I
119THCONGRESS
1
STSESSION H. R. 2472
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety
of infant and toddler food, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH27, 2025
Mrs. S
YKES(for herself, Mr. PALLONE, and Mr. KRISHNAMOORTHI) intro-
duced the following bill; which was referred to the Committee on Energy
and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
ensure the safety of infant and toddler food, and for
other purposes.
Be it enacted by the Senate and House of Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Improving Newborns’ 4
Food and Nutrition Testing Safety Act of 2025’’ or the 5
‘‘INFANTS Act of 2025’’. 6
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SEC. 2. DEFINITION OF INFANT AND TODDLER FOOD. 1
Section 201 of the Federal Food, Drug, and Cosmetic 2
Act (21 U.S.C. 321) is amended by adding at the end the 3
following: 4
‘‘(tt) The term ‘infant and toddler food’ means food 5
which purports to be or is represented as food for children 6
up to 24 months of age, including infant formula.’’. 7
SEC. 3. CONTAMINANTS IN FOOD. 8
Chapter IV of the Federal Food, Drug, and Cosmetic 9
Act (21 U.S.C. 341 et seq.) is amended by adding at the 10
end the following: 11
‘‘SEC. 425. SAMPLING AND TESTING FOR CONTAMINANTS IN 12
FOOD. 13
‘‘(a) S
AMPLING ANDTESTING.— 14
‘‘(1) I
N GENERAL.—The owner, operator, or 15
agent in charge of a food facility that manufactures 16
or processes food, including infant and toddler food, 17
in final product form intended for sale to consumers 18
shall— 19
‘‘(A) collect representative samples of each 20
such food; and 21
‘‘(B) conduct testing of the samples for 22
contaminants, including toxic elements. 23
‘‘(2) R
EQUIREMENT FOR SAMPLING PLAN .— 24
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‘‘(A) IN GENERAL.—The owner, operator, 1
or agent in charge of a facility described in 2
paragraph (1) shall— 3
‘‘(i) prepare a written sampling plan 4
for all sampling and testing required under 5
this section; and 6
‘‘(ii) ensure that all sampling and 7
testing conducted under this section is con-8
ducted in accordance with the sampling 9
plan. 10
‘‘(B) R
EQUIREMENTS.—A sampling plan 11
under subparagraph (A) shall identify— 12
‘‘(i) the number of sampling units and 13
sample unit size based upon appropriate 14
criteria for identifying, in a representative 15
fashion, the levels of contaminants in each 16
food; and 17
‘‘(ii) one or more appropriate test 18
methods and procedures to be used to ana-19
lyze the samples. 20
‘‘(C) G
UIDANCE.—Not later than 18 21
months after the date of enactment of this sec-22
tion, the Secretary shall issue guidance to assist 23
food facilities in developing sampling plans. 24
Such guidance may, as determined appropriate 25
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by the Secretary, address when samples should 1
be tested for specific species of contaminants. 2
‘‘(3) C
ONTAMINANTS TO BE TESTED .—Each 3
sample taken pursuant to a sampling plan under 4
this section shall be tested for levels of lead, cad-5
mium, mercury, arsenic, and any other contaminant, 6
including other toxic elements, that the Secretary 7
may specify by regulation. 8
‘‘(4) F
REQUENCY OF TESTING .—The sampling 9
and testing conducted under this section shall be 10
conducted at least once per quarter of each calendar 11
year. 12
‘‘(5) F
OODS TO BE TESTED .—The sampling 13
and testing conducted under this section shall be 14
conducted for— 15
‘‘(A) infant and toddler foods, in final 16
package form; and 17
‘‘(B) such other foods as the Secretary 18
may specify, by regulation, as appropriate to 19
protect public health. 20
‘‘(b) R
ECORDKEEPING.— 21
‘‘(1) I
N GENERAL.—The owner, operator, or 22
agent in charge of a facility described in subsection 23
(a)(1) shall maintain, for not less than 2 years or 24
the shelf-life of each infant and toddler food manu-25
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factured or processed at the facility, whichever is 1
longer, records documenting the sampling and test-2
ing conducted under this section with respect to the 3
food. 4
‘‘(2) R
EQUIREMENTS.—Records required by 5
paragraph (1) to be maintained shall include a de-6
tailed description of the foods sampled and tested, 7
the number of samples and tests performed, the size 8
and number of items in each sample unit, a copy of 9
the facility’s sampling plan, identification of the en-10
tity conducting the sampling, identification of the 11
entity conducting the testing, and the analytical 12
methods used to perform the sampling and testing. 13
‘‘(3) A
PPLICABILITY.—This subsection applies 14
to all records of sampling and testing conducted 15
under this section, regardless of the findings. 16
‘‘(c) L
ABORATORYACCREDITATION.—The owner, op-17
erator, or agent in charge of a food facility described in 18
subsection (a)(1) shall ensure that testing conducted pur-19
suant to this section is performed in accordance with 20
international standards by a laboratory that is accredited 21
