[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4436 Introduced in Senate (IS)]
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118th CONGRESS
2d Session
S. 4436
To improve the safety of infant formula through testing of infant
formula for microorganisms and toxic elements, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 3, 2024
Mr. Peters (for himself and Mr. Hoeven) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To improve the safety of infant formula through testing of infant
formula for microorganisms and toxic elements, 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 ``Protect Infant Formula from
Contamination Act''.
SEC. 2. MANDATING TESTING OF INFANT FORMULA.
Section 412(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350a(e)) is amended--
(1) in paragraph (1), in the matter following subparagraph
(B)--
(A) by striking ``promptly'';
(B) by inserting ``, within 24 hours of acquiring
such knowledge'' after ``such knowledge''; and
(C) by striking ``the infant formula'' and
inserting ``an infant formula'';
(2) by redesignating paragraph (2) as paragraph (5);
(3) in paragraph (5), as so redesignated, by striking
``paragraph (1)'' and inserting ``paragraphs (1) and (2)''; and
(4) by inserting after paragraph (1) the following:
``(2) If the result of any testing of a sample from any production
aggregate of finished infant formula product is confirmed as a positive
analytical result for any microorganism for which finished product
testing is required under section 106.55(e) of title 21, Code of
Federal Regulations (or any successor regulation), the manufacturer
shall--
``(A) within 24 hours of acquiring a confirmed positive
analytical result, notify the Secretary of such knowledge,
regardless of whether such product has left an establishment
subject to the control of the manufacturer;
``(B) promptly consult with the Secretary for proper
isolation of the affected product, and, as the Secretary may
require, cease distribution and properly dispose of the
affected product; and
``(C) promptly provide to the Secretary results and
isolates from a positive sample of such product.
``(3) Not later than 72 hours after receipt by the Secretary of a
notification under paragraph (2)(A), the Secretary shall respond to the
manufacturer of the infant formula to begin discussions regarding
investigation and corrective action, and, as appropriate, share the
findings of the Secretary with the manufacturer.
``(4) Not later than 90 days after receipt of a notification under
paragraph (1) or (2), the Secretary shall confirm, including through
the collection of documentation, that the manufacturer submitting the
notification performed, or is performing, an appropriate investigation
and corrective action, if applicable. The Secretary shall consider, as
part of the review of the root cause investigation, the analytical
method used to conduct laboratory testing and, as appropriate, the
potential for cross contamination of the sample by handling and
testing. The manufacturer shall make such documentation available to
the Secretary electronically or by other means, if requested by the
Secretary.''.
SEC. 3. REPORTING TO IMPROVE THE SAFETY AND SUPPLY OF INFANT FORMULA.
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) Reporting To Improve the Safety and Supply of Infant
Formula.--
``(1) Progress report.--Not later than 180 days after the
date of enactment of the Protect Infant Formula from
Contamination Act, the Secretary shall issue a progress report
on implementation of the recommendations to improve the safety
and supply of infant formula contained in the report titled,
`Immediate National Strategy to Increase the Resiliency of the
U.S. Infant Formula Market', issued by the Food and Drug
Administration in March 2023. Such progress report shall
include additional authorities or resources that the Secretary
may require for purposes of improving the safety and supply of
infant formula.
``(2) Quarterly reports on supply chain.--Not later than
270 days after the date of enactment of the Protect Infant
Formula from Contamination Act, and not less frequently than
quarterly for the 5-year period thereafter, the Secretary shall
submit a report on the most current, critical supply chain data
for infant formula, including in-stock rates, to--
``(A) the Committee on Health, Education, Labor,
and Pensions; the Committee on Agriculture, Nutrition,
and Forestry; and the Subcommittee on Agriculture,
Rural Development, Food and Drug Administration, and
Related Agencies of the Committee on Appropriations of
the Senate; and
``(B) the Committee on Energy and Commerce; the
Committee on Agriculture; and the Subcommittee on
Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies of the Committee
on Appropriations of the House of Representatives.
``(3) Consultation.--The Secretary, in accordance with the
National Strategy set forth in the report described in
paragraph (1), shall engage with the Department of Agriculture
and other relevant agencies of the Federal Government regarding
ongoing efforts to address immediate formula needs and build
long-term resiliency into the infant formula market.
``(4) Annual reports on adequacy of supply.--Not later than
270 days after the date of enactment of the Protect Infant
Formula from Contamination Act, and not less frequently than
annually for the 5-year period thereafter, the Secretary
shall--
``(A) engage with infant formula manufacturers to
determine evidence-based practices that can be
implemented to maximize infant formula supply and
infant safety, including the value of high frequency
testing in identifying contamination events and
bracketing potentially contaminated product, the impact
of corrective action on contamination events, and
evidence-based recommendations for enhancing infant
formula supply and safety; and
``(B) submit a report to the committees described
in subparagraphs (A) and (B) of paragraph (2) that
identifies the modifications to manufacturer practices
and actions described in subparagraph (A), if any, that
could be implemented to improve infant formula supply
and safety.''.
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