--- Reported (Senate)
+++ Engrossed (Senate)
@@ -1,165 +1,21 @@
[From the U.S. Government Publishing Office]
-[S. 272 Reported in Senate (RS)]
+[S. 272 Engrossed in Senate (ES)]
<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
+AN ACT
To improve the safety of infant formula through testing of infant
-formula for microorganisms and toxic elements, and for other purposes.
+formula for microorganisms, 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.
@@ -278,11 +134,12 @@
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
+Passed the Senate April 28, 2026.
+
+Attest:
+
+Secretary.
119th CONGRESS
2d Session
@@ -291,13 +148,7 @@
_______________________________________________________________________
-A BILL
+AN ACT
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
+formula for microorganisms, and for other purposes.