H.R. 8429

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8429 Introduced in House (IH)]

<DOC>

119th CONGRESS
2d Session
H. R. 8429

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

April 22, 2026

Mr. Krishnamoorthi (for himself, Ms. Stansbury, Mr. Magaziner, Mrs. 
Sykes, Ms. Norton, Ms. Tlaib, Ms. DeLauro, Ms. Dean of Pennsylvania, 
and Mr. Lieu) 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 contaminants in infant and toddler 
food, and for other purposes.

Be it enacted by the Senate and House of Representatives 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 2026''.

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 amended 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 element) in--
``(i) any infant or toddler food; and
``(ii) food predominantly composed of a 
fruit or vegetable puree or juice.
``(B) Additional limits.--If the Secretary 
determines appropriate upon review of relevant health 
data and other relevant available information, the 
Secretary, by administrative order, may--
``(i) establish limits for contaminants, 
including toxic elements, in infant or toddler 
food, in addition to the limits for toxic 
elements described in subparagraph (A); and
``(ii) establish limits for contaminants, 
including toxic elements, in food predominantly 
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 
assessments, data from State and local health 
departments, 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 use of such 
substances cannot be avoided in the production of the 
applicable food and its ingredients, based on an 
evaluation of alternative ingredients, use of best 
manufacturing and agricultural practices, and full 
compliance with section 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 Register 
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 scientific 
evidence concerning the proposed or final 
limit.
``(3) Changes to limits.--If the Secretary determines 
appropriate after review of relevant data and assessments and 
other available and relevant health information, the Secretary 
may revise any limit established under this subsection by 
administrative order published in the Federal Register in 
accordance 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 December 31, 
2026.
``(ii) For arsenic, not later than December 
31, 2026.
``(iii) For cadmium, not later than April 
30, 2027.
``(iv) For mercury, not later than April 
30, 2029.
``(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 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 determined 
adulterated, at the final product form, under section 402(j), 
if such food bears or contains any contaminant (including any 
toxic element) in excess 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 revised, following the procedure described in 
paragraph (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.--
``(1) In general.--Beginning not later than 180 days after 
the date of enactment of the Baby Food Safety Act of 2026, the 
owner, operator, or agent in charge of a facility engaged in 
manufacturing or processing infant or toddler food, food 
predominantly composed of a fruit or vegetable puree or juice, 
or such other food as the Secretary may specify by regulation, 
for consumption in the United States, shall--
``(A) have a control program in place for toxic 
elements and contaminants subject to limits 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 collected from 
the final food product for toxic elements and 
contaminants, in accordance with a sampling plan 
described in paragraph (2).
``(2) Requirements for sampling and testing plan.--
``(A) In general.--The owner, operator, or agent in 
charge of a facility described in paragraph (1) shall--
``(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 described 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 analyze the 
samples; and
``(iii) appropriate testing frequencies not 
less frequently than every quarter and whenever 
a significant change in the product or process 
necessitates such testing.
``(C) Guidance.--Not later than 18 months after the 
date of enactment of the Baby Food Safety Act of 2026, 
the Secretary shall 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 
contaminants, and standards for compliance.
``(3) Contaminants to be tested.--In carrying out the 
sampling and testing under this subsection, 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 Secretary may 
specify, in accordance 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) 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 appropriate 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 maintained 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 required 
under paragraph (2);
``(v) identification of the entity 
conducting the sampling;
``(vi) identification of the entity 
conducting the testing;
``(vii) identification of the analytical 
methods used to perform the sampling and 
testing;
``(viii) analytical findings of the 
sampling 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 described in paragraph (1) shall 
ensure that testing required pursuant to this subsection is 
performed in accordance with international standards by a 
laboratory that--
``(A) is in compliance with the requirements 
regarding laboratory accreditation described in section 
422; or
``(B) if the requirements described in subparagraph 
(A) do not apply to the laboratory, is accredited by an 
accreditation body that conforms 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 pursuant to this 
subsection.
``(c) Record Availability.--
``(1) In general.--Upon request by the Secretary, 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.--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 advance of or in lieu of an inspection, within a 
reasonable timeframe, within reasonable limits, and in a 
reasonable manner, and in either electronic or physical form, 
at the expense of such owner, operator, or agent. The 
Secretary'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 described in paragraph (2) 
confirmation of the receipt.
``(4) Authority of the secretary.--Nothing in this 
subsection supplants the authority of the Secretary to conduct 
sampling, testing, or inspections 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 beginning on the date that is 2 
years after the date of enactment 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 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 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 element 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 section 425.''.
(2) Prohibited act.--Section 301 of the Federal 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 INSPECTIONS.

(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 Applied 
Nutrition, shall finalize an implementation plan for the Food and Drug 
Administration to achieve its goal of compliance, not later than 
January 20, 2027, with the rule issued by the Food and Drug 
Administration titled, ``Requirements for Additional Traceability 
Records for Certain Foods'' (87 Fed. Reg. 70910 (November 21, 2022)) 
(or any successor rule). Such plan shall include a description of--
(1) any resource needs of the Food and Drug Administration;
(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 facility 
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 targets 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 enactment 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 ensure that such goal is met in the next 2 years.
(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 subparagraph (C), the 
aggregate inspection findings of such inspections, and 
the compliance rate of foreign food importers with 
certification standards;''.

SEC. 5. RECORDS FOR OR IN LIEU OF CERTAIN INSPECTIONS.

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), respectively;
(2) by inserting after subparagraph (A) the following new 
subparagraph:
``(B)(i) Any records or other information that the Secretary may 
remotely inspect or copy under authority 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 reasonable timeframe, within reasonable 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 description of the records or other information requested.
``(ii) The activities described in this clause are records relating 
to--
``(I) the manufacturing, processing, sampling, testing, 
packing, transporting, distributing, receiving, 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 pursuant to a request made under 
this section.''.

SEC. 6. MANDATORY RECALL AUTHORITY.

Section 423(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350l(a)) is amended by inserting after ``animals,'' the 
following: ``or that an article of food is adulterated under paragraph 
(a)(1) or (j) of section 402,''.
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