(c) ANNUAL REPORT REGARDING FOOD.—Section 
1003(h)(1) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 393(h)(1)) is amended— 
(1) in subparagraph (E), by striking ‘‘and’’ at 
the end; 
(2) in subparagraph (F), by striking the period 
and inserting ‘‘; and’’; and 
(3) by adding at the end the following: 
‘‘(G) the nature of domestic facility and 
foreign facility inspections described in subpara-
graph (C), the aggregate inspection findings of 
such inspections, and the compliance rate of 
foreign food importers with certification stand-
ards;’’. 
SEC. 5. RECORDS FOR OR IN LIEU OF CERTAIN INSPEC-
TIONS. 
Section 704(a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 374(a)(4)) is amended— 
(1) 
by 
redesignating 
subparagraphs 
(B) 
through (D) as subparagraphs (C) through (E), re-
spectively; 
(2) by inserting after subparagraph (A) the fol-
lowing new subparagraph: 
‘‘(B)(i) Any records or other information that the 
Secretary may inspect under authority of this Act from 
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a person that owns or operates, or is an agent in charge 
of, an establishment that is engaged in any of the activi-
ties described in clause (ii) shall, upon the request of the 
Secretary, be provided to the Secretary by such person, 
in advance of or in lieu of an inspection, within a reason-
able timeframe, within reasonable limits, and in a reason-
able manner, and in either electronic or physical form, at 
the expense of such person. The Secretary’s request shall 
include a sufficient description of the records requested. 
‘‘(ii) The activities described in this clause are 
records relating to— 
‘‘(I) the manufacturing, processing, packing, 
transporting, distributing, receiving, holding, or im-
porting of an article of food; or 
‘‘(II) the distribution or use of animal feed 
bearing or containing a veterinary feed directive 
drug, or the issuance of a veterinary feed directive.’’; 
and 
(3) by adding at the end the following: 
‘‘(F) Section 703 does not apply to records or other 
information obtained pursuant to a request made under 
this section.’’. 
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 
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after ‘‘animals,’’ the following: ‘‘or if the Secretary deter-
mines through any means that an article of infant and 
toddler food (other than infant formula) bears or contains 
a contaminant that renders the product adulterated under 
section 402(a)(1),’’. 
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 shall establish and implement an environ-
mental monitoring program to verify the effectiveness of 
sanitation and hygiene controls where the food has the po-
tential to be exposed to environment pathogens during the 
manufacturing and packing process. The environmental 
monitoring program shall be written and include proce-
dures for determining sample location, number 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, lead, arsenic, mer-
cury, or a reliable indicator organism. 
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‘‘(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. 
‘‘(e) RECORDS.— 
‘‘(1) AVAILABILITY
TO
THE
SECRETARY.—A 
manufacturer shall make all the records required 
under this section available promptly to the Sec-
retary, upon request, for inspection and copying. 
‘‘(2) MAINTENANCE.—Records of environmental 
monitoring conducted 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. 
‘‘(3) 
CONDITIONS
OF
INSPECTION.—Any 
records 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 or in lieu of an inspection, within a rea-
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sonable 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 de-
scription 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. 
‘‘(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 
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