by an accreditation body that conforms to international 22
accreditation standards. Testing conducted under this sec-23
tion is not subject to the requirements regarding labora-24
tory accreditation described in section 422. 25
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‘‘(d) RECORDSAVAILABILITY.— 1
‘‘(1) I
N GENERAL.—The owner, operator, or 2
agent in charge of a food facility described in sub-3
section (a)(1) shall make all records required under 4
this section available promptly to the Secretary, 5
upon request, for inspection and copying. Upon re-6
quest of the Secretary, such an owner, operator, or 7
agent in charge shall provide within a reasonable 8
time an English translation of records maintained in 9
a language other than English. 10
‘‘(2) R
ECORDS AVAILABILITY IN LIEU OF AN IN -11
SPECTION.—Any records that the Secretary may in-12
spect under this section shall, upon the request of 13
the Secretary, be provided to the Secretary by the 14
owner, operator, or agent in charge of a food facility 15
described in subsection (a)(1), in advance of or in 16
lieu of an inspection, within a reasonable timeframe, 17
within reasonable limits, and in a reasonable man-18
ner, and in either electronic or physical form, at the 19
expense of such owner, operator, or agent. The Sec-20
retary’s request shall include a sufficient description 21
of the records requested. 22
‘‘(3) C
ONFIRMATION.—Upon receipt of records 23
requested under paragraph (2), the Secretary shall 24
provide to the person confirmation of receipt. 25
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‘‘(4) AUTHORITY OF THE SECRETARY .—Noth-1
ing in this subsection supplants the authority of the 2
Secretary to conduct inspections otherwise permitted 3
under this Act in order to ensure compliance with 4
this Act. 5
‘‘(e) D
ELAYEDAPPLICABILITY.—The requirements 6
for sampling and testing under this section apply begin-7
ning on the date that is 180 days after the date on which 8
the Secretary publishes the guidance required by sub-9
section (a)(2)(C).’’. 10
SEC. 4. ADULTERATION. 11
Section 402 of the Federal Food, Drug, and Cosmetic 12
Act (21 U.S.C. 342) is amended by adding at the end the 13
following: 14
‘‘(j) If it is an article of food and the owner, operator, 15
or agent in charge of a food facility that manufactures 16
or processes such food— 17
‘‘(1) is subject to the requirements of section 18
425; and 19
‘‘(2) fails to comply with the requirements of 20
such section with regard to that article.’’. 21
SEC. 5. RECORDS FOR OR IN LIEU OF CERTAIN INSPEC-22
TIONS. 23
Section 704(a)(4) of the Federal Food, Drug, and 24
Cosmetic Act (21 U.S.C. 374(a)(4)) is amended— 25
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(1) by redesignating subparagraphs (B), (C), 1
and (D) as subparagraphs (C), (D), and (E), respec-2
tively; 3
(2) by inserting after subparagraph (A) the fol-4
lowing: 5
‘‘(B)(i) Any records or other information that the 6
Secretary may inspect under authority of this Act from 7
a person that owns or operates an establishment that is 8
engaged in any of the activities described in clause (ii) 9
shall, upon the request of the Secretary, be provided to 10
the Secretary by such person, in advance of or in lieu of 11
an inspection, within a reasonable timeframe, within rea-12
sonable limits, and in a reasonable manner, and in either 13
electronic or physical form, at the expense of such person. 14
The Secretary’s request shall include a sufficient descrip-15
tion of the records requested. 16
‘‘(ii) The activities described in this clause are the 17
following: 18
‘‘(I) The manufacturing, processing, packing, 19
transporting, distributing, receiving, holding, or im-20
porting of an article of food. 21
‘‘(II) The distribution or use of animal feed 22
bearing or containing a veterinary feed directive 23
drug, or the issuance of a veterinary feed directive.’’; 24
and 25
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(3) by adding at the end the following: 1
‘‘(F) Section 703 does not apply to requests for 2
records or other information when those requests are 3
made under this section.’’. 4
SEC. 6. MANDATORY RECALL AUTHORITY. 5
Section 423(a) of the Federal Food, Drug, and Cos-6
metic Act (21 U.S.C. 350l(a)) is amended by inserting ‘‘or 7
if the Secretary determines through any means that an 8
article of infant and toddler food (other than infant for-9
mula) bears or contains a contaminant that renders the 10
product adulterated under section 402(a)(1),’’ after ‘‘ani-11
mals,’’. 12
SEC. 7. REPORT FINAL PRODUCT POSITIVE TEST RESULTS 13
FOR RELEVANT PATHOGENS IN INFANT FOR-14
MULA. 15
Section 412 of the Federal Food, Drug, and Cosmetic 16
Act (21 U.S.C. 350a) is amended— 17
(1) in subsection (e)— 18
(A) in paragraph (1)— 19
(i) in the first sentence, by striking 20
‘‘promptly’’ and inserting ‘‘, within 24 21
hours of acquiring such knowledge,’’; and 22
(ii) in the second sentence, by striking 23
‘‘the infant formula’’ and inserting ‘‘an in-24
fant formula’’; 25
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(B) by redesignating paragraph (2) as 1
