[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>