119-hr2472

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2472 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 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

 March 27, 2025

 Mrs. Sykes (for herself, Mr. Pallone, 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 Representatives 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 2025'' or the ``INFANTS Act of 2025''.

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.--
 ``
        (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 conducted 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 analyze the 
 samples.
 ``
            (C) Guidance.--Not later than 18 months after the 
 date of enactment of this section, the Secretary shall 
 issue guidance to assist food facilities in developing 
 sampling plans. Such guidance may, as determined 
 appropriate 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, cadmium, 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 manufactured or processed at the facility, 
 whichever is longer, records documenting the sampling and 
 testing conducted under this section with respect to the food.
 ``

    (2) Requirements.--Records required by paragraph

    (1) to 
 be maintained shall include a detailed 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 entity 
 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, operator, or agent in 
charge of a food facility described in subsection

    (a)

    (1) shall ensure 
that testing conducted pursuant 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 section is not 
subject to the requirements regarding laboratory accreditation 
described in 

section 422.
 ``
            (d) Records Availability.--
 ``

    (1) In general.--The owner, operator, or agent in charge 
 of a food facility described in subsection

    (a)

    (1) shall make 
 all records required under this section available promptly to 
 the Secretary, upon request, for inspection and copying. Upon 
 request 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 inspection.--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 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 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

    (2) , the Secretary shall provide to the person 
 confirmation of receipt.
 ``

    (4) Authority of the secretary.--Nothing 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 beginning on the date that is 180 days 
after the date on which the Secretary publishes the guidance required 
by subsection

    (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 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) ,
            (C) , and
            (D) as 
 subparagraphs
            (C) ,
            (D) , and
        (E) , respectively;

    (2) by inserting after subparagraph
        (A) the following:
 ``
        (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 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 requested.
 ``
            (ii) The activities described in this clause are the following:
 ``
            (I) The manufacturing, processing, packing, transporting, 
 distributing, receiving, holding, or importing 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

    (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 Cosmetic 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 formula) bears or contains a contaminant that 
renders the product adulterated under 

section 402

    (a)

    (1) ,'' after 
``animals,''.

SEC. 7. REPORT FINAL PRODUCT POSITIVE TEST RESULTS FOR RELEVANT 
 PATHOGENS IN INFANT FORMULA.

 

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 
 infant formula'';
        (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 product 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 

section 117.3 of title 21, Code of Federal 
Regulations (or any successor regulation)), the manufacturer shall--
 ``
        (A) within 24 hours of acquiring such confirmation, 
 notify the Secretary of such confirmation regardless of whether 
 such infant formula has left an establishment subject to the 
 control of the manufacturer;
 ``
        (B) consult with the Secretary for proper disposal and 
 properly dispose of the affected product; and
 ``
            (C) provide to the Secretary results and isolates from a 
 positive sample of such infant formula.
 ``

    (3) Not later than 90 days after receipt of a notification under 
paragraph

    (1) or

    (2) , the Secretary shall confirm through the 
collection of documentation that the manufacturer submitting the 
notification performed, or is performing, appropriate corrective 
action. The manufacturer shall make such documentation available to the 
Secretary during an inspection and, upon request of the Secretary, 
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 Monitoring for Cronobacter Spp 
and Salmonella.--
 ``

    (1) In general.--A manufacturer of powdered 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, number of samples to be taken, 
 and timing and frequency of sample collection and testing.
 ``

    (2) Sampling location and number of samples.--A 
 manufacturer of powdered infant formula shall ensure that the 
 sampling locations from which samples will be taken, and the 
 number of sites to be tested during routine environmental 
 monitoring pursuant to an environmental monitoring program 
 under paragraph

    (1) , are adequate to determine whether 
 sanitation and hygiene controls are effective.
 ``

    (3) Timing and frequency.--A manufacturer of powdered 
 infant formula shall ensure that the timing and frequency for 
 collecting testing samples pursuant to an environmental 
 monitoring program under paragraph

    (1) are adequate to 
 determine whether sanitation and hygiene controls are 
 effective.
 ``

    (4) Records.--
 ``
        (A) Availability to the secretary.--A 
 manufacturer of powdered infant formula shall make all 
 records required under this subsection available 
 promptly to the Secretary, upon request, for inspection 
 and copying.
 ``
        (B) Maintenance.--Records of environmental 
 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.
 ``
            (C) Conditions of inspection.--Any records that 
 the Secretary may inspect under this subsection shall, 
 upon the request of the Secretary, be provided to the 
 Secretary by the manufacturer of powdered infant 
 formula, 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 
 manufacturer. The Secretary's request shall include a 
 sufficient description of the records requested.
 ``
            (D) Confirmation of receipt.--Upon receipt of 
 records requested under subparagraph
            (C) , the Secretary 
 shall provide to the person confirmation of receipt.
 ``

    (5) Authority of the secretary.--Nothing 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.
 ``

    (6) Delayed applicability.--The requirements of this 
 subsection apply beginning on the date that is 180 days after 
 the date of enactment of this subsection.
 ``

    (7) Rule of construction.--Nothing in this subsection 
 shall be construed to exempt an infant formula manufacturer 
 from the requirements of this Act, including the requirements 
 of this section and 

section 418.''.
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