119-s272

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 272 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 272

 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

 January 28, 2025

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. NOTIFICATIONS FOR 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 1 business day 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) ; and

    (3) 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 1 business day of acquiring a confirmed 
 positive analytical result, notify the Secretary of such 
 result, 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 or the whole 
 genetic sequence from any confirmed positive analytical result.
 ``

    (3) Not later than 1 business day 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 and for inspection under 

section 704.''.

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, 
 `Long-Term National Strategy to Increase the Resiliency of the 
 U.S. Infant Formula Market', issued by the Food and Drug 
 Administration in January 2025. 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 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) Reports on adequacy of supply.--Not later than 1 
 year, 3 years, and 5 years after the date of enactment of the 
 Protect Infant Formula from Contamination Act, the Secretary 
 shall--
 ``
        (A) engage with public stakeholders, infant 
 formula manufacturers, and other stakeholders, as 
 determined by the Secretary, to determine evidence-
 based practices that can be implemented to maximize 
 infant formula supply and infant safety, which may 
 include the value of high frequency testing for 
 purposes of 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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