I 
118TH CONGRESS 
2D SESSION 
H. R. 8385 
To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 
of food and limit the presence of contaminants in infant and toddler 
food, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 14, 2024 
Mr. KRISHNAMOORTHI (for himself and Mr. CA´RDENAS) 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 food and limit the presence of con-
taminants in infant and toddler food, and for other pur-
poses. 
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 ‘‘Baby Food Safety Act 
of 2024’’. 
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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 
that purports to be, or is represented as being, specifically 
for infants or children up to the age of 24 months.’’. 
SEC. 3. CONTAMINANTS IN FOOD, INCLUDING INFANT AND 
TODDLER FOOD. 
(a) IN GENERAL.—Chapter IV of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 425. CONTAMINANTS IN FOOD, INCLUDING INFANT 
AND TODDLER FOOD. 
‘‘(a) ADMINISTRATIVE ORDERS FOR CONTAMINANTS 
IN FOOD.— 
‘‘(1) IN GENERAL.—Within the applicable time-
frame specified in paragraph (4), the Secretary, by 
administrative order— 
‘‘(A) shall establish limits on— 
‘‘(i) lead, cadmium, mercury, and 
total arsenic in infant and toddler food; 
‘‘(ii) lead, cadmium, mercury, and 
total arsenic in food pouches made with 
fruit or vegetable puree or juice; and 
‘‘(iii) lead and arsenic in juice; and 
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‘‘(B) if the Secretary determines appro-
priate upon review of relevant health data and 
other relevant available information, may— 
‘‘(i) establish limits for additional con-
taminants in infant and toddler food; 
‘‘(ii) establish limits for additional 
contaminants in juice; 
‘‘(iii) establish limits for additional 
contaminants in food pouches made with 
fruit or vegetable puree or juice; and 
‘‘(iv) revise limits established pursu-
ant to subparagraph (A). 
‘‘(2) PROCEDURE.—In establishing or revising 
any limit under paragraph (1), the Secretary shall— 
‘‘(A) evaluate relevant health data and 
other information the Secretary considers rel-
evant; 
‘‘(B) take into account relevant differences 
among food types, groups, and categories, as 
appropriate, including the extent to which the 
presence of a contaminant cannot be avoided; 
and 
‘‘(C) notwithstanding the requirements of 
subchapter II of chapter 5 of title 5, United 
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States Code, and chapter 6 of title 5, United 
States Code— 
‘‘(i) publish any administrative order 
under paragraph (1) in the Federal Reg-
ister following— 
‘‘(I) publication of a proposed 
order in the Federal Register; and 
‘‘(II) consideration of comments 
to a public docket open for not fewer 
than 45 calendar days; and 
‘‘(ii) set forth in any proposed or final 
administrative order under paragraph (1) 
a substantive summary of the valid sci-
entific evidence concerning the proposed or 
final limit. 
‘‘(3) ADDITIONAL CONTAMINANTS; CHANGES TO 
LIMITS.—If the Secretary determines appropriate 
after review of relevant data and available health in-
formation, the Secretary may revise any limit estab-
lished under this subsection by administrative order 
published in the Federal Register in accordance with 
paragraph (2)(C). 
‘‘(4) TIMEFRAME FOR INITIAL LIMITS.— 
‘‘(A) PROPOSED ORDERS.—Subject to the 
requirements of paragraph (2)(C), the Sec-
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retary shall issue proposed orders for limits 
under paragraph (1)(A) as follows: 
‘‘(i) For lead, not later than Decem-
ber 31, 2025. 
‘‘(ii) For total arsenic, not later than 
December 31, 2025. 
‘‘(iii) For cadmium, not later than 
April 30, 2026. 
‘‘(iv) For mercury, not later than 
April 30, 2028. 
‘‘(B) FINAL ORDERS.—The Secretary shall 
issue each final administrative order for a limit 
established pursuant to paragraph (1)(A) not 
later than the earlier of— 
‘‘(i) the applicable deadline for a final 
order specified in paragraph (1); or 
‘‘(ii) 18 months after issuance of the 
respective proposed order. 
‘‘(5) CRITERIA.—The limits established under 
this section shall represent the level at which the 
Secretary finds necessary for the protection of public 
health. In determining such limits the Secretary 
shall take into account the extent to which the use 
of such substance is required or cannot be avoided 
in the production of each such article, and the other 
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ways in which a consumer may be affected by the 
same or other contaminants, taking into consider-
ation relevant information and data that has been 
made available. 
‘‘(6) ADULTERATED FOOD.—A food may be de-
termined adulterated, at the final product stage, 
under section 402(j), if such food bears or contains 
any contaminant in excess of a limit established 
under this subsection when considering variability of 
the validated method of analysis. 
‘‘(7) PERIODIC REVIEW.—The Secretary shall 
periodically review the limits established under this 
subsection, taking into consideration relevant infor-
mation and available data to consider whether such 
limits should be revised, following the procedure de-
scribed in paragraph (2), in accordance with the cri-
teria specified in paragraph (5). 
