H.R. 7867

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7867 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 7867

To amend the Federal Food, Drug, and Cosmetic Act to establish 
standardized pathogen and microorganism testing of infant formula 
products and manufacturing facilities, to mandate notification of 
specific positive tests and inspection classifications, and for other 
purposes.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

March 9, 2026

Ms. DeLauro (for herself, Mrs. Grijalva, Mr. Panetta, Ms. Jacobs, Ms. 
Norton, Ms. Wilson of Florida, Mr. Bishop, Ms. Williams of Georgia, Mr. 
Pappas, Mr. Quigley, Mr. Krishnamoorthi, Ms. Schakowsky, Ms. Tlaib, Mr. 
Thanedar, Ms. Ross, Mr. Van Drew, Ms. Dean of Pennsylvania, and Mr. 
Cohen) introduced the following bill; which was referred to the 
Committee on Energy and Commerce

_______________________________________________________________________

A BILL

To amend the Federal Food, Drug, and Cosmetic Act to establish 
standardized pathogen and microorganism testing of infant formula 
products and manufacturing facilities, to mandate notification of 
specific positive tests and inspection classifications, 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 ``Infant Formula Safety Modernization 
Act of 2026''.

SEC. 2. MEASURES TO ENHANCE THE SAFETY OF INFANT FORMULA.

(a) Good Manufacturing Practices.--
(1) In general.--Section 412(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350a(b)) is amended by adding at 
the end the following:
``(5)(A) The Secretary shall by regulation update the good 
manufacturing practices for infant formulas established under this 
subsection to require the manufacturer of an infant formula to conduct 
pathogen and microorganism testing of--
``(i) the infant formula manufacturing facilities of the 
manufacturer; and
``(ii) in addition to other applicable testing requirements 
under this Act, the finished infant formula product of the 
manufacturer.
``(B) The regulations issued under subparagraph (A) shall--
``(i) require the Commissioner of Food and Drugs to develop 
a list of pathogens and microorganisms that infant formula 
manufacturers must test for in infant formula manufacturing 
facilities and finished infant formula products, which list 
shall include clostridium botulinum and such other pathogens 
and microorganisms as the Secretary designates;
``(ii) specify the recommended frequency of environmental 
testing, including requirements for testing in Zones 2 and 3 of 
an infant formula manufacturing facility;
``(iii) require the manufacturer of an infant formula to 
submit to the Secretary a written notification of any positive 
test result for a pathogen or microorganism referred to in 
clause (i) in infant formula, not later than one business day 
following the date of the result, even if the formula has not 
left the control of the manufacturer;
``(iv) for the purposes of inspections conducted under this 
Act, require the manufacturer of an infant formula to retain 
records of any positive test result for a pathogen or 
microorganism referred to in clause (i)--
``(I) in infant formula; or
``(II) in the infant formula manufacturing facility 
of the manufacturer; and
``(v) require Commissioner of Food and Drugs to establish 
and enforce clear, consistent inspection and compliance 
standards for all infant formula products, regardless of their 
country of origin.
``(C) In this paragraph:
``(i) The term `Zone 2', with respect to an infant formula 
manufacturing facility, means areas directly adjacent to 
locations where infant formula could be exposed during 
manufacturing, but that are not food-contact surfaces.
``(ii) The term `Zone 3', with respect to an infant formula 
manufacturing facility, means areas further away from direct 
infant formula exposure than Zone 2, yet still within the 
processing environment; contamination in Zone 3 could reach 
Zone 2 (and thus the infant formula) through movement of 
people, equipment, or airflow.''.
(2) Deadline.--Not later than 90 days after the date of 
enactment of this Act, the Secretary shall issue final 
regulations under section 412(b)(5)(A) of the Federal Food, 
Drug, and Cosmetic Act (as added by paragraph (1) of this 
subsection).
(b) Congressional Notification Requirements.--Section 412 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by 
adding at the end the following:
``(n) Congressional Notification Requirements.--(1) If the 
Secretary receives from a manufacturer a written notification of any 
test result that is a positive analytical result for a pathogen or 
microorganism in finished infant formula pursuant to subsection 
(b)(5)(B)(iii), the Secretary shall, not later than one business day 
following the date of such receipt, provide a written notice of such 
receipt to the appropriate committees of Congress.
``(2) If the Food and Drug Administration issues an `official 
action indicated' classification (or an equivalent classification) 
following an inspection of an infant formula manufacturing facility, 
the Secretary shall, not later than one business day following the date 
of such issuance, provide a written notice of such issuance to the 
appropriate committees of Congress.
``(3) In this subsection, the term `appropriate committees of 
Congress' means--
``(A) the Committee on Appropriations and the Committee on 
Energy and Commerce of the House of Representatives; and
``(B) the Committee on Appropriations and the Committee on 
Health, Education, Labor, and Pensions of the Senate.''.
(c) Conforming Amendment.--Section 412(b)(4)(A)(i) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b)(4)(A)(i)) is amended by 
striking ``paragraph (2)(B)'' and inserting ``paragraphs (2)(B) and 
(5)(A)''.
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