Keep Infant Formula Safe and On the Shelves Act of 2022

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety and supply of infant formula, and for other purposes. 1. Short title This Act may be cited as the Keep Infant Formula Safe and On the Shelves Act of 2022 2. Product safety (a) Inspections and audits Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a (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 (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. 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. 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 (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 (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 (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. . 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 (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. . 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)

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.