H.R. 8964

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8964 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 8964

To improve the safety of pasteurized donor human milk and enhance 
regulation.

_______________________________________________________________________

IN THE HOUSE OF REPRESENTATIVES

May 21, 2026

Ms. DeLauro (for herself, Mrs. Trahan, Mr. Van Drew, Mr. Pappas, Ms. 
Dean of Pennsylvania, and Mr. McGarvey) introduced the following bill; 
which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

A BILL

To improve the safety of pasteurized donor human milk and enhance 
regulation.

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 ``Developing Oversight for Nutrition 
through the Official Regulation of Milk Act'' or the ``DONOR Milk 
Act''.

SEC. 2. REGULATION OF PASTEURIZED DONOR HUMAN MILK.

(a) Definitions.--Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended--
(1) in subsection (ss)--
(A) in paragraph (1), by striking ``or'' at the 
end;
(B) in paragraph (2), by striking the period at the 
end and inserting ``; or''; and
(C) by adding at the end the following:
``(3) pasteurized donor human milk.''; and
(2) by adding at the end the following:
``(tt) The term `pasteurized donor human milk' means human milk 
which--
``(1) is expressed by a mother and donated for use by a 
recipient that is not the mother's own infant; and
``(2) has been collected, pasteurized, and dispensed 
without additives.''.
(b) Clarification of Food Manufacturer Registration Requirement.--
Section 415(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350d(c)(1)) is amended by adding at the end the following: 
``Beginning on the date of the enactment of the DONOR Milk Act, a food 
establishment that manufactures, processes, packs, or holds critical 
foods shall not be considered a nonprofit food establishments in which 
food is prepared for or served directly to the consumer and the 
exception in the preceding sentence shall no longer apply to such a 
facility''.
(c) Annual Inspections of Donor Human Milk Manufacturers.--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) Annual Inspections of Donor Human Milk Manufacturers.--
Beginning not later than 1 year after the date of the enactment of this 
subsection, and not less frequently than once each year thereafter, the 
Secretary shall conduct inspections, including unannounced inspections, 
of the facilities of each entity that manufactures, processes, packs, 
or holds pasteurized donor human milk in accordance with a risk-based 
approach to ensure compliance with relevant food safety and food 
labeling requirements under this Act or any other provision of law 
administered by the Secretary.''.
(d) Compliance Grants for Donor Human Milk Manufacturers.--Section 
412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a), as 
amended by subsection (c) of this section, is further amended by adding 
at the end the following:
``(o) Compliance Grants for Donor Human Milk Manufacturers.--
``(1) In general.--The Secretary shall make grants to 
nonprofit entities that manufacture, process, pack, or hold 
pasteurized donor human milk and are registered under section 
415(c) to assist such entities in complying with this Act, 
including through assisting such entities with respect to 
making any upgrades in equipment, obtaining necessary 
certifications, and entering into contracts with third parties 
for food safety quality consultations.
``(2) Authorization of appropriations.--There are 
authorized to be appropriated $8,000,000, to remain available 
until expended, to carry out paragraph (1).''.
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