[Congressional Record Volume 169, Number 51 (Tuesday, March 21, 2023)]
[Senate]
[Page S871]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 27. Mr. LEE submitted an amendment intended to be proposed by him 
to the bill S. 316, to repeal the authorizations for use of military 
force against Iraq; which was ordered to lie on the table; as follows:

       At the appropriate place, insert the following:

     SEC. __. EXEMPTIONS FROM FDA REQUIREMENTS WITH RESPECT TO 
                   INFANT FORMULA.

       (a) Waivers.--
       (1) In general.--In the case that an infant formula 
     shortage is established through a joint resolution, with 
     respect to any infant formula imported into the United States 
     during the 90-day period beginning on the date specified in 
     such joint resolution--
       (A) the requirements under section 412 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 350a) shall not apply;
       (B) such infant formula may be manufactured, processed, 
     packed, or held in a facility in a country described in 
     subsection (d) that is not registered under section 415 of 
     such Act (21 U.S.C. 350d);
       (C) the requirements under parts 106 and 107 of title 21, 
     Code of Federal Regulations, shall not apply; and
       (D) such infant formula shall not be considered to be 
     misbranded or adulterated solely on the basis of not being in 
     compliance with the requirements of such section 412 or 415, 
     or such part 106 or 107.
       (2) Renewal of waiver period.--A waiver of requirements 
     under paragraph (1) shall automatically renew for additional 
     90-day periods until such infant formula shortage is 
     terminated through a subsequent joint resolution.
       (b) Notification Requirement.--
       (1) In general.--A person who introduces or delivers for 
     introduction into interstate commerce an infant formula 
     pursuant to subsection (a) shall notify the Secretary if such 
     person has knowledge which reasonably supports the conclusion 
     that such infant formula--
       (A) may not provide the nutrients required by section 
     412(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     350a(i)); or
       (B) is a product that meets any criterion under section 
     402(a) of such Act (21 U.S.C. 342(a)), or which otherwise may 
     be unsafe for infant consumption.
       (2) Knowledge defined.--For purposes of paragraph (1), the 
     term ``knowledge'' as applied to a person subject to such 
     subparagraph means--
       (A) the actual knowledge that the person had; or
       (B) the knowledge which a reasonable person would have had 
     under like circumstances or which would have been obtained 
     upon the exercise of due care.
       (c) Recall Authority.--If the Secretary determines that 
     infant formula introduced or delivered for introduction into 
     interstate commerce pursuant to subsection (a) is a product 
     described in subsection (b)(1)(B), the manufacturer or 
     importer shall immediately take all actions necessary to 
     recall shipments of such infant formula from all wholesale 
     and retail establishments, consistent with recall regulations 
     and guidelines issued by the Secretary.
       (d) Countries Described.--A country described in this 
     subsection is any of the following:
       (1) Australia.
       (2) Israel.
       (3) Japan.
       (4) New Zealand.
       (5) Switzerland.
       (6) South Africa.
       (7) The United Kingdom.
       (8) A member country of the European Union.
       (9) A member country of the European Economic Area.
       (e) Definition.--In this section, the term ``infant 
     formula'' has the meaning given that term in section 201(z) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     321(z)).
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