PROTECT INFANT FORMULA FROM CONTAMINATION ACT

Quick facts

Record: Senate Floor
Section type: Floor speeches
Chamber: Senate
Date: April 28, 2026
Congress: 119th Congress
Why this source matters: This section came from the Senate floor portion of the record.

Linked context

People mentioned: Lummis, Cynthia M.
Bills and resolutions: S. 272 (119th Congress)
Committees: Committee on Health, Education, Labor, and Pensions, Committee on Agriculture, Nutrition, and Forestry, Committee on Appropriations

Readable version of the official text

Ms. LUMMIS. Mr. President, I ask unanimous consent that the Senate proceed to the immediate consideration of Calendar No. 306, S. 272.

The PRESIDING OFFICER. The clerk will report the bill by title.

The senior assistant bill clerk read as follows:

A bill (S. 272) to improve the safety of infant formula

through testing of infant formula for microorganisms and

toxic elements, and for other purposes.

There being no objection, the Senate proceeded to consider the bill,

which had been reported from the Committee on Health, Education, Labor, and Pensions, with an amendment to strike all after the enacting clause and insert the part printed in italic, as follows:

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

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.”.

Ms. LUMMIS. Mr. President, I ask unanimous consent that the committee-reported substitute amendment be agreed to; that the bill, as amended, be considered read a third time and passed; and that the motion to reconsider be considered made and laid upon the table.

The PRESIDING OFFICER. Without objection, it is so ordered.