[Congressional Record Volume 168, Number 133 (Saturday, August 6, 2022)]
[Senate]
[Page S4317]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 5334. Mr. LEE submitted an amendment intended to be proposed by 
him to the bill H.R. 5376, to provide for reconciliation pursuant to 
title II of S. Con. Res. 14; which was ordered to lie on the table; as 
follows:

       At the appropriate place, insert the following:

     SEC. __. TEMPORARY EXEMPTIONS FROM FDA INFANT FORMULA 
                   REQUIREMENTS.

       (a) In General.--With respect to any infant formula 
     described in subsection (e) and introduced or delivered for 
     introduction into interstate commerce during the 187-day 
     period beginning on the date of the enactment of this Act--
       (1) the requirements under section 412 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 350a) shall not apply;
       (2) such infant formula may be manufactured, processed, 
     packed, or held in a domestic or foreign facility that is not 
     registered under section 415 of such Act (21 U.S.C. 350d);
       (3) the requirements under parts 106 and 107 of title 21, 
     Code of Federal Regulations, shall not apply; and
       (4) 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.
       (b) Notification Requirement.--
       (1) In general.--A person who introduces or delivers for 
     introduction into interstate commerce an infant formula as 
     described in subsection (a) shall notify the Secretary of 
     Health and Human Services (referred to in this subsection as 
     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 manufacturer 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 described in subsection (e) and introduced or 
     delivered for introduction into interstate commerce 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) Clarification.--Section 801(j) of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 381(j)) shall apply with 
     respect to any infant formula introduced or delivered for 
     introduction into interstate commerce pursuant to this 
     section during the 187-day period beginning on the date of 
     the enactment of this Act.
       (e) Infant Formula Described.--Infant formula is described 
     in this subsection if the infant formula--
       (1) is classified under heading 1901.10 of the Harmonized 
     Tariff Schedule of the United States;
       (2) was approved by the agency of the government of that 
     country that regulates infant formula; and
       (3) is imported from--
       (A) Australia;
       (B) Israel;
       (C) Japan;
       (D) New Zealand;
       (E) Switzerland;
       (F) South Africa;
       (G) the United Kingdom;
       (H) a member country of the European Union; or
       (I) a member country of the European Economic Area.
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