-
tural 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 treat-
ment facility where raw agricultural commod-
ities are the only food treated, and the treat-
ment is in a manner that does not change the
status of the food as a raw agricultural com-
modity (including treatment through washing,
waxing, fumigating, and packing such commod-
ities 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
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in section 409(h)(6), and any of the following cir-
cumstances 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 por-
tion 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 ap-
plied for such use on food packaging (without regard
to whether the substance is intended to have an on-
going 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
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Rodenticide Act, this clause does not exclude any sub-
stance 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 Tech-
nical 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 regula-
tion issued before the date of the enactment of
the Food Quality Protection Act of 1996) is
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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 ‘‘sub-
paragraphs (1) and (2)’’.
Passed the House of Representatives October 7,
1998.
Attest:
ROBIN H. CARLE,
Clerk.