[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7933 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 7933
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety
and supply of infant formula, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 3, 2022
Ms. DeLauro (for herself, Mr. Bishop of Georgia, Ms. Barragan, Ms.
Pressley, Mr. San Nicolas, Mr. Larson of Connecticut, Mr. Thompson of
California, Ms. Wild, Ms. Norton, Mr. Nadler, Mr. Lawson of Florida,
Mr. Sarbanes, Mrs. Bustos, Ms. Tlaib, Mrs. Napolitano, Ms. Wilson of
Florida, Mr. Cooper, Mr. Blumenauer, Mr. Carbajal, Mr. Evans, Mrs.
Trahan, Mr. Pocan, Mr. Trone, Mr. Torres of New York, Mr. Cicilline,
Mr. Danny K. Davis of Illinois, Ms. Speier, Ms. Underwood, Mr.
DeSaulnier, Mrs. Carolyn B. Maloney of New York, Mr. Carson, Mrs.
Hayes, Ms. Pingree, Ms. Bonamici, Mr. Levin of California, Mr.
Courtney, Ms. Meng, Mr. Perlmutter, Ms. Chu, Mr. Bowman, Ms. Titus, Ms.
Dean, Ms. Schakowsky, Ms. Bass, Ms. Lee of California, Mrs. Demings,
Mr. Krishnamoorthi, Mr. Raskin, Ms. Schrier, Mr. Pappas, Ms. Blunt
Rochester, Mr. Kilmer, Mr. Casten, Ms. Ross, Ms. Stevens, Mrs.
Lawrence, Ms. Spanberger, Mr. Cohen, Mr. Panetta, Ms. Porter, Mrs.
Watson Coleman, Mr. Michael F. Doyle of Pennsylvania, Mr. Connolly, Ms.
Castor of Florida, Mr. Himes, Ms. McCollum, Mr. Crow, Mr. Gallego, Mr.
Swalwell, Ms. Scanlon, Mr. Welch, Ms. Clark of Massachusetts, Ms.
Roybal-Allard, Mr. Soto, Mr. Case, Mr. Cardenas, Ms. Jackson Lee, Ms.
Kuster, Mr. Langevin, and Ms. Lois Frankel of Florida) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committees on Financial Services,
Education and Labor, and Agriculture, for a period to be subsequently
determined by the Speaker, in each case for consideration of such
provisions as fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to improve the safety
and supply of infant formula, 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 ``Keep Infant Formula Safe and On the
Shelves Act of 2022''.
SEC. 2. PRODUCT SAFETY.
(a) Inspections and Audits.--Section 412 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 350a) is amended by adding at the end the
following:
``(j) Inspections and Audits.--
``(1) In general.--Not less than every 6 months, the
Secretary shall inspect the facilities of each manufacturer of
infant formula registered under subsection (c).
``(2) Unannounced inspections.--Not later than 6 months
after the date of enactment of the Keep Infant Formula Safe and
On the Shelves Act of 2022, and not less than once per calendar
year thereafter, the Secretary shall conduct unannounced
inspections of the facilities of each manufacturer of infant
formula registered under subsection (c), including such
facilities with no history of notable regulatory findings.
``(3) Automatic comprehensive food safety audit.--If the
Secretary makes a notable regulatory finding at any facility of
a manufacturer of infant formula during an inspection or audit,
the Secretary shall require such facility to undergo a
comprehensive food safety audit that includes--
``(A) a root cause analysis;
``(B) enhanced testing; and
``(C) comprehensive environmental samples
throughout the facility.
``(4) Audits.--The Secretary shall increase the frequency
of comprehensive food safety audits of a facility of a
manufacturer of infant formula registered under subsection (c)
if there are persistent notable regulatory findings at such
facility.
``(5) Microbial test results.--
``(A) In general.--During any inspection or audit
by the Secretary of a facility of a manufacturer of
infant formula, the manufacturer shall provide to the
Secretary the results of all microbial tests conducted
by or for the facility during the period of 15 years
preceding the date of the inspection or audit.
``(B) Fines.--If the Secretary finds that a
facility is in violation of subparagraph (A), such
violation shall be treated as an infraction for
purposes of imposing a fine in accordance with title
18, United States Code.''.
