Antimicrobial Regulation Technical Corrections Act of 1998
PL 105-324 (H.R.4679), enacted 10/30/1998

PUBLIC LAW 105-324—OCT. 30, 1998 
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 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 
Technical Corrections Act of 1998". 
the "Antimicrobial Regulation 
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)(l)" 
and all that follows through the end of subparagraph (1) and 
inserting the following: 
"(q)(l)(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 
Oct. 30, 1998 
[H.R. 4679] 
Antimicrobial 
Regulation 
Technical 
Corrections Act 
of 1998. 
21 u s e 301 note. 
112 STAT. 3036 
PUBLIC LAW 105-324—OCT. 30, 1998 
(including treatment through washing, waxing, fumigating, 
and packing such commodities in such manner). 
"(Ill) The substance is appUed 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)(l) 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.". 
PUBLIC LAW 105-324—OCT. 30, 1998 
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: 
CONGRESSIONAL RECORD, Vol. 144 (1998): 
Oct. 7, considered and passed House. 
Oct. 9, considered and passed Senate.