II 

117TH CONGRESS 

2D SESSION S. 4257 

To amend the Child Nutrition Act of 1966 to establish requirements for 

infant formula cost containment contracts, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 18 (legislative day, MAY 17), 2022 

Ms. STABENOW (for herself, Mr. BOOZMAN, Mr. LEAHY, Mr. HOEVEN, Mr. 

BROWN, Mr. MARSHALL, Ms. KLOBUCHAR, Mrs. CAPITO, Mr. BENNET, 

Mr. TILLIS, Mrs. GILLIBRAND, Ms. COLLINS, Ms. SMITH, Mr. GRASSLEY, 

Mr. BOOKER, Mrs. FISCHER, Mr. WARNOCK, Mr. CORNYN, Mr. CASEY, 

Mr. LUJA ́N, Mr. DURBIN, Ms. HASSAN, Ms. DUCKWORTH, and Mr. 

KELLY) introduced the following bill; which was read twice and referred 

to the Committee on Agriculture, Nutrition, and Forestry 

A BILL 

To amend the Child Nutrition Act of 1966 to establish 

requirements for infant formula cost containment contracts, 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 ‘‘Access to Baby For5 mula Act of 2022’’. 


pamtmann on DSKBC07HB2PROD with BILLS
2 

•S 4257 IS

1 SEC. 2. INFANT FORMULA REQUIREMENTS. 

2 Section 17 of the Child Nutrition Act of 1966 (42 

3 U.S.C. 1786) is amended— 

4 (1) in subsection (b), by adding at the end the 

5 following: 

6 ‘‘(24) SUPPLY CHAIN DISRUPTION.—The term 

7 ‘supply chain disruption’ means a shortage of sup8 plemental foods that impedes the redemption of food 

9 instruments, as determined by the Secretary.’’; 

10 (2) in subsection (h)(8), by adding at the end 

11 the following: 

12 ‘‘(L) INFANT FORMULA COST CONTAIN13 MENT CONTRACT REQUIREMENTS.— 

14 ‘‘(i) IN GENERAL.—Not later than 

15 120 days after the date of enactment of 

16 this subparagraph, the Secretary shall 

17 issue an interim final rule to require that 

18 each infant formula cost containment con19 tract entered into between a State and an 

20 infant formula manufacturer on or after 

21 the effective date of the interim final rule 

22 includes remedies in the event of an infant 

23 formula recall, including how an infant for24 mula manufacturer will protect against dis25 ruption to program participants in the 

26 State. 


pamtmann on DSKBC07HB2PROD with BILLS
3 

•S 4257 IS

1 ‘‘(ii) REBATES.—In the case of an in2 fant formula recall, an infant formula 

3 manufacturer contracted to provide infant 

4 formula under this section shall comply 

5 with the contract requirements under 

6 clause (i). 

7 ‘‘(iii) REGULATIONS.—The Secretary 

8 shall promulgate regulations to carry out 

9 this subparagraph— 

10 ‘‘(I) pursuant to section 808(2) 

11 of title 5, United States Code; and 

12 ‘‘(II) that shall be carried out 

13 without regard to chapter 35 of title 

14 44, United States Code (commonly 

15 known as the ‘Paperwork Reduction 

16 Act’). 

17 ‘‘(M) MEMORANDUM OF UNDER18 STANDING.—Not later than 30 days after the 

19 date of enactment of this subparagraph, the 

20 Secretary shall ensure that there is a memo21 randum of understanding that establishes pro22 cedures to promote coordination and informa23 tion sharing between the Department of Agri24 culture and the Department of Health and 

25 Human Services regarding any supply chain 


pamtmann on DSKBC07HB2PROD with BILLS
4 

•S 4257 IS

1 disruption, including a supplemental food re2 call.’’; and 

3 (3) by adding at the end the following: 

4 ‘‘(r) EMERGENCIES AND DISASTERS.— 

5 ‘‘(1) DEFINITIONS.—In this subsection: 

6 ‘‘(A) EMERGENCY PERIOD.—The term 

7 ‘emergency period’ means a period during which 

8 there is— 

9 ‘‘(i) a public health emergency de10 clared by the Secretary of Health and 

11 Human Services under section 319 of the 

12 Public Health Service Act (42 U.S.C. 

13 247d); 

14 ‘‘(ii) a renewal of a public health 

15 emergency described in clause (i) pursuant 

16 to section 319 of that Act (42 U.S.C. 

