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Code · BILL · 119th Congress · H.R. 2472 (Introduced in House) — To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of infant and toddler food, and for other purp... · Sec. 7

Sec. 7. Report final product positive test results for relevant pathogens in infant formula

262 words·~1 min read·/bill/119/hr/2472/ih/section-7

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Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ) is amended— in subsection (e)— in paragraph (1)— in the first sentence, by striking promptly and inserting , within 24 hours of acquiring such knowledge, ; and in the second sentence, by striking the infant formula and inserting an infant formula ; by redesignating paragraph
(2)as paragraph (4); in paragraph (4), as so redesignated, by striking paragraph
(1)and inserting paragraphs
(1)and
(2); and by inserting after paragraph
(1)the following: If the result of any in-process or finished product testing of an infant formula that has been processed by the manufacturer is confirmed as a positive analytical result for any environmental pathogen (as defined in section 117.3 of title 21, Code of Federal Regulations (or any successor regulation)), the manufacturer shall— within 24 hours of acquiring such confirmation, notify the Secretary of such confirmation regardless of whether such infant formula has left an establishment subject to the control of the manufacturer; consult with the Secretary for proper disposal and properly dispose of the affected product; and provide to the Secretary results and isolates from a positive sample of such infant formula. Not later than 90 days after receipt of a notification under paragraph
(1)or (2), the Secretary shall confirm through the collection of documentation that the manufacturer submitting the notification performed, or is performing, appropriate corrective action. The manufacturer shall make such documentation available to the Secretary during an inspection and, upon request of the Secretary, electronically or by other means. .
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Sec. 7
Report final product positive test results for relevant pathogens in infant formula
U.S.C.§ 350a
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