‘‘(b) SAMPLING AND TESTING FOR CONTAMINANTS 
IN FOOD, INCLUDING INFANT AND TODDLER FOOD.— 
‘‘(1) IN GENERAL.—Beginning not later than 
180 days after the date of enactment of the Baby 
Food Safety Act of 2024, the owner, operator, or 
agent in charge of a facility engaged in manufac-
turing or processing infant and toddler food, food 
pouches made with fruit or vegetable puree or juice, 
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or juice for consumption in the United States 
shall— 
‘‘(A) have a control program pursuant to 
section 418 in place for contaminants subject to 
ordered limits under subsection (a), or be in 
compliance with the Juice Hazard Analysis 
Critical Control Points Program of the Food 
and Drug Administration, as applicable; 
‘‘(B) be in compliance with regulations 
promulgated under section 420(b); 
‘‘(C) collect representative samples of each 
such food in final product form in accordance 
with a sampling plan described in paragraph 
(2); and 
‘‘(D) conduct testing of the samples col-
lected from the final food product for contami-
nants, in accordance with such sampling plan. 
‘‘(2) REQUIREMENTS FOR SAMPLING PLAN.— 
‘‘(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 subsection; and 
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‘‘(ii) ensure that all sampling and 
testing conducted under this subsection is 
conducted in accordance with the sampling 
plan. 
‘‘(B) SAMPLING PLAN.—A sampling plan 
required by 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 the Baby 
Food Safety Act of 2024, the Secretary shall 
issue guidance to assist facilities described 
under paragraph (1) with developing sampling 
plans. Such guidance may, as the Secretary de-
termines appropriate, address when samples 
should be tested for specific species of contami-
nants. 
‘‘(3) CONTAMINANTS TO BE TESTED.—In car-
rying out the sampling and testing under this sub-
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section, the owner, operator, or agent in charge of 
a facility described in paragraph (1) shall ensure 
that each sample is tested for levels of— 
‘‘(A) lead, cadmium, mercury, and total ar-
senic; and 
‘‘(B) any other contaminant that the Sec-
retary may specify by regulation, and in accord-
ance with the sampling plan under paragraph 
(2). 
‘‘(4) FOODS
TO
BE
TESTED.—The sampling 
and testing conducted under this subsection shall be 
conducted for— 
‘‘(A) infant and toddler foods, in final 
product form; 
‘‘(B) pouches made with fruit and vege-
table puree or juice; 
‘‘(C) juice; and 
‘‘(D) such other foods in final product 
form as the Secretary may specify, by regula-
tion, as appropriate to protect the public health. 
‘‘(5) RECORDKEEPING.— 
‘‘(A) IN GENERAL.—The owner, operator, 
or agent in charge of a facility described in 
paragraph (1) shall maintain, for not less than 
2 years or the shelf-life of each food product 
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manufactured or processed by the facility, 
whichever is longer, records documenting the 
sampling plan and results of testing conducted 
under this subsection with respect to the food. 
The owner, operator, or agent in charge of such 
a facility shall make such records available for 
inspection by the Secretary upon request by the 
Secretary. 
‘‘(B) REQUIREMENTS.—The records main-
tained as required under subparagraph (A) 
shall include— 
‘‘(i) a detailed description of the foods 
sampled and tested; 
‘‘(ii) the number of samples and tests 
performed; 
‘‘(iii) the size and number of items in 
each sample unit; 
‘‘(iv) a copy of the sampling plan re-
quired under paragraph (2); 
‘‘(v) identification of the entity con-
ducting the sampling; 
‘‘(vi) identification of the entity con-
ducting the testing; and 
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‘‘(vii) identification of the analytical 
methods used to perform the sampling and 
testing. 
‘‘(C) APPLICABILITY.—The requirements 
of this paragraph shall apply to all records of 
sampling and testing conducted pursuant to 
this subsection, regardless of the findings. 
‘‘(6) 
LABORATORY
ACCREDITATION.—The 
owner, operator, or agent in charge of a facility de-
scribed in paragraph (1) shall ensure that testing re-
quired pursuant to this subsection is performed in 
accordance with international standards by a labora-
tory that is accredited by an accreditation body that 
conforms to international accreditation standards. 
Testing conducted under this subsection is not sub-
ject to the requirements regarding laboratory accred-
itation described in section 422. 
‘‘(7) SAMPLING AND TESTING PROGRAM.—The 
Secretary shall develop and implement a sampling 
and testing program for infant and toddler food for 
sale to consumers that is sufficient to— 
‘‘(A) support the periodic review under 
subsection (a)(7) of limits on lead, cadmium, 
mercury, and arsenic in infant and toddler food; 
and 
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‘‘(B) independently verify the effectiveness 
of the sampling and testing conducted pursuant 
to this subsection by the owner, operator, or 
agent in charge of a food facility. 
