SEC. 6. MANDATORY RECALL AUTHORITY. 
Section 423(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350l(a)) is amended by inserting 
after ‘‘animals,’’ the following: ‘‘or that an article of food 
is adulterated under paragraph (a)(1) or (j) of section 
402,’’. 
SEC. 7. ENVIRONMENTAL MONITORING. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by section 3, 
is further amended by adding the following: 
‘‘SEC. 426. ENVIRONMENTAL MONITORING OF INFANT AND 
TODDLER FOOD. 
‘‘(a) IN GENERAL.—A manufacturer of infant and 
toddler food (other than infant formula) shall establish 
and implement an environmental monitoring program to 
verify the effectiveness of sanitation and hygiene controls 
during the manufacturing and packaging process where 
the food has the potential to be exposed to pathogens. The 
environmental monitoring program shall be written and 
include procedures for determining sample location, num-
ber of samples to be taken, and timing and frequency of 
sample collection and testing. 
‘‘(b) ORGANISMS
SAMPLED.—The environmental 
monitoring program under subsection (a) shall include 
testing for environmental pathogens or a reliable indicator 
organism. 
VerDate Sep 11 2014 
20:30 Aug 27, 2024
Jkt 049200
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H9105.IH
H9105
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(c) SAMPLING LOCATION AND NUMBER OF SAM-
PLES.—A manufacturer of infant and toddler food shall 
ensure that the sampling locations from which samples 
will be taken, and the number of sites to be tested during 
routine environmental monitoring are adequate to deter-
mine whether sanitation and hygiene controls are effective. 
‘‘(d) TIMING AND FREQUENCY.—The timing and fre-
quency for collecting and testing samples shall be ade-
quate to determine whether sanitation and hygiene con-
trols are effective, and shall occur not less frequently than 
every 3 years. 
‘‘(e) RECORDS.— 
‘‘(1) AVAILABILITY
TO
THE
SECRETARY.—A 
manufacturer of infant and toddler food shall make 
all the records required under this section available 
promptly to the Secretary, upon request by the Sec-
retary, for inspection and copying. 
‘‘(2) MAINTENANCE OF RECORDS PERTAINING 
TO ENVIRONMENTAL MONITORING.—Records of envi-
ronmental sampling, testing, and monitoring con-
ducted pursuant to this section shall be established 
and maintained by the manufacturer for not less 
than 2 years or the shelf-life of the food, whichever 
is longer. 
VerDate Sep 11 2014 
20:30 Aug 27, 2024
Jkt 049200
PO 00000
Frm 00020
Fmt 6652
Sfmt 6201
E:\BILLS\H9105.IH
H9105
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(3) 
CONDITIONS
OF
INSPECTION.—Any 
records or other information that the Secretary may 
inspect under this section shall, upon the request of 
the Secretary, be provided to the Secretary by the 
manufacturer, in advance of, at the time of, or in 
the case in which an in-person inspection would be 
unsafe, in lieu of, an in-person, on-site inspection, 
within a reasonable timeframe, within reasonable 
limits, and in a reasonable manner, and in either 
electronic or physical form, at the expense of such 
manufacturer. The Secretary’s request shall include 
a sufficient description of the records requested. 
‘‘(4) CONFIRMATION
OF
RECEIPT.—Upon re-
ceipt of the records requested under paragraph (3), 
the Secretary shall provide to the manufacturer con-
firmation of receipt. 
‘‘(f) AUTHORITY OF THE SECRETARY.—Nothing in 
this section supplants the authority of the Secretary to 
conduct inspections otherwise permitted under this Act in 
order to ensure compliance with this Act. 
‘‘(g) EFFECTIVE DATE.—The requirements of this 
section shall apply beginning on the date that is 2 years 
after the date of enactment of the Baby Food Safety Act 
of 2024. 
VerDate Sep 11 2014 
20:30 Aug 27, 2024
Jkt 049200
PO 00000
Frm 00021
Fmt 6652
Sfmt 6201
E:\BILLS\H9105.IH
H9105
ssavage on LAPJG3WLY3PROD with BILLS
‘‘(h) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to exempt any manufacturer from 
the requirements of this Act, including the requirements 
under section 418.’’. 
Æ 
VerDate Sep 11 2014 
20:30 Aug 27, 2024
Jkt 049200
PO 00000
Frm 00022
Fmt 6652
Sfmt 6301
E:\BILLS\H9105.IH
H9105
ssavage on LAPJG3WLY3PROD with BILLS