II 

118TH CONGRESS 

2D SESSION S. 4436 

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 

JUNE 3, 2024 

Mr. PETERS (for himself and Mr. HOEVEN) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To improve the safety of infant formula through testing 

of infant formula for microorganisms and toxic elements, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protect Infant For5 mula from Contamination Act’’. 

6 SEC. 2. MANDATING TESTING OF INFANT FORMULA. 

7 Section 412(e) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 350a(e)) is amended— 


ssavage on LAPJG3WLY3PROD with BILLS
2 

•S 4436 IS

1 (1) in paragraph (1), in the matter following 

2 subparagraph (B)— 

3 (A) by striking ‘‘promptly’’; 

4 (B) by inserting ‘‘, within 24 hours of ac5 quiring such knowledge’’ after ‘‘such knowl6 edge’’; and 

7 (C) by striking ‘‘the infant formula’’ and 

8 inserting ‘‘an infant formula’’; 

9 (2) by redesignating paragraph (2) as para10 graph (5); 

11 (3) in paragraph (5), as so redesignated, by 

12 striking ‘‘paragraph (1)’’ and inserting ‘‘paragraphs 

13 (1) and (2)’’; and 

14 (4) by inserting after paragraph (1) the fol15 lowing: 

16 ‘‘(2) If the result of any testing of a sample from 

17 any production aggregate of finished infant formula prod18 uct is confirmed as a positive analytical result for any 

19 microorganism for which finished product testing is re20 quired under section 106.55(e) of title 21, Code of Federal 

21 Regulations (or any successor regulation), the manufac22 turer shall— 

23 ‘‘(A) within 24 hours of acquiring a confirmed 

24 positive analytical result, notify the Secretary of 

25 such knowledge, regardless of whether such product 


ssavage on LAPJG3WLY3PROD with BILLS
3 

•S 4436 IS

1 has left an establishment subject to the control of 

2 the manufacturer; 

3 ‘‘(B) promptly consult with the Secretary for 

4 proper isolation of the affected product, and, as the 

5 Secretary may require, cease distribution and prop6 erly dispose of the affected product; and 

7 ‘‘(C) promptly provide to the Secretary results 

8 and isolates from a positive sample of such product. 

9 ‘‘(3) Not later than 72 hours after receipt by the Sec10 retary of a notification under paragraph (2)(A), the Sec11 retary shall respond to the manufacturer of the infant for12 mula to begin discussions regarding investigation and cor13 rective action, and, as appropriate, share the findings of 

14 the Secretary with the manufacturer. 

15 ‘‘(4) Not later than 90 days after receipt of a notifi16 cation under paragraph (1) or (2), the Secretary shall con17 firm, including through the collection of documentation, 

18 that the manufacturer submitting the notification per19 formed, or is performing, an appropriate investigation and 

20 corrective action, if applicable. The Secretary shall con21 sider, as part of the review of the root cause investigation, 

22 the analytical method used to conduct laboratory testing 

23 and, as appropriate, the potential for cross contamination 

24 of the sample by handling and testing. The manufacturer 

25 shall make such documentation available to the Secretary 


ssavage on LAPJG3WLY3PROD with BILLS
4 

•S 4436 IS

1 electronically or by other means, if requested by the Sec2 retary.’’. 

3 SEC. 3. REPORTING TO IMPROVE THE SAFETY AND SUPPLY 

4 OF INFANT FORMULA. 

5 Section 412 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 350a) is amended by adding at the end 

7 the following: 

8 ‘‘(n) REPORTING TO IMPROVE THE SAFETY AND

9 SUPPLY OF INFANT FORMULA.— 

10 ‘‘(1) PROGRESS REPORT.—Not later than 180 

11 days after the date of enactment of the Protect In12 fant Formula from Contamination Act, the Sec13 retary shall issue a progress report on implementa14 tion of the recommendations to improve the safety 

15 and supply of infant formula contained in the report 

16 titled, ‘Immediate National Strategy to Increase the 

17 Resiliency of the U.S. Infant Formula Market’, 

18 issued by the Food and Drug Administration in 

19 March 2023. Such progress report shall include ad20 ditional authorities or resources that the Secretary 

21 may require for purposes of improving the safety 

22 and supply of infant formula. 

23 ‘‘(2) QUARTERLY REPORTS ON SUPPLY

24 CHAIN.—Not later than 270 days after the date of 

25 enactment of the Protect Infant Formula from ConVerDate Sep 11 2014 20:54 Jul 17, 2024 Jkt 049200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4436.IS S4436

ssavage on LAPJG3WLY3PROD with BILLS
5 

•S 4436 IS

1 tamination Act, and not less frequently than quar2 terly for the 5-year period thereafter, the Secretary 

3 shall submit a report on the most current, critical 

4 supply chain data for infant formula, including in5 stock rates, to— 

6 ‘‘(A) the Committee on Health, Education, 

7 Labor, and Pensions; the Committee on Agri8 culture, Nutrition, and Forestry; and the Sub9 committee on Agriculture, Rural Development, 

10 Food and Drug Administration, and Related 

11 Agencies of the Committee on Appropriations of 

12 the Senate; and 

13 ‘‘(B) the Committee on Energy and Com14 merce; the Committee on Agriculture; and the 

15 Subcommittee on Agriculture, Rural Develop16 ment, Food and Drug Administration, and Re17 lated Agencies of the Committee on Appropria18 tions of the House of Representatives. 

19 ‘‘(3) CONSULTATION.—The Secretary, in ac20 cordance with the National Strategy set forth in the 

21 report described in paragraph (1), shall engage with 

22 the Department of Agriculture and other relevant 

23 agencies of the Federal Government regarding ongo24 ing efforts to address immediate formula needs and 


ssavage on LAPJG3WLY3PROD with BILLS
6 

•S 4436 IS

1 build long-term resiliency into the infant formula 

2 market. 

3 ‘‘(4) ANNUAL REPORTS ON ADEQUACY OF SUP4 PLY.—Not later than 270 days after the date of en5 actment of the Protect Infant Formula from Con6 tamination Act, and not less frequently than annu7 ally for the 5-year period thereafter, the Secretary 

8 shall— 

9 ‘‘(A) engage with infant formula manufac10 turers to determine evidence-based practices 

11 that can be implemented to maximize infant 

12 formula supply and infant safety, including the 

13 value of high frequency testing in identifying 

14 contamination events and bracketing potentially 

15 contaminated product, the impact of corrective 

16 action on contamination events, and evidence17 based recommendations for enhancing infant 

18 formula supply and safety; and 

19 ‘‘(B) submit a report to the committees de20 scribed in subparagraphs (A) and (B) of para21 graph (2) that identifies the modifications to 

22 manufacturer practices and actions described in 

23 subparagraph (A), if any, that could be impleVerDate Sep 11 2014 20:54 Jul 17, 2024 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4436.IS S4436

ssavage on LAPJG3WLY3PROD with BILLS
7 

•S 4436 IS

1 mented to improve infant formula supply and 

2 safety.’’. 

Æ 


ssavage on LAPJG3WLY3PROD with BILLS