(b) Cronobacter Sakazakii.--The Secretary of Health and Human
Services, acting through the Director of the Centers for Disease
Control and Prevention, and in consultation with the Council of State
and Territorial Epidemiologists, shall consider adding cronobacter
sakazakii to the list of nationally notifiable diseases and conditions
under the National Notifiable Diseases Surveillance System.
SEC. 3. SUPPLY.
(a) Strategic National Stockpile.--Not later than 90 days after the
date of enactment of this Act, the Secretary of Agriculture, in
consultation with the Assistant Secretary for Preparedness and Response
of the Department of Health and Human Services and the Administrator of
the Federal Emergency Management Agency, shall--
(1) perform an assessment of--
(A) short- and long-term storage of infant formula,
including the possibility of storage of infant formula
in a Federal stockpile; and
(B) models for distribution of infant formula
during shortages; and
(2) submit a report to the Congress on the results of such
assessment.
(b) Notification by Manufacturers of Circumstances That Could Lead
to a Shortage of Infant Formula or Essential Medical Food.--
(1) Requirement.--Chapter IV of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding the
following at the end:
``SEC. 424. NOTICE OF CIRCUMSTANCES THAT COULD LEAD TO A SHORTAGE.
``(a) Notice Requirement.--Not later than 5 business days after a
manufacturer of infant formula or essential medical food becomes aware
of circumstances that could lead to a shortage of infant formula or
essential medical food in the United States, such manufacturer shall
give written notice of such circumstances to the Secretary.
``(b) Definition.--In this section, the term `essential medical
food' means a food that--
``(1) is formulated to be consumed or administered
enterally under the supervision of a physician;
``(2) is intended for the specific dietary management of a
disease or condition for which distinctive nutritional
requirements, based on recognized scientific principles, are
established by medical evaluation; and
``(3) is identified by the Secretary as being essential for
any urgent medical condition.
``(c) Fines.--If the Secretary finds that a manufacturer of infant
formula or essential medical food is in violation of the requirement of
this section to give written notice, such violation shall be treated as
an infraction for purposes of imposing a fine in accordance with title
18, United States Code.''.
(c) List of Facilities That Could Be Converted To Manufacture
Infant Formula.--Section 412 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 350a), as amended by section 2(a), is further amended by
adding at the end the following:
``(k) List of Facilities That Could Be Converted.--The Secretary
shall--
``(1) not later than 90 days after the date of enactment of
this subsection, identify and compile a list of all
manufacturing facilities in the United States that could be
converted to manufacture infant formula in the event of a
shortage;
``(2) on an annual basis, update such list; and
``(3) post such up-to-date list on the public website of
the Food and Drug Administration.''.
(d) Reporting by Manufacturers During a Shortage.--Section 412 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as amended
by subsection (c), is further amended by adding at the end the
following:
``(l) Reporting by Manufacturers During a Shortage.--In the event
of a shortage of infant formula in the United States, the Secretary may
require manufacturers of infant formula to report to the Secretary--
``(1) the quantity of infant formula in the inventories of
such manufacturers and their distributors;
``(2) the location of recent or upcoming shipments of
infant formula by such manufacturers and their distributors;
``(3) the capacity of such manufacturers and their
distributors to redistribute their inventories of infant
formula based on geographical needs; and
``(4) the quantity by which such manufacturers could
increase their output of infant formula.''.
SEC. 4. USE OF AUTHORITIES UNDER THE DEFENSE PRODUCTION ACT OF 1950 FOR
FOOD.
Section 101 of the Defense Production Act of 1950 (50 U.S.C. 4511)
is amended by adding at the end the following:
``(e) Treatment of Food.--For purposes of this title, title III,
and title VII, food (including infant formula and the ingredients
necessary to produce infant formula) is a critical material essential
to the national defense.''.
SEC. 5. ENSURING WORKER SAFETY AND HEALTH.
The Assistant Secretary of Labor for Occupational Safety and
Health shall issue a fact sheet and provide technical assistance to
each manufacturer of infant formula registered under section 412(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(c)) to promote
compliance with occupational safety and health standards promulgated
under section 6 of the Occupational Safety and Health Act of 1970. Such
fact sheet and technical assistance shall include information on
recognized hazards and on the specific occupational safety and health
standards, and any other legal requirements under the Occupational
Safety and Health Act of 1970, that apply to such manufacturer.
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