SEC. 2. DEFINITION OF INFANT OR 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 or toddler food’ means food 
that purports to be, or is represented as being, for infants 
or children up to the age of 24 months. Such term does 
not include infant formula.’’. 
SEC. 3. CONTAMINANTS IN FOOD, INCLUDING INFANT OR 
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 
OR TODDLER FOOD. 
‘‘(a) ADMINISTRATIVE ORDERS FOR CONTAMINANTS, 
INCLUDING TOXIC ELEMENTS, IN FOOD.— 
‘‘(1) IN GENERAL.— 
‘‘(A) REQUIRED
LIMITS.—The Secretary, 
by administrative order, shall establish limits on 
the toxic elements of lead, cadmium, mercury, 
and arsenic (or a species of any such toxic ele-
ment) in— 
‘‘(i) any infant or toddler food; and 
‘‘(ii) food predominantly composed of 
a fruit or vegetable puree or juice; 
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‘‘(B) ADDITIONAL
LIMITS.—If the Sec-
retary determines appropriate upon review of 
relevant health data and other relevant avail-
able information, the Secretary, by administra-
tive order, may— 
‘‘(i) establish limits for contaminants, 
including toxic elements, in infant or tod-
dler food, in addition to the limits for toxic 
elements described in subparagraph (A); 
and 
‘‘(ii) establish limits for contaminants, 
including toxic elements, in food predomi-
nantly composed of a fruit or vegetable 
puree or juice, in addition to the limits for 
toxic elements described in subparagraph 
(A). 
‘‘(2) PROCEDURE.—In establishing or revising 
any limit under paragraph (1), the Secretary shall— 
‘‘(A) evaluate relevant health data and as-
sessments, data from State and local health de-
partments, and other information the Secretary 
considers relevant; 
‘‘(B) take into account relevant differences 
among food types, groups, and categories, as 
appropriate, including the extent to which the 
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use of such substances cannot be avoided in the 
production of the applicable food and its ingre-
dients, based on an evaluation of alternative in-
gredients, use of best manufacturing and agri-
cultural practices, and full compliance with sec-
tion 418; and 
‘‘(C) notwithstanding the requirements of 
subchapter II of chapter 5 of title 5, United 
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) CHANGES TO LIMITS.—If the Secretary de-
termines appropriate after review of relevant data 
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and assessments and other available and relevant 
health information, the Secretary may revise any 
limit established under this subsection by adminis-
trative order published in the Federal Register in ac-
cordance with paragraph (2). 
‘‘(4) TIMEFRAME FOR INITIAL LIMITS.— 
‘‘(A) PROPOSED ORDERS.—Subject to the 
requirements of paragraph (2), the Secretary 
shall issue proposed orders for limits under 
paragraph (1)(A) as follows: 
‘‘(i) For lead, not later than Decem-
ber 31, 2025. 
‘‘(ii) For arsenic, not later than De-
cember 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 subparagraph (A) or 
(B) of paragraph (1) not later than 18 months 
after issuance of the respective proposed order. 
‘‘(5) CRITERIA.—The limits established under 
this section shall represent the level at which the 
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contaminant may render the infant or toddler food 
injurious to health. In determining such limits the 
Secretary shall take into account the extent to which 
the use of such substance cannot be avoided in the 
production of each such food and its ingredients, 
based on an evaluation of alternative ingredients, 
use of best manufacturing and agricultural practices, 
and compliance with section 418. 
‘‘(6) ADULTERATED FOOD.—A food may be de-
termined adulterated, at the final product form, 
under section 402(j), if such food bears or contains 
any contaminant (including any toxic element) in ex-
cess of a limit established under this subsection. 
‘‘(7) PERIODIC REVIEW.—The Secretary shall 
review, not less frequently than every 4 years, the 
limits established under this subsection, taking into 
consideration relevant information and available 
data to consider whether such limits should be re-
vised, following the procedure described in para-
graph (2), in accordance with the criteria specified 
in paragraph (5). 
‘‘(b) SAMPLING AND TESTING FOR TOXIC ELEMENTS 
AND CONTAMINANTS IN FOOD, INCLUDING INFANT AND 
TODDLER FOOD.— 
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‘‘(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 or toddler food; food pre-
dominantly composed of a fruit or vegetable puree or 
juice; or such other food as the Secretary may speci-
fy by regulation, for consumption in the United 
States, shall— 
‘‘(A) have a control program in place for 
toxic elements and contaminants subject to lim-
its under subsection (a)(1); 
‘‘(B) collect representative samples of each 
such food in final product form in accordance 
with a sampling plan described in paragraph 
(2); and 
‘‘(C) conduct testing of the samples col-
lected from the final food product for toxic ele-
ments and contaminants, in accordance with a 
sampling plan described in paragraph (2). 
