[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 272 Reported in Senate (RS)]
<DOC>
Calendar No. 306
119th CONGRESS
2d 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, Mr. Hoeven, Ms. Collins, Ms. Smith, Mrs.
Shaheen, Ms. Hassan, Mr. Kaine, and Ms. Baldwin) introduced the
following bill; which was read twice and referred to the Committee on
Health, Education, Labor, and Pensions
January 28, 2026
Reported by Mr. Cassidy, with an amendment and an amendment to the
title
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Protect Infant Formula from
Contamination Act''.</DELETED>
<DELETED>SEC. 2. NOTIFICATIONS FOR TESTING OF INFANT FORMULA.</DELETED>
<DELETED> Section 412(e) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350a(e)) is amended--</DELETED>
<DELETED> (1) in paragraph (1), in the matter following
subparagraph (B)--</DELETED>
<DELETED> (A) by striking ``promptly'';</DELETED>
<DELETED> (B) by inserting ``, within 1 business day
of acquiring such knowledge'' after ``such knowledge'';
and</DELETED>
<DELETED> (C) by striking ``the infant formula'' and
inserting ``an infant formula'';</DELETED>
<DELETED> (2) by redesignating paragraph (2) as paragraph
(5); and</DELETED>
<DELETED> (3) by inserting after paragraph (1) the
following:</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 3. REPORTING TO IMPROVE THE SAFETY AND SUPPLY OF INFANT
FORMULA.</DELETED>
<DELETED> Section 412 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 350a) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(n) Reporting To Improve the Safety and Supply of Infant
Formula.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.''.</DELETED>
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
genome sequence data 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 and any revisions to the recommendations as a
result of any infant formula recalls since the publication of
the report, as appropriate.
``(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, including
events associated with botulism or other contaminants,
and bracketing potentially contaminated product, the
impact of corrective action on contamination events,
including events associated with botulism or other
contaminants, 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.''.
Amend the title so as to read: ``A bill to improve the
safety of infant formula through testing of infant formula for
microorganisms, and for other purposes.''.
Calendar No. 306
119th CONGRESS
2d Session
S. 272
_______________________________________________________________________
A BILL
To improve the safety of infant formula through testing of infant
formula for microorganisms and toxic elements, and for other purposes.
_______________________________________________________________________
January 28, 2026
Reported with an amendment and an amendment to the title