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