17 247d); 

18 ‘‘(iii) a major disaster declared by the 

19 President under section 401 of the Robert 

20 T. Stafford Disaster Relief and Emergency 

21 Assistance Act (42 U.S.C. 5170); or 

22 ‘‘(iv) an emergency declared by the 

23 President under section 501 of the Robert 

24 T. Stafford Disaster Relief and Emergency 

25 Assistance Act (42 U.S.C. 5191). 


pamtmann on DSKBC07HB2PROD with BILLS
5 

•S 4257 IS

1 ‘‘(B) QUALIFIED ADMINISTRATIVE RE2 QUIREMENT.—The term ‘qualified administra3 tive requirement’ means— 

4 ‘‘(i) a requirement under this section; 

5 and 

6 ‘‘(ii) any regulatory requirement pro7 mulgated pursuant to this section. 

8 ‘‘(2) MODIFICATION OR WAIVER OF REQUIRE9 MENTS.—Notwithstanding any other provision of 

10 law, during an emergency period, the Secretary may 

11 modify or waive any qualified administrative require12 ment for a State agency if— 

13 ‘‘(A) the qualified administrative require14 ment cannot be met by the State agency during 

15 any portion of the emergency period due to the 

16 conditions that prompted the emergency period; 

17 and 

18 ‘‘(B) the modification or waiver of the 

19 qualified administrative requirement— 

20 ‘‘(i) is necessary to provide assistance 

21 to participants of the program established 

22 by this section; and 

23 ‘‘(ii) does not substantially weaken the 

24 nutritional quality of supplemental foods 

25 provided under the program. 


pamtmann on DSKBC07HB2PROD with BILLS
6 

•S 4257 IS

1 ‘‘(3) DURATION.—A modification or waiver 

2 under paragraph (2) shall be in effect for a period 

3 determined by the Secretary, but not later than 60 

4 days after the end of the applicable emergency pe5 riod. 

6 ‘‘(s) PRODUCT RECALLS AND SUPPLY CHAIN DIS7 RUPTIONS.— 

8 ‘‘(1) DEFINITION OF QUALIFIED ADMINISTRA9 TIVE REQUIREMENT.—In this subsection, the term 

10 ‘qualified administrative requirement’ has the mean11 ing given the term in subsection (r)(1). 

12 ‘‘(2) MODIFICATION OR WAIVER OF REQUIRE13 MENTS.—Notwithstanding any other provision of 

14 law, in order to address a supplemental food product 

15 recall or supply chain disruption, the Secretary may 

16 modify or waive a qualified administrative require17 ment to allow 1 or more State agencies— 

18 ‘‘(A) to permit vendors authorized to par19 ticipate in the program under this section to ex20 change or substitute authorized supplemental 

21 foods obtained with food instruments with food 

22 items that are not identical (including in brand 

23 and size); 

24 ‘‘(B) to modify or waive any requirement 

25 with respect to medical documentation for the 


pamtmann on DSKBC07HB2PROD with BILLS
7 

•S 4257 IS

1 issuance of noncontract brand infant formula, 

2 except the requirements for participants receiv3 ing Food Package III (as defined in section 

4 246.10(e)(3) of title 7, Code of Federal Regula5 tions (as in effect on the date of enactment of 

6 this subsection)); 

7 ‘‘(C) to modify or waive the maximum 

8 monthly allowance for infant formula; 

9 ‘‘(D) to modify or waive any additional re10 quirement with respect to supplemental food 

11 products provided under the program under 

12 this section if the modification or waiver— 

13 ‘‘(i) may facilitate increased access to 

14 those products; 

15 ‘‘(ii) does not substantially weaken the 

16 nutritional quality of those products; and 

17 ‘‘(iii) is in accordance with any appli18 cable guidance or directive from the Ad19 ministrator of Food and Drugs determined 

20 to be applicable by the Secretary. 

21 ‘‘(3) DURATION.—A modification or waiver 

22 under paragraph (2)— 

23 ‘‘(A) may be— 


pamtmann on DSKBC07HB2PROD with BILLS
8 

•S 4257 IS

1 ‘‘(i) available for a period of not more 

2 than 45 days, to begin on a date deter3 mined by the Secretary; and 

4 ‘‘(ii) renewed, subject to the condition 

5 that the Secretary shall provide notice of 

6 the renewal not less than 15 days before 

7 the renewal shall take effect; and 

8 ‘‘(B) shall not be available after the date 

9 that is 60 days after the supplemental food 

10 product recall or supply chain disruption for 

11 which the modification or waiver is established 

12 ceases to exist.’’. 

Æ 


pamtmann on DSKBC07HB2PROD with BILLS