Keep Infant Formula Safe and On the Shelves Act of 2022
Bill: H.R.7933 | Sponsor: Rep. DeLauro, Rosa L. (D-CT)
Policy area: Health

Summary:
Keep Infant Formula Safe and On the Shelves Act of 2022
This bill requires the Food and Drug Administration (FDA) to periodically inspect infant formula manufacturing facilities and addresses related issues.
The FDA must periodically conduct inspections, including unannounced inspections, of infant formula manufacturer facilities. If the FDA makes a notable regulatory finding at such a facility, the manufacturer must undergo a comprehensive food safety audit that includes a root cause analysis, enhanced testing, and comprehensive environmental samples.
A manufacturer of infant formula or essential medical food must notify the FDA no later than five business days after becoming aware of circumstances that could lead to a shortage of the relevant product in the United States.
Further, the FDA must create and annually update a list of U.S. manufacturing facilities that could be converted to manufacture infant formula during a shortage. In the event of a shortage, the FDA may require infant formula manufacturers to provide certain information, such as the quantity of formula in a manufacturer's inventory.
The bill also establishes under statute that food, including infant formula, is a critical material essential to the national defense and therefore subject to authorities under the Defense Production Act of 1950. (Such authorities authorize the President to take various actions, such as requiring businesses to prioritize certain government contracts and incentivizing the domestic industrial base to expand the production of critical materials.)
The Occupational Safety and Health Administration must issue a fact sheet and provide technical assistance to infant formula manufacturers to promote compliance with occupational health and safety standards.

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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