I 
118TH CONGRESS 
1ST SESSION H. R. 6770 
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 
DECEMBER 13, 2023 
Mrs. SYKES
(for herself, Mr. PALLONE, Mr. CA´RDENAS, and Mr. 
KRISHNAMOORTHI) introduced 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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Improving Newborns’ 
Food and Nutrition Testing Safety Act of 2023’’ or the 
‘‘INFANTS Act of 2023’’. 
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SEC. 2. DEFINITION OF INFANT AND TODDLER FOOD. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
‘‘(tt) The term ‘infant and toddler food’ means food 
which purports to be or is represented as food for children 
up to 24 months of age, including infant formula.’’. 
SEC. 3. CONTAMINANTS IN FOOD. 
Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the 
end the following: 
‘‘SEC. 425. SAMPLING AND TESTING FOR CONTAMINANTS IN 
FOOD. 
‘‘(a) SAMPLING AND TESTING.— 
‘‘(1) IN
GENERAL.—The owner, operator, or 
agent in charge of a food facility that manufactures 
or processes food, including infant and toddler food, 
in final product form intended for sale to consumers 
shall— 
‘‘(A) collect representative samples of each 
such food; and 
‘‘(B) conduct testing of the samples for 
contaminants, including toxic elements. 
‘‘(2) REQUIREMENT FOR SAMPLING PLAN.— 
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‘‘(A) IN GENERAL.—The owner, operator, 
or agent in charge of a facility described in 
paragraph (1) shall— 
‘‘(i) prepare a written sampling plan 
for all sampling and testing required under 
this section; and 
‘‘(ii) ensure that all sampling and 
testing conducted under this section is con-
ducted in accordance with the sampling 
plan. 
‘‘(B) REQUIREMENTS.—A sampling plan 
under subparagraph (A) shall identify— 
‘‘(i) the number of sampling units and 
sample unit size based upon appropriate 
criteria for identifying, in a representative 
fashion, the levels of contaminants in each 
food; and 
‘‘(ii) one or more appropriate test 
methods and procedures to be used to ana-
lyze the samples. 
‘‘(C) GUIDANCE.—Not later than 18 
months after the date of enactment of this sec-
tion, the Secretary shall issue guidance to assist 
food facilities in developing sampling plans. 
Such guidance may, as determined appropriate 
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by the Secretary, address when samples should 
be tested for specific species of contaminants. 
‘‘(3) CONTAMINANTS
TO
BE
TESTED.—Each 
sample taken pursuant to a sampling plan under 
this section shall be tested for levels of lead, cad-
mium, mercury, arsenic, and any other contaminant, 
including other toxic elements, that the Secretary 
may specify by regulation. 
‘‘(4) FREQUENCY OF TESTING.—The sampling 
and testing conducted under this section shall be 
conducted at least once per quarter of each calendar 
year. 
‘‘(5) FOODS
TO
BE
TESTED.—The sampling 
and testing conducted under this section shall be 
conducted for— 
‘‘(A) infant and toddler foods, in final 
package form; and 
‘‘(B) such other foods as the Secretary 
may specify, by regulation, as appropriate to 
protect public health. 
‘‘(b) RECORDKEEPING.— 
‘‘(1) IN
GENERAL.—The owner, operator, or 
agent in charge of a facility described in subsection 
(a)(1) shall maintain, for not less than 2 years or 
the shelf-life of each infant and toddler food manu-
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factured or processed at the facility, whichever is 
longer, records documenting the sampling and test-
ing conducted under this section with respect to the 
food. 
‘‘(2) REQUIREMENTS.—Records required by 
paragraph (1) to be maintained shall include a de-
tailed description of the foods sampled and tested, 
the number of samples and tests performed, the size 
and number of items in each sample unit, a copy of 
the facility’s sampling plan, identification of the en-
tity conducting the sampling, identification of the 
entity conducting the testing, and the analytical 
methods used to perform the sampling and testing. 
‘‘(3) APPLICABILITY.—This subsection applies 
to all records of sampling and testing conducted 
under this section, regardless of the findings. 
‘‘(c) LABORATORY ACCREDITATION.—The owner, op-
erator, or agent in charge of a food facility described in 
subsection (a)(1) shall ensure that testing conducted pur-
suant to this section is performed in accordance with 
international standards by a laboratory that is accredited 
by an accreditation body that conforms to international 
accreditation standards. Testing conducted under this sec-
tion is not subject to the requirements regarding labora-
tory accreditation described in section 422. 
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‘‘(d) RECORDS AVAILABILITY.— 
‘‘(1) IN
GENERAL.—The owner, operator, or 
agent in charge of a food facility described in sub-
section (a)(1) shall make all records required under 
this section available promptly to the Secretary, 
upon request, for inspection and copying. Upon re-
quest of the Secretary, such an owner, operator, or 
agent in charge shall provide within a reasonable 
time an English translation of records maintained in 
a language other than English. 
‘‘(2) RECORDS AVAILABILITY IN LIEU OF AN IN-
SPECTION.—Any records that the Secretary may in-
spect under this section shall, upon the request of 
the Secretary, be provided to the Secretary by the 
owner, operator, or agent in charge of a food facility 
described in subsection (a)(1), in advance of or in 
lieu of an inspection, within a reasonable timeframe, 
within reasonable limits, and in a reasonable man-
ner, and in either electronic or physical form, at the 
expense of such owner, operator, or agent. The Sec-
retary’s request shall include a sufficient description 
of the records requested. 
‘‘(3) CONFIRMATION.—Upon receipt of records 
requested under paragraph (2), the Secretary shall 
provide to the person confirmation of receipt. 