‘‘(8) GUIDANCE.—The Secretary shall issue 
guidance to assist food facilities in complying with 
this subsection. 
‘‘(c) RECORD AVAILABILITY.— 
‘‘(1) IN GENERAL.—Upon request by the Sec-
retary, the owner, operator, or agent in charge of a 
facility described in subsection (b)(1) shall— 
‘‘(A) make all records required under this 
section available promptly to the Secretary for 
inspection and copying; and 
‘‘(B) provide within a reasonable time an 
English translation of such records maintained 
in a language other than English. 
‘‘(2) RECORD 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 facility de-
scribed in subsection (b)(1), in advance of or in lieu 
of an inspection, within a reasonable timeframe, 
within reasonable limits, and in a reasonable man-
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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 (1) or (2), the Secretary 
shall provide to the owner, operator, or agent de-
scribed in paragraph (2) confirmation of the receipt. 
‘‘(4) AUTHORITY OF THE SECRETARY.—Noth-
ing in this subsection supplants the authority of the 
Secretary to conduct sampling, testing, or inspec-
tions otherwise permitted under this Act in order to 
ensure compliance with this Act. 
‘‘(d) DELAYED APPLICABILITY.—The requirements 
for sampling and testing under this section shall apply be-
ginning on the date that is 2 years after the date of enact-
ment of this subsection. 
‘‘(e) PREEMPTION OF STATE AND LOCAL REQUIRE-
MENTS REGARDING FOOD INGREDIENTS AND CONTAMI-
NANTS
IN FOOD, INCLUDING INFANT
AND TODDLER 
FOOD.—No State or political subdivision of a State may 
establish or continue in effect with respect to contami-
nants in food, including infant and toddler food, food 
pouches made with fruit or vegetable puree or juice, and 
juice, any requirement that is different from, or in addi-
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tion to, or not identical with any requirement under this 
section, and relates to contaminant sampling and testing, 
contaminant limits, disclosure of contaminant test results, 
contaminant labeling, contaminant warnings, or any other 
matter related to contaminants in food.’’. 
(b) IMPORTER REQUIREMENTS.—Section 805(c)(4) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
384a(c)(4)) is amended, by inserting ‘‘, including as de-
scribed in section 425(b)’’ before the period at the end. 
(c) ENFORCEMENT.— 
(1) ADULTERATION.—Section 402 of the Fed-
eral 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 in final product form 
that is an infant and toddler food, a food pouch made with 
fruit or vegetable puree or juice, or juice and— 
‘‘(1) such food bears or contains any contami-
nant in excess of limits established under section 
425(a); or 
‘‘(2) the owner, operator, or agent in charge of 
a facility that manufactures or processes the food is 
not in compliance with subsection (b) or (c) of sec-
tion 425.’’. 
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(2) PROHIBITED ACT.—Section 301 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 331) 
is amended by adding at the end the following: 
‘‘(jjj) The failure of an owner, operator, or agent in 
charge of a facility that manufactures or processes food 
to comply with applicable requirements under subsection 
(b) or (c) of section 425.’’. 
SEC. 4. IMPLEMENTATION OF FOOD TRACEABILITY PLAN; 
STUDY ON INSPECTIONS; REPORTING ON IN-
SPECTIONS. 
(a) IMPLEMENTATION
PLAN.—The Secretary of 
Health and Human Services (referred to in this section 
as the ‘‘Secretary’’), acting through the Commissioner of 
Food and Drugs, in coordination with the FDA Human 
Foods Program and the Center for Food Safety and Ap-
plied Nutrition, shall finalize an implementation plan for 
the Food and Drug Administration to achieve its goal of 
compliance, not later than January 20, 2026, with the rule 
issued by the Food and Drug Administration titled, ‘‘Re-
quirements for Additional Traceability Records for Cer-
tain Foods’’ (87 Fed. Reg. 70910 (November 21, 2022)). 
Such plan shall include a description of— 
(1) any resource needs of the Food and Drug 
Administration; 
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(2) strategies for facilitating compliance with 
the rule; and 
(3) detailed plans for communicating with and 
educating regulated entities, non-Federal regulatory 
partners, and regulatory staff of the Food and Drug 
Administration about the requirements under the 
rule. 
(b) STUDY ON INSPECTIONS.—The Secretary shall— 
(1) conduct a study to— 
(A) determine the annual number of facil-
ity inspections that is sufficient to determine 
that imported foods are held to the same safety 
standards as domestic food; and 
(B) identify whether such inspection tar-
gets are consistent with the targets in the most 
recent annual report regarding food conducted 
under section 1003(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 393(h)); 
and 
(2) not later than 1 year after the date of en-
actment of this Act, submit a report to Congress on 
the findings of such study, and, if applicable, any 
factors preventing the Secretary from meeting its 
goal for the number of inspections and a plan to en-
sure that such goal is met in the next 2 years. 
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