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