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‘‘(4) AUTHORITY OF THE SECRETARY.—Noth-
ing in this subsection supplants the authority of the 
Secretary to conduct inspections otherwise permitted 
under this Act in order to ensure compliance with 
this Act. 
‘‘(e) DELAYED APPLICABILITY.—The requirements 
for sampling and testing under this section apply begin-
ning on the date that is 180 days after the date on which 
the Secretary publishes the guidance required by sub-
section (a)(2)(C).’’. 
SEC. 4. ADULTERATION. 
Section 402 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 342) is amended by adding at the end the 
following: 
‘‘(j) If it is an article of food and the owner, operator, 
or agent in charge of a food facility that manufactures 
or processes such food— 
‘‘(1) is subject to the requirements of section 
425; and 
‘‘(2) fails to comply with the requirements of 
such section with regard to that article.’’. 
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— 
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(1) by redesignating subparagraphs (B), (C), 
and (D) as subparagraphs (C), (D), and (E), respec-
tively; 
(2) by inserting after subparagraph (A) the fol-
lowing: 
‘‘(B)(i) Any records or other information that the 
Secretary may inspect under authority of this Act from 
a person that owns or operates an establishment that is 
engaged in any of the activities 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 reasonable timeframe, within rea-
sonable limits, and in a reasonable manner, and in either 
electronic or physical form, at the expense of such person. 
The Secretary’s request shall include a sufficient descrip-
tion of the records requested. 
‘‘(ii) The activities described in this clause are the 
following: 
‘‘(I) The manufacturing, processing, packing, 
transporting, distributing, receiving, holding, or im-
porting of an article of food. 
‘‘(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 
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(3) by adding at the end the following: 
‘‘(F) Section 703 does not apply to requests for 
records or other information when those requests are 
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 ‘‘or 
if the Secretary determines through any means that an 
article of infant and toddler food (other than infant for-
mula) bears or contains a contaminant that renders the 
product adulterated under section 402(a)(1),’’ after ‘‘ani-
mals,’’. 
SEC. 7. REPORT FINAL PRODUCT POSITIVE TEST RESULTS 
FOR RELEVANT PATHOGENS IN INFANT FOR-
MULA. 
Section 412 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a) is amended— 
(1) in subsection (e)— 
(A) in paragraph (1)— 
(i) in the first sentence, by striking 
‘‘promptly’’ and inserting ‘‘, within 24 
hours of acquiring such knowledge,’’; and 
(ii) in the second sentence, by striking 
‘‘the infant formula’’ and inserting ‘‘an in-
fant formula’’; 
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(B) by redesignating paragraph (2) as 
paragraph (4); 
(C) in paragraph (4), as so redesignated, 
by striking ‘‘paragraph (1)’’ and inserting 
‘‘paragraphs (1) and (2)’’; and 
(D) by inserting after paragraph (1) the 
following: 
‘‘(2) If the result of any in-process or finished prod-
uct testing of an infant formula that has been processed 
by the manufacturer is confirmed as a positive analytical 
result for any environmental pathogen (as defined in sec-
tion 117.3 of title 21, Code of Federal Regulations (or 
any successor regulation)), the manufacturer shall— 
‘‘(A) within 24 hours of acquiring such con-
firmation, notify the Secretary of such confirmation 
regardless of whether such infant formula has left 
an establishment subject to the control of the manu-
facturer; 
‘‘(B) consult with the Secretary for proper dis-
posal and properly dispose of the affected product; 
and 
‘‘(C) provide to the Secretary results and iso-
lates from a positive sample of such infant formula. 
‘‘(3) Not later than 90 days after receipt of a notifi-
cation under paragraph (1) or (2), the Secretary shall con-
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firm through the collection of documentation that the 
manufacturer submitting the notification performed, or is 
performing, appropriate corrective action. The manufac-
turer shall make such documentation available to the Sec-
retary during an inspection and, upon request of the Sec-
retary, electronically or by other means.’’. 
SEC. 8. ENVIRONMENTAL MONITORING. 
Section 412 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a) is amended by adding at the end 
the following: 
‘‘(n) REQUIREMENTS FOR ENVIRONMENTAL MONI-
TORING FOR CRONOBACTER SPP AND SALMONELLA.— 
‘‘(1) IN
GENERAL.—A manufacturer of pow-
dered infant formula shall establish and implement 
an environmental monitoring program to verify the 
effectiveness of sanitation and hygiene controls 
where the food has the potential to be exposed to 
Cronobacter spp. or Salmonella. The environmental 
monitoring program shall be written and include 
procedures for determining sampling location, num-
ber of samples to be taken, and timing and fre-
quency of sample collection and testing. 
‘‘(2) SAMPLING
LOCATION
AND
NUMBER
OF 
SAMPLES.—A manufacturer of powdered infant for-
mula shall ensure that the sampling locations from 
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which samples will be taken, and the number of sites 
to be tested during routine environmental moni-
toring pursuant to an environmental monitoring pro-
gram under paragraph (1), are adequate to deter-
mine whether sanitation and hygiene controls are ef-
fective. 
‘‘(3) TIMING
AND
FREQUENCY.—A manufac-
turer of powdered infant formula shall ensure that 
the timing and frequency for collecting ant testing 
samples pursuant to an environmental monitoring 
program under paragraph (1) are adequate to deter-
mine whether sanitation and hygiene controls are ef-
fective. 
‘‘(4) RECORDS.— 
‘‘(A) AVAILABILITY TO THE SECRETARY.— 
A manufacturer of powdered infant formula 
shall make all records required under this sub-
section available promptly to the Secretary, 
upon request, for inspection and copying. 
‘‘(B) MAINTENANCE.—Records of environ-
mental monitoring conducted pursuant to this 
subsection shall be maintained for not less than 
2 years or the shelf-life of the infant formula, 
whichever is longer. 
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