II 117th CONGRESS 2d Session S. 4257 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. Luján , 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. Short title This Act may be cited as the Access to Baby Formula Act of 2022 . 2. Infant formula requirements Section 17 of the Child Nutrition Act of 1966 ( 42 U.S.C. 1786 ) is amended— (1) in subsection (b), by adding at the end the following: (24) Supply chain disruption The term supply chain disruption means a shortage of supplemental foods that impedes the redemption of food instruments, as determined by the Secretary. ; (2) in subsection (h)(8), by adding at the end the following: (L) Infant formula cost containment contract requirements (i) In general Not later than 120 days after the date of enactment of this subparagraph, the Secretary shall issue an interim final rule to require that each infant formula cost containment contract entered into between a State and an infant formula manufacturer on or after the effective date of the interim final rule includes remedies in the event of an infant formula recall, including how an infant formula manufacturer will protect against disruption to program participants in the State. (ii) Rebates In the case of an infant formula recall, an infant formula manufacturer contracted to provide infant formula under this section shall comply with the contract requirements under clause (i). (iii) Regulations The Secretary shall promulgate regulations to carry out this subparagraph— (I) pursuant to section 808(2) of title 5, United States Code; and (II) that shall be carried out without regard to chapter 35 of title 44, United States Code (commonly known as the Paperwork Reduction Act ). (M) Memorandum of understanding Not later than 30 days after the date of enactment of this subparagraph, the Secretary shall ensure that there is a memorandum of understanding that establishes procedures to promote coordination and information sharing between the Department of Agriculture and the Department of Health and Human Services regarding any supply chain disruption, including a supplemental food recall. ; and (3) by adding at the end the following: (r) Emergencies and disasters (1) Definitions In this subsection: (A) Emergency period The term emergency period means a period during which there is— (i) a public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ); (ii) a renewal of a public health emergency described in clause (i) pursuant to section 319 of that Act ( 42 U.S.C. 247d ); (iii) a major disaster declared by the President under section 401 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act ( 42 U.S.C. 5170 ); or (iv) an emergency declared by the President under section 501 of the Robert T. Stafford Disaster Relief and Emergency Assistance Act ( 42 U.S.C. 5191 ). (B) Qualified administrative requirement The term qualified administrative requirement means— (i) a requirement under this section; and (ii) any regulatory requirement promulgated pursuant to this section. (2) Modification or waiver of requirements Notwithstanding any other provision of law, during an emergency period, the Secretary may modify or waive any qualified administrative requirement for a State agency if— (A) the qualified administrative requirement cannot be met by the State agency during any portion of the emergency period due to the conditions that prompted the emergency period; and (B) the modification or waiver of the qualified administrative requirement— (i) is necessary to provide assistance to participants of the program established by this section; and (ii) does not substantially weaken the nutritional quality of supplemental foods provided under the program. (3) Duration A modification or waiver under paragraph (2) shall be in effect for a period determined by the Secretary, but not later than 60 days after the end of the applicable emergency period. (s) Product recalls and supply chain disruptions (1) Definition of qualified administrative requirement In this subsection, the term qualified administrative requirement has the meaning given the term in subsection (r)(1). (2) Modification or waiver of requirements Notwithstanding any other provision of law, in order to address a supplemental food product recall or supply chain disruption, the Secretary may modify or waive a qualified administrative requirement to allow 1 or more State agencies— (A) to permit vendors authorized to participate in the program under this section to exchange or substitute authorized supplemental foods obtained with food instruments with food items that are not identical (including in brand and size); (B) to modify or waive any requirement with respect to medical documentation for the issuance of noncontract brand infant formula, except the requirements for participants receiving Food Package III (as defined in section 246.10(e)(3) of title 7, Code of Federal Regulations (as in effect on the date of enactment of this subsection)); (C) to modify or waive the maximum monthly allowance for infant formula; (D) to modify or waive any additional requirement with respect to supplemental food products provided under the program under this section if the modification or waiver— (i) may facilitate increased access to those products; (ii) does not substantially weaken the nutritional quality of those products; and (iii) is in accordance with any applicable guidance or directive from the Administrator of Food and Drugs determined to be applicable by the Secretary. (3) Duration A modification or waiver under paragraph (2)— (A) may be— (i) available for a period of not more than 45 days, to begin on a date determined by the Secretary; and (ii) renewed, subject to the condition that the Secretary shall provide notice of the renewal not less than 15 days before the renewal shall take effect; and (B) shall not be available after the date that is 60 days after the supplemental food product recall or supply chain disruption for which the modification or waiver is established ceases to exist. .