‘‘(2) REQUIREMENTS FOR SAMPLING AND TEST-
ING PLAN.— 
‘‘(A) IN GENERAL.—The owner, operator, 
or agent in charge of a facility described in 
paragraph (1) shall— 
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‘‘(i) prepare a written plan for all 
sampling and testing required under this 
subsection; and 
‘‘(ii) ensure that all sampling and 
testing conducted under this subsection is 
conducted in accordance with the plan de-
scribed in clause (i). 
‘‘(B) SAMPLING
PLAN.—A sampling and 
testing 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 toxic elements and 
contaminants in each food; 
‘‘(ii) one or more appropriate test 
methods and procedures to be used to ana-
lyze the samples; and 
‘‘(iii) appropriate testing frequencies 
not less frequently than every quarter and 
whenever a significant change in the prod-
uct or process necessitates such testing. 
‘‘(C) GUIDANCE.—Not later than 18 
months after the date of enactment of the Baby 
Food Safety Act of 2024, the Secretary shall 
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issue guidance to assist facilities described 
under paragraph (1) with developing sampling 
and testing plans. Such guidance shall address 
the standards for adequate and appropriate 
sampling and testing of each toxic element and 
contaminant as required by the Secretary, the 
minimum frequency at which samples should be 
tested for toxic elements and contaminants or 
specific species of toxic elements or contami-
nants, and standards for compliance. 
‘‘(3) CONTAMINANTS TO BE TESTED.—In car-
rying out the sampling and testing under this sub-
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 arsenic; 
and 
‘‘(B) any other contaminant that the Sec-
retary may specify, in accordance with the sam-
pling 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; 
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‘‘(B) foods predominantly composed of a 
fruit or vegetable puree or juice; and 
‘‘(C) such other foods in final product 
form as the Secretary has specified, as appro-
priate for the protection of 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 
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 and copying 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; 
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‘‘(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; 
‘‘(vii) identification of the analytical 
methods used to perform the sampling and 
testing; 
‘‘(viii) analytical findings of the sam-
pling and testing; and 
‘‘(ix) such other data and information 
as the Secretary may require. 
‘‘(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— 
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‘‘(A) is in compliance with the require-
ments regarding laboratory accreditation de-
scribed in section 422; or 
‘‘(B) if the requirements described in sub-
paragraph (A) do not apply to the laboratory, 
is accredited by an accreditation body that con-
forms to international accreditation standards. 
‘‘(7) SAMPLING AND TESTING PROGRAM.—The 
Secretary shall develop and implement a sampling 
and testing program for infant and toddler food that 
is sufficient to— 
‘‘(A) support the periodic review under 
subsection (a)(7) of limits on toxic elements in 
infant and toddler food; and 
‘‘(B) independently verify that products 
are compliant with the limits proscribed pursu-
ant to 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 
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‘‘(B) provide within a reasonable time an 
English translation of such records maintained 
in a language other than English. 
‘‘(2) RECORD AVAILABILITY.—Any records that 
the Secretary may inspect 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 described in subsection (b)(1), in ad-
vance of or in lieu of an inspection, within a reason-
able timeframe, within reasonable limits, and in a 
reasonable manner, and in either electronic or phys-
ical form, at the expense of such owner, operator, or 
agent. The Secretary’s request shall include a suffi-
cient 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-
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ginning on the date that is 2 years after the date of enact-
ment of this subsection.’’. 
(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 ‘‘monitoring and 
verifying the accuracy of records described in section 
425(b)’’ after ‘‘for shipments,’’. 
(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 predominantly 
composed of a fruit or vegetable puree or juice, or such 
other food as the Secretary may specify and— 
‘‘(1) such food bears or contains any toxic ele-
ment or contaminant in excess of a limit 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.’’. 
(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: 
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‘‘(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)) 
(or any successor rule). Such plan shall include a descrip-
tion of— 
(1) any resource needs of the Food and Drug 
Administration; 
(2) strategies for facilitating compliance with 
the rule; and 
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(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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(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 remotely inspect or copy under authority 
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of this Act from a person that owns or operates, or is an 
agent in charge of, 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, 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 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 or other in-
formation requested. 
‘‘(ii) The activities described in this clause are 
records relating to— 
‘‘(I) the manufacturing, processing, sampling, 
testing, packing, transporting, distributing, receiv-
ing, holding, or importing 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 obtained 
or copied, or other information obtained or copied pursu-
ant to a request made under this section.’’. 
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