[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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