I 
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 Cos-
metic Act to enhance the safeguards applicable with re-
spect to infant formula. 
Be it enacted by the Senate and House of Representa-
tives 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 CRIT-
ICAL 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: 
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‘‘(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 manu-
facturer 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 mis-
branded, 
the manufacturer shall, within 24 hours, notify the Sec-
retary 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 manu-
facturer may be adulterated due to pathogen contamina-
tion (such as confirmation of a positive analytical result 
from any in-process or finished product testing), the man-
ufacturer 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 for-
mula has left an establishment subject to the control 
of the manufacturer; and 
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‘‘(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 re-
quirements or procedures specified by the Secretary. 
‘‘(4) If the Secretary determines that an infant for-
mula presents a risk to human health, the manufacturer 
shall immediately take all actions necessary to cease dis-
tribution of such infant formula and recall shipments of 
such infant formula from all wholesale and retail establish-
ments, 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 Sec-
retary shall immediately notify the appropriate congres-
sional committees what, if any, accountability mechanisms 
were, or will be, invoked for such failure. 
‘‘(6) The Director of the Office of Critical Foods— 
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‘‘(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, appro-
priate corrective action, including a root cause anal-
ysis; 
‘‘(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 mecha-
nisms 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; 
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‘‘(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 manufac-
turer 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 ‘patho-
gen’ means a microorganism of public health signifi-
cance.’’. 
(b) TIMING.— 
(1) 
NOTIFICATION
REQUIREMENTS.—Para-
graphs (1), (2), (3), (4), (8), and (9) of subsection 
(e) of section 412 of the Federal Food, Drug, and 
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Cosmetic Act (21 U.S.C. 350a), as amended by sub-
section (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 im-
plementation of such process. 
Æ 
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