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 mean-
ing of the Federal Insecticide, Fungicide, and Rodenticide Act,
including all active and inert ingredients of such pesticide. Notwith-
standing 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 micro-
organisms (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 propyl-
ene 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 commod-
ity, 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 treat-
ed, and the treatment is in a manner that does not change
the status of the food as a raw agricultural commodity
H. R. 4679—2
(including treatment through washing, waxing, fumigating,
and packing such commodities in such manner).
‘‘(III) The substance is applied during the transpor-
tation 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 sub-
stance 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 defini-
tion.’’.
(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.’’.
H. R. 4679—3
(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.