[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4262 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  2d Session
                                S. 4262

To temporarily allow the importation of infant formula free of duty and 
        free of quantitative limitation, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                 May 19 (legislative day, May 17), 2022

    Mr. Lee introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To temporarily allow the importation of infant formula free of duty and 
        free of quantitative limitation, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Formula Act of 2022''.

SEC. 2. INCREASING THE SUPPLY OF INFANT FORMULA.

    (a) In General.--During the 180 day period beginning on the date of 
the enactment of this Act, infant formula classified under heading 
1901.10 of the Harmonized Tariff Schedule of the United States shall 
enter the United States free of duty and free of quantitative 
limitation, if such formula--
            (1) is imported from a country on the list published by the 
        Secretary of Health and Human Services under subsection (c)(1) 
        or a member country of the European Union; and
            (2) is lawfully marketed in the country of origin.
    (b) Guidance.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this subsection and in subsection (c) as the 
        ``Secretary'') shall, not later than 7 days after the date of 
        enactment of this Act, issue, and periodically update, as 
        appropriate, guidance for domestic and foreign manufacturers of 
        infant formula in order to increase availability of such 
        formula in the United States that is safe and nutritionally 
        adequate.
            (2) Elements of the guidance.--The guidance under paragraph 
        (1) shall address the following:
                    (A) Information to be submitted to the Secretary by 
                foreign and domestic manufacturers of infant formula 
                for consideration with regard to the introduction into 
                interstate commerce (including importation) of infant 
                formula that is safe and nutritionally adequate but 
                that may not comply with all applicable statutory and 
                regulatory requirements. Such information shall 
                include--
                            (i) safety and nutritional adequacy of the 
                        infant formula;
                            (ii) product identification information;
                            (iii) the quantity of the infant formula 
                        intended for introduction into interstate 
                        commerce;
                            (iv) a copy of the label for the infant 
                        formula (with information on any allergens 
                        present on the product label and adequate 
                        instructions for safe product preparation and 
                        use) and description of the packaging of the 
                        infant formula; and
                            (v) manufacturing information, including 
                        test results, and facility compliance and 
                        inspection history.
                    (B) Information for manufacturers planning to 
                increase domestic production of infant formula for 
                purposes of addressing the ongoing shortage.
            (3) Priority.--The guidance under paragraph (1) shall 
        provide for priority consideration for manufacturers that are 
        able to produce large volumes of such infant formula quickly.
    (c) Importation From Countries Meeting Certain Standards.--
            (1) In general.--Not later than 7 days after the date of 
        enactment of this Act, the Secretary shall publish a list of 
        countries the Secretary determines to have manufacturing and 
        safety standards for infant formula that are similar, 
        equivalent, or otherwise suitable, as compared to United States 
        standards.
            (2) Personal and commercial importation.--Beginning on the 
        date on which the list of countries is published under 
        paragraph (1), for a period not to exceed 180 days, the 
        Secretary shall allow personal and commercial importation of 
        infant formula from any country on such list, as well as from 
        any member country of the European Union, without regard to the 
        guidance under subsection (b)(2) and the requirements of 
        section 412 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 350a), section 415 of such Act (21 U.S.C. 350d), and 
        parts 106 and 107 of title 21, Code of Federal Regulations.
    (d) Definition.--In this section, the term ``infant formula'' has 
the meaning given such term in section 201(z) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321(z)).

SEC. 3. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND 
              CHILDREN.

    (a) Access for WIC Beneficiaries.--Notwithstanding any other 
provision of law, any infant formula (as defined in section 2(d)) 
imported into the United States pursuant to section 2(c)(2) is eligible 
for purchase using benefits received under the special supplemental 
nutrition program for women, infants, and children established by 
section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786).
    (b) Product Recalls and Supply Chain Disruptions.--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.''; and
            (2) by adding at the end the following:
    ``(r) Product Recalls and Supply Chain Disruptions.--
            ``(1) Definition of qualified administrative requirement.--
        In this subsection, the term `qualified administrative 
        requirement' means--
                    ``(A) a requirement under this section; and
                    ``(B) any regulatory requirement promulgated 
                pursuant to this section.
            ``(2) Modification or waiver of requirements.--
        Notwithstanding any other provision of law, the Secretary shall 
        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) shall be available for a period of not more 
                than 180 days beginning on the date of enactment of 
                this subsection; and
                    ``(B) may be 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.''.
                                 <all>