paragraph (4); 2
(C) in paragraph (4), as so redesignated, 3
by striking ‘‘paragraph (1)’’ and inserting 4
‘‘paragraphs (1) and (2)’’; and 5
(D) by inserting after paragraph (1) the 6
following: 7
‘‘(2) If the result of any in-process or finished prod-8
uct testing of an infant formula that has been processed 9
by the manufacturer is confirmed as a positive analytical 10
result for any environmental pathogen (as defined in sec-11
tion 117.3 of title 21, Code of Federal Regulations (or 12
any successor regulation)), the manufacturer shall— 13
‘‘(A) within 24 hours of acquiring such con-14
firmation, notify the Secretary of such confirmation 15
regardless of whether such infant formula has left 16
an establishment subject to the control of the manu-17
facturer; 18
‘‘(B) consult with the Secretary for proper dis-19
posal and properly dispose of the affected product; 20
and 21
‘‘(C) provide to the Secretary results and iso-22
lates from a positive sample of such infant formula. 23
‘‘(3) Not later than 90 days after receipt of a notifi-24
cation under paragraph (1) or (2), the Secretary shall con-25
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firm through the collection of documentation that the 1
manufacturer submitting the notification performed, or is 2
performing, appropriate corrective action. The manufac-3
turer shall make such documentation available to the Sec-4
retary during an inspection and, upon request of the Sec-5
retary, electronically or by other means.’’. 6
SEC. 8. ENVIRONMENTAL MONITORING. 7
Section 412 of the Federal Food, Drug, and Cosmetic 8
Act (21 U.S.C. 350a) is amended by adding at the end 9
the following: 10
‘‘(n) R
EQUIREMENTS FOR ENVIRONMENTAL MONI-11
TORING FORCRONOBACTERSPP ANDSALMONELLA.— 12
‘‘(1) I
N GENERAL.—A manufacturer of pow-13
dered infant formula shall establish and implement 14
an environmental monitoring program to verify the 15
effectiveness of sanitation and hygiene controls 16
where the food has the potential to be exposed to 17
Cronobacter spp. or Salmonella. The environmental 18
monitoring program shall be written and include 19
procedures for determining sampling location, num-20
ber of samples to be taken, and timing and fre-21
quency of sample collection and testing. 22
‘‘(2) S
AMPLING LOCATION AND NUMBER OF 23
SAMPLES.—A manufacturer of powdered infant for-24
mula shall ensure that the sampling locations from 25
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which samples will be taken, and the number of sites 1
to be tested during routine environmental moni-2
toring pursuant to an environmental monitoring pro-3
gram under paragraph (1), are adequate to deter-4
mine whether sanitation and hygiene controls are ef-5
fective. 6
‘‘(3) T
IMING AND FREQUENCY .—A manufac-7
turer of powdered infant formula shall ensure that 8
the timing and frequency for collecting testing sam-9
ples pursuant to an environmental monitoring pro-10
gram under paragraph (1) are adequate to deter-11
mine whether sanitation and hygiene controls are ef-12
fective. 13
‘‘(4) R
ECORDS.— 14
‘‘(A) A
VAILABILITY TO THE SECRETARY .— 15
A manufacturer of powdered infant formula 16
shall make all records required under this sub-17
section available promptly to the Secretary, 18
upon request, for inspection and copying. 19
‘‘(B) M
AINTENANCE.—Records of environ-20
mental monitoring conducted pursuant to this 21
subsection shall be maintained for not less than 22
2 years or the shelf-life of the infant formula, 23
whichever is longer. 24
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‘‘(C) CONDITIONS OF INSPECTION .—Any 1
records that the Secretary may inspect under 2
this subsection shall, upon the request of the 3
Secretary, be provided to the Secretary by the 4
manufacturer of powdered infant formula, in 5
advance of or in lieu of an inspection, within a 6
reasonable timeframe, within reasonable limits, 7
and in a reasonable manner, and in either elec-8
tronic or physical form, at the expense of such 9
manufacturer. The Secretary’s request shall in-10
clude a sufficient description of the records re-11
quested. 12
‘‘(D) C
ONFIRMATION OF RECEIPT .—Upon 13
receipt of records requested under subpara-14
graph (C), the Secretary shall provide to the 15
person confirmation of receipt. 16
‘‘(5) A
UTHORITY OF THE SECRETARY .—Noth-17
ing in this subsection supplants the authority of the 18
Secretary to conduct inspections otherwise permitted 19
under this Act in order to ensure compliance with 20
this Act. 21
‘‘(6) D
ELAYED APPLICABILITY .—The require-22
ments of this subsection apply beginning on the date 23
that is 180 days after the date of enactment of this 24
subsection. 25
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‘‘(7) RULE OF CONSTRUCTION .—Nothing in 1
this subsection shall be construed to exempt an in-2
fant formula manufacturer from the requirements of 3
this Act, including the requirements of this section 4
and section 418.’’. 5
Æ
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