[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5316 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 5316

  To amend section 412 of the Federal Food, Drug, and Cosmetic Act to 
   enhance the safeguards applicable with respect to infant formula.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            August 29, 2023

  Ms. Porter (for herself and Mrs. McClain) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
  To amend section 412 of the Federal Food, Drug, and Cosmetic Act to 
   enhance the safeguards applicable with respect to infant formula.

    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 ``Safeguarding Kids and Families from 
Critical Food Disruptions Act of 2023''.

SEC. 2. SAFEGUARDING KIDS AND FAMILIES FROM CRITICAL FOOD DISRUPTIONS.

    (a) In General.--Subsection (e) of section 412 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350a) is amended to read as follows:
    ``(e)(1) If the manufacturer of an infant formula has knowledge 
which reasonably supports the conclusion that an infant formula which 
has been processed by the manufacturer and which has left an 
establishment subject to the control of the manufacturer--
            ``(A) may not provide the nutrients required by subsection 
        (i); or
            ``(B) may be otherwise adulterated or misbranded,
the manufacturer shall, within 24 hours, notify the Secretary and the 
Director of the Office of Critical Foods of such knowledge.
    ``(2) If the manufacturer of an infant formula has knowledge which 
reasonably supports the conclusion that an infant formula which has 
been processed by the manufacturer may be adulterated due to pathogen 
contamination (such as confirmation of a positive analytical result 
from any in-process or finished product testing), the manufacturer 
shall--
            ``(A) within 24 hours, notify the Secretary and the 
        Director of the Office of Critical Foods of such knowledge, 
        regardless of whether such infant formula has left an 
        establishment subject to the control of the manufacturer; and
            ``(B) provide to the Secretary, for the purpose of 
        sequencing, results and isolates from a positive sample of such 
        infant formula.
    ``(3) In submitting a notification under paragraph (1) or (2), a 
manufacturer shall adhere to any submission requirements or procedures 
specified by the Secretary.
    ``(4) If the Secretary determines that an infant formula presents a 
risk to human health, the manufacturer shall immediately take all 
actions necessary to cease distribution of such infant formula and 
recall shipments of such infant formula from all wholesale and retail 
establishments, consistent with recall regulations and guidelines 
issued by the Secretary.
    ``(5)(A) Not later than 72 hours after receipt by the Director of 
the Office of Critical Foods of a notification under paragraph (1) or 
(2), the Director shall contact the manufacturer of the infant formula, 
or an affiliate thereof in the United States, to discuss corrective 
action.
    ``(B) If there is a failure of the Director of the Office of 
Critical Foods to act within 72 hours after receipt of a notification 
as required by subparagraph (A), the Secretary shall immediately notify 
the appropriate congressional committees what, if any, accountability 
mechanisms were, or will be, invoked for such failure.
    ``(6) The Director of the Office of Critical Foods--
            ``(A) not later than 90 days after receipt by the Director 
        of a notification under paragraph (1) or (2), shall confirm 
        that the manufacturer submitting the notification performed, or 
        is performing, appropriate corrective action, including a root 
        cause analysis;
            ``(B) in making such confirmation, may collect 
        documentation during an inspection, electronically, or by other 
        means; and
            ``(C) shall notify the appropriate congressional committees 
        if the Director is unable to make such confirmation and what, 
        if any, accountability mechanisms were, or will be, invoked for 
        such failure.
    ``(7) Not later than the end of each of calendar years 2024, 2025, 
and 2026, the Secretary shall submit to the Congress a report 
containing--
            ``(A) the number of notifications received under paragraph 
        (1) or (2) during the fiscal year ending in the respective 
        calendar year;
            ``(B) the average number of hours it took the Director of 
        the Office of Critical Foods to initiate contact, as required 
        by paragraph (5), in response to such notifications;
            ``(C) the longest and shortest time it took the Director of 
        the Office of Critical Foods to so initiate contact;
            ``(D) the average number of days it took the Director of 
        the Office of Critical Foods to confirm corrective action, as 
        required by paragraph (6), in response to such notifications; 
        and
            ``(E) the longest and shortest number of days it took the 
        Director of the Office of Critical Foods to so confirm 
        corrective action.
    ``(8) For purposes of paragraphs (1) and (2), the term `knowledge' 
as applied to a manufacturer means--
            ``(A) the actual knowledge that the manufacturer had; or
            ``(B) the knowledge which a reasonable person would have 
        had under like circumstances or which would have been obtained 
        upon the exercise of due care.
    ``(9) For purposes of paragraph (2), the term `pathogen' means a 
microorganism of public health significance.''.
    (b) Timing.--
            (1) Notification requirements.--Paragraphs (1), (2), (3), 
        (4), (8), and (9) of subsection (e) of section 412 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as 
        amended by subsection (a), apply upon the enactment of this 
        Act.
            (2) Response by secretary.--Not later than 180 days after 
        the date of enactment of this Act, the Secretary of Health and 
        Human Services, acting through the Director of the Office of 
        Critical Foods, shall establish a process for carrying out 
        paragraphs (5) and (6) of subsection (e) of section 412 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as 
        amended by subsection (a), and begin implementation of such